Biosecurity and Dual Use Research

Report on Biosecurity and Dual Use

Research

A Report for the Dutch Research Council

Project Leader: Professor Seumas Miller

Postdoctoral Fellow: Dr. Michael J. Selgelid

Postdoctoral Fellow: Dr. Koos van der Bruggen

January 2011

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ABOUT THIS REPORT

This report was prepared on behalf of the Dutch Research Council research project

Biosecurity and Dual Use Research. The research was conducted by the 3TU Centre for

Ethics and Technology (CET) as well as the Centre for Security, Safety and Justice (CSSJ) in

The Hague. CET is a Joint research centre of the three technical universities in the

Netherlands conducting multidisciplinary research on ethics and technology.

CSSJ is a cooperative enterprise between Leiden University and Delft University of

Technology, and one engaged in the study of security issues from a multidisciplinary

perspective (technical and social sciences as well as humanities).

The researchers thank the members of a valorization panel. This panel met twice. From their

professional experience the members of the panel gave valuable comments and suggestions.

Members of the panel were:

Ruud Busker, TNO (organisation for technology and research)

Frans Delemarre, Crucell (biopharmaceutical company)

Bob Ent, Ministry of Economic Affairs, Agriculture and Innovation

Sven Hamelink, Ministry of Security & Justice

Peter Huijsmans, Ministry of Defense

Margot Llompart, Ministry of Education, Culture and Science

Ineke Malsch . Malsch Techno Evaluation (Consultancy)

Ron Massink, Delft University of Technology

Sico van der Meer, Netherlands Institute for International Relations Clingendael

Lous van Vloten-Doting, former Biosecurity Working Group Royal Netherlands

Academy of Arts and Sciences

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The report is in two parts:

Part A: Possibilities or Intentions: The Concept of Dual-Use Reconsidered

Part A is authored by Dr. Koos van der Bruggen. Dr. van der Bruggen is a postdoctoral

fellow as part of the research team, employed by Delft University of Technology/University

Leiden/Campus The Hague CSSJ. The authorship of and views presented in Part A are

exclusively those of Dr. van der Bruggen.

Part B: The Ethics and Regulation of Dual-Use in the Biological Sciences

Part B is co-authored by Professor Seumas Miller and Dr. Michael J. Selgelid. Professor

Miller is the project leader, employed by Delft University of Technology. Dr. Selgelid is a

postdoctoral fellow as part of the research team, employed by Delft University of

Technology. The authorship and views presented in Part B are exclusively those of Professor

Miller and Dr. Selgelid.

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Contents

About This Report ...................................................................................................................... 1

Contents ...................................................................................................................................... 3

Part A Possibilities or Intentions: The Concept of Dual Use Reconsidered .............................. 7

A:1 Introduction ..................................................................................................................... 7

A:2 A Short History of the Dual Use Concept ....................................................................... 8

A:3 Life Sciences, Biological Weapons and Dual Use ........................................................ 11

A:3.1 Synthetic Biology and Dual Use ............................................................................ 13

A:3.2 Biodefense and Dual Use ....................................................................................... 16

A:3.2.1 What are the risks of biodefense research? ..................................................... 17

A:3.2.2 How useful/necessary is biodefense research? ................................................ 18

A:4 Dual Use Reconsidered: Consequences or Intentions? ................................................. 18

A:5 Securitization of Life Sciences And of Public Health. .................................................. 22

A:6 Weighing the Arguments .............................................................................................. 26

A:7 Dual Use Policy in the Life Sciences Reconsidered: Some Preliminary Conclusions . 31

A:7.1 Definition ............................................................................................................... 32

Part B The Ethics and Regulation of Dual Use in the Biological Sciences ............................. 34

B:1 Introduction ................................................................................................................... 34

B:2 Universities .................................................................................................................... 40

B:2.1 Academic Freedom ................................................................................................. 44

B:2.2 Progress in Science ................................................................................................. 47

B:2.3 Policy Development ............................................................................................... 49

B:3 Private Firms ................................................................................................................. 53

B:3.1 Levels (and Modes) of Intervention ....................................................................... 54

B3:2 Purposes/Aims of Interventions (Harms and Benefits) ........................................... 57

B:3.2.1 Biotechnology .................................................................................................. 57

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B:3.3 Objects (and Modes) of Intervention ...................................................................... 59

B:3.4 Modes of Intervention ............................................................................................ 62

B:3.4.1 Export Controls ............................................................................................... 62

B:3.4.2 Education and Training ................................................................................... 64

B:3.4.3 Countermeasures ............................................................................................. 65

B:3.4.4 Summary of Policy Options ............................................................................ 65

B:4 Ethics, Regulation and Government .............................................................................. 68

B:4.1 Impermissible Research .......................................................................................... 68

B:4.1.1 Biological Weapons Convention ..................................................................... 69

B:4.2 Codes of Conduct ................................................................................................... 70

B:4.3 Mandatory Physical Safety and Security Regulation ............................................. 71

B:4.4 Control via Licensing/Screening etc. of Dual-Use Technologies/Techniques ....... 72

B:4.5 Mandatory Education and Training ........................................................................ 74

B:4.6 Mandatory Personnel Security Regulation ............................................................. 74

B:4.7 Censorship/Constraint of Dissemination ................................................................ 75

B:4.8 Professionalisation .................................................................................................. 76

B:4.9 An Independent Authority ...................................................................................... 77

B:5 Recommendations for Consideration ............................................................................ 84

Appendix Key Laws, Regulations and Codes .......................................................................... 86

Global/International ............................................................................................................. 86

Protocol for the Prohibition of the use in war of Asphyxiating Poisonous or Other

Gases, and of Bacteriological Methods of Warfare (1925) .......................................... 86

Biological and Toxin Weapons Convention (BTWC) ................................................. 87

Guidelines For Transfers of Sensitive Chemical or Biological Items (Australia Group)

...................................................................................................................................... 88

Biorisk Management.Laboratory Biosecurity Guidance. (WHO) .............................. 89

Best Practice Guidelines on Biosecurity for BRCS. (OECD) ..................................... 89

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Resolution 1540 (UNSC) ............................................................................................. 90

Declaration of Science and the Use of Scientific Knowledge (UNESCO) .................. 93

European Union .................................................................................................................... 93

Green Paper on Bio-preparedness (2007) ........................................................................ 93

EU CBRN Action Plan (2009) ......................................................................................... 94

National Initiatives ............................................................................................................... 94

Netherlands ....................................................................................................................... 94

List of Strategic Goods ................................................................................................. 94

Code of Conduct for Biosecurity (2007) ...................................................................... 95

The Netherlands Code of Conduct for Scientific Practice ........................................... 96

United Kingdom ............................................................................................................... 96

Anti-terrorism, Crime and Security Act 2001 .............................................................. 96

British Medical Association (BMA). Biotechnology, weapons and humanity (1999). 96

The Royal Society. The Roles of Codes of Conduct in Preventing the Misuse of

Scientific Research ....................................................................................................... 97

United States .................................................................................................................... 98

List of Select Agents and Toxins (HHS AND USDA) ................................................ 98

Publis Health Security and Bioterrorism Preparedness and Response Act of 2002Ve 98

H.R. 5498, The WMD Prevention and Preparedness Act of 2010............................... 98

Proposed Framework for the Oversight of Dual Use Life Sciences Research:

Strategies for Minimizing the Potential Misuse of Research Information. (NSABB) . 99

Strategic Plan for Outreach and Education On Dual Use Research Issues (NSABB)100

Australia ......................................................................................................................... 100

Weapons of Mass Destruction (Prevention of Proliferation) Act 1995 ..................... 100

Crimes (Biological Weapons) Act 1976 .................................................................... 100

Non Governmental organisations ....................................................................................... 101

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International Committee of the Red Cross (ICRC): Biotechnology, Weapons and

Humanity: ICRC Outreach to the Life Science Community on Preventing Hostile Use

of the Life Sciences .................................................................................................... 101

International Academic Panel (IAP): IAP Statement on Biosecurity ........................ 101

The World Medical Association (WMA): The World Medical Association

Declaration of Washington on Biological Weapons. ................................................. 103

International Council for Science (ICSU): Freedom, Responsibility and Universality

of Science ................................................................................................................... 103

International Union of Microbiological Societies (IUMS): IUMS Code of Ethics

against Misuse of Scientific Knowledge, Research and Resources ........................... 105

Wellcome Trust: Wellcome Trust Position Statement on Bioterrorism and Biomedical

Research ..................................................................................................................... 105

American Medical Association:Guidelines to Prevent Malevolent Use of Biomedical

Research ..................................................................................................................... 107

Europabio: Europabio´s core ethical values ............................................................... 108

Other Initiatives .................................................................................................................. 108

Steinbruner et. Al., A Prototype Protective Oversight System .................................. 108

Global Compact for Infectious Diseases ................................................................... 109

References .............................................................................................................................. 111

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PART A

POSSIBILITIES OR INTENTIONS: THE CONCEPT OF DUAL USE

RECONSIDERED1

KOOS VAN DER BRUGGEN

A:1 INTRODUCTION

This paper has been written in the context of the research project Biosecurity and Dual use

research. The central question of this project is: What is – from a moral point of view – a

realizable and acceptable policy for dealing with dual use issues?

The answer to this question depends on the answers to two series of sub-questions. Directly

related to the regulatory policy are questions as: Is a decision on dual use to be made by the

scientific community or by politicians? Are some research projects morally impermissible?

Should the results of some research projects be censored, e.g. how to enhance the

transmissibility of a dangerous pathogen? The presumption is against restricting scientific

freedom, but can there be exceptions and, if so, on what grounds? What are the implications

for a project and for researchers if research qualifies as dual use? How could or should

researchers and policy makers cope with this dual use character? What oversight measures are

desirable and feasible? What awareness raising programs ought to be established? Answering

these questions will lead to a proposal for a regulatory framework, which will present

applicable and acceptable measures.

But before answering these questions it is necessary to know what we are talking about if we

are talking about dual use. This paper will concentrate on the issue of dual use in order to

develop an acceptable, adequate and applicable definition of the dual use concept for

researchers, universities, companies and policy makers. It is relevant that a definition of dual

use is shared by all involved parties. A clarification of the dual use concept and its scope of

application would greatly facilitate the work of policymakers seeking to ensure security while

avoiding undesirable interventions of government in the conduct of science. It is important to

have a clear view of the scope of dual use issues and one that builds upon, but goes beyond,

1 Van der Bruggen is the sole author of this part of the report.

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the view developed in the influential Fink-report.2 Salient here is the method of demarcating

the area of dual use by recourse to so-called ‘experiments of concern’, e.g. experiments that

enhance the virulence of pathogens.3 Attention has to be paid to the emergence of dual use

issues arising from recent developments in synthetic biology. The possibility of creating

pathogens de novo has added a whole new dimension to the dual use issue. Another area in

need of further detailed attention is biodefence. In particular, biodefence research concerned

with developing protections against biological weapons raises special problems. While

ostensibly concerned only with protection of populations from bio-warfare and bio-terrorism,

in practice research in this area is very similar to the kind of research that would be

undertaken by those seeking to develop biological weapons.

A:2 A SHORT HISTORY OF THE DUAL USE CONCEPT

Dual use is not a concept that is unique to the life sciences. The (possibility of) dual use is as

old as engineering and designing. Literally dual use means nothing more and nothing less

than that a certain activity or a certain object can be applied in at least two ways. This is the

case with almost everything that has been designed or developed, but also with objects that

are not human made, such as natural herbs. To give some examples: a kitchen knife can be

used to cut, but also sometimes as an alternative for a screw driver and indeed also to stab

someone. Palliative pills are meant to alleviate pain, but if you take enough of these pills they

can be used for committing suicide. This list can be continued endlessly. Almost every

artefact and many natural products can be applied in a dual or even multiple use way. The

dual or multiple ways an artefact can be used are not always intended by the designer. A

screwdriver is not designed to stab a person. In pharmaceutical research unexpected or

unintended effects of medicines also can lead to dual use. Sometimes the original function

even is displaced by the unintended one. A well-known example is the Viagra pill. This pill

had been designed against angina pectoris, but is now used for almost 100% to solve erection

problems.

2 National Research Council, Biotechnology Research in an Age of Terrorism, (Washington, DC: National Academies Press,

2004)

3 National Research Council, Biotechnology Research in an Age of Terrorism, (Washington, DC: National Academies Press,

2004); Miller, Seumas and Michael J. Selgelid. Ethical and Philosophical Consideration of the Dual-Use Dilemma in the

Biological Sciences (Dordrecht: Springer, 2008).

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Although serendipity surely is an interesting phenomenon in (life) sciences, most scientists

and engineers do not spend a lot of time thinking about the unintended or unexpected side-

effects that can occur when their products are used.4 They think even less about intentional

misuse. Making scientists, engineers and other designers aware of the possible misuse of their

‘brainchild’ is the main goal of the dual use policy that has been developed in the life sciences

during the past years.

Based on the intention of the engineers and designers some distinctions can be made when

declaring an artefact or an activity to be dual use. If the starting point is the military field, dual

use is a concept indicating that new technological developments in the military field are also

useful for non-military purposes. History shows some well known examples of this spin-off

effect of military technology. Areas of spin-off include variable fields as communications,

fuels, weather observation, power sources, protective clothing, and displays. Immediately

after the Cold War dual use of technology from this perspective was – in the United States

and elsewhere – seen as a necessary means to stimulate civil as well as military technology.

This is because it was to be expected that expenditures for Defence would be cut down

because there was no longer an enemy that had to be resisted or deterred. From the civil side

there was a tendency that American technology was no longer automatically the best in

quality of manufacture or design. What was more logical than looking for common solutions

for common problems?5 Although he highlights some difficulties Alic concludes that “DoD

(Department of Defence) has more to gain, in an immediate way, from commercial

technologies than civilian industries do from military technologies and military spending.

DoD should not be judged the right and proper vehicle for supporting U.S. R&D and

technology development where the objectives lie primarily on the civilian side of the

economy. On the other hand, by reducing the isolation of defence from the rest of the

economy, dual-use policies could help the U.S. develop and produce more affordable weapon

systems.”6 It is remarkable that in this article – indeed, published before the terrorist attacks

on US properties – there is hardly any attention for security risks or for dual use as we know it

nowadays.

4 Andel, Pek van. “Anatomy of the unsought finding: serendipity: origin, history, domains, traditions, appearances, patterns

and programmability.” British Journal for the Philosophy of Science, 45, no. 2 (1994): 631–648.The Dutch author Pek van

Andel belongs to the few scientists who wrote about the phenomenon of serendipity.

5 Alic, John A. “The Dual Use of Technology. Concepts and Policies. Technology in Society 16, no. 2 (1994): 155–172 6 Alic, John A. “The Dual Use of Technology. Concepts and Policies. Technology in Society 16, no. 2 (1994): 170

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The concept of dual use that is at stake in present day discussions refers to (civil) products

and technologies that can be used for beneficial purposes as well as for malicious purposes.

As was said above this possibility of dual use of artefacts and of knowledge is possible with

almost everything that is designed or produced. But today the most common application of

this concept of dual use is related to weapons of mass destruction (WMD). Perhaps since

nuclear weapons are the most important of the WMD the concept was applied quite early in

debates about the risk of misuse of nuclear technology. But what is exactly meant by dual use

in this ‘nuclear’ context? There seems no better source for finding out than the International

Atomic Energy Agency (IAEA). This organization writes on its website:

The IAEA was created in 1957 in response to the deep fears and expectations

resulting from the discovery of nuclear energy. Its fortunes are uniquely geared to

this controversial technology that can be used either as a weapon or as a practical

and useful tool…The Statute outlines the three pillars of the Agency’s work –

nuclear verification and security, safety and technology transfer.7

The words dual use are not explicitly used (did maybe even not yet exist in 1957), but that

dual use issues did and do belong to the core business of IAEA was clear from the very

beginning. In the more recent IAEA Safeguard Glossary dual use is defined as: a nuclear

related dual use item is “an item which has a technical use in both nuclear and non-nuclear

applications, and is subject to certain conditions of supply because such items could make a

major contribution to a nuclear explosive activity.”8 Notable in this definition is the

distinction between nuclear and non-nuclear applications, while one should expect at least

also a distinction between peaceful (beneficial) and non-peaceful (malicious) nuclear

applications or military and non-military applications. Are those not just the differences that

matter? The concept of dual use in relation to nuclear weapons is most significant because of

the regime of arms control. Inspections of IAEA are mainly directed at discovering intended

or perhaps unintended activities of countries that can be seen as a breach of the Non

Proliferation Treaty (NPT). Because of this link with the NPT states are the main actors that

IAEA focuses upon, as can be seen in the recent discussions about Iran and North Korea. But

of course the risks of (nuclear) terrorism have not gone unnoticed by IAEA. In its mid term

strategy for the period 2006-2011 IAEA has as one of its goals to “Develop a comprehensive

7 International Atomic Energy Agency. History of the IAEA. http://www.iaea.org/About/history.html . (14 October 2010). 8 International Atomic Energy Agency Safeguard Glossary (Vienna: IAEA, 2001): 36

11

set of recommendations and guidelines for the international community, for the prevention,

detection and response to acts of nuclear terrorism or other malicious acts, along with an

appropriate review process.”9

A:3 LIFE SCIENCES, BIOLOGICAL WEAPONS AND DUAL USE

How is the dual use concept introduced and applied in relation to the life sciences? To gain

insight in this question it is useful to start with describing the arms control context of

biological weapons. This context is determined by the Biological and Toxin Weapons

Convention (BTWC). The BTWC was signed in 1972 and came into force in 1975. In those

years BTWC was one of a greater number of arms control agreements during the Cold War

period. The BTWC became possible – as Fidler and Gostin write – when the United States

decided unilaterally to terminate its offensive program on biological weapons.10 The Soviet

Union and other main powers followed. And so the first treaty that required real disarmament

came into being!11 The main article of the BTWC is article I:

Each State Party to this Convention undertakes never in any circumstances to

develop, produce, stockpile or otherwise acquire or retain:

(1) Microbial or other biological agents, or toxins whatever their origin or method

of production, of types and in quantities that have no justification for prophylactic,

protective or other peaceful purposes;

(2) Weapons, equipment or means of delivery designed to use such agents or

toxins for hostile purposes or in armed conflict.12

Has the concept of dual use been an important element of the Convention? To be honest, this

was not the case until after the anthrax attacks of 2001. The words “dual use” do not appear in

the text of the Convention nor in any of the final declarations of the six review conferences

9 International Atomic Energy Agency. Medium Term Strategy 2006–2011 http://www.iaea.org/About/mts2006_2011.pdf.

(14 October 2010)

10 Fidler, David P. and Lawrence O. Gostin. Biosecurity in the Global Age. Biological Weapons, Public Health and the Rule

of Law. (Stanford: Stanford University Press, 2008): 47).

11 Other treaties, such as the SALT agreements on nuclear weapons, did not go further than determining maximum numbers of weapons or missiles.

12 United Nations. Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction (10 April 1972), http://www.unog.ch/80256EDD006B8954/(httpAssets)/C4048678A93B6934C1257188004848D0/$file/BWC-text-English.pdf (25 January 2011)

12

that have been organized since 1980. Article X on the peaceful use of biological agents is the

most relevant article in relation to dual use:

(1) The States Parties to this Convention undertake to facilitate, and have the right

to participate in, the fullest possible exchange of equipment, materials and

scientific and technological information for the use of bacteriological (biological)

agents and toxins for peaceful purposes. Parties to the Convention in a position to

do so shall also cooperate in contributing individually or together with other

States or international organizations to the further development and application of

scientific discoveries in the field of bacteriology (biology) for prevention of

disease, or for other peaceful purposes.

(2) This Convention shall be implemented in a manner designed to avoid

hampering the economic or technological development of States Parties to the

Convention or international cooperation in the field of peaceful bacteriological

(biological) activities, including the international exchange of bacteriological

(biological) and toxins and equipment for the processing, use or production of

bacteriological (biological) agents and toxins for peaceful purposes in accordance

with the provisions of the Convention.13

The relevance of Article X is most highlighted by developing countries, because they hope to

take profit of “exchange of equipment, materials and scientific and technological information

for the use of bacteriological (biological) agents and toxins.” Sometimes the complaint is

heard that the developed countries are not very much interested in this article X. During the

review conferences many attempts have been made to come to a better implementation of this

article. As Piers Millet writes: “This article has the most additional understandings of all the

articles included in the Final Declarations [of the Review Conferences].”14

During the Sixth Review Conference (2006) explicit attention was given to what is called the

misuse of biotechnology: “The Conference recognizes that while recent scientific and

technological developments in the field of biotechnology would increase the potential for

cooperation among States Parties and thereby strengthen the Convention, they could also

13 United Nations. Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction (10 April 1972), http://www.unog.ch/80256EDD006B8954/(httpAssets)/C4048678A93B6934C1257188004848D0/$file/BWC-text-English.pdf (25 January 2011) 14 Millet, Piers. “The Biological and Toxin Weapons Convention.” Revue scientifique et technique (International Office of Epizootics) 25, no. 1 (2006): 35-52.

13

increase the potential for the misuse of both science and technology.”15 Because of this the

Conference decides to contribute one of the intersessional meetings to “Oversight, education,

awareness raising, and adoption and/or development of codes of conduct with the aim of

preventing misuse in the context of advances in bio-science and bio-technology research with

the potential of use for purposes prohibited by the Convention.”16 In 2008 an Expert Meeting

and an Intersessional Meeting of States Parties were organized about the risks of misuse of

biotechnology. In a report which synthesizes the discussions of the Expert Meeting 2008 the

concept of dual use is mentioned in relation to the development of codes of conduct.17 Dual

use is linked to three different words: biological agents or toxins, potential (of research) and

directly to research. These different ways to apply dual use confirm that dual use is not an

unequivocal concept. Before elaborating on this I will pay attention to two more specific

developments where the concept of dual use is at stake.

A:3.1 Synthetic Biology and Dual Use

Since the 1970s new developments in the life sciences have given rise to a lot of public

debate. It started with the discussions about recombinant DNA, which led to the Asilomar

conference on the risks of biotechnology.18 Debates followed about developments as cloning,

stem cell technology, the genomics project and most recently synthetic biology. Until a few

years ago dual use was not an issue in these discussions. The main questions referred to the

acceptability of the research as such: is cloning allowed?; may embryonic stem cells be used

for medical purposes?; should the synthetic production of living cells be forbidden?; etc.

15 United Nations Meeting of States Parties to the Bacteriological (Biological) and Toxins Weapons Convention. Final

Document of Sixth Review Conference of the States Parties to the Convention on the Prohibition of the Development,

Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction (Geneva, 2006): p.

19.

16 United Nations Meeting of States Parties to the Bacteriological (Biological) and Toxins Weapons Convention. Final Document of Sixth Review Conference of the States Parties to the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction (Geneva, 2006): : 25) 17 United Nations Meeting of States Parties to the Bacteriological (Biological) and Toxins Weapons Convention. Synthesis of

Considerations, Lessons, Perspectives, Recommendations, Conclusions and Proposals drawn from the Presentations,

Statements, Working Papers and Interventions on the Topics under Discussion at the Meeting of Experts – Submitted by the

Chairman BWC/MSP/2008/L.1. (Geneva, 2008): 7−8.

18 Berg, Paul, David Baltimore, Sydney Brenner, Richard O, Roblin III and Maxine.F. Singer. “Summary Statement of the

Asilomar Conference on Recombinant DNA Molecules.” Proceedings of the National Academies of Science 72, no. 6 (1975):

1981–1984.

14

It is remarkable that dual use was seen as an important issue almost from the beginning of the

development of synthetic biology.19 What is the dual use risk of synthetic biology? Tucker

and Zilinskas argue that “at present, the primary threat of misuse [of synthetic biology]

appears to come from state-level biological warfare programs.” They refer to former Soviet

scholars who could be engaged in such projects. But on the same page they state that these

developments are “extremely unlikely.”20 Tucker and Zilinskas point to other risks: one of

the possible scenarios for the deliberate misuse of synthetic biology involves a “lone

operator,” such as a highly trained molecular biologist who develops an obsessive grudge

against certain individuals or groups (or society as a whole).21 The other risk comes from so

called biohackers, e.g. college kids who are eager to demonstrate their technological

abilities.22 The growth of the number of do-it-yourself-biologists has indeed got attention of

the authorities. The FBI “has adopted what some call a ‘neighbourhood watch’ stance. The

approach relies on biohackers monitoring their own community and reporting behaviour they

find threatening.”23 If indeed second hand tools for genome assembly are becoming available

to the public at affordable costs then this would seem to add weight to the concerns over

possible misuse of synthetic biology research.24

The main question from my perspective is if there is a difference between dual use issues in

‘classic’ biology and in synthetic biology. Tucker and Zilinskas state that “the most likely

misapplication of synthetic biology for hostile purposes involves the recreation of known

pathogenic viruses in the laboratory.”25 If this is the case, the new element is in the aspect of

19 Vriend, Hub de. Constructing Life. Early Reflections on the Emerging Field of Synthetic Biology (The Hague: Rathenau Institute, 2006): 54−57 20 Tucker, Jonathan B. and Raymond A. Zilinskas. “The Promise and Perils of Synthetic Biology.” The New Atlantis (2006): http://www.synbiosafe.eu/uploads/pdf/The%20Promise%20and%20Perils%20of%20Synthetic%20Biology.pdf, (14 October 2010): 38)

21 Tucker, Jonathan B. and Raymond A. Zilinskas. “The Promise and Perils of Synthetic Biology.” The New Atlantis (2006): http://www.synbiosafe.eu/uploads/pdf/The%20Promise%20and%20Perils%20of%20Synthetic%20Biology.pdf, (14 October 2010): 17

22 Tucker, Jonathan B. and Raymond A. Zilinskas. “The Promise and Perils of Synthetic Biology.” The New Atlantis (2006): http://www.synbiosafe.eu/uploads/pdf/The%20Promise%20and%20Perils%20of%20Synthetic%20Biology.pdf, (14 October 2010): 18).

23 Ledford, Heidi. “Life Hackers.” Nature 467 (October 2010): 650–652.

24 Balmer, Andrew and Paul Martin. Synthetic Biology. Social and Ethical Challenges (Nottingham: Institute for Science and Society, University of Nottingham, 2008) 25 Tucker, Jonathan B. and Raymond A. Zilinskas. “The Promise and Perils of Synthetic Biology.” The New Atlantis (2006): http://www.synbiosafe.eu/uploads/pdf/The%20Promise%20and%20Perils%20of%20Synthetic%20Biology.pdf, (14 October 2010): 16

15

recreation (e.g. of the Spanish flu virus). Problems can arise if such a recreated virus is

misused for biological weapons or bioterrorism. But there is essentially no difference with the

dual use issue in traditional biology. What has to be explored is if the possibilities of dual use

are greater or different in the field of synthetic biology. Although there still are many

unknown factors Tucker and Zilinskas think it “likely that, given the difficulty of anticipating

and assessing the risks associated with synthetic organisms, synthetic biology will require a

new approach to regulation that differs significantly from the NIH Guidelines on recombinant

DNA.” 26 Already in 2006 the US synthetic biology community proposed some measures that

can be seen as an addendum of existing guidelines:

• Insist That All Commercial Gene Synthesis Houses Adopt Current Best Practice

Screening Procedures.

• Create and Endorse New Watch-Lists To Improve Industry Screening Programs.

• Create a Confidential Hotline For Biosafety and Biosecurity Issues.

• Affirm Members’ Ethical Obligation to Investigate and Report Dangerous Behavior.

• Create a Community-Wide Clearinghouse for Identifying and Tracking Potential

Biosafety/Biosecurity Issues.

• Endorse Biosecurity/Biosafety R&D Priorities.27

An important question regarding the possible dual use has a rather pragmatic character: why

take the long and complex way of synthesizing a biological weapon, if in practice there are

many more and easier ways to reach the same result? It seems that all thinking about possible

misuse of synthetic biology still has a rather high hypothetical value. Of course it is very

useful to pay attention to these possible developments in an early stage, but risks should not

be overemphasized and – more important – possible dual use should not get such a high

priority that promising developments in synthetic biology are hampered or that talented

researchers from abroad (especially from suspected countries) do not get the chance to

participate in research.

26 Tucker, Jonathan B. and Raymond A. Zilinskas. “The Promise and Perils of Synthetic Biology.” The New Atlantis (2006): http://www.synbiosafe.eu/uploads/pdf/The%20Promise%20and%20Perils%20of%20Synthetic%20Biology.pdf, (14 October 2010): 19 27 Maurer, S.M., K.V. Lucas & S. Terrell From Understanding to Action. Community-Based Options for Improving Safety

and Security in Synthetic Biology (Berkeley: University of California, 2006)

16

A:3.2 Biodefense and Dual Use

“Biodefense is the science and technology and policy of how to protect against infections

caused by biological weapons of terrorism and emerging infections.”28 Biodefense is not a

new phenomenon. As long as there are biological weapons, research has been done to find

defensive measures against the use of these weapons. At least implicitly biodefense research

is allowed for by Article 1 of the BTWC:

Each State Party to this Convention undertakes never in any circumstances to

develop, produce, stockpile or otherwise acquire or retain: microbial or other

biological agents, or toxins whatever their origin or method of production, of

types and in quantities that have no justification for prophylactic, protective or

other peaceful purposes (…).

In other words, biodefense research can be justified if there are prophylactic or protective

purposes. One of the great practical difficulties with this arrangement is that the kind of

research and the relevant biological agents are the same as the kind of research and agents that

are used for developing biological weapons. Most biodefense research is done by countries

(as the United States and the United Kingdom) that have a history of doing research on

biological weapons. An example of this research are the experiments with anthrax that were

conducted on the Scottish island of Gruinard during the Second World War by the UK, the

US and Canada. Only in the 1990’s was the island declared ‘cleared’ by the authorities.

Furthermore it is generally assumed that an accident with an anthrax experiment in

Sverdlovsk in Russia in April 1979 (during the Soviet regime) caused more than 70 deaths. It

is not very likely that these or other countries – most of which are now BTWC state parties –

would resume research and development in the field of biological weapons, but until today

the knowledge is available. In biodefense research this knowledge is kept up to date. What is

the legitimacy of biodefense research? The main arguments for biodefense research are

detection and protection. By biodefense research instruments can be developed that make an

early detection of biological weapons possible. And that of course is very important for

preventing a possible attack and for (early) warning of the people in a region that is or could

be attacked. Protection against an attack with biological weapons can be achieved by

preventive measures, such as giving people a vaccine that immunizes them against some

28 Biodefense Journal (2007)

http://biodefensejournal.org/Old%20additions/George%20Mason%20Bio%20Defense%20Journal.pdf (14 October 2010)

17

diseases. Also countermeasures can be prepared that help in curing or diminishing the

consequences of a disease.

All these applications of biodefense have in common that it is necessary to possess and use

microbial and other biological agents, or toxins, that are the basic elements for biological

weapons. This leads to the following questions: 1) what are the risks of biodefense research

and 2) how useful/necessary is biodefense research?

A:3.2.1 What are the risks of biodefense research?

Lisa Donohoe describes some consequences of doing more biodefence research:

• Creating stocks of highly dangerous diseases such as anthrax, tularaemia, and

botulism (“select agents”);

• Increasing number of high-containment facilities of biosafety Levels (BSL) 2, 3, 4

(highest risk);

• Need for an increasing number of new, less experienced researchers and student

researchers;

• Higher risk of accidents;

• Increasing risk of accidental release, theft, diversion, and creation of novel agents.29

As in all other life sciences research activities it is very important to be aware of accidents and

mistakes. In other word biosafety has to be guaranteed and optimized, in biodefense

laboratories even with greater efforts than in other laboratories. This remark sounds like a

truism, because defence research institutes belong to the most secured institutions. Security

measures are also – or, probably, even primarily – directed at internal and external threats.

Threats are e.g. theft of biological agents, attacks on the building, disturbance of the research

processes etc. These threats can come from external as well as internal sources. That threats

from inside are not imaginary became clear by the story of Bruce Ivins, the man who was

responsible for the anthrax letters of 2001.

Bruce Ivins was a microbiologist and senior biodefence researcher at the US Army Medical

Research Institute of Infectious Diseases (USAMRIID). The FBI is convinced that he was the

29 Donohoe, Lisa. What is Dual Use Research? (2008) at http://www.nti.org/h_learnmore/lesson_plans/proliferation_threats_biotechnology_risks_dual_research/what_is_dual_use_research.ppt (14 October 2010).

18

(only) responsible for the anthrax letters of 2001. Ivins committed suicide in July 2008, just

before he would have been arrested. The news that the well respected scientist Bruce Ivins

was the man behind the anthrax letters came as a great shock not only to his colleagues and

friends, but no less to politicians and policy makers who were involved in biosecurity policy.

It made them aware of the threats from inside.

One of the consequences of the Ivins affair is that much more than in the past attention is

given to people that are working in biodefense laboratories and in other research institutes.

Besides biosafety and biosecurity the concept of biosurety has been introduced. Biosurety is

directed at the reliability of researchers and other employees. Of course there had always been

screenings of new personnel, but too often these screenings were not repeated. Changes in the

situation or behaviour, such as a divorce or drinking habits, were not registered. Biosurety

policy also entails that employees are asked to look at each other and to report if they see

remarkable changes.

A:3.2.2 How useful/necessary is biodefense research?

The arguments for biodefense research are clear: detection, early warning, prevention and – if

necessary – reducing the effects of the use of biological weapons. In principle there is nothing

wrong with that. But – as we saw above – the research itself leads to specific risks. Do these

risks outweigh the benefits? That depends of course of these benefits. Benefits are related to

the threat that is countered. This leads to the question how the threat is to be estimated. A

complicating factor is indeed the fact that biodefense research itself could be a threat

enhancing activity. This finding could lead to a circular argument. This is not the place to

conclude that because of its inherent risks biodefense research should not be done, but it

surely is an argument to make threat analysis a permanent element in the decision making

about biodefense.

A:4 DUAL USE RECONSIDERED: CONSEQUENCES OR INTENTIONS?

The concept of dual use has spread widely in the life sciences during the past decade. But still

there is a lot of ambiguity and discussion about what is meant by it and how, when and by

whom the concept is or should be applied. Pustovit and Williams perceive two main

approaches to dual use technology: the Anglo-American pragmatic approach and the

19

continental metaphysical approach.30 According to the authors these approaches are based on

different understandings of technology: the Anglo-American approach “is associated with

technology notion as a sequence of processes and operations aimed to products with

necessary and useful for people properties. The second one with enough neutral definition –

understanding of technology as use of organized knowledge for aiming at practical goals by

systems of machines and people that are put in order.”31 In this view the Anglo-American

approach is allegedly directed at concrete technologies, the continental one also at the role and

intentions of people. The authors illustrate the American view by referring to the phrase “dual

use research of concern” that has been developed in the already mentioned famous Fink-

report of the National Research Council,32 the starting point and analytical fundament of the

present biosecurity debate in the United States, but not only there. Dual Use Research of

Concern is defined as “research that, based on current understanding, can be reasonably

anticipated to provide knowledge, products, or technologies that could be directly misapplied

by others to pose a threat to public health and safety, agriculture, plants, animals, the

environment, or material.”33 The list of experiments of concern has now an almost official

status. Experiments of concern are those that:

• Demonstrate how to render a vaccine ineffective;

• Confer resistance to therapeutically useful antibiotics or antiviral agents;

• Enhance the virulence of a pathogen or render a non-pathogen virulent;

• Increase the transmissibility of a pathogen;

• Alter the host range of a pathogen;

• Enable the invasion of diagnosis and/or detection by established methods;

• Enable the weaponization of a biological agent or toxin.

30 Pustovit, Svitlana V. and Erin D. Williams. “Philosophical Aspects of Dual Use Technologies.” Science and Engineering

Ethics 16, no. 1 (2010): 17–31

31 Pustovit, Svitlana V. and Erin D. Williams. “Philosophical Aspects of Dual Use Technologies.” Science and Engineering

Ethics 16, no. 1 (2010): 17–31: 2)

32 National Research Council, Biotechnology Research in an Age of Terrorism, (Washington, DC: National Academies Press, 2004) 33 National Research Council, Biotechnology Research in an Age of Terrorism, (Washington, DC: National Academies Press, 2004)

20

It is referred to in many other publications, such as the report that Miller and Selgelid wrote

for the Australian government.34 Miller and Selgelid add some other categories:

• Genetic sequencing of pathogens;

• Synthesis of pathogenic micro-organisms;

• Any experiment with variola virus (smallpox);

• Attempts to recover/revive past pathogens.

According to Pustovit and William, in declaring the above activities or technologies as ‘dual

use’, the emphasis is laid upon the possible consequences of applications of the technology as

such. Indeed, it is not difficult to describe those consequences for all of the above

‘experiments of concern’. An example is altering the host range of a pathogen. If a pathogen

can be changed in such a way that it can survive not only in e.g. animals, but also in human

beings, this can lead to new diseases for mankind. Animal diseases become human diseases.

And because antibiotics or other remedies for such new diseases do not (yet) exist, the

consequences can be disastrous. The risk of the transfer of animal diseases to humans is not

imaginary, as is shown by the bird flu and more recently in The Netherlands by the Q-fever

that is transmitted to humans by pregnant goats and sheep.

When the emphasis is put on possible consequences of (mis)use of technologies, there is a

risk that there is no or too little attention for the – according to Pustovit and Williams’s

continental – aspect of threat or intention, or only in a very general way. From this

‘continental’ perspective the assignment of the label “dual use” should not only be determined

by the biological, chemical or physical properties of the technology as such, but also by

realistic interpretations and expectations about the way the technology will be used. In other

words: an artefact, a technology or a natural product will become “dual use” only by a

combination of (technical) properties and intentions. Let me again make the comparison with

the kitchen knife: only in very exceptional circumstances a knife becomes a weapon.

In fact, Miller and Selgelid’s approach clearly emphasises both consequences and intentions.

For example, Miller and Selgelid explicitly state: “For something to be an instance of a dual

use dilemma both outcomes (the two horns of the dual use dilemma) need to be (actually or

34 Miller, Seumas and Selgelid, Michael J., Ethical and Philosophical Consideration of the Dual-Use Dilemma in the Biological Sciences (Dordrecht, The Netherlands: Springer, 2008).

21

potentially) intended…”35 So Pustovit and Williams’ presentation of a sharp dichotomy

between the views expressed in the literature is misleading. That said, it is important to make

clear that both intentions and consequences are in play.

That the identification of an intention is relevant for defining dual use is also the point of

view of John Forge.36 He highlights the special sort of intentions that are at stake in

biosecurity: threats. “To classify something as dual use should not simply be the flag that the

item could have some bad use, that some bad use is in theory possible (…) for artefacts at

least, there has to be some threat to make and use an improvised weapon for it to be dual use.”

Furthermore Forge remarks that threats come and go. This means that a technology or an

artefact that is labelled as dual use today does not have to be necessarily a dual use issue

tomorrow. This is a very relevant remark, because it focuses attention on questions as; is there

a threat?; what kind of a threat is it?; who determines if there is a threat?; Is this threat serious

enough to declare a technology or an artefact as dual use etc. Maybe the most important, but

often neglected, question is: When does a threat, and thus a dual use marking, disappear and

who is to decide this?

Before further elaborating on these questions, I will make some remarks on the relationship

between threats and intentions. This will be done by introducing two translations of the word

threat in Dutch: dreiging and bedreiging. They mark a difference that does not exist in the

same way in English. Bedreiging is used if an actor is threatening to act in a certain way, e.g.

with using violence. In that case he is threatening to do something (e.g. using violence).

Threat as bedreiging looks at a situation from the perspective of the subject of a threat.

Dreiging on the other hand focuses at the perspective of the person or group that is or feels

threatened. The dreiging perspective of threat does not have to coincide with that of

bedreiging. Someone can feel threatened while in fact there is no real threat, because no one

has the intention to commit an action against this person. The reverse is also possible:

someone does not feel threatened, while in fact a real threat exists, because an actor has the

intention to commit a crime or a terrorist action. There are indications that the aspect of

dreiging is most influential in the recent debates on biosecurity. Because of that the risk exists

35 Miller, Seumas and Selgelid, Michael J., Ethical and Philosophical Consideration of the Dual-Use Dilemma in the Biological Sciences (Dordrecht, The Netherlands: Springer, 2008): 12). 36 Forge, John “A Note on the Definition of ‘Dual Use’” Science and Engineering Ethics 16, no. 1 (2009) : 111–118

22

that in declaring an activity as dual use an emphasis is laid on the dual use potentiality and an

underestimation of the aspect of intentionality (bedreiging).

Since the terrorist attacks and the anthrax letters of 2001 almost irreversible steps have been

taken to counter a possible terrorist or – more specifically – bioterrorist threat. Now, almost

10 years later the question could be raised if the events since 2001 still justify this focus on

bioterrorism and biosecurity: What is the real threat (bedeiging)?If we take a look at the

examples of actual bioterror attacks that are presented as illustrations (or perhaps even proofs)

of the threat, it is remarkable that – even in the recent National Strategy for Countering

Biological Threats of the US National Security Council37 – only three already well known

examples and one suspicion are recorded. These examples are: the Rajneeshee attack with a

contaminated salad in Oregon (1984); contamination with anthrax spores by Aum Shinrykio

(Japan) and the anthrax letters in the US (2001). The suspicion that Al Qaida might be

preparing a bioterrorist attack was found after the occupation of Afghanistan. Three examples

in more than 25 years! Of course the seriousness of each of these examples should not be

underestimated. But for politicians and for decision makers in the life sciences it should be a

serious consideration if these cases really justify the whole range of measures that haven been

taken during the past years. Judith Reppy summarizes the developments in life sciences of the

past decade with the conclusion that “concerns about bioterrorism raise the issues of dual-use

technology in a field that until recently was not of much interest to the military.”38 These

developments have lead to what is called a securitization of life sciences and of public

health.39

A:5 SECURITIZATION OF LIFE SCIENCES AND OF PUBLIC HEALTH.

Securitization is a concept that was developed in the 1990s by the Danish political scientist

Ole Wæver. Because of that securitization is seen as a concept of the Copenhagen School of

International Relations. This school is closely related to the English School, represented by

theorists as Barry Buzan. For Wæver security is a speech act: “It is by labeling something a

37 Forge, John “A Note on the Definition of ‘Dual Use’” Science and Engineering Ethics 16, no. 1 (2009) : 111–118

38 Reppy, Judith. “Managing Dual-Use Technology in an Age of Uncertainty.” The Forum 4, no.1 (2006): 7)

39 Alexander Kelle argues that the process of securitization in the life sciences started already in the 1990s. Kelle Alexander. Bioterrorism and the Securitization of Public Health in the United States of America – Implications for Public Health and Biological Weapons Arms Control Bradford Regime Review Paper No. 2 (Bradford: Bradford University 2005).

23

security issue that it becomes one.”40 Stating that a particular referent object is threatened in

its existence claims a right to extraordinary measures to ensure the referent objects’ survival.

The issue is then moved out of the sphere of normal politics into the realm of emergency

politics, where it can be dealt with swiftly and without the normal (democratic) rules and

regulations of policy making. For the content of security this means that it has no longer any

given meaning but that it can be anything a securitizing actor says it is. Security – understood

in this way – is a social construction, with the meaning of security dependent on what is done

with it.41

‘Security’ is the move that takes politics beyond the established rules of the game

and frames the issue as a special kind of politics or as above politics.

Securitization can thus be seen as a more extreme version of politicization. In

theory, any public issue can be located on the spectrum ranging from

nonpoliticized (…) through politicized (…), to securitized (…). This link between

politicization and securitization does not imply that securitization always goes

through the state, politicization as well as securitization can be enacted in other

fora as well.”42 Securitization studies aim to understand "who securitizes, on what

issues (threats), for whom (referent object), why, with what results, and not least,

under what conditions.43

According to Fidler and Gostin securitization of public health means “that the theory and

practice of public health are increasingly considered in security terms.”44 It is clear that since

the attacks of 9/11 securitization processes have taken place in many fields. This is a rather

new development, not only in health care, but also in the broader world of the life sciences.

As Reppy says, public health and life sciences on the one hand and security on the other hand

40 Wæver, Ole. Aberystwyth, Paris, Copenhagen New Schools in Security Theory and the Origins between Core and

Periphery. Paper presented at the ISA Conference Montreal (2006): 13)

41 Taureck, Rita. “Securitisation theory – The Story so far: Theoretical inheritance and what it means to be a post-structural realist.” 4th annual CEEISA convention (University of Tartu, 25–27 June 2006). 42 Taureck, Rita. “Securitisation theory – The Story so far: Theoretical inheritance and what it means to be a post-structural realist.” 4th annual CEEISA convention (University of Tartu, 25–27 June 2006): 23−24 43 Buzan, Barry, Ole Wæver, and Jaap de Wilde. Security: A New Framework for Analysis (Boulder: Lynne Rienner

Publishers, 1998): 32)


of Law. (Stanford: Stanford University Press, 2008): 121)

24

were until a few years ago almost completely separated worlds. Biologists and other life

scientists were – unlike the physicists – not involved in security politics, except for a

relatively limited group of biologists and other life scientists who were working in Defence

laboratories in order to develop biological weapons or to contribute to biodefense research.45

But most of these life scientists did not take part in public debates on biological weapons or –

broader – weapons of mass destruction unlike e.g. physicists did on nuclear weapons.46 This

has changed in the past decade. That development indeed leads to answering the questions of

the Copenhagen school: who securitizes, on what issues (threats), for whom (referent object),

why, with what results, and not least, under what conditions. The following reasons can be

distinguished for the securitization of the life sciences (Van der Bruggen 2009).

A first reason for securitization is – as already mentioned – the reference to the events of 11

September 2001 and the anthrax letters in the same period. Undoubtedly these events were an

important reason for seriously considering if life sciences could be a source for terrorist

attacks. But some qualification has to be considered. First of all: the Bruce Ivins story (see

above) has made clear that the attack was the result of the actions of one deranged researcher

who was working in one of the Defence laboratories. He had no link with any terrorist or

radicalized (Muslim) organization. Of course this makes his deeds no less repugnant, but this

fact should have influenced the threat analysis. Of course it has taken some years before this

conclusion could be drawn definitively, but from the beginning the experts knew that the

anthrax spore was coming from one of the American Defence laboratories. It was and is very

unlikely that other employees of Defence laboratories would undertake comparable activities.

And of course it was also a legitimate question to investigate what the risks were that a

comparable threat could be expected from terrorist groups. But how credible is it to expect a

bioterrorist threat from these groups? Are there really any indications for such an

expectation? Of course intelligence services will have to perform their inquiries. And it is

understandable that they do not make all their results public. So it cannot be excluded that

there really are some indications for a threat. But even if there was or is a threat, the question

remains what kind of reactions and countermeasures are justified.

45 Bruggen, Koos van der, “Science of Mass Destruction: How Biosecurity Became an Issue for Academies of Science,” in Biosecurity. Origins, Transformations and Practices, eds. Brian Rappert and Chandre Gould (Basingstoke: Palgrave MacMillan, 2009): 69) 46 A well-known example of the involvement of physicists is the Pugwash Conference, which was initiated by concerned scientists as Albert Einstein. See: www.pugwash.org

25

A second reason for securitization is linked to the initiatives of the BTWC State Parties

during the 5th and 6th review conferences and the intersessional meetings to stimulate

awareness raising among scientists, e.g. by developing codes of conduct. Attention – also

within BTWC – shifted from state actors to non state actors and the risks of bioterrorism.

And, of course, most of these discussions were held in the same time that the world was

confronted with a series of terrorist attacks. This gave an extra argument to involve the

scientific world in the BWC activities.47

A next important factor is the occurrence of new infectious diseases that threaten humans as

well as animals: HIV/AIDS, SARS and the Bird Flu are the most well-known examples.

Some authors – as Fidler and Gostin – put naturally occurring infectious diseases under the

heading of ‘biosecurity’.48 They see this broadening of the security concept as an effort to

release the concept of security from the “traditional state centred military-biased

perspective.”49 In their opinion public health and security are unjustly two almost completely

separated worlds. They refer to the recently developed concept of human security to defend

their view.50 Although there are divergent interpretations of human security, a common

denominator is that the concept of security should be broader than national or military

security. All proponents agree that the primary goal of human security is the protection of

human individuals. This broadening of the concept of security implies that there should not

only be attention for prevention of possible threats of intentional spreading diseases. Security

issues are also at stake because of the effects of diseases, irrespective if these are intentionally

causes or not. Pandemics can lead to societal unrest and even upheavals.

Attention to biosecurity issues was in at least two ways also influenced by globalization. First,

a growing number of international personal and commercial contacts may contribute to a

faster and more extensive spread of viruses around the world. Local epidemics can become

national or even global epidemics. There are examples of other sources for diseases (such as

47 Revill. J. and M.Dando. “The Rise of Biosecurity in International Arms Control.” In Biosecurity.Origins, transformations

and Practices, eds. Brian Rappert and Chandre Gould (Basingstoke: Palgrave MacMillan, 2009): 41−59.


of Law. (Stanford: Stanford University Press, 2008): 2


of Law. (Stanford: Stanford University Press, 2008): 6

50 Human Security Centre. The Human Security Report 2005.War and Peace in the 21st Century (New York: Oxford University Press, 2005).

26

the malaria mosquito) that are spread to new regions (e.g. because of climatic changes or as a

‘stowaway’ in a plane or ship). Globalization also promotes the international contacts

between scientists and researchers. Personal exchange, appointments abroad and international

conferences have grown exponentially during the past decades. The advantages of this

development are obvious. Science and technology flourish because of it. More people from

more countries are able to contribute to science. But there is the other side that intentional

misuse is made of scientific results. In The Netherlands the example of the Pakistani nuclear

scientist Dr. Khan is well known. From May 1972 to December1975 he was working at an

engineering firm based in Amsterdam and a subcontractor to the URENCO consortium

specializing in the manufacture of nuclear equipment. URENCO’s primary enrichment

facility was at Almelo, Netherlands. A.Q. Khan, in his capacity, would eventually have an

office at that facility by late 1974. In 1975, following India's 1974 nuclear test, Khan was

reported to have been asked by the then-prime minister to take charge of Pakistan’s uranium-

enrichment program. In early 1976, Dr. Khan left the Netherlands with secret URENCO

blueprints for uranium centrifuge.

Last but not least another consequence of globalization is that terrorist activities are no longer

limited to regional and local conflicts. Groups as Al Qaeda have made the entire world into

their working area.

A:6 WEIGHING THE ARGUMENTS

Taking all these developments into account, the question remains if the biosecurity risk

indeed is significantly greater than 10 or 25 years ago. Is it really necessary and justified

mobilizing the life sciences community and making them aware, or are we pulled along in a

whirlpool of developments that have led to an overexposure of not or hardly existing

biosecurity risks? It is not easy to give a validated answer to this question, if only − as was

said before − because there is much confidential information of intelligence services and other

government officials on the occurrence of incidents. Moreover it is hard to prove that or why

some incidents have not happened. Comparable discussions took place on the effectiveness of

nuclear deterrence during the Cold War: it cannot be proven that nuclear deterrence really has

prevented the occurrence of (nuclear) war. But is this the case because of the effectiveness of

nuclear deterrence or maybe because there was no real threat?

In criticizing the – in his view – overexposure of terrorist threats in the Netherlands a reader

of a Dutch newspaper claimed that he had been a very successful anti-dragon-fighter for more

27

than 30 years, because all that time no dragon had dared to assault a citizen. Of course this

reaction can be seen as a way to ridicule the serious efforts of authorities to reduce terrorist

threats. That should not be fair, because it is undeniable that there is a certain kind of risk. But

such a reaction may also lead to reconsideration of the threat and of all measures that have

been taken. Let it be said that in many countries there are procedures for reconsidering threats

and evaluating measures. The Dutch National Coordinator for Counterterrorism publishes at

his website a threat level (varying from minimal via limited and substantial to critical) that is

updated regularly on the basis of relevant information from intelligence services and other

relevant sources.51 But adapting the threat level does not always imply that also measures are

adapted, reduced or withdrawn. Measures that have been taken or laws that have been

accepted remain unchanged, often long after the reasons for their existence have disappeared

or if it is clear that the measures do not contribute to the desired outcome. Many useless and

time-consuming measures on airports are for many citizens the most striking examples.

Can the same be said of dual use policy for the life sciences? Before answering this question

some possible reasons and backgrounds for the current security policy will be discussed.

We live in a risk society. The concept of risk society has been developed by the German

sociologist Ulrich Beck. Because of technological and social developments the number and

the kind of risks have grown in society. Risk is defined by Beck as "a systematic way of

dealing with hazards and insecurities induced and introduced by modernization itself''.52 Of

course risks have always existed, but in present days many new risks are the consequence of

modernization: pollution, nuclear waste, (new) diseases as HIV–AIDS. A lot of these risks are

not proportionally divided: people from developing countries have a much greater risk than

people in the developed countries and within countries poor people are worse off than richer

people. The emergence of the risk society goes accompanied by a social and political

development that is characterized by a growing individualization and a changing view on

state responsibility. The state is not able and not willing to take up all responsibilities of its

citizens. People are expected to make their own arrangements and to take their own

preventive measures.

But that does not mean that states do not have and do not take their own responsibility. By

way of an example consider the risk policy in The Netherlands. Since 1989 there is the rule

51 National Coordinator Counterterrorism. http://english.nctb.nl. (14 October 2010)

52 Beck, Ulrich. Risk Society, Towards a New Modernity (London: Sage Publications, 1992): 21

28

that nobody should be exposed to risks that lead to a chance of dying of more than 10-6.

Policy measures had to be taken to guarantee this result. These results are not everywhere

attainable with the same efforts. In the neighbourhood of airports or fuel-depots the risks are

much higher, so more measures should have to be taken to reach the intended result. In

practice that is not happening. Around airports the accepted chance of dying is 10-5! This

higher risk is based on the tension between equity and efficiency. Absolute equity in risk can

lead to inefficiency. The social cost would get too high if a universal chance of 10-6 would be

accepted. Of course do not all citizens accept these higher risks, as is shown by debates and

protest meetings of people around airports? However, often greater risks are acceptable for

groups of people. This is because the experience of risk is not only determined by empirical

data, but also by social circumstances. People are willing to accept higher risks under certain

conditions, e.g. if they think that they can manage the risks themselves (e.g. in car driving), or

if they have financial profits (e.g. people working at an airport or at a nuclear power plant).

This subjective element in the experience of risks can also be found in discussions about

security. A distinction can be made between objective and subjective security. Objective

security is the degree of security in a society (country, city or neighbourhood) as measured on

the basis of an as realistic as possible calculation of threats and risks, or in the Dutch

terminology of real bedreigingen. It is evident that this degree of security cannot always be

presented in hard numbers, but it is possible to produce reliable assessments, e.g. based on

statistics. Subjective security is the degree of security, as it is experienced by citizens. It

refers to the dreiging that is experienced. Subjective security is not necessarily related to

objective security. It occurs that people sometimes feel less secure than their objective

situation would allow. Often experiences from the past or other personal factors are

responsible for this reaction. But also the influence of mass media should not be

underestimated!

After September 2001 the threat of a terrorist attack moved up the chart of security risks.

From the beginning it was clear that government saw a prominent role for itself in reducing

that threat. This is understandable because terrorism belongs to the kinds of threats that are

directed against the state as such, which is not the case with e.g. airplane crashes. This link

with the ‘core business’ of government led to a revival of the role of the state as the ultimate

guardian of security. Shortly after September 11 Francis Fukuyama (one of the prophets of

neo-liberalism) wrote very strikingly that it is not the Microsofts of this world that send

29

aircraft carriers.53 Therefore a state with its monopoly of violence is necessary! The new

security issues made clear that there are domains where public and political responsibilities

come first. In The Netherlands as well as in most other countries these responsibilities have

been taken by government. In the years since 9-11 numerous (new) activities and institutions

have aimed to reduce terrorist threats. And in general these activities were supported by the

population, even when they involved (apparent) limitations of individual freedom or privacy.

This acceptance can be related to a high level of subjective insecurity. Many people thought

that the attacks of 9-11 could have a sequel in Europe or The Netherlands. This was of course

confirmed by the attacks in Madrid (2004) and London (2005) and – within the Dutch context

– by the murder of Theo van Gogh (2004).

But how does this subjective (feeling of) insecurity relate to the objective level of insecurity

that is caused by potential bioterrorism? Currently more people die in car accidents than in

bioterror attacks. But arguably the social shock and distress is much greater. This can be

explained by the fact that terrorist attacks hit society as such. If 3000 people would have been

killed after the WTC had fallen down because of an earthquake, the shock would have been

great also, but incomparable with what happened after 9-11. The essence of the state and the

capability of the state to protect its citizens were at stake! The terrorist attack was seen as an

act of war, comparable with the attack on Pearl Harbour in 1941. This view explains the

reaction of governments, not only in the United States, but also in The Netherlands.

Governments are willing to spend relatively much more financial and personal means to

counter terrorist threats than traffic risks. The weighing between ‘equity’ and ‘efficiency’ is

different in both cases

Another phenomenon that can be observed is the tendency of thinking in worst case analysis

rather than in probabilities. Again a plausible explanation can be given. Our views and images

of terrorism have been formed by – let it be said again – the attack on the World Trade Centre

and the massive attacks in Madrid and London. For these kinds of terrorist attacks even a new

name has been created, catastrophic terrorism: attacks using weapons of mass destruction or

more simple methods to kill thousands of civilians for political pressure, political theatre, or

crazed self-expression. Although political authorities are aware of the low probability of

terrorist attacks they are prepared for the worst. Besides the reason already stated (terrorism as

53 Fukuyama, Francis. “Amerika moet een gewoon land worden.” NRC Handelsblad, (18 September 2001) Translation from article in Financial Times

30

an attack against the essence of the state) also a more psychological reason for this policy can

be recognized. This reason can be identified as anticipated decision regret.

Anticipated decision regret is an attitude of people which leads them to take actions that are

directed at preventing possible future incidents. If I take this preventive measure now, it will

mean that I do not have to blame myself (or get blamed by others) for not having done

everything to prevent that incident from happening. This attitude also can be observed in

health care. A growing number of preventive screening tests is offered that provide

information of the chance of developing some kind of disease. It is often not taken in

consideration that the chance of really getting this disease is very small. And it is possible that

the measures that are taken to prevent the disease negatively influence lifestyles. The Dutch

medical sociologist Tjeerd Tijmstra gives some – often hilarious – examples of anticipated

decision regret: if a mother gets a screening test for her child offered for a disease for which

the risk is 1 in 90,000, there is a great willingness to participate.54 And even if it is explained

to people that the chance of getting a car accident while driving to the clinic is about as much

as that particular risk, still many people decide to go on. Their motivation seems to be:

suppose our baby does develop that disease, then we should not forgive ourselves not to have

done everything to prevent it. There are signals that this anticipated decision regret has

become an attitude in security issues also. But in the field of security governments and other

public agencies (such as scientific organizations) are bearers of the attitude more than

individual citizens. After 9/11 – let it be repeated again – security measures against possible

terrorist attacks have been given an enormous priority. It looks as if governments are willing

to invest a lot of energy in minimizing the chances of terrorist attacks. They do not want to

take the risk that they have not done everything to prevent an assault. This attitude can be

based on experience. Officials of the Dutch government were reproached for not having done

enough to prevent the murder of film director Theo van Gogh (2004). These reproaches have

led to decisions that are directed at minimizing the chance of new attacks. With – in general –

societal and political support a good deal of money and a lot of energy are devoted to this

topic. It is not farfetched to suppose that this is one of the effects of our common anticipated

decision regret.

54 Tijmstra, Tjeerd, “Het imperatieve karakter van medische technologie en de betekenis van ‘geanticipeerde beslssingsspijt.” In Ingebouwde normen. Medische technieken doorgelicht, eds. Marc Berg and Annemarie Mol. (Utrecht:van der Wees, 2001) 40–45.

31

A:7 DUAL USE POLICY IN THE LIFE SCIENCES RECONSIDERED: SOME

PRELIMINARY CONCLUSIONS

The considerations that have been presented in the previous pages might lead the reader to the

assumption that there is not much need to worry about bioterrorism and that most measures

are highly exaggerated. That would not be a correct assumption. There are reasons to be

cautious about the risks of bioterrorism. The message of this paper is: do not stop thinking!

And let it be repeated: in general Dutch politicians and officials indeed did not stop with

thinking. Anti terrorist policy is not carried out on autopilot. The periodic adoption of the alert

lever by NCTb is an example. Officials of NCTb and of the Intelligence services are also the

first ones to stress that possible acts of CBRN-terrorism do almost certainly not imply the use

of weapons of mass destruction with thousands of victims, but of less destructive (although of

course still very dangerous and harmful) weapons.

But still it is possible that politicians and officials are so much preoccupied with anti terrorism

policy that all information is interpreted in such a way that it strengthens the conviction that

already exists. In that case information that contradicts this conviction or that is not directly

relevant could be underestimated or neglected. A focus on security issues can lead to an

attitude where other policy issues are subordinated to security issues or will be judged only in

their relation to security issues. To give a fictitious, but not unrealistic, example from the life

sciences: why is a student from a Middle East country coming to this European laboratory for

his PhD research? The idea that this person just wants to become a good scientist in order to

help his country in fighting serious diseases could be set aside by the bias driven view that he

or she could be a potential terrorist, so “we will watch him and prevent him from stealing

materials.” The much criticized measure by Dutch government forbidding the access of

Iranian students to nuclear research sites can be seen as an example of such a one-sided or

biased vision. This measure has been declared unlawful by Dutch judges.

This example brings us back to the dual use policy as it has been developed in the past years.

The conclusion is that there is nothing wrong with more awareness of the potential dual use

that can be made with the materials or the results of life sciences research, but this awareness

should not become so predominant that distrust is the default attitude in a laboratory. The

KNAW code of conduct has proven to be an appropriate method to make life scientists and

32

other people that are involved in biotechnological research aware of the dual use issue.55

Maybe there could be one undesired consequence: could it not be a side effect that not only

benevolent scientists become aware of the possible misuse of the biological agents they are

working with, but also potential terrorists? This is an always returning dilemma in security.

As it was said in a discussion on codes of conduct in the USA: “a code of conduct can make

good people better, but probably has negligible impact on intentionally malicious

behaviour.”56

In almost all discussions that were entered in relation to the Code of Conduct a conclusion

was that such a Code alone is not enough to limit the risk of the misuse of dual use

technology. In The Netherlands measures have been taken to reduce the risk of dual use

research and technology beyond the spheres of awareness. It will be important to go on with

this policy on the basis of cooperation between all involved parties: scientists, funding

organisations, universities, hospitals, politicians, officials of ministries and of course experts

on terrorism and anti-terrorism. Such cooperation does not only take away possible

misunderstandings, but it is also an appropriate remedy against possible tunnel visions.

A:7.1 Definition

The purpose of this article was to develop an acceptable, adequate and applicable definition of

the dual use concept for researchers, universities, companies and policy makers.

The conclusion of the above cannot be otherwise than that such a definition of dual use should

encompass more than only the technical or physical properties of a biological agent. Dual use

policy should be based upon a deliberate consideration of technical possibilities, threats and

intentions and possible consequences. Can these aspects be unified in the intended

“acceptable, adequate and applicable definition of the dual use concept”?

Such a definition will be broader than existing definitions of dual use. The most common and

authoritative definition still is the one in the Fink-report: Dual Use Research of Concern is:

Research that, based on current understanding, can be reasonably anticipated to provide

knowledge, products, or technologies that could be directly misapplied by others to pose a

55 Koninklijke Nederlandse Akademie van Wetenschappen. Eindverslag van de Werkgroep Biosecurity (Amsterdam: KNAW, 2009) 56 National Scientific Advisory Board on Biosecurity (2007). International workshop of the National Science Advisory Board

for Biosecurity, 25−27 February 2007 (Washington, D.C.:NSABB, 2007)

33

threat to public health and safety, agriculture, plants, animals, the environment, or material.57

The definition is explained by the list of seven experiments of concern. In a recent publication

Selgelid proposes three plausible definitions of dual use science and technology:

• That which has both civilian and military applications;

• That which can be used for both beneficial/good and harmful/bad purposes, and

• That which has both beneficial/good and harmful/bad purposes – where the

harmful/bad purposes involve weapons, and usually weapons of mass destruction.58

As the authors of the Fink report and Selgelid are aware, uncertainties are inherent to both

threats and expected damage. Moreover, as argued above, both intentions and consequences

need to be involved in defining dual use. Further, too much emphasis on worst case scenarios

is problematic. These kinds of scenarios describe the disasters that (can) take place if indeed

the biological agent is misused for terrorist or criminal intentions. But worst cases are not by

definition realistic scenarios. Because of that a definition of dual use should not only be based

on elements that point to worst cases. So – with all necessary restraint – this definition will be

proposed:

A dual use problem arises when

• research, based on current understanding, can be reasonably anticipated to provide

knowledge, products, or technologies that could be misapplied and;

• there is a recognizable threat and a not negligible chance of such misuse and;

• there are serious consequences for society and science (public health and safety,

agriculture, plants, animals, the environment, or material).

57 National Research Council, Biotechnology Research in an Age of Terrorism, (Washington, DC: National Academies Press, 2004)

58 Selgelid, Michael. “Dual-Use Research Codes of Conduct: Lessons from the Life Sciences.” Nanoethics 3 (2009): 175–

183.

34

PART B

THE ETHICS AND REGULATION OF DUAL USE IN THE

BIOLOGICAL SCIENCES

SEUMAS MILLER AND MICHAEL J. SELGELID59

B:1 INTRODUCTION

As explained in detail in Part A of this report, the so-called “dual-use dilemma” arises in the

context of research in the biological and other sciences as a consequence of the fact that one

and the same piece of scientific research sometimes has the potential to be used for harm as

well as for good. Consider as an example of this kind of dilemma recent research on the

mousepox virus.60 On the one hand, the research program on the mousepox virus should have

been pursued since it may well have led to a genetically engineered sterility treatment that

would have helped combat periodic plagues of mice in Australia. On the other hand, this

research project should not have been pursued since it led to the creation of a highly virulent

strain of mousepox and the possibility of the creation – by, say, a terrorist group

contemplating a biological attack – of a highly virulent strain of smallpox resistant to

available vaccines.

A dual-use dilemma is an ethical dilemma, and an ethical dilemma for the researcher as well

as for those (e.g. governments) who have the power or authority to assist or impede the

researcher’s work. It is an ethical dilemma since it is about promoting good in the context of

the potential for also causing harm, e.g. the promotion of health in the context of providing

the wherewithal for the killing of innocents. It is an ethical dilemma for the researcher not

because he or she is aiming at anything other than a good outcome; typically, the researcher

intends no harm, but only good. Rather, the dilemma arises for the researcher because of the

potential actions of others. Malevolent non-researchers might steal dangerous biological

agents produced by the researcher; alternatively, other researchers – or at least their

governments or leadership – might use the results of the original researcher’s work for

59 Miller and Selgelid are equal authors of this part of the report. 60 Jackson, Ronald J., Ramsay, Alistair J., Christensen, Carina D., Beaton, Sandra, Hall, Diana F., and Ramshaw, Ian A.,

“Expression of Mouse Interleukin-4 by a Recombinant Ectromelia Virus Suppresses Cytolytic Lymphocyte Responses and

Overcomes Genetic Resistance to Mousepox,” Journal of Virology 75, no. 3 (2001): 1205–1210

35

malevolent purposes. The malevolent purposes in question include bioterrorism, biowarfare

and blackmail for financial gain.

Naturally, not all ethical dilemmas or, for that matter, ethical violations are unlawful or

subject to regulation; nor ought they to be. However, where the ethical violations in question

are serious and/or where the ethical risks are grave there may well be a need for regulation

and, in some cases, the criminalization of the behavior in question. We take it that dual use

dilemmas in the biological sciences give rise to ethical risks of a magnitude that warrants

regulation at least.

In the recent and not so recent past, a number of governments have sought to develop

weapons of mass destruction (WMDs), including biological weapons, and in some cases have

actually used them, e.g. the use of mustard gas by the German and British armies in World

War I (WW1), the dropping of atomic bombs on Hiroshima and Nagasaki by the US Air

Force in World War II (WW2), the existence of a large-scale biological weapons program in

the Soviet Union from 1946-1992, and the use of chemical agents against the Kurds by

Saddam Hussein’s regime in 1988.

Moreover, there have been some high profile ‘defections’ of scientists from western countries

to authoritarian states with WMD programs. For example, Dr Abdul Qadeer Khan joined and

in large part established Pakistan’s nuclear weapons program after working for Urenco in the

Netherlands; and Frans van Anraat (also from the Netherlands) went to Iraq to assist Saddam

Hussein’s WMD program in producing mustard gas.

Further, there have been a number of acts, or attempted acts, of bioterrorism, notably by the

Aum Shinrikyo in Japan (they attempted to acquire and use anthrax and botulinum toxin), Al-

Qaeda (they attempted to acquire and use anthrax) and the so-called Amerithrax attacks

(involving the actual use of anthrax).

In the aftermath of the 11th September 2001 attacks in the US, bioterrorism is widely

considered to be a real threat, especially to populations in western countries. Moreover, it is

seen as a greater threat from non-state terrorist groups than, say, nuclear WMDs, given the

availability of the materials and technical knowledge necessary to produce the relevant

biological agents and the feasibility of weaponisation. This is not to say that there are not

obstacles for would-be bioterrorists, including the dangers to themselves in handling

pathogens. But it is to say that there is a non-negligible bioterrorist threat, and it is likely to

increase rather than decrease.

36

A small number of animal, plant and human pathogens are readily obtainable from nature, and

bioterrorists with minimal microbiological training could use these to inflict causalities or

economic damage.

Techniques of genetic engineering have been available for some time to enhance the

virulence, transmissibility and so on of naturally occurring pathogens. This gives rise to the

possibility of terrorists getting their hands on pathogens with (say) enhanced virulence and for

which there are no vaccines. Indeed, some of these techniques of enhancement are such that

bioterrorists with advanced microbiological training could themselves deploy them.

Recent developments in synthetic genomics have exacerbated the problem even further. It is

now possible to create pathogens de novo, i.e., to construct deadly viruses from scratch.

Accordingly, in the not too distant future a would-be terrorist will no longer need to go to an

inhospitable region to find a naturally occurring pathogen such as Ebola, or to steal a highly

virulent and transmissible pathogen such as smallpox from one of a very small number of

very secure laboratories, or even to deploy standard recombinant DNA techniques to enhance

the virulence and transmissibility of some more readily available pathogen. Rather he or she

could buy a bench-top DNA synthesizer and potentially use it to assemble a specified

genomic sequence of a highly virulent and transmissible pathogen from readily available raw

materials.

Again, this is not to say that there are not obstacles to terrorists, including those mentioned

above, as well as the current lack of know-how and technological capability regarding

synthetic genomics amongst most cohorts of researchers and laboratory workers, and

whatever safeguards exist now, e.g., the US Select Agent regulations, or can be put into place

over the next few years.

In short, some research in the biological sciences has the potential for great harm, as well as

great good and, unfortunately, there are any number of malevolent individuals, political and

religious groups and governments ready, willing and (increasingly) able to use this research to

cause harm rather than to do good. This is the larger context in which the dual-use dilemma in

the biological sciences arises.

A favored method of mapping the terrain of dual-use dilemmas has been by recourse to so-

called experiments of concern. According to the NRC report “experiments of concern” are

those that would:

1. demonstrate how to render a vaccine ineffective;

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2. confer resistance to therapeutically useful antibiotics or antiviral agents;

3. enhance the virulence of a pathogen or render a non-pathogen virulent;

4. increase the transmissibility of a pathogen;

5. alter the host range of a pathogen;

6. enable the evasion of diagnosis and/or detection by established methods; or

7. enable the weaponization of a biological agent or toxin.61

Other possible categories are:

8. Genetic sequencing of pathogens;

9. Synthesis of pathogenic micro-organisms;

10. Any experiment with variola virus (smallpox);

11. Attempts to recover/revive past pathogens.62

The dual-use dilemma is obviously a dilemma for researchers, viz. those researchers involved

in biological research that has the potential to be misused by bioterrorists, criminal

organizations and governments developing biowarfare capabilities. But it is also a dilemma

for the private and public institutions, including universities, that fund or otherwise enable

research to be undertaken. The dilemma is made more acute for university-based researchers

and for universities, given their commitments to such values as academic freedom and the

unfettered dissemination of research findings; and for private companies, given their

commitment to free-enterprise. More generally, it is a dilemma for the individual

communities for whose benefit or, indeed, to whose potential detriment, the research is being

conducted, and for the national governments who bear the moral and legal responsibility of

ensuring that the security of their citizens is provided for. Finally, in the context of an

increasingly interdependent set of nation-states – the so-called, global community – the dual-

use dilemma has become a dilemma for international bodies such as the United Nations.

Part B of this report has four sections and an appendix. The first section is this introduction.

The next three sections reflect (respectively) the three principal kinds of institutions

61 National Research Council, Biotechnology Research in an Age of Terrorism, (Washington, DC: National Academies Press, 2004) 62 Miller, Seumas and Selgelid, Michael J., Ethical and Philosophical Consideration of the Dual-Use Dilemma in the Biological Sciences (Dordrecht, The Netherlands: Springer, 2008).

38

implicated in dual use issues in the biological sciences, namely, universities, private firms and

governments. At the conclusion of the fourth section on ethics, regulation and government is a

set of recommendations.

As has been made clear, our main focus in Part B of this report is with moral or ethical (we

use the terms interchangeably) concerns and with regulation in so far as it relates to such

ethical concerns. There is, of course, a close relationship between the moral and the legal and,

more specifically, between the ethical and the regulatory. For instance, typically criminal

laws, such as the laws against murder, assault and theft, ‘track’ or follow antecedent moral

principles; there is a law against murder, for example, precisely because we regard murder as

morally wrong. Nevertheless, the moral and the legal are conceptually distinct, and the

distinction needs to be kept in mind in what follows. An important corollary of the existence

of this moral/legal distinction is that it is not necessarily the case that every research practice

rightly regarded as immoral or unethical should always be made unlawful. There is also a

close relationship between the legal and the regulatory. Many actions are subject to both laws

and regulations. Thus many activities that are lawful are nevertheless subject to regulation,

e.g. health and safety regulations governing food production. However, the regulation in

question is not necessarily government regulation; professional activity, for example, is

typically subject to regulations devised and imposed by professional associations.

There are a number of general ethical and regulatory issues that need to be addressed in

relation to dual use issues in the biological sciences. They include the following ones.

(A) Morally and Legally Impermissible Research

• What, if any, research in the biological sciences that gives rise to a dual-use dilemma is

completely morally unacceptable and, therefore, ought to be unlawful?

• What purposes are served by dual-use research in the biological sciences and, specifically,

what harms and benefits are consequent upon this research (or likely to be consequent),

e.g. increasing human understanding, saving lives, generating profits, enabling new

methods of biowarfare?

• Assuming that it is the national and international legislators (and their respective

communities) who ought to decide what general kinds of dual use research in the

biological sciences, if any, ought to be unlawful by virtue of the grave risks that they pose,

who is to decide what specific research is in fact of one or more of the kinds in question,

e.g. university-based biosafety/biosecurity committees?

39

(B) Physical and Legal/Regulatory Conditions under which (Permissible) Experiments of

Concern ought to be undertaken.

• Who (personnel) or what (organizations) ought to be allowed to undertake dual use

research?

• In relation to the various categories of prima facie permissible research that, nevertheless,

give rise to dual-use dilemmas, what are the safety and security – and associated

regulatory – conditions under which this research ought to be undertaken, e.g. background

checks and security clearance for research personnel, training programs, licensing of

laboratories?

(C) Commercialisation of Dual Use Research

• What dual use research ought to be allowed to be commercialised, i.e. undertaken in the

private sector for profit?

• Under what conditions should commercialised dual use research be allowed, e.g.

screening of buyers, licensing of sellers.

(D) Dissemination

• In relation to permissible, safe and secure research in the biological sciences that,

nevertheless, gives rise to dual-use dilemmas what, if any, restrictions ought to be placed

on its dissemination in scientific journals, the mass media etc.?

• In relation to permissible, safe and secure research in the biological sciences that,

nevertheless, gives rise to dual-use dilemmas who ought to decide what, if any, research

findings ought not to be disseminated or ought to have restrictions placed on their

dissemination, e.g. journal editors, newspaper editors?

(E) Regulatory Authorities

• What regulatory architecture ought to be put in place in universities and in commercial

firms to address the ethical concerns with, and to support the regulation of , dual use

research/dissemination in the biological sciences?

• What regulatory authorities ought to be established to advise governments and others on

dual use issues and to ensure compliance with regulations?

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B:2 UNIVERSITIES63

By definition, dual-use research is morally problematic. On the one hand, such research

provides benefits (at least potentially); on the other hand, there is the risk of misuse by rogue

states, terrorists groups and the like.

Broadly speaking, the most obvious benefits of university-based research in the biological

sciences of the kind in question are: the protection of human life and physical health against

diseases (including novel ones); the protection of existing, and (more controversially) the

provision of novel, food sources; and the protection of human populations against biological

weapons. Typically, the research undertaken in university departments and laboratories has as

its purpose to provide these benefits to humanity.

By contrast, the potential burdens of such research are death and sickness caused by the use of

biological agents as weapons in the hands of malevolent state actors, terrorist groups, criminal

organizations and individuals. Understandably, the security risks associated with their

research are not in the forefront of the minds of biological scientists in universities. Indeed,

they may have little understanding of the nature of the security risks; after all, they are not

security experts.

Accordingly, fine-grained analyses of the benefits and burdens of such research needs the

input not only of scientists but of security experts and, for that matter, health economists,

regulators and various other groups. Such analyses would elaborate on the additional kinds of

benefit/burden and recipients/bearers thereof, e.g. the economic wealth accrued by large

pharmaceutical corporations and their shareholders, the economic costs of expensive,

unsuccessful (or only marginally beneficial) research programs in the biological sciences and,

more generally, the dis/utility and in/justice of specific allocations of resources to, and the

distribution of benefits and burdens from, different research programs in the biological

sciences.

Fine-grained ethical analyses of dual-use research in the biological sciences would seek to

quantify actual and potential benefits and burdens, and actual and potential recipients/bearers

of these benefits and burdens. These analyses would also identify a range of salient policy

options. Each option would embody a set of trade-offs between present and future benefits

63 Some of the material in this section is taken from Seumas Miller and Michael Selgelid Ethical and Philosophical Consideration of the Dual-Use Dilemma in the Biological Sciences (Dordrecht: Springer, 2008).

41

and burdens, and recipients and bearers thereof. The construction of these options and the

process of selection between them would consist in large part in the application of various

ethical principles, including human rights principles – e.g. right to life, freedom of inquiry,

and free speech – and principles of utility and of justice. Here we note that there is no simple

inverse relationship between specific benefits and burdens such that, for example, any

increase in security requires a reduction in scientific freedom. Rather an increase in security

might simply involve greater safety precautions and, therefore, a financial cost without any

commensurate reduction in scientific freedom. At any rate, relevant benefits and burdens need

to be disaggregated and subjected to individual analysis in the context of any process of

determining trade-offs and selecting options.

In its most obvious form, the dual-use dilemma consists in the fact that research undertaken to

promote human health might instead be used to destroy human health. As such, the dilemma

gives rise to questions of security; what are reasonable and ethically justified forms and

degrees of security in this context?

Moreover, research undertaken to enhance a nation’s or community’s security sometimes has

the potential to achieve the reverse. Collaboration between universities and government on

biodefense projects is a case in point.

Thus some novel pathogens only exist as disease threats because scientists created them. In

2003, for example, a team of US scientists at St Louis University led by Mark Buller,

supported by a National Institute of Allergy and Infectious Diseases (NIAID) biodefence

grant, repeated a previously-published Australian experiment on mousepox (described

above)64 with the intention of developing a pharmaceutical countermeasure. In the

experiment, mice infected with genetically-modified mousepox virus recovered when treated

with a combination of antiviral drugs. As mousepox is closely related to the variola major

(smallpox) virus, the result led Buller’s team to hope that a treatment against genetically

engineered smallpox could be developed.65 Later, however, the scientists went further by

applying the mousepox enhancement technique to the cowpox virus which, unlike mousepox,

infects humans. The rationale was reportedly “[t]o better understand how easy or difficult it

64 Jackson, Ronald J., Ramsay, Alistair J., Christensen, Carina D., Beaton, Sandra, Hall, Diana F., and Ramshaw, Ian A., “Expression of Mouse Interleukin-4 by a Recombinant Ectromelia Virus Suppresses Cytolytic Lymphocyte Responses and Overcomes Genetic Resistance to Mousepox,” Journal of Virology 75, no. 3 (2001): 1205–1210 65 Roos, Robert, Scientists Research Antidotes to Super Mousepox Virus (University of Minnesota, 6 November 2003), http://www.cidrap.umn.edu/cidrap/content/bt/smallpox/news/nov0603mousepox.html (8 November 2003)

42

would be to apply the same kind of genetic engineering to the human smallpox virus and

make it more lethal.”66 Although such work has been justified as “necessary to explore what

bioterrorists might do”, other scientists have questioned the utility and wisdom of enhancing

viruses.67

Evidently, the notion of security in play is a complex notion. Sometimes seeking to enhance

one’s own security threatens someone else’s security and, as we have just seen, attempts to

increase security can backfire. Moreover, even at its most obvious level security is a complex

notion. It consists in part in the physical security of, for example, samples of biological agents

judged to be dangerous (according to, say, a Select Agent Rule) against theft. Again, orders

for samples or equipment might need to be screened. Relatedly, security consists in part in the

processes in place to ensure, for example, that the researchers themselves cannot, or will not,

conduct research for malevolent purposes, e.g. licensing of laboratories, background checks

on researchers. Further, security implies security agencies or other institutional entities that

provide or enhance, directly or indirectly, the security in question. Sub-institutional entities

such as university-based biosafety/biosecurity committees – expanded biosafety committees

(IBCs) – which might screen research applications and the like are a case in point.

Security in this sense also consists in part in restrictions that might be placed on the

dissemination of the research findings of academics in relation to dangerous discoveries, e.g.

how to enhance the virulence of a pathogen. Such censorship might be full or partial. If

partial, perhaps the findings of an experiment might be reported but not in such a way that the

experiment could be replicated.

This is an important issue in the life sciences in particular, because the tradition of

information sharing in the life sciences has historically been almost completely open,

especially in comparison with nuclear science, where discoveries with implications for

weapons-making are automatically “born classified.”

While the protection of security and public health may arguably provide grounds for limiting

dissemination of information related to dual-use discoveries, at least in certain instances, the

issue of censorship should not be taken lightly, especially censorship of the work of

66 Wright, Susan, “Taking Biodefense Too Far,” Bulletin of the Atomic Scientists (November/December 2004), http://www.thebulletin.org/issues/2004/nd04/nd04wright.html (1 November 2004). 67 Smith, Deborah, “Call to Stop Deadly Viruses Getting into Wrong Hands,” Sydney Morning Herald (29 December 2003): 5. MacKenzie, Debora, “US Develops Lethal New Viruses,” New Scientist (29 October 2003), http://www.newscientist.com/article.ns?id=dn4318 (3 February 2005)

43

academics. Governmental control over dissemination of information poses threats to widely

cherished goods such as academic freedom (of inquiry), scientific autonomy, and freedom of

speech itself. It is commonly held that these things are not only good in themselves but

essential to the progress of science. Governmental control over science has an unfortunate

history illustrated by examples ranging from Galileo in renaissance Europe to Lyshenko in the

former Soviet Union.

So on the one hand there is threat to academic and scientific freedom posed by censorship

and, on other hand, the potential dangers of dissemination of scientific findings. These

dangers are illustrated by the mousepox study.

In 2001 the Journal of Virology published the accidental discovery of a group of Australian

scientists who were attempting to produce an infectious contraceptive for mice, which

periodically breed out of control in parts of Australia. The scientists spliced a single foreign

gene into a mild mousepox virus in the hope of creating a genetically engineered sterility

treatment. The gene – interleukin-4 (IL-4) – helps regulate immune system reactions. The

effect, however, was to create a strain of mousepox so virulent that it killed both mice with

natural resistance to mousepox and mice that had been vaccinated against mousepox.68 A

disturbing implication of this result is that adding an IL-4 gene might similarly increase the

virulence of smallpox (or some other poxvirus that infects humans) and potentially allow the

virus to overcome vaccination (which is our only defense against smallpox, for which there is

no known treatment). The genetic engineering technique used in this study is relatively

straightforward and described in standard microbiology textbooks. No extraordinary

equipment or facilities are required.

Scientific openness and the free sharing of information are important to the methodology of

the scientific enterprise as a whole. In response to claims that the mousepox study and others

like it should not have been published, or to claims that the materials and methods sections of

such articles should have been altered or omitted, for example, defenders of publication point

out the importance of recognizing the extent to which a discovery in one area of science may

have profound implications for progress in other areas. Because limiting description of

materials and methods would interfere with processes considered essential to science – i.e.,

68 Jackson, Ronald J., Ramsay, Alistair J., Christensen, Carina D., Beaton, Sandra, Hall, Diana F., and Ramshaw, Ian A.,

“Expression of Mouse Interleukin-4 by a Recombinant Ectromelia Virus Suppresses Cytolytic Lymphocyte Responses and

Overcomes Genetic Resistance to Mousepox,” Journal of Virology 75, no. 3 (2001): 1205–1210

44

replication and verification – it was objected that such a practice would be at odds with the

way that science actually works.

For these and other reasons – including the commonly held belief among scientists that

knowledge is good in-and-of itself69 – many in the scientific community strongly believe that

things like secrecy and/or governmental control over science is contrary to what science is

about. According to Robert Oppenheimer, for example, who provided the scientific

leadership of the Manhattan project which produced the first atomic weapons in the United

States, “Secrecy strikes at the very root of what science is, and what science is for.”70 From

this perspective, even self-censorship is problematic from a scientific standpoint.

B:2.1 Academic Freedom71

Oppenheimer’s argument invokes academic freedom and, by implication, the human right to

freedom of intellectual inquiry. It is worth spelling out some of ethical issues here. In what

follows we provide a brief analysis of academic freedom.

The argument for the principle of academic freedom begins with the premise that freedom of

intellectual inquiry is a fundamental human right.

Thus conceived, freedom of intellectual inquiry is not an individual right of the ordinary kind.

Although it is a right which attaches to individuals, as opposed to groups, it is not a right

which an individual could exercise by him/herself. Communication, discussion and inter-

subjective methods of testing are social, or at least interpersonal, activities. However, it is

important to stress that they are not activities which are relativised to social or ethnic or

political groups; in principle, intellectual interaction can and ought to be allowed to take place

between individuals irrespective of whether they belong to the same social, ethnic or political

group. In short, freedom of intellectual inquiry, or at least its constituent elements, is a

fundamental human right. Note that being a fundamental human right it can, at least in

principle, sometimes override collective interests and goals including organisational, and even

69 Kitcher, Philip. Science, Truth, and Democracy (New York: Oxford University Press: 2001).

70 Schweber, Silvan S., In the Shadow of the Bomb: Bethe, Oppenheimer, and the Moral Responsibility of the Scientist

(Princeton, NJ: Princeton University Press, 2000).

71 Some of the material in this section originally appeared in Seumas Miller “Academic Autonomy” in (ed.)

Tony Coady Why Universities Matter (Sydney: Allen and Unwin, 2000). See also Seumas Miller The Moral

Foundations of Social Institutions (New York: Cambridge University Press, 2010).

45

national, economic interests and goals. This ‘trumping’ property of human rights is a

constitutive element of liberal democracy; a form of polity whose legitimacy is based in part

on its capacity and willingness to protect human rights including, at times, against

infringements emanating from the government of the day.

If freedom of intellectual inquiry is a human right then like other human rights, such as the

right to life and to freedom of the person, it is a right which academics as humans possess

along with all other citizens. But how does this bear upon the specific institutional purpose of

the university to acquire, transmit and disseminate knowledge?

Before we can answer this question we need to get clearer on the relationship between the

human right to freely engage in intellectual inquiry on the one hand, and knowledge or truth

on the other.

Freedom of intellectual inquiry and knowledge are not simply related as means to end, but

also conceptually. To freely inquire is to seek the truth by reasoning. Truth is not an external

contingently connected end which some inquiries might be directed towards if the inquirer

happened to have an interest in truth, rather than, say, an interest in falsity. Rather truth is

internally connected to intellectual inquiry. An intellectual inquiry which did not aim at the

truth would not be an intellectual inquiry, or at least would be defective qua intellectual

inquiry. Moreover, here aiming at truth is aiming at truth as an end in itself. (This is not

inconsistent with also aiming at truth as a means to some other end.) Further, to engage in free

intellectual inquiry in our extended sense involving communication with, and testing by,

others, is to freely seek the truth by reasoning with others. Intellectual inquiry in this sense is

not exclusively the activity of a solitary individual.

Given that freedom of intellectual inquiry is a human right, and given the above described

relationship between intellectual inquiry and truth (or knowledge) we can now present the

argument in relation to freedom of intellectual inquiry. This argument in effect seeks to recast

the notion of freedom of intellectual inquiry in order to bring out the potential significance for

conceptions of the university of the claim that freedom of intellectual inquiry is a human

right.

(1) Freedom of intellectual inquiry is a human right.

(2) Freedom of intellectual inquiry is (principally) freedom to seek the truth by reasoning

with others.

(3) Freedom to seek the truth by reasoning with others is a fundamental human right.

46

Let us grant the existence of a human right to freely pursue the truth by reasoning with others.

What are the implications of this right for universities and for academics’ freedom of inquiry?

Given such a right of intellectual inquiry, it is plausible to conclude that the university is

simply the institutional embodiment of that moral right. In short, the university is the

institutional embodiment of the right to freely seek the truth by reasoning with others.

The following claims now seem warranted.

First, universities have been established as centres wherein independence of intellectual

inquiry is maintained. This flows from the proposition that the university is an institutional

embodiment of the moral right of the inquirers to freely undertake their intellectual inquiries.

Universities are not, for example, research centres set up to pursue quite specific intellectual

inquiries determined by their external funders. Nor should particular inquiries undertaken by

academics at universities be terminated on the grounds that some external powerful group, say

government, might not find the truths discovered in the course of these inquiries politically

palatable.

Second, universities have a duty to disseminate scholarship and research to the community.

Intellectual inquiry is not only a human right, it is an activity which produces external

benefits. For example, knowledge is a means to other goods, including economic well-being.

Accordingly, and notwithstanding the rights of academics to freely inquire, it is reasonable

that, qua community supported institutions, universities take on an obligation to ensure that

their intellectual activities have a flow through effect to the wider community in terms of such

external benefits. Thus dissemination of research (usually) has obvious benefits to the

community, including health and economic benefits.

On the view of the university under consideration, interference in the process of the free

pursuit of knowledge in universities strikes at one of the fundamental purposes for which

universities have been established. Such interference could not be justified, for example, on

the grounds that whereas free inquiry might be necessary for the acquisition of knowledge in

many instances, in some particular instance free inquiry was not leading to knowledge, and

therefore in this case free inquiry could be interfered with without striking at the basic

purposes of the university as an institution.

Moreover, the university, in so far as it pursues this purpose, can so pursue it, even if so doing

is inconsistent with the collective goals and interests of the community or government. In this

respect the right of intellectuals to pursue the truth is akin to the right of the judiciary to

47

pursue justice even in the face of conflicting collective goals and interests, including the

national interest. For example, European academics researching political or ethical issues in

say, China, have a right to publish that research notwithstanding the damage it might do to

present diplomatic relations and economic prospects.

Notwithstanding the importance of the human right of intellectual inquiry and its centrality to

the institution of the university, freedom of intellectual inquiry in general, and of scientific

inquiry in particular is not an absolute right. Specifically, it can be overridden if its exercise

comes into conflict with other human rights, notably the right to life. Accordingly, if a

contingency arose, such as war or a pandemic or a potential terrorist attack, then the duty of a

scientist to disseminate her findings could well be overridden. Doubtless, in relation to most

academic research such contingencies are exceptions, and should be treated as such.

Nevertheless, given the high risk to human life and health posed by misuse of research in

synthetic biology and related areas, such biological research constitutes a special case.

Censorship of academic research needs special justification. However, that justification is, in

general terms, available in the areas in question, e.g. the high risk of misuse by terrorists of

such research. Naturally, censorship of any specific research or research project will not only

need some justification, it will need a specific justification that details the high risk of misuse

of this specific research project outcome by terrorists, e.g. the research outcome is a highly

virulent, easily transmissible and readily weaponised pathogen.

B:2.2 Progress in Science

Though the above objection to censorship on the basis of academic freedom is legitimate it is

not necessarily decisive in all cases. However, there are other arguments typically put against

censorship of a more utilitarian kind. Chief among these is the argument from scientific

progress; academic freedom, including freedom of dissemination, is necessary for scientific

progress.

Things like “scientific openness”, the “free sharing of information”, and “academic freedom”

are a matter of degree. As such they should be recognized as ideals rather than accurate

characterizations or requirements of science. The perfect realization of such things cannot be

essential to the progress of science, because science has already progressed, and continues to

progress with great rapidity, despite the fact that they have never been perfectly realized. On

the other hand, this does not show that the substantial, if imperfect, realisation of these ideals

is not necessary for the progress of science.

48

Apparent counter-examples to the idea that scientific openness and the free sharing of

information are essential to the progress of science are provided by nuclear physics (which

has involved a long history of censorship) and the keeping of trade secrets in science-based

industries. On the other hand, it could be argued that progress in nuclear physics depended

ultimately on the freely disseminated work of Einstein and others.

Similar points can be made about “academic freedom” and “freedom of inquiry” more

generally. Given that researchers’ choices are so heavily limited by things like the availability

of funding and other resources, and government and industry driven imperatives, for example,

the idea that such freedoms are essential to science and its progress is, arguably, to some

extent undermined by the status quo. Science moves forward despite the reality of various

kinds of limits to the freedoms enumerated above. However, once again, the existence of such

limits does not demonstrate that academic freedom and freedom of inquiry are not necessary

for long term progress in science, much less that these things are not good in themselves.

One might admit that science has suffered from these admittedly real constraints on freedom

but nonetheless claim that science would have advanced even further than it has if there had

been more freedom and openness in science than has actually been the case. Even if correct,

however, this would not go to show that no restrictions on the dissemination of scientific

information are warranted. The progress of science is just one of many legitimate social aims

that must be taken into consideration by scientists and policy makers alike. The progress of

science is important – as is the human right to freedom of inquiry and the institutional right to

academic freedom – but other things such as public health/security are important too; and

there is no compelling reason to think that these two kinds of goals will never conflict or that

the former should always be given absolute priority over the latter (or vice-versa), in cases of

conflict, regardless of the extent to which the latter is threatened.

A commonsense position is that trade-offs need to be made between, say, rights to

disseminate and scientific progress on the one hand, and security/public health needs on the

other, and a reasonable balance struck between these and other values. On this view, we

should sometimes be willing to make at least small sacrifices in the way of public health

and/or security when this is necessary to achieve enormous benefits with regard to the

progress of science; and we should sometimes be willing to make at least very small sacrifices

with regard to the progress of science when this is necessary to achieve enormous benefits

regarding public health and/or security. Either way, it should be recognized that, though there

may be cases of conflict, the promotion of public health/security will often be instrumental in

49

the promotion of science and that the promotion of science will often be instrumental in the

promotion of public health and security. Public health and social stability are required for

science to function, and the products of science will include means for protecting health and

means for defending society against potential adversaries.

B:2.3 Policy Development

Dual use research in the universities is a primary area of focus in debates about biosecurity

and bioterrorism, and there have been numerous relevant policy developments. In 2003, for

example, a “Journal Editors and Authors Group” issued a joint “Statement on Scientific

Publication and Security” in Science, Nature, the Proceeding of the National Academy of

Sciences, and the American Society for Microbiology journals. The statement indicated that

these journals would screen submissions for “safety and security issues” and that when “harm

of publication outweighs the potential societal benefits ... the paper should be modified or not

published.” 10

In 2004 the US National Research Council (NRC) published an influential report on

biological dual use research titled Biotechnology Research in an Age of Terrorism, which is

also widely known as “The Fink Report.”2 Among other things, the NRC called for increased

education of the scientific community about the dual use dilemma; recommended that the role

of Institutional Biosafety Committees (IBCs) be expanded to include review of research

proposals for dual use risks (as well as environmental dangers); recommended self-

governance of the scientific community (as opposed to governmental censorship) in matters

related to publication of dual use research findings; and called for the establishment of a new

advisory board to provide guidance to US government regarding the oversight of dual use

research. Such a body, the National Science Advisory Board for Biosecurity (NSABB), was

established in 2004; and its working groups aim to develop criteria for identifying dual use

research of concern, tools for controlling dissemination of information, science codes of

conduct, policy recommendations regarding synthetic genomics, and means for international

collaboration in the oversight of dual use life science research.11

The NSABB has also played a role reviewing papers raising dual use issues. A controversial

study involving resurrection of the 1918 flu, for example, was sent to the NSABB for review

prior to publication in 2005, and members voted unanimously that the paper should be

published. The Editor-in-Chief of the journal, however, subsequently wrote that he would

have published the study even if the NSABB had voted otherwise.12 This highlights the fact

50

that the status quo in the US (where dual use life sciences research has received the majority

of attention) relies on voluntary self-governance of the scientific community in matters of

censorship – i.e., as recommended by the NRC. Referral of papers to the NSABB is

voluntary, and its decisions are not legally binding.

In relation to policy development, we have drawn up the tables below which summarise and

taxonomise various policy interventions in relation to dual use issues.

Policy regarding dual use can be understood as existing within the following background

structure. The tables below (and the ones in the sections following this one) are reflective of

this structure.

Firstly, there are the institutional actors who could and perhaps should intervene in relation to

dual use concerns. The relevant institutional actors include institutional entities such as

universities, private firms, governments, and professional associations, sub-institutional

entities such as biosafety committees and biosecurity committees, and individual actors such

as scientists, editors, managers, employees, and government officials. More specifically, we

have sought to identify the responsibilities that can and perhaps should attach to these

institutional actors, e.g. responsibility to monitor research applications, to ensure that a

laboratory complies with safety requirements, or to educate academics and students in relation

to dual use issues.

Secondly, there are the objects of intervention, e.g. the kinds of entity that might be subject to

regulation. These include materials, laboratory equipment, scientific journals, personnel,

institutional processes and, indeed, institutions and sub-institutional elements themselves (e.g.

universities are the object of intervention by government).

Thirdly, there are the modes of intervention. These include the creation or extension of

institutional entities (e.g. biosafety/biosecurity committees), regulation (e.g. prohibition),

implementation of licensing, screening and auditing processes, censorship of publications,

and the provision of training programs.

Fourthly there are the purposes of these various interventions. These include awareness

raising, education (e.g. in relation to dual use issues), compliance (e.g. with safety protocols)

and deterrence (e.g. from performing prohibited experiments).

51

TABLE 1: TYPES OF REGULATIONS OF DUAL USE MATERIALS, RESEARCH ETC.

Materials Transport

Equipment Technology Research Projects

Laboratories University Firms Academic Articles

Mass Media Publication

Government

Select Agents X X Licensing X X X X Screening of Orders X X X X Prohibition X X X X X X Partial Censorship X X Full Censorship X X Creation of Institutions/ Sub-institutional Entities

X X X

In Table 1 the heading for each column names a kind of item that is potentially subjected to regulation by virtue of its dual use character. The side-heading for each row (on the left hand side of the table) names a type of regulation. An X placed in a box indicates that the kind of item in the column is or perhaps ought to be subjected to the type of regulation named in that row. Thus materials (the first column heading) are subjected to select agent rules (a type of regulation named in the first row); laboratories (sixth column) are subjected to licensing (second row) and some laboratories might be prohibited (fourth row). Note that governments can create new institutions e.g. statutory authorities, or extend the remit of existing ones, and commercial firms and universities can create sub-institutional entities within themselves, e.g. biosafety/biosecurity committees or extend the remit of existing ones.

52

TABLE 2: THE UNIVERSITY: RESPONSIBILITIES ATTACHING TO INSTITUTIONAL ACTORS

Individual Students

Individual Scientists

Biosafety & Biosecurity Committees

University Academic Editors

Professional Association

Independent Authority

Funding Agencies

Research Project X X X X X X Physical Safety & Security: Regulatory Compliance

X X X

Personnel Security X X X Awareness Raising Training/Education

X X X X

Dual Use Policy X X Censorship/Constraint of Material proposed for Dissemination

X X X

Accountability Systems, e.g. complaints/discipline system, code of conduct, audit system, monitoring system

X X X

Conduct of Accountability Processes, e.g. audits, monitoring, discipline

X X X X X

Countermeasure R&D X X X

Table 2 identifies a range of responsibilities with respect to dual use issues that arise in universities and that attach to relevant institutional actors. Universities are a primary site of concern in relation to dual use issues principally because their academic staff and students conduct dual use research that is typically published in academic journals. Moreover, much of this dual use research is funded by government and the private sector; and funding agencies have responsibilities with respect to the dual use research that they fund. The column headings name some of these various institutional actors, e.g. scientists, biosafety/biosecurity committees, universities. The side heading for each row (on the left hand side of the table) names an institutional responsibility that (where an ‘X’ appears) the actors named in the columns have, or ought to have. Naturally, the institutional responsibilities are ultimately grounded in ethical concerns arising from dual use activities. Thus individual students (first column), individual scientists, (second column), biosafety/biosecurity committees (third column), universities (fourth column), independent authorities and funding agencies all have responsibilities with respect to research projects (first row) that raise dual use concerns. Note that the independent authorities are national agencies that we recommend (see final section of this report) ought to be established as a result of safety and security concerns in the biological sciences, including (but not restricted to) dual use concerns.

53

B:3 PRIVATE FIRMS

Thus far we have been largely focused on university research in the biological sciences in

particular. However, it is important to highlight the extent to which private sector research is

also relevant to – and raises special issues for – the dual-use dilemma. The biotechnology

industry has, of course, been a key driver of the genetic sciences which have made the dual-

use dilemma so prominent in recent years. While the free sharing of information and the

pursuit of knowledge are central values of academic research, however, industrial research is

usually primarily motivated by the pursuit of profits. This has several implications. One is

that industrial discoveries are often kept secret rather than published or otherwise widely

shared with the academic community. While this might alleviate worries about the

publication of dangerous discoveries that might result from such research (and make one

doubt that complete openness in the sharing of information is essential to the progress of

science), it also means that there is less public awareness of the discoveries taking place – and

less public scrutiny of the extent to which the relevant research is dangerous. Furthermore,

while academic scientists presumably usually have the good of humanity as a top concern,

one might justifiably worry that private companies will sometimes be comparatively less

reluctant to pursue research with the potential for malevolent use insofar as their primary

concern is (by admission) the promotion of profits rather than, necessarily, the benefit of

humankind. A final cause for concern is that private research is not generally subject to the

same institutional oversight (via institutional ethics committees) as that which takes place in

universities. We point all this out to show that research of private industry is relevant to the

dual-use dilemma too – and that it raises special issues of its own. Free enterprise is an

important social good; but, because society may be threatened by dangerous industrial

research, it may be argued that more oversight of industrial research is warranted. For

example, companies who synthesise the genes of viruses, e.g. potentially Ebola and smallpox,

should be required to report any requests involving genomes from infectious organisms that

could be used as a weapon of mass destruction (WMD). In the western world this would be

feasible. However, much of this work is now carried out in China and India where regulations

to this effect would be far more difficult to impose and enforce. These points should be kept

in mind in the discussion of regulation that follows.

54

B:3.1 Levels (and Modes) of Intervention

One indicator of the extent to which the private sector has been neglected in discussion/debate

about the dual use dilemma is that so much attention has been placed on potential

implementation of (1) a broadened research review process, and (2) a publication review

process, as key means of preventing against dangers of dual use research and technology.

With regard to (1) a popular idea is that existing IBCs should expand their role to evaluate

research proposals for dual use dangers as well as the other things (i.e., biosafety) they

ordinarily examine. Proposals regarding this kind of intervention are implicitly (if not

explicitly) usually about research institutions other than those in private sector – because the

review processes in question do not play such a great/essential role (and are usually not

required and often not taking place) in the private sector to begin with. In the United States,

for example, IBC review processes are required for research institutions that receive US

government funding – but such review processes are voluntary (and often not taking place) in

the private sector. Filippa Corneliussen, for example, observes that:

The [relevant] NIH guidelines were introduced in 1976, soon after genetic

modification became a tool for biological research, and have since undergone a

number of amendments. Today, researchers who receive NIH grants are required

to follow the guidelines, whereas others at both public and private institutions are

encouraged to do so on a voluntary basis. Among other things, the NIH

guidelines require institutions to establish institutional biosafety committees

(IBCs) to review and approve recombinant DNA research. The review process

includes independent assessment of the facilities and containment levels that are

required, as well as the procedures for training personnel who are involved in the

research. When possible, institutions are encouraged to open their IBC meetings

to the public and are obliged, upon request, to make the minutes from such

meetings freely available.72

Given its importance, however, she argues that the private sector’s exemption from such

requirements73 is not benign:

72Corneliussen, Filippa “Adequate regulation, a stop-gap measure, or part of a package?” EMBO Reports 7 (2006): S50–

S52

73 Which, it should be emphasised, involve training requirements as well as review processes.

55

Biotechnology is exploited most intensively in commercial enterprises. This is

also where the potential for misuse is most acute, as a result of heavy investments

in both intellectual property and highly specialized equipment. In terms of

industry, [a Sunshine Project study conducted in 2004] found that only about 70

firms had NIH registered IBCs. According to Estimates by Ernst and Young

(2005), the US biotechnology industry comprises about 1,500 companies. Not all

of these conduct recombinant DNA research; nevertheless, 70 seems an

unexpectedly low figure. Of the 70 firms, only 26 responded to the [Sunshine

Project] survey, 14 of which provided minutes. None of the minutes were deemed

to be adequate ... The survey further revealed that some private sector IBCs did

not review specific research projects, but instead issued blanket approvals without

regard for individual project details ... The same report cites Merck as stating “We

currently do not perform any research or manufacturing that requires IBC review,

the committee has therefore been dissolved” [and cites other companies such as

Hoffman-La Roche and IDEC saying similar things].74

For proposals regarding expansion of research review processes to be more relevant to the

private sector, therefore, the proposition would need to be that research review processes get

expanded by both (1) increasing what gets reviewed at research institutions that already have

research review processes in place and (2) increasing where reviews take place by making

them required wherever relevant research occurs (i.e., whether or not government funding is

provided). If research review is sufficiently important (regarding promotion/protection of

public interests) for the government to be justified in coercing/regulating those to which it

provides funds, it is not obvious why research review is not also sufficiently important

(regarding promotion/protection of public interests) to coerce/regulate research institutions in

general (whether or not they receive government funding). (This is not, of course, to suggest

that research review would have to be coerced – as opposed to being incentivised in other

ways – in order to play an important role in dual use research governance.)

Proposals regarding review at the publication stage are also less relevant to the private sector,

because given the importance of trade secrets and so on (and that research in the private sector

is motivated by commercial/profit rather than academic interests), publication of results of

private sector research does not play such a great/essential role (and is often not taking place)

74 Corneliussen, Filippa “Adequate regulation, a stop-gap measure, or part of a package?” EMBO Reports 7 (2006): S50–S52.

56

in the private sector to begin with. (If dangerous private sector research discoveries are not

made public (via publication), on the other hand, their occurrence is perhaps (at least

somewhat) less problematic.)

An important question concerns the extent to which dual-use research of concern takes place

in the private sector as opposed the public sector: Does the former involve more or less than

in the latter? Though we have not found much explicit discussion of this question in the

literature, there is no obvious reason to believe private sector research would/should involve

less of the kind of research expected to yield dual use results (of concern) than in the public

sector. Given the biotechnology industries’ concern with things like vaccine and therapeutic

drug development, for example, it is not unlikely that discoveries related to vaccine or drug

resistance might arise. It is here worth remembering that one of the most salient examples of

a problematic dual-use discovery was the mousepox experiment in Australia. The ultimate

aim of the researchers in this case was to develop a means of pest control – and they

accidentally discovered that they produced a vaccine resistant strain of mousepox in the

process. The aim to develop a means of pest control, however, is exactly the kind of research

one might expect in the private sector (i.e., given the profits that might be expected from this

kind of technology) – so there is no reason to think that this kind of project would generally

be more likely to occur in the public sector (where it did, by chance, occur in the mousepox

case) as opposed to the private sector. Meanwhile, as indicated by Corneliussen (above), a

large proportion of biotechnology R&D (which is commonly considered a primary concern in

current debates about dual use life science) occurs in the private sector in particular. The

importance of private sector research with regard to the dual use problem more generally is

indicated by Finlay:

[T]he environment in which proliferation risks occur is shaped largely by the

private sector. Privately-owned companies not only produce and operate nuclear,

chemical, and biological industrial equipment, but they also carry out, by far, the

greatest share of the basic R&D for the relevant technologies, goods, and methods

of application.75

75 Brian Finlay, “Minding Our Business: The Role of the Private Sector in Managing the WMD Supply Chain,” WMD Insights (February 2009), http://www.stimson.org/print.cfm?pub=1&ID=753

57

B3:2 Purposes/Aims of Interventions (Harms and Benefits)

One consensus that has emerged in debates about dual use research governance is that we

should aim to strike a balance between the protection of security, on the one hand, and the

promotion of scientific/technological progress on the other – the idea being that interventions

aimed at protecting against dual use security dangers should not come at too high a cost in

terms of the advancement of science and the benefits (in terms of development of useful

products/technologies) thereby enabled for society. When consideration is given to the

potential need for more interventions at the level of the private sector, the importance of

taking economic benefits into consideration also becomes salient. In addition to striking a

balance between the protection of security and scientific/technological progress, that is, we

should also aim to strike a balance between the protection of security and the

promotion/protection of economic interests – the idea being that interventions (in this case

potentially involving the regulation of industry) aimed at protecting against dual use dangers

should not come at too high a cost in terms of the economic benefits associated with a

flourishing/unhampered (e.g., biotechnology) industry. The importance of striking this latter

kind of balance has been emphasised in regard to the WHO’s revised (2005) International

Health Regulations in particular. These were explicitly designed with the aim to protect

public health against emerging infectious diseases while, at the same time, minimising

potentially negative economic impact that more heavy regulations would be expected to have.

Policy makers recognised that both goals matter, and that neither should be given absolute

priority over the other. The same kind of approach would likewise be apt in the context of

dual use life science regulation.

B:3.2.1 Biotechnology

The importance of the biotechnology industry, meanwhile, should not be underestimated,

either with regard to the societal benefits of emerging biotechnology or with respect to the

economic importance of this sector. It is well known, for example, that the US government

decision to fund the Human Genome Project (which was the largest and most expensive

biological research project at the time it was conducted) was aimed at both kinds of goals.

With regard to the latter, a well known aim of governmental decision makers was to maintain

a competitive advantage over Japan in the emerging biotechnology industry.76

76 Cooke-Deegan, Robert, The gene wars: Science, politics, and the human genome (New York: Norton, 1994); especially Chapter 15.

58

Biotechnology is variously defined/described as “a continuum of different bio-techniques

ranging from non-controversial tissue culture to controversial genetic engineering embodied in

‘modern biotechnology’”77 or “the manipulation of genetic material in living organisms or the

derivatives thereof.”78 “At its simplest”, according to the Biotechnology Industry

Organization (BIO), “biotechnology harnesses cellular and biomolecular processes and puts

them to work for us.”79 Biotechnology is often claimed to be “the leading technology of the

21st century”80 which has “been dubbed the biotech century”81 or “The BioCentury.”82

Existing and/or hoped for applications of biotechnology, inter alia, include:

• Medicine (e.g., vaccines, drugs, diagnostics, genetic therapy, stem cell therapy)

• Agriculture (e.g., crops with greater output, nutritional yield, resistance to

pests/diseases/herbicides, reduced need of water/fertilizer, and/or that have less

environmental impact and/or “increased [production] efficiency (time

management)”83)

• Biofuels (which are sustainable and/or reduce greenhouse gas emissions)

• Means of cleaning toxic waste

In its 2010 report, BIO reported that

Today, there are more than 250 biotechnology health care products and vaccines

available to patients, many for previously untreatable diseases. More than 13.3

farmers around the world use agricultural biotechnology to increase yields,

prevent damage from insects and pests and reduce farming’s impact on the

environment. And more than 50 biorefineries are being built across North

77 Fourth Meeting of the Committee on Sustainable Development (CSD-4) 78 Industrial College of the Armed Forces, Final Report: Biotechnology Industry (Washington D.C.: Industry Study, National Defense University, 2008). 79 Biotechnology Industry Organization, Healing, Fueling, Feeding: How Biotechnology Is Enriching Your Life (Washington, D.C.: BIO, 2010). 80 Fourth Meeting of the Committee on Sustainable Development (CSD-4) 81 Biotechnology Industry Organization, “Banking on Biotech”, Fortune (June 9, 2003). 82 Biotechnology Industry Organization, Healing, Fueling, Feeding: How Biotechnology Is Enriching Your Life (Washington, D.C.: BIO, 2010). 83 Industrial College of the Armed Forces, Final Report: Biotechnology Industry (Washington D.C.: Industry Study, National Defense University, 2008).

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America to test and refine technologies to produce biofuels and chemicals from

renewable biomass, which can help reduce greenhouse gas emissions.84

With regard to the economy, according to the BIO:

The biotech health sector has a vital role in enhancing our competitiveness,

serving as an engine of growth and helping foster a highly skilled workforce that

excels in math and science. The need for a highly skilled workforce in the biotech

health sector creates investments in education and rewarding, portable, high

paying jobs .... The biotech health sector provides an important impact to state

employment rates and economic output, and significant investments in biotech

research and jobs will only continue to increase these impacts to state and national

economies.85

Rapid economic growth in this sector is revealed, inter alia, by a jump in the

Biopharmaceutical Sector from 1,602,698 total supported jobs in 1996 to 3,233,920 in 2006 –

a compound annual growth rate of 7.3%.

BIO reports that

• 1.3 million people were employed in the biotech industry in 2006, and these jobs

generated 6.2 million related jobs throughout the rest of the economy, a job multiplier

of 5.8.

• Biotechnology firms in the United States spent $25.1 Billion on biotechnology

research and development, accounting for 75% of the total biotechnology R&D

expenditures.86

B:3.3 Objects (and Modes) of Intervention

As in the public sector, interventions aimed at private sector research (and, perhaps to a

lesser extent, publication) is presumably relevant and arguably important. But

intervention here would require a substantial revision regarding current practice – and

84 Biotechnology Industry Organization, Healing, Fueling, Feeding: How Biotechnology Is Enriching Your Life (Washington, D.C.: BIO, 2010). 85 Biotechnology Industry Organization, Healing, Fueling, Feeding: How Biotechnology Is Enriching Your Life (Washington, D.C.: BIO, 2010). 86 Biotechnology Industry Organization, Healing, Fueling, Feeding: How Biotechnology Is Enriching Your Life (Washington, D.C.: BIO, 2010).

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dangerous research results in the private sector are at least somewhat less problematic if

they are not routinely made public (as is usually the case in the public sector).

In any case, interventions aimed at control of dual use materials – e.g., pathogens (select

agents), laboratory equipment, cultivation and purification equipment, dispersal

technology and so on – are (and/or would be) key to private sector interventions (as the

private sector partly involves manufacture, trade, and transport of such things).

Particular attention has recently focused on questions about how to control trade in DNA

sequences in the synthetic life sciences (i.e. synthetic genomics and synthetic biology).87

At present there are roughly 50 companies worldwide that produce gene length DNA

sequences for commercial purposes. While some are voluntarily screening orders for

suspect sequences (the worry being that these may be used by malicious actors to

synthesise a bioweapons agent/pathogen), in most countries they are not required to do

so – and there are no widely accepted and/or standardized guidelines about what should

occur when suspect orders are identified. (On some prominent proposals it is not even

suggested that suspect orders should be reported anywhere when they occur, as opposed

to merely being recorded for future reference – i.e., in the event of a bioterrorist attack

with the agent in question.) Some advocates of vendor screening have argued that this

could provide bottom up governance pressure on industry – if scientists adopt a code of

conduct that calls for only buying from vendors that screen, then this would put market

pressure on companies that produce/sell sequences to implement screening. Some

sequence manufacturers, meanwhile, have explicitly expressed desire that there be clear

regulations regarding screening processes.

Another concern is that (even when screening by vendors takes place) it might be

possible for perpetrators to avoid detection by splitting their orders – i.e. ordering part(s)

of the problematic (e.g., select agent) sequence from one company and part(s) of the

problematic sequence from another company (so that thresholds regarding extent/degree

of similarity to select agent genomes are not reached by the screening software/process

of either company) – and then string them together. The worry is that mere screening at

the vendor level may identify orders of concern but miss acquisitions of concern by

those who split orders. This problem could be addressed via the establishment of a (e.g.,

87 Samuel, Gabriella, Selgelid, Michael J., and Kerridge, Ian “Back to the Future: Controlling Synthetic Life Sciences Trade

in DNA Sequences” Bulletin of the Atomic Scientists 66, no. 59-20 (2010).

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global) clearinghouse to which all orders are reported – because such a clearinghouse

could monitor the total acquisitions of buyers (who would need to be registered) from all

suppliers.88

Recent controversy has also surrounded the growing illicit production and trade (e.g.,

via the internet) in botulinum toxin (the most deadly substance known to science),

spurred by its commercial application in cosmetics and the resultant proliferation of

counterfeit botox as described by Raymond Zilinskas at the Dual Use Bioethics

workshop in Canberra in February 2010 and reported in Scientific American.89

Finlay observes that:

The market for therapeutic drugs containing botulinum toxin ... will grow to an

estimated $2.1 billion by 2010. This has led to an explosion of new industry

actors entering the market space, both in the United States and around the globe.

Depending on the integrity of the new entrants, this could have profound

implications for national security. For example, recently, and over the objections

of U.S. lawmakers, Ipsen Pharmaceuticals ... began exporting its botulinum toxin

product into Iran and has since initiated a series of clinical trials in the country,

sharing potentially sensitive dual-use information with Tehran.

[This case] and hundreds others like it, highlight the ease with which states and

terrorists organizations could exploit legitimate businesses up and down the

supply chain to obtain dual-use knowledge and technologies. They also illustrate

the inability of existing control measures to contain this growing threat and the

need to modernize the global nonproliferation toolkit. Most importantly, they

exemplify the growing size and complexity of the market, and the critical role of

private sector collaboration in preventing the proliferation of weapons of mass

destruction (WMD) and managing proliferation risks. In today’s security

environment, a diverse set of forces is gathering, presenting a growing challenge

to the practicality of the existing nonproliferation regime and to governments’

88 Samuel, Gabriella, Selgelid, Michael J., and Kerridge, Ian “Back to the Future: Controlling Synthetic Life Sciences Trade in DNA Sequences” Bulletin of the Atomic Scientists 66, no. 59-20 (2010). 89 Coleman, Ken and Raymond Zilinskas, “Fake Botox, Real Threat,” Scientific American (June 2010).

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ability to prevent proliferation without the determined efforts of the private

sector.90

As noted in other discussions of proliferation and terrorism prevention, the relevance of

the finance sector as an object of intervention should also be considered. Just as “banks

[have been] complicit in activities contributing to proliferation-sensitive nuclear

activities, or to facilitate the purchase of sensitive materials”,91 the same kind of danger

applies to the context of dual use biotechnology.

B:3.4 Modes of Intervention

B:3.4.1 Export Controls

Export controls are the common mechanism for addressing trade and transport of dual

use materials in the private sector. In the United States “[t]he Bureau of Industry and

Security (BIS) of the US Department of Commerce administers the Export

Administration Regulations (EAR), including the Commerce Control List of Dual-Use

Items. The US Department of State’s Directorate of Defense Trade Controls (DDTC)

administers the International Traffic in Arms Regulation (ITAR), which incorporates the

United States Munitions List.”92 (While this “US birfurcation of administrative and

legal controls over dual-use and military-use items is not typical for other developing

countries”,93 the Obama Administration has recently called for a relevant change in

policy (i.e., increased integration).)

With regard to international regimes, the Australia Group is an informal multilateral

export control regime especially concerned with dual use materials related to biological

and chemical weapons.

Biological agents subject to export controls, include viruses, bacteria, fungi, and

toxins which may be harmful to people, plants, and/or animals. An easy reference

90 Brian Finlay, “Minding Our Business: The Role of the Private Sector in Managing the WMD Supply Chain,” WMD Insights (February 2009), http://www.stimson.org/print.cfm?pub=1&ID=753 91 Brian Finlay, “Minding Our Business: The Role of the Private Sector in Managing the WMD Supply Chain,” WMD Insights (February 2009), http://www.stimson.org/print.cfm?pub=1&ID=753 92 Berlack, Evan R. “Strategic Export Controls and the Private Sector”, in Business and Security: Public–Private Sector Relationships in a New Security Environment, eds. Alyson J.K. Bailes and Isabel Frommelt (London: Oxford University Press, 2004) 93 Berlack, Evan R. “Strategic Export Controls and the Private Sector”, in Business and Security: Public–Private Sector Relationships in a New Security Environment, eds. Alyson J.K. Bailes and Isabel Frommelt (London: Oxford University Press, 2004)

63

guide to controlled biological agents, and related production equipment, including

exemptions, is provided at www.australiagroup.net

Although most of the listed agents are considered to be high risk in relation to

biological weapons proliferation, many universities will carry a range of them for

research purposes. The Australian Government does not wish to impede the

exchange of material for legitimate research purposes, but it is important to be

aware that some biological agents are subject to export controls. The potential for

subsequent culture scale-up and misuse makes the unregulated export of live

cultures of particular concern. A range of larger capacity cultivation, harvesting,

purification and preservation equipment and technologies is also controlled.94

In addition to questions concerning the exact lists of materials to be controlled by this and

other export regimes, limitations include the extent to which the Australia Group lacks

coverage – i.e., given that major players such as Russia, China, and India are not participants –

and that “the multilateral export control regimes are voluntary in nature and have no

enforcement mechanisms, relying instead on ‘peer pressure’.”95

Another concern about export control regimes is the apparent lack of awareness and/or

compliance with export regulations (e.g., which require that export licences are

sought/obtained) on the part of industry – and that strengthening requirements and/or

(domestic) enforcement (in the absence of globally harmonized regulations) threatens to put

businesses in participatory countries at a competitive disadvantage. Commentators on export

control measures have warned against governments taking an overly adversarial/coercive

stance with respect to businesses whose cooperation is wanted and that other kinds of

incentives should be sought. Finlay argues that

Regulating a growing and increasingly unwieldy set of private actors is one

component of prevention, but it is not simply a challenge of lack of regulation. In

the past decade alone, the events of September 11, 2001, the breakup of A.Q.

Khan’s one-stop-shopping network, and many other incidents have shown how

bad actors have looked for and exploited market opportunities. The response of

lawmakers around the globe have typically been more of the same: state-centric,

94 Australian Government, Chemical and Biotech Industry Export Controls DPS JUN070/06 (March 2009) 95 Berlack, Evan R. “Strategic Export Controls and the Private Sector”, in Business and Security: Public–Private Sector Relationships in a New Security Environment, eds. Alyson J.K. Bailes and Isabel Frommelt (London: Oxford University Press, 2004)

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supply-side controls, including tighter export controls, restrictions on access to

technology, new measures to forcibly halt the physical transfer of suspected items,

enhanced aviation, port, harbour, and container security, tighter controls on visas

and immigration, and rigorous enforcement of domestic regulations. For private

companies, complying with these new and sometimes uneven regulations, while

paying more for insurance premiums, having to scrutinize their practices, and

being confronted by diminished public perceptions in an uncertain world have all

had a deleterious effect on their overall business environment. According to many

firms, occasionally misguided and excessive government action against terrorism

is more often a greater danger to corporate interests than the potential impact of

terrorist incidents themselves.96

Many of the above noted limitations of export control regimes might be handled well by a

Global Infectious Disease Compact or Treaty97 (though a mere compact might not be strong

enough if international enforcement is needed/wanted) – which could specify enforcement

mechanisms at both international and domestic levels.

B:3.4.2 Education and Training

Calls for research and training of researchers at other (e.g., public) research institutions could

likewise apply to the private sector, and at least some commentators have explicitly advocated

this. Incorporation of relevant education at the undergraduate and postgraduate level – and

establishment of codes of conduct by professional societies – would, in any case, hopefully

raise awareness and help shape a culture of responsibility in the private sector.

Revill and Mancini claim that

The role of industry in education could also prove a valuable intervention point

for biosecurity education. Like academies of science, the biotechnology industry

is likely to have greater sway upon science students than are social scientists or

policymakers who, in some cases, are already perceived as overly burdening and

constraining scientific research. Moreover, such a process could present benefits

96 Brian Finlay, “Minding Our Business: The Role of the Private Sector in Managing the WMD Supply Chain”, originally published in WMD Insights, February 2009, available at http://www.stimson.org/print.cfm?pub=1&ID=753

97

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and opportunities for corporations to demonstrate a commitment to social and

ethical responsibility.98

B:3.4.3 Countermeasures

Countermeasures are wanted to detect and protect against dangers of a potential bioterrorist

attack (or use of biological weapons by state actors) – i.e. to minimise harm in the event that

malicious use of dual-use science and technology takes place. Industry could obviously play

an important role in the development of such countermeasures but may currently lack

sufficient incentives to develop such measures given the hypothetical nature of the threat in

question and the resultant lack of an existing clear market for things that would be wanted

when and if such an event were to occur.99 Versions of incentive schemes such as Advanced

Purchase/Market Commitments100 and/or Pogge’s Health Impact Fund101 proposal might be

devised to incentivise this kind of R&D in the absence of other/existing market incentives.102

B:3.4.4 Summary of Policy Options

In relation to policy development, we have drawn up the tables below which summarise and

taxonomies various policy interventions in relation to dual use issues.

As noted in Section 2, policy regarding dual use can be understood as existing within the

following background structure. The tables below are reflective of this structure.

98 Revill, James and Giulo Mancini, “Implementing and Measuring the Efficacy of Biosecurity and Dual-use Education”, in Education and Ethics in the Life Sciences: Strengthening the Prohibition of Biological Weapons, ed. Brian Rappert (Canberra: ANU E Press, 2010):, http://epress.anu.edu.au/education_ethics/pdf_instructions.html (25 January 2010) 99 Rob Floyd, in conversation, has previously mentioned the importance of this issue.

100 Kremer, Michael and Rachel Glennerster. Strong Medicine: Creating Incentives for Pharmaceutical Research on Neglected Diseases (Princeton, NJ: Princeton University Press, 2004). 101 Hollis, Aidan and Thomas Pogge. The Health Impact Fund: Making New Medicines Accessible for All (Incentives for Global Health, 2008). 102 Thomas Pogge, in conversation, has indicated that he and colleagues are currently working on ways to amend the HIF proposal to address the need to incentivise R&D of drugs that would be needed to protect against hypothetical threats like this.

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TABLE 3: THE PRIVATE SECTOR: RESPONSIBILITIES ATTACHING TO INSTITUTIONAL ACTORS

Employees – Lab workers

Employees – Scientists

Employees – Management

Biosafety & BiosecurityCommittees

Firms Shareholders Suppliers/ Customers

Professional Association

Industry Association

Independent Authority

Funding bodies

Research Project (review)

X X X X X X X X

Publication review and/or censorship/ constraint r/e dissemination

X X X X X X X

Physical Safety & Security: Regulatory Compliance

X X X X X X X X X X

Personnel Security (e.g., background checks)

X X X

Awareness Raising Training/Education

X X X X X X X X X X

Dual Use Policy Making

X X X X X X

Accountability Systems, e.g. complaints/discipline system, code of conduct, audit system, monitoring system

X X X X X X X

Conduct of Accountability Processes, e.g. audits, monitoring, discipline

X X X X X X X X X X

Trade and Transport Rules (compliance)

X X X X X X X X X

Countermeasure R&D

X X X X X X

Table 3 identifies a range of responsibilities with respect to dual use issues that arise in the private sector and that attach to relevant institutional

actors. Private sector considerations regarding dual use issues are critical because a large proportion of (if not most) dual use research

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presumably occurs in the private sector (which is usually not subject to routine oversight mechanisms employed in university settings) –and

because private companies are commonly involved in the manufacture, trade, and transport of dual use materials. The column headings name

some of the key institutional actors, e.g. employee lab workers, scientists, and managers. The side heading for each row (on the left hand side of

the table) names an institutional responsibility that (where an ‘X’ appears) the actors named in the columns have, or ought to have. In addition to

responsibilities of actors in the university sector, key private sector responsibilities include those associated with trade and transport regulations

(e.g., export controls). The responsibility to develop countermeasures against biological attack is shared by both the university and the private

sector – and this kind of R&D would/should sometimes involve public-private partnerships. Because countermeasure R&D (e.g., of new

vaccines, antibiotics, and anti-virals) would need to be incentivised (especially in the private sector), funding bodies may have an especially

strong responsibility regarding countermeasure R&D in particular. Although many firms do not currently employ biosafety committees like

those (usually required) in the public/university sector, this table reflects the recommendation that such committees should be established in the

private sector.

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B:4 ETHICS, REGULATION AND GOVERNMENT

This final section of Part B of this report concerns the role of government, both at a national

and an international level, with respect to the ethics and regulation of dual use issues. The

section will make use of key elements of the prior discussion of dual use research in

universities and the private sector. Moreover, it will conclude with a set of recommendations

for further consideration.

A number of key ethical and regulatory issues in respect of dual use research conducted in

universities and private firms – and, for that matter in government laboratories – have

emerged from the discussion in previous sections. Moreover, in these earlier sections we also

identified the responsibilities of a number of institutional actors in the universities and the

private sector who could and perhaps should intervene in relation to various objects of dual

use concern (including existing pathogens, novel processes in synthetic biology (e.g. DNA

sequencing), personnel risks, and safety and security procedures (e.g. in laboratories)), and do

so using a variety of modes of intervention ranging from awareness raising, training and

education through to censorship and other forms of prohibition.

However, we have not explicitly dealt with the responsibilities of governments, and

governments have a key role to play not only directly via legislation and regulation but

indirectly via ensuring that universities, private firms, professional associations and other

institutions discharge their responsibilities. Governments also have a crucial role contributing

to the development of policies that addresses dual use concerns. And, of course, governments

act at an international, as well as a national, level.

In what follows we address the key ethical and regulatory issues (both problems and possible

solutions) identified in earlier sections. These issues are: impermissible research, codes of

conduct, physical safety and security, the control via licensing/screening etc. of dual-use

technologies and techniques, education and training, personnel security, censorship,

professionalization, and the establishment of an independent authority.

B:4.1 Impermissible Research

In relation to the responsibilities of institutional actors, a key area of prior concern is the

allocation of responsibilities with respect to permissible and impermissible research. Who is

to be the decision-maker in relation to determining whether or not an instance of an identified

type of experiment of concern is permissible or impermissible? The candidates for decision-

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maker are: the individual researcher; the specific institution hosting the research project in

question, i.e. a university, corporation or government research centre; an independent

authority; the government. In the case of the university, the decision-maker would presumably

be a collegial body comprised of relevant scientists (at least).

As we have seen, freedom of inquiry is a human right that finds institutional expression in

universities in the form of academic freedom. In the context of a liberal democracy there is a

presumption against governmental restriction of human rights, including in the name of

protecting other human rights. Moreover, arguably progress in science is importantly

dependent on academic freedom. Thus the development of counter-measures to existing

bioterrorist threats might rely on a high degree of scientific freedom. As we have seen above,

the question of whether research is morally permissible or impermissible is an extremely

difficult issue, and it is by no means obvious who the ultimate decision-maker ought to be.

However, there is one area in which there is agreement both with respect to the

impermissibility of the research and with respect to the centrality of the role of governments,

namely, the development of biological weapons. In relation to grey areas we have floated the

idea of an independent authority (see below).

B:4.1.1 Biological Weapons Convention

Given the general threat to public health posed by transmissible pathogens, and given that

biological agents can be used as WMDs in the hands of state actors, terrorist groups and

criminal organisations, there is an imperative to strictly regulate the development, production,

stockpiling, weaponisation and use of pathogens. At the international level, a key instrument

in this regard is the Biological Weapons Convention (BWC) – more precisely, Convention on

the Prohibition of the Development, Production and Stockpiling of Bacteriological

(Biological) and Toxin Weapons and on Their Destruction. (Signed at London, Moscow and

Washington on 10th April 1972; Entered into force on 26th March 1975; Depositories – UK,

USA and Soviet governments.)

The general aim to which the BWC is directed is, “for the sake of mankind, to exclude

completely the possibility of bacteriological (biological) agents and toxins being used as

weapons. Convinced that such use would be repugnant to the conscience of mankind and that

no effort should be spared to minimise this risk.”

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In accordance with Article 1 of the BWC, “Each State Party to this Convention undertakes

never in any circumstances to develop, produce, stockpile or otherwise acquire or retain:

1. Microbial or other biological agents, or toxins whatever their origin or method of

production, of types and in quantities that have no justification for prophylactic,


2. Weapons, equipment or means of delivery designed to use such agents or toxins for

hostile purposes or in armed conflict.”

While the BWC is an important step in relation to its stated aims of prohibiting and

eliminating the possibility of using biological agents as weapons, it has a number of possible

loopholes and lacunae.

The BWC evidently has requirements regarding technology transfers from prohibited to non-

prohibited purposes and vice-versa.103 For example, technology transfers from non-prohibited

purposes, eg. prophylactic, to prohibited, eg. military offensive, are prohibited under all

circumstances.

However, the BWC does not make a formal distinction between civilian and military

purposes. Indeed, in speaking of “protective purposes” (clause 1, above) the BWC seems to

allow protective military purposes. This has the consequence that a technology transfer from

civilian to military is allowable, if the latter purpose is protective and not offensive. But now

an issue arises as to what counts as protective, as opposed to offensive.

Moreover, the BWC does not provide for any robust verification processes, eg. unlike the

Chemical Weapons Convention (CWC) there is no international organisation or national

authority to verify compliance with the BWC. It is evident that there is a need to implement

robust verification procedures as a matter of urgency, and that this is primarily the

responsibility of governments, albeit professional bodies and the like have an ancillary

advocacy role.

B:4.2 Codes of Conduct

Science codes of conduct may play important roles in raising awareness about the dual use

phenomenon, requirements of relevant weapons conventions, and scientists’ social

103 Zanders, Jean Pascal, “Introduction,” Minerva 40, no. 1 (2002): 9.

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responsibilities. Development and adoption of appropriate codes of conduct may facilitate the

winning of public trust in the scientific enterprise and the avoidance of overregulation by

government. Codes of conduct could potentially be voluntary or enforced (by research

institutions, professional societies, and/or government).

While codes of conduct may play valuable roles in dealing with problems posed by dual-use

science and technology, they also have limitations. One common critique of codes of conduct

points to challenges regarding their level of specificity. One point is that any science code of

conduct that would be generally acceptable to all sciences and scientists would presumably be

one which merely listed uncontroversial commonsense precepts that conscientious people

would presumably seek to follow whether or not they were enshrined in codes of conduct. A

second point is that any science code of conduct that was general enough to apply to all

sciences may lack sufficient detail to clearly prescribe action in the specific contexts of

particular sciences. While a response to the second concern may be the idea that different

sciences need their own codes of conduct, a proliferation of potentially conflicting codes may

then arise and raise questions about which has ultimate authority. In any case, according to

critics, the more specific detail that is put into codes (for any particular sciences) to make

them more clearly prescriptive about who should do what under what circumstances, the more

controversial and less widely accepted they would be.

A second major critique of science codes of conduct holds that, unless they are enforced,

codes of conduct will be ineffective. The point here is simply that those who would do the

kinds of things ruled out by codes of conduct are precisely the kinds of people that would not

follow (voluntary) codes of conduct to begin with. To be truly effective, according to many,

codes of conduct must be enforced by sanctions.104

B:4.3 Mandatory Physical Safety and Security Regulation

Should there be regulations providing for mandatory physical safety and security of the

storage, transport and physical access to samples of pathogens, equipment, laboratories etc.?

The answer is presumably in the affirmative.

104 This section draws from Selgelid, Michael. “Dual-Use Research Codes of Conduct: Lessons from the Life Sciences.” Nanoethics 3 (2009): 175–183.

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In theory, the specific content of these regulations might be determined either by a

government agency, an independent authority, a professional association of scientists or the

specific institution hosting the research programs in question. However, governments bear the

ultimate institutional and moral responsibility for the safety and security of their citizens,

including the researchers themselves, in so far as that safety and security is a matter of the

physical conditions under which potentially harmful (albeit permissible) research is to be

undertaken and the physical elements thereof stored, transported etc. Accordingly, the

government would at least need to be able to satisfy itself that the regulatory system,

including the regulations and their enforcement mechanisms, governing the physical safety

and security of dual-use experimentation are adequate.

The application of many of these regulations could be undertaken by, for example, biosafety

committees operating at the institutional level, e.g. a university-based biosafety committee

(expanded into a biosafety-biosecurity committee). However, these committees would need in

turn to be accountable to government (perhaps via an independent authority).

B:4.4 Control via Licensing/Screening etc. of Dual-Use

Technologies/Techniques

Should there be mandatory licensing and other controls of dual-use

technologies/techniques/DNA synthesisers/pathogen samples? Only certain laboratories in the

public sector and the private sector might be licensed to engage in research involving the use

of certain dual-use technologies. For example, laboratories that undertake genetic engineering

of pox viruses would have the means to make recombinant smallpox viruses. Similarly,

researchers studying influenza virus and using reverse genetics could easily construct a 1918

flu virus with available information.

The establishment of a licensing authority to conduct such a licensing process would be a

significant addition to the mechanisms available to contain the dangers associated with the

dual-use dilemma. However, it raises a number of important questions. One set of question

concerns the criteria that the licensing authority would deploy in its licensing process. Is there

a presumption in favour of granting a licence; the criteria having been framed for the sole

purpose of eliminating licence applicants that are manifestly unable to provide a safe and

secure research environment? Are the criteria to be used to determine the issuing of licences

objective and publicly available? Another set of questions pertains to the status and make-up

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of the licensing authority; is it, for example, independent of government in the sense that its

decisions are binding and not able to be overridden by government?

These questions are important in the context of the concerns one might have in relation to

government interference with freedom of intellectual inquiry (who decides what is

permissible research?) and freedom of speech/dissemination of research findings (who

decides what research findings can be disseminated and to whom?). The point is that a

licensing authority could be given, at least in principle, powers that would in effect override

human rights to freedom of intellectual inquiry and freedom of dissemination (and associated

rights to academic freedom) by licensing, say, only government research centres. However, a

solution to this problem is possibly provided by the establishment of an independent authority

(see below).

As discussed above in Section 3, an important security issue has arisen in relation to trade in

(synthesised) DNA sequences.

There is a growing industry in the commercial production/distribution of made-to-order

sequences and an associated dual use danger, namely, the possibility that would-be

bioterrorists acquire the sequences necessary to produce biological weapons pathogens (such

as smallpox, which they would otherwise lack easy access to) from such companies.

Accordingly, there is a need for screening of orders. However, mere vendor-level screening

may fail to identify (and thus prevent) “acquisitions of concern” since a would-be bioterrorist

could order part(s) of the desired sequence from one vendor and part(s) of the desired

sequence from (an)other vendor(s) and thus acquire a problematic set of sequences without

triggering “hits” via the screening done by any given vendor. To identify and prevent

“acquisitions of concern” it might thus be necessary for vendors to report all orders to a

central (international) clearinghouse--which would screen the total set of sequences being

ordered (from all vendors) by any given purchaser for problematic matches with pathogen

sequences. At the more restrictive end of the spectrum, policy would require that approval

from such a clearinghouse is sought, and obtained, before any given order is filled.105

105 For more on the idea of a clearinghouse, see Samuel, Gabriella, Selgelid, Michael J., and Kerridge, Ian “Back to the

Future: Controlling Synthetic Life Sciences Trade in DNA Sequences” Bulletin of the Atomic Scientists 66, no. 59-20

(2010).

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A final point regarding licensing concerns the mode of regulation. While licensing relates to

export controls on dangerous materials, the NSABB has argued that the current mode of such

regulation – which largely relies on lists of Select Agents (i.e. especially dangerous pathogens

with biological weapons potential) – may need to be revised.106 Rather than relying on lists of

particular pathogens/agents, according to NSABB, we may need a more “functional”

approach that also, for example, captures genetic sequences coding for especially dangerous

functions.

B:4.5 Mandatory Education and Training

Given the potential harms arising from the eleven identified types of experiments of concern

it is clear that some process of education and/or training for relevant researchers and other

personnel is called for. There is a question as to the precise content of such education and

training. However, at the very least those working in laboratories would need to have received

safety and security training in relation to the physical safety and security of the storage,

transport and physical access to samples of pathogens, equipment, laboratories etc. In

addition, there is a need to ensure that editors and others responsible for the dissemination of

potentially harmful information are aware of the issues in relation to dual-use research

findings. In short, some forms of mandatory education and/or training are justified. What the

precise content of such education/training programs ought to be, and who ought to be

responsible for their provision, remain open questions. However, it is an institutional and

moral responsibility of government to ensure that minimal training/education programs in

relation to potentially harmful dual-use research and dissemination of dual-use research

findings are being provided (even if not by government itself).

B:4.6 Mandatory Personnel Security Regulation

Physical safety and security of a research environment, including access by non-authorised

persons, e.g. potential thieves, is one thing; however, personnel security in relation to

researchers, e.g. background checks, screening of researchers in relation to any history of

mental illness, political affiliations with extremist groups etc., is quite another. Doubtless it is

106 C/f National Science Advisory Board for Biosecurity. Addressing Biosecurity Concerns Related to the Synthesis of Select

Agents (Washington, D.C.: NSABB, June 2006),

http://oba.od.nih.gov/biosecurity/pdf/Final_NSABB_Report_on_Synthetic_Genomics.pdf (27 January 2011).

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prudent, indeed it is a moral requirement, that access to virulent pathogens be disallowed to a

researcher diagnosed as a psychopath or to a known member of a terrorist organisation. On

the other hand, other things being equal, government officials prying into the lives of

university students enrolled in degrees in the biological sciences is an unwarranted intrusion

of civil liberties. Here, as elsewhere, the devil is in the detail, and there is a need for specific

policies to be framed in the light of a range of human rights, academic and scientific

considerations as well as security concerns.

One way forward here might be to develop a system of security checks for personnel working

in licensed laboratories but (absent special considerations) not for other research personnel.

B:4.7 Censorship/Constraint of Dissemination

As we have seen above, the question of whether research findings ought to be freely

disseminated, censored or their dissemination in some lesser way restricted is an extremely

difficult issue and it is by no means obvious who the ultimate decision-maker ought to be.

Freedom of speech and freedom of dissemination of knowledge are human rights that find

institutional expression in universities in the form of academic freedom. In the context of a

liberal democracy there is a presumption against governmental restriction of human rights,

including in the name of protecting other human rights. Moreover, arguably progress in

science is importantly dependent on scientific – and, therefore, academic – freedom. On the

other hand, restrictions on the dissemination of new scientific research that is likely to

facilitate the malevolent purposes of bioterrorists is warranted.

A relevant important distinction here is that made above between 1st tier (i.e., most

dangerous) and 2nd tier (i.e., less dangerous) dual-use research. For example, 1st tier research

findings might need to be disseminated in such a way that anyone being informed of these

findings would not be able to replicate the experiments that enabled the results reported in the

findings. (It goes without saying, nevertheless, that experiments would need to be replicated

(by those with adequate security clearance) to the extent necessary to ensure scientific

verification.)

A final point here is that given the status attached to numbers and quality of publications by

scientists – and the corresponding connection between status seeking behaviour and scientific

advancement – censoring or otherwise restricting the dissemination of scientific work may to

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a corresponding extent undermine scientific advancement, unless alternative reward structures

for the scientists in question are developed, e.g. monetary payments, medals.

B:4.8 Professionalisation

Life science disciplines could be professionalized in a manner similar to medicine and

engineering. Professionalization is a middle position between top-down and bottom up

science governance strategies, and, according to Weir and Selgelid, would involve something

along the lines of the following:

In most jurisdictions a profession is a legally mandated association granted a

monopoly over specialized practices, a delimited authority delegated by sovereign

states. Professional organizations require statutory legislation that constitutes

colleges with broad powers. The officers of the colleges are elected by members

of the college and are expected to become advocates for the profession. All

professional practitioners are licensed and belong to an association/college which

sets standards of practice for its members. To be licensed a practitioner must

undergo education and training required by the college and, increasingly, ongoing

education. The registrars of colleges license practitioners and may also initiate

hearings into the professional conduct of licensed practitioners, hearings that may

order anything from dismissal of the charges to delicensing of the practitioner.

The legal structure and powers granted a profession are intended to align expert

practices with the public good.107

Potential advantages of professionalization as a governance strategy may include the

following:

[P]rofessionalization breaks with the strong polarization between science-

community-based and state-based regulation that has characterized so much

discussion ... The combination of legislated mandate and collegial self-governance

provides a flexible mechanism of professional accountability for a profession as a

whole and for its individual practitioners. Second, professionalization is a strategy

for constructing the [life scientist] as a responsible subject. This would extend and

formalize already existing community discussion about integrating scientific

107 C/f Weir, Lorna and Selgelid M.J., “Professionalization as a Governance Strategy for Synthetic Biology,” Systems and Synthetic Biology 3 (2009): 91–97

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practice with ethical and social obligations. A profession defines the fiduciary

responsibilities of practitioners to clients and of the profession to public good. It

assures adequate educational standards for its practitioners both at the point of

licensing and through educational programmes after licensing. Professions act to

create competent practitioners and to deal with incompetent ones. By these means

professions socially demonstrate that their practitioners are adhering to the ethical

obligations with which they have been entrusted. Third, professionalization is

linked to the formation of an ethos. By ethos we mean the sense of attachment and

commitment that persons feel to the groups of which they form part. The

formation of a professional ethos for [life science disciplines] would involve the

emergence of a distinctive way of thinking and feeling for members of that

profession. The professional ethos would also orient [life scientists] to their work

as an ongoing ethical task.108

In the context of dual use life science, professional societies could, inter alia, play a key role

in the establishment, promulgation and enforcement of codes of conduct (e.g., requiring

referral of studies and/or publications to relevant review boards). Given the involvement of

engineering in synthetic biology, the professionalization of synthetic biology may be

especially apt (given precedents of professionalization of engineering disciplines).109

B:4.9 An Independent Authority

In the light of security requirements, on the one hand, and the need to protect academic and

scientific freedom on the other, arguably, an independent authority ought to be established.

Such an authority would be independent of both the research institutions (universities,

corporations and government research centres) and government. This independent authority

would comprise scientists, security experts (including those with the highest feasible level

security clearance) and ethicists. Indeed, it may well be that this independent authority should

have as part of its remit to consider: (a) wider safety and security issues in the biological

science, i.e. not simply dual use concerns; (b) safety and security issues (including but not

108 C/f Weir, Lorna and Selgelid M.J., “Professionalization as a Governance Strategy for Synthetic Biology,” Systems and Synthetic Biology 3 (2009): 91–97. 109 C/f Weir, Lorna and Selgelid M.J., “Professionalization as a Governance Strategy for Synthetic Biology,” Systems and Synthetic Biology 3 (2009): 91–97.

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restricted to dual use concerns) in related scientific areas such as nanotechnology, i.e. should

consider safety and security issues in the biological and converging sciences.

This independent authority would have ultimate decision-making powers in relation to both

the conduct of dual-use research and the dissemination of dual-use research findings.

Moreover, it might also be responsible for issuing licenses to laboratories in relation to dual-

use technologies (and providing for personnel security). Other things being equal, decisions of

this independent authority would not be able to be overridden by government. Naturally, other

things might not be equal. For example, the decisions of the independent authority would

have to comply with regulations enacted by government; to this extent it would be

accountable to government.

In addition, this independent authority might have an accountability role on behalf of

government in relation to the application of government regulations in respect of physical

safety and security, and dual-use education and training. Its determinations in these respects

would not be final; rather these determinations would have the status of advice to

government.

Under this arrangement researchers might be required to submit any research proposals falling

within categories of concern to IBCs for review; and they would be required to submit any

research findings which end up falling within categories of concern to IBCs after the fact (i.e.

if a relevant dual-use discovery is unexpectedly made). In cases where sufficient dangers of

experimentation or of information dissemination are foreseen, the IBCs will refer the studies

to the independent authority for determination.

It is important to note that even under this form of meta-regulation the independent authority

would have the power to intervene at any lower level, including overturning decisions at the

lower level and auditing the work of the IBCs. In effect, this independent body would have

the ultimate authority to determine what was permissible or impermissible dual-use research,

and to determine whether and in what form dual-use research findings could be disseminated.

In addition to the research screening process described above, a national code of scientific

conduct including statements analogous to the American Medical Association’s (AMA’s)

Guidelines to Prevent the Malevolent Use of Biomedical Research would be developed by the

independent authority. The code would include the requirement that scientists refer any

research or research findings that falls within the eleven categories of experiments of concern

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to IBCs or other institutional ethics committees for determination. The code of conduct would

be legally binding and apply to those working in industry as well as academia.

The advantage of an independent authority would be that there is a decision making body

embodying both the scientific and the security expertise required for rigorous analysis of the

security risks of research and of publication. The development of a code of conduct would

help to ensure that any research falling within the category of types of experiments of concern

will be sent for adjudication by those with more expertise than the (ordinary, educated)

researcher. IBCs’ and ethics committees’ members will receive advanced training. The

independent authority’s members will have the highest degree of relevant expertise, and the

independent authority will embody scientific and security expertise. The lower level

committees (i.e., IBCs) will, as necessary, refer especially difficult cases to the independent

authority for final judgment. On the other hand, an enforceable code of conduct with similar

benefits could be developed by the relevant professional association and applied by the IBCs

(see below).

Because ultimate decision making authority in problematic cases will not lie in the hands of

either the individual researcher or the individual institution (or collegial committee of

scientists, in the case of universities), previously mentioned problems regarding bias and

conflicts of interest will be addressed. If the independent authority is appropriately

constituted then it is less likely that its decisions would be biased towards either the

promotion of science, freedom of inquiry/expression, or towards the promotion of security.

Finally, the two-tiered screening procedure would ensure a degree of efficiency: the

independent authority would make determinations only in a fraction of cases, since IBCs

would make determinations in the bulk of cases.

The disadvantage of such an independent authority is that this takes decision making authority

out of the hands of individual researchers/editors and out of the hands of collegial committees

of scientists, at least in the case of dual-use research and dissemination of the findings of

dual-use research falling within categories of concern. Accordingly, individual intellectual

freedom, freedom of dissemination, and academic freedom are thereby diminished. Moreover,

there may well be adverse effects on the progress of science. Also there is likely to be a cost

to such a process and for the running of the independent body, and one would question the

benefits of such a body in terms of efficiency and equity.

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The possibility that publication would be prohibited in certain areas of potentially important

research would deter scientists from working in such areas insofar as rewards and recognition

associated with publication and other forms of dissemination (such as conference

presentations) would be less certain. It is not unlikely that progress in areas of science

important to the promotion of both human health and security/defence would be stalled as a

result. Because it will not be determined if publication, for example, is permitted until after

research takes place, researchers will avoid pursuit of projects where the likelihood of

prohibition on publication (or other forms of dissemination) is greatest despite the importance

of much of this research.

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TABLE 4: REGULATION OF, AND OTHER INTERVENTIONS IN RELATION TO, PERSONNEL ENGAGED IN DUAL USE ACTIVITIES

Scientists Students Laboratory Assistants Managers (Firms) Employees (Firms) Academic Editors Mass Media – Editors, Journalists

Subject to Screening/Background Checks

X X X X X

Registration X X Awareness Raising X X Training X X Education X X X Codes of Conduct X X Subject to Accountability/Oversight, e.g. audits, monitoring,

X X X X X X X

The range of personnel engaged in dual use activities, such as dual use research, production of dual use technology, distribution of materials used in dual use experiments, dissemination of dual use research findings and so on, is quite broad. The column headings name some of these various categories of personnel, e.g. scientists, managers of commercial firms providing DNA synthesising services, editors of publications disseminating dual use research findings. The side headings for each row (on the left hand side of the table) names a mode of intervention, e.g. registration, training. Thus scientists (first column) engaged in dual use research are, or ought to be, subjected to background checks (first row), registration (second row) and an educative process in relation to dual use issues (fifth row).

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TABLE 5: RESPONSIBILITIES OF NATIONAL AND INTERNATIONAL GOVERNMENTAL AND NON-GOVERNMENTAL ACTORS

National

Governments

International

Governmental

Organisations

Relevant Non-

Governmental

Organisations

Professional

Associations

Multinational

Corporations

International Treaties and Agreements X X

Dual Use Policy Making X X

Prevention/defence

(police/security agencies)

X X

Criminal investigation X X X

Countermeasures X X X X

Rules for Research: Screening, Behaviour, Funding, Publishing X X X X

Physical Safety & Security X X X

Trade and Transport Rules X X X

Awareness Raising, Education and Training X X X X

Accountability Systems, e.g. complaints/discipline system, code

of conduct, audit system, monitoring system

X X X

This table deals with a range of responsibilities with respect to dual use issues that arise in national and international governmental and non-governmental actors. The column headings name some of the main governmental and non-governmental actors. First there are the sovereign national governments. These governments cooperate in a multitude of International Governmental Organisations such as the UN, UN related organisations as WHO and UNESCO, furthermore regional organisations as the EU and other specialised organisations as OECD, but also NATO. A third group consists of relevant international as well as national Non-governmental Organisations: International Committee of the Red Cross, Inter Academic Panel, international peace movements etc. The group of (international) professional organisations is of great relevance for dual use issues. Organisations as the World medical association (and national Medical associations), the International Union of Microbiological Societies have been very helpful in developing dual use policy. Last but not least there is an important role for multinational corporations in this field (pharmaceutical and biotechnology industry).

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The side heading for each row (on the left hand side of the table) names a responsibility that the actors named in the columns have, or ought to have in relation to political and ethical concerns arising from dual use activities. In relation to (non)-governmental organisations these responsibilities can be distinguished.

National governments have developed a range of international treaties and agreements to reduce the risks of biological weapons and to promote biosecurity. These treaties and agreements are translated in national and international dual use policy making measures (e.g. by legislation).Governments have special responsibilities in preventing misuse of biological agents by methods of prevention, intelligence and defence. And if incidents take place there is the task of criminal investigation. Also developing and taking countermeasures (e.g. developing/deploying vaccines) are tasks of the public sector.

In relation to (possible) dual use research more specific regulation is developed: rules for screening, appropriate behaviour, funding, publishing etc.

Special attention is given to physical safety & security by introducing or strengthening measures that can guarantee this safety and security. Biological Science is a global activity. This means that there is a lot of international trade and transport as well as international visits and conferences. Because of that trade and transport rules are of eminent importance. Awareness is the alpha and omega of biosecurity. Because of that national and international governmental and non-governmental organisations have to pay attention to awareness raising, education and training. Last but not least accountability systems have to be developed in order to take care of the compliance of involved parties and persons of the relevant regulations. Audit and monitoring systems may be needed for enforcing compliance.

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B:5 RECOMMENDATIONS FOR CONSIDERATION

In the light of the previous discussion, we have compiled the following list of

recommendations for further consideration in relation to addressing dual use concerns in

the biological sciences.

(1) Mandatory awareness raising, training, and education, as required (see table 4).

(2) Extend the remit of existing biosafety committees in universities to include

biosecurity issues.

(3) Require commercial firms to establish biosafety/biosecurity committees.

(4) Develop enforceable professional codes of conduct for relevant personnel (e.g.,

scientists).

(5) At the national level, establish an independent authority to deal with safety and

security issues in biological/converging sciences including, but not restricted to,

dual use issues.

(6) Select agent rules should be revised to be based on functionality rather than lists

of agents.

(7) Governments should make/implement an international/multilateral agreement

regarding safety and security issues in the biological sciences, including but not

restricted to, dual use issues.

(8) National legislation and protocols regarding safety and security issues in the

biological sciences, including but not restricted to dual use issues, should be

standardised and harmonised. (E.g., export controls should apply worldwide.)

(9) Control over buying and selling of DNA sequences and/or other dual use

materials should be overseen by an international clearinghouse established

under a multilateral agreement (i.e., all orders would need to be reported to, and

approved by, the clearinghouse).

(10) Verification procedures should be added to Biological and Toxins Weapons

Convention.

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(11) Dual use measures will be periodically reviewed/revised at the institutional,

national, and international level.

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APPENDIX110

KEY LAWS, REGULATIONS AND CODES

GLOBAL/INTERNATIONAL

Protocol for the Prohibition of the use in war of Asphyxiating Poisonous or Other Gases,

and of Bacteriological Methods of Warfare (1925)111

The undersigned Plenipotentiaries, in the name of their respective Governments:

(Here follow the names of Plenipotentiaries)

Whereas the use in war of asphyxiating, poisonous or other gases, and of all

analogous liquids materials or devices, has been justly condemned by the general

opinion of the civilized world; and

Whereas the prohibition of such use has been declared in Treaties to which the

majority of Powers of the world are Parties; and

To the end that this prohibition shall be universally accepted as a part of

International Law, binding alike the conscience and the practice of nations;

Declare:

That the High Contracting Parties, so far as they are not already Parties to Treaties

prohibiting such use, accept this prohibition, agree to extend this prohibition to

the use of bacteriological methods of warfare and agree to be bound as between

themselves according to the terms of this declaration.

The High Contracting Parties will exert every effort to induce other States to

110 This appendix was compiled by Koos van der Bruggen 111 International Comission for the Red Cross. Protocol for the Prohibition of the Use of Asphyxiating, Poisonous or Other Gases, and of Bacteriological Methods of Warfare (Geneva, 17 June 1925) http://www.icrc.org/ihl.nsf/FULL/280?OpenDocument (25 Jan 2011)

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accede to the present Protocol. Such accession will be notified to the Government

of the French Republic, and by the latter to all Signatory and Acceding Powers,

and will take effect on the date of the notification by the Government of the

French Republic.

The present Protocol of which the French and English texts are both authentic,

shall be ratified as soon as possible. It shall bear today's date.

The ratifications of the present Protocol shall be addressed to the Government of

the French Republic, which will at once notify the deposit of such ratification to

each of the Signatory and Acceding Powers.

The instruments of ratification and accession to the present Protocol will remain

deposited in the archives of the Government of the French Republic.

The present Protocol will come into force for each Signatory Power as from the

date of deposit of its ratification, and, from that moment, each Power will be

bound as regards other Powers which have already deposited their ratifications.

In witness whereof the Plenipotentiaries have signed the present Protocol.

Done at Geneva in a single copy, the seventeenth day of June, One Thousand

Nine Hundred and Twenty-Five.

Biological and Toxin Weapons Convention (BTWC)112

The Convention on the Prohibition of the Development, Production and Stockpiling of

Bacteriological (Biological) and Toxin Weapons and on their Destruction, commonly

known as the Biological Weapons Convention (BWC) or Biological and Toxin Weapons

Convention (BTWC), opened for signature in 1972 and entered into force in 1975. It was

the first multilateral disarmament treaty banning an entire category of weapons. It

effectively prohibits the development, production, acquisition, transfer, retention,

112 United Nations. Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction (10 April 1972), http://www.unog.ch/80256EDD006B8954/(httpAssets)/C4048678A93B6934C1257188004848D0/$file/BWC-text-English.pdf (25 January 2011)

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stockpiling and use of biological and toxin weapons and is a key element in the

international community’s efforts to address the proliferation of weapons of mass

destruction.

States Parties to the Biological Weapons Convention undertake "never in any

circumstances to develop, produce, stockpile or otherwise acquire or retain:

1. microbial or other biological agents, or toxins whatever their origin or method of

production, of types and in quantities that have no justification for prophylactic,


2. weapons, equipment or means of delivery designed to use such agents or toxins

for hostile purposes or in armed conflict."

As a result of prolonged efforts by the international community to establish a new

instrument that would supplement the 1925 Geneva Protocol, the Convention on the

Prohibition of the Development, Production and Stockpiling of Bacteriological

(Biological) and Toxin Weapons and on their Destruction, better known as the Biological

Weapons Convention (BWC), opened for signature on 10 April 1972. The BWC, the first

multilateral disarmament treaty banning the production and use of an entire category of

weapons, entered into force on 26 March 1975. Over the intervening years, increasing

numbers of States joined the Convention, which currently has 155 States Parties and 16

Signatory States. The BWC effectively prohibits the development, production,

acquisition, transfer, stockpiling and use of biological and toxin weapons and is a key

element in the international community’s efforts to address the proliferation of weapons

of mass destruction

Guidelines For Transfers of Sensitive Chemical or Biological Items (Australia Group)113

The Australia Group (AG) is an informal forum of countries which, through the

harmonisation of export controls, seeks to ensure that exports do not contribute to the

113 The Australia Group. Guidelines for Transfers of Sensitive Chemical or Biological Items (January 2009), http://www.australiagroup.net/en/guidelines.html (25 January 2011).

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development of chemical or biological weapons. Coordination of national export control

measures assists Australia Group participants to fulfill their obligations under the

Chemical Weapons Convention and the Biological and Toxin Weapons Convention to

the fullest extent possible

Biorisk Management.Laboratory Biosecurity Guidance. (WHO) 114

The Laboratory biosafety manual (LBM3), published in 2004 in its third edition (2), has

already provided guidance to laboratory workers on how to perform laboratory work

safely, to laboratory managers on how to set up a managerial approach to biosafety and to

regulatory authorities, to help them consider necessary aspects for the development of

adequate national biosafety regulations. A top-down approach associated with bottom-up

support for biosafety regulations has been very successful in advancing the biosafety

agenda.

The present document aims to expand the laboratory biosecurity concepts introduced in

LBM3, and to strike a balance between the long-known biosafety procedures and

practices described in LBM3 and the more recently introduced and broader biosecurity

concepts. It further introduces the overarching "biorisk management" approach that has

resulted from careful thinking, comprehensive study of prevailing practices and

recommendations, review of international norms and standards, and relevant ethical

considerations Shortcomings currently observed in a number of settings are discussed,

and practical solutions are proposed.

The document is intended for the use of relevant national regulatory authorities,

laboratory directors (laboratory managers) and laboratory workers, all of whom play key

roles in the field of biosciences and in public health in general.

Best Practice Guidelines on Biosecurity for BRCS. (OECD) 115

114 World Health Organization. Biorisk Management: Laboratory Biosecurity Guidance WHO/CDS/EPR/2006.6 (September 2006), http://www.who.int/csr/resources/publications/biosafety/WHO_CDS_EPR_2006_6.pdf (25 January 2011) 115 Organization for Economic Co-Operation and Development, OECD Best Practice Guidelines for Biological Resource Centres (2007), http://www.oecd.org/dataoecd/7/13/38777417.pdf (27 January 2011)

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This document comprises the report of the Task Force on Biological Resource Centres

(TFBRC) on Best Practice Guidelines for BRCs. The report comprises two main parts.

Part I sets out the background and rationale to the project as well as describing the

methodology used for articulation of the best practice guidelines. A number of general

recommendations (principally related to the implementation and review of the best

practice guidelines) are set out in Chapter IV. Part II of the report comprises the best

practice guidelines themselves. Four sets of best practice guidelines are included dealing

with (i) general quality aspects, (ii) biosecurity-related issues, (iii) specific guidelines for

BRCs holding and and supplying micro-organisms, and; (iv) specific guidelines for BRCs

holding and and supplying human-derived materials. A fifth section in part II provides

optional best practice guidelines on the establishment of national certification systems

related to the best practices.

Resolution 1540 (UNSC)116

The Security Council, (…)

Acting under Chapter VII of the Charter of the United Nations,

1. Decides that all States shall refrain from providing any form of support to non-State

actors that attempt to develop, acquire, manufacture, possess, transport, transfer or use

nuclear, chemical or biological weapons and their means of delivery;

2. Decides also that all States, in accordance with their national procedures, shall adopt

and enforce appropriate effective laws which prohibit any non-State actor to manufacture,

acquire, possess, develop, transport, transfer or use nuclear, chemical or biological

weapons and their means of delivery, in particular for terrorist purposes, as well as

attempts to engage in any of the foregoing activities, participate in them as an

accomplice, assist or finance them;

3. Decides also that all States shall take and enforce effective measures to establish

domestic controls to prevent the proliferation of nuclear, chemical, or biological weapons

116 United Nations, Security Council Resolution 1540 (24 April 2004), http://www.un.org/Docs/sc/unsc_resolutions04.html (27 January 2011)

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and their means of delivery, including by establishing appropriate controls over related

materials and to this end shall:

(a) Develop and maintain appropriate effective measures to account for and secure such

items in production, use, storage or transport;

(b) Develop and maintain appropriate effective physical protection measures;

(c) Develop and maintain appropriate effective border controls and law enforcement

efforts to detect, deter, prevent and combat, including through international cooperation

when necessary, the illicit trafficking and brokering in such items in accordance with

their national legal authorities and legislation and

consistent with international law;

(d) Establish, develop, review and maintain appropriate effective national export and

trans-shipment controls over such items, including appropriate laws and regulations to

control export, transit, trans-shipment and re-export and controls on providing funds and

services related to such export and trans-shipment such as

financing, and transporting that would contribute to proliferation, as well as establishing

end-user controls; and establishing and enforcing appropriate criminal or civil penalties

for violations of such export control laws and regulations;

4. Decides to establish, in accordance with rule 28 of its provisional rules of procedure,

for a period of no longer than two years, a Committee of the Security Council, consisting

of all members of the Council, which will, calling as appropriate on other expertise,

report to the Security Council for its examination, on the implementation of this

resolution, and to this end calls upon States to present a first report no later than six

months from the adoption of this resolution to the Committee on steps they have taken or

intend to take to implement this resolution;

5. Decides that none of the obligations set forth in this resolution shall be interpreted so

as to conflict with or alter the rights and obligations of State Parties to the Nuclear Non-

Proliferation Treaty, the Chemical Weapons Convention and the Biological and Toxin

Weapons Convention or alter the responsibilities of the

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International Atomic Energy Agency or the Organization for the Prohibition of Chemical

Weapons;

6. Recognizes the utility in implementing this resolution of effective national control lists

and calls upon all Member States, when necessary, to pursue at the earliest opportunity

the development of such lists;

7. Recognizes that some States may require assistance in implementing the

provisions of this resolution within their territories and invites States in a position to do

so to offer assistance as appropriate in response to specific requests to the States lacking

the legal and regulatory infrastructure, implementation experience and/or resources for

fulfilling the above provisions;

8. Calls upon all States:

(a) To promote the universal adoption and full implementation, and, where necessary,

strengthening of multilateral treaties to which they are parties, whose aim is to prevent

the proliferation of nuclear, biological or chemical weapons;

(b) To adopt national rules and regulations, where it has not yet been done, to ensure

compliance with their commitments under the key multilateral nonproliferation treaties;

(c) To renew and fulfill their commitment to multilateral cooperation, in particular within

the framework of the International Atomic Energy Agency, the Organization for the

Prohibition of Chemical Weapons and the Biological and Toxin Weapons Convention, as

important means of pursuing and achieving their common

objectives in the area of non-proliferation and of promoting international cooperation for

peaceful purposes;

(d) To develop appropriate ways to work with and inform industry and the public

regarding their obligations under such laws;

9. Calls upon all States to promote dialogue and cooperation on nonproliferation so as to

address the threat posed by proliferation of nuclear, chemical, or biological weapons, and

their means of delivery;

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10. Further to counter that threat, calls upon all States, in accordance with their national

legal authorities and legislation and consistent with international law, to take cooperative

action to prevent illicit trafficking in nuclear, chemical or biological weapons, their

means of delivery, and related materials;

11. Expresses its intention to monitor closely the implementation of this resolution and, at

the appropriate level, to take further decisions which may be required to this end;

12. Decides to remain seized of the matter.

Declaration of Science and the Use of Scientific Knowledge (UNESCO)117

Preamble

1. Science for knowledge; knowledge for progress

2. Science for peace

3. Science for development

4. Science in society and science for society

EUROPEAN UNION

Green Paper on Bio-preparedness (2007)118

This Green Paper intends to stimulate a debate and launch a process of consultation at

European level on how to reduce biological risks, and to enhance preparedness and

response ("bio-preparedness"). This consultation may lead to concrete actions within the

ambit of the Community's and Union's competence, in the field of bio-preparedness in

2008. Concrete actions may have to be presented and developed separately in specific

strands of work following the applicable decision-making procedures and, where

appropriate, impact assessment.

117 United Nations Educational, Scientific and Cultural Organization, Declaration on Science and the Use of Scientific Knowledge. Text adopted by the World Conference on Science (1 July 1999), http://www.unesco.org/science/wcs/eng/declaration_e.htm (27 January 2011). 118 Comission of the European Communities. Green Paper on Bio-Preparedness (Brussels, 11 July 2007), http://eur-lex.europa.eu/LexUriServ/site/en/com/2007/com2007_0399en01.pdf (27 January 2011).

94

In order to improve the ability of the EU to prevent, respond to and recover from a

biological incident or deliberate criminal activity, the coherence of actions in different

policy sectors requires that all relevant stakeholders in Member States and at EU level be

consulted e.g. national authorities responsible for risk prevention and response, public

health (i.e human, animal and plant health), customs, civil protection, law enforcement

authorities, the military, bio-industry, epidemiological and health communities, academic

institutions and bioresearch institutes.

EU CBRN Action Plan (2009)119

Actions on

1.Prevention

2.Detection

3.Preparedness and response

4.Actions applicable to CBRN prevention, detection and response.

NATIONAL INITIATIVES

Netherlands

List of Strategic Goods120

The lists of goods from the export control regimes and from the CW Convention are

brought together by the European Union. This list is divided into ten categories.

Cat. 0 Nuclear Materials

119 Eureopean Union. EU CBRN Action Plan, (2009) http://ec.europa.eu/home-affairs/summary/docs/com_2009_0273_annexe_2_en.pdf (27 January 2011).

120 Rijksoverheid. Annex II – Dual-use goederenlijst (cat. 0 t/m 9) – bijlage I van

verordening (11 June 2010) http://www.rijksoverheid.nl/onderwerpen/exportcontrole-strategische-

goederen/documenten-en-

publicaties/rapporten/2010/06/11/Annex+II+Dual+use+goederenlijst+cat+0+t+m+9+bijlage+I+van+verordening.

html (27 January 2011).

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Cat. 1 Materials, chemicals, "microorganisms", "toxins"

Cat. 2 Materials processing

Cat. 3 Electronics

Cat. 4 Computers

Cat .5 Telecommunications and "information security"

Cat. 6 Sensors and Lasers

Cat. 7 Navigation and Avionics electronics

Cat. 8 Marine and ships

Cat. 9 Aerospace and Propulsion

Law on Terrorist Crimes (2004)121

The attacks of 11 September have resulted in examination if at international and national

level criminal law is sufficiently tailored to terrorism. In the context of European Union a

framework prepared and adopted on June 13, 2002. This bill implements this Framework

Decision combating terrorism for the Netherlands.

Code of Conduct for Biosecurity (2007)122

The rules laid down in the Biosecurity Code of Conduct call for implementation and

compliance at different levels. These levels correspond with the various target groups

identified in the code. Calls for awareness, accountability and oversight are targeted

mainly at individuals: researchers, laboratory workers, managers and others. Other

provisions apply to research institutions or financing or monitoring agencies.

Because the provisions of the code of conduct apply at different levels and to different

types of organization, it is the responsibility of the organizations themselves to tailor the

practical implementation of the code of conduct to the needs of their institution. In

practice, many of the rules in the code of conduct

121 Staatsbladvan het Koninkrijk der Nederlanden. Wet van 24 juni 2004 tot wijziging en aanvulling van het Wetboek van Strafrecht en enige andere wetten in verband met terroristische misdrijven (Wet terroristische misdrijven)(2004), http://www.eerstekamer.nl/behandeling/20040630/publicatie_wet/f=/w28463st.pdf (27 January 2011). 122 Koninklijke Nederlandse Akademie van Wetenschappen (KNAW). Code of Conduct for Biosecurity (28 November 2010), http://www.knaw.nl/Content/Internet_KNAW/actueel/bestanden/Code_of_conduct_biosecurity.pdf (27 January 2011)

96

will already be implemented by virtue of existing rules and guidelines based on biosafety

policy or occupational health and safety legislation. However, additional rules and

provisions will sometimes be necessary.

The Netherlands Code of Conduct for Scientific Practice123

In 2004, the VSNU (Union of Dutch Universities) published its Code of Conduct for

Scientific Practice, which outlines principles of good scientific teaching and research.

The increasing importance of research in the fields of product development and policy

has led to the steady rise of contract research projects within universities. In its Code of

Conduct the VSNU describes good scientific practice in terms of scrupulousness,

reliability, verifiability, impartiality, and independence. If the validity and status of

academic research is to be guaranteed then it is important to adhere to these five

established norms.

United Kingdom

Anti-terrorism, Crime and Security Act 2001124

An Act to amend the Terrorism Act 2000; to make further provision about terrorism and

security; to provide for the freezing of assets; to make provision about immigration and

asylum; to amend or extend the criminal law and powers for preventing crime and

enforcing that law; to make provision about the control of pathogens and toxins; to

provide for the retention of communications data; to provide for implementation of Title

VI of the Treaty on European Union; and for connected purposes.

British Medical Association (BMA). Biotechnology, weapons and humanity (1999)125

123 Association of Universities in the Netherlands. Code of Conduct for Scientific Practice (25 October 2004), http://www.vsnu.nl/web/show/id=120790/langid=42 (27 January 2011) 124 Anti-Terrorism, Crime and Security Act of 2001 (United Kingdom), http://www.legislation.gov.uk/ukpga/2001/24/contents (27 January 2011) 125 British Medical Association. Biotechnology, weapons and humanity (22 September 2006), http://www.bma.org.uk/health_promotion_ethics/warfare_weapons/BioWeaponsII.jsp?page=1&media=print (27 January 2011).

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This second BMA report on Biotechnology, weapons and humanity describes the

alarming gap between the quickening pace of scientific discoveries that could be misused

and the desperately slow development of international arms control. It builds on the first

BMA report of 1999 and provides practical suggestions on how the principles embodied

in the Chemical Weapons Convention and the Biological and Toxin Weapons

Convention can be upheld.

The Royal Society. The Roles of Codes of Conduct in Preventing the Misuse of Scientific

Research126

The key points made in this paper are as follows.

Codes of conduct can help to reduce misuse of science research.

The process of producing codes raises awareness amongst the target group and fosters

discussion on the potential for misuse.

Having a code provides a valuable educational tool for students and employees.

The process of defining the code should include extensive consultation with the target

groups to ensure that it is workable; it should also increase the number of individuals

aware of the issues of concern.

It is extremely difficult to list the guiding principles that underpin all scientific work

without producing bland and generic statements.

There are clear benefits in producing more detailed codes of practice or conduct that

concentrate on a specific area of the life sciences and target audience.

126 The Royal Society. The roles of codes of conduct in preventing the misuse of scientific research (9 June 2005), http://royalsociety.org/The-roles-of-codes-of-conduct-in-preventing-the-misuse-of-scientific-research-/ (27 January 2011).

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Many valuable guidelines and principles for the professional conduct of scientists already

exist at organizational, national and international level.

Introducing extended codes of conduct or practice based on existing health and safety

regulations will provide an opportunity for education and training to reinforce these

regulations.

United States

List of Select Agents and Toxins (HHS AND USDA)127

Publis Health Security and Bioterrorism Preparedness and Response Act of 2002128Ve

The events of September 11, 2001, reinforced the need to enhance the security of the

United States food supply. Congress responded by passing the Public Health Security and

Bioterrorism Preparedness and Response Act of 2002 ("the Bioterrorism Act" or "the

Act") (PL107-188), which President Bush signed into law on June 12, 2002.(1) The Act is

divided into the following five titles:

• Title I – National Preparedness for Bioterrorism and Other Public Health

Emergencies;

• Title II – Enhancing Controls on Dangerous Biological Agents and Toxins;

• Title III – Protecting Safety and Security of Food and Drug Supply;

• Title IV – Drinking Water Security and Safety; and

• Title V – Additional Provisions.

H.R. 5498, The WMD Prevention and Preparedness Act of 2010129

127 Centre for Disease Control. HHS AND USDA Select Agents AND TOXINS (17 November 2008), http://www.selectagents.gov/Select%20Agents%20and%20Toxins%20List.html (27 January 2011). 128 United States Food and Drug Administration. Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (PL107-188), Letter from Center Director (17 July 2002), http://www.fda.gov/Food/FoodDefense/Bioterrorism/ucm111086.htm (27 January 2011) 129 HR 5498: WMD Prevention and Preparedness Act of 2010 (United States), http://www.gpo.gov/fdsys/pkg/BILLS-111hr5498rh/pdf/BILLS-111hr5498rh.pdf (27 January 2011).

99

Purpose: To enhance homeland security by improving efforts to prevent, deter, prepare

for, detect, attribute, respond to, and recover from an attack with a weapon of mass

destruction (WMD) and for other purposes.

This bill addresses the range of actions necessary to counter the WMD threat – including

the threat of a biological attack – as identified through the Committee on Homeland

Security’s oversight work and the recommendations of the Commission on the

Prevention of WMD Proliferation and Terrorism in their final report, entitled “World At

Risk.” The bill addresses all aspects of the security and emergency management

framework – prevention and deterrence, preparedness, detection, attribution,

response, and recovery.

Proposed Framework for the Oversight of Dual Use Life Sciences Research: Strategies

for Minimizing the Potential Misuse of Research Information. (NSABB)130

The recommendations of the NSABB in the report that follows are not intended as

guidelines but rather as a framework for the development – by the federal government –

of a comprehensive system for the responsible identification, review, conduct, and

communication of dual use research. In this report, the NSABB identifies principles that

should underpin the oversight of dual use life sciences research, lists key features of such

oversight (e.g., federal guidelines, awareness and education, evaluation and review of

research for dual use potential, assessment and management of risk, compliance, and

periodic evaluation at the local (e.g., research institution) and federal levels of the impact

and effectiveness of oversight procedures) and proposes roles and responsibilities for

researchers, institutions, the institutional review entity, and the NSABB and other federal

government entities. The report also describes the major steps in local oversight of dual

use life sciences research, including evaluation of life sciences research for its dual use

potential, review of research identified as being potentially dual use of concern, conduct

130 National Science Advisory Board for Biosecurity. Proposed Framework for the Oversight of Dual Use Life Sciences Research: Strategies for Minimizing the Potential Misuse of Research Information (June 2007), http://oba.od.nih.gov/biosecurity/pdf/Framework%20for%20transmittal%200807_Sept07.pdf (27 January 2011).

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of dual use research of concern in accordance with risk management strategies, and

responsible communication of research with dual use potential.

Strategic Plan for Outreach and Education On Dual Use Research Issues (NSABB)131

From the start of its deliberations, the NSABB has been concerned that awareness within

the life sciences community of dual use research issues is insufficient and, when

awareness exists, the importance of the issue tends to be underappreciated. Since

researchers bear the primary responsibility for the integrity of their work, the NSABB

recognized early that awareness of dual use research issues by the scientific community

would be fundamental to any successful system of oversight. Such a system would

depend on the ability of researchers to recognize the dual use potential of their work and

to consider options on how best to minimize the risk that their findings may be misused

or misapplied toward malevolent goals. The NSABB also realized that greater

understanding of the importance of the dual use research issue by the research

community would help maximize engagement by the various stakeholders in the

oversight process.

Australia

Weapons of Mass Destruction (Prevention of Proliferation) Act 1995132

An Act to prohibit the supply or export of goods that will or may be used in, and the

provision of services that will or may assist, the development, production, acquisition or

stockpiling of weapons capable of causing mass destruction or missiles capable of

delivering such weapons

Crimes (Biological Weapons) Act 1976133

131 National Science Advisory Board for Biosecurity. Strategic Plan for Outreach and Education On Dual Use Research Issues (10 December 2008), (http://oba.od.nih.gov/biosecurity/PDF/FinalNSABBReportonOutreachandEducationDec102008.pdf (27 January 2011). 132 Weapons of Mass Destruction (Prevention of Proliferation) Act 1995 (Australia), http://www.comlaw.gov.au/comlaw/Legislation/ActCompilation1.nsf/0/615DF1E1B813886CCA256F7100512DF8/$file/WeapMassDestrPrevProlif95.pdf (27 January 2011).

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Implementation for Australia of the BTWC.

NON GOVERNMENTAL ORGANISATIONS

International Committee of the Red Cross (ICRC): Biotechnology, Weapons and

Humanity: ICRC Outreach to the Life Science Community on Preventing Hostile Use of

the Life Sciences134

The ICRC is involved in a number of activities around the world as part of its initiative

on Biotechnology, Weapons and Humanity. This kind of promotion and dissemination of

international humanitarian law rules at the individual and institutional level against

biological weapons is vital. In an increasingly inter-connected world, awareness and

preventive action is required at every level of society to help reduce the risk of

technology developed to benefit humanity being used for hostile purposes.

International Academic Panel (IAP): IAP Statement on Biosecurity135

In recent decades scientific research has created new and unexpected knowledge and

technologies that offer unprecedented opportunities to improve human and animal health

and environmental conditions. But some science and technology can be used for

destructive purposes as well as for constructive purposes. Scientists have a special

responsibility when it comes to problems of "dual use" and the misuse of science and

technology.

The 1972 Biological and Toxin Weapons Convention reinforced the international norm

prohibiting biological weapons, stating in its provisions that "each state party to this

Convention undertakes never in any circumstances to develop, produce, stockpile or

otherwise acquire or retain: microbial or other biological agents, or toxins whatever

133 (Biological Weapons) Act of 1976 (Australia) http://www.austlii.edu.au/au/legis/cth/consol_act/cwa1976243/ (27 January 2011). 134 International Committee of the Red Cross. Biotechnology, Weapons and Humanity: ICRC outreach to the life science community on preventing hostile use of the life sciences (7 May 2004), http://www.icrc.org/web/eng/siteeng0.nsf/html/5Z7CWQ (27 January 2011) 135 Interacademy Panel on International Issues. IAP Statement on Biosecurity (2005) http://www.interacademies.net/File.aspx?id=5401 (27 January 2011)

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their origin or method of production, of types and in quantities that have no justification

for prophylactic or other peaceful purposes." Nevertheless, the threat from biological

weapons is again a live issue. This statement presents principles to guide individual

scientists and local scientific communities that may wish to define a code of conduct for

their own use.

These principles represent fundamental issues that should be taken into account when

formulating codes of conduct. They are not intended to be a comprehensive list of

considerations.

1. Awareness. Scientists have an obligation to do no harm. They should always take into

consideration the reasonably foreseeable consequences of their own activities. They

should therefore:

• always bear in mind the potential consequences – possibly harmful – of

their research and recognize that individual good conscience does not

justify ignoring the possible misuse of their scientific endeavour;

• refuse to undertake research that has only harmful consequences for

humankind.

2. Safety and Security. Scientists working with agents such as pathogenic rganisms or

dangerous toxins have a responsibility to use good, safe and secure laboratory

procedures, whether codified by law or common practice.

3. Education and Information. Scientists should be aware of, disseminate information

about and teach national and international laws and regulations, as well as policies and

principles aimed at preventing the misuse of biological research.

4. Accountability. Scientists who become aware of activities that violate the Biological

and Toxin Weapons Convention or international customary law should raise their

concerns with appropriate people, authorities and agencies.

5. Oversight. Scientists with responsibility for oversight of research or for evaluation of

projects or publications should promote adherence to these principles by those under their

control, supervision or evaluation and act as role models in this regard.

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The World Medical Association (WMA): The World Medical Association Declaration of

Washington on Biological Weapons.

Adopted by the WMA General Assembly, Washington 2002; editorial changes made

during the May 2003 Council Session, 136The World Medical Association recognizes the

growing threat that biological weapons might be used to cause devastating epidemics that

could spread internationally. All countries are potentially at risk. The release of

organisms causing smallpox, plague, anthrax or other diseases could prove catastrophic

in terms of the resulting illnesses and deaths compounded by the panic such outbreaks

would generate. At the same time, there is a growing potential for production of new

microbial agents, as expertise in biotechnology grows and methods for genetic

manipulation of organisms become simpler. These developments are of special concern

to medical and public health professionals because it is they who best know the potential

human suffering caused by epidemic disease and it is they who will bear primary

responsibility for dealing with the victims of biological weapons. Thus, the World

Medical Association believes that medical associations and all who are concerned with

health care bear a special responsibility to lead in educating the public and policy makers

about the implications of biological weapons and to mobilize universal support for

condemning research, development, or use of such weapons as morally and ethically

unacceptable.

International Council for Science (ICSU): Freedom, Responsibility and Universality of

Science137

Implementation of the Principle of the Universality of Science is fundamental to

scientific progress. This Principle embodies freedom of movement, association,

expression and communication for scientist s, as well as equitable access to data,

information and research materials. These freedoms are highly valued by the scientific

136 World Medical Association. WMA Declaration of Washington on Biological Weapons (16 May 2003). http://www.wma.net/en/30publications/10policies/b1/index.html (27 January 2011) 137 International Council for Science. Freedom, Responsibility and Universality of Science (2008), http://www.icsu.org/Gestion/img/ICSU_DOC_DOWNLOAD/2205_DD_FILE_Freedom_Responsibility_Universality_of_Science_booklet.pdf (27 January 2011)

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community and generally well accepted by government s and policy makers. Hence,

scientist s are normally able to travel to international meetings, associate with colleagues

and freely express their opinions regardless of factors such as ethnic origin, religion,

citizenship, language, political stance, gender, sex or age. However, this is not always the

case and so it is impor tant to have mechanisms in place at the local, national and

international levels to monitor compliance with this principle and intervene when

breaches occur. The International Council for Science (ICSU) and it s global network of

Members provide one such mechanism to which individual scientist s can turn for

assistance.

The Principle of the Universality of Science focuses on scientific right s and freedoms but

implicit in these are a number of responsibilities. Individual scientist s have a

responsibility to conduct their work with honesty, integrity, openness and respect, and a

collective responsibility to maximize the benefit and minimize the misuse of science for

society as a whole.

Balancing freedoms and responsibilities is not always a straight forward process. For

example, openness and sharing of data and materials may be in conflict with a scientist’s

desire to maintain a competitive edge or an employer’s requirement s for protecting

intellectual proper ty. In some situations, for example during wars, or in specific areas of

research, such as development of global surveillance technologies, the appropriate

balance between freedoms and responsibilities can be extremely difficult to define and

maintain.

The benefit s of science for human well-being and development are widely accepted. The

increased average human lifespan in most par t s of the world over the past century can

be at tributed, more or less directly, to scientific progress. At the same time, it has to be

acknowledged that technologies arising from science can inadvertently have adverse

effect s on people and the environment. Moreover, the deliberate misuse of science can

potentially have catastrophic effect s. There is an increasing recognition by the scientific

community that it needs to more fully engage societal stakeholders in explaining,

developing and implementing research agendas.

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A central aspect of ensuring the freedoms of scientist s and the longer term future of

science is not only conducting science responsibly but being able to publicly demonstrate

that science is being conducted responsibly. Individual scientist s, their associated

institutions, employers, funders and representative bodies, such as ICSU, have a shared

role in both protecting the freedoms and propagating the responsibilities of scientist s.

This is a role that needs to be explicitly acknowledged and embraced. It is likely to be an

increasingly demanding role in the future.

International Union of Microbiological Societies (IUMS): IUMS Code of Ethics against

Misuse of Scientific Knowledge, Research and Resources138

There has always been the potential for dual application of scientific knowledge for

beneficial or malicious purpose. However, current societal and geopolitical changes have

increased the risk of the misuse of this knowledge. The IUMS reaffirms its major goal is

to promote research and the open exchange of scientific information for advancement of

the health and welfare of humankind and the environment and strongly discourages any

uses of knowledge and resources to the contrary.IUMS is opposed to the misuse of

microbiological knowledge, research and resources. In particular, IUMS also strives to

promote ethical conduct of research and training in the areas of biosecurity and biosafety

so as to prevent use of microorganisms as biological weapons and therefore to protect the

public's health and to promote world peace.

Wellcome Trust: Wellcome Trust Position Statement on Bioterrorism and Biomedical

Research139

Balancing benefit and risk

The Trust recognises that there are particular concerns regarding research that could

directly result in, or enable the future development of, pathogens and toxins which could

138 International Union of Microbiological Societies. IUMS Code of Ethics against Misuse of Scientific Knowledge, Research and Resources (26 April 2011), http://www.nvvm-online.nl/downloads/IUMS_CodeOfEthics_20070903.pdf (27 January 2011) 139 Wellcome Trust. Position statement on bioterrorism and biomedical research. http://www.wellcome.ac.uk/About-us/Policy/Policy-and-position-statements/WTD002767.htm (27 January 2011)

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potentially serve as bioweapons. A committee convened by the US National Academy of

Sciences recently identified seven classes of experiment to illustrate the types of

endeavour that would require careful review by informed experts. The experiments this

committee specified are those that would:

• demonstrate how to render a vaccine ineffective

• confer resistance to therapeutically useful antibiotics or antiviral agents

• enhance the virulence of a pathogen, or render a non-pathogen virulent

• increase transmissibility of a pathogen

• alter the host range of a pathogen

• enable the evasion of diagnostic and detection modalities

• enable the weaponisation of a biological agent or toxin.

The Trust considers that in order to address these legitimate concerns, it is important that

appropriate processes exist at institutional, national and international levels for the review

and oversight of research that could result in such outcomes.

The Trust would emphasise, however, that further research involving harmful biological

pathogens and toxins will be crucial in the fight to combat the diseases that these agents

cause and to improve our ability to respond to bioterrorist attacks. In most cases the risks

associated with such research will be minor in comparison with the potential benefits.

The Trust considers that the creation and dissemination of scientific knowledge is a

definite and tangible public good, which would need to be set against risks that may

sometimes be hypothetical and hard to quantify.

The Trust believes, therefore, that regulatory processes must not unduly restrict this

essential research. Any additional regulatory requirements that may be introduced should

apply only to those research projects where there is tangible cause for concern. The Trust

expects that this will represent a very small proportion of the many research projects

undertaken in academic research laboratories that involve the use of pathogens and

toxins.

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American Medical Association:Guidelines to Prevent Malevolent Use of Biomedical

Research140

Physicians who engage in biomedical research are bound by the ethical obligations of the

medical profession and also are required to meet responsibilities of the scientific

community. Beyond their commitment to the advancement of scientific knowledge and

the betterment of public health, physician-researchers must strive to maintain public trust

in the profession through their commitment to public welfare and safety, as demonstrated

through individual responsibility, commitment to peer review, and transparency in the

design, execution, and reporting of research.

Biomedical research may generate knowledge with potential for both beneficial and

harmful application. Before participating in research, physician-researchers should assess

foreseeable ramifications of their research in an effort to balance the promise of benefit

from biomedical innovation against potential harms from corrupt application of the

findings.

In exceptional cases, assessment of the balance of future harms and benefits of research

may preclude participation in the research; for instance, when the goals of research are

antithetical to the foundations of the medical profession, as with the development of

biological or chemical weapons. Properly designed biomedical research to develop

defenses against such weapons is ethical.

The potential harms associated with some research may warrant regulatory oversight.

Physician-researchers have a responsibility not only to adhere to standards for research,

but also to lend their expertise to the development of safeguards and oversight

mechanisms, both nationally and internationally. Oversight mechanisms should balance

the need to advance science with the risk of malevolent application.

After research has been conducted, consideration should be given to the risk of

unrestricted dissemination of the results. Only under rare circumstances should findings

140 American Medical Association. Guideline to Prevent Malevolent Use of Biomedical Research (2005), http://www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics/opinion2078.shtml (27 January 2011)

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be withheld, and then only to the extent required to reasonably protect against dangerous

misuse.

These ethical principles should be part of the education and training of all physicians involved in biomedical research.

Europabio: Europabio´s core ethical values141

We are committed to realising the potential of biotechnology to improve the quality of human life.

We give priority to health, safety, and environmental protection when undertaking the research,

development, manufacture and distribution of our products and services.

We develop and use biotechnology with full respect for human dignity and human rights.

We communicate and share information about biotechnology and its derived products and services in a

balanced manner, stating both benefits and risks.

We engage in a dialogue with those concerned about ethical and societal implications of biotechnology.

We treat animals in a respectful manner and, when at all possible, we limit their use in research. Any

disproportionate suffering to animals involved in our research and/or other parts of our work is avoided and

the highest standards of well-being are maintained.

We support the conservation of biological diversity.

We oppose the use of biotechnology to make any weapons and will not develop or produce biological

weapons.

We support the exchange of biotechnology between developed and developing countries duly considering

each country’s cultural values.

Other Initiatives

Steinbruner et. Al., A Prototype Protective Oversight System142

In an effort to encourage productive discussion of the problem and its implications, this monograph

discusses an oversight process designed to bring independent scrutiny to bear throughout the world

141 The European Association for Bioindustries. EuropaBio’s Core Ethica Values (October 1998), http://www.europabio.org/documents/corevalues.pdf (27 January 2011) 142 John Steinbruner, Elisa D. Harris, Nancy Gallagher and Stacy M. Okutani. Pathogens: A Prototype Protective Oversight System (The Center for International and Security Studies at Maryland, MD: 2007), http://www.cissm.umd.edu/papers/files/pathogens_project_monograph.pdf (27 January 2011).

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without exception on fundamental research activities that might plausibly generate massively destructive or

otherwise highly dangerous consequences. The suggestion is that a mandatory, globally implemented

process of that sort would provide the most obvious means of protecting against the dangers of advances in

biology while also pursuing the benefits. The underlying principle of independent scrutiny is the central

measure of protection used in other areas of major consequence, such as the handling of money, and it is

reasonable to expect that principle will have

to be actively applied to biology as well.

The monograph outlines an advanced oversight arrangement, provisionally labeled the Biological

Research Security System (BRSS), which is designed to help prevent destructive applications of biology,

whether inadvertent or deliberate.

Global Compact for Infectious Diseases 143

Goals of the Compact

To develop a comprehensive four part agreement – the Compact – between states, the

private sector and other stakeholders that will limit and control known, newly discovered

or deliberately created infectious diseases:

Compact Core Mission I

Establish, maintain and monitor a shared international data and knowledge base for

infectious diseases, including but not limited to biosurveillance information, relevant

pharmaceutical data and suites of services and skills.

Compact Core Mission II

Establish, maintain and monitor a network of international basic science research centers

that will support fundamental investigations into the pathophysiology of certain microbial

threats to global health.

Compact Core Mission III

143 Institute for Strategic Threat Analysis and Response. ISTAR Infectious Disease Compact (2007) http://www.istar.upenn.edu/compact/index.html (27 January 2011)

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Expand capabilities for the production of vaccines and therapeutics expressly for

emerging and reemerging infections

Compact Core Mission IV

Establish, maintain and monitor international standards of conduct as well as best

laboratory and regulatory practices

Through the implementation of these four core missions, the Compact will minimize the

impact of infectious diseases on national and international health, social and economic

development and international security

111

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Biosecurity and Dual Use Research

Documents