Governance and Ethics in the EU Governance and Ethics in the EU Pēteris Zilgalvis, J.D. Head of Unit Governance and Ethics European Commission Responsible.

Governance and Ethics in the EUGovernance and Ethics in the EU

Pēteris Zilgalvis, J.D.Head of Unit

Governance and Ethics European Commission

Responsible research in the European Research Area

Content:

• The European policy drive

• The European Research Area and ethics

• EC Recommendation on nanotechnology code of conduct

• Europe faces fundamental social and environmental challenges:Maintaining current standards of living while adressing; – Aging populations– Fierce global economic competition– Climate change, loss of biodiversity and other environmental issues

• Europe’s answer to these challenges is the Lisbon Agenda, launched in 2000 and a central pillar in EU policies:

to achieve a competitive and dynamic economy, capable of sustainable growth, and with more and better jobs and greater social cohesion.

• Science and research play a pivotal role in the transition to this ‘knowledge society’

Science, Economy and Society

the broader policy perspective:

The European Research Area

• The establishment of the European Research Area (ERA) is a core element in the strategy to reach the objectives of the Lisbon Agenda

• The European Research Area, or ERA, will establish an `internal market` for research:

– Where researchers, technology and knowledge circulate freely; (brain circulation, not brain drain)

– Where qualifications, experience, and social security rights of knowledge workers are portable across borders;

– Where networks of scientists have access to world-class infrastructure and facilities, and to which foreign researchers are drawn and retained;

– And where there is pan-European co-operation and co-ordination of national research activities, in order in order to support the best research throughout Europe.

The European Research Area

EU research policy in light of the Lisbon Agenda

• High governance, ethical, legal and social standards in science and research are of paramount importance:

– In and of themselves, as these standards reflect our adherence to the ethical values and fundamental rights on which the EU is founded

– They add to the quality of research and increase its alignment with social needs and expectations

Ethics and governance in the ERA

• Establishing a robust the ethics infrastructure in the ERA

• Furthering open governance of research

• Funding European ‘ELSA’ research activities via its 7th Framework Prgramme (FP7)

Furthering high ethics and governance standards in the ERA:

Ethics and governance in the ERA

• EC ethical review– carried out on all EC funded research projects that are ethically

‘sensitive’

• Forum of National Ethics Councils (NEC Forum)– An independent informal platform for exchange of best practices in

the field of ethics and science

• European Network of Research ethics Committees (EUREC)– Networking and providing training for members of RECs

• European Group on Ethics (EGE)– independent and multidisciplinary advisory body which reports to

the President of the European Commission

Ethics activities by the EC

A robust ethics infrastructure in the ERA

Coordination at various levels:

NEC ForumNEC Forum

EURECEUREC

EGEEGE(advises EC)(advises EC)

EuropeanEuropeanCommissionCommission

Ethics Activities by the EC

A robust ethics infrastructure in the ERA

• Funding research projects on ethics and providing input to relevant policy developments

– A rich portfolio of ethics research projects, resulting from calls for proposals on e.g.:

• Ethics and new / emerging fields of science and technology• Promotion of pan-European and international awareness of the ethical

aspects of security technology• Privacy and emerging fields of science and technology• Networking and capacity-building activities to support ethics

committees• Governance and ethics of the responsible development of

nanosciences and nanotechnologies

– Involvement in policy developments, e.g. the revision of directive Directive 86/609 on the use of animals in research, and taking targeted actions

Ethics Activities by the EC

A topical example on EC ethics and governance:

The EC “Recommendation to the Member States on a Code of Conduct for Responsible Nanosciences and Nanotechnologies Research”

NANOTECHNOLOGY. WHAT IS AT STAKE?

• Ethical acceptability of technology

• Early identification of benefits and risks

• European and international research cooperation and governance

NANOTECH IS DIVERSE

Human Health Nanomedicine

Detectors/surveillance Security

Environment Safety

(PROSPECTIVE/CURRENT) ETHICAL ISSUES

• Human enhancement- ICT brain implants, augmentation of senses, retardation of ageing

• Predicitive Nanomedicine: growing gap between diagnosis and possible therapy

• Surveillance and Detection: Balance between privacy and security

(PROSPECTIVE) CURRENT RISK ISSUES

• Mainly: Safety of nanoparticles

• Application of Precautionary Principle

• Implementation of Code of Conduct

FUTURE SCIENCE/SOCIETY ACTIONS AND CHALLENGES

• Involving civil society actors in nanotech research

• Acceptability of Technology: consumer product satisfaction is crucial

• Map regulatory needs at EU and international levels

European Commission policies

• Adoption of European Strategy for Nanotechnology (May 2004) and Action Plan(June 2005) emphasising the need for a “safe, integrated and responsible development of N&N.

• Announcement of adoption of Code of Conduct at international level

Nanosciences and NanotechnologiesCommission’s activities:

CO-OPERATION 32413-Health 6100-Food, Agriculture and Biotechnology 1935 -Information and Communication Technologies 9050 -Nanosciences, Nanotechnologies, Materials and new Production Technologies 3475 -Energy 2350 -Environment (including Climate Change) 1890 -Transport (including Aeronautics) 4160 -Socio-economic Sciences and Humanities 623 -Space 1430-Security 1400 IDEAS (European Research Council) 7510PEOPLE 4750CAPACITIES 4097JRC 1751

FP7 Budget: 50521 M

€

Nanosciences and NanotechnologiesCommission’s activities:

In total: doubling of the rate of funding expected over duration of FP7 compared to FP6

FP7 Budget: 50521 M

€

Why a Code of Conduct for Responsible Nanosciences and Nanotechnologies Research?

A Recommendation from the Commission to the Member States in the field of N&N research constitutes a strong political signal in line with its previous commitments.

The harmonisation of laws of the Member States being excluded from research policy, the Community can use non-binding instruments, such as recommendations (Art. 211 of the EC Treaty), to fulfil the tasks and obligations enshrined in the Treaty.

Why a Code of Conduct for Responsible Nanosciences and Nanotechnologies Research?

The Recommendation, through the Member States, addresses all stakeholders in N&N Research,

Proposes the adoption and promotion of a Code of Conduct for Responsible N&N Research (both private and public laboratories)

Calls for the application of the Precautionary Principle to N&N Research.

The Code of Conduct

ACTIONS TO BE TAKEN– Stakeholders awareness, Open and pluralistic forum for discussion

• Make information accessible and understandable• Share best practices in N&N research• Scientific peer-review• Scientific integrity• Application of existing laws and regulations• Applying ethical review requirements

Applying ethical review requirements

How to approach proposals involving N&N in Ethical Review?

The Ethical Review Panel should report in the Ethical Review Report (ERR):

– Any violation of fundamental rights or fundamental ethical principles, at either the research or development stages; – Fundamental rights implications of any possible restrictions on informed consent and on publication of research results related to human health;– Particularly relevant for ethical review of dual-use linked to N&N research.

N&N and Ethical Review–Specific research activities aiming to gain a better understanding of ethical, legal and societal impacts of the new fields opened by N&N;

–Degree of awareness of researchers of the Code of Conduct for Responsible N&N Research itself and of the opinion of the EGE on the ethical aspects of nanomedicine;

–The extent to which the future implications have been taken into account, notably through participatory foresight processes involving ethical committees;

Applying ethical review requirements

Implementation of the Code of Conduct

EC ACTIONS:

– Meetings with stakeholders, e.g. 17-18 November 2008, Brussels

– Wordwide dissemination and dialogue; e.g. cooperation with Argentinean and South African regulatory bodies

–Monitoring and reviewing the Code (biannually) In cooperation with the EU Member States

–Meetings with the MS in autumn 2009, Poland interested?

–FP7 funded projects that further dialogue and analysis; e.g. DEEPEN, NANOPLAT and NanoCap

An example of forthcoming analysis: ”DEEPEN” project

Social Studies of Technology:

how values are embedded in nanotechnology R&D

Public engagement methodologies: unravelling the ‘lay

ethics’ that a diverse public use to develop

their own concerns and deliberations

Philosophical and normative analysis:

deepening ethical understanding of issues

posed by emerging nanotechnologies

FP7: FP7: http://cordis.europa.eu/fp7/home_en.htmlFP7 FP7 CallsCalls: : http://cordis.europa.eu/fp7/dc/index.cfmhttp://cordis.europa.eu/nanotechnology/src/eu_funding.htm

Nanotechnology Nanotechnology HomepagesHomepages::http://ec.europa.eu/nanotechnology/index_en.htmlhttp://cordis.europa.eu/nanotechnology/

Nanotechnology andNanotechnology and SocietySociety::http://ec.europa.eu/research/science-society/

Nanosciences and Nanotechnologies Nanosciences and Nanotechnologies PolicyPolicy ::http://cordis.europa.eu/nanotechnology/actionplan.htm

More on nanotechnology:More on nanotechnology:

References

Contact:

Pēteris Zilgalvis, J.D.Head of Unit, Governance and EthicsEuropean Commission, Research Directorate-GeneralDirectorate L: Science, Economy and Society SDME 7/67Rue de la Loi 200, B-1049 Bruxelles BelgiumTel. (+32-2) 2950935 Fax. [email protected]