The European Union strategy on Biotechnology: after the 2005 EC report

PROPEURPROPEURPLANT AND ANIMAL GENOMES IN PLANT AND ANIMAL GENOMES IN

RELATION TO BIODIVERSITYRELATION TO BIODIVERSITYTheme 3, workshop 2, Paris 5-6 May 2006Theme 3, workshop 2, Paris 5-6 May 2006

The European Union The European Union strategy on strategy on

Biotechnology: after the Biotechnology: after the 2005 EC report2005 EC report

Dr David ColesDirector

Enhance International Limited

The 2002 Biotechnology The 2002 Biotechnology StrategyStrategy

A key component of the EU 2000 A key component of the EU 2000 Lisbon Strategy Lisbon Strategy ““to become the most to become the most competitive and dynamic knowledge-based competitive and dynamic knowledge-based economy in the world, capable of sustainable economy in the world, capable of sustainable economic growth with more and better jobs and economic growth with more and better jobs and greater social cohesion.”greater social cohesion.”

““Life sciences and biotechnology are widely Life sciences and biotechnology are widely recognised to be, after information technology, recognised to be, after information technology,

the next wave of the knowledge-based the next wave of the knowledge-based economy, creating new opportunities for our economy, creating new opportunities for our

societies and economies.”societies and economies.”

COM (2002) 27 Life sciences and biotechnology – A Strategy for Europe

The MandateThe Mandate The European Council in Stockholm in

March 2001 invited the Commission, together with the Council,

“to examine measures required to utilise the full potential of biotechnology and strengthen the European biotechnology sector's competitiveness in order to match leading competitors while ensuring that those developments occur in a manner which is healthy and safe for consumers and the environment, and consistent with common fundamental values and ethical principles.”

Important Elements of the Important Elements of the 2002 Biotechnology Strategy2002 Biotechnology Strategy

“How can Europe best attract the human, industrial and financial resources to develop and apply these technologies to meet society’s needs and increase its competitiveness?”

“Broad public support is essential, and ethical and societal implications and concerns must be addressed. How can Europe deliver effective, credible and responsible policies which enjoy the confidence and support of its citizens?”

“How can Europe best respond to the global challenges, develop its domestic policies with a clear international perspective and act internationally to pursue its interests?”

“Our democratic societies should offer the necessary safeguards and channels of dialogue to ensure that the development and application of life sciences and biotechnology take place respecting the fundamental values recognised by the EU in the Charter of Fundamental Rights.”

COM (2002) 27 Life sciences and biotechnology – A Strategy for Europe

ScopeScope

Health Care (medicines, genetic Health Care (medicines, genetic testing, pharmacogenomics, stem testing, pharmacogenomics, stem cells…..)cells…..)

Agriculture (food and non-food)Agriculture (food and non-food)

Environment & Industrial processesEnvironment & Industrial processes

ActionsActions Building Knowledge through researchBuilding Knowledge through research Mobilising resources (training, collaboration, Mobilising resources (training, collaboration,

encouraging SME’s)encouraging SME’s) Increasing development capacity (access to Increasing development capacity (access to

funding)funding) Responsible Governance incorporating:Responsible Governance incorporating:

Societal engagementSocietal engagement Ethical valuesEthical values Informed consumer choiceInformed consumer choice Enhancing public confidence in regulationEnhancing public confidence in regulation Respect for single marketRespect for single market

International collaborationInternational collaboration Coherence and co-operationCoherence and co-operation

Conclusions of the 2005 Conclusions of the 2005 ReportReport

Reference to refocussing the Lisbon Reference to refocussing the Lisbon Agenda and its central strategy of Agenda and its central strategy of “actions “actions that promote jobs and growth consistent that promote jobs and growth consistent with sustainable development”with sustainable development” (Barosso - (Barosso - 2005 2005 Robert Schuman Lecture for the Lisbon Council)Robert Schuman Lecture for the Lisbon Council)

2004 was year of “consolidation rather 2004 was year of “consolidation rather than growth” than growth”

Need for reflection on the role of Life Need for reflection on the role of Life Sciences and Biotechnology in the Sciences and Biotechnology in the renewed Lisbon Agenda.renewed Lisbon Agenda.

CompetitivenessCompetitiveness

EU biotech. is not performing well EU biotech. is not performing well compared with USA. Growth of knowledge compared with USA. Growth of knowledge but not developing markets. The financing but not developing markets. The financing gap (later in the business cycle) is the gap (later in the business cycle) is the biggest single barrier to competitiveness.biggest single barrier to competitiveness.

Commission proposal for a Commission proposal for a “Competitiveness and Innovation “Competitiveness and Innovation Programme (€4.2 bn for 2007-2013) to Programme (€4.2 bn for 2007-2013) to support innovation and improve access to support innovation and improve access to financefinance

In addition, FP7 will include a new financing In addition, FP7 will include a new financing instrument, the “risk-sharing finance instrument, the “risk-sharing finance facility” to provide loans for infrastructurefacility” to provide loans for infrastructure

CompetitivenessCompetitiveness

Most of the 2005 report focuses on Most of the 2005 report focuses on recommendations of the Competitiveness in recommendations of the Competitiveness in Biotechnology Advisory Group (CBAG) – set Biotechnology Advisory Group (CBAG) – set up in 2003.up in 2003.

Key Issue: IPR and the failure of MSs to Key Issue: IPR and the failure of MSs to implement Directive 98/44/EC. The implement Directive 98/44/EC. The Commission also proposes to monitor any Commission also proposes to monitor any economic consequences of divergence economic consequences of divergence between MS legislation on IPR.between MS legislation on IPR.

Benchmarking of European public Benchmarking of European public biotechnology policies shows a general biotechnology policies shows a general increase in policies favouring biotechnology.increase in policies favouring biotechnology.

Funding European ResearchFunding European Research

FP6 focus on SME’s – some success FP6 focus on SME’s – some success but still more SME involvement needed but still more SME involvement needed

Need for more streamlined Need for more streamlined administration (simplification planned administration (simplification planned for FP7) to increase numbers of SMEs. for FP7) to increase numbers of SMEs.

Development of a European Development of a European “Knowledge-based Bio-economy” – “Knowledge-based Bio-economy” – networking MSs activities on networking MSs activities on development and innovation.development and innovation.

Confidence in Science-based Confidence in Science-based regulatory oversightregulatory oversight

Pharmaceutical LegislationPharmaceutical Legislation CBAG indicate registration procedures for CBAG indicate registration procedures for

medicines are complex and expensive and may medicines are complex and expensive and may disincentivise SMEsdisincentivise SMEs

2004 – Commission introduces new regulation 2004 – Commission introduces new regulation for SME’s – lower fees, clear guidelines and for SME’s – lower fees, clear guidelines and free administrative support by EMEAfree administrative support by EMEA

EC proposes to give incentives to develop EC proposes to give incentives to develop medicines specifically for children through a medicines specifically for children through a new regulation on paediatric medicinenew regulation on paediatric medicine

Confidence in Science-based Confidence in Science-based regulatory oversightregulatory oversight

GMO LegislationGMO Legislation Member States repeatedly fail to agree on Member States repeatedly fail to agree on

marketing of GM productsmarketing of GM products Commission places products on market through Commission places products on market through

comitology procedurescomitology procedures CBAG recommend it should be up to MSs CBAG recommend it should be up to MSs

themselves to implement EU legislation on themselves to implement EU legislation on GMOsGMOs

Commission believes it should continue to fulfil Commission believes it should continue to fulfil its legal obligations to proceed with approvals its legal obligations to proceed with approvals and expects more active co-operation from MSs. and expects more active co-operation from MSs.

N.B. – No reference to societal concerns or N.B. – No reference to societal concerns or consumer choiceconsumer choice

Newly Emerging IssuesNewly Emerging Issues

Tissue engineeringTissue engineering clear regulatory framework neededclear regulatory framework needed Stakeholder consultation in mid 2005Stakeholder consultation in mid 2005 proposal adopted by EC at end of 2005 proposal adopted by EC at end of 2005

on “advanced therapy” products - on “advanced therapy” products - covering gene therapy, somatic cell covering gene therapy, somatic cell therapy and tissue engineeringtherapy and tissue engineering

Newly Emerging IssuesNewly Emerging Issues

Genetic TestingGenetic Testing EU-wide information exchange on best EU-wide information exchange on best

practicepractice Evaluation of clinical validity of genetic testsEvaluation of clinical validity of genetic tests Protection of workers personal data wrt Protection of workers personal data wrt

employmentemployment Consider setting standards for genetic Consider setting standards for genetic

testing under Article 152 or 153 of the Treatytesting under Article 152 or 153 of the Treaty Consider genetic testing in the light of Consider genetic testing in the light of

Directive 98/79/EC on in vitro medical Directive 98/79/EC on in vitro medical devicesdevices

Newly Emerging IssuesNewly Emerging Issues

PharmacogeneticsPharmacogenetics Regulations should be developed in anticipation Regulations should be developed in anticipation

of application of pharmacogenetics in drug of application of pharmacogenetics in drug development and evaluationdevelopment and evaluation

No legislation without wide consultationNo legislation without wide consultation BiobanksBiobanks

Growth of biobanks and differing national Growth of biobanks and differing national regulations present ethical concerns and hinder regulations present ethical concerns and hinder effective collaborationeffective collaboration

Commission to establish recommendations for Commission to establish recommendations for general principles governing biobanksgeneral principles governing biobanks

Consider the need for an Opinion from the EGEConsider the need for an Opinion from the EGE

The JRC Biotechnology The JRC Biotechnology Assessment StudyAssessment Study

Purpose:Purpose: An evaluation of the consequences, An evaluation of the consequences,

opportunities and challenges of modern opportunities and challenges of modern biotechnology for Europebiotechnology for Europe

To increase public awareness and To increase public awareness and understanding of life sciences and understanding of life sciences and biotechnologybiotechnology

Communication and “stakeholder“ Communication and “stakeholder“ involvement identified as an involvement identified as an important element of the studyimportant element of the study

The JRC Biotechnology The JRC Biotechnology Assessment Study – Main Assessment Study – Main

TasksTasks Task 1Task 1

Mapping of modern biotechnologies and applicationsMapping of modern biotechnologies and applications Analysis of data availability and identification of indicatorsAnalysis of data availability and identification of indicators

Task 2Task 2 Mapping adoption of modern biotech in the EUMapping adoption of modern biotech in the EU Evaluation of economic, social and environmental Evaluation of economic, social and environmental

consequences, opportunities and challengesconsequences, opportunities and challenges Assessment of emerging applicationsAssessment of emerging applications Discussion of potential risks, social non-acceptance and Discussion of potential risks, social non-acceptance and

ethical concerns – including consequences of non-adoption ethical concerns – including consequences of non-adoption of certain technologiesof certain technologies

Task 3Task 3 Relating economic, social and environmental consequences Relating economic, social and environmental consequences

to EU policy objectivesto EU policy objectives Assessment of future impacts of biotechnologyAssessment of future impacts of biotechnology

Reflections on the 2005 Report Reflections on the 2005 Report and JRC studyand JRC study

Refocussing of Lisbon resulted in greater Refocussing of Lisbon resulted in greater emphasis on bringing products to market.emphasis on bringing products to market.

Does this raise ethical and/or societal concerns?Does this raise ethical and/or societal concerns? Medical biotech – not a major problem. Perceived Medical biotech – not a major problem. Perceived

failure is not at research stage but later in the failure is not at research stage but later in the product cycle. Measures proposed for SMEs are product cycle. Measures proposed for SMEs are largely financial incentives and administrative largely financial incentives and administrative simplification – but no relaxation of regulationssimplification – but no relaxation of regulations

GM food – Consumer choice may be being GM food – Consumer choice may be being compromised by Commission driving through compromised by Commission driving through product placement in the marketproduct placement in the market

““Stakeholder” consultation focuses on regulators, Stakeholder” consultation focuses on regulators, industry and the medical profession – little or no industry and the medical profession – little or no explicit provision for more general societal and explicit provision for more general societal and public inputpublic input

Does the EU believe there is a case for Does the EU believe there is a case for constraint or intervention in the market to constraint or intervention in the market to

mitigate ethical concerns?mitigate ethical concerns?

In principle – yes: The 2002 Biotech Strategy talks In principle – yes: The 2002 Biotech Strategy talks aboutabout ““Developing life sciences and biotechnology in Developing life sciences and biotechnology in

harmony with ethical values and societal goals”harmony with ethical values and societal goals” and says:and says:The Commission proposes to apply the highest standards of governance of lifesciences and biotechnology along 5 main action lines:· Societal dialogue and scrutiny should accompany and guide the development oflife sciences and biotechnology· Life sciences and biotechnology should be developed in a responsible way inharmony with ethical values and societal goals Informed choice should facilitate demand-driven applications· Science-based regulatory oversight should enhance public confidence· Basic regulatory principles and legal obligations should be respected to safeguard the Community single market and international obligations.

However……However……

References to References to ethics, values and ethics, values and consumer choice consumer choice have decreased have decreased markedly with each markedly with each annual annual Biotechnology Biotechnology Strategy reportStrategy report

0

5

10

15

20

25

30

35

40

2002 2003 2004 2005

Ethics &ValuesChoice

The “refocused Lisbon Agenda” mentions The “refocused Lisbon Agenda” mentions them not at allthem not at all

ConclusionConclusion

Ethics is a politically sensitive issue Ethics is a politically sensitive issue particularly at the EU levelparticularly at the EU level

Consumer choice is a politically sensitive Consumer choice is a politically sensitive issue particularly at the international level.issue particularly at the international level.

There is always a risk that economic There is always a risk that economic imperatives might seek to overide ethical imperatives might seek to overide ethical and societal concerns or that these and societal concerns or that these concerns might retard progress and make concerns might retard progress and make the EU uncompetitive. the EU uncompetitive.

It is essential for the EU to maintain the It is essential for the EU to maintain the right balance and ensure wide societal right balance and ensure wide societal involvement in any debate.involvement in any debate.