1. PROPEUR PLANT AND ANIMAL GENOMES IN RELATION TO BIODIVERSITY Theme 3, workshop 2, Paris 5-6 May 2006 The European Union strategy on Biotechnology: after the 2005 EC report Dr David Coles Director Enhance International Limited

2. The 2002 Biotechnology Strategy A key component of the EU 2000 Lisbon Strategy “to become the most competitive and dynamic knowledge-based economy in the world, capable of sustainable economic growth with more and better jobs and greater social cohesion.” A key component of the EU 2000 Lisbon Strategy “to become the most competitive and dynamic knowledge-based economy in the world, capable of sustainable economic growth with more and better jobs and greater social cohesion.” “Life sciences and biotechnology are widely recognised to be, after information technology, the next wave of the knowledge-based economy, creating new opportunities for our societies and economies.” COM (2002) 27 Life sciences and biotechnology – A Strategy for Europe

3. The 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.”

4. Important Elements of the 2002 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

5. Scope Health Care (medicines, genetic testing, pharmacogenomics, stem cells…..) Health Care (medicines, genetic testing, pharmacogenomics, stem cells…..) Agriculture (food and non-food) Agriculture (food and non-food) Environment & Industrial processes Environment & Industrial processes

6. Actions Building Knowledge through research Building Knowledge through research Mobilising resources (training, collaboration, encouraging SME’s) Mobilising resources (training, collaboration, encouraging SME’s) Increasing development capacity (access to funding) Increasing development capacity (access to funding) Responsible Governance incorporating: Responsible Governance incorporating: Societal engagement Societal engagement Ethical values Ethical values Informed consumer choice Informed consumer choice Enhancing public confidence in regulation Enhancing public confidence in regulation Respect for single market Respect for single market International collaboration International collaboration Coherence and co-operation Coherence and co-operation

7. Conclusions of the 2005 Report Reference to refocussing the Lisbon Agenda and its central strategy of “actions that promote jobs and growth consistent with sustainable development” (Barosso - 2005 Robert Schuman Lecture for the Lisbon Council) Reference to refocussing the Lisbon Agenda and its central strategy of “actions that promote jobs and growth consistent with sustainable development” (Barosso - 2005 Robert Schuman Lecture for the Lisbon Council) 2004 was year of “consolidation rather than growth” 2004 was year of “consolidation rather than growth” Need for reflection on the role of Life Sciences and Biotechnology in the renewed Lisbon Agenda. Need for reflection on the role of Life Sciences and Biotechnology in the renewed Lisbon Agenda.

8. Competitiveness EU biotech. is not performing well compared with USA. Growth of knowledge but not developing markets. The financing gap (later in the business cycle) is the biggest single barrier to competitiveness. EU biotech. is not performing well compared with USA. Growth of knowledge but not developing markets. The financing gap (later in the business cycle) is the biggest single barrier to competitiveness. Commission proposal for a “Competitiveness and Innovation Programme (€4.2 bn for 2007-2013) to support innovation and improve access to finance Commission proposal for a “Competitiveness and Innovation Programme (€4.2 bn for 2007-2013) to support innovation and improve access to finance In addition, FP7 will include a new financing instrument, the “risk-sharing finance facility” to provide loans for infrastructure In addition, FP7 will include a new financing instrument, the “risk-sharing finance facility” to provide loans for infrastructure

9. Competitiveness Most of the 2005 report focuses on recommendations of the Competitiveness in Biotechnology Advisory Group (CBAG) – set up in 2003. Most of the 2005 report focuses on recommendations of the Competitiveness in Biotechnology Advisory Group (CBAG) – set up in 2003. Key Issue: IPR and the failure of MSs to implement Directive 98/44/EC. The Commission also proposes to monitor any economic consequences of divergence between MS legislation on IPR. Key Issue: IPR and the failure of MSs to implement Directive 98/44/EC. The Commission also proposes to monitor any economic consequences of divergence between MS legislation on IPR. Benchmarking of European public biotechnology policies shows a general increase in policies favouring biotechnology. Benchmarking of European public biotechnology policies shows a general increase in policies favouring biotechnology.

10. Funding European Research FP6 focus on SME’s – some success but still more SME involvement needed FP6 focus on SME’s – some success but still more SME involvement needed Need for more streamlined administration (simplification planned for FP7) to increase numbers of SMEs. Need for more streamlined administration (simplification planned for FP7) to increase numbers of SMEs. Development of a European “Knowledge- based Bio-economy” – networking MSs activities on development and innovation. Development of a European “Knowledge- based Bio-economy” – networking MSs activities on development and innovation.

11. Confidence in Science-based regulatory oversight Pharmaceutical Legislation Pharmaceutical Legislation CBAG indicate registration procedures for medicines are complex and expensive and may disincentivise SMEs CBAG indicate registration procedures for medicines are complex and expensive and may disincentivise SMEs 2004 – Commission introduces new regulation for SME’s – lower fees, clear guidelines and free administrative support by EMEA 2004 – Commission introduces new regulation for SME’s – lower fees, clear guidelines and free administrative support by EMEA EC proposes to give incentives to develop medicines specifically for children through a new regulation on paediatric medicine EC proposes to give incentives to develop medicines specifically for children through a new regulation on paediatric medicine

12. Confidence in Science-based regulatory oversight GMO Legislation GMO Legislation Member States repeatedly fail to agree on marketing of GM products Member States repeatedly fail to agree on marketing of GM products Commission places products on market through comitology procedures Commission places products on market through comitology procedures CBAG recommend it should be up to MSs themselves to implement EU legislation on GMOs CBAG recommend it should be up to MSs themselves to implement EU legislation on GMOs Commission believes it should continue to fulfil its legal obligations to proceed with approvals and expects more active co-operation from MSs. Commission believes it should continue to fulfil its legal obligations to proceed with approvals and expects more active co-operation from MSs. N.B. – No reference to societal concerns or consumer choice N.B. – No reference to societal concerns or consumer choice

13. Newly Emerging Issues Tissue engineering Tissue engineering clear regulatory framework needed clear regulatory framework needed Stakeholder consultation in mid 2005 Stakeholder consultation in mid 2005 proposal adopted by EC at end of 2005 on “advanced therapy” products - covering gene therapy, somatic cell therapy and tissue engineering proposal adopted by EC at end of 2005 on “advanced therapy” products - covering gene therapy, somatic cell therapy and tissue engineering

14. Newly Emerging Issues Genetic Testing Genetic Testing EU-wide information exchange on best practice EU-wide information exchange on best practice Evaluation of clinical validity of genetic tests Evaluation of clinical validity of genetic tests Protection of workers personal data wrt employment Protection of workers personal data wrt employment Consider setting standards for genetic testing under Article 152 or 153 of the Treaty Consider setting standards for genetic testing under Article 152 or 153 of the Treaty Consider genetic testing in the light of Directive 98/79/EC on in vitro medical devices Consider genetic testing in the light of Directive 98/79/EC on in vitro medical devices

15. Newly Emerging Issues Pharmacogenetics Pharmacogenetics Regulations should be developed in anticipation of application of pharmacogenetics in drug development and evaluation Regulations should be developed in anticipation of application of pharmacogenetics in drug development and evaluation No legislation without wide consultation No legislation without wide consultation Biobanks Biobanks Growth of biobanks and differing national regulations present ethical concerns and hinder effective collaboration Growth of biobanks and differing national regulations present ethical concerns and hinder effective collaboration Commission to establish recommendations for general principles governing biobanks Commission to establish recommendations for general principles governing biobanks Consider the need for an Opinion from the EGE Consider the need for an Opinion from the EGE

16. The JRC Biotechnology Assessment Study Purpose: Purpose: An evaluation of the consequences, opportunities and challenges of modern biotechnology for Europe An evaluation of the consequences, opportunities and challenges of modern biotechnology for Europe To increase public awareness and understanding of life sciences and biotechnology To increase public awareness and understanding of life sciences and biotechnology Communication and “stakeholder“ involvement identified as an important element of the study Communication and “stakeholder“ involvement identified as an important element of the study

17. The JRC Biotechnology Assessment Study – Main Tasks Task 1 Task 1 Mapping of modern biotechnologies and applications Mapping of modern biotechnologies and applications Analysis of data availability and identification of indicators Analysis of data availability and identification of indicators Task 2 Task 2 Mapping adoption of modern biotech in the EU Mapping adoption of modern biotech in the EU Evaluation of economic, social and environmental consequences, opportunities and challenges Evaluation of economic, social and environmental consequences, opportunities and challenges Assessment of emerging applications Assessment of emerging applications Discussion of potential risks, social non-acceptance and ethical concerns – including consequences of non-adoption of certain technologies Discussion of potential risks, social non-acceptance and ethical concerns – including consequences of non-adoption of certain technologies Task 3 Task 3 Relating economic, social and environmental consequences to EU policy objectives Relating economic, social and environmental consequences to EU policy objectives Assessment of future impacts of biotechnology Assessment of future impacts of biotechnology

18. Reflections on the 2005 Report and JRC study Refocussing of Lisbon resulted in greater emphasis on bringing products to market. Refocussing of Lisbon resulted in greater 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 failure is not at research stage but later in the product cycle. Measures proposed for SMEs are largely financial incentives and administrative simplification – but no relaxation of regulations Medical biotech – not a major problem. Perceived failure is not at research stage but later in the product cycle. Measures proposed for SMEs are largely financial incentives and administrative simplification – but no relaxation of regulations GM food – Consumer choice may be being compromised by Commission driving through product placement in the market GM food – Consumer choice may be being compromised by Commission driving through product placement in the market “Stakeholder” consultation focuses on regulators, industry and the medical profession – little or no explicit provision for more general societal and public input “Stakeholder” consultation focuses on regulators, industry and the medical profession – little or no explicit provision for more general societal and public input

19. Does the EU believe there is a case for constraint or intervention in the market to mitigate ethical concerns? In principle – yes: The 2002 Biotech Strategy talks about “ Developing life sciences and biotechnology in harmony with ethical values and societal goals” and says: In principle – yes: The 2002 Biotech Strategy talks about “ Developing life sciences and biotechnology in harmony with ethical values and societal goals” and says: The Commission proposes to apply the highest standards of governance of life sciences and biotechnology along 5 main action lines: · Societal dialogue and scrutiny should accompany and guide the development of life sciences and biotechnology · Life sciences and biotechnology should be developed in a responsible way in harmony 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.

20. However…… References to ethics, values and consumer choice have decreased markedly with each annual Biotechnology Strategy report References to ethics, values and consumer choice have decreased markedly with each annual Biotechnology Strategy report The “refocused Lisbon Agenda” mentions them not at all

21. Conclusion Ethics is a politically sensitive issue particularly at the EU level Ethics is a politically sensitive issue particularly at the EU level Consumer choice is a politically sensitive issue particularly at the international level. Consumer choice is a politically sensitive issue particularly at the international level. There is always a risk that economic imperatives might seek to overide ethical and societal concerns or that these concerns might retard progress and make the EU uncompetitive. There is always a risk that economic imperatives might seek to overide ethical and societal concerns or that these concerns might retard progress and make the EU uncompetitive. It is essential for the EU to maintain the right balance and ensure wide societal involvement in any debate. It is essential for the EU to maintain the right balance and ensure wide societal involvement in any debate.