Governing Emerging Technologies: Concerns, Values and Regulatory Instruments

1. Governing Emerging Technologies: Concerns, Values and Regulatory Instruments In Argentina’s Stem Cell Governance PRIME International Conference Mexico City 24-26 September 2008 Shawn H.E. Harmon Research Fellow, Innogen

2. ARGENTINA – A STATE OF FLUX I. The Scientific Setting II. The Social Setting III. The Moral Setting IV. The ‘GET: Social Values’ Project V. Call for Participants www.innogen.ac.uk

3. I. THE SCIENTIFIC SETTING • The General / International Context • Understanding of SC function is in its infancy • Hurdles remain to effective and efficient clinical application • Utility and superiority of ESCs versus SSCs contested • The Argentine Context • Moving to human trials with adult SC therapies, including • cerebral infarction and diabetes. • Multi-centre international collaborations pursued re: adult SC • therapies for congenital heart disease. • World leader in SCR spending (Thorn, 2005; Biocrawler). • Little empirical evidence on how much SCR is being undertaken, • but biotechnology and SCR innovation has been identified as • public objective. www.innogen.ac.uk

4. II. THE SOCIAL SETTING • The General / International Context • Nexus of competitive healthcare research, commerce and clinical practice. • Site of divisive opinions on socially significance issues and concerns: • When does human life commence? • What is the meaning of personhood? • What risks and practices are acceptable? • How do we protect women (in the ESC context)? • The Argentine Context • Conservative Catholic-influenced social environment but expressing social contradictions (eg: abortions illegal, but regularly sought, often obtained, and rarely discussed; neither regenerative medicine nor SCR have received full public debate). • Emerging from economic crisis/collapse, but vigorously pursuing biotech and SCR as a vehicle for sustainable development (Declaration of Buenos Aires 2005). • Administering some (non-embryonic) SC-based treatments (Greenwood et al., 2006). www.innogen.ac.uk

5. III. THE MORAL SETTING • The General / International Context (ESCR) • Some concerned that: (1) science will have no limits; (2) individual human life will be devalued; and (3) human relations will become confused. • Others concerned that: (1) knowledge will be stymied by minority; (2) personal freedom will be infringed; and (3) unnecessary suffering will endure. • International debates disclose 4 moral positions, each turning on a consideration of these concerns: (1) the Prohibitive Position; (2) the Restrictive Position; (3) the Permissive Position; and (4) the Facilitative Position. • Underlying these positions are shared values, including: (1) respect for human dignity; (2) sanctity of life; (3) individual autonomy; and (4) social solidarity. www.innogen.ac.uk

6. The Moral Setting Cont’d • Positions Defined and Consequences • Prohibitive:Human life and personhood commence simultaneously at the moment of fertilisation; the embryo has unique potential to develop into a complex organism substantially different from its origins or any other known entity. No instrumental destruction; research embryos can only be used to assist fertility of donor woman. • Restrictive: Ibid. No instrumental destruction; research embryos can only be used from existing cell lines. • Permissive:Though human, the embryo lacks the necessary characteristics of personhood – sentience, consciousness, reasoning; although deserving of some “moral awe”, embryos are not sacrosanct and those left over from IVF can be used in pursuit of worthy/virtuous ends. Research embryos can be generated from IVF surplus. • Facilitative:The embryo is a collection of cells little different from any other bodily tissue; the acquisition of personhood is a gradual process rather than an event. Research embryos can be generated from IVF surplus, specific donations or cloning. www.innogen.ac.uk

7. The Moral Setting Cont’d • The Argentine Context • Little debate to date on research regulation or on stem cell • research more specifically. • But: • Argentina has ratified the American Convention on Human Rights which stipulates that “everyone has the right to have his life protected … from the moment of conception”; and • Argentina has constitutionally entrenched Catholic dogma (which views the creation of embryos for research as the creation of “sacrificial victims”). • Thus, one might expect the prohibitive or restrictive positions to be most prominently represented. www.innogen.ac.uk

8. IV. THE ‘GET: SOCIAL VALUES’ PROJECT Governing Emerging Technologies: Social Values & Stem Cell Regulation in Argentina ESRC Ref. RES-000-22-2678 When 1 April 2008 – 31 March 2010 What Project considers the interaction between SOCIAL VALUES and the LAW in stem cell governance in Argentina GoalMap the public debates around stem cell science Analyse the Argentine regulatory model as it evolves Dialogue with stakeholders re: relevant ethical concerns and moral values Jointly consider how to effectively translate values into legal mechanisms HowDocumentary research on Argentine social and legal setting Questionnaires to key Argentine stakeholders (scientific, social, regulatory) Interviews with key Argentine stakeholders (scientific, social, regulatory) www.innogen.ac.uk

9. The ‘GET: Social Values’ Project Cont’d Why Argentina is a developing country actively pursuing biotech (stem cell) solutions for modern problems Argentina is commencing the regulatory journey Argentina has the chance (and the intention) of being a regional (and world?) leader in the science and a model for its governance Outputs Workshop with Argentine Stakeholders (with Prof. Fabiana Arzuaga) Policy Briefs Academic Papers, Conference Presentations, and Final Report www.innogen.ac.uk

10. The ‘GET: Social Values’ Project Cont’d • Preliminary Conclusions on the Social/Moral • The moral position to which one subscribes will determine in large part one’s view of the acceptability of SCR. • Each position is grounded on (the same small pool of) universal moral values. • The moral foundations of these positions has made consensus on the propriety of ESCR impossible. • Argentina has not yet undertaken any broad stakeholder engagement which might better elucidate the prevalent social/moral concerns • BUT • Allowing such a participatory activity to focus on the unsolvable problems of defining when humanity begins and what personhood means, although exposing the variety of views in Argentina, will diminish the utility of the exercise, which would be to determine a way forward for Argentina in light of the international reality and ongoing research. www.innogen.ac.uk

11. The ‘GET: Social Values’ Project Cont’d • Preliminary Conclusions on the Legal • Argentina has a complex, fragmented, and uncoordinated sci-tech innovation environment with no specific regenerative medicine or SCR regulation. • Peripherally relevant instruments include: • Research • Prohibition on Human Cloning Research (Decreto 200/1997) • Commercialisation • IP Law (Ley 11.723) • Patents & Utility Models Law (Ley 24.481) • Therapy • Transplantation Law (Ley 24.193) • Medicines Law (Ley 16.463). www.innogen.ac.uk

12. The ‘GET: Social Values’ Project Cont’d The 1997 Decree in Focus Stem Cell Sourcing Recital 1: There is a duty to protect human dignity. Article 1: All experiments relating to human cloning are prohibited. Stem Cell Research Purposes Recital 4: There is a need to control all activities associated with human cloning (which would include SCR). NA: No further references to the purposes for which SCR can be undertaken, though it is an activity frequently “associated” with human cloning. Participant Safeguards NA: No binding safeguards for participants in SCR or the related fields of IVF. Commercialisation NA: No specific regulations on the commercialisation of SCR. www.innogen.ac.uk

13. The ‘GET: Social Values’ Project Cont’d The 1997 Decree Cont’d Monitoring Mechanisms NA: No institution is erected to monitor research (and ensure compliance with cloning ban), and no regulatory authority over SCR or the related field of IVF. Enforcement & Sanctions NA: No sanctions for breach of cloning prohibition or in relation to SCR activities. www.innogen.ac.uk

14. The ‘GET: Social Values’ Project Cont’d • The 1997 Decree Cont’d • Rhetoric of sanctity and dignity as restraint (suggestive of the prohibitive or restrictive position). • Minimalist regime which encloses or “black boxes” a specified activity deemed reprehensible, but otherwise permits SCR to take place outwith regulation. • Little chance for policy-makers to: • (1) shape research trajectories; • (2) measure social acceptability of science; or • (3) manage science uptake/dissemination. • Fails to translate the moral values suggested into legal rules insofar as it de facto permits a permissive position to prevail. www.innogen.ac.uk

15. The ‘GET: Social Values’ Project Cont’d • Next Steps • Argentina has established a Stem Cell Commission and a Ministry of Science & Technology, which is working closely with the Ministry of Health. • Argentina has held a preliminary international workshop on stem cell regulation (29 November 2007) with key regulatory, scientific and academic stakeholders. • Argentina is considering the way forward to a new, comprehensive human tissue regime which will govern stem cells. • SO … • We will interview key stakeholders in the science, academic, and policy fields to survey their objectives for legislation and the underlying values they feel are important to the new regime. www.innogen.ac.uk

16. V. CALL FOR PARTICIPANTS We are interested in hearing from all Argentine stakeholders in the stem cell setting. Please participate in this project. For more information or to register your interest to participate, contact me at shawn.harmon@ed.ac.uk. THANK YOU. www.innogen.ac.uk

17. The support of the Economic and Social Research Council (ESRC) is gratefully acknowledged. The work presented forms part of the programme of the ESRC Genomics Network at Innogen.