Governing Emerging Technologies

1. Governing Emerging Technologies Project Overview and Core Regulatory Issues Shawn H.E. Harmon Research Fellow Argentine Stem Cell Commission 14 October 2008

2. Introduction I. The GET: Social Values Project II. Early Project Findings & Conclusions III. Research Findings from the STS Community IV. Issues for Argentina V. Summation VI. Call for Participation

3. The ‘GET: Social Values’ Project Governing Emerging Technologies: Social Values & Stem Cell Regulation in Argentina ESRC Ref. RES-000-22-2678 Duration • April 2008 – March 2010 Overview • This ESRC-funded project considers the governance of stem cell research, particularly human embryonic stem cell research, in Argentina, and the interaction between SOCIAL VALUES and the LAW in Argentine stem cell governance

4. The Project Cont’d Objectives • Dialogue with stakeholders re: relevant ethical concerns and moral values • Consider how to effectively translate values into legal mechanisms • Map the public debates and law-making process re: stem cell science • Analyse the Argentine regulatory model as it evolves Justifications • Argentina is a developing country actively pursuing biotech (stem cell) solutions for modern problems • Argentina is commencing the regulatory journey, as this conference demonstrates • Argentina has the chance (and the intention) of being a regional (world?) leader in the science, and of creating an exportable model for its governance

5. The Project Cont’d Methodology • Research on Argentine social and legal setting • Questionnaires to key Argentine stakeholders • Interviews with key Argentine stakeholders Expected Outputs • Presentations (Buenos Aires, November 2007; Rotterdam, August 2008; Mexico City, September 2008; Buenos Aires, October 2008; etc.) • Papers (Panoptica, Developing World Bioethics, etc.) • Policy Briefs (4:2008; 5:2008; etc.) • Stakeholder Workshop (with Prof. Fabiana Arzuaga) (2009) • Final Report to ESRC with data and analysis (2010)

6. Early Conclusions of the ‘GET: Social Values’ Project Scientific Undertaking • Very little evidence of the extent of research being undertaken in Argentina, but: • Argentine stakeholders have already entered multi-centre international collaborations on adult stem cell research and trials (eg: congenital heart disease) (Greenwood et al., 2006); • Argentina has been identified as a world leader in stem cell spending (Thorn, 2005); • Argentina has identified biotechnology (and stem cell) research as a key means of sustainable development and competitive economic growth in the high-tech sector (Declaration of Buenos Aires 2005).

7. Early Conclusions Cont’d Scientific Regulation • Argentina has a complex, fragmented, and uncoordinated sci-tech innovation environment which was hindered by the economic crisis. • Argentina has no specific stem cell research regulation, but peripherally relevant legal instruments, including the 1997 Prohibition on Cloning (Decree 200/1997), which was a very limited executive instrument with little input from key stakeholders, and the Human Transplantation Act 2007, which created INCUCAI, but which is directed at clinical stage protocols as opposed to earlier or basic research.

8. Early Conclusions Cont’d The 1997 Decree What It Says: • There is a duty to protect human dignity (Recital 1). • There is a need to control all activities associated with human cloning (Recital 4). • All experiments relating to human cloning are prohibited (Article 1). But, There Are No: • references to the sourcing of stem cells or the purposes for which stem cell research can be directed despite stem cell research being “associated with” cloning; • binding safeguards for participants in stem cell research (women as sources of embryos or patients as clinical trials subjects), or in the related fields of reproductive medicine; • specific regulations on the commercialisation of stem cell research; • sanctions for breach of the cloning ban, or institutions to monitor research.

9. Early Conclusions Cont’d The 1997 Decree Cont’d • The Decree uses the rhetoric of sanctity as restraint and dignity as restraint • The Decree encloses or “black boxes” a specified activity deemed reprehensible (cloning), but otherwise permits stem cell research to take place outwith regulation. • The Decree offers no opportunity for policy-makers to: (1) shape research trajectories; (2) measure social acceptability of science; or (3) manage science uptake/dissemination.

10. Early Conclusions Cont’d Key Interests • Very little public evidence of the primary interests driving Argentina’s actions, but some motivations of the new Ministry of Science & Technology (and others) are the desire to: (1) enhance national pride and stability; (2) build on existing biotech research strengths; (3) emerge in strength from the recent economic crisis, and alleviate persistent economic fragility.

11. Early Conclusions Cont’d Future • The GET: Social Values project will continue to map out the processes undertaken to achieve a stem cell (or human tissue) governance regime. • It is expected that the GET: Social Values project will: • uncover more about key interests of stakeholders; • explore with stakeholders the core underlying values that stakeholders feel are important (and that they would like to see take an influencing role in the governance of the science).

12. Research Findings from STS Core Ideas re: the Governance of Science • Technologies are not neutral, nor are their adoption by society which may interpret or deploy them, or limit their use or dissemination, according to moral values, theories of justice, political expediency. • The law governing innovation or specific high-technologies (like stem cell research) needs to ‘hold open a space’ for new technologies to be captured by the law, thereby facilitating the endurance of the law.

13. STS Findings Cont’d Key Questions for Policy-Makers to Consider • Does the (proposed) law clearly identify who has responsibilities, and what those responsibilities are? • What political agenda and moral values are reflected in, or enhanced by, the (proposed) law? • Who has been given a voice (a policy-influencing role) in the preparation of the (proposed) law (ie: is there a diversity of representation and ideas)?

14. Issues for Argentina Key ‘Big-Picture’ Questions • What sort of society do you want, and how can science help realise that idea? (Why are you developing and what can this element of development achieve?) • Where are your existing scientific strengths, in what direction do you want to take them, and how does that feed into your (above) conception of society? • In what scientific fields do you want to build new strengths, and how does that feed into your (above) conception of society? • Who gets to speak when you are determining science (and societal) trajectories? (What is the role of elites, publics, culture, foreigners?)

15. Issues Cont’d Key Governance Process Questions Who is defining the problem you are addressing? Who is shaping the strategy for addressing the problem? (Who is driving the development project?) Who is participating in the science governance exercise (ie: what is the role of the Stem Cell Commission, publics, individuals, Prof. Laurie, myself)?

16. Issues Cont’d Key Legislative Substance Questions • Are you intending to create a narrow legal instrument (on stem cells) or a broader governance regime applicable to all elements of research relating to, or reliant on, human tissue? (Which is better and how will it interact or connect with the therapies regime?) • Do you allow the science to shape the law and therefore do you need to classify beings (eg: human, hybrid, animal)? • How specific do you need to be with respect to sourcing human tissue (eg: adults, children, cadavers, aborted foetuses, surplus IVF embryos, altruistic embryo donation, IVF egg-sharing schemes, cloning, hybridisation)? • X

17. Summation • If Argentina wishes to become a leader it must: • train and export academics so the world will develop tools to understand you and incorporate your ideas/needs; • be reflective (consider how decisions are made, how they change society and whether society is moving in a direction desired by all/most; • facilitate collaborations (like ours) which probe and assess, and which thread out (ie: which continue and revisit rather than dip down in a single small project). • The GET: Social Values project is an attempt to offer UK expertise/insight to Argentina, encourage/facilitate Argentina’s self-reflection, and secure evidence (re: values) so that Argentina (science) becomes visible to the world.

18. Please Participate! We want to hear from Argentine stakeholders acting or interested in the governance of stem cell research. For more information, see: http://www.law.ed.ac.uk/ahrc/esrcvaluesproject/index.asp To participate, contact: shawn.harmon@ed.ac.uk The support of the Economic and Social Research Council is gratefully acknowledged.

19. Thank You This forms part of the work of AHRC SCRIPT, ESRC Innogen, and the ESRC-funded ‘GET: Social Values’ Project, all at the University of Edinburgh.