Governing Emerging Technologies:The Regulatory Model and its Underlying Values

in Argentine Stem Cell Governance – A State of Flux

4S Annual MeetingRotterdam

20-23 August 2008

Shawn H.E. HarmonResearch Fellow, Innogen

ARGENTINA – A STATE OF FLUX

I.The Scientific Setting

II.The Legal Setting

III.The Social Setting

IV.The Moral Setting

V.The 1997 Decree in Focus

VI.The ‘GET: Social Values’ Project

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I. THE SCIENTIFIC SETTING

Imperfect Comprehension

Understanding of SC function is in its infancy

Significant hurdles remain to their effective and efficient clinical application

Contested Utility

Debate over whether ESCs are superior to SSCs

SC therapies have leapt from lab to clinic(in defiance of the (more ponderous)hypothesis-to-trial process.

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The Scientific Setting Cont’d

The Argentine Context

• Moving to human trials with adult SC therapies, includingcerebral infarction and diabetes.

• Multi-centre international collaborations pursued re: adult SCtherapies 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 aspublic objective.

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II. THE LEGAL SETTING

Plurality of Regulation

No legal harmonisation of substantive practices in the SCR field; some international instruments exist (eg: Universal Declaration on the Human Genome and Human Rights

1997), but very little of it is binding.

The Argentine Context

• Complex, fragmented and uncoordinated sci-tech innovation environment with no specific regenerative medicine or SCR regulation (Thorn, 2005; Rivera-Lopez, 2002; Chudnovsky, 1999).

• One instrument which addresses a SCR-related practice (cloning) is the Prohibition on Human Cloning Research (Decree 200/1997).

• Peripherally relevant instruments are: Commercialisation – IP Law (Ley 11.723), Patents & Utility Models Law (Ley 24.481); Therapy – Transplantation Law (Ley 24.193), Medicines Law (Ley 16.463).

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III. THE SOCIAL SETTING

Division and Contestation

• SCR is a nexus of healthcare research, clinical practice, and commerce, not necessarily comfortable bedfellows.

• SCR is the site of divisive opinions onissues of social significance, including:

– 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)?

• Answers to these questions are driven by a range of conflicting concerns.

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The Social Setting Cont’d

The Argentine Context

• Generally, a conservative, heavily Catholic-influenced social environment.

• Social contradictions are disclosed insofar as abortions are illegal, but regularly sought and rarely discussed; indeed neither regenerative medicine nor SCR have ever received a full public debate.

• Developing country emerging from economic crisis/collapse, but vigorously pursuing biotech and SCR as a vehicle for sustainable development (Declaration of Buenos Aires 2005).

• Already administering some (non-embryonic) SC-based treatments (Greenwood et al., 2006).

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IV.THE MORAL SETTING

Embryonic Stem Cell Research

• Some stakeholders are concerned that:

Science will have no limits;

Individual human life will be devalued;

Human relations will become confused.

• Other stakeholders are concerned that:

Knowledge will be stymied by minority;

Personal freedom will be infringed;

Unnecessary suffering will endure.

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The Moral Setting Cont’d

ESCR Moral Positions

• International debates disclose 4 moral positions (labeled functionally as opposed to philosophically), each turning on a consideration of the above issues.

• The 4 moral positions are:

1. The Prohibitive Position

2. The Restrictive Position

3. The Permissive Position

4. The Facilitative Position

• Underlying values are human dignity,sanctity of life, autonomy, solidarity.

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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.

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The Moral Setting Cont’d

The Argentine Context

• Little debate to date on research regulation or on stem cellresearch 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”).

• Given the above, one might expect the prohibitive or restrictive positions to be most prominently represented.

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The Moral Setting Concluded

• 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.

SO …

• Fundamental disagreement combined with ongoing research demands rule-making.

• Because there is no morally “correct” way forward, the rules must be negotiated.

• The best mechanism for negotiated rule-making is legislative.

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SUGGESTED LEGISLATIVE FRAMEWORK

Given the state of science and the social concerns, the rules chosen should address:

1. SC Sourcing;

2. SCR Purposes;

3. Participant Safeguards;

4. Commercialisation;

5. Monitoring Mechanisms; and

6. Enforcement and Sanctions,

and in doing so, it should be socially aware and morally grounded.

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V. 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.

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The 1997 Decree Cont’d

Commercialisation

NA: No specific regulations on the commercialisation of SCR.

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.

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The 1997 Decree Concluded

• Use of a rhetoric of sanctity and dignity as restraint (suggestive of the adoption of a prohibitive or restrictive position).

• However, a minimalist regime is used which encloses or “black boxes” a specified activity deemed reprehensible, but otherwise permits SCR to take place outwith regulation.

• Thus, little chance for policy-makers to:

(1) shape research trajectories;

(2) measure social acceptability of science; or

(3) manage science uptake/dissemination.

• It fails to translate the moral values suggested into legal rules insofar as it de facto permits a permissive position to prevail.

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BUT …

… Argentina is in a state of flux.

• It has established a new Ministry of Science & Technology.

• The MST together with the Ministry of Health is reviewing related legislation (Human Transplantation Law) and has passed related legislation (Cord Blood Law).

• It has established a Stem Cell Commission.

• It has held a preliminary international workshop on stem cell regulation (29 November 2007) with key regulatory, scientific and academic stakeholders.

• It is now considering the way forward to a new, comprehensive human tissue regime which will, obviously, provide governance for stem cells.

Therefore …

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VI. 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

Goal Map the public debates around stem cell scienceAnalyse the Argentine regulatory model as it evolvesDialogue with stakeholders re: relevant ethical concerns and moral valuesJointly consider how to effectively translate values into legal mechanisms

How Documentary research on Argentine social and legal settingQuestionnaires to key Argentine stakeholders (scientific, social, regulatory)Interviews with key Argentine stakeholders (scientific, social, regulatory)

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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, as this conference demonstrates

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 BriefsAcademic Papers, Conference Presentations, and Final Report

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The ‘GET: Social Values’ Project Cont’d

All Argentine stakeholders in the stem cell setting(legislators, regulators, scientists, academics, entrepreneurs, civil society)

Should consider participating in this project.

For more information or to register your interest to participate,contact me at shawn.harmon@ed.ac.uk.

THANK YOU.

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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.