Differing policies and practices on stem cell research and regenerative medicine across the world Objective: How to understand –and deal with- these variations in a context of increasing international stem cell research?
1. Ethical debates on stem cell research and regenerative medicine2. Origin, nature and consequences of international variation regarding stem cell research and regenerative medicine3. Regulatory framework in Europe. The case of Spain4. REMEDiE Project findings
INITIAL CONCERNS ON CONTEMPORARY CONCERNS : EMBRYOS BEYOND THE EMBRYO Sources of hES cells (SCNT vs New sources of stem cells : Altered Excess IVF embryos) Nuclear transfer (ANT) embryos Human cloning and induced pluripotent stem (IPs) Embryo destruction cells Commodification of human Safety of clinical trials with stem cell biological material therapies Hubristic quest for regenerative immortality Donors‟ respect and protection: Mixing human and animal informed consent, rights to the species downstream research uses… Pro-life, Potentiality arguments, Commercial applications dignity Exploitation, social justice Ethics of whether stem cell research should be conducted Ethics of how stem cell research ought to be conducted: oversightJuengst, E. and M. Fossel,, 2000Hyun, I. 2010
How to balance the therapeutic promises of regenerative medicine with the complex socio-ethical issues involved? “This interplay between promise and controversy is partially responsible of the enormous variation that exists among the environments in which stem cell research is conducted in different jurisdictions around the world”(Caulfield et al, 2009)
Different definitions, i.e. “embryo” Different levels of government involvement : public (Europe) vs private (self regulated model in Israel, China or India). Differing regulations (across and within jurisdictions) about: The procurement of gametes, embryos and other cells from humans The derivation and uses of new hES cells The funding sources Patent policies (EU vs US) Clinical trial regulations, including privacy rules, informed consent and assessment of risk Isasi & Knoppers 2006 ; Caulfield,et al., 2009
Research practice standards Research conduct Technical standards relating to cell line derivation, banking, distribution, maintenance and use of stem cell lines Health care systems Different responses to clinical developments Public perceptions and public involvement Caulfield,et al., 2009 ; Pardo & Calvo,2008
Multifaceted, overlapping and discordant regimes may Encourage stem cell tourism, exploitation Threaten social justice and individual protection… Negatively influence the sharing of materials and data Inhibit collaboration at both national and international levels Restrict the flow of knowledge and researchers Create distrust
What degree of consistency is required for effective cooperation? How to achieve some interoperability, harmonization or convergence in stem cell research without disrespecting pluralism on cultural, religious and social norms and values? Is public policy on morally contentious issues only feasible when there is a high level of consensus? (E.U) Some attempts, such as the International Society for Stem Cell Research, have to face the reality that different understandings regarding core values and principles endure between policy makers, society representatives and researchers.Isasi & Knoppers 2006 ; Caulfield,et al., 2009
Growing international networks and collaborations New opportunities for ethical education of migrant scientists: Is an international science ethos possible and desirable?
ASPECTS WHERE DEBATES WHERECONSENSUS AND POLICY IRREDUCIBLE UNIFORMITY SEEM DISAGREEMENT IS LIKELY POSSIBLE TO PERSIST Research standards Moral status of the Cell line quality embryo Scientific integrity Commodification and patentability of human Reproductive cloning biological material (UN) What dignity means and how this concept should be applied
Consensus may not always be an attainable objective. On the other hand, it may not always be necessary Clearly identifying the extent and the reasons for disagreement is a valuable objective But: “The consequences of discord are too high to allow the inconsistency to continue… perhaps, the spectre of a dialogue of the deaf, with market forces driving progress on this ethically sensitive issue will bring stakeholders to the discussion table”(Isasi and Knoppers, 2006)
The role public opinion plays in the policy makiing process varies considerably UK : Human Fertilisation and Embryology Authority (2009) France: Révision des Lois de Bioéthique (2010) US IOM and National Research Council: Guidelines for Human Embryonic Stem Cell Research, (2005) International: International Society for Stem Cell Research
Restrictive policies: tight regulation or blank prohibition. Strong government intervention. Focus on protection Intermediate policies: many practices allowed but closely controlled by modest State intervention Liberal policies: most technologies and methods are permitted provided that procedural rules and governance are observed. Focus on Medical progress (Isasi and Knoppers, 2006)
Option 1 Option 2 Option 3 Option 4 Prohibition of Prohibition of Allow procurement of Allowing creation of procurement of procurement but hES cells from human embryos, hES cells from allowing supernumerary human including SCNT, for human embryos importation embryos but prohibition research purposes of creation of human embryos for research purposes including cloning Denmark, Estonia, Finland, Greece, Austria, Germany UK Hungary, France, Ireland Belgium Netherlands, Italy Spain Norway Switzerland,(A. Webster) More restrictive More liberal
Color Policy Type Permissive (e.g., SCNT is specifically permitted under certain conditions) Permissive Compromise (e.g., SCNT is prohibited; hESC research using supernumerary IVF embryos is specifically permitted or not prohibited) Restrictive Compromise (e.g., hESC research only permitted using cell lines created before a certain date) Prohibitive (e.g., research using embryos or cell products derived from embryos is prohibited)
Research with embryos and foetuses (1988) Stem cell research (Only spare embryos 2006 also SCNT 2007) Biobanks: intermediate/flexible model of consent Guarantees of protection: informed consent, confidentiality, equity, security (oversight) Comisión de Garantías para la Donación y Utilización de Células y Tejidos Humanos) Comité Nacional de Ética
Formal Respect for the Oviedo Convention but clear endorsement of research and innovation Principle of Gratuity in all donation of biological material is required, but oocyte procurement in Spain is reimbursed (compensated 600-900€) Human embryo creation for research purposes is explicitly forbidden, but SNCT is allowed
Article 33. Obtaining of embryonic cells.1. The creation of human pre-embryos and embryosexclusively for experimentation purposes isprohibited.2. The use of any technique for obtaining human stemcells for therapeutic or research purposes is allowed,but only when it does not entail the creation of a pre-embryo or an embryo exclusively for this purpose, inaccordance with the terms provided in this Law,including the activation of ovocites through nucleartransfer.
Historic factors Political environment Compromise Pragmatism of the legislator: Art. 33: Obtención de células de origen embrionario Redefinition of “embryo” “Oocyte activation” vs “fecundation”
l. “Embryo”: a phase of embryonic developmentfrom the moment in which the fertilised ovocite isfound in the uterus of a woman until thebeginning of organogenesis and which ends 56days from the moment of fertilisation
Clinical trials deploying stem cells have grown over the past 7 years from c.50 to c. 2250, mainly US-based The main European hubs for commercial activity in regenerative medicine are Germany, France, Spain and the UK – 90 companies (mostly SMEs) across Europe Lack of harmonized clinical trials regulation in the EU compared with the USA: this has implications for competition, regulatory coherence and business models (A. Webster)
The implementation of an „embryo destruction‟ principle in patent law within the examination of patentability remains a pressing question in different patent jurisdictions. Standardization is double-edged inasmuch as it can also impose a method on the community that may drive science towards early, sub-optimal models of biological markers. discrete communities of bioethics are differentiated by cultures – especially shared language - and different academic traditions (A. Webster)
Greater coordination of a multi level governance framework will be necessary to ensure more effective support for RM Geographical and technological stratification of the European RM sector is highly relevant for targeting any policy initiative to support the industry European policies should monitor existing trends toward indirect forms of commercialization of oocytes for reproductive and research purposes (A. Webster)
Consensus on RM is not only dependent on moral factors, but also on contingencies such as historical constraints, the existence of groups of pressure, the prevalent political ideology, individual leadership of policy makers and their ability to create pragmatic regulations which “do the job” while avoiding controversy.
Caulfield, T., et al., The stem cell research environment: a patchwork of patchworks. Stem Cell Rev, 2009. 5(2): p. 82-8. Hyun, I., The bioethics of stem cell research and therapy. J Clin Invest, 2010. 120(1): p. 71-5. Juengst, E. and M. Fossel, The ethics of embryonic stem cells-- now and forever, cells without end. JAMA, 2000. 284(24): p. 3180-4. Isasi, R.M. and B.M. Knoppers, Mind the gap: policy approaches to embryonic stem cell and cloning research in 50 countries. Eur J Health Law, 2006. 13(1): p. 9-25. Pardo, R., C. Midden, and J.D. Miller, Attitudes toward biotechnology in the European Union. J Biotechnol, 2002. 98(1): p. 9-24. Dickenson, D.L., Cross-cultural issues in European bioethics. Bioethics, 1999. 13(3-4): p. 249-55.
A detailed examination of the political economy of globalized regenerative medicine, applying this to highly significant policy and public issues within Europe An integrated, interdiscipinary series of projects organized around three inter-related streams of research – markets, politics, bioethics The development of a global database to identify global (inter-related) trends and to develop visualization techniques to map these Acknowledgement: Pr. A. Webster
OVERVIEW OF THE WORKPACKAGES AND THEIR RELATIONSHIP WP 9: Policy engagement and Communication of results WP 7: Regenerative medicine database WP6: global bioethics: IP and cultural WP1:global difference market: WP5: global investment bioethics: WP3: global WP4: global culture, politics: politics: bioethics WP2: transnational states, and cultural global science strategies conflict market trading REMEDiE WP. 8 Coordination of analysis/ WP 10 Management of the Consortium (A. Webster)
May 2008. Partners Kick-off Meeting Kings Manor, University of York, UK January 2009. Challenges to Stem Cell Translation and Policy. Wellcome Trust, London, UK June 2010. Regenerative Medicine in 21c: Managing Uncertainty at the Global Level. The Pyle Center, Wisconsin, Madison, USA April 2011. Bringing Regenerative Medicine to the Clinic: Trials and Tribulations in Europe and Beyond. University of the Basque Country, Bilbao, Spain
Members: Itziar Alkorta Idiakez (IP) Iñigo de Miguel Beriain David Rodríguez-Arias (since 01/2011) Objectives To compile and analyze cultural variance in bioethics concerning regenerative medicine To understand the political significance of the debate: its impact on governance relations at the sub- political, political and legislative levels To identify possible forms of compromise in ethically and socially controversial issues
Hypotheses Shared values is the most relevant mapping factor of bioethics communities The emergent global bioethical discourse may create the conditions for a balancing of conflicting cultural values in Europe Methods Questionnaire about definitions Interviews with European and non European bioethicists (scholars and policy makers) involved in the RM debate Literature review
Are there identifiable currents of thought in the ethics of stem cell research and regenerative medicine? Which are the shared viewpoints within them? Which are the main disagreements between them? What kind of ties between communities and networks of bioethics in this field? Cultural, religious, language Values, principles Can different models policy making on Stem Cell Research be identified? Forms of involvement of the public in the DM processes
REMEDiE: Regenerative Medicine in Europe Emerging needs and challenges in a global context Department of Sociology and the York Management School, University of York, UK Faculty of Science and Technology, Law Department, University of Basque Country, Spain Institute of Political Science, University of Hannover, Germany The REMEDiE Consortium Department of Political Science, University of Vienna, Austria Center for Ethics and Law in Biomedicine, Central European University, Hungary Global Biopolitics Research Group, Kings College London, UKhttp://www.york.ac.uk/satsu/remedie/
18-19 April 2011University of the Basque Country, Bilbao, Spain