1. David Rodríguez-Arias
david.rodriguez-arias@ehu.es

2. http://blogs.nature.com/news/thegreatbeyond/2011/01/pictu
re_post_world_map_of_scie_1.html?WT.ec_id=NEWS-20110201

3.  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?

4. 1. Ethical debates on stem cell research and
regenerative medicine
2. Origin, nature and consequences of
international variation regarding stem cell
research and regenerative medicine
3. Regulatory framework in Europe. The case of
Spain
4. REMEDiE Project findings

5. 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: oversight
Juengst, E. and M. Fossel,, 2000
Hyun, I. 2010

6. 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)

7.  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

8.  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

9. 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

10.  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

11.  Growing international networks and
collaborations
 New opportunities for ethical education of
migrant scientists: Is an international science
ethos possible and desirable?

12. ASPECTS WHERE DEBATES WHERE
CONSENSUS 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

13.  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)

14.  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

15.  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)

16. 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

17. 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)

18.  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

19.  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

20. Article 33. Obtaining of embryonic cells.
1. The creation of human pre-embryos and embryos
exclusively for experimentation purposes is
prohibited.
2. The use of any technique for obtaining human stem
cells 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, in
accordance with the terms provided in this Law,
including the activation of ovocites through nuclear
transfer.

21.  Historic factors
 Political environment
 Compromise
 Pragmatism of the legislator:
 Art. 33: Obtención de células de origen
embrionario
 Redefinition of “embryo”
 “Oocyte activation” vs “fecundation”

22. l. “Embryo”: a phase of embryonic development
from the moment in which the fertilised ovocite is
found in the uterus of a woman until the
beginning of organogenesis and which ends 56
days from the moment of fertilisation

23. www.york.ac.uk/satsu/remedie

24.  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)

25.  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)

26.  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)

27.  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.

28.  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.

29. David Rodríguez-Arias
david.rodriguez-arias@ehu.es

30.  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

31. 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)

32.  May 2008. Partner's 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

33.  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

34.  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

35.  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

36. 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, King's College London,
UK
http://www.york.ac.uk/satsu/remedie/

38. 18-19 April 2011
University of the Basque Country, Bilbao, Spain