Transcript Impact of the Oviedo Convention on Legislation in Western Europe Olivier Guillod

Impact of the Oviedo Convention
on Legislation in Western Europe
Olivier Guillod
Institute of Health Law Neuchâtel
University of
Agenda
1. Oviedo Convention and Western
European countries
2. Reservations made by Western European countries
3. New national laws on biomedicine
4. Oviedo Convention and the European Court of Human Rights
5. Concluding remarks
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Oviedo Convention and
Western European countries
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8 Western European countries have ratified the
Convention so far :
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Denmark 1999
Greece 1998
Iceland 2004
Norway 2006
Portugal 2001
San Marino 1998
Spain 1999
Switzerland 2008
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Oviedo Convention [OC] and
Western European countries
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6 additional Western European countries
have signed the Convention so far :
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Finland 1997
France 1997
Italy 1997
Luxembourg 1997
Netherlands 1997
Sweden 1997
Evolution of the position in France
– Position of the Council of State in 1998
– Position of the same Council in 2009
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No discrepancy between French law and the OC
Common European fight against ethical erosion
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Oviedo Convention and
Western Europe
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9 Western European countries neither signed
nor ratified the Convention so far :
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Andorra
Austria
Belgium
Germany
Ireland
Liechtenstein
Malta
Monaco
United Kingdom
Why ?!?
– Grounds may vary widely
– Germany…
– United Kingdom…
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Additional protocols and
Western European countries
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Protocol on the prohibition of cloning, 1998
– 5 ratifications: Greece, Iceland, Portugal, Spain and Switzerland
– Nine signatures: Denmark, Finland, France, Italy, Luxembourg,
Nertherlands, Norway, San Marino and Sweden
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Protocol on transplantation of organs and tissues, 2002
– No ratification in Western Europe
– Nine signatures: Finland, Greece, Iceland, Italy, Luxembourg,
Netherlands, Portugal, Spain and Switzerland
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Protocol on biomedical research, 2005
– No ratification in Western Europe
– Seven signatures: Denmark, Greece, Iceland, Italy, Luxembourg,
Portugal and Sweden
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Protocol on genetic testing for health purposes, 2008
– No ratification in Western Europe
– Three signatures: Finland, Iceland and Luxembourg
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Reservations to the Oviedo Convention
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Extent of reservations gives an idea of the general
acceptability of the OC
Three Western european countries made reservations
Denmark
– Reservation to article 10 para 2 OC (right to information about
health of registered persons not always guaranteed)
– Reservation to article 20 para 2 OC (removal of regenerative
tissue from a minor also for mother/father)
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Norway
– Reservation to article 20 para 2 OC (removal of regenerative
tissue from a minor also for mother/father/child/close relative)
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Reservations to the Oviedo Convention
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Switzerland
– Reservation to article 20 para 2 OC (removal of regenerative
tissue from a minor also for mother/father/child; art 13 LTranspl.)
– Reservation to articles 19 and 20 OC (removal of an organ on a
living donor may also be a primary option)
– (Temporary) reservation to article 6 para 3 OC (some cantonal
laws grant to the physician the power to decide for an
incompetent patient)
 The small number of reservations shows a very good
acceptance of the material rules in the OC from countries
which decided to ratify the Convention
 All Western European countries which issued a
reservation made it on the same point : article 20 OC
(and so did also Croatia)
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New national laws on biomedicine
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The influence of the Oviedo Convention on national laws
is very difficult to assess
Many national laws have been adopted on biomedical
issues throughout Western Europe for the last twelve
years, e.g.
– France: Law n° 2004/800 on bioethics, from August 6, 2004
– Denmark: Law on health, from June 24, 2005
– Spain: Law N° 41/2002 on the autonomy of patients and Law N°
14/2007 on biomedical research
– Greece: Law N° 3089 on medically assisted reproduction, from
December 22, 2002
– Norway: Law N° 100 on the use of biotechnology in human
medicine, from December 2003 and Law N° 44 on medical and
health research from June 20, 2008
– Portugal: Law N° 32/2006 on medically assisted procreation,
from July 26, 2006
– Etc. etc.
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New national laws on biomedicine
• The case of Switzerland
– 1992 : constitutional amendment mandating the Swiss
Confederation to legislate on genetics and on
reproductive medicine
– 1999 : constitutional amendment mandating the Swiss
Confederation to legislate on organ transplantation
– September 25, 2009 : Parliament approved a
constitutional amendment mandating the Swiss
Confederation to legislate on biomedical research
(must still be approved in a popular referendum that
should be held on March 7, 2010)
– Intense legislative activity for the past 15 years
– Swiss Parliament has taken into account the Oviedo
Convention, but principles of medical law generally
recognized before the Oviedo Convention were quite
close to the rules set forth in the OC
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New national laws on biomedicine
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Main pieces of recent Swiss legislation passed before
ratification of the Oviedo Convention
– Law on medically assisted procreation (2001)
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Prohibition of cloning [= 1. AP]
Prohibition of creating embryos for research purposes [= 18/2 OC]
No sex selection [= 14 OC]
No interventions on the human genome [= 13 OC]
– Law on medicinal products (2002)
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Rules on clinical trials of new drugs [= 16-17 OC]
– Law on research with embryonic stem cells (2005)
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Protection of embryos [= 18/1 OC]
– Law on sterilisation (2005)
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Informed consent [= 5-6 OC]
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New national laws on biomedicine
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Main pieces of recent Swiss legislation passed before
ratification of the Oviedo Convention
– Law on human genetic testing (2007)
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Non-discrimination [= 11 OC]
Tests for health purposes [= 12 OC]
Informed consent [5-6 OC]
Confidentiality of genetic data [= 9 OC]
– Law on organ, tissue and cell transplantation (2007)
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Rules generally compatible with 19-20 OC
Two exceptions which were the object of two reservations from
Switzerland upon ratification of the Oviedo Convention in 2008
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New national laws on biomedicine
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Main pieces of recent Swiss legislation passed after
ratification of the Oviedo Convention
– Reform of the Swiss civil code (December 19, 2008)
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Informed consent (= 5 OC)
Protection of persons not able to consent (= 6 OC)
Protection of persons who have a mental disorder (= 7 OC)
Informed consent in an emergency situation (= 8 OC)
Advanced directives with binding effect (goes beyond 9 OC)
– First draft of a Law on biomedical research (2009)
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Would cover the whole field of biomedical research
Compatible with art. 15 to 17 of the Oviedo Convention
 Oviedo Convention has been one of the most
influential factors in the completion of a Swiss biolaw
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OC and the ECourtHR
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The Oviedo Convention may also
have an indirect influence on national
laws through the European Court of
Human Rights in Strasbourg
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ECourtHR may be requested to give an advisory opinion
on the interpretation of the OC, according to art. 29 OC
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OC mentioned as part of the relevant international law,
even in cases involving a country which did not ratify the
OC (e.g. Glass v. United Kingdom, 2004)
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OC used to interpret article 8 ECHR (right to respect for
private and family life) and article 2 ECHR (right to life)
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Concluding remarks
 The Oviedo Convention expresses the prevalent view in
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Western Europe on the appropriate legal answers to
biomedical issues
Each new ratification of the OC is an important step
towards reinforcing a set of common European values
based on Human Rights
Ratification by the « big » Western European countries
(especially Germany, France and United Kingdom) is
desirable
It is important to rely on people or institutes in each
country who are ready to publicize and promote the OC
At the same time, ratifying the OC is a significant internal
process for any European country : it compels the
country to scrutinize its own laws on fundamental issues
for the future of mankind
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