Impact of the Oviedo Convention on Legislation in Western Europe 06/12/2018 Impact of the Oviedo Convention on Legislation in Western Europe Olivier Guillod Institute of Health Law - University of Neuchâtel Prénom Nom

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 Bratislava / 06.12.18

Oviedo Convention and Western European countries 8 Western European countries have ratified the Convention so far : Denmark 1999 Greece 1998 Iceland 2004 Norway 2006 Portugal 2001 San Marino 1998 Spain 1999 Switzerland 2008 Bratislava / 06.12.18

Oviedo Convention [OC] and Western European countries 6 additional Western European countries have signed the Convention so far : 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 No discrepancy between French law and the OC Common European fight against ethical erosion Bratislava / 06.12.18

Oviedo Convention and Western Europe 9 Western European countries neither signed nor ratified the Convention so far : Andorra Austria Belgium Germany Ireland Liechtenstein Malta Monaco United Kingdom Why ?!? Grounds may vary widely Germany… United Kingdom… Bratislava / 06.12.18

Additional protocols and Western European countries 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 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 Protocol on biomedical research, 2005 Seven signatures: Denmark, Greece, Iceland, Italy, Luxembourg, Portugal and Sweden Protocol on genetic testing for health purposes, 2008 Three signatures: Finland, Iceland and Luxembourg Bratislava / 06.12.18

Reservations to the Oviedo Convention 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) Norway Reservation to article 20 para 2 OC (removal of regenerative tissue from a minor also for mother/father/child/close relative) Bratislava / 06.12.18

Reservations to the Oviedo Convention 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) Bratislava / 06.12.18

New national laws on biomedicine 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. Bratislava / 06.12.18

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 Bratislava / 06.12.18

New national laws on biomedicine Main pieces of recent Swiss legislation passed before ratification of the Oviedo Convention Law on medically assisted procreation (2001) 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) Rules on clinical trials of new drugs [= 16-17 OC] Law on research with embryonic stem cells (2005) Protection of embryos [= 18/1 OC] Law on sterilisation (2005) Informed consent [= 5-6 OC] Bratislava / 06.12.18

New national laws on biomedicine Main pieces of recent Swiss legislation passed before ratification of the Oviedo Convention Law on human genetic testing (2007) 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) 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 Bratislava / 06.12.18

New national laws on biomedicine Main pieces of recent Swiss legislation passed after ratification of the Oviedo Convention Reform of the Swiss civil code (December 19, 2008) 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) 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 Bratislava / 06.12.18

OC and the ECourtHR The Oviedo Convention may also have an indirect influence on national laws through the European Court of Human Rights in Strasbourg ECourtHR may be requested to give an advisory opinion on the interpretation of the OC, according to art. 29 OC 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) OC used to interpret article 8 ECHR (right to respect for private and family life) and article 2 ECHR (right to life) Bratislava / 06.12.18

Concluding remarks  The Oviedo Convention expresses the prevalent view in 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 Bratislava / 06.12.18