Draft additional Protocol to the Convention on Human Rights and Biomedicine, on biomedical research

Parliamentary Assembly
Assembl�e parlementaire

Draft additional Protocol to the Convention on Human Rights and Biomedicine, on biomedical research

Doc. 10121
31 March 2004

Report
Committee on Culture, Science and Education
Rapporteur: Mrs Majl�ne Westerlund Panke, Sweden, Socialist Group

Summary

The additional protocol on biomedical research increases the effectiveness of the protection of human dignity without imposing unnecessary barriers to the freedom of research. The Parliamentary Assembly welcomes this further enrichment of the Convention on Human Rights and Biomedicine. It recommends that the Committee of Ministers open it for signature as soon as possible and urges all states Signatories and Parties to the Convention on Human Rights and Biomedicine to sign it.

In this context the Assembly regrets that 28 out of the 45 member states of the Council of Europe have not yet ratified or acceded to the Bioethics Convention and urges them to do so as soon as possible.

I.          Draft opinion [Link to the adopted text]

1.         The additional protocol to the Convention on Human Rights and Biomedicine on biomedical research is the third in the series of additional protocols to the Convention, after those on the prohibition of cloning human beings (1997) and on transplantation of organs and tissues of human origin (2001). The Parliamentary Assembly welcomes this further enrichment of the Convention.

2.         Freedom of research is necessary for the progress of knowledge. It is part of freedom of thought and freedom of expression and should therefore be recognised as a human right.

3.         The development of knowledge in the field of biomedicine, with a view to saving lives, treating disease and improving quality of life, depends on research, including research on human beings.

4.         Such research, however, has both cultural and ethical implications. It must respect the dignity and identity of human beings and guarantee to those who participate in it respect for their integrity and all their other rights and fundamental freedoms.

5.         The aim of the additional protocol to the Convention on Human Rights and Biomedicine is to increase the effectiveness of the protection of human dignity. It does so without imposing unnecessary barriers to the freedom of research.

6.         The Assembly is in favour of the protocol and in consequence recommends that the Committee of Ministers open it for signature as soon as possible. It urges all states Signatories and Parties to the Convention on Human Rights and Biomedicine to sign it on the day of its opening.

7.         The Assembly regrets that 28 out of the 45 member states of the Council of Europe have not yet ratified or acceded to the Bioethics Convention and urges them to do so as soon as possible.

II.         Explanatory memorandum

by Mrs Majl�ne Westerlund Panke

Introduction

1.         The additional protocol to the Convention on Human Rights and Biomedicine (Bioethics Convention), on Biomedical Research is the third in the series of additional protocols to this Convention, after those on the prohibition of cloning human beings (1997) and concerning transplantation of organs and tissues of human origin (2001).

2.         The Bioethics Convention was opened for signature in April 1997 and entered into force in December 1999. Altogether 31 member States have signed the Convention and 17 have ratified. There are 14 signatures still not followed by ratification (of which 11 are more than 6 years old), and 14 other member States have not signed yet.

3.         In many countries ratification of the Convention involves reviewing a number of laws in order to ensure that internal legislation is in full conformity with the Convention. Some countries are in the process of revising their legislation in this field and have declared that they will ratify the Convention at the conclusion of the process.

4.         My own country, Sweden, signed the convention in 1997 but has not yet ratified it . Revising our legislation in this field is almost concluded. Both the government and the Parliament feel that it is now possible for Sweden to ratify the Convention.

5.         The fact that Mexico has requested permission from the Committee of Ministers to sign the Convention shows that this European contribution to the world bioethics debate is acknowledged beyond our borders and underlines the importance of its implementation throughout Europe.

6.         The protocol on the prohibition of cloning human beings was opened for signature in January 1998 and entered into force in March 2001. As of February 2004, 29 States have signed of which 14 have ratified it. This protocol is the only international legally binding instrument prohibiting the cloning of human beings and therefore should be ratified by as many member States as soon as possible in order both to prevent this unethical practice in our member States and to demonstrate Europe's consensus on this issue of worldwide importance.

7.         The protocol on transplantation of organs and tissues of human origin was opened for signature in January 2002, signed by 12 states and is not yet into force as only three states have ratified it.

8.         In its Recommendation 1160 (1991) on the preparation of a convention on bioethics, the Assembly had recommended that the Committee of Ministers “envisage a framework convention comprising a main text with general principles and additional protocols on specific aspects. The convention should provide a flexible formula with regard to its form, but must not constitute the lowest common denominator as to its content.” It is worrying that in some countries the process of ratifying the Convention has not been considered a priority on parliamentary and governmental agendas and it is to be hoped that those States that have not signed the Convention and its Protocols do so as soon as possible so as to remove doubt as to their commitment to the implementation of its principles. This is particularly crucial in the context of a worldwide debate on issues such as cloning where the impression of a divided European opinion does not help the resolution of complex issues.

Biomedical research

9.         “Freedom of research, which is necessary for the progress of knowledge, is part of freedom of thought” as stated in the Universal declaration on the Human Genome and Human Rights (Art.12b) adopted by Unesco in November 1997. The Charter of Fundamental rights of the European Union proclaim that “the arts and scientific research shall be free of constraints” (Art.13).

10.       Freedom of research is a notion which is generally well accepted by public opinions in our countries. When the purpose of such research is the improvement of human health, as is the case of biomedical research, its acceptability is even greater.

11.       As the preamble to the additional Protocol rightly states, “progress in medical and biological sciences, in particular advances obtained in biomedical research, contributes to saving lives and improving quality of life”. The development of research in the field of biomedicine has been very rapid and has already produced good results for example in the fight against cancer (screening campaign and regular monitoring) and the development of new therapies, as well as in screening for genetic diseases (for example cystic fibrosis, thalassemia, muscular dystrophy).Further advancement of knowledge and practice in the field of biomedical science depends on further research. This inevitably necessitates research on human beings.

12.       Freedom to research on human beings is not however unlimited. Its limits are the object and purpose of the additional Protocol: “protect the dignity and identity of all human beings and guarantee everyone, without discrimination, respect for their integrity and other rights and fundamental freedoms with regard to any research involving interventions on human beings”.

13.       Any legal framework on research involving human beings should protect the individual while opening prospects for research. The key word is balance. Balance between scientific freedom on one hand and the respect for those who are the subjects of research on the other hand but also balance between possible future benefits and present inconveniences, taking into account that those who suffer the inconveniences of research in the present are not always those who benefit from its results in the future.

14.       Balance should also be sought between the needs of society and the need for freedom of research. The freedom of the researcher in the choice of methods should be balanced with respect for the individuals who are subjected to that research.

The additional Protocol

15.       The additional Protocol lays down rules which should be followed in the full range of research activities in the health field involving interventions, physical or otherwise intrusive, on human beings, including embryos in vivo but not embryos in vitro (which would be the subject of another protocol).

16.       Some of the most important principles laid down are:

the absence of alternatives to research on human beings;

the avoidance of unreasonable risks or burdens;

the scientific quality of the research project;

its approval by a competent body, based on the opinion of an independent ethics committee, and supervision by a qualified researcher;

the adequate and complete information of those who are asked to take part in the research project and

their informed, free, express, specific and documented consent, consent which may be withdrawn at any phase of the research.

17.       The additional protocol does not deal with the ownership of the data collected during a research project involving human beings in the case of withdrawal of consent. In your rapporteur’s view such withdrawal should not give the individual the possibility of preventing the data concerning him/her, and collected before the withdrawal, from being used. Otherwise the whole project could be jeopardised.

18.       The additional protocol devotes two chapters to the protection of special groups. The stronger protection is (naturally) that of persons not able to consent to research, where five additional specific conditions are imposed. It should be noted however that, strict as they are, such conditions allow for more flexibility than the EU Clinical Trials Directive (2001/20/EC), which is criticised by scientists for its restrictiveness, in particular concerning consent.

19.       Other groups of persons specially protected are pregnant and breastfeeding women, persons in emergency clinical situations and persons deprived of liberty. Further groups not considered in the body of the additional protocol might need also some special protection. These groups, which include conscripts and medical students (mentioned in the explanatory report to the protocol), are covered however by the general prohibition of undue influence in Article 12 of the protocol.

20.       The inclusion or exclusion of particular groups among those which deserve special protection is subjective and therefore controversial.

Conclusion

21.       The additional protocol under examination is not exhaustive and, in certain cases, your rapporteur would have preferred a slightly different approach but does not think that such differences justify formal amendments by the Committee.

22.               Overall the additional protocol provides for balanced and appropriate protection for those who take part in research projects without hampering research. It ensures proper supervision of research projects, transparency of methods and accountability. It is therefore a useful complement to the series of legal texts produced by the Council of Europe in the field of biomedicine.

Reporting committee: Committee on Culture, Science and Education.

Reference to committee: Doc. 9924, Reference No 2877 of 29.11.2003.

Draft recommendation: unanimously adopted by the committee on 18 March 2004.

Members of the committee: MM. de Puig (Chairperson), Baroness Hooper, MM. Prisacaru, Smorawinski (Vice-Chairpersons), Apostoli, Banks (Alternate: Walter), Barbieri, Mrs Bemelmans-Videc, MM. Berceanu, Braga, Buzatu (Alternate: Ionescu), Mrs Castro, MM. Colombier, Cubreacov, Dacic, Dalgaard, Debono Grech, Mrs Delvaux-Stehres, MM. Devinski, Dragassakis, Mrs Dromberg, Mrs Eymer, Mrs Fern�ndez-Capel (Alternate: Mrs Agudo), MM. Gadzinowski, Galchenko, Mrs Glovacki-Bernardi, MM. Goutry, Gross, G�nd�z I, G�nd�z S, Gunnarsson, Mrs Hadziahmetovic, MM. Hegyi, Henry, Howlin, Huseynov R, Iannuzzi, Jakic, Jakovljev (Alternate: Prica), Jarab, Mrs Katseli, Mr Kocharyan, Mrs Labucka, MM. Legendre, Lengagne, Letzgus, Libicki, Livaneli, Mrs Lucyga, MM.Malgieri, Marxer, McNamara, Mrs Melandri, MM. Melnikov, Mestan, Mezihorak, Mrs Milotinova, Mrs Morganti, Mrs Muttonen, MM. Nazar� Pereira, O’Hara, Mrs Ohlsson, MM. Rakhansky, Randegger, Mrs Reps, MM. Ribeira Ambatlle, Rockenbauer, Rybak, Mrs Samoilovska-Cvetanova (Alternate: Mrs Petrova-Mitevska), MM. Schneider, Shybko, Šileikis, Sizopoulos, Mrs Skarb�vik, MM. Sudarenkov (Alternate: Korobeynikov), van Thijn, Tusek, Vakilov , Mrs Westerlund Panke, Mr. Wodarg, ZZ (Georgia), ZZ (Russia).

N.B. The names of those present at the meeting are printed in italics

Head of secretariat: Mr Grayson

Secretaries to the committee: Mr Ary, Mrs Theophilova-Permaul