Draft Convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine: Convention on Human Rights and Biomedicine[1]

 

Doc. 7654

24 September 1996

 

OPINION

Rapporteur: Mr Schwimmer

Austria, Group of the European People's Party


Contents

I.          Introduction

II.         General observations

III.       Consent for interventions in the health and research fields

IV.       Protection of the human genome

V.        Protection of embryos

VI.       Conclusions

I. Introduction

1.         Since the initial presentation of a draft European Convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine in July 1994, the intense debate which flared up and went on amid controversy in public, in national parliaments and institutions and in the Parliamentary Assembly of the Council of Europe, has shown how seriously this issue is regarded by society and how suitably the Parliamentary Assembly acted in recommending the preparation of a bioethics convention.

2.         Confrontation with biotechnology arouses anxieties in each individual, and these must be taken seriously by the responsible authorities; the Parliamentary Assembly has therefore constantly observed and critically scrutinised developments in the field of biology, medicine, technology and genetic engineering from the angle of human rights safeguards.

            The Parliamentary Assembly has come to the conclusion that a European outline convention on this topic is no doubt the only way to ensure integrated and comprehensive Europe-wide protection of human rights and the integrity and dignity of the human being.

3.         For that reason, the Parliamentary Assembly did not immediately accept a first draft in the matter, notwithstanding its great urgency, but took the time to make a thorough examination of the draft text in connection with a public debate, and finally delivered a highly critical opinion by recommending a general revision of the draft.

4.         The revision was conducted on the instructions of the Committee of Ministers by the CDBI Steering Committee, and appeared to abide by the opinion of the Parliamentary Assembly in the main. The Parliamentary Assembly now needs to ascertain whether this new text meets the high standards of the Council of Europe with regard to human rights and human dignity.

II. General observations

5.         A cursory perusal of the draft convention re-submitted by the Committee of Ministers suffices to discern that the structure of the text has been appreciably improved by division into designated sections incorporating provisions which belong together and thus bringing a certain logical order to the arrangement of the text; this makes the convention more approachable and more easily manageable for the purpose of practical application.

6.         The newly devised abbreviated title, "Convention on Human Rights and Biomedicine", is better suited to the goal set by the convention, namely that the naturally tense relationship between biomedical potential and the individual's right to preserve his integrity and dignity are to be placed in a legal framework where the dignity and integrity of all human beings are adequately and comprehensively protected.

            Furthermore, the usage of the term "bioethics" caused repeated misunderstandings because the English-speaking world also employs the idea in other contexts.

7.         In its opinion of 2 February 1995 on the draft bioethics convention (Opinion No. 184 (1995)), the Parliamentary Assembly made sixteen proposals for amendments but, as can be seen from the new draft before us, not all were given effect by the CDBI.

8.         Article 1 (Purpose and object) was not amended by the CDBI compared to the original draft of July 1994; consequently, the additional phrase requested by the Parliamentary Assembly to the effect that the substantial provisions of the convention should be introduced into national legislation was not considered.

9.         Article 3 (Equitable access to health care), compared to the original draft, is merely rearranged apart from the additional stipulation that health care shall be of appropriate quality, which is presumably intended to replace the addition recommended by the Assembly that "Services offered to the public ... shall be subject ... to control of their quality". However, it does so only to the extent that quality is introduced, whereas control is not.

10.        The principles recommended by the Assembly in relation to questions of consent for interventions in the health field were, on the whole, satisfactorily complied with in Chapter II Consent.

11.        The CDBI did not meet the Assembly's request, concerning Article 22 [former 13] (Disposal of a removed part of the human body), for clarification of the words "only if this is done in conformity with appropriate information and consent procedures", but left the phrase unaltered and unamplified.

12.        The Parliamentary Assembly's view that the text should embody a general ban on creation of human embryos, that the protection of embryos should be regulated by a separate protocol, and that the provision on research on embryos not developed for more than fourteen days should be deleted, was only partly followed by the CDBI in the new Article 18 (Research on embryos in vitro).

13.        The exclusion of any possible intervention in the human germ cell line desired by the Parliamentary Assembly has not materialised, judging by the new wording in Article 13 (Interventions on the human genome).

14.        In the original draft, Article 18 provided for "communication of results of genetic testing"; the Parliamentary Assembly wanted it stipulated that this must be in accordance with national legislation on data protection.

15.        The words "according to the conditions and procedure prescribed by law" have not been deleted from the new version as the Parliamentary Assembly wished, but merely replaced by similar phrasing in Article 24 (Compensation for undue damage).

16.        The Parliamentary Assembly's idea on "setting up a body for interpretation of the convention" has been incorporated into the new text in Article 29 (Interpretation of the convention).

17.        Notwithstanding the Parliamentary Assembly's recommendation to delete from the article on "Non-member states" the passage "and by the unanimous vote of the representatives of the Contracting States entitled to sit on the Committee of Ministers", Article 34 [former 28] in the final provisions was left unchanged.

18.        The "prohibition of a reservation clause" in respect of the provisions on intervention in the human genome and research on embryos (now Articles 13 and 18), which the Parliamentary Assembly desired, was not embodied in the new draft.

19.        The European Parliament Committee on Legal Affairs and Citizen Rights examined the original draft and in its report (known as the Pelttari report) was guided by the same principles as the Parliamentary Assembly of the Council of Europe.

            Although the report narrowly missed gaining a majority in the plenary session of the European Parliament, owing to differences over proposals for amendment, we should take its arguments into consideration.

III.  Consent for interventions in the health and research fields

20.        The arrangements in the old draft regarding matters of consent for health and research purposes, which justifiably came under such strong criticism, now appear in a separate chapter "Consent" where they are set out much more clearly and comprehensively as regards both the structure of the text and the stylistic formulation. Above all, they are defined according to the spirit, if not the letter, of the Parliamentary Assembly's conceptions.

21.        Most importantly, a significant improvement has been made regarding the question of consent for medical intervention in the health field for persons not able to consent, as the provisions have been substantively broadened to cover all eventualities in Article 6 and clearly distinguished from other questions.

22.        The important and highly sensitive matter of protection of persons unable to consent in research situations is now very clearly regulated in Article 16. Authorisation of intervention carries eight conditions in all: no alternative of comparable effectiveness exists; the hazards for research subjects are properly balanced with the potential benefits of the research; the research project is independently evaluated by a body with regard to its merit, importance and ethical acceptability; the persons concerned are to be informed of their rights and of the legal provisions made for their protection; research of comparable effectiveness cannot be performed on persons able to consent; the consent stipulated in Article 6 has been given expressly and in writing; the person concerned does not object.

23.        In addition to these conditions, which must be met in their entirety, it is possible "exceptionally and under the protective conditions prescribed by law" to undertake research which does not have the potential to produce results of direct benefit to the subject, provided that two further conditions are fulfilled: "the research has the aim of contributing, through significant improvement in the scientific understanding of the individual's condition, disease or disorder, to the ultimate attainment of results capable of conferring benefit to the person concerned or to other persons in the same age category or afflicted with the same disease or disorder or having the same condition; the research entails only minimal risk and minimal burden for the individual concerned".

24.        This possibility of course diverges from the original principle formulated by the Parliamentary Assembly that no intervention for research purposes must be performed on a person unable to consent, unless there are direct benefits to health. Nevertheless, as medical practitioners and researchers have been able to credibly demonstrate and prove in the face of some very critical-minded parliamentarians, it is the sole possibility in certain cases (for example, Alzheimer's disease or research into immune reactions in children) of achieving at least indirect health benefits for the persons affected and for other patients with the same afflictions. The condition that the research entails only minimal risk and minimal burden for the individual concerned does not give carte blanche but signifies, for instance, the taking of a blood sample.

25.        These stipulations nevertheless place all those concerned under a heavy responsibility, especially doctors, the legal representatives of patients unable to consent, and the competent body. The provisions do not appear to regulate this body with altogether sufficient clarity as regards its independence, composition and balance.

26.        But it should not be overlooked that in the end the will of the patient is also decisive where the patient expresses a refusal in any form whatsoever  although, as mentioned above, this does not release those taking part in the authorisation procedure from their responsibility.

27.        The protection of persons unable to consent to removal of organs has been significantly improved by comparison with the original version. For instance, it has been stipulated by way of conditions that there is no compatible donor available who has the capacity to consent, the recipient is a brother or sister of the donor, the donation has the potential to be life-saving, the rules of authorisation laid down in Article 6 (Protection of persons not able to consent) are complied with, and the potential donor does not object.

IV. Protection of the human genome

28.        In the new draft, Chapter IV Human genome, the freshly introduced prohibition of discrimination (Article 11): "Any form of discrimination against a person on grounds of his or her genetic heritage is prohibited" is to be warmly welcomed.

29.        The new Article 12 (Predictive genetic tests) amplifies or specifies the permitted cases of tests which, as provided in the original draft, may be performed only for health purposes or for scientific research linked to health purposes. They are now made subject to the additional condition of appropriate genetic counselling, which also represents an advance. Such counselling should also include a thorough and relevant discussion of all research findings and medical data, together with their social and psychological effects.

30.        These genetic tests and their results are accordingly to be used only in the health field and in scientific research linked with health purposes, and for no other purpose. Yet this is not completely secured since Article 26 paragraph 1 of the convention (Restrictions on the exercise of the rights) would permit communication to third parties even without the consent or knowledge of the person concerned in the case of overriding community interests. In order to rule out this possibility, it would be expedient to place Article 12 among the exceptions specified in Article 26 paragraph 2. Since communication of the results of genetic tests poses a particular problem, it seems necessary to make the prohibition of communication in Article 12 still more specific.

31.        Finally, in this area the danger of social discrimination is especially great. Early calculation of risks is very much in the interest of employers and insurance companies alike. This is liable to cause discrimination against persons with a genetic predisposition for an illness even if transmission of their personal data is prohibited, unless there are also safeguards against use of data concerning persons passed as healthy by their genetic test. Consequently, for the safety of the community and the protection of the individual's identity, all that should be permitted is communication of results of genetic tests as evidence in official procedure concerning a criminal act or a person's descent.

32.        The new formulation of Article 13 (Intervention on the human genome) does not make it altogether unequivocal as the Parliamentary Assembly wished that an intervention on the human genome may only be undertaken if there is no intervention in the human germ cell line. The new wording of the draft would leave a loophole for intervention in the human germ cell line, since although it does indeed prohibit intervention on the human genome seeking to modify the germ cell line, the present text of the draft would permit actual albeit quite fortuitous interference with the germ cell line during interventions without the explicit aim of altering the genome of descendants.

            Consequently, it seems expedient to establish with clarity that an intervention in the germ cell line may not be an aim or an accepted secondary effect, because the human genome is an integral part of personal identity and dignity and as such inviolable.

33.        The new Article 14 (Non-selection of sex) does prohibit the use of medically assisted procreation for the purpose of choosing a child's sex, but allows it in exceptional cases to avoid a serious hereditary sex-related disease. Now, the exception permitted under this provision gives rise to a legal situation in which firstly eugenic abortion, as it is called, is allowed and secondly the danger of abuse is very great. Indeed, the purported aim of preventing the birth of a child with a serious hereditary sex-related disease can also be used as a pretext to "prevent" a child of the undesired sex and this is undesirable in the framework of the present convention upholding human dignity, the principle of equality, and equal opportunity.

V. Protection of the human embryo

34.        After the strong criticism of the old draft in connection with research on embryos in vitro, the Parliamentary Assembly decided to recommend a text embodying a general ban on creation of embryos for research purposes, regulating the protection of embryos in a separate protocol, and omitting the provision concerning research on embryos beyond fourteen days of development.

35.        In the present draft it is stated, as the Parliamentary Assembly recommended, that the creation of human embryos for research purposes is prohibited. In addition, however, one encounters the terse provision that where research on embryos in vitro is allowed, adequate protection of the embryo is to be ensured! For a European outline convention, this reference to national legal situations is definitely insufficient, besides the fact that the required adequate protection of the embryo is in no way further specified or illustrated.

36.        According to the purport of this provision, germ cells and human embryos are not regarded as human life but merely as experimental material. However, the Christian understanding of the human being, which in our cultural sphere is shared by many non-practising believers, places insuperable limits on the application of technical capability.

            The most important right to be protected by the convention is the right to life and physical integrity. Thus research on the human embryo should be prevented as contrary to human dignity.

VI. Conclusions

37.        The general aim of the convention does not consist in protection of freedom of research; rather, it is devoted to protecting human dignity in the use of scientific methods. Consequently, whenever interests are to be weighed up, individual human rights take precedence over scientific interests.

38.        For its practical implementation, the convention requires a valid explanation of certain technical terms and legal concepts.

39.        Regarding Article 2, it is to be noted that the interests of society and those of science do not necessarily overlap in each case.

40.        The question of the reservation clause should be reconsidered once again.

41.        With regard to the intended protocols to the convention, it would be expedient to formalise co-operation on the Convention on Human Rights and Biomedicine between the steering committee and the three Assembly committees concerned.

42.        In the light of the foregoing, we consider it appropriate for certain amendments to be made to the draft convention. There is a clear need:

                    to bind the Contracting Parties to avail themselves of all necessary means in order to implement the convention provisions;

                    to allow communication of genetic test results only where it serves as evidence in official procedure concerning a criminal offence or a person's descent, and to prohibit it even where the person concerned agrees or is under a contractual obligation;

                    to stipulate that intervention on the human genome may only be performed for preventive, therapeutic or diagnostic purposes, and that intervention in the human germ cell line can be neither an aim nor an accepted secondary effect;

                    to prohibit the creation of human embryos for research purposes and the research on living human embryos;

                    to secure the Parliamentary Assembly's right to give opinions on proposals for amendments to the convention and its protocols;

                    to stress that the competent body for examination of a research project must be independent and multidisciplinary.

43.        These proposals are the subject of amendments by the Committee on Legal Affairs and Human Rights to the draft opinion presented by the Committee on Science and Technology.

Amendments to the draft opinion on the draft Convention on Human Rights and Biomedicine presented by the Committee on Science and Technology

[Doc. 7622]

to be tabled by Mr Schwimmer (Austria, EPP),

Rapporteur for opinion, on behalf of the Committee on Legal Affairs and Human Rights

Amendment No. 1

            In the draft opinion, in paragraph 6, add a new sub-paragraph as follows:

            "amend Article 1 (Purpose and object) of the draft convention by inserting a second sentence as follows:

            `The Parties to this convention shall take all legislative and administrative actions necessary to give effect to and carry out the provisions of this convention within their own territories.'"

Amendment No. 2

            In the draft opinion, in paragraph 6, add a new sub-paragraph as follows:

            "modify Article 2 (Primacy of the human being) of the draft convention as follows:

            `The interests and welfare of the human being shall prevail over the sole interest of society or science.'" [modification underlined]

Amendment No. 3

            In the draft opinion, in paragraph 6, add a new sub-paragraph as follows:

            "amend Article 12 (Predictive genetic tests) of the draft convention by adding the two following sub-paragraphs:

            `2.        Results of genetic tests may only be communicated where they serve to determine a person's descent or as evidence in official procedure to try a criminal offence.

            3.         Even where the person concerned has consented or is bound by contract, the results of predictive genetic tests shall be used strictly in accordance with paragraphs 1 and 2 above.'"

Amendment No. 4

            In the draft opinion, in paragraph 6, add a new sub-paragraph as follows:

            "replace Article 13 (Intervention on the human genome) of the draft convention by the following text:

            `An intervention on the human genome may only be undertaken for preventive, therapeutic or diagnostic purposes. Intervention in the human germ cell line shall be neither an aim nor an accepted secondary effect.'"

Amendment No. 5

            In the draft opinion, in paragraph 6, add a new sub-paragraph as follows:

            "amplify Article 16.iii (Protection of persons undergoing research) of the draft convention as follows:

            `the research project has been approved by the independent multidisciplinary competent body after independent examination of its scientific merit, including the importance of the aim of the research, and ethical acceptability,'" [added text underlined]

Amendment No. 6

            In the draft opinion, in paragraph 6, add a new sub-paragraph as follows:

            "replace Article 18 (Research on embryos in vitro) of the draft convention by the following text:

            `The creation of human embryos for research purposes and the research on living human embryos is prohibited.'"

Amendment No. 7

            In the draft opinion, in paragraph 6, add a new sub-paragraph as follows:

            "amplify Article 26 paragraph 2 (Restrictions on the exercise of the rights) of the draft convention as follows:

            `The restrictions contemplated in the preceding paragraph may not be placed on Articles 11, 12, 13, 14, 16, 17, 20 and 21.'" [added text underlined]

Amendment No. 8

            In the draft opinion, in paragraph 6, add a new sub-paragraph as follows:

            "amend Article 32 paragraph 6 (amendments to the convention) of the draft convention by amplifying it as follows:

            `The committee shall examine the proposal not earlier than two months after it has been forwarded by the Secretary General in accordance with paragraph 5.  The committee shall submit the text adopted by a two-third majority of the votes cast to the Committee of Ministers for approval. The Committee of Ministers shall transmit the adopted text, before approval, to the Parliamentary Assembly for opinion.  After its approval, this text shall be forwarded to the Parties for ratification, acceptance or approval.'" [added text underlined]


            Reporting committee: Committee on Science and Technology (Doc. 7622).

            Committee for opinion: Committee on Legal Affairs and Human Rights.

            Reference to committee: Doc. 7124 and Reference No. 1956 of 28 June 1994.

            Opinion approved by the committee on 2 September 1996.

            Secretaries to the committee: Mr Plate, Ms Chatzivassiliou, Ms Kleinsorge and Ms Clamer.


[1]. By the Committee on Legal Affairs and Human Rights.