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

 

Doc. 7622

19 July 1996

 

Opinion

Rapporteur: Mr PLATTNER, Switzerland, Socialist Group

Summary

The Assembly welcomes the work that has been achieved by the Steering Committee on Bioethics for many long years and which it finalised on 7 June last by adopting the draft Convention on Human Rights and Biomedicine.

Although it could be improved in some areas, this draft is in tune with the thinking behind the proposals made by Assembly Opinion No. 184 and provides satisfactory responses by completing and improving the drafting. It represents the maximum degree of European consensus that can be achieved at present. Once adopted its innovative nature will serve as a model for national legislators.

As was the case for the draft convention, the Assembly intends to be associated through its reflexion and a public debate with the preparation of the draft protocols concerning organ transplantation, medical research and the protection of embryos which should be transmitted for an opinion as soon as they have been finalised.

I. Draft Opinion

1.    The adoption on 7 June 1996 by the Steering Committee on Bioethics (CDBI) of a revised draft convention marked the culmination of many long years of work. In this connection, the Assembly draws particular attention to its Recommendations 934 (1982) on genetic engineering, 1046 (1986) and 1100 (1989) on the use of human embryos and foetuses, and 1160 (1991) on the preparation of a convention on bioethics, as well as its Opinion No. 184 (1995) on the first draft convention, in which it recommended that the Committee of Ministers "review thoroughly" the draft text.

2.    The new draft convention is more complete and better structured as a whole. The order in which its provisions are placed and the links between them are more logical than in the initial draft. The text has been more carefully worded, and the addition of new articles, for example, on organ transplantation, constitutes an improvement. On some points, such as the protection of embryos, the articles have been kept brief and are intended merely to provide the basis for the future protocols.

3.    The draft text is in tune with the thinking behind the Assembly's proposals, although the exact wording of the individual amendments has not always been followed. A series of newly drafted provisions provide a satisfactory response to one of the Assembly's main concerns, namely the question of "consent" and, in particular, the protection of persons unable to give consent. At the same time, a further guarantee is enshrined in a new provision, based on the Assembly's amendments, concerning the role to be played by the European Court of Human Rights in interpreting the convention.

4.    The Assembly believes that the new draft convention is a coherent and balanced text. It represents the maximum degree of European consensus that can be achieved at present. Once it has been adopted, the convention will serve as a universal benchmark and will encourage many states to comply with and go beyond the standards it lays down.

5.    As with all texts based on compromise, it could, however, be improved in some areas. In the view of the Assembly, the draft convention provides no clear guidance on the question of the communication of the results of genetic tests to third parties. This problem, which is likely to assume considerable social and economic importance in the years ahead, cannot be left unmentioned.

6.    The Assembly therefore recommends that the Committee of Ministers:

i.    amend the draft convention by adding a new paragraph worded as follows to Article 12 (Predictive genetic tests): "The communication of results of genetic testing outside the health field may be allowed only in accordance with the provisions of Article 26 paragraph 1 of this Convention and in accordance with national legislation on data protection";

ii.    adopt the amended draft convention without referring it back to the CDBI and open it for signature before the end of this year, as any further delay could jeopardise the innovative nature of the text as a model for national legislators;

iii.    establish a timetable for the preparation of the draft protocols on organ transplantation, medical research and the protection of embryos, instruct the CDBI also to prepare a protocol on genetics, and transmit each draft protocol to the Assembly for opinion as soon as it has been finalised.

II. Explanatory memorandum by Mr PLATTNER

I. Introduction

1.    The Parliamentary Assembly has held some ten debates on problems relating to bioethics in the space of ten years. Two of them were on the subject of the use of human embryos and foetuses for diagnostic, therapeutic, scientific, industrial and commercial purposes. Another three covered the actual idea of a European convention and its content. A full list of the texts on bioethics adopted by the Assembly and the Committee of Ministers, together with an account of all the work done, have been presented in detail in previous documents, particularly in reports of the Committee on Science and Technology (Docs. 6449, 7156 and 7210). It does not seem appropriate to reiterate them here. Mr Palacios, who was rapporteur for many years, has had the honour and privilege of being very closely involved in this intellectual venture, and it is a great pleasure for me to be present, as your rapporteur, at its political culmination in the form of a European instrument.

2.    The arguments the Assembly has put forward over the years for a codification of work in this sphere remain valid: the legal vacuum surrounding bioethics is almost as total as it was ten years' ago, in spite of a growing awareness among the public in various countries and despite the setting up here and there of national, regional or other ethics committees. Consequently, a European convention signed and ratified by a greater number of countries is now more essential than ever, with a view to both:

    _    preserving human dignity and mental and physical integrity,

    _    clearing up misunderstandings and dispelling unjustified fears so that the scientific community can work in a calm and lawful environment.

3.    The idea of a bioethics convention is neither a political whim nor a piece of bureaucratic over-zealousness. It is a response to a social need and to the worries of a public which felt ill-informed, excluded and even threatened by scientific developments taking place at a heady speed and with consequences it had difficulty judging. So this idea stemmed from a reaction of public opinion. It could not therefore be "a matter for specialists", an accusation which has sometimes been levelled at the Council of Europe. For its part, the Parliamentary Assembly has always taken care to widen the discussions to a huge variety of circles as the draft went through its various phases.

4.    The relationship between science and political decision-taking is sometimes complex. Recent history is rich in examples of such complicated relations, of mutual exploitation and even of abuses. Science has frequently tempted totalitarian regimes, and vice versa. The advantage of democracies is that they are soundly based on human rights and ethics. They are not like authoritarian regimes, having no dogma, no "official truth". Democratic society proceeds by consensus, and social, like other, problems are solved through open discussions. It is all a matter of balance and proportion. The dichotomy between "values" and "interests" also has to be seen from the angle of a move away from opposition towards agreement. In the more specific case of bioethics, democratic societies will strike the right balance between the progress of biomedical science and the inviolable rights of the human species.

II. On the revised draft convention

5.    Since the adoption of Opinion No. 184 by the Assembly in February 1995 on the basis of the first draft convention, the Steering Committee on Bioethics (CDBI), on the instructions of the Committee of Ministers, has continued its work with a view to preparing a revised draft. Ultimately, on 7 June 1996, the CDBI adopted a new text, by thirty votes to one, with two abstentions. The resulting text is reproduced in Appendix I to this report, in the form of a comparative table containing the initial and revised drafts, together with the amendments proposed by the Assembly in Opinion No. 184. An explanatory report also exists, prepared by the CDBI, and this will be published during the weeks ahead. The Committee on Science and Technology has very carefully monitored the phases through which the new draft has progressed, and has endeavoured to maintain dialogue with the CDBI during this phase.

6.    The new draft is slightly longer, better structured and more complete. The order in which its provisions are placed and the links between them are more logical than in the initial draft. It has been more carefully worded, although, as often happens when the aim is perfection, the precise meaning of some sentences becomes clear only on a second reading. The draft is in tune with the spirit of the Assembly's proposals as a whole, although the exact wording of individual amendments has not always been adopted. The Assembly's main philosophy, which was that references should be made to the future protocols in respect of controversial issues currently not really clear from the technical point of view, has been put into practice. On the other hand, the writers have introduced at least one basic reference to these issues into the draft, to justify the preparation of protocols on specific aspects.

7.    We are aware of the difficulties of reconciling the different, and even conflicting, viewpoints of a wide range of countries having different cultures, histories and scientific traditions, especially now that the membership of the CDBI has risen from twenty-seven states in 1993 to thirty-nine in 1996, when Russia joined the committee. What is more, by its very nature, the subject required a multidisciplinary approach; hence the very varied membership of the steering committee. Dialogue was not always easy between ethics experts, legal experts and members of the medical profession. In spite of these arguments, the Committee on Science and Technology has on many occasions expressed regret at the delay in completion of the draft. In fact, after the publication of the first draft and the two ensuing Assembly debates, the eyes of the public were on the Council of Europe, and deadlock at this stage might have been regarded as a political failure.

8.    The great majority of these difficulties have now been overcome. The text we have before us is good on the whole, although it could be improved on a number of points. Consultations between the Committee of Ministers, Assembly and CDBI must not be allowed to become a matter of each sending the ball back to the other, with no final conclusion being reached. For its part, the Assembly is to give its opinion for the last time in the present report, and the Committee of Ministers will have to decide the most sensitive points before the convention is opened for signature by states. The draft protocols will be examined subsequently, as they are completed.

9.    As there have already been several discussions on the draft as a whole, the Committee on Science and Technology has focused this final examination on the most controversial issues. Furthermore, as certain general provisions or provisions which are part of the final clauses of the draft convention are of a purely legal nature, it was deemed preferable for these to be dealt with in depth by the competent committee.

III. Examination of the provisions

Title and preamble

10.    The Assembly did not put forward any amendments on this aspect. It is nevertheless important to emphasise two points, which are the philosophical starting point of the draft convention.

    Firstly, a careful reading of the title _ somewhat long in a concern for precision _ makes it unambiguously clear that this draft is based on the primacy of the human being. It is designed "for the protection of human rights and dignity of the human being with regard to the application of biology and medicine", thus excluding techniques relating to animals and plants.

    The second principle stems from the first: the references made in the preamble to international and European human rights texts are intended to establish continuity between these and the draft convention. Thus the new text is bound up with the Council of Europe's main vocation and an integral part of its work.

    The explanatory report accompanying the draft convention has been written in an inspired and concise manner on this point, enabling readers to place the argument in the right context and eliminate certain preconceptions.

    Since the title is quite long, the words "Convention on Human Rights and Biomedicine" have been added as the future proper name of the convention. This seems acceptable, as it is more to the point than the well established name "Bioethics Convention".

Chapter II - Consent

Article 5 (General Rule)

11.    This is a fundamental provision. The principle of consent to medical treatment and research was first set down in print after the second world war and with the adoption of the Nuremberg code. The wording of this article has been improved through the addition of the second paragraph, introducing the principle of giving the person concerned information about the nature, possible consequences and risks involved in intervention.

12.    The Assembly's proposal to amend the first paragraph so that consent had to be not only "free and informed" but also "express and specific" was not accepted. The explanatory report gives the reasons for this. Article 5 is a general one. Situations which might require consent in a written form, such as organ transplants, are the subject of references to more specific articles (see Article 16.v, Article 17 and Article 19).

Article 6 (Protection of persons not able to consent)

13.    This is a far more complex point. Articles 6 and 7 of the initial draft have been merged into a single article. The parts of the initial text between square brackets, which had made the text more difficult to understand, have been deleted. The confusion which previously existed between "legally incapacitated persons" and those with "a reduced capacity of understanding" has been avoided. The new text is clearer and immediately highlights the principle of "direct benefit" which the Assembly holds dear. Also as proposed by the Assembly, the principle that "information" be given, for which Article 5 provides, applies to the "person or body" required to give authorisation on behalf of the person not able to consent.

14.    We should like to explain in passing how the misunderstandings resulting from the interpretation and translation of certain concepts fuelled the previous impassioned debates. What happened was that the term "incapacitated persons", mistranslated into German as "handicapped persons", was the source of much argument. The explanatory report gives details which will soothe our colleagues and enlighten the media.

Chapter IV - Human genome

Articles 11 to 14

15.    This is one of the subjects most open to speculation and giving rise to concern. Genetics is one of the most promising disciplines where the fight against hereditary diseases is concerned (see Appendix II). There is, however, a risk of misuse of genetic techniques which, unlike other medical intervention, not only concerns the patient individually (gene therapy), but is also likely to modify characteristics transmissible to descendants (genetic modifications).

16.    What ought to be more generally understood is the distinction between negative genetic engineering (for example in order to cure blindness) and positive genetic engineering (the purpose of which is improvement). Attempts at the latter come close to eugenics, an early twentieth century science which was exploited for the purposes of racial supremacy. But "genetic determinism" or "social Darwinism" are the last things we wish to revive at a time when social and ethnic tensions have already reached an explosive level. It is the duty of democracies to protect the individual and society from the establishment of biogenetic hierarchies.

17.    In this context, the most sensitive aspects of this chapter of the draft convention are:

a.    prohibition of any discrimination against a person on the grounds of his or her genetic heritage. This general rule constitutes a solid base for future Protocoles aimed at further developing the protection of human rights against any abuse of the rapidly increasing knowledge about genetic predispositions.

b.    protection of the species through the prohibition of intervention affecting the genetic heritage, in which respect Article 13 is an important safeguard. The Assembly's amendment, adding a prohibition of any intervention "in the human germ cell line", that is, in human reproductive cells, has been taken up by postulating that the aim of an intervention seeking to modify the human genome may not be "to introduce any modification in the genome of any descendants

c.    protection of the individual and of society through a judicious regulation of tests to predict genetic diseases and the use of the results of these tests. Notwithstanding the non-discrimination claude in Article 11, the convention must give a clear signal on this subject, since the question will assume dramatic proportions in the years to come, and will be a far more important social phenomenon than Aids tests.

18.    There are already some countries where employers, financial institutions and, more particularly, insurance companies, are sorely tempted to use the results of these tests before offering contracts. The moratoria in force at the moment will shortly come to an end. If no remedy is found for this situation, a new social category will emerge, a "genetically inferior" group of people who, for reasons over which they have no control, will find that they are refused jobs, loans and life insurance. This is why the Assembly should fully support Article 12, which restricts tests to health purposes.

19.    Everybody should be in a position to have unhindered access to genetic testing which may serve their health purposes. Therefore, it is important to prevent third parties from making use of genetic information. Otherwise, the individual could refuse to undergo a test and obtain essential information about his or her health because of the fear of consequences. This holds in particular when the attainment of social goods is involved (e.g. employment, life, health and disability insurance). Therefore, the use of results of genetic testing acquired in the framework of health care is possible only for health purposes or for scientific research linked to health purposes, notwithstanding the free contractual relationship. An Article, restricting not only the performance of such tests, but also the communication of their results, is urgently needed. I therefore propose to maintain the corresponding amendment formerly accepted by the Parliamentary Assembly, i.e. to insert a second paragraph of Article 12 as follows:

    "The communication of results of genetic testing outside the health field may only be allowed in accordance with the provisions of Article 26 paragraph 1 of this Convention and in accordance with the national legislation about data protection".

20.    On the other hand, the individual who has knowledge of his or her genetic constitution might try to use this unduly, in particular in the case of private insurance contracts. It is left to national law, taking into account especially the notion of good faith and the general principle forbidding the abuse of law, to specify the appropriate solutions.

 

Chapter V - Scientific research

Articles 15 to 17

21.    The initial draft contained few provisions on research. After numerous amendments had been proposed by the Assembly and by governments, it was felt necessary to restructure these provisions through the addition of Articles 16 and 17. The main statement in Article 15 about freedom to carry out research is retained, a freedom which is based not solely on a fundamental right, but also on "the considerable progress its results bring in terms of the health and well-being of patients", as the explanatory report says. This freedom is nevertheless subject to the protective provisions relating both to the scientific relevance of the project concerned and to the express prior consent of the persons concerned.

22.    Article 17 (2) provides for an exception to the general rule that intervention is for the "direct benefit of the person", as stated in Chapter II on "Consent". Very strict conditions are nonetheless attached to this exception: experiments carried out on minors or on other persons without the capacity to consent are subject to authorisation by their legal representatives, on the one hand, and must have the potential to contribute to progress in the fight against certain diseases from which they are suffering, on the other hand. Infant myopathy and certain mental disorders are good examples in this sphere. On this ethical basis, and with the safeguards mentioned, this article seems acceptable.

Article 18: Research on embryos in vitro

23.    The focal point of the chapter on research is the use of embryos. As proposed by the Assembly, the Committee of Ministers has instructed the CDBI to prepare a protocol on the protection of human embryos and foetuses. In the light of this, the reference to this question in the draft convention simply stipulates certain fundamental principles. In Opinion No. 184, the Assembly had proposed that a single sentence be retained: "The creation of human embryos for research purposes is prohibited". This rule has been taken up in paragraph 2 of Article 18.

24.    The question of research into embryos in vitro not developed beyond fourteen days had been deleted at the last minute by the Assembly and referred to the future protocol. It has to be pointed out for the sake of accuracy, that this subject has, on several occasions, given rise to impassioned debate in the Assembly. Following prolonged deliberations, the prohibition of the creation of embryos in vitro for research was retained in the text of Recommendation 1046 (1986). Then Recommendation 1100 (1989) authorised experimental research on pre-embryos, but only when they are non-viable pre-implantation embryos, meaning those created with a view to procreation, but unable to be used for this purpose solely on the grounds of intrinsic or specific damage or defects making them unsuitable for procreation from the scientific and human standpoints. From the scientific point of view, the embryos concerned being predestined to die (not through the will of the researcher), their use for research should not give rise to any objections. This position is ethically correct and also takes account of the de facto situation in several countries. The wording proposed for Article 18 does not exclude the adoption of an approach of this kind when a protocol is prepared.

Chapter VI - Organ and tissue removal from living donorsfor transplantation purposes

Articles 19 and 20

25.    The initial draft made only very limited provision in respect of organ and tissue transplantation. Thus Articles 19 and 20 are new ones, intended to lay the foundations for a future protocol. The transplantation of organs or tissue is a technique which is very much at the development stage. At the same time, unfortunately, it is accompanied by exploitation and abuse. There has been a shocked public reaction to articles or reports in the media on organ trafficking across continents. It was the duty of the draft convention to deal with the subject, and the Assembly can welcome this.

26.    Once again, a problem area is the removal of organs or tissue from persons without the capacity to consent. The principle here is that such removals are prohibited. A single exception is admissible: the removal of regenerative tissue (today this concerns only bone marrow) between brothers and/or sisters . This exception is justified in the light of the strong human bonds required between donor and recipient and in consideration of the restrictive conditions set forth.

27.    The CDBI's decision to refer the regulation of removals from deceased donors to the future protocol seems appropriate.

Chapter VII - Prohibition of financial gain and disposal of a part of the human body

Articles 21 and 22

28.    Article 21 of the new draft enshrines the principle that "The human body and its parts shall not, as such, give rise to financial gain". This is a noble principle, and its inclusion in the convention was essential. The collateral provision regulating the disposal of a part of a human body has been transferred to his place as Article 22. The explanations given in the explanatory report as to the meaning of the terme "appropriate information and consent procedures" are adequate.

29.    The question of patents has not been considered in this Chapter. Such is the complexity of the problem of patents that a detailed study is considered necessary before any regulations can be drawn up.

30.    It is nevertheless the case that genetic engineering on living material is taking huge steps forward, and transgenic production techniques have already been developed based on animals. The Harvard mouse, a transgenic mouse used in cancer research, received worldwide publicity when a patent was applied for and granted in the United States.

31.    A little later, in 1991 and 1992, again in America, Dr. Venter, who is in charge of the national human genome project, made a patent application on behalf of the National Institutes of Health (NIH) covering a total of 2 400 ESTs (expressed sequence tags), which are DNA fragments from the human brain. Several applications have been submitted in Europe subsequently. Some 20 000 ESTs are now available on databases. Patent applications are silent about the specific use of the ESTs or of the corresponding genes. They refer to hypothetical uses.

32.    This is where things start to get complicated. On the one hand because patent applications relating to parts of the human body are a qualitative departure for which public opinion is not ready, and, on the other hand, because patent applications for discoveries of which neither the practical usefulness nor technical application is known raise severe ethical and legal problemsSee footnote 3.

33.    The Parliamentary Assembly reacted by adopting Recommendation 1240 on the protection and patentability of material of human origin. It is clear from this that the European Patent Convention of 1973 was not designed to meet this new scientific development and its ethical and legal consequences. The Assembly therefore proposed that this issue be studied during preparation of a bioethics convention and protocols. At the moment, the draft convention contains nothing about this subject. We can but reiterate here a wish to see this point dealt with in depth in a protocol covering genetic manipulation. At the same time, consultations could start with the European Patent Office (EPO) with a view to an improvement of the system.

IV. Conclusions

34.    Politicians are often blamed for having a view of political problems which is restricted by the dates of elections. The bioethics debate, however, relates to a medium, or even long-term problem. By discussing bioethics on many occasions, covering every aspect in a painstaking, thorough and impassioned way, the members of the Parliamentary Assembly have once again demonstrated their attachment to democratic values and human rights, and their vision. In an economic climate where competition is fierce and Europe's competitiveness is under challenge in many fields, including biotechnology, they have not succumbed to the temptation to sacrifice the essential to commercial and other considerations. We should like to salute everyone who has made a contribution or proffered criticism _ some of which has been contradictory and some even severe _ thereby enriching the debate and upholding the reputation and standards of the Council of Europe. We are particularly grateful at this time for the major contribution made by Mr Palacios, the Assembly's rapporteur and "guiding light" for so many years. We are very sorry that he was unable to bring this venture to its conclusion in his role as its intellectual guide.

35.    We are persuaded that the Bioethics Convention, once adopted, will be the third mainstay of the Council of Europe, alongside the European Convention on Human Rights and the European Social Charter. It will also provide a universal reference point and will encourage many states to achieve and exceed the standards laid down in it. The draft we have before us today, while it is not perfect, does represent a European consensus at the highest level. It is a text based on long discussions, years of negotiation and delicate balances.

36.    As we pointed out at the beginning, this report confines itself to considering the aspects of the draft convention which had originally been most controversial. The provisions relating to procedure, follow-up, reservations and ratifications are certainly important, but are not likely to give rise to a significant change in substance. The other competent committees of the Assembly are bound to look at a few points which they consider useful. As for the Committee on Science and Technology, it is able to give its agreement to the text as a whole, subject to the inclusion of our amendment to Article 12, which we consider to be of major social significance.

Appendix I

Comparative study of initial and final texts of the draft convention

Draft Convention transmitted by the Committee of Ministers on 11 July 1994

Amendments proposed by the Assembly on February 2 1995

Draft convention adopted by the CDBI on 7 June 1996

Title

 Draft Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Bioethics Convention

Preamble

The Member States of the Council of Europe, the other States [and the European Community] signatories hereto,

Bearing in mind the Universal Declaration of Human Rights proclaimed by the General Assembly of the United Nations on 10 December 1948;

Bearing in mind the Convention for the Protection of Human Rights and Fundamental Freedoms of 4 November 1950;

Bearing in mind the International Covenant on Civil and Political Rights of 16 December 1966;

Bearing also in mind the Convention for the Protection of Individuals with regard to Automatic Processing of Personal Data of 28 January 1981.

  

Title

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

Preamble

The Member States of the Council of Europe, the other States and the European Community signatories hereto,

Bearing in mind the Universal Declaration of Human Rights proclaimed by the General Assembly of the United Nations on 10 December 1948;

Bearing in mind the Convention for the Protection of Human Rights and Fundamental Freedoms of 4 November 1950;

Bearing in mind the European Social Charter of 18 October 1961.

Bearing in mind the International Covenant on Civil and Political Rights and the International Covenant on Economic, Social and Cultural Rights of 16 December 1966;

Bearing in mind the Convention for the Protection of Individuals with regard to Automatic Processing of Personal Data of 28 January 1981;

Bearing also in mind the Convention on the Rights of the Child of 20 November 1989;

Conscious of the accelerating developments in biology and medicine;

Convinced of the need to respect the human being both as an individual and as a member of the human species and recognising the importance of ensuring the dignity of the human being;

Conscious that the misuse of biology and medicine may lead to acts endangering human dignity;

Affirming that progress in biology and medicine should be used for the benefit of present and future generations;

Considering that the aim of the Council of Europe is the achievement of a greater unity between its members and that one of the methods by which that aim is to be pursued is the maintenance and further realisation of human rights and fundamental freedoms;

Stressing the need for international co-operation so that all humanity may enjoy the benefits of biology and medicine;

Recognising the importance of promoting a public debate on the questions posed by the application of biology and medicine and the responses to be given thereto;

Wishing to remind all members of society of their rights and responsibilities;

Taking account of the work of the Parliamentary Assembly in this field, including Recommendation 1160 (1991) on the preparation of a Convention on bioethics;

 

Considering that the aim of the Council of Europe is the achievement of a greater unity between its members and that one of the methods by which that aim is to be pursued is the maintenance and further realisation of human rights and fundamental freedoms;

Conscious of the accelerating developments in biology and medicine;

Convinced of the need to respect the human being both as an individual and as a member of the human species and recognising the importance of ensuring the dignity of the human being;

Conscious that the misuse of biology and medicine may lead to acts endangering human dignity;

Affirming that progress in biology and medicine should be used for the benefit of present and future generations;

Stressing the need for international co-operation so that all humanity may enjoy the benefits of biology and medicine;

Recognising the importance of promoting a public debate on the questions posed by the application of biology and medicine and the responses to be given thereto;

Wishing to remind all members of society of their rights and responsibilities;

Taking into account of the work of the Parliamentary Assembly in this field, including Recommendation 1160 (1991) on the preparation of a Convention on bioethics;

Resolving to take such measures as are necessary to safeguard human dignity and the fundamental rights of the individual with regard to the application of biology and medicine;

Have agreed as follows:

 

Resolving to take such measures as are necessary to safeguard human dignity and the fundamental rights and freedoms of the individual with regard to the application of biology and medicine;

Have agreed as follows:

Chapter I

Article 1 (Purpose and object)

 Parties to this Convention shall 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 the application of biology and medicine.
        

At the end of Article 1, , add the following new sentence:

"They shall introduce the substantial provisions of this convention into their national legislation".

Chapter I - General provisions

Article 1 (Purpose and object)

 Parties to this Convention shall 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 the application of biology and medicine.

Article 2 (Primacy of the human being)

The interests and welfare of the human being shall prevail over the sole interest of society and science.

No restrictions shall be placed on the exercise of the rights contained in this Convention other than such as are prescribed by law and are necessary in a democratic society in the interest of public safety, for the prevention of disorder or crime, for the protection of public health or for the protection of the rights and freedoms of others.

[The second paragraph has now been moved to Article 26 of the new draft.]

 

Article 2 (Primacy of the human being)

The interests and welfare of the human being shall prevail over the sole interest of society and science.

Article 4 (Equitable access)

Parties shall take appropriate measures with a view to providing, within their jurisdiction, equitable access to health care, taking into account health needs and available resources.

In Article 4, add a new paragraph to read as follows:

"Services offered to the public involving the use of the biomedical services and techniques shall be subject, in the interest of the protection of the persons concerned, to control of their quality".

Article 3 (Equitable access to health care)
Parties, taking into account health needs and available resources, shall take appropriate measures with a view to providing, within their jurisdiction, equitable access to health care of appropriate quality.

Article 3 (Professional standards)

Any intervention in the health field, including research, must be carried out in accordance with relevant professional obligations and standards

.

Article 4 (Professional standards)

Any intervention in the health field, including research, must be carried out in accordance with relevant professional obligations and standards.

Article 5 (Consent)

No intervention may be carried out in the health field without the free and informed consent of the person undergoing it.

The person concerned may freely withdraw consent at any time.

Amend Article 5, paragraph 1, to read as follows:

"No intervention may be carried out in the health field without the informed, free, express and specific consent of the person undergoing it"

Chapter II - Consent

Article 5 (General rule)

An intervention in the health field may only be carried out after the person concerned has given free and informed consent to it.

This person shall beforehand be given appropriate information as to the purpose and nature of the intervention as well as on its consequences and risks.

The person concerned may freely withdraw consent at any time.

Article 6 (Protection of persons lacking capacity)

Interventions may be carried out on [legally incapacitated persons] [persons who have no legal capacity to give consent] and those who, though legally capable [to give consent], have a reduced capacity of understanding, only for their direct benefit and under protection conditions approved by law.

[In exceptional cases and in accordance with the law, in cases where a significant benefit may be derived and, provided that sufficient protection of the incapacitated person is guaranteed, [non-beneficial interventions] [interventions with no direct individual benefit] may be carried out on an incapacitated person in the two following situations:

- in the case of medical research where there is a negligible risk and minimal burden for the individual concerned, provided that equally effective research may not be carried out on subjects with full capacity and that there is not equally effective alternative method to research;

- in the case of removal of regenerative tissues for transplantation purposes between persons having close personal or family relations, provided that there is no donor with full capacity nor any equally effective alternative method.]

Replace Article 6 by the following text:

"Interventions may be carrried out on persons who have no legal capacity of giving consent and those who, though legally capable of giving consent, have a reduced capacity of understanding, only for their direct benefit and with the consent of their legal representative or an authority or an individual authorised or designated under his national law.

A legally incapacitated person may not undergo medical research unless it is expected to produce a direct and significant benefit to his health.

Any refusal by the incapacitated person must always be respected.

Article 6 (Protection of persons not able to consent)

1. Subject to Articles 17 and 20 below, an intervention may only be carried out on a person who does not have the capacity to consent, for his or her direct benefit.

2. Where, according to law, a minor does not have the capacity to consent to an intervention, the intervention may only be carried out with the authorisation of his or her representative or an authority or a person or body provided for by law.

The opinion of the minor shall be taken into consideration as an increasingly determining factor in proportion to his or her age and degree of maturity.

3. Where, according to law, an adult does not have the capacity to consent to an intervention because of a mental disability, a disease or for similar reasons, the intervention may only be carried out with the authorisation of his or her representative or an authority or a person or body provided for by law.

The individual concerned shall as far as possible take part in the authorisation procedure.

4. The representative the authority, the person or the body mentioned in paragraphs 2 and 3 above shall be given, under the same conditions, the information referred to in Article 5.

5. The authorisation referred to in paragraphs 2 and 3 above may be withdrawn at any time in the best interests of the person concerned.

 

At national level a body (an independent multidisciplinary ethical committee) should be set up to oversee any intervention involving mentally handicapped persons.

For the purposes of this Convention, "incapacitated persons" means

- persons who have a reduced capacity of understanding;

- persons whose capacity to possess rights and to be bound by obligations is limited, either for reasons of age or because of mental
illness;

- persons having a de facto incapacity"

 

Article 10 (Mental disorders)

Patients whose ability to decide what is in their best interests is impaired by mental disorders may be subjected, without their consent and on the protective conditions prescribed by law, to an intervention aimed at treating their mental disorders where, without such treatment, serious harm is likely to result to their health. The protective conditions prescribed by law shall include supervisory, control and appeal procedures.

  

Article 7 (Protection of persons who have mental disorder)

Subject to protective conditions prescribed by law, including supervisory, control and appeal procedures, a person who has a mental disorder of a serious nature may be subjected, without his or her consent, to an intervention aimed at treating his or her mental disorder only where, without such treatment, serious harm is likely to result to his or her health.

Article 7 (Consent of incapacitated persons)

The individual undergoing the intervention shall, as far as possible, be involved in the consenting procedure.

The consent of minors shall be regarded as an increasingly determining factor in proportion to their age and capacity of discernment.

If adults, though legally incapacitated, are capable of understanding, their consent is required.

In Article 7, at the end of paragraph 2, add the following words:

"and also the free and informed consent of the parent(s) or legal guardian(s) is ncessary".

In Article 7, at the end of paragraph 3, add the following words:

"and no intervention may be undertaken without their consent."

[See Articles 6, 17 and 20]

Article 8 (Emergency situation)

When because of an emergency situation the appropriate consent cannot be obtained, any medically necessary intervention may be carried out immediately for the benefit of the health of the individual concerned.

 

Article 8 (Emergency situation)

When because of an emergency situation the appropriate consent cannot be obtained, any medically necessary intervention may be carried out immediately for the benefit of the health of the individual concerend.

Article 9 (Previously expressed wishes)
The previously expressed wishes relating to a medical intervention by a patient who is not, at the time of the intervention, in a state to express his wishes shall be taken into account.

  

Article 9 (Previously expressed wishes)
The previously expressed wishes relating to a medical intervention by a patient who is not, at the time of the intervention, in a state to express his or her wishes shall be taken into account.

� Article 12 (Privacy and access to information)

Everyone has the right to respect for private life in the health field.

Individuals are entitled to know any information collected about their health. However, the wishes of individuals not to be so informed shall be observed.

In exceptional cases, restrictions may be placed by law on the exercise of the rights contained in the preceding paragraph in the interests of the patient.

 

Chapter III - Private life and right to information

Article 10 (Private life and right to information)
1. Everyone has the right to respect for private life in relation to information about his or her health.

2. Everyone is entitled to know any information collected about his or her health. However, the wishes of individuals not to be so informed shall be observed.

3. In exceptional cases, restrictions may be placed by law on the exercise of the rights contained in paragraph 2 in the interests of the patient.
   

Chapter IV - Human genome

Article 11 (Non-discrimination)
Any form of discrimination against a person on grounds of his or her genetic heritage is prohibited.

Article 17 (Tests predictive of genetic disease)

Tests which are predictive of genetic diseases or that may identify a genetic predisposition to a disease may only be performed for health purposes or for scientific research linked to health purposes.

  

Article 12 (Predictive genetic tests)

1. Tests which are predictive of genetic diseases or which serve either to identify the subject as a carrier of a gene responsible for a disease or to detect a genetic predisposition or susceptibility to a disease may be performed only for health purposes or for scientific research linked to health purposes, and subject to appropriate genetic counselling.

Article 18 (communication of results)

The communication of results of genetic testing outside the health field may only be allowed in accordance with the provisions of Article 2 paragraph 2 of this Convention.

At the end of Article 18, add the following words: "and in accordance with the national legislation about data protection".

[Deleted]

Article 16 (Human genome)
An intervention on the human genome may only be undertaken for preventive, therapeutic or diagnostic purposes and as lon as the aim is not to interfere with the germ cell line.

Replace Article 16 with the following text:

"An intervention on the human genome may only be undertaken for preventive, therapeutic or diagnostic purposes without any intervention in the human germ cell line."

Article 13 (Interventions on the human genome)

An intervention seeking to modify the human genome may only be undertaken for preventive, diagnostic or therapeutic purposes and only if its aim is not to introduce any modification in the genome of any descendants.

 


Article 14 (Non-selection of sex)

The use of techniques of medically assisted procreation shall not be allowed for the purpose of choosing a future child's sex, except where serious hereditary sex-related disease is to be avoided.

Article 14 (Scientific research)

Scientific research in the field of biology and medicine shall be carried out freely in accordance with this Convention and with the other legal provisions ensuring the protection of the human being.

 

Chapter V - Scientific research

Article 15 (General rule)
Scientific research in the field of biology and medicine shall be carried out freely, subject to the provisions of this Convention and the other legal provisions ensuring the protection of the human being.

   

Article 16 (Protection of persons undergoing research)

Research on a person may only be undertaken if all the following conditions are met:

i.there is not alternative of comparable effectiveness to research on humans,

ii. the risks which may be incurred by that person are not disproportionate to the potential benefits of the research,

iii. the research project has been approved by the competent body after independent examination of its scientific merit, including the importance of the aim of the research, and ethical acceptability,

iv. the persons undergoing research have been informed of their rights and the safeguards prescribed by law for their protection,

v. the necessary consent as provided for under Article 5 has been given expressly, specifically and is documented. Such consent may be freely withdrawn at any time.
   

Article 17 (Protection of persons not able to consent to research)

1. Research on a person without the capacity to consent as stipulated in Article 5 may be undertaken only if all the following conditions are met:

i. the conditions laid down in Article 16, sub-paragraphs (i) to (iv), are fulfilled;

ii. the results of the research have the potential to produce direct benefit to his or her health;

iii. research of comparable effectiveness cannot be carried out on individuals capable of giving consent;

iv. the necessary authorisation provided for under Article 6 has been given specifically and in writing, and

v. the person concerned does not object.

2. Exceptionally and under the protective conditions prescribed by law, where the research has not the potential to produce results of direct benefit to the health of the person concerned, such research may be authorised subject to the conditions laid down in paragraph 1, sub-paragraphs (i), (iii), (iv) and (v) above, and to the following additional conditions:

   

i. 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.

ii. the research entails only minimal risk and minimal burden for the individual concerned.

Article 15 (Research on embryos in vitros)

1. Where research on embryos in vitro is allowed by law, such research may only be permitted in the case of embryos which have not been developed for more than 14 days.

2. The creation of human embryos solely for research purposes is prohibited.

Delete the first paragraph of Article 15

In Article 15, paragraph 2, delete the word "solely".

Article 18 (Research on embryos in vitro).

1. Where the law allows research on embryos in vitro, it shall ensure adequate protection of the embryo.

2. The creation of human embryos for research purposes is prohibited.
   

Chapter VI - Organ and tissue removal from living donors for transplantation purposes

Article 19 (General rule)

1. Removal of organs or tissue from a living person for transplantation purposes may be carried out solely for the therapeutic benefit of the recipient and where there is no suitable organ or tissue available from a deceased person and no other alternative therapeutic method of comparable effectiveness.

2. The necessary consent as provided for under Article 5 must have been given expressly and specifically either in written form or before an official body.
   

Article 20 (Protection of persons not able to consent to organ removal)

1. No organ or tissue removal may be carried out on a person who does not have the capacity to consent under Article 5.

2. Exceptionally and under the protective conditions prescribed by law, the removal of regenerative tissue from a person who does not have the capacity to consent may be authorised provided the following conditions are met:

i. there is no compatible donor available who has the capacity to consent,

ii. the recipient is a brother or sister of the donor,

iii. the donation must have the potential to be life-saving for the recipient,

iv. the authorisation provided for under paragraphs 2 and 3 of Article 6 has been given specifically and in writing, as provided for by law,

v. the potential donor concerned does not object.

Article 11 (Prohibition of financial gain)

The human body and its parts shall not, as such, give rise to financial gain.

 

Chapter VII - Prohibition of financial gain and disposal of a part of the human body

Article 21 (Prohibition of financial gain)

The human body and its parts shall not, as such, give rise to financial gain.

Article 13 (Disposal of a removed part of the human body)

When in the course of an intervention any part of a human body is removed, it may be stored and used for a purpose other than that for which it was removed, only if this is done in conformity with appropriate information and consent procedures.

In Article 13 the words: "only if this is done in conformity with apropriate information and consent procedures" are to be clarified.

Article 22 (Disposal of a removed part of the human body)

When in the course of an intervention any part of a human body is removed, it may be stored and used for a purpose other than that for which it was removed, only if this is done in conformity with appropriate information and consent procedures.

Article 19 (Infringements of the principles)

The Parties shall provide appropriate judicial protection to prevent or to put a stop to an unlawful infringement of the rights and principles set forth in this Convention at short notice.

 

Chapter VIII - Infringements of the provisions of the Convention

Article 23 (Infringement of the rights or principles)
The Parties shall provide appropriate judicial protection to prevent or to put a stop to an unlawful infringement of the rights and principles set forth in this Convention at short notice.

Article 20 (Compensation for undue damage)
The person who has suffered undue damage resulting from an intervention is entitled to fair compensation according to the conditions and procedures prescribed by law.

In Article 20, delete "according to the conditions and procedure prescribed by law"

Article 24 (Compensation for undue damage)

The person who has suffered undue damage resulting from an intervention is entitled to fair compensation according to the conditions and procedures prescribed by law.

Article 21 (Sanctions)

Parties shall provide for appropriate sanctions to be applied in the event of infringement of the provisions contained in this Chapter.

 

Article 25 (Sanctions)

Parties shall provide for appropriate sanctions to be applied in the event of infringement of the provisions contained in this Convention.

   

Chapter IX - Relation between this Convention and other provisions

Article 26 (Restrictions on the exercise of the rights)

1. No restrictions shall be placed on the exercise of the rights and protective provisions contained in this Convention other than such as are prescribed by law and are necessary in a democratic society in the interest of public safety, for the prevention of crime, for the protection of public health or for the protection of the rights and freedoms of others.

2. The restrictions contemplaced in the preceding paragraph may not be placed on Articles 11, 13, 14, 16, 17, 19, 20 and 21.

Article 22 (Wider protection)

None of the provisions of this chapter shall be interpreted as limiting or otherwise affecting the possibility for a Party to grant a wider measure of protection with regard to the application of biology and medicine than is stipulated in this Convention.

 

Article 27 (Wider protection)

None of the provisions of this Convention shall be interpreted as limiting or otherwise affecting the possibility for a Party to grant a wider measure of protection with regard to the application of biology and medicine than is stipulated in this Convention.

Article 23 (public debate)
The Parties shall see to it that the fundamental questions raised by the developments of biology and medicine are the subject of appropriate public discussion in the light, in particular, of relevant medical, social, economic, ethical and legal implications, and that their possible application is made the subject of appropriate consultation.

  

Chapter X - Public debate

Article 28 (public debate)
Parties to this Convention shall see to it that the fundamental questions raised by the developments of biology and medicine are the subject of appropriate public discussion in the light, in particular, of relevant medical, social, economic, ethical and legal implications, and that their possible application is made the subject of appropriate consultation.

 

Add a new Article worded as follows:

"For the purpose of observing the application of the convention on the territory of the Contracting Parties and of interpreting the text of the convention, a monitoring body in connection with the European Court of Human rights is hereby set up".

Chapter XI - Interpretation and follow-up of the Convention

Article 29 (Interpretation of the Convention)

The European Court of Human Rights may give, without direct reference to any specific proceedings pending in a court, advisory opinions on legal questions concerning the interpretation of the present Convention at the request of:

- the Government of a Party, after having informed the other Parties,

- the Committee set up by Article 32, with membership restricted to the Representatives of the Parties to this Convention, by a decision adopted by a two-third majority of votes cast.

Article 25 (Reports on the application of the Convention)

On receipt of a request from the Secretary General of the Council of Europe any Party shall furnish an explanation of the manner in which its internal law ensures the effective implementation of any of the provisions of the Convention.

 

Article 30 (Reports on the application of the Convention)
On receipt of a request from the Secretary General of the Council of Europe any Party shall furnish an explanation of the manner in which its internal law ensures the effective implementation of any of the provisions of the Convention.

Article 24 (Protocols)

Protocols may be concluded in pursuance of Article 26, with a view to developing, in specific fields, the principles contained in this Convention.

The Protocols shall be open for signature by Signatories of the Convention. They shall be subject to ratification, acceptance or approval. A signatory may not ratify, accept or approve Protocols without previously or simultaneously ratifying the Convention.

 

Chapter XII - Protocols

Article 31 (Protocols)

Protocols may be concluded in pursuance of Article 32, with a view to developing, in specific fields, the principles contained in this Convention.

The Protocols shall be open for signature by Signatories of the Convention. They shall be subject to ratification, acceptance or approval. A signatory may not ratify, accept or approve Protocols without previously or simultaneously ratifying accepting or approving the Convention.

Chapter V

Article 26 (Amendments to the Convention)
1. For the purposes of this article a Committee is hereby set up.

2. The Committee referred to in the preceding paragraph shall be composed of one delegation per Party, appointed by the Government of the said Party. Each delegation shall have one vote. Any State referred to in Article 27 or invited to accede to the Convention in acordance with the provisions of Article 28 which is not a Party to this Convention may be represented on the Committee by an observer. [If the European Community is not a party it may be represented on the Committee by an observer.]

3. Any proposal for an amendment to this Convention, and any proposal for a Protocol or for an amendment to a Protocol, presented by a Party, the Committee or the Committee of Ministers shall be communicated to the Secretary General of the Council of Europe and forwarded by him to the member States of the Council of Europe, [to the European Community,] to any Signatory, to any Party, to any State invited to sign this Convention in accordance with the provisions of Article 27 and to any State invited to accede to it in accordance with the provisions of Article 28.

In Article 26, paragraph 2 (and elsewhere), replace "European community" by "European Union".

Chapter XIII - Amendments to the convention

Article 32 (Amendments to the Convention)

1. The tasks assigned to "the Committee" in the present Article and in Article 29 shall be carried out by the Steering Committee on Bioethics (CDBI), or by any other committee designated to do so by the Committee of Ministers.

2. Without prejudice to the specific provisions of Article 29, each member State of the Council of Europe, as well as each Party to the present Convention which is not a member of the Council of Europe, may be represented and have one vote in the Committee when the Committee carries out the tasks assigned to it by the present Convention.

3. Any State referred to in Article 33 or invited to accede to the Convention in accordance with the provisions of Article 34 whcih is not Party to this Convention may be represented on the Committee by an observer. If the European Commmunity is not a Party it may be represented on the Committee by an observer.

4. In order to monitor scientific developments, the present Convention shall be examined within the Committee no later than five years from its entry into force and thereafter at such intervals as the Committee may determine.

4. The Committee shall meet not earlier than two months after a proposal has been forwarded by the Secretary General in accordance with paragraph 3 and examine the proposal. It shall submit the text adopted by a two-third majority of the votes cast to the Committee of Ministers for approval. After its approval, this text shall be forwarded to the Parties for ratification, acceptance or approval.

5. Any amendment shall enter into force, in respect of those Parties which have accepted it, on the first day of the month following the expiration of a period of one month after the date on which five Parties, including at least four member States of the Council of Europe, have informed the Secretary General that they have accepted it.

In respect of any Party which subsequently accepts it, the amendment shall enter into force on the first day of the month following the expiration of a period of one month after the date on which that Party has informed the Secretary General of its acceptance.
        

  

5. Any proposal for an amendment to this Convention, and any proposal for a Protocol or for an amendment to a Protocol, presented by a Party, the Committee or the Committee of Ministers shall be communicated to the Secretary General of the Council of Europe and forwarded by him to the member States of the Council of Europe, to the European Community, to any Signatory, to any Party, to any State invited to sign this Convention in accordance with the provisions of Article 33 and to any State invited to accede to it in accordance with the provisions of Article 34.

6. 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-thirds majority of the votes cast to the Committee of Ministers for approval. After its approval, this text shall be forwarded to the Parties
for ratification, acceptance or approval.

7. Any amendment shall enter into force, in respect of those Parties which have accepted it, on the first day of the month following the expiration of a period of one month after the date on which five Parties, including at least four member States of the Council of Europe, have informed the Secretary General that they have accepted it.

In respect of any Party which subsequently accepts it, the amendment shall enter into force on the first day of the month following the expiration of a period of one month after the date on which that Party has informed the Secretary General of its acceptance.

Article 27 (Signature, ratification and entry into force)

1. This Convention shall be open for signature by the member States of the Council of Europe, the non-member States which have participated in its elaboration [and by the European Community].

2. This Convention is subject to ratification, acceptance or approval. Instruments of ratification, acceptance or approval shall be deposited with the Secretary General of the Council of Europe.

3. This Convention shall enter into force on the first day of the month following the expiration of a period of three months after the date on which five States, including at least four member States of the Council of Europe, have expressed their consent to be bound by the Convention in accordance with the provisions of paragraph 2 of the present Article.

4. In respect of any Signatory which subsequently expresses its consent to be bound by it, the Convention shall enter into force on the first day of the month following the expiration of a period of three months after the date of the deposit of its instrument of ratification, acceptance or approval.

 

Chapter XIV - Final clauses

Article 33 (Signature, ratification and entry into force)
1. This Convention shall be open for signature by the member States of the Council of Europe, the non-member States which have participated in its elaboration and by the European Community.

2. This Convention is subject to ratification, acceptance or approval. Instruments of ratification, acceptance or approval shall be deposited with the Secretary General of the Council of Europe.

3. This Convention shall enter into force on the first day of the month following the expiration of a period of three months after the date on which five States, including at least four member States of the Council of Europe, have expressed their consent to be bound by the Convention in accordance with the provisions of paragraph 2 of the present Article.

4. In respect of any Signatory which subsequently expresses its consent to be bound by it, the Convention shall enter into force on the first day of the month following the expiration of a period of three months after the date of the deposit of its instrument of ratification, acceptance or approval.

Article 28 (Non-member States)

1. After the entry into force of this Convention, the Committee of Ministers of the Council of Europe may, after consultation of the Parties, invite any non-member State of the Council of Europe to accede to this Convention by a decision taken by the majority provided for in Article 20, sub-paragraph d of the Statute of the Council of Europe, and by the unanimous vote of the representatives of the Contracting States entitled to sit on the Committee on Ministers.

2. In respect of any acceding State, the Convention shall enter into force on the first day of the month following the expiration of a period of three months after the date of deposit of the instrument of accession with the Secretary General of the Council of Europe.

In Article 28, paragraph 1, delete "and by the unanimous vote of the representatives of the Contracting States entitled to sit on the Committee of Ministers".

Article 34 (Non-member States)
1. After the entry into force of this Convention, the Committee of Ministers of the Council of Europe may, after consultation of the Parties, invite any non-member State of the Council of Europe to accede to this Convention by a decision taken by the majority provided for in Article 20, sub-paragraph d of the Statute of the Council of Europe, and by the unanimous vote of the representatives of the Contracting States entitled to sit on the Committee on Ministers.

2. In respect of any acceding State, the Convention shall enter into force on the first day of the month following the expiration of a period of three months after the date of deposit of the instrument of accession with the Secretary General of the Council of Europe.

Article 29 (Territories)
1. Any Signatory may, at the time of signature or when depositing its instrument of ratification, acceptance or approval, specify the territory or territories to which this Convention shall apply. Any other State may formulate the same declaration when depositing its instrument of accession.

2. Any Party may, at any later date, by a declaration addressed to the Secretary General of the Council of Europe, extend the application of this Convention to any other territory specified in the declaration and for whose international relations it is responsible or on whose behalf it is authorised to give undertakings. In respect of such territory the Convention shall enter into force on the first day of the month following the expiration of a period of three months after the date of receipt of such declaration by the Secretary General.

3. Any declaration made under the two preceding paragraphs may, in respect of any territory specified in such declaration, be withdrawn by a notification addressed to the Secretary General. The withdrawal shall become effective on the first day of the month following the expiration of a period of three months after the date of receipt of such notification by the Secretary General.

 

Article 35 (Territories)

1. Any Signatory may, at the time of signature or when depositing its instrument of ratification, acceptance or approval, specify the territory or territories to which this Convention shall apply. Any other State may formulate the same declaration when depositing its instrument of accession.

2. Any Party may, at any later date, by a declaration addressed to the Secretary General of the Council of Europe, extend the application of this Convention to any other territory specified in the declaration and for whose international relations it is responsible or on whose behalf it is authorised to give undertakings. In respect of such territory the Convention shall enter into force on the first day of the month following the expiration of a period of three months after the date of receipt of such declaration by the Secretary General.

3. Any declaration made under the two preceding paragraphs may, in respect of any territory specified in such declaration, be withdrawn by a notification addressed to the Secretary General. The withdrawal shall become effective on the first day of the month following the expiration of a period of three months after the date of receipt of such notification by the Secretary General.

Article 30 (Reservations)

1. Any Signatory may, at the time of signature or when depositing its instrument of ratification, acceptance or approval, make a reservation to Article[s]... of this Convention. No other reservation may be made.

Any other State may make the same reservation[s] when depositing its instrument of accession.

2. Any Signatory or any other State which makes a reservation shall notify the Secretary General of the Council of Europe of the relevant contents of its internal law.

3. Any Party which extends the application of this Convention to a territory mentioned in the declaration referred to in Article 29, paragraph 2, may, in respect of the territory concerned, make a reservation in accordance with the provisions of the preceding paragraphs.

4. Any Party which has made the reservation mentioned in this Article may withdraw it by means of a declaration addressed to the Secretary General of the Council of Europe. The withdrawal shall become effective on the first day of the month following the expiration of a period of one month after the date of its receipt by the Secretary General.

In Article 30, at the end of the first paragraph, add:

"No reservations may be made in respect of Articles 15 and 16"

[13 and 18 in the new draft]

Article 36 (Reservations)

1. Any State and the European Community may, when signing this Convention or when depositing the instrument of ratification, make a reservation in respect of any particular provision of the Convention to the extent that any law then in force in its territory is not in conformity with the provision. Reservations of a general character shall not be permitted under this article.

2. Any reservation made under this article shall contain a brief statement of the relevant law.

3. Any Party which extends the application of this Convention to a territory mentioned in the declaration referred to in Article 33, paragraph 2, may, in respect of the territory concerned, make a reservation in accordance with the provisions of the preceding paragraphs.

4. Any Party which has made the reservation mentioned in this Article may withdraw it by means of a declaration addressed to the Secretary General of the Council of Europe. The withdrawal shall become effective on the first day of the month following the expiration of a period of one month after the date of its receipt by the Secretary General.

Article 31 (Denunciation)
1. Any Party may at any time denounce this Convention by means of a notification addressed to the Secretary General of the Council of Europe.

2. Such denunciation shall become effective on the first day of the month following the expiration of a period of three months after the date of receipt of the notification by the Secretary General.

 

Article 37 (Denunciation)
1. Any Party may at any time denounce this Convention by means of a notification addressed to the Secretary General of the Council of Europe.

2. Such denunciation shall become effective on the first day of the month following the expiration of a period of three months after the date of receipt of the notification by the Secretary General.

Article 32 (Notifications)
The Secretary General of the Council of Europe shall notify the member States of the Council, [the European Community,] any Signatory, any Party and any other State which has been invited to accede to this Convention of:

a. any signature;

b. the deposit of any instrument of ratification, acceptance, approval or accession;

c. any date of entry into force of this Convention in accordance with Articles 27 or 28;

d. any amendment adopted in accordance with Article 26, and the date on which such an amendment enters into force;

e. any declaration made under the provisions of Article 29;

f. any reservation and withdrawal of reservation made in pursuance of the provisions of Article 30;

 

Article 38 (Notifications)
The Secretary General of the Council of Europe shall notify the member States of the Council, the European Community, any Signatory, any Party and any other State which has been invited to accede to this Convention of:

a. any signature;

b. the deposit of any instrument of ratification, acceptance, approval or accession;

c. any date of entry into force of this Convention in accordance with Articles 31 or 32;

d. any amendment or Protocol adopted in accordance with Article 30, and the date on which such an amendment or Protocol enters into force;

e. any declaration made under the provisions of Article 33;

f. any reservation and withdrawal of reservation made in pursuance of the provisions of Article 34;

g. any other act, notification or communication relating to this Convention.

In witness whereof the undersigned, being duly authorised thereto, have signed this Convention.

Done at...., the...., in English and French, both texts being equally authentic, in a single copy which shall be deposited in the archives of the Council of Europe. The Secretary General of the Council of Europe shall transmit certified copies to each member State of the Council of Europe, to the European Community, to the non-member States which have participated in the elaboration of this Convention, and to any State invited to accede to this Convention.

 

g. any other act, notification or communication relating to this Convention.

In witness whereof the undersigned, being duly authorised thereto, have signed this Convention.

Done at...., the...., in English and French, both texts being equally authentic, in a single copy which shall be deposited in the archives of the Council of Europe. The Secretary General of the Council of Europe shall transmit certified copies to each member State of the Council of Europe, to the European Community, to the non-member States which have participated in the elaboration of this Convention, and to any State invited to accede to this Convention.

Appendix II

Scientific research concerning the human genome

A survey of scientific research on the human genome may aid comprehension of the possibilities available in this field as regards therapeutic, genetic, technological and other applications. Any legal and ethical treatment must be interpreted and assessed against this background.

Investigation into the material basis of genes and how they act has been one of the major focuses of biological research over the last half century. Studies of inheritance and of the dramatic effects of gene mutations foreshadowed two major discoveries, firstly the chemical basis of the gene is DNA and secondly that genes specify the synthesis of proteins. These crucial landmarks opened up the fields of molecular and biochemical genetics and led in turn to the development of novel recombinant DNA technologies which provided new approaches to many unsolved problems, such as the organisation of genetic information in eukaryotes, the regulation of embryonic development, differentiation, antibody production and vaccine development, as well as the molecular structure of proteins. Recombinant DNA techniques also permitted the production of proteins in prokaryotes and eukaroytes, the isolation, analysis and manipulation of individual genes, detection of genetic defects leading to heritable conditions, and ways of detecting an affected foetus or carriers at risk of producing an affected offspring. Indeed, a multibillion ecu biotechnology industry is emerging to exploit the potential of recombinant DNA.

As more and more genes were mapped and sequenced it became clear that a valuable resource was being generated that could have a major impact on basic research as well as health and disease. A programme to map, sequences and interpret proteins, and thereby to understand the genetic basis of homo sapiens, was thus conceived. The task is exciting, vast and will promote more in the way of co-ordinated national and international research collaboration than anything that has gone before. It is claimed that the human genome programme is the largest biological science venture of all time; the implications for mankind of understanding the human genetic blueprint will certainly be vast.

The human genome consists of some 3 thousand million bases on twenty-four distinct chromosomes; it is believed these compose some fifty to one hundred thousand genes. At present only 2% of the genes has been assigned specific chromosomal locations. The aim of the Human Genome Programme is to locate the position of all of the DNA and to decode the genetic information contained therein; this will of course include aberrant information present in disease genes. Strategies centre on construction of the genetic map, the physical map and ultimately the complete DNA sequence.

New research technologies developed as a consequence of the human genome programme will benefit research in many areas of biology and medicine, such as cell growth and organ development, morphogenesis and ageing. Gene sequence data will aid basic science through the design of drugs, receptors and diagnostic reagents, such as probes for genetic disorders and for blood or tissue identification. Industrial processes involving the use of bacteria, yeasts or fungi could be improved through the construction of improved strains, while both agriculture and animal husbandry could benefit from the development of species suited to particular environments (some countries express reservations over the ethics of such activities, however). The translation of DNA sequence into protein sequence and the understanding of protein structure and function will also advance more rapidly as a consequence of genome research. It is absolutely crucial that Europe has the opportunity to make a competitive contribution to these major scientific advances.

It is anticipated that the human genome programme will also aid the understanding of many of the genetic diseases that afflict man and will in turn facilitate their treatment. Of the four thousand or so single gene disorders now known, less than 10% are understood at the genetic level. A final scale human map will permit localisation of disease genes, while their sequences will ultimately reveal function. Data generated by the project will also facilitate complete understanding of diseases that are not primarily due to genetic disorders, since it is the protein products of genes which are involved in pathogenesis, defence mechanisms and normal development. The end point of genome research is also worth stressing, for this will encompass both the generation of information for counselling on severe genetic disorders and the production of screening kits for those diseases, and only those diseases, where a clear health benefit can be perceived. Health services must be prepared for the implementation of these applications.

The human genome analysis programme will rapidly increase our knowledge of the chromosomal location of defective single disease genes. Amongst those already identified are the genes for cystic fibrosis (chromosome 7) Duchenne muscular dystrophy (chromosome X), polycystic kidney disease (chromosome 16), Huntington's disease (chromosome 4), retinoblastoma (chromosome 13) and familial Alzheimer's disease (chromosome 21); many of these can now be detected during pregnancy. The ability to detect individuals who are carriers for specific gene defects will also facilitate epidemiological studies of the risks associated with environmental or occupational factors. Problems of susceptibility to cadiovascular heart disease, "essential" hypertension, some forms of cancer, diabetes, schizophrenia, multiple sclerosis and mental retardation will be resolved more easily and may well benefit from international co-operative efforts.

Opportunities opened up as a consequence of human genome analysis include:

i.    better risk detection and diagnosis either through the techniques of molecular genetics, or through use of biochemical, immunochemical, histochemical and other techniques to detect phenotypic abnormality in genetically determined disorders;

ii.    identification and better knowledge of gene products, with opportunities for improvements in diagnosis, better drug design and gene therapy where there is a clear health benefit;

iii.    better understanding of disease, which will not only contribute to more precise diagnosis and more satisfactory treatments, but also offer potential opportunities for identifying methods for prevention and/or avoiding the serious complications of established diseases. There may be considerable opportunities in relation to those common disorders in which genetic factors play a role

Reporting committee: Committee on Science and Technology.

Budgetary implications for the Assembly: none.

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

Draft opinion provisionally adopted by the committee on 11 July 1996.

Secretaries to the committee: Mr Perin and Mr Torc�toriu

Footnote: 1This provisional report is distributed in conformity with Rule 28 (2) of the Rules of Procedure.

Footnote: 2 By the Committee on Science and Technology.

Footnote: 3 1. Fuller information about this subject may be found in an opinion of the Committee on Science and Technology on the protection and patentability of material of human origin (Doc. 7068 (1994)).

Footnote: 4        European Science Foundation: Report on Genome Research, Extract of Doc. 7068 of the Parliamentary Assembly.