11 July 1994

Doc. 7124

REQUEST FOR AN OPINION

FROM THE COMMITTEE OF MINISTERS

TO THE ASSEMBLY

on the 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

(in conformity with the decision taken by the Ministers' Deputies

at their 515th meeting on 21 June 1994)

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

AND EXPLANATORY MEMORANDUM

Directorate of Legal Affairs

Strasbourg, July 1994

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;

      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;

      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:

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.

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.

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 (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.

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.

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 protective 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 no 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.]1

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 for discernment.

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

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 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 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 11 (Prohibition of financial gain)

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

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.

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.

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.

Article 15 (Research on embryos in vitro)

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.

Article 16 (Human genome)

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

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 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.

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.

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.

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 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.

CHAPTER II

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 III

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 IV

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.

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 accordance 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.

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.

CHAPTER VI - Final clauses

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.

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 of 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 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.

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 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;

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.

DRAFT EXPLANATORY REPORT

TO THE DRAFT BIOETHICS CONVENTION

      INTRODUCTION

1.       For several years now, the Council of Europe, through the work of the Parliamentary Assembly and of the ad hoc Committee of experts on Bioethics (CAHBI), later renamed the Steering Committee on Bioethics (CDBI), has concerned itself with the problems confronting mankind as a result of advances in medicine and biology. At the same time, a number of countries have done their own internal work on these topics, and this work is proceeding. So far, therefore, two types of endeavour have been undertaken, one at a national and the other at international level.

2.       Basically, these studies are the fruit of observation and concern: observation of the radical developments in science and their applications to medicine and biology, ie fields in which people are directly involved; concern about the ambivalent nature of many of these advances. The scientists and practitioners behind them have worthy aims and often attain them. But some of the known or alleged developments of their work are taking or could potentially take a dangerous turn, as a result of a distortion of the original objectives. Science, with its new complexity and extensive ramifications, thus presents a dark side or a bright side according to how it is used.

3.       It has subsequently become necessary to ensure that the beneficial side prevails by developing awareness of what is at stake and constantly reviewing all the possible consequences. No doubt the ethics committees and other national bodies and legislators, as well as the international organisations, have already applied themselves to this task, but their efforts have remained either restricted to a particular geographical area or incomplete because of their focus on a particular topic. On the other hand, common values are more often than not claimed as a basis for the various texts, opinions and recommendations. But differences may nonetheless become apparent in connection with certain aspects of the problems dealt with. Even simple definitions may give rise to profound differences.

Drafting of a Convention

4.       It has thus become apparent that there was a need to make a greater effort to harmonise existing standards. In June 1991, in its Recommendation 11602 (Rapporteur: Mr Marcelo PALACIOS), the Parliamentary Assembly recommended that the Committee of Ministers "envisage a framework convention comprising a main text with general principles and additional protocols on specific aspects". In September of the same year the Committee of Ministers instructed the CAHBI "to prepare, in close co-operation with the Steering Committee for Human Rights (CDDH) and the European Health Committee (CDSP) ... a framework Convention, open to non-member States, setting out common general standards for the protection of the human person in the context of the biomedical sciences /and/ Protocols to this Convention, relating to, in a preliminary phase: organ transplants and the use of substances of human origin; medical research on human beings".

5.       In March 1992 the CAHBI, which has been chaired in turn by Mrs Paula KOKKONEN (Finland), Mr Octavi QUINTANTA (Spain) and Mrs Johanna KITS NIEUWENKAMP (The Netherlands), set up a Working Party to prepare the draft Convention. The members of the Working Party, which was chaired by Dr Michael ABRAMS (United Kingdom), were: Mr Jean MICHAUD (France) (Rapporteur), Dr Stefan WINTER (Germany), Dr Ferenc OBERFRANK (Hungary), Mr Salvatore PUGLISI (Italy) (Co-ordinator), Dr Henriette ROSCAM ABBING (Netherlands), Dr Göran HERMERÉN (Sweden), Mrs Ruth REUSSER (Switzerland) and the chair of the CDBI.

6.       As a result of this work a Convention on Bioethics was prepared. The draft was finalised by the CDBI on ... and adopted by the Committee of Ministers on ...

7.       Various international instruments already provide protection and guarantees for mankind: the Universal Declaration of Human Rights, the International Convenant on Civil and Political Rights, the Convention for the Protection of Human Rights and Fundamental Freedoms and the Convention for the Protection of Individuals with regard to Automatic Processing of Personal Data.

8.       They must now be supplemented by other texts so that full account is taken of the potential implications of scientific actions.

9.       The principles enshrined in these instruments remain the basis of our conception of human rights; hence they are set out at the beginning of the preamble to the Convention, of which they are the cornerstone.

10.       Starting with the preamble, however, it was necessary to take account of the actual developments in medicine and biology, while indicating the need for them to be used solely for the benefit of present and future generations. This concern has been affirmed at three levels:

-       The first is that of the individual, who had to be shielded from any threat resulting from the improper use of scientific developments. Several articles of the Convention illustrate the wish to make it clear that pride of place ought to be given to the individual:

      .       protection against unlawful interference with the human body, prohibition of the use of all or part of the body for financial gain, restriction of the use of genetic testing, etc.

-       The second level relates to society. Indeed, in this particular field, to a greater extent than in many others, the individual must also be considered to constitute part of a social corpus. Whenever choices are involved in regard to the application of certain developments, the latter must be recognised and endorsed by the community. This is why public debate is so important and is given a place in the Convention.

      Nevertheless, the interests at stake are not equal; they are graded to reflect the priority attached to the interests of the individual as opposed to those of science and society alone. The adjective "alone" makes it clear that care must be taken not to neglect the latter; they must come immediately after the interests of the individual.

-       The third and final concern relates to the human species. Many of the current achievements and forthcoming advances are based on genetics. Progress in knowledge of the genome is producing more ways of influencing and acting on it. The risks associated with this growing area of expertise should not be ignored. It is no longer the individual or society that is imperilled but the human species itself. The Convention sets up safeguards, starting with the preamble where reference is made to the benefits to future generations and to all humanity, while provision is made throughout the text for the necessary legal guarantees to protect the identity of the human being.

11.       It is in this spirit that a ban is imposed on interventions on the human genome which, if not restricted to somatic therapy, might affect the individual's lineal descent.

12.       The discussions leading up to the preparation of the Convention brought to light two contrary requirements for the text:

13.       Some of the provisions will not require amendment. They are the ones which refer to previous Conventions and proclaim human rights. There are others which owe their wording to scientific knowledge and in their cas the possibility of revision cannot be ruled out depending on developments in science. However, such developments must in no circumstances weaken the force of the first set of provisions.

14.       The problem which the Convention seeks to resolve will arise again in the future, perhaps more acutely. Trying to solve it by placing obstacles in the path of the progress of scientific knowledge would amount to disregarding man's right to knowledge and his freedom to extend it. But some broad guidelines are needed for the application of this knowledge, in order to protect man, society and the species.

15.       This Convention is therefore devoted to the enunciation of general principles. The protocols that will be attached to it deal with particular fields of biology and medicine. The first two protocols are concerned with organ transplantation and medical research respectively.

Comments on the provisions of the Convention

Title

16.       The title of the instrument is "Convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine: Bioethics Convention".

17.       The reference to human rights provided a necessary connection between the Convention and the principles defined in the texts which guarantee protection for such rights. The Convention is, for instance, entirely consistent with the Convention for the Protection of Human Rights and Fundamental Freedoms of 4 November 1950. The two Conventions share not only the same underlying approach but also many ethical principles and legal concepts. The concept of the human being found in the remainder of the text was adopted because of its general character. The idea of dignity, which constitutes the essential value to be upheld, can be considered to cover the other values, which are emphasised subsequently.

18.       The phrase "application of biology and medicine", which is also used in Article 1, was preferred to "life sciences" in particular, which was considered too broad. It restricts the scope of the Convention to human medicine and biology, thereby excluding animal and plant biology insofar as they do not concern human medicine or biology. The Convention thus covers all medical and biological applications concerning human beings, including preventive, diagnostic, therapeutic and research applications.

19.       The term "bioethics" was used in a supplementary title to give a succinct and convenient indication of the purpose of the text.

Preamble

20.       This refers to various international instruments on the protection of human rights, with which the Convention has affinities, and to the work of the Parliamentary Assembly which constituted an important stage in the preparation of the Convention.

21.       The preamble refers to the developments in medicine and biology which should be used only for the benefit of present and future generations and not be diverted in ways that run counter to their proper objective. It proclaims the respect due to man as an individual and as a member of the human species. It concludes that progress, human benefit and protection can be reconciled if public awareness is aroused by an international instrument devised by the Council of Europe in line with its vocation. Stress is laid on the need for international co-operation to extend the benefits of progress to the whole of mankind.

Article 1 (Purpose and object)

22.       This article defines the Convention's scope and purpose.

23.       The aim of the Convention is to guarantee everyone's rights and fundamental freedoms and, in particular, their integrity with regard to the application of biology and medicine. It also sets out to secure the dignity and identity of human beings in this sphere. The Convention does not define the terms "everyone" or "human being". In the absence of unanimous agreement on the definition of these terms among the member States of the Council of Europe, it was decided to allow domestic law to define them. It was noted that the European Convention on Human Rights, which likewise uses the term "everyone", did not define this term either. It was nevertheless acknowledged that it was a generally accepted principle that human dignity had to be respected as soon as life began.

24.       Accordingly, although the Convention does not define "human being", it was agreed to construe the expression broadly, covering both the connotation of individuality and that of membership of the human race. The phrase "identity of the human being" thus assumes its full meaning in this context.

Article 2 (Primacy of the human being)

25.       In this article the Convention, the aim of which is to protect human rights and dignity, affirms the primacy of the human being over the sole interest of science and society. Priority is given to the former, which must take precedence over the latter in the event of a conflict between them. However, this article is not intended to prohibit all research not beneficial to the person who is the subject of it, but there must be rules setting out the conditions on which such research may be carried out on the persons in question, such as for example those foreseen under Article 6 for research on incapacitated persons.

26.       The whole Convention is inspired by the principle of the primacy of the human being, and all its articles must be interpreted in this light.

27.       The second paragraph of this article lists possible exceptions to the principle stated in the first paragraph. The restrictions defined therein apply to the rights contained in all the provisions of the Convention, without prejudice to any specific restrictions which this or that article may involve.

28.       The wording of this second paragraph largely echoes Article 8 (2) of the European Convention on Human Rights. The exceptions it defines are aimed at protecting collective interests (public safety, the protection of public health and the prevention of disorder or crime) or the rights and freedoms of others .

29.       The restriction based on the prevention of disorder makes it possible, for example, for respect for privacy to be restricted by permitting a judicial authority to order a test to be carried out in order to identify the perpetrator of a crime.

30.       Compulsory isolation of a patient with a serious infectious disease is a typical example of an exception for reasons of public health.

31.       A person who may, due to his or her mental disorder, be a possible source of serious harm to others may, according to the law, be placed as an involuntary patient.

32.       Protection of the rights of others may, for example, justify an order by a judicial authority for a test to be carried out to establish parentage.

33.       However, the protection of the patient's health is not mentioned in this paragraph as one of the factors justifying an exception to the provisions of the Convention as a whole. In order to clarify its scope, it seemed preferable to define this exception in each of the provisions expressly alluding to it. Article 10, for example, specifies the conditions on which individuals suffering from mental disorders may, without their consent, be given treatment if their health might suffer otherwise.

34.       Moreover, defending the economic well-being of the country and national security are not included amongst the general exceptions referred to in the second paragraph of this article, unlike Article 8 of the European Convention on Human Rights. It did not appear desirable, in the context of this Convention, to make the exercise of fundamental rights chiefly concerned with the protection of a person's rights in the health sphere subject to the economic well-being of the country or to national security. The economic aspect is however referred to in Article 4 by the words "available resources"; however, in the context of this article this notion does not represent a reason for allowing for an exception to the rights secured in other provisions of the Convention.

35.       The reasons mentioned in this paragraph should not be regarded as justifying an absolute exception to the rights secured by the Convention. To be admissible, restrictions must be prescribed by law and be necessary in a democratic society for the protection of the collective interest in question. These conditions must be interpreted in the light of the criteria established with regard to the same notions by the case law of the European Court of Human Rights. In particular, the restrictions must meet the criteria of necessity and proportionality, taking into account the social and cultural conditions proper to each State. The term "prescribed by law" should be interpreted in accordance with the meaning usually given to them by the European Court of Human Rights, ie a formal law is not required and each State may adopt the form of domestic law it considers most appropriate.

Article 3 (Professional standards)

36.       This article lays down a principle applicable to doctors and members of the health care professions generally. From the term "professional standards" it follows that this article does not concern persons other than healthcare professionals called upon to perform medical acts, for example in an emergency.

37.       The term "intervention" must be understood here in a general sense; it covers all acts, whether for the purpose of diagnosis, preventive care, treatment or rehabilitation or in a research context.

38.       As an intervention is an act performed on a human being, it must be both humane and competently performed. Doctors and, generally speaking, all professionals involved in carrying out a medical act are subject to ethical and legal requirements and must be competent and careful.

39.       Competence must primarily be determined in relation to the scientific knowledge and clinical experience appropriate to a profession or speciality at a given time. In this respect, it is explicitly indicated that the administration of care must be consistent with established scientific facts. Nevertheless, it is accepted that professional standards do not necessarily prescribe a line of action as being the only one possible: recognised medical practice may, indeed, allow several possible forms of intervention, thus leaving some freedom of choice as to methods or techniques.

40.       Further, a particular course of action must be judged in the light of the specific health problem raised by a given patient. It is acknowledged that an intervention must meet the criteria of relevance and proportionality between the aim pursued and the means used.

41.       Professional standards are not identical in all countries. The same medical duties vary slightly from one society to another. Moreover, in some countries certain professional standards may or may not derive from a text (in the form of statutory or professional codes of ethics, for example), whereas no such texts exist in other countries.

42.       Professional standards cover not only what is done in the course of an intervention, but also how it is done. In some countries they take the form of professional codes of ethics, in other codes of medical conduct, health law or medical ethics or any other means of ensuring respect for the rights and interests of patients.

Article 4 (Equitable access)

43.       This article defines an aim and imposes an obligation on States to use their best endeavours to reach it.

44.       The aim is to ensure equitable access to health care in accordance with the person's medical needs. "Health care" means the medical services - diagnostic, preventive, therapeutic and rehabilitative - designed to maintain or improve a person's state of health or alleviate a person's suffering.

45.       Access to health care must be equitable. In this context, "equitable" means first and foremost the absence of unjustified discrimination. Although not synonymous with absolute equality, equitable access implies effectively obtaining a satisfactory degree of care.

46.       The Parties to the Convention are required to take appropriate steps to achieve this aim as far as the available resources permit. The purpose of this provision is not to create an individual right on which each person may rely in legal proceedings against the State, but rather to prompt the latter to adopt the requisite measures as part of its social policy in order to ensure equitable access to health care.

47.       Although States are now making substantial efforts to ensure a satisfactory level of health care, the scale of this effort largely depends on the volume of available resources. Moreover, State measures to ensure equitable access may take many different forms and a wide variety of methods may be employed to this end.

Article 5 (Consent)

48.       This article deals with consent and establishes a fundamental legal rule, ie that no one may in principle be forced to undergo an intervention without their consent. Human beings must therefore be able freely to give or refuse their informed consent to any intervention involving their person. This rule makes clear the patient's autonomy in his relationship with health care professionals. The word "intervention" is understood in its widest sense, as in Article 3 - that is to say, it covers any act performed on a person for reasons of health and encompasses diagnosis, preventive care, treatment, rehabilitation and research.

49.       In order for their consent to be valid, the persons in question must have been informed about the relevant facts regarding the intervention being contemplated. The information need not always be exhaustive. It must, however, always include the "relevant facts" - that is to say, all the factors that might influence the person's choice, including, possibly, any alternatives to the intervention proposed or the danger of the intervention failing. Moreover, this information must be sufficiently clear and suitably worded for the layman who is to undergo the intervention. The patient must be put in a position, through the use of terms he or she can understand, to weigh up the necessity or usefulness of the aim and methods of the intervention against its risks and the discomfort or pain it will cause.

50.       Consent may take various forms. It may be express or implied. Express consent may be either verbal or written. Article 5, which is general and covers very different situations, does not require any particular form of consent. The latter will largely depend on the nature of the intervention. It is agreed that express consent would be inappropriate as regards many routine medical acts. The consent may therefore often be implicit, as long as the patient is sufficiently informed. In some cases, however, eg invasive diagnostic acts or treatments, express consent may be required. Moreover, the patient's express, specific written consent should normally be sought for participation in research.

51.       Freedom of consent implies that consent may be withdrawn at any time and that the patient's decision shall be respected once he or she has been fully informed of the consequences. There may however be departures from this principle. For example, it may be permissible in certain States, in accordance with the professional standards applying to a particular case under Article 3, for a doctor not to interrupt an intervention once it has begun if this interruption would seriously harm the patient's health.

52.       Furthermore, Article 2 of the Convention, as well as Articles 6, 7, 8, and 10 define the instances in which the exercise of the rights contained in the Convention and hence the need for consent may be limited.

53.       Information is the patient's right, but as provided for in Article 12, the patient's possible wish not to be informed must be observed. This does not however obviate the need to seek consent.

Article 6 (Protection of persons lacking capacity)3

54.       Some individuals may not validly give their consent to an intervention due to either their age or their altered mental state. It is therefore necessary to specify the conditions under which an intervention may be carried out on these incapacitated people in order to ensure their protection.

55.       This article deals with cases in which interventions may be carried out on such persons. Three categories of incapacitated persons are concerned: minors, persons of full age who are legally incapable of giving consent and persons of full age who are de facto incapable of giving consent. The article therefore applies not only to persons who are legally incapable in the strict sense of the term, irrespective of whether they are minors or persons of full age who are legally incapable, but also to persons who are de facto incapable, that is to say to persons who are legally capable but whose capacity of understanding is temporarily or permanently seriously reduced.

56.       Two principles are adopted: 1. No intervention on an incapacitated person (in the widest sense of the term) may be carried out except on the protective conditions accepted by national law. This protection may take the form of action by persons (parents or guardians) who are entitled to give their authorisation; 2. The intervention must be intended to benefit the incapacitated person.

57.       However, the article provides for two situations where national law may authorise non-beneficial interventions on an incapacitated person: medical research of significant value and donation of regenerative tissue for transplants. These two exceptions are nevertheless accompanied by precise conditions. In both instances, refusal by the incapacitated person must always be respected and in such cases the intervention may not take place. It has to be noted that the term "non-beneficial interventions" also includes interventions which may be for the indirect benefit of the individual.

58.       As far as research is concerned, a fundamental requirement is that there is no equally effective alternative method. This means, for example, that no research experiment will be allowed if similar results could be achieved from tests using animals. This also means that recourse to an invasive method will not be permitted if a similarly effective non-invasive method exists.

59.       Likewise, in the case of research not carried out for the direct benefit of an incapacitated subject, one proviso is that there is no alternative subject with full capacity. The use of incapacitated persons therefore has to be the sole possibility, as it will be, for example, in improving the understanding of say children diseases or of certain psychiatric disorders such as dementia in adults. Such research can only be carried out, respectively, on children or the adults concerned.

60.       An additional and as fundamental condition is that the research must represent only a negligible risk and minimal burden for the incapacitated persons, for example the taking of a blood sample from a child.

61.       The necessity of such research can only be justified by the expected benefit resulting from the outcome of the research for the category of persons to which the incapacitated patient belongs. For example, minors may take part in research into a disease from which they themselves suffer, whilst it is not foreseen that they will benefit from the results of this research, provided that the benefit which may be derived from the research by children affected by the disease is significant.

62.       Another condition is that sufficient protection of the incapacitated person must be guaranteed. In this regard there are two levels of protection: not only must the research be approved by an ethics committee which will, inter alia, consider whether recourse to incapacitated subjects is warranted, but in addition the agreement either of the subject himself or of his legal representative or of an authority is required.

63.       When all these conditions are met, the exception contained in the present article appears compatible with the sense of Article 7 of the International Covenant on Civil and Political Rights4.

64.       When transplanting regenerative tissue, at least the following conditions must be satisfied before removing such tissue from an incapacitated person.

65.       There must be no equally effective alternative method. If tissues are removed from an incapacitated person, it is necessary that the transplant should be vital for the recipient, that no "conventional" treatment should therefore exist and that similar results cannot be obtained with cultured tissues or with tissues of animal origin.

66.       Another fundamental condition is that the tissue in question must be regenerative; it must be able to recover its functions and mass after partial ablation, an example being bone marrow and skin; organs such as kidneys are therefore excluded. This limitation is explained by the fact that persons should not be irreversibly deprived of one of their organs if they are unable to consent to the procedure.

67.       A further requirement concerns the risk for the incapacitated person. The general principle with regard to transplants is that no organ or tissue (as is the case here) may be removed when the risk to the donor's health is disproportionate to the expected benefit to the recipient. This may for example be the case for removal of parts of certain regenerative tissues. If the donor is an incapacitated person, it is necessary that the benefit to the receiver must not just be proportionate but particularly substantial.

68.       Furthermore it is also required, as in the case of research, that sufficient protection of the incapacitated person is guaranteed. Thus the express consent either of the subject himself or of his legal representative or the agreement of an authority is required. Under the condition of sufficient protection one must also check that the incapacitated person or his legal representative have not been improperly influenced, in particular within the family where one could fear that pressures are being exercised because the life of another member of the family is at stake.

69.       The lack of a donor with full capacity is also a condition, within reasonable limits.

70.       Finally, close personal or family relations must exist between the recipient and the incapacitated donor, in order to prevent tissues being obtained improperly.

Article 7 (Consent of incapacitated persons)

71.       This article deals with the participation of incapacitated persons in the process of obtaining consent, which must not be ruled out. This idea is reflected in the obligation (first paragraph) to involve incapacitated persons in the consenting procedure whenever possible. Thus, it will be necessary to explain to them the significance and circumstances of the intervention and then obtain their opinion, even if this is not a determining factor.

72.       In the particular case of minors, the second paragraph of the article states that a minor's consent (which is understood here to be assent or refusal) should be regarded as an increasingly determining factor in proportion to their age and capacity for discernment. This means that in certain situations for which provision is made in national law and which take account of the nature and seriousness of the intervention as well as the minor's age and ability to understand, the minor's consent should increasingly carry more weight in the final decision. If the minor's consent is required, there may be a conflict between his or her position and that of the legal representative. It lies with domestic law to decide in these cases. In some cases, for example such as those of young people below the age of majority, the minor's consent may be considered as being not only a necessary but a sufficient condition for certain interventions, as the law prescribes in some States.

73.       This provision is consistent with Article 12 of the United Nations Convention on the Rights of the Child, which stipulates that "States Parties shall assure to the child who is capable of forming his or her own views the right to express those views freely in all matters affecting the child, the views of the child being given due weight in accordance with the age and maturity of the child."

74.       Lastly, the third paragraph of Article 7 specifies that the consent of adults who are legally incapacitated but capable of understanding is a sine qua non condition for the intervention. It must be made clear that such consent is essential, in that the intervention must not be carried out against the wishes of the persons concerned; but their consent alone may not suffice if the opinion of the legal representative or a supervisory authority has to be sought under domestic law. However, Article 10 of the Convention constitutes an exception to Article 7 paragraph 3 by providing that persons suffering from mental disorders may be subjected, without their consent and only on certain conditions, to an intervention aimed at treating their mental disorders.

75.       It should be noted that bankrupts, squanderers and prisoners, who are incapacitated in certain respects under the law of several countries, do not as such fall within the category of legally incapacitated persons referred to in Article 6 in so far as they are capable of discernment; consequently, they can as a rule, under Article 7 paragraph 3, validly consent or object to an intervention in the health field when their physical or mental integrity is at stake.

Article 8 (Emergency situations)

76.       In emergencies, doctors are faced with a conflict between their duty to provide care and their duty to seek the patient's consent. This article exempts the practitioner in such situations from the obligation to seek the consent of the patient, or of the legal representative where appropriate, and enables them to act immediately. As it departs from the general rule laid down in Articles 5, 6 and 7 it is accompanied by conditions.

77.       First, this possibility is restricted to emergencies which prevent the practitioner from obtaining the appropriate consent. The article applies both to persons who are capable and to persons who are unable either de jure or de facto to give consent. An example that might be put forward is that of a patient in a coma who is thus unable to give his consent, or that of a doctor who is unable to contact an incapacitated person's legal representative who would normally have to consent to an urgent intervention.

78.       Next, the possibility is limited solely to medically necessary interventions. However, this possibility is not limited to life-saving interventions. Interventions for which a delay is acceptable are excluded.

79.       Lastly, the article specifies that the intervention must be carried out for the immediate benefit of the individual concerned.

Article 9 (Previously expressed wishes)

80.       Whereas Article 8 obviates the need for consent in emergencies, this article is designed to cover cases where persons capable of understanding have previously expressed their consent (ie either assent or refusal) with regard to foreseeable situations where they would not be in a position to express an opinion about the intervention.

81.       The article therefore covers not only the emergencies referred to in Article 8 but also situations where individuals have foreseen that they might be unable to give their valid consent, for example in the event of a progressive disease such as senile dementia.

82.       The article lays down that when persons have previously expressed their wishes, these must be taken into account. Nevertheless, taking previously expressed wishes into account does not mean that they should necessarily be followed. For example, when the wishes were expressed a long time before the intervention and science has since progressed, there may be grounds for not heeding the patient's opinion. The practitioner should thus, as far as possible, be satisfied that the wishes of the patient apply to the present situation and are still valid.

Article 10 (Mental disorders)

83.       This article deals with the specific question of the treatment of patients suffering from mental disorders which prevent them from deciding what is in their interest. In some circumstances it enables doctors to disregard the patient's refusal to undergo an intervention.

84.       The first condition is that the person must be suffering from a mental disorder. The term is not limited to mental diseases in the strict sense; it also includes mental handicap. In order for the article to apply, an impairment of the person's mental faculties must have been observed.

85.       The second condition is that treatment of the mental disorders concerned must be involved. In accordance with Article 5 or Article 7 paragraph 3 as the case may be, the practitioner must therefore necessarily seek the consent of the patient, if the latter is capable of discernment, for all interventions apart from those aimed at treating mental disorders, for which they do not need to seek the patient's consent. In other words, if patients capable of understanding refuse an intervention not aimed at treating a mental disorder, their opposition must be respected in the same way as for other patients capable of understanding.

86.       The third condition is that, without the treatment, serious harm is likely to result to the patient's health. The article is concerned only with the risk to the patient's own health, whereas Article 2 (2) of the Convention permits patients to be treated against their will in order to protect other people's rights and freedoms (for example, in the event of violent behaviour).

87.       The last condition is that the protective conditions laid down in national law must be observed. The article specifies that these conditions must include appropriate supervisory, control and appeal procedures, such as mediation by a judicial authority. This requirement is understandable in view of the fact that it will be possible for an intervention to be carried out on a person who has not consented to it; it is therefore necessary to provide an arrangement for adequately protecting the rights of that person. In this connection, it should be noted that Recommendation R (83) 2 of the Committee of Ministers of the Council of Europe concerning the legal protection of persons suffering from mental disorder placed as involuntary patients establishes a number of principles which must be respected during psychiatric treatment and placement. The Hawaii Declaration of the World Psychiatric Association of 10 July 1983 and its revised versions, as well as Parliamentary Assembly Recommendation 1235 (1994) on psychiatry and human rights, should also be mentioned.

Article 11 (Prohibition of financial gain)

88.       This article applies the principle of human dignity set forth in the preamble and in Article 1.

89.       It states in particular that the human body and its parts must not, as such, give rise to financial gain. Under this provision organs and tissues proper, including blood, should not be bought or sold or give rise to financial gain for the person from whom they have been removed or for a third party, whether an individual or a corporate entity such as a hospital. However, technical acts (sampling, testing, storage, culture, transport, etc) which are performed on the basis of these items may legitimately give rise to reasonable remuneration. For instance, this article does not prohibit the sale of tissue which is part of a medical device since the tissue is not sold as such. Further, this article does not prevent a person from whom an organ or tissue has been taken from receiving compensation which, while not constituting remuneration, compensates that person equitably for expenses incurred or loss of income (for example as a result of hospitalisation).

90.       The provision does not refer to such tissues as hair and nails, which are discarded tissues, and the sale of which is not an affront to human dignity.

Article 12 (Privacy and access to information)

91.       The first paragraph establishes the right to privacy in the health field, thereby reaffirming the principle introduced in Article 8 of the European Convention on Human Rights and reiterated in the Convention for the Protection of Individuals with Regard to Automatic Processing of Personal Data. It should be pointed out that, under Article 6 of the latter Convention, personal data concerning health constitute a special category of data and are as such subject to special rules.

92.       However, restrictions to the respect of privacy are possible under Article 2 paragraph 2. For example, a judicial authority may thus order that a test be carried out in order to identify the author of a crime (exception based on the prevention of disorder) or to determine the filiation link (exception based on the protection of the rights of others).

93.       The first sentence of the second paragraph lays down that individuals are entitled to know any information collected about their health. This right is of fundamental importance in itself but also conditions the effective exercise of other rights such as the right of consent set forth in Article 5.

94.       A person's "right to know" encompasses all information collected about his or her health, whether it be a diagnosis, prognosis or any other relevant fact.

95.       The right to know goes hand in hand with the "right not to know", which is provided for in the second sentence of the second paragraph. Patient may have their own reasons for not wishing to know about certain aspects of their health. A wish of this kind must be observed. The patient's exercise of the right not to know this or that fact concerning his health is not regarded as an impediment to the validity of his consent to an intervention; for example, he can validly consent to the removal of a cyst despite not wishing to know its nature.

96.       In some circumstances, the right to know or not to know may be restricted in the patient's own interest or else on the basis of Article 2 (2) in order to protect the rights of a third party or of society.

97.       For example, the last paragraph of this article provides that in exceptional cases domestic law may place restrictions on the right to know or not to know in the interests of the patient's health (eg a prognosis of death which might, in certain cases if passed on to the patient, seriously worsen his or her condition). In these cases, the doctor's duty to provide information conflicts with the interests of the patient's health. It is for domestic law, taking account of the social and cultural background, to solve this conflict. Domestic law may justify the doctor in sometimes withholding information or, at all events, disclosing it with circumspection. This is the meaning of what is commonly referred to as "therapeutic exception", being the restriction of a right, it must be limited to cases where it is strictly necessary, avoiding any paternalistic attitude.

98.       Furthermore, it may be of vital importance for patients to know certain facts about their health, even though they have expressed the wish not to know them. For example, the knowledge that they have a predisposition to a disease might enable them to take preventive measures. In this case, a doctor's duty to provide care, as laid down in Article 3, might conflict with the patient's right not to know. Here too it will be for domestic law to indicate whether the doctor, in the light of the circumstances of the particular case, may make an exception to the right not to know.

99.       At the same time, certain facts concerning the health of a person who has expressed a wish not be to told about them may be of special interest to a third party, as in the case of a disease transmittable to a partner, for example. In such a case, the seriousness of the risk to the third party might, on the basis of Article 2 (2), warrant his or her right taking precedence over the patient's right not to know.

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

100.       Parts of the human body are often removed in the course of interventions, for example surgery. The aim of this article is to ensure the protection of individuals with regard to parts of their body which are thus removed and then stored or used for a purpose different from that for which they have been removed. Such a provision is necessary in particular because much information on the individual may be derived from any part of his body, however small (blood, hair, bone, skin, organ, etc), and even when the sample is anonymous the analysis may yield information about identity.

101.       This provision thus establishes a rule consistent with the general principle in Article 5 on consent, ie that parts of the body which have been removed during an intervention for a specified purpose must not be stored or used for a different purpose unless the relevant conditions governing information and consent have been observed.

102.       The information and consent arrangements may vary according to the circumstances, thus allowing for flexibility since the express consent of an individual to the use of parts of his body is not systematically needed. In some cases, it will be sufficient for a patient or his or her representative, who have been duly informed (for instance, by means of leaflets handed to the persons concerned at the hospital), not to express their opposition. In other cases, depending on the nature of the use to which the removed parts are to be put, express and specific consent will be necessary, in particular where sensitive information is collected about identifiable individuals.

Article 14 (Scientific research)

103.       Freedom of scientific research in the field of biology and medicine is justified not only by humanity's right to knowledge, but also by the considerable progress its results bring as far as health is concerned.

104.       Nevertheless, such freedom is not absolute. In medical research it is limited by the fundamendal rights of individuals expressed in particular by the provisions of the Convention and by other legal provisions which protect the human being, such as those which provide for the submission of research projects to ethics committees. In this connection, it should be pointed out that the first article of the Convention specifies that its aim is to protect the dignity and identity of human beings and guarantee to everyone, without discrimination, respect for their integrity as well as for other rights and fundamental freedoms. Any research will therefore have to observe these principles.

Article 15 (Research on embryos in vitro)

105.       The advisibility of research on in vitro embryos leads to great debates within the public and raises many difficult ethical questions5. In any case, as it has been mentioned in relation to Article 1, it is a generally accepted principle that human dignity has to be respected as soon as life begins. If there is to be research, it must be subject to protective conditions for the embryo.

106.       This article does not take a stand about the admissibility of the principle of research on embryos. However, in view of the fact that such research is being conducted in some States, the first paragraph defines a limit which must be respected: national law must not authorise research on embryos which have been developed for more than fourteen days. The expression "developed for more than fourteen days" implies that any period during which the embryo has simply been preserved by freezing or any other method is not included. The fourteen day period constitutes a maximum which States may reduce. When research on embryos is permitted by national law, it will not only be subject to the restrictions contained in the Convention. Like any other research, it will have to respect the dignity and identity of the human being and comply with the legal rules affording such protection. National law will therefore provide for additional protective conditions.

107.       Paragraph 2 of the article prohibits the creation of human embryos with the intention to do research on them.

Article 16 (Human genome)

108.       The advance of science, in particular in knowledge of the genome and the applications deriving therefrom, have raised questions and even great fears. Whilst developments in this field may lead to great benefit for humanity, there is fear that the misuse of these developments may endanger not only the individual but the species itself. This raises the question of what limits should be set to interventions on the human genome.

109.       Interventions in the field of research or application and aimed at modifying the human genome are allowed by this article on two conditions.

110.       The first is that the intervention must be undertaken for preventive, therapeutic or diagnostic purposes. Consequently, interventions aimed at modifying genetic characteristics not related to a disease are prohibited, for instance those aiming at modifying behavioural features which do not constitute a disease.

111.       The second condition is that the aim of the intervention must not be to interfere with the germ cell line (human reproductive cells) of a person who has already been born or of that of an unborn child. However, it does not rule out interventions for a somatic purpose which might have unforeseen side-effects on the germ cell line. In this respect, it has been pointed out that as these interventions are still at an experimental stage, they must be authorised through appropriate procedures such as, for example, evaluation by ethics committees6. It is therefore possible that such committees might not authorise an intervention already known to have side-effects on subsequent generations.

112.       The proviso that an intervention must not intentionally interfere with the germ cell line has been discussed at length. The advisability of providing for exceptions to this rule in the light of recent or expected scientific developments in the medical field was examined. However, it was felt that, at the present stage of scientific knowledge, it was impossible to know all the effects that these interventions might have on following generations. Owing to this uncertainty, it was decided to adopt the rule as it appears in Article 16 of the Convention.

Article 17 (Tests predictive of genetic diseases)

113.       The possibilities for tests which are predictive of genetic diseases are developing quickly. These tests cover both the detection of the presence of genetic factors for a disease or a predisposition to a multifactorial genetic disease. Sometimes the predisposition is certain to lead to a disease developing, sometimes it only indicates the possibility of the development of a disease. In the latter case early detection allows for preventive measures, such as adapting the lifestyle or environmental conditions. Testing can be predictive for the possible development of a serious disease later on in life. When applied with diligence in the individual health care setting early detection of a genetic disease or predisposition may have advantages for the future health of the individual, in particular when it allows for early measures, which may influence positively one's health. Tests which are predictive of genetic diseases allow also for informed decisions on one's offspring. The right to know as well as the right not to know are of particular importance in this field. Problems for the individual stemming from tests which are predictive of genetic diseases to which medical science has no suitable therapy, can usually be met appropriately in the individual doctor-patient relationship. A complicating factor is that testing generates information not only on the individual concerned, but also on future offspring and on biologically related family member7. The right to privacy thus involves more than one individual and calls for particular attention. Hence the importance of appropriate professional standards to be developed in this field, as well as the necessity to fully meet with the informed consent requirement.

114.       The situation is even more complicated with predictive testing for serious late onset diseases, when there is at present no treatment available. In such diseases, screening should remain exceptional, including when screening is related to scientific research: It would put too much strain on the free participation and on the privacy of individuals.

115.       Because of the particular problems which are related to predictive testing, it is necessary to strictly limit its applicability to health purposes for the individual. Scientific research likewise should be carried out in the context of developing medical treatment. Experimental testing methods, provided they are performed in this context, are as such covered by the present article.

116.       Because there is an apparent risk that use is made of genetic testing possibilities outside health care (for instance in the case of medical examination prior to an employment contract) it is of importance to clearly distinguish between health care purposes for the benefit of the individual on the one hand and third parties' interests, which may be commercial, on the other hand.

117.       Therefore, predictive genetic testing as part of pre-employment medical examinations, is excluded whenever it does not serve a health purpose. However, national law may allow for the performance of a test predictive of a genetic disease outside the health field for one of the reasons and under the conditions provided for in Article 2 paragraph 2 of the Convention.

118.       Article 17 prohibits predictive tests for reasons other than health or health-related research, even with the assent of the person concerned. This covers the field of insurance, for example. An insurance company will not be entitled to subject the conclusion or modification of an insurance policy to the holding of a predictive genetic test. Nor will it be able to refuse the conclusion or modification of such a policy on the ground that the applicant has not submitted to a test, as the conclusion of a policy cannot reasonably be made conditional on the performance of an illegal act.

119.       Predictive genetic testing in the case of employment or private insurance contracts does not have a health purpose and would imply a disproportionate infringement on the rights of the individual to privacy.

120.       In particular circumstances, when the working environment could have negative consequences on the health of an individual because of a genetic predisposition, predictive genetic testing may be offered in employment situations. This however may be done only in the case where there are no reasonable possibilities to improve on working conditions, provided the tests clearly serve the health condition of the individual and the right not to know is respected.

Article 18 (Communication of results)

121.       People should have unhindered access to genetic testing which may serve their health purposes. In order to be able to take advantage of these techniques in the health care setting, external factors which might interfere with people's free choice to use genetic services in health care should be barred. It must be noted that the scope of Article 18 which deals with the results of any genetic test is broader than that of Article 17 which only concerns predictive test of genetic diseases or of genetic predisposition to a disease.

122.       Therefore it is important to prevent third parties from making use of genetic information which the individual has acquired by making use of genetic services in health care. This holds in particular when the attainment of social goods is involved (for instance, employment, life, health and disability insurance). Therefore, the communication of results of genetic testing acquired in the framework of health care for other purposes is forbidden, notwithstanding the free contractual relationship. Otherwise, the individual could refuse to undergo a test and obtain essential information about his or her health because of the fear of consequences. However, the article states that national law may allow for the communication of the results of a genetic test outside the health in certain cases under the conditions provided for in Article 2 paragraph 2. Such communication should thus be a necessary measure in a democratic society and serve one of the purposes referred to in this article.

123.       Furthermore, the individual who has knowledge of his or her genetic constitution could 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.

Article 19 (Infringements of the principle)

124.       This article requires the Parties to provide for the possibility of judicial action to prevent or put a stop to an infringement of the principles set forth in the Convention. It therefore covers not only infringements which have already begun and are ongoing but also the threat of an infringement.

125.       The judicial protection requested must be appropriate and proportionate to the infringement or the threats of infringement of the principles. Such is the case, for example, with proceedings initiated by a public prosecutor in cases of infringements affecting several persons unable to defend themselves, in order to put an end to the violation of their rights.

126.       Under the Convention, the appropriate protective machinery must be capable of operating rapidly as it has to allow an infringement to be prevented or halted at short notice. This requirement can be explained by the fact that, in many cases, the very integrity of an individual has to be protected and an infringement of this right might have irreversible consequences.

127.       The judicial protection thus provided by the Convention applies only to unlawful infringements or to threats thereof. The reason for this qualifying adjective is that the Convention itself, in Article 2 (2), permits restrictions to the free exercise of the rights it recognises.

Article 20 (Compensation for undue damage)

128.       This article sets forth the principle that any person who has suffered undue damage resulting from an intervention is entitled to fair compensation. The Convention uses the expression "undue damage" because in medicine some damage, such as amputation, is inherent in the therapeutic intervention itself.

129.       The due or undue nature of the damage will have to be determined in the light of the circumstances of each case. The cause of the damage must be an intervention in the widest sense, taking the form of either an act or an omission. The intervention may or may not constitute an offence. In order to give entitlement to compensation, the damage must result from the intervention.

130.       Compensation conditions and procedures are prescribed by national law. In many cases, this establishes a system of individual liability based either on fault or on the notion of risk or strict liability. In other cases, the law may provide for a collective system of compensation irrespective of individual liability.

131.       On the subject of fair compensation, reference can be made to Article 50 of the European Convention on Human Rights, which allows the Court to afford just satisfaction to the injured party.

Article 21 (Sanctions)

132.       This article requires the Parties to prescribe sanctions for any infringements of the principles contained in the Convention. The text specifies that these sanctions must be appropriate. They may therefore be of a professional, civil, administrative or penal nature, depending on the circumstances and legal traditions of each State.

Article 22 (Wider protection)

133.       In pursuance of this article, the Parties may apply rules of a more protective nature than those contained in the Convention. In other words, the text lays down a common core of standards with which States must comply, while allowing them to provide greater protection of the human being and of human rights with regard to applications of biology and medicine.

134.       A conflict may arise between the various rights established by the Convention, for example between a scientist's right of freedom of research and the rights of a person submitting to the research (Article 14). However, the expression "wider protection" must be interpreted in the light of the purpose of the Convention, as defined in Article 1, namely the protection of the human being with regard to the application of biology and medicine. In the example quoted, any additional statutory protection can only mean greater protection for a person submitting to research.

Article 23 (Public consultation)

135.       The purpose of this article is to prompt the Parties to create greater public awareness of the fundamental questions raised by the application of biology and medicine. Society's views must be ascertained as far as possible with regard to problems concerning its members as a whole. To this end, appropriate public discussion and consultation are recommended. The word "appropriate" leaves the Parties free to select the most suitable procedures.

Article 24 (Protocols)

136.       The Convention establishes principles valid for all applications of biology and medicine. This article makes provision for the immediate drawing up of protocols containing rules on specific fields. As the purpose of the protocols is to develop further the principles contained in the Convention, their provisions should not depart from these principles. In particular, they cannot lay down rules affording human beings less protection than that resulting from the principles of the Convention.

137.       To be able to sign or ratify a protocol, a State must have simultaneously or previously signed or ratified the Convention. On the other hand, States which have signed or ratified the Convention will not be obliged to sign or ratify a protocol.

1 ¹ It should be pointed out that, while the whole text is still only a draft, the passages in square brackets are considered by the CDBI to need detailed re-examination. Although the CDBI has managed to identify the principles contained therein, the wording has still to be carefully revised.

2 ¹See Doc 6449, report of the Committee of science and technology, rapporteur: M. Palacios

3 ¹ It should be pointed out that, while the whole text is still only a draft, the passages which appear in square brackets in the draft Convention are considered by the CDBI to need detailed re-examination. Although the CDBI has managed to identify the principles contained therein, the wording has still to be carefully revised.

4 ¹ Article 7: No one shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment. In particular, no one shall be subjected without his free consent to medical or scientific experimentation.

5 ¹       The Committee of Ministers has entrusted the CDBI with the preparation of a Protocol on the protection of the human embryo and foetus.

6 ¹ Article 15 of Recommendation R (90) 3 of the Committee of Ministers to the member States on medical research provides that "all proposed medical research plans should be the subject of an ethical examination by an independent and multidisciplinary committee".

7 ²       The Committee of Ministers of the Council of Europe has adopted two Recommendations on screening: Recommendation R (90) 13 on prenatal genetic screening, prenatal genetic diagnosis and associated genetic counselling and Recommendation R (92) 3 on genetic testing and screening for health care purposes.