The Convention On Human Rights And Human Dignity In Biology And Medicine: Convention On Human Rights And Biomedicine

Original Language Title: Par Konvenciju par cilvēktiesību un cieņas aizsardzību bioloģijā un medicīnā: Konvenciju par cilvēktiesībām un biomedicīnu

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Read the untranslated law here: https://www.vestnesis.lv/ta/id/202995

The Saeima has adopted and the President promulgated the following laws: The Convention on human rights and human dignity in biology and medicine: Convention on human rights and Biomedicine, article 1. Convention for the protection of human rights and dignity in biology and medicine: Convention on human rights and Biomedicine (hereinafter referred to as the Convention) with this law is accepted and approved.
2. article. The Ministry of health to coordinate the fulfilment of the obligations provided for in the Convention.
3. article. The Convention shall enter into force on its article 33 within the time and in order, and the Ministry of Foreign Affairs shall notify the newspaper "journal".
4. article. The law shall enter into force on the day following its promulgation. With the law put the Convention in English and its translation into Latvian language.
The Parliament adopted the law in 2009 December 10.
President Valdis Zatlers in Riga V 2009 on 30 December 2004, the 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 Biomedicin in Oviedo, 4. IV. 1997 preamble the member States of the Council of Europe, the other States and the European Community, to the signator heret, 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 Freedom 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 Individual 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;
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 freedom;
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 importanc of ensuring the dignity of the human being;
Conscious that the misus of biology and medicine may lead to endangering human dignity acts;
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 importanc of promoting a public debate on the questions posed by the application of biology and medicine and the responses to be given theret;
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 Recommendations 1160 (1991) on the preparation of a convention on Bioethics;
Resolving to take such measure with the axis of the safeguards human dignity not cessary and the fundamental rights and freedom of the individual with regard to the application of biology and medicine, have agreed as follows: Chapter I-General provision Article 1 – purpose and object parties to this Convention shall protect the dignity and identity of all human being and guarantee everyone, without discrimination respect for their integrity, and other rights and fundamental freedom with regards to the application of biology and medicine. Each Party shall take in its internal law the cessary to give effect "to the provision of this Convention.
Article 2 – Primacy of the human being the interests and welfare of the human being shall prevails over the sole interest of society or science.
Article 3-equitable access to health care parties, taking into account health needs and available resources, shall take the appropriate measure with a view of providing them, within their jurisdiction, equitable access to health care of appropriate quality.
Article 4 – Professional standards Any intervention in the health field, including research, must be carried out in accordanc with relevant professional obligations and standards.
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 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 considerations 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. The authorisation referred to in paragraphs 2 and 3 above may be withdrawn at any time in the best interests of the person concerned.
Article 7 – Protection of persons who have a 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 8 – Emergency situation When because of an emergency situation the appropriate consent cannot be obtained, any medically be no intervention may be carried out cessary 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 or her wishes shall be taken into account.
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 relations 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 the individual not to be so informed shall be observed.
3. In exceptional cases, the restriction may be placed by law on the exercise of the rights in paragraph 2 led 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 12 – predictive genetic test test 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 purpose or for scientific research linked to health purpose, and subject to appropriate genetic counselling.
Article 13 – Intervention on the human genome An intervention seeking to modify the human genome may only be undertaken for the preventive, diagnostic or therapeutic purpose and only if it is not the translocated aim any modification in the genome of any descendant.
Article 14 – Non-selection of sex the use of medically assisted procreation techniques of 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.
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 provision of this Convention and the other legal provision for 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 no alternative of effectiveness in their research on comparabl humans;
II. the risks which may be incurred by that person are not disproportionat 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 assessment of the importanc of the aim of the research, and multidisciplinary review of its ethical acceptability;
IV. the persons undergoing research have been informed of their rights and the safeguards prescribed by law for their protection;
v. the cessary consent as provided for under article 5 has been given expressly, specifically and is documented. Such a consent may be withdrawn at any time freely.
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 condition laid down in article 16, sub-paragraph (i) to (iv), are fulfilled;
II. the results of the research have the potential to produce real and direct benefit to his or her health;
III. research of a comparabl effectiveness cannot be carried out on the individual is capable of giving consent;
IV. the authorisation provided for under article cessary 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 condition laid down in paragraph 1, sub-paragraph a i, III, iv and v above, and to the following additional condition: 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 attainmen 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 entail only minimal risk and minimal burden for the individual concerned.
Article 18 – Research on in vitro embryo 1. Where the law allows research on embryo in vitro, it shall ensur-adequat protection of the embryo.
2. The creation of human embryo for research purpose of is prohibited.
Chapter VI – Organ and tissue removal from living donors for transplantation purpose of article 19 – General rule Removal of organs 1 or tissue from a living person for the purpose of transplantation may be carried out solely for the therapeutic benefit of the recipient and where there is no organ or tissue is suitabl available from a deceased person and no other alternative therapeutic method of comparabl effectiveness.
2. The consent provided for under axis cessary 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 or tissue removal 1 of organ 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 condition be with me a : 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, in accordanc with the law and with the approval of the competent body;
v. the potential donor concerned does not object.
Chapter VI – Prohibition of financial gain and disposal of (a) 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 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 procedure.
Chapter VIII – Infringement of the provision 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 24 – Compensation for damage of the undu

The person who has suffered the damage resulting from an undu intervention is entitled to fair compensation according to the conditions and procedures prescribed by law.
Article 25 – sanctions parties shall provide for appropriate sanctions to be applied in the event of infringement of the provision was led in this Convention.
Chapter IX – Relations between this Convention and other provision of article 26 – Restriction on the exercise of the rights of the restriction shall be 1 is placed on the exercise of the rights and protective provision has led in this Convention other than such as are prescribed by law and with not a democratic society in the cessary 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 freedom of others.
2. The restriction of the contemplated in the preceding paragraph may not be placed on articles 11, 13, 14, 16, 17, 19, 20 and 21. Article 27 – Wider protection none of the provision of this Convention shall be interpreted as limiting or otherwise regimes by 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 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 with 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 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-thirds majority of the votes cast.
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 of implementation ensur the effective of any of the provision of the Convention.
Chapter XII protocols article 31 – – Protocol Protocol for may be concluded in pursuanc of article 32, with a view to developing, in specific fields, the principles led in this Convention.
The Protocol shall be open for signature by a Signator of the Convention. They shall be subject to ratification, acceptance or approval. A Signatory may not ratify.â, accept or approve the Protocol without previously or simultaneously ratifying accepting or approving the Convention.
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 (CDB), or by any other Committee designated to do so by the Committee of Minister.
2. Without prejudice to the specific provision 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 carr 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 accordanc with the provision of article 34 which is not 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.
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 determin.
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 shall be communicated by the Minister of 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 accordanc with the provision of article 33 and to any State invited to accede to it in accordanc with the provision of article 34.6. The Committee shall examin the proposal not earlier than two months after it has been forwarded by the Secretary General in accordanc with paragraph 5. The Committee shall submit the text adopted by a two-thirds majority of the votes cast to the Committee of Minister 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 accept 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 XIV-Final clauss's 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 elaborations and by the European Community.
2. This Convention is subject to ratification, acceptance or approval. The instrument 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 accordanc with the provision of paragraph 2 of the present article.
4. In respect of any Signatory which subsequently express their consent to it 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 34 – Non-member States

1. After the entry into force of this Convention, the Committee of Minister 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, 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 Minister.
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 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 formulat 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 undertaking. 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 withdrawals 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 36 – reservations 1 Any State and the European Community may, when signing this Convention or when depositing the instrument of ratification, acceptance, approval or accession, make a reservation in respect of any particular provision of the Convention to the exten to 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 extend the application of this Convention to a territory mentioned in the declaration referred to in article 35, paragraph 2, may, in respect of the territory concerned, make a reservation in accordanc with the provision of the preceding paragraph.
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 withdrawals 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 37 – Denunciation 1 Any Party may at any time.» denounc 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 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 accordanc with articles 33 or 34;
d. any amendment or Protocol adopted in accordanc with article 32, and the date on which such an amendment or Protocol enter into force;
e. any declaration made under the provision of article 35;
f. any reservations and withdrawals of reservations made in pursuanc of the provision of article 36;
g. any other Act, notification or communication relating to this Convention.
In witness whereof the undersigned, being duly authorised, have signed theret this Convention.
Done at Oviedo (Asturias), this 4th day of April 1997, 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 cop to each member State of the Council of Europe, to the European Community, to the non-member States which have participated in the elaborations of this Convention, and to any State invited to accede to this Convention.
 
Convention for the protection of human rights and dignity in biology and medicine: Convention on human rights and Biomedicine-Oviedo, 04.04.1997. Preamble the Member States of the Council of Europe, other countries and the European Community which have signed this Convention, in the light of the Universal Declaration of human rights of 1948, which on December 10 unveiled United Nations General Assembly;
taking into account the 1950 November 4, the Convention for the protection of human rights and fundamental freedoms;
taking into account the 18 October 1961, the European Social Charter;
having regard to the December 16, 1966, the International Covenant on Civil and political rights and the International Covenant on economic, social and cultural rights;
in the light of 28 January 1981, the Convention on the protection of individuals with regard to the automatic processing of personal data;
taking into account the 20 November 1989 on the Convention on the rights of the child;
considering that the aim of the Council of Europe is to achieve greater unity between its members and that one of the means to achieve this is the human rights and fundamental freedoms currently and the future;
realizing that biology and medicine is evolving faster;
convinced that people must respect both as individuals and as a human race, and recognizing the importance of ensuring respect for human dignity;
realizing that the incorrect application of biology and medicine knowledge may lead to actions that undermine human dignity;
Affirming that progress in biology and medicine should be used for both this and the next generations;
Stressing that international cooperation is necessary to the application of biology and medicine achievements benefit of all mankind;
                                                                                                       

Recognizing the importance of promoting public discussion of biology and medical issues and the application of responses to these questions;
Desiring to remind all members of the public of their rights and obligations;
taking into account the work of the Parliamentary Assembly in this area, including recommendation 1160 (1991) on the elaboration of a Convention on Bioethics;
deciding to take the measures necessary for every human dignity, the protection of fundamental rights and freedoms in relation to the application of biology and medicine use knowledge, have agreed on the following.
CHAPTER I. General provisions article 1. Purpose and object parties to this Convention shall protect the dignity and identity of all people and everyone without discrimination guaranteed by his integrity and respect for other rights and freedoms in relation to the application of biology and medicine knowledge.
Each Party shall take the necessary measures to incorporate the provisions of the Convention into national law.
2. article. Individuals as a first priority must always be to the interests and well-being of the individual, not only in the interests of society or science.
3. article. Equitable access to health care by taking into account the health needs of the population and the resources available, the Parties shall take appropriate measures within their jurisdiction to ensure fair access appropriate quality health care.
4. article. Standards of professional conduct any activity in the health sector, including research, must be carried out in accordance with professional obligations and standards of professional conduct.
CHAPTER II. Article 5 of the agreement. As a general rule, any health-related activities may be carried out only by the person concerned for the voluntary and informed consent.
This person should receive adequate information on the purpose and nature of this activity, as well as on its consequences and risks.
The person concerned may at any time withdraw the consent freely.
6. article. Protection of persons not able to consent 1. except for article 17 and 20 cases referred to, in relation to a person who is not capable of giving consent, health-related activities may be carried out only if it gives that person directly.
2. If, under the law, a minor may not consent to health-related activities, then this operation can only be performed with the minor's legal representative or an authority, person or instance permission.
In the opinion of the minor in accordance with his or her age and degree of maturity should be granted more and more important role in the decision making.
3. If, under the law cannot give consent to an adult health related activities of their mental retardation, sickness or other similar reasons, this operation can be done only through his representative or statutory authority, person or instance permission.
The person involved as much as possible, to participate in the authorization procedure.
4. paragraph 2 and paragraph 3, the representative, the authority, the person or authority to receive the information according to the conditions referred to in article 5.
5. paragraph 2 and 3 licences referred to in paragraph 1 may be withdrawn at any time, subject to the interests of the person concerned.
7. article. With psychiatric disorders diseased persons subject to the legislation of the protection envisaged measures, including monitoring, verification, and appeal procedures, persons who have serious mental disorders, the treatment of these disorders may be subject to health-related activities without the person's consent only if such treatment could cause serious damage to their health.
8. article. A critical situation Where critical situations, it is not possible to obtain the consent of the person concerned in good health may immediately take any medical need.
9. article. The above expression of will If the clinical operation the patient is able to express your will, to take into account his previously expressed will for this medical action.
CHAPTER III. Private life and right to information article 10. Private life and right to information 1. everyone has the right to respect for his private life in relation to information about his health.
2. Everyone has the right to know all the information accumulated in terms of his health. However, the respect of human desire not to receive such information.
3. In exceptional cases, in the interest of the patient rights legislation, provide for limitations of rights referred to in paragraph 2.
CHAPTER IV. The human genome article 11. The prohibition of discrimination is prohibited any discrimination against persons because of its genetic heritage.
12. article. Predictive genetic tests tests that can predict the genetic disease or identify a disease carrying gene, as well as genetic predisposition or susceptibility to a disease may be performed solely on behalf of the health goals or for scientific research, on behalf of the health-related goals, and providing appropriate genetic counselling.
13. article. Intervention intervention in the human genome, expect to modify the human genome may only take preventive, diagnostic or curative purposes and only if its aim is not to cause a change in the gene pool of progeny.
14. article. Sex selection prohibition of assisted reproduction is not allowed during the use of medical technology, which allows you to select the next child's sex, except when necessary to avoid serious gender-linked inherited diseases.
CHAPTER V. Scientific research article 15. As a general rule scientific research in biology and medicine are carried out freely, subject to the provisions of this Convention and the other legal provisions ensuring the protection of the people.
16. article. The studies involved the protection of persons involved in the research can be performed only if all the following conditions are met: (i) no other equally effective) alternative, which could replace the studies with human involvement;
II) person risks not disproportionately large in comparison to the potential benefits of the research;
III) research project has been approved by the competent body after independent scientific evaluation of the quality, including the importance of the objectives of the study and evaluation of a comprehensive project evaluation ētiskum;
(iv)) the parties involved in the research are informed of their rights and legal safeguard measures;

v) provided for in article 5 of the agreement is necessary to give clear, specific and documented. This consent can be withdrawn at any time freely.
Article 17. Protection of persons not able to give consent to engage in study 1. Involve the study of the person is not capable of giving consent as provided for in article 5, only be subject to compliance with all of the following conditions are met: (i)) of article 16 are fulfilled i) – (iv) the conditions provided for in subparagraph);
(ii)) the results of the study can make a real and direct benefit to the health of the person concerned;
III) it is not possible to equivalent efficiency studies with persons who are incapable of giving consent;
IV) specifically and in writing is received the permit provided for in article 6;
v) involved no objection raised.
2. subject to the legislation of the protection measures in exceptional cases when the survey cannot give direct benefits to the health of the person concerned, may allow, if compliance with paragraph 1 (i)), (ii)), (iv) and (v))), as well as the following additional conditions are met: (i)) significantly improved scientific understanding of the person's health condition, disease or disorder, the results of the study can potentially benefit the person concerned or other persons that belong to the same age group that suffers from the same disease or disorder or having the same disease;
II) study associated with minimal risk and the burden on the person involved.
18. article. Research with embryos in vitro 1. If the law permits to conduct research with embryos in vitro, it is necessary to ensure adequate protection of the embryo.
2. the creation of human embryos for research purposes is prohibited.
CHAPTER VI. Organs and tissue taken from living donors for transplantation purposes article 19. General provision 1. organ or tissue sampling from living people for the purposes of transplantation can be performed solely to provide rehabilitative benefits recipient and only if not available on the dead person's organs or tissues and no other equally effective treatments.
2. the required consent provided for in article 5, should be clearly and specifically either in writing, or in front of an official instance.
20. article. Protection of persons not able to consent to organ removal 1. Organs or tissues may not remove a person who is not capable of giving consent in accordance with article 5.
2. in exceptional cases and in accordance with the statutory protective measures may be authorised to take regeneration able tissues from a person who is not capable of giving consent; in such a case, the following conditions shall be satisfied: (i)) is not available to donors who can give consent;
(ii)) the recipient is a brother or sister of the donor;
III) it should be possible for this donation to save the recipient's life;
IV) article 6, paragraph 2 and 3 for the permission must be given for specific and written in accordance with relevant legislation and must be approved by the competent authority;
v the potential donor) objection.
CHAPTER VII. Prohibition to make a profit and use the parts of the human body article 21. Prohibition to benefit the human body or its parts must not be a source of profit.
22. article. A removed part of the human body Where the use of health-related activities is removed a part of the human body, it can store and use the other purpose, not only for the reasons it was removed, but it can only do so in accordance with appropriate information and consent procedures.
CHAPTER VIII. Violations of the provisions of the Convention article 23. Violations of the rights or principles parties shall provide adequate legal protection to prevent or stop immediately this Convention and principles of law illegal infringements.
24. article. Excessive compensation of damage to the Person harmed by medical intervention, excessive injury, are entitled to fair compensation according to the conditions laid down in national legislation and procedures.
25. article. Sanctions if the rules are breached this Convention, the Parties shall ensure that appropriate penalties are applied.
CHAPTER IX. The relationship of the Convention with other provisions article 26. 1. Restrictions on the right of the rights under this Convention and the application of measures of protection should not be any limit, unless such restrictions not provided for by law and are necessary in a democratic society in the interests of public safety, to prevent crimes, protect public health or other human rights and freedoms.
2. the restrictions referred to in the preceding paragraph shall not apply to 11, 13, 14, 16, 17, 19, 20 and 21.
27. article. Wider protection none of the provisions of the Convention be interpreted to limit or otherwise affect the possibilities of one of the parties with regard to the application of biology and medicine use knowledge to make for more protective measures than those of this Convention.
CHAPTER X. Public consultation article 28. Public consultation a party to this Convention considers that the relevant issues arising in connection with the biological and medical advances, the public should be consulted, in particular their medical, social, economic, ethical and legal aspects, and that the use of this achievement should take appropriate advice.
CHAPTER XI. The interpretation and implementation of the Convention in the assay article 29. The interpretation of the Convention the European Court of human rights, can not directly referring to a specific legal case, to give an advisory opinion on legal matters relating to the interpretation of this Convention shall, at the request of a party, the Government-by informing the other parties;
-in accordance with article 32 of the Committee, whose members may be the only representatives of the parties to this Convention, and which shall act by a two-thirds majority.
30. article. Reports on the implementation of this Convention at the request of the Secretary-General of the Council of Europe, the party concerned must provide an explanation on how its legislation to ensure the effective implementation of the provisions of the Convention.
CHAPTER XII. Protocols Article 31. Protocols in accordance with article 32 may conclude protocols in specific areas to implement the principles contained in this Convention.
These protocols may be signed by the signatory parties to the Convention. They shall be subject to ratification, acceptance or approval. The signatory party may not ratify, accept or approve protocols, if before or at the same time not ratified, accepted or approved this Convention.
CHAPTER XIII. Amendments to the Convention article 32. Amendments to the Convention

1. the tasks referred to in article 29 of this and "Committee" Bioethics Committee made (CDB) or by any other Committee designated by the Committee of Ministers.
2. Without prejudice to the provisions of article 29, each Member State of the Council of Europe, as well as each party to the Convention, which is not a Member State of the Council of Europe, the Committee can have representation and one vote when the Committee shall carry out the tasks defined in this Convention.
3. Each State referred to in article 33 or invited the country to accede to this Convention in accordance with article 34 of the rules, but which is not a party to this Convention, may be represented by an observer in the Committee. If the European Community is not a party, the Committee may be represented by an observer.
4. To follow scientific developments, the Committee assessed the Convention no later than five years after its entry into force and thereafter as often as the Committee determines.
5. Any party to this Convention to propose amendments to the Convention, any proposal for a protocol or the amendments to the Protocol or to the Committee of Ministers, the Committee shall notify the Secretary-General of the Council of Europe, who shall forward it to the Member States of the Council of Europe, European Community, each of the signatory, each party, each country which invited to sign this Convention in accordance with the provisions of article 33, and that each country invited to join it in accordance with the provisions of article 34.
6. The Committee shall examine the proposal not earlier than two months after the Secretary-General sent in accordance with paragraph 5. With two-thirds of the vote, the Committee adopted document handed to the Committee of Ministers for approval. After the approval of this document shall be referred to the parties for ratification, acceptance or approval.
7. each amendment shall enter into force for parties that have adopted it, on the first day of the month after the month of the date on which five parties, including at least four Member States of the Council of Europe, have informed the Secretary General and adopted this amendment.
With regard to the parties that the amendments adopted later, it shall enter into force on the first day of the month after the month of the date on which the party concerned has informed the Secretary-General of its acceptance.
CHAPTER XIV. The provisions of article 33 of the end. The signing, ratification and entry into force 1 this Convention shall be open for signature by the Member States of the Council of Europe, countries which are not Council of Europe members, but have participated in the elaboration of this Convention as well as the European Community.
2. this Convention shall be 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. the Convention shall enter into force on the first day of the month following the expiration of three months from the date on which five States, including at least four Member States of the Council of Europe, in accordance with paragraph 2 of this article have expressed their consent to this Convention.
4. For each signatory party, which subsequently expressed consent to be bound by the Convention, it shall enter into force on the first day of the month following the expiration of three months from the date on which it deposited its instrument of ratification, acceptance or approval.
34. article. Countries that are not Member States of the Council of Europe 1. After the entry into force of this Convention, the Committee of Ministers of the Council of Europe, after consulting the parties, invite any non-Member State of the Council of Europe to accede to this Convention, on the basis of the decision adopted by the Council of Europe Statute, article 20) provided for in paragraph d of the majority, and with the unanimous vote, which participated in the Convention, participating countries, who have the right to participate in the Committee of Ministers.
2. In respect of any acceding State, this Convention shall enter into force on the first day of the month following the expiration of three months from the date on which that State deposited its instrument of accession with the Secretary-General of the Council of Europe.
35. article. 1. The territory of any signatory party, signing the Convention or when depositing the instrument of ratification, acceptance or approval, you can specify the territory or territories to which the Convention will apply. Any other country can come up with the same declaration when depositing its instruments of accession.
2. any party, addressing the Declaration to the Secretary-General of the Council of Europe, may extend this Convention to any other territory specified in the Declaration and is on the international relations of which that party is responsible, and which is empowered to enter into commitments. With regard to this territory, the Convention shall enter into force on the first day of the month following the expiration of three months from the date on which the Secretary-General received the following declaration.
3. Any under the two preceding paragraphs shall prepare a declaration in respect of any territory specified in such declaration, be withdrawn by sending a notification addressed to the Secretary General. Withdrawal shall take effect on the first day of the month following the expiration of three months from the date on which the Secretary-General received the following announcement.
36. article. Reservations 1. any national and European Community when signing this Convention or depositing an instrument of ratification, acceptance, approval or accession, may make a reservation in respect of any of the provisions of the Convention to the extent that someone is in force in its territory does not comply with the current rules. General Disclaimer this article does not allow.
2. in any envisaged under this article must include the disclaimer in the short presentation.
3. any party that Convention apply to article 35, paragraph 2 of the Declaration, in respect of that territory can provide reservations in accordance with the provisions of the preceding paragraph.
4. any party to come up with the disclaimer referred to in this article, you can undo it by addressing the Declaration to the Secretary-General of the Council of Europe. Withdrawal shall take effect on the first day of the month after the month of the date on which the Secretary-General received it.
37. article. Denunciation 1 any party may at any time denounce this Convention by 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 three months from the date on which the Secretary-General received this notification.
38. article. Notifications the Secretary General of the Council of Europe shall notify the Member States of the Council, the European Community, to the signer, each party or other country that invited to accede to this Convention, of a) any signature;
(b)) any instrument of ratification, acceptance, approval or accession depositing;

c) any date on which the Convention enters into force in accordance with article 33 or 34.;
(d) any amendment or Protocol), adopted in accordance with article 32, and the date on which such an amendment or Protocol enters into force;
e) any statement in accordance with the provisions of article 35;
f Disclaimer and Disclaimer) any withdrawal in accordance with the provisions of article 36;
g) any other Act, notification or communication relating to this Convention.
In witness whereof the undersigned, being duly authorized, have signed this Convention.
Convention prepared Oviedo (Asturij) 1997 April 4 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, European Community, countries which are not Council of Europe members, but have participated in the elaboration of this Convention and to any State invited to accede to this Convention.