Biomedicine & Bioethics

Human Rights and Biomedicine

In the early 1990s, the Council of Europe member States became aware of the rapid developments in biological and medical research. While they agreed that present and future generations would greatly benefit from the progress made, they were also conscious that the misuse of biomedical technology could lead to acts endangering human dignity.

In order to protect all human beings in their dignity, both as individuals and as members of the human species, they set up the Convention on Human Rights and Biomedicine in 1999. Since then, the Convention has been supplemented with a number of Additional Protocols, and further treaties in the field of biomedicine and bioethics were drafted or are in preparation.

 

Convention on Human Rights and Biomedicine (CETS No. 164)

The full name of this treaty is Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine. It was opened for signature in Oviedo (Principality of Asturias, Spain) and is, therefore, also known as Oviedo Convention. It entered into force in 1999 and is the first legally binding international treaty on the protection of human rights in the biomedical field.

The Convention on Human Rights and Biomedicine serves as a framework convention: While the Parties to the Convention have committed themselves to complying with the provisions set forth in the treaty, they are free to decide what kind of measures are needed at the national level to do so.

Parties to the Convention on Human Rights and Biomedicine have committed themselves i.a. to

  • put the interests and welfare of human beings before the interests of society or science
  • provide equitable access to health care of appropriate quality
  • carry out any intervention in the health field, including research, in accordance with relevant professional obligations and standards

Under the Convention on Human Rights and Biomedicine any intervention in the health field, including research, can only be carried out if the person concerned has given free and informed consent to it, and he or she may freely withdraw consent at any time. If a person doesn’t have the capacity to consent, an intervention, including research, can be undertaken only if that person benefits directly from it, and it must be authorised by his or her representative, or an authority provided for by law.

The Convention on Human Rights and Biomedicine also prohibits a number of actions, among them are:

  • any discrimination against a person on the grounds of his or her genetic heritage
  • the performance of tests which are predictive of genetic diseases for other reasons than health purposes
  • the modification of the human genome for other than preventive, diagnostic or therapeutic purposes
  • the modification of the human genome with the aim of altering the genome of any descendants
  • medically assisted procreation for the purpose of choosing a future child’s sex, except where a serious hereditary sex-related disease is to be avoided
  • the creation of human embryos for research purposes
  • using the human body and its parts, as such, for financial gain

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

 

Committee on Bioethics (DH-BIO)

On behalf of the Council of Europe’s Committee of Ministers, the Committee on Bioethics (DH-BIO) – until 2012 Steering Committee on Bioethics (CDBI) – is responsible for various tasks.

Among them are the monitoring of scientific developments in the field of biomedicine; the elaboration of further Additional Protocols to the Convention on Human Rights and Biomedicine; the organisation of international conferences and symposiums on the protection of human rights in the biomedical field; the publication of studies and guidelines on relevant topics.

Furthermore, the Committee on Bioethics (DH-BIO) co-operates with relevant bodies within the Council of Europe, such as the European Directorate for the Quality of Medicines & HealthCare (EDQM), as well as with other intergovernmental organisations and their specialised bodies.

The Committee on Bioethics (DH-BIO) consists of bioethics experts appointed by the Governments of the Council of Europe Member States. Each Member State has one vote in the Committee; plenary meetings are held twice a year.

 

Additional Protocols to the Convention on Human Rights and Biomedicine

 

 

Additional Protocol on Cloning of Human Beings (CETS No. 168)

The Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, on the Prohibition of Cloning Human Beings came into force in 2001.

It was drafted by the Council of Europe member States after scientists had succeeded in the cloning of mammals through embryo splitting and nuclear transfer.

State Parties to this Additional Protocol agree that the instrumentalisation of human beings through the deliberate creation of genetically identical human beings is contrary to human dignity and thus constitutes a misuse of biology and medicine.

They commit themselves to prohibiting any intervention seeking to create a human being genetically identical to another human being, whether living or dead – “genetically identical” meaning a human being sharing with another the same nuclear gene set.

 

Additional Protocol on Transplantation (CETS No. 186)

 The Additional Protocol to the Convention on Human Rights and Biomedicine concerning Transplantation of Organs and Tissues of Human Origin came into force in 2006.

In order to prevent the commercialisation of parts of the human body involved in organ & tissue procurement, this Additional Protocol stipulates the conditions under which organ & tissue removal from a living donor as well as from the body of a deceased person may be carried out.

State Parties to this Additional Protocol, therefore, commit themselves to prohibiting organ & tissue trafficking as well as the advertising of the need for, or availability of, organs or tissues, with a view to offering or seeking financial gain or comparable advantage.

Furthermore, Parties to this Additional Protocol are required to

  • guarantee that a system exists to provide equitable access to transplantation services for patients
  • ensure the traceability of organs & tissues
  • allocate organs & tissues only among patients on an official waiting list, in conformity with transparent, objective and duly justified rules according to medical criteria
  • facilitate the rapid and safe transportation of organs & tissues to and from their territory
  • consider confidential all personal data relating to the person from whom organs or tissues have been removed and those relating to the recipient
  • take all appropriate measures to promote the donation of organs & tissues

 

Additional Protocol on Biomedical Research (CETS No. 195)

The Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research came into force in 2007. It elaborates on certain provisions made in the Convention on Human Rights and Biomedicine regarding biomedical research.

The Additional Protocol states that while advancement of biomedical science and practice is dependent on knowledge and discovery which necessitates research on human beings, it is paramount, that the dignity, rights, safety and well-being of all human beings participating in research be protected.

State Parties, therefore, have to commit themselves to introducing a number of safeguards. Among them are the following:

  • every research project must be submitted for examination of its ethical acceptability to an ethics committee
  • the ethics committee must be independent and produce an opinion containing reasons for its conclusion
  • persons being asked to participate in a research project must be given adequate information in a comprehensible form, and this information must be documented
  • no research on a person is allowed to be carried out without the informed, free, express, specific and documented consent of the person, and he or she can freely withdraw consent at any phase of the research
  • any information of a personal nature collected during biomedical research must be considered as confidential and treated as such
  • on completion of the research, a report or summary must be submitted to the ethics committee

Research on persons without the capacity to consent or on persons in specific situations – research during pregnancy or breastfeeding, research on persons in emergency clinical situations or persons deprived of liberty – are only allowed to be undertaken under certain conditions, specified in the Protocol.

 

Additional Protocol on Genetic Testing (CETS No. 203)

The Additional Protocol to the Convention on Human Rights and Biomedicine concerning Genetic Testing for Health Purposes was opened for signature in 2008 and will come into force after the ratification by 5 States, at least 4 of them member States of the Council of Europe.

This Additional Protocol applies to genetic tests carried out not for research purposes, but for health purposes, for example tests predictive of a monogenic disease, tests serving to detect a genetic predisposition or genetic susceptibility to a disease, or tests serving to identify the subject as a healthy carrier of a gene responsible for a disease.

 
State Parties have to comply with certain provisions. I.a. they have to

  • prevent stigmatisation of persons or groups in relation to genetic characteristics
  • ensure that genetic services are of appropriate quality
  • make clinical utility of a genetic test an essential criterion for deciding to offer this test to a person
  • make sure that a genetic test for health purposes is only performed under individualised medical supervision
  • protect the personal data of a person derived from a genetic test
  • facilitate access for the general public to objective information on genetic tests

Furthermore, they commit themselves to only allowing a health screening programme involving the use of genetic tests to be implemented if it has been approved by a competent body; and approval may only be given after independent evaluation of its ethical acceptability.

 

Further Conventions on Biomedicine and Bioethics

 
Council of Europe Convention against Trafficking in Human Organs (CETS No. 216)

 
The Council of Europe Convention against Trafficking in Human Organs was opened for signature in March 2015. It is open to member States of the Council of Europe as well as non-member States and will enter into force after ratification by 5 States, at least 3 of them Council of Europe member States.
 
The aim of the Convention is to prevent and combat trafficking in human organs by criminalising certain acts; to protect the rights of victims as well as to facilitate national and international co-operation on action against trafficking in human organs.

 

Preventing trafficking in human organs

In order to prevent trafficking in human organs, State Parties have to

  • ensure the existence of a transparent domestic system for the transplantation of human organs
  • provide equitable access to transplantation services for patients
  • adequately collect, analyse and exchange information related to illicitly obtained human organs in co-operation with all relevant authorities
  • provide information to and strengthen training of healthcare professionals and relevant officials
  • promote awareness-raising campaigns about the unlawfulness and dangers of trafficking in human organs
  • prohibit the advertising of the need for, or availability of human organs, for payment or comparable advantage

 

Combating trafficking in human organs

In order to combat trafficking in human organs, State Parties are obliged to establish certain actions as a crime under domestic law. Among them are the following:

  • the removal of human organs without the free, informed and specific consent of the donor
  • the removal of human organs in exchange for payment or comparable advantage to the donor or a third party, or the receiving of such benefits
  • the removal of human organs outside the framework of the domestic transplantation system
  • the solicitation and recruitment of an organ donor, or a recipient, for payment or comparable advantage
  • the promising, offering or giving of any undue advantage to healthcare professionals or public officials with a view to having a removal or implantation of a human organ performed or facilitated – as well as the accepting of such offers
  • the preparation, preservation, storage, transportation, transfer, receipt, import or export of illicitly removed human organs

 

Protecting the rights of victims

State Parties must take legislative and other measures to protect the rights and interests of victims, i.a. by

  • assisting and supporting them in their physical, psychological and social recovery
  • protecting victims and witnesses of the crime as well as their families from potential retaliation or intimidation connected to criminal investigations
  • giving victims access to legal aid, free of charge where warranted
  • providing, in their domestic law, for the right of victims to compensation from the perpetrators

 
National and international co-operation

State Parties commit themselves to co-operating with each other to the widest extent possible for the purpose of investigations or proceedings concerning illicitly obtained human organs, including seizure and confiscation. Where no other applicable treaties exist, they agree to consider this Convention as the legal basis for extradition or mutual legal assistance in criminal matters. Furthermore, they designate a national contact point for the exchange of information about trafficking in human organs.

 
Committee of the Parties

Once the Convention will have entered into force for the tenth State Party, a Committee of the Parties will be set up in order to monitor the implementation of this Convention. It will be composed of representatives of the Parties to the Convention and will be responsible for setting up its rules of procedure.
 
 
Brochure on Bioethics at the Council of Europe (PDF)
 
 
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Photos: © Council of Europe