The Oviedo Convention: Human Rights in Biomedicine

The Oviedo Convention on Human Rights and Biomedicine

The Oviedo Convention, officially called the Convention on Human Rights and Biomedicine, is a Council of Europe treaty adopted in Oviedo in 1997. It entered into force in 1999 and has 31 ratifications.

It establishes binding minimum standards to protect human rights in biomedicine. While there is high divergence between states—for instance, it is considered "too restrictive" for the UK and "not restrictive enough" for Germany—it serves as a reference for EU law and the United Nations.

Article 27: Protection Standards

Each country may provide people with more protection than the Convention requires, but never less.

Article 1: Main Objective

To protect the dignity and identity of all human beings and to guarantee everyone, without discrimination, respect for their integrity, requiring that each party shall take the necessary measures in its internal law to enforce it.

Article 2: The Person Comes First

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

Article 3: Fair Access to Healthcare

Countries must ensure that everyone has equitable access to good healthcare, according to their needs and financial means.

Article 4: Professional Standards

Any medical intervention or research must follow professional rules and obligations.

Article 5: Informed Consent

Before any medical intervention, the person must freely give consent after receiving clear information about the procedure and the consequences and risks involved.

Article 7: Persons with Mental Disorders

If a person has a serious mental disorder, they may be treated without consent only if, without treatment, their health would suffer serious harm. There must be laws controlling this situation and allowing appeals against the decision.

Article 8: Emergencies

In an emergency, if consent cannot be obtained, a necessary intervention may be carried out to save the person’s health. If a person cannot speak at the exact moment, previously expressed wishes shall be taken into account.

Article 9: Previously Expressed Wishes

If someone already expressed their wishes concerning treatment and cannot currently express themselves, those wishes must be respected.

Article 10: Privacy and Information

Everyone has the right to privacy regarding information about their health. People also have the right to know that information, unless they explicitly state they do not want to know it.

Article 11: Non-Discrimination

Nobody may be discriminated against because of their genetic heritage.

Article 12: Genetic Tests

Tests predicting genetic diseases may only be carried out for health purposes or health-related scientific research, and always with appropriate genetic counselling.

Article 13: Modifying the Genome

The human genome may only be modified for preventive, diagnostic, or therapeutic purposes, and never if the changes are intended to be passed on to descendants.

Article 15: Freedom of Research

Scientific research in biology and medicine may be carried out freely, but always respecting the Convention and laws protecting human beings.

Article 18: Research on Embryos

If a country allows research on embryos in vitro, it must ensure adequate protection for them. However, creating embryos solely for research purposes is prohibited.

Article 16: Protection in Research

Research involving human beings requires the following conditions:

• There is no other equally effective alternative.
• The risks are not disproportionate to the possible benefits.
• An independent committee with several experts must approve the project.
• The person must know their rights and legal guarantees.
• The person must give express, specific, and written consent.
• Consent may be withdrawn at any time.

Article 19: Transplants from Living Persons

An organ or tissue may only be removed from a living person if:

• It is for the benefit of the recipient.
• There is no suitable organ from a deceased person.
• There is no equally effective alternative treatment.

Consent must be given in writing or before an official body.

Article 21: No Profit from the Human Body

The human body and its parts must not give rise to financial gain.

Article 22: Use of Removed Body Parts

If a part of the body is removed during an intervention, it may only be stored or used for another purpose if the person is informed and gives consent.

Article 23: Judicial Protection

Countries must provide rapid legal protection to stop any violation of the rights contained in the Convention.

Article 24: Compensation for Damage

If a person suffers unjustified harm because of an intervention, they have the right to fair compensation according to the law.

Article 25: Sanctions

Countries must establish sanctions for people who violate the Convention.

Article 30: Reports

If the Secretary General of the Council of Europe requests it, each country must explain how it is applying the Convention.

Article 29: Interpretation

The European Court of Human Rights may give opinions on how to interpret the Convention if requested by a government or a special committee.

2021 Court Decision

The Court decided that it does not have competence to give an opinion on a question related to Article 29 of the Oviedo Convention.

Questions Addressed

• What protection conditions must a country regulate to comply with the minimum requirements of Article 7 (persons with mental disorders)?
• If someone is treated without consent to protect other people from serious harm (covered by Article 26, not Article 7), should the same protection conditions apply?

Supervision: The DH-BIO

The Committee on Bioethics (DH-BIO) has been responsible since 2012 for everything related to the Convention and for protecting human rights in biomedicine. Each country may send one or more high-level representatives with experience in bioethics and human rights, with each country holding one vote.