The Oviedo Convention and human rights principles regarding health
The European Convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine (ETS No. 164) of 1997, or the “Oviedo Convention,” promotes the protection of human rights in biomedicine at a transnational level. The Oviedo Convention is a framework instrument meaning it contains general principles intended to be translated into domestic law by signatories. The Oviedo Convention contains many novel principles and requirements built on principles and rights contained in “previous international human rights treaties, such as the International Covenant on Civil and Political Rights of 1966 and the European Convention on Human Rights (ECHR) of 1950 (e.g. the rights to life, to physical integrity and to privacy, the prohibition of inhuman or degrading treatment and of any form of discrimination).” The Oviedo Convention is inspired by and grounded in the rights to life, physical integrity and privacy, and prohibition of discrimination enacted through the ECHR. For the European Court of Human Rights, the Oviedo Convention has been used as an interpretative framework to elucidate and better understand the scope and significance of these rights in the context of biomedicine.
The significance of these constituent human rights for the Oviedo Convention cannot be overstated. As a whole the Convention is designed to “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 1). Across the Convention certain values and ends are explicitly upheld and protected, while others can be inferred through specific requirements. Above all, human dignity and the primacy of the patient are key to the Convention:
“The notion of human dignity is clearly the bedrock of the Oviedo Convention. According to the Explanatory Report, “the concept of human dignity (...) constitutes the essential value to be upheld. It is at the basis of most of the values emphasised in the Convention.” Recalling the history of the instrument, one of the members of the drafting group recognizes that “it was soon decided that the concept of dignity, identity and integrity of human beings/individuals should be both the basis and the umbrella for all other principles and notions that were to be included in the Convention.””
Reference is made to other values and rights across the Oviedo Convention, such as the rights to life, physical integrity and privacy, and the prohibition of discrimination. For example, Article 10 reaffirms the right to privacy introduced in Article 8 of the ECHR and the Convention for the Protection of Individuals with regard to Automatic Processing of Personal Data:
- “Everyone has the right to respect for private life in relation to information about his or her health.
- Everyone is entitled to know any information collected about his or her health. However, the wishes of individuals not to be so informed shall be observed.”
Following the transparency requirements implied by the right to privacy in Article 10, Article 5 of the Oviedo Convention affirms the well-established requirement for informed consent in medicine:
“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.”
According to the Explanatory Report, the requirement for consent “makes clear patients’ autonomy in their relationship with health care professionals and restrains the paternalist approaches which might ignore the wish of the patient.” Paragraphs 35 and 36 of the Report provide further details on the specific requirements for consent to be considered free and informed including constraints on the doctor’s influence on a patient’s decision and requirements concerning the quality, breadth, and clarity of information provided:
“35. The patient's consent is considered to be free and informed if it is given on the basis of objective information from the responsible health care professional as to the nature and the potential consequences of the planned intervention or of its alternatives, in the absence of any pressure from anyone. Article 5, paragraph 2, mentions the most important aspects of the information which should precede the intervention but it is not an exhaustive list: informed consent may imply, according to the circumstances, additional elements. 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. This information must include the purpose, nature and consequences of the intervention and the risks involved. Information on the risks involved in the intervention or in alternative courses of action must cover not only the risks inherent in the type of intervention contemplated, but also any risks related to the individual characteristics of each patient, such as age or the existence of other pathologies. Requests for additional information made by patients must be adequately answered.
36. Moreover, this information must be sufficiently clear and suitably worded for the person 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.”
Article 10 provides both a “right to know” and a “right not to know” about their health status and any information collected about their health. These rights are core elements of the doctor-patient relationship envisioned in the Oviedo Convention. If patients are entitled to make an informed decision about their care, it follows that they are entitled to receive adequate information to make that decision in an informed manner.
Concerning discrimination, Article 11 explicitly prohibits discrimination on the grounds of genetic heritage. Likewise, Article 3 provides for equitable access to healthcare of an appropriate quality:
“Parties, taking into account health needs and available resources, shall take appropriate measures with a view to providing, within their jurisdiction, equitable access to health care of appropriate quality.”
Inequality in access to care or standards of care could be considered a violation of the prohibition on discrimination contained in Article 14 of the ECHR, in particular in relation to discrimination in “association with a national minority, property, birth or other status” (see section entitled “Inequality in access to high quality healthcare”). Similarly, Article 4 addresses quality of care and professional standards in healthcare and research:
“Any intervention in the health field, including research, must be carried out in accordance with relevant professional obligations and standards.”
The Oviedo Convention understandably does not specify quality standards to be met in healthcare and research, but rather leaves the determination of standards to professional bodies and domestic law of signatories of the Convention according to local health needs and available resources. With that said, as the Convention prescribes a minimum standard for human rights protections, member states can choose to enact higher standards in their translation of the Convention into domestic law. With regards to quality of care standards, this can be done in relation to Articles 3 and 4. Paragraph 30 of the Explanatory Report clarifies the parties envisioned as setting these professional obligations and standards:
“30. All interventions must be performed in accordance with the law in general, as supplemented and developed by professional rules. In some countries these rules take the form of professional codes of ethics (drawn up by the State or by the profession), in others codes of medical conduct, health legislation, medical ethics or any other means of guaranteeing the rights and interests of the patient, and which may take account of any right of conscientious objection by health care professionals.”
Paragraphs 31 and 32 elaborate on the nature of medicine as a profession, variation in standards across countries, the commitment of doctors to uphold ethical and legal standards, and the content and development of standards over time:
“31. The content of professional standards, obligations and rules of conduct is not identical in all countries. The same medical duties may vary slightly from one society to another. However, the fundamental principles of the practice of medicine apply in all countries. Doctors and, in general, all professionals who participate in a medical act are subject to legal and ethical imperatives. They must act with care and competence, and pay careful attention to the needs of each patient.
32. It is the essential task of the doctor not only to heal patients but also to take the proper steps to promote health and relieve pain, taking into account the psychological well-being of the patient. Competence must be determined primarily in relation to the scientific knowledge and clinical experience appropriate to a profession or speciality at a given time. The current state of the art determines the professional standard and skill to be expected of health care professionals in the performance of their work. In following the progress of medicine, it changes with new developments and eliminates methods which do not reflect the state of the art. Nevertheless, it is accepted that professional standards do not necessarily prescribe one 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.”
Following this, Paragraph 33 of the Explanatory Report provides a brief indication of the ideal model for the doctor-patient relationship with respect to choosing interventions:
“33. Further, a particular course of action must be judged in the light of the specific health problem raised by a given patient. In particular, an intervention must meet criteria of relevance and proportionality between the aim pursued and the means employed. Another important factor in the success of medical treatment is the patient's confidence in his or her doctor. This confidence also determines the duties of the doctor towards the patient. An important element of these duties is the respect of the rights of the patient. The latter creates and increases mutual trust. The therapeutic alliance will be strengthened if the rights of the patient are fully respected.”
The Oviedo Convention thus specifies a number of rights and requirements relating to or derived from human rights protected in other contexts. Key values and interests can be derived from the topics addressed throughout the Convention. These values embedded in human rights principles regarding health can guide the development of a theoretical framework for the doctor-patient relationship. Specifically, the Oviedo Convention prescribes and discusses the following values:
- Human dignity
- Primacy of patient interests over societal and scientific interests
- Right to life
- Physical integrity
- Privacy and identity
- Informed consent
- Right to know and right not to know
- Prohibition of discrimination and inequality in access to healthcare
- Quality of care standards
In the section entitled “Theoretical framework of the doctor-patient relationship”, these values will be discussed in the context of the goals of medicine as a profession and societal good and used as the basis to develop a theoretical framework for the doctor-patient relationship. This framework, and the values underpinning it derived from the Convention, suggests that certain goods must be met in the doctor-patient relationship. Likewise, different models for clinical encounters and the doctor-patient relationship will align better or worse with these values. These issues will be picked up in the aforementioned section following a brief overview of AI systems in medicine.
To situate this report in ongoing policy work by the Council of Europe, it is important to briefly note recent reports that have addressed other areas of work relevant to the impact of AI in healthcare. The “Protocol amending the Convention for the Protection of Individuals with regard to Automatic Processing of Personal Data (CETS No. 223)” was opened in October 2018 and is set to be ratified in October 2023. The Protocol amends Convention ETS No. 108. Of particular relevance to AI in medicine is its revision of Article 8 (now Article 9) of the Convention to grant individuals a variety of data protection rights:
“Every individual shall have a right:
- Not to be subject to a decision significantly affecting him or her based solely on an automated processing of data without having his or her views taken into consideration;
- to obtain, on request, at reasonable intervals and without excessive delay or expense, confirmation of the processing of personal data relating to him or her, the communication in an intelligible form of the data processed, all available information on their origin, on the preservation period as well as any other information that the controller is required to provide in order to ensure the transparency of processing in accordance with Article 8, paragraph 1;
- to obtain, on request, knowledge of the reasoning underlying data processing where the results of such processing are applied to him or her;
- to object at any time, on grounds relating to his or her situation, to the processing of personal data concerning him or her unless the controller demonstrates legitimate grounds for the processing which override his or her interests or rights and fundamental freedoms;
- to obtain, on request, free of charge and without excessive delay, rectification or erasure, as the case may be, of such data if these are being, or have been, processed contrary to the provisions of this Convention;
- to have a remedy under Article 12 where his or her rights under this Convention have been violated;
- to benefit, whatever his or her nationality or residence, from the assistance of a supervisory authority within the meaning of Article 15, in exercising his or her rights under this Convention.”
Many of these rights mirror protections in the General Data Protection Regulation (GDPR), a data protection framework implemented by the European Commission in 2018, including a limited right not to be subject to an automated decision, a right to obtain information on data processing, and rights to request rectification and erasure of personal data. These rights may come provide an important backbone to protect the ideal of informed consent in medical applications of AI by providing access to information about the scope and nature of automated processing.
The October 2020 report “Artificial intelligence in health care: medical, legal and ethical challenges ahead,” published by the Parliamentary Assembly of the Council of Europe and drafted by its Committee on Social Affairs, Health and Sustainable Development, proposed a draft recommendation responding to the growing impact of AI in healthcare. The report’s explanatory memorandum discusses in great detail the various medical, legal, and ethical impacts envisioned for AI, which include:
- Need for ethical review in biomedical research and limitations on competences and capacities of ethics review bodies to assess the unique risks and opportunities of AI
- Liability of AI providers in medicine and healthcare
- Protection of personal data in the context of harmonising data systems and supporting AI innovation and research in Europe, in particular
- Ensuring lawfulness, fairness, purpose specification, proportionality, privacy-by-design and default, responsibility, compliance, transparency, data security, and risk management
- Challenges of guaranteeing meaningful control and informed consent for patients and other data subjects
- Positive obligations for states to protect life and health via national reporting mechanisms
- Navigating the tension between “freedom to innovate” and meaningful protection of human rights
Rather than being discussed in detail here, these and other points raised in prior reports from the Council of Europe are reflected in the discussion of potential impacts on the doctor-patient relationship in the section entitled “Potential impact of AI on the doctor-patient relationship”.