In the European health field, the Council of Europe1 and European Union2 are the major players.3 The organisations share the same fundamental values of human rights, democracy and the rule of law. The Council of Europe has coordinated inter-governmental co-operation in the field of health among its member states since 1954. Protection and promotion of health is an important aspect of the organisation’s human rights mandate. The European Union (
In relation to health and healthcare, the organisations have a close relationship. Their official co-operation dates back to 1985. Joint Declarations stress the importance of harmonisation at the level of both European institutions and at national level. Joint programmes have been developed since 1993.6
2 Human Rights
The Council of Europe’s European Convention for the Protection of Human Rights and Fundamental Freedoms (
The jurisprudence of the European Court on Human Rights has an important impact on national health policies. The Court may also give advisory opinions on legal questions concerning the interpretation of the Biomedicine Convention.
The Council of Europe’s European Social Charter (
The entry into force in 2009 of the
However, to date, the
As to the Council of Europe’s European Social Charter, the European Social Committee, charged with its supervision, routinely assesses whether national measures implementing
3 Council of Europe and European Union: Complementarity and Partnership
Although distinct organisations as to their respective roles and design, in the field of health and health-related human rights, in many ways the roles of the Council of Europe and the European Union are complementary. The ‘points of contact’ include subjects covered by Protocols to the Convention of Human Rights and Biomedicine. Besides the advantage of having a broader geographical reach, the Council of Europe, with its human rights instruments and through its soft law15 may provide for more ample protection than
Another example of co-work between the Council of Europe and the European Union is the Handbook on European Data Protection Law (2014), jointly prepared by the European Union Agency for Fundamental Rights (
Less well-known is the ‘Partnership for Good Governance’ between both organisations in the health field.20 This co-operation dates back to 1985. Joint programmes in the context of this partnership (based on co-funding) have been developed since 1993.21 With the signing of a Memorandum of Understanding by the Council of Europe and the
4 The European Directorate for the Quality of Medicines and Health Care (
The European Directorate for the Quality of Medicines and Health Care (
4.1 Medicinal Products
4.2 Substances of Human Origin
The preparation, use and quality assurance of blood components also falls under the aegis of the
Likewise, a Guide for the quality and safety of organ transplantation and a Guide for the quality and safety of tissues and cells for human application (cell therapy) are drawn up under the aegis of the
The principles guiding the work of the
Ensuring human dignity, maintenance and realisation of human rights and fundamental freedoms;
Protection of donor and recipient through the development of ethical, quality and safety standards in the field of organ, tissue and cell donation and human application;
Voluntary donation of materials of human origin;
Fight against trafficking.
Organ shortages, or lack of access to a deceased donor programme, have encouraged organ trafficking, often involving patients seeking potential donors abroad. Although many countries allow non-resident living donation, there are variations in their approaches. They include the data collected, the screening and consent process, the reimbursement of loss of earnings and justifiable expenses (such as travel and medical costs) related to the donation procedure, and access to post-operative follow-up care. Assessing the validity of their consent to donation — which must be free, specific and informed — is vital. For protecting a non-resident living organ donor the Council of Europe has drawn up a special Resolution.31
5 European Pillar of Social Rights
The Preamble to the
The Pillar puts emphasis on new and more effective rights for citizens e.g. by linking economic and social rights. By establishing a European Pillar of Social Rights, the European Union intends to underline the relevance of social rights in its institutions and policies. As indicated by Nicoletti,
There is an urgent need to enhance existing synergies and find effective solutions to emerging conflicts. It must be ensured that the fundamental rights enshrined in the Charter are fully respected by decisions or legislation of the States Parties resulting directly or indirectly from changes in
The Pillar text refers to Social Protection and Inclusion, under which heading health-, and long-term care are grouped:
Para. 16: Healthcare: Everyone has the right to timely access to affordable, preventive and curative health care of good quality.
Para. 18: Long term care: Everyone has the right to affordable long-term care services of good quality, in particular home-care and community-based services.
To cite Secretary General Jagland of the Council of Europe:
To meet this challenge, we must promote legal certainty and coherence between European standard-setting systems protecting fundamental social rights. Ensuring that the European Social Charter, the Social Constitution of Europe, is central to the Pillar will contribute to this objective and make Europe not only more prosperous, but also more equitable and united.39
6 It Takes Two to Tango: Multi-level Governance
Economic freedoms should not be protected at the expense of the social right to healthcare. Instead, law- and policy-making in the
CoE: 48 Member States.
The United Nations (
25 June 2012, adopted by the Council on 20 July 2015 (
A Memorandum of Understanding was signed in 2007. EEAS.EUROPA.EU.
Prohibition of cloning human beings, Transplantation of organs and tissues of human origin, Biomedical research, Genetic testing for health purposes.
Collective complaints lodged by social partners and other non-governmental organisations.
National reports drawn up by Contracting Parties.
Charter of Fundamental Rights of the European Union, Preamble.
Cases cannot be brought in the ECtHR against the European Union, but the Court has ruled that states cannot escape their human rights obligations by saying that they were implementing
Art. 53 Charter Fundamental Rights.
‘Bosphorus Airways’ v. Ireland (no. 45036/98), Judgment (Grand Chamber) of 30 June 2005, case law concerning the European Union, EcrtHR, Factsheet, April 2017, p. 3.
The 1961 Charter, Additional Protocols to it of 1988 and 1995 and Revised Charter of 1996.
Complementarity often takes the form of recommendations. Next to the Council of Europe’sCommittee of Ministers recommendations in the field of blood transfusion and transplantation of organs, they include recommendations on genetic testing and screening for health care purposes (Rec. 92(3), on the protection of medical data, Rec. 97(5), on xenotransplantation (Rec. 2003(10), on the protection of the human rights and dignity of persons with mental disorder (Rec.2004(10), on research on biological materials of human origin (Rec.2006(4), on the processing of personal data in the context of employment (Rec.2015(5) and on processing of personal health related data for insurance purposes, resulting from genetic tests Rec.2016(8).
On genetics, see also Henriette Roscam Abbing, ‘Editorial: New EU rules for in vitro diagnostic genetic tests, a first step in the right direction’,
See supra note 15.
General Data Protection Regulation, (
European Union Agency for Fundamental Rights, Update of Handbook on European Data Protection Law, European Agency for Fundamental Rights website, under projects.
Memorandum of Understanding between the Council of Europe and the European Union, signed 11 May 2007. The Memorandum is in line with the joint co-operation and partnership signed 1 April 2001 (
The current joint programme of six years (2014-2020) addresses health and wellbeing of youth, and more specifically human rights and health care in prisons in Georgia.
The European Union regards the Council of Europe as the Europe-wide reference source for human rights. In this context, the relevant Council of Europe norms will be cited as a reference in European Union documents. The decisions and conclusions of its monitoring structures will be taken into account by the European Union institutions where relevant. The European Union will develop co-operation and consultations with the Commissioner for Human Rights with regard to human rights.
The European Medicines Agency (
Medi-Crime Convention, entered into force in 2016.
The classification into ‘Over the Counter’ or ‘prescription-only’ medicines has implications for patient safety, accessibility of medicines to patients and responsible management of health care expenditure. The decision on the prescription status and related supply conditions is a core competency of national health authorities.
Ph.Eur. — since mid-2016 in its 9th edition.
12 October 1995.
Organs, Tissues and Cells of Human Origin, Council of Europe Resolutions, Recommendations and Reports, 3rd Edition (2017).
The Council of Europe’s Committee of Social Rights tasked with the supervision of compliance with the
The 1961 Charter, the Additional Protocol of 1988, the Additional Protocol of 1995 and the Revised Charter of 1996.
European Social Charter and European Union Law, Council of Europe European Social Charter, www.Coe.int.
The Pillar initiative was presented by the European Commission at the Turin Forum on Social Rights in Europe organised by the Council of Europe in Turin on 18 March 2016.
European Pillar of Social Rights, Booklet.
Ms Michelle Niocoletti, Vice President Parliamentary Assembly, High Level Conference on the European Social Charter, Executive Summary, Council of Europe, October 2014, pp. 2, 3.
Jagland, Opinion of the Secretary General of the Council of Europe on the European Union initiative to establish a European Pillar of Social Rights, Strasbourg, 2 December 2016.
European Parliament, Policy Department, Employment and Social Affairs, A European Pillar of Social Rights, First Reaction (Briefing), August 2016, p. 6.
Opinion of the Secretary General of the Council of Europe on the European Union initiative to establish a European Pillar of Social Rights, Council of Europe Strasbourg, 2 December 2016.