The new Recommendation CM/Rec(2023)1 was approved on 1 February 2023 by the Committee of Ministers at the Council of Europe to promote access to medicinal products and medical equipment in a situation of shortage. The Recommendation, that is completed by an Explanatory Memorandum to member states, has been drafted under the responsibility of the Secretary General of the Council of Europe, on the basis of the discussions held in the Steering Committee for Human Rights in the fields of Biomedicine and Health (CDBIO) and in its predecessor, the Committee on Bioethics (DH-BIO), as well as the remarks and proposals made by delegations.
The Recommendation is a consequence of the experience gained during the Covid-19 pandemic, when shortages of many medicinal products and medical devices occurred. It aims to establish a common base of procedural principles to safeguard during shortages the fundamental rights of individuals who need medical treatments for serious or life-threatening health conditions.The Recommendation focuses, among others, on the absence of discrimination, the prioritisation based on medical criteria and the compliance with the principles of accountability, transparency and inclusiveness. It also recommends a system to be in place to prevent and mitigate situations of shortage and to better prepare for such shortages.