There are two organisations that are involved in the governance of MAR at the European level: the European Union (EU) and the Council of Europe (CoE).
The EU is a supra-national organisation with 27 Member States and three main institutions: the European Commission, the European Parliament, and the Council. The European Commission represents the interests of the EU as a whole, while the European Parliament represents the interests of the EU citizens and the Council represents the interests of the national governments of EU Member States. Together, these three institutions produce legislation that is binding throughout the EU.
In 2004, the EU has adopted the EU Tissues and Cells Directive (EUTCD). This Directive sets out requirements regarding the quality and safety of tissues and cells for human application. While some paragraphs refer specifically to reproductive cells, the EUTCD has a broader scope, dealing with a diverse range of tissues and cells.
From 2017 to 2019, the Directorate General for Health and Food Safety of the European Commission (DG SANTE) conducted an evaluation of the EU legislation on blood, tissues and cells. ESHRE actively contributed to the evaluation process in stakeholder consultations and meetings with DG SANTE officials. The evaluation report highlights the shortcomings of the EUTCD in the field of MAR, such as the insufficient protection of third-party donors and children born from MAR.
Currently, the EU is revising its legislation on blood, tissues and cells to address the shortcomings that were identified in the evaluation. In this process, ESHRE has submitted input to stakeholder consultations and participated in several workshops organised by DG SANTE and by an external contractor. The key points that ESHRE is advocating for in the revision are outlined in our position paper. DG SANTE aims to publish a proposal for the revised Directives in the first quarter of 2022. After publication, the proposal needs to be adopted by the European Parliament and the Council, who can still make amendments to the proposal.
In addition to the regulation through binding legislation, the EU also provides practical guidelines for professionals, for instance through the European Centre for Disease Prevention and Control (ECDC), the EU agency responsible for the defense against infectious diseases.
For more information on the activities of the EU in the field of tissues and cells, please visit the following website: https://ec.europa.eu/health/blood_tissues_organs/tissues_en
The CoE is an international organization with 47 member countries, among which are all 27 EU Member States. The CoE’s main area of activity is the field of human rights. Since access to good quality medicines and healthcare is a basic human right, the CoE is actively working on health-related topics, including MAR. The CoE’s work on tissues and cells is carried out by the European Committee on Organ Transplantation (CD-P-TO) within the CoE’s European Directorate for the Quality of Medicines & HealthCare (EDQM).
In cooperation with experts, the CD-P-TO develops technical guidance on medical treatments, which can be used as a reference by clinicians. MAR is covered in the Guide to the Quality and Safety of Tissues and Cells, which includes one chapter on MAR and one chapter on fertility preservation. Both of these chapters were written in collaboration with ESHRE.
For more information on the activities of the CoE in the field of tissues and cells, please visit the following website: https://www.edqm.eu/en/transplantation-areas-work
All EU Member States are required to have a Competent Authority (CA) in place that is responsible for implementing the requirements established in the EUTCD at national level.
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