Governance of Medically Assisted
Reproduction (MAR) in Europe
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 European Union (EU)
The EU is a supra-national organisation with 27 Member States and three main institutions: the European Commission, the European Parliament, and the Council of the EU. 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 contributed to this evaluation process through stakeholder consultations and meetings with DG SANTE officials. The evaluation report highlighted the shortcomings of the current EUTCD in the field of MAR, such as the insufficient protection of third-party donors and children born from MAR.
Following the evaluation, the European Commission began its revision of the legislation on blood, tissues and cells to address the shortcomings identified in the evaluation report. In this process, ESHRE submitted input to stakeholder consultations and participated in several workshops organised by DG SANTE and by an external contractor. The key points and recommendations that ESHRE advocated for during the revision process were outlined in our position paper at that time. Many of them were positively taken into account.
In July 2022, the European Commission concluded their revision of the legal framework for blood, tissues and cells in the EU, and published a Proposal for a Regulation on Substances of Human Origin (SoHO) intended for human application. The proposed Regulation should collectively apply to all SoHO, including reproductive tissues and cells, with the exception of solid organs for transplantation. Since the EUTCD is a Directive, it sets common goals for EU Member States to achieve but leaves them with flexibility on how to implement it in their national laws. In contrast, the SoHO Regulation will be directly applicable in all Member States.
Although ESHRE has generally welcomed the SoHO Regulation Proposal, we continue to actively voice the views of experts in human reproduction and embryology on the elements of this legislation that still need to be improved and clarified to ensure maximum benefit to patients, donors, and children born from MAR, as well as to professionals involved in MAR treatments.
To this end, ESHRE has engaged with the European Commission by responding to another stakeholder consultation and participating in multiple meetings with DG SANTE officials. We have also shared our recommendations with representatives of the European Parliament on several occasions and shared our latest position paper on the SoHO Regulation Proposal with relevant stakeholders.
The proposed SoHO Regulation is now being discussed in parallel by the Council of the EU and the European Parliament, who can still make amendments to it. Only once the final text is agreed upon and adopted does the Regulation come into effect, although there will be a 2- to 3-year transition period before all its provisions apply.
In addition to the regulation of MAR through binding legislation, the EU aims to reinforce the importance of practical guidelines for professionals that are provided through the European Centre for Disease Prevention and Control (ECDC), the EU agency responsible for the defence against infectious diseases, and the Council of Europe’s European Directorate for the Quality of Medicines & HealthCare (EDQM).
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 Council of Europe (CoE)
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 from different fields, 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
Governance at national level
All EU Member States are currently required to have a National Competent Authority (NCA) in place that is responsible for implementing the requirements established in the EU legislation at national level.