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European Society of Human Reproduction and Embryology

ESHRE

The main aim of the European Society of Human Reproduction and Embryology is to promote interest in infertility care and to aim for a holistic understanding of reproductive biology and medicine.

Lobbying Activity

Meeting with Marco La Marca (Cabinet of Commissioner Dubravka Šuica) and NOVE and

29 Apr 2025 · Fertility

Response to EU Life sciences strategy

14 Apr 2025

With regard to key emerging research areas, ESHRE would like to emphasise the importance of reproductive medicine as a core area of life sciences. Please find attached a document presenting several topics from this field on which further research is expected to have a particularly high and beneficial impact for individuals, science, and society as a whole. We would also like to highlight the need to not only support research that is aimed at developing new products or technologies, but also other important research that can lead to improved patient care or reducing the burden of disease, such as studies on prevention or long-term safety studies on certain treatments. These research areas are likely of lower interest to commercial actors, so it is important for public actors like the EU to place a focus on them. With regard to the collection and use of data, the life sciences strategy should develop measures to facilitate and support the collection of real-world data in registries and to increase the usefulness of registry data. This should include facilitating the connection between different data sources, such as registries on medically assisted reproduction with obstetric or paediatric registries. Lastly, we would like to emphasise the importance of collaborating with scientific societies throughout the development and implementation of the life sciences strategy, and involving them in any discussions that will take place in this process, e.g., on how to align technological advancements with societal values and ethics. Scientific societies bring together the top experts from their fields, create fora for discussions, and engage in research and training activities. They are therefore ideally suited to act as a connection between the scientific community and policymakers.
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Response to Interim evaluation of the EU4Health Programme 2021-2027

5 Jan 2024

The European Society of Human Reproduction and Embryology (ESHRE) appreciates the EU4Health programme as one of the EUs key instruments to have a positive impact on public health. In particular, we would like to highlight the positive impact of actions in the field of Substances of Human Origin (SoHO), which contribute to improving the quality and safety of SoHO based treatments, including medically assisted reproduction to treat infertility. Infertility affects ca. 25 million citizens in the EU. It creates profound suffering in the individuals affected and puts a substantial burden on health systems in EU countries. While the quality and safety of medically assisted reproduction is of utmost importance, there are many other aspects of infertility that require urgent action as well, such as the prevention of infertility, fertility education, and psychosocial support for infertile patients. Funding for actions on these aspects within the EU4Health programme could make a substantial contribution to reducing the burden of infertility in the EU. Furthermore, it is important to consider that infertility does not exist in isolation, but often interplays with other conditions like cancer or mental health problems. The EU4Health programme should take these interactions into account and use the potential for synergies, e.g., by making sure that the need to provide information on the impact of cancer treatments on fertility and options for fertility preservation to cancer patients is considered in actions aimed at improving cancer care. The attached document outlines a number of key topics related to infertility where EU funding could have a positive impact. ESHRE hopes that these topics will be taken into consideration in the development of future workplans under the EU4Health programme and subsequent health programmes.
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Response to Revision of the Union legislation on blood, tissues and cells

8 Sept 2022

ESHRE welcomes the Commission’s publication of the Proposal for a Regulation on standards of quality and safety for substances of human origin (SoHOs) intended for human application. While we have already made a number of recommendations for the field of medically assisted reproduction (MAR) during its drafting phase, we would like to use this opportunity to express our position on the published proposal and present additional recommendations and remarks to be considered in the upcoming negotiations. To provide an overview, ESHRE is appreciative of the following provisions under the proposed SoHO Regulation and considers them to be a positive result of our advocacy activities for the field of MAR in this regard: --> Harmonization of practices across EU Member States, through means of a joint Regulation; harmonising the authorisation process of new MAR technology/methodology and SoHO establishments, the data collection requirements, and the inspections’ quality, content and evaluation methods at EU level; --> Replacing the current terminology referring to ‘partner donation’ and non-partner ‘donation’ with appropriate and revised terms describing ‘within couple use’ and ‘third-party donation’; --> Strengthened scope in terms of donor and offspring protection: o Mandatory third-party donor health evaluations; o Mandatory registration and follow-up of third-party donors subjected to a surgical procedure in order to donate, donors who are treated with hormones to facilitate donation, and those who donate on a frequent and repeated basis; o Mandatory reporting concerning both third-party donors and offspring from MAR, including serious adverse occurrences (SAOs) reporting, which is now proposed to additionally entail genetic conditions transmitted to offspring from MAR as SAOs; o Standards setting the conditions and regulatory requirements for compensation and reimbursement allowances from SoHO entities to donors at the national level to ensure their financial neutrality and prevent the provision of financial incentives or inducements to promote third-party donations; --> Strengthened recipient protection in relation to the use of unnecessary, inefficacious, and/or unvalidated add-on procedures for MAR; --> Extended role and participation of experts within the scope of this Regulation, including the assessments of SoHO preparations, inspections of SoHO establishments and SoHO entities, and their participation at the meetings of the SoHO Coordination Board; --> Extended requirements for formal qualification and specialized training of inspectors for SoHO entities and establishments, who shall be trained for specific types of establishments (e.g., MAR clinics); --> Extended legal basis and requirements for data collection, together with strengthened role of international registries in the related SoHO activities. On the other hand, ESHRE also finds it of utmost importance to express some recommendations on the aspects of the proposed SoHO Regulation that need to be revisited, specified and/or clarified, in our opinion, with relevance to the field of MAR: --> Distinction between ‘within couple use’ and ‘third-party donation’, as well as the use of terms such as ‘recipients’, ‘donors’, ‘patients’, and ‘partners’ under different circumstances in the field of MAR, need to be made clear throughout the whole legislative text, and mainly definitions in Article 3, to avoid ambiguity and misinterpretation; --> Active involvement of experts from scientific societies (e.g., ESHRE) in the development and updating of ECDC and EDQM guidelines should be based on a formal requirement and agreement, rather than ad hoc practice and good relations; and --> Patient involvement and role should be strengthened and explicitly described, for instance, regarding the meetings of the SoHO Coordination Board. Please, see the full version of ESHRE statement in the attached document.
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Response to Interim evaluation of Horizon Europe

26 Jul 2022

The European Society of Human Reproduction and Embryology (ESHRE) welcomes the opportunity to provide feedback on the Horizon Europe programme. We would like to use this opportunity to raise awareness on the need for funding for research in the area of infertility and Medically Assisted Reproduction (MAR). Infertility affects approximately 25 million citizens in Europe. Over the past decades, infertility treatment has evolved fast and has helped many people to become parents. Nevertheless, several gaps in the knowledge on infertility and MAR require further research to ensure evidence-based clinical practice. The attached document sets out several key topics related to infertility and MAR that should be considered for inclusion in future work programmes of Horizon Europe. Funding for research on these topics will contribute to reducing the negative impacts of infertility on the individuals affected, as well as on society as a whole.
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