On 5 December, more than 80 participants came together in Brussels for the stakeholder event of the European monitoring of Medically Assisted Reproduction (EuMAR) project. This three-year project was initiated in January 2023, after ESHRE was awarded an EU grant to build a pan-European cycle-by-cycle registry of medically assisted reproduction (MAR) treatments. One year into the project, the team set out to provide an update to the key collaborators and stakeholders on the progress made so far and the plans for the next two years.
The event was opened by Prof Carlos Calhaz-Jorge, the chair of EuMAR’s Project Steering Committee. He welcomed the participants, which came from all over Europe and included representatives of national authorities, national fertility societies, patient organisations, as well as ESHRE experts. Calhaz-Jorge acknowledged that the EuMAR project is very ambitious, but he noted that there are already many “believers” in the room who support the project and are convinced of its feasibility. He also expressed the hope that some doubts among the more sceptical participants could be resolved by the end of the day.
The programme started with Prof Christine Wyns, who presented an overview of the project aims and structure. She highlighted the three main objectives: constructing a data flow model that is tailored to all different national contexts, defining a harmonised set of parameters on which data is to be collected, and developing a technical solution for the registry, including a patient code that can follow patients across clinics and countries without being identifiable in the EuMAR registry.
To build the data flow model, the project team had carried out a survey among all EU Member States, as well as bilateral calls with each country, to understand the current national data collection systems. Dr Cristina Magli presented the results of this exercise, highlighting that there are big differences between existing data collection systems, ranging from countries with no data collection to countries with a detailed and complete cycle-by-cycle registry with a unique patient ID number. To accommodate for the different local situations, she explained that the EuMAR registry should allow data transfer from existing national registries, as well as direct data submission from MAR clinics in countries where there is no national cycle-by-cycle registry.
Just in time for St. Nicholas Eve, Prof. Jesper Smeenk brought a present for the audience: the finalised set of parameters for the EuMAR registry. These were long awaited by the stakeholders, especially those that are running cycle-by-cycle registries, who would like to know whether the required parameters match with the ones that they are already collecting. Smeenk emphasised that the selected 64 parameters represent the basic data needed to monitor MAR treatments, so they are probably already included in most existing registries.
Subsequently, patient representative Bojana Santic presented the patients’ perspective on EuMAR. She asked the participants to put themselves in the shoes of an infertile patient and shared her deeply personal story of having to travel abroad for MAR treatment and struggling with a lack of knowledge and transparency on the risks and chances of success of different treatments. With the patient organisation Fertility Europe, Santic is advocating for MAR treatments that are evidence-based, safe and accessible across Europe. She emphasised that high quality data is essential for any policy change and expressed hope that the EuMAR project will contribute to increasing transparency and stimulating policies that are patient-centred.
The next session of the event went more into detail on the technical aspects of the project. To allow for the calculation of cumulative outcomes, it is essential that the different steps of a patient’s treatment journey can be linked in the registry. EuMAR’s legal advisors Ruben Roex and Jolien Clemens explained how this can be achieved in line with the EU’s data protection law. “From a legal perspective, now is the right time for this project”, Roex explained, as there have been two recent rulings of the Court of Justice of the EU that clarified that it is not necessary to follow the strict rules of the General Data Protection Regulation (GDPR) in cases where there is no reasonable possibility for the data recipient to trace back the patient from which the data originated. As shown in the subsequent presentation on the technical solution by Prof Wyns, a lot of effort was put into developing a system that satisfies this requirement, by using a one-way encryption (“black-box”) system for the patient code and putting the patient in charge of sharing their code when moving to a different clinic or country.
The last session focused on the future of the EuMAR project. Prof Christian de Geyter elaborated on the plans to conduct a pilot study, which will test the implementation of the registry in up to five countries over one year. Furthermore, Prof Smeenk explained that there are plans to increase the registry’s value by investigating the possibility of linking it to other registries and platforms. One of these platforms is the EU Substances of Human Origin (SoHO) platform, which is currently under development by the European Commission and will collect data on all SoHO activities, including the activities of MAR clinics. Stefaan Van Der Spiegel, sector lead for SoHO at the Commission, presented this project to the group and highlighted the possible synergies between EuMAR and the EU SoHO platform, since clinics will have the option to delegate their activity reporting to registries like the EuMAR registry.
After a final report of EuMAR’s communication and dissemination activities presented by ESHRE’s communications manager Laura Rossignoli, the meeting came to an end. Project Steering Committee chair Calhaz-Jorge was satisfied with the outcome: “I consider the event was a great success. I’m convinced we overcame doubts in some spirits and got an even more involved environment in what concerns the “believers”.
Co -Funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or HaDEA. Neither the European Union nor the granting authority can be held responsible for them.
Co-funded by the European Union.
Project: 101079865 — EuMAR — EU4H-2021-PJ2
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