The capacities of universities to carry out cutting-edge health research and deliver solutions to current and future health emergencies (such as the COVID-19 pandemic) requires that the right enabling conditions are in place. Over the past year, the Health Deans have maintained their strong commitment to engaging in EU health research policy to ensure that citizens have access to innovative disease treatments and diagnostic techniques in Europe.
Addressing the obstacles medical research is facing
In June 2021, The Guild reiterated its strong concern that the General Data Protection Regulation (GDPR) and the lack of harmonization of its implementation across countries have been posing serious limitations on the sharing and reuse of health data. Existing obstacles hinder collaborative health research projects and multinational clinical trials. This reduces our capacities to engage in large cross-institutional studies and to contribute to the development of new and more effective medicines and diagnostic techniques. Considering how crucial access to data is for health research and clinical studies, the Health Deans urge the European Commission to find solutions, via the envisaged European Health Data Space (EHDS), to facilitate the reuse of health data for research purposes.
In their recommendations published in June 2021, the Health Deans called for clarifying GDPR provisions and harmonizing their implementation. They underlined the need for revised rules on data protection and patients’ consent to data processing and transfer, and advocated for support to the development of privacy-enhancing technologies. Our Deans’ proposals served as a basis for contributing to the Open Public Consultation on the EHDS and for a bilateral meeting with Director Andrzej Rys (Directorate-General for Health and Food Safety (DG SANTE) in October 2021.
This work informed The Guild’s response to the Commission’s proposal for an EHDS in May. We welcomed the commitment to overcome different national interpretations of GDPR and the facilitation of collaboration between national competent authorities through a new EHDS Board for better interoperability of health data sets. But we also urged the Commission to go further than the anonymization of health data. To maximize the effectiveness of health research, it was essential to give patients the option to volunteer their health data for secondary (research) use.
Call to enable multinational clinical trials
The Guild argues that the EHDS will be instrumental in facilitating multinational clinical trials too. During the COVID-19 pandemic, the fragmentation of clinical trials generated an insufficient number of studies with reliable data and conclusions and therefore hindered regulatory decision-making in the European Union. The Health Deans welcomed the recent EU initiatives which DG SANTE’s Edit Szepessy presented to them in March 2022. The entry into force of the Clinical Trial Regulation, the launch of the Clinical Trials Information System (CTIS), and the Accelerating Clinical Trials in the EU (ACT EU) initiative, all could contribute to solving this pressing and highly detrimental issue.
However, a Guild statement published in March 2022 contends that these initiatives could be more ambitious by including medical devices in their scope. We also argue that they should be closely articulated with the future EHDS, as solutions for sharing health data will be crucial for the conduct of clinical trials in multiple countries.
Setting recommendations on the use of animals in research
A resolution of the European Parliament adopted in September 2021, which called for an action plan for an accelerated phase-out of the use of animals in research, prompted a reaction of the Health Deans. In a statement published in March 2021, The Guild highlights the full commitment of the research community to the so called 3R principle intended for a better protection of the animals used in research (replacement, reduction, refinement). Indeed, technical progress has allowed for a significant reduction in the number of animals used for research purposes.
However, the Health Deans contend that alternative animal-free methods cannot entirely and systematically replace animals yet. These technological limitations are compounded by uncertainties about when a full replacement will be possible without altering the quality and reliability of health research. Consequently, a ban on animal research (immediate or after a set timeline) would put health research under major threat and limit the capacities of universities to provide solutions to health challenges.
The Guild welcomed that in February 2022 the European Commission publicly rejected the European Parliament’s idea of an action plan for an accelerated phase-out of the use of animals in research. We publicly supported its main argument that the current legal framework gives animals used in research sufficiently strong protection. We also support the Commission’s aim to replace the use of animals in research as soon as scientifically possible. While warning against any hasty ban, The Guild also recommends further efforts to ensure fit-for-purpose rules on the use of animals in research as well as increased transparency.