Under the leadership of our legal team, we collaborated with colleagues and physicians from Denmark, Sweden, Spain and Croatia on a study on the challenges of transnational collaboration on rare diseases at the request of the Panel for the Future of Science and Technology (STOA).
Over 30 million EU citizens suffer from a rare disease, which is defined by a prevalence of less than one in 2,000. However, a large amount of patient data is required to research and treat rare diseases. However, individual hospitals are often unable to generate the necessary data due to the small number of their own patients.
In order to enable Europe-wide collaboration between different hospitals treating rare diseases and thus solve both the challenges of patient volume and strengthen the exchange of expertise between doctors across Europe, we analysed the legal requirements arising in particular from data protection law, the directive on patients’ rights in cross-border healthcare and the regulation on orphan medicinal products with the support of our European colleagues. The opportunities arising from the European Health Data Space and the European Reference Network were also included.
The aim was to show the European Commission which legal conditions need to be created in order to increase the number of patients and thus the development of clinical expertise. The focus was on the following objectives:
- involvement of European rare disease experts in the treatment of a patient with a rare disease (primary use of patient data),
- access to data from patients with a rare disease (in the form of findings), even if doctors are not involved in the treatment, in order to optimise treatment for their own patients,
- access to patient data for research purposes.
In our opinion, there are currently hurdles, particularly in terms of data protection law, when processing patient data across national borders. The research privilege under Art. 9 (2) lit. j GDPR, but also the possibility of obtaining consent, harbours too many legal uncertainties with regard to the intended objectives of the study.
In order to achieve the objectives nevertheless, we have proposed, among other things, the introduction of a central European centre whose task is to collect and manage patient data in compliance with data protection requirements, also to enable the necessary real-time access to patient data.
The results of the study have already been presented to the STOA committee in Strasbourg and the EU’s SANT subcommittee. It is currently intended to initiate the implementation of the study’s recommendations before the end of the EU Parliament’s legislative period in June 2024.
The study “Addressing challenges to European multi-country collaboration models for rare diseases”, in which we participated, has now been published and can be found via the following link: