Diverging EU Health Regulations – Urgent Need for Harmonization

Recently, an article has been published in the Journal of Cancer Policy explaining the lack of co-ordination and convergence at the EU level as well as within the Member States concerning the legal framework of health research. EORTC currently observes alarming signals indicating that future research and data sharing generated by international research projects are seriously endangered.

Nowadays, major breakthroughs are achieved in the knowledge of molecular biology leading to changes in design and conduct of innovative clinical research. The current legal framework for health research is developed and revised by several Directorate-Generals (DGs) dealing with clinical trials, data protection, in-vitro diagnostic tests and biomarkers. Also medical devices and advanced therapy directives and regulations have to be taken into consideration, all within a single trial. Such a fragmentation of the legal framework and national laws leads to inconsistencies, wasting time and scarce resources of sponsors.

With the rapid development of new technologies and personalized treatments, biomarkers, gene signatures and other advances in diagnostic development became of the utmost importance in the field of oncology. There is a strong call for both, drugs and diagnostic tools to be developed in parallel. On the other hand, the regulatory environment is not keeping up with the rapid technological advances and therefore slows down the researchers in their move towards such co-developments.

Back in 2012, the EU issued three key draft regulations critical to the field of healthcare research: the clinical trials regulation (CTR), the in-vitro diagnostics regulation (IVDR) and the data protection regulation (DPR). In the field of personalized cancer treatment, the rise of biomarker-based clinical trials, performed internationally to access molecularly defined patient populations in the EU would fall simultaneously under the CTR and IVDR with the additional need to comply with the general DPR, which emphasizes the importance of co-ordination between all these regulations.

As the three regulations are developed by different DGs with somehow divergent priorities, the way these regulations currently come-up together is not really optimal, revealing numbers of contradictions and issues arising specifically from their cumulative application.

The clinical trial directive showed that the devil is in the details and details arise during implementation. Therefore, EORTC believes that the only way to insure an efficient implementation of the three regulations is to harmonize the requirements simultaneously through a multi-stakeholder and multi-DG open dialogue, optimizing the use of implementation instruments embedded into these regulations for the benefit of the European patients.