The Guild welcomes the Commission Communication on the Pharmaceutical Strategy for Europe as an essential step towards the creation of a European Health Union.
Research and innovation are key components of the pharmaceutical value chain. The Guild strongly supports the Pharmaceutical Strategy’s acknowledgement of the importance of investment in this area and the planned support via the Horizon Europe and the EU4Health programmes.
The Strategy addresses some of the challenges highlighted in The Guild’s position paper published in September 2020. This includes the need to address unmet health needs in areas where there is a lack of interest from industrial shareholders, and the need to align existing regulatory frameworks with rapidly developing innovations in medicine. In this respect, we welcome the Commission’s planned actions to increase cooperation in scientific advice on clinical study design and we call for a strong involvement of the academic community in this process.
We congratulate the Commission for its efforts in ensuring the full implementation of the Clinical Trials Regulation (EU No 536/2014) and its work to make the new framework supportive of innovative trial designs and pragmatic trials which are mainly organised by academia. The Regulation, which will become applicable in 2021, after the development of a fully functional EU clinical trials portal and database, will ensure greater coordination in the assessment and oversight of clinical trials, while addressing new developments such as complex trials. The implementation of the new provisions will be a step in the right direction to facilitate the conduct of clinical trials in the EU.
While recognising the value of these actions, we reiterate our call for a dedicated framework to facilitate the pursuit of multinational clinical studies within the EU, backed by adequate funding. The scope of such a framework should go beyond times of crisis and should include the creation of a platform where researchers from all EU countries can express an interest in joining multinational clinical studies. We do hope that the increased collaboration advanced by the Strategy and the reinforced role of the European Medicines Agency (EMA) in the coordination of clinical trials in health emergencies will provide the basis for such a wider framework.
Finally, we strongly support the development of a European Health Data Space (EHDS). Today researchers face significant barriers in the sharing and re-use of health data, which is an obstacle to scientific discoveries and to harnessing the potential of data-driven science. The EDHS holds the promise to help solving these issues and facilitate health research. To achieve this, it is crucial to solve issues related to the interpretation of the General Data Protection Regulation (GDPR) and ensure the interoperability of data required for health research.
The Guild is committed to continuing to work with the European Commission in the implementation of the Strategy.
Proposals for the Pharmaceutical Strategy for Europe - Position Paper | 15 September 2020
This article was first published on 26 November by The Guild.