Following today’s publication of the proposed amendments to Directive 2001/24/EU, EFPIA has underlined its support for the new proposals aimed at strengthening EU-level collaboration on HTA with focus on clinical benefit assessments.

Commenting on the proposals, EFPIA Director General Nathalie Moll said. “Access to innovative health technologies for EU patients is a shared goal. Our healthcare systems are facing some unprecedented challenges from an ageing population and the increasing prevalence of diseases such as diabetes, cancer and dementia. Undoubtedly, the 7000 new medicines in development; new treatments like gene and cell therapies or combination therapies for patients fighting cancer will play a key role in addressing these challenges. Continued collaboration on how we introduce these new technologies into our healthcare systems will be key. HTA is an important part of that process, informing health care decision makers about the relative value of health technologies. In our view, the Commission’s proposals represent a positive, collective step forward in supporting access to new treatments for patients across Europe”.

Within the proposals, EFPIA believes that joint clinical assessments will facilitate faster access, avoid duplication at national level and deliver greater consistency, clarity and predictability for everyone involved in the process. Joint scientific consultations or “early dialogue” will help to ensure that medicine development programmes meet the data and evidence requirements of both future regulatory and clinical benefit assessments. The inclusion of horizon scanning will facilitate better planning and management of the introduction of new health technologies that have a significant impact on patients, on healthcare systems and on society.

Like with any substantial policy development, there will be areas of implementation that require further examination and discussion. At EFPIA, we look forward to continuing the dialogue with all stakeholders including patients, healthcare professionals, representatives from Member States and EU Institutions to ensure that the proposals help us achieve the shared goal of improving the availability of innovative health solutions to patients across Europe.