Commission Proposal for a European Regulation on HTA: Europe cannot afford an inefficient system for joint clinical assessments

In light of the inclusion of the Commission Proposal for a European Regulation on HTA as an AOB at the 9 December EPSCO, EFPIA, representing the research-based pharmaceutical industry operating in Europe, expresses its strong concerns over the risk that EU member states will opt for what will inevitably lead to an inefficient system of joint clinical assessments. Europe needs to speak with a coherent voice on clinical evidence in the best interests of patients and our healthcare systems.

Unless the Regulation includes a clear role for the Commission as outlined in Article 7 of the proposal and ensures effective use of joint assessments it will create duplication and fail to address the current fragmentation across EU member states in the assessment of clinical evidence. Such an outcome, after almost 20 years of EU-funded cooperation, would fail to serve patients and miss an important opportunity for creating real efficiency and true European added value.

At a time when science is radically changing treatment paradigms, a well-functioning European capacity for joint assessments is essential. EFPIA has engaged in European collaboration on clinical HTA since its inception in the early 2000s. EFPIA members have submitted pharmaceutical products to the EUnetHTA collaboration, meant to build real-life expertise to conduct joint clinical assessments.

EFPIA supports the original Commission Proposal for a Regulation on HTA published in January 2018. It ensures effective harmonisation of clinical data requirements and removal of duplicative assessments, hence accelerating processes throughout Europe, as well as the sustainability of EU clinical HTA collaboration. None of these objectives can be met in a project-based collaboration like EUnetHTA.

Europe’s new Health Commissioner, Stella Kyriakades highlighted her intent to “work closely with all other stakeholders in order to try and find a way forward for this consensus for health technology assessment.” She signaled that. “It’s become obvious that the voluntary way is not working. We need the standard and we need to move forward.”

EFPIA agrees with the Commissioner’s assessment, believing that the future legislative framework will only achieve its aims if:
  • the Commission, as guardian of the treaties, has a clear oversight on the procedural framework, including ensuring that the rights of manufacturers are respected;
  • the Regulation provides for effective use of joint clinical assessments and non-duplication at national level.

EFPIA’s Director General, Nathalie Moll, said “An unpredictable system whereby Member States decide on a case by case basis if and how they commit themselves to use jointly conducted clinical-scientific assessments will not facilitate more efficient access, but will delay it further. It will create unnecessary administrative and regulatory barriers to patients’ access. "Under these circumstances, it may be best to delay implementation of a permanent process for the joint production of clinical assessments until Member States and industry have established sufficient trust in the quality of own joint work and can formally commit to the undisputed use of jointly produced clinical assessments in national decision-making processes. Until such point of trust in the joint work can be reached, Member States, as well as companies should be formally entitled to decide their participation in the new system on a case-by-case basis. Ultimately, what we all want is a system that improves the availability of innovative technologies for patients. Delays, inconsistencies and duplications should not be an option.”