EU HTA; compromise but at what cost?

EFPIA notes with concern the provisional agreement on increased EU-level cooperation of member states on health technology assessment (HTA) reached by the European Parliament and Council negotiators. EFPIA strongly supports a system to pool resources and high level expertise so that medicines can be assessed jointly for their relative effectiveness on the basis of clinical evidence and that joint early scientific dialogue can take place with HTA agencies.   

However, we regret that a stronger framework for the use of Joint Clinical Assessments could not be agreed upon. We maintain that the shape of the compromise risks introducing an unpredictable system whereby Member States decide on a case-by-case basis if and how they commit themselves to use jointly conducted clinical assessments. This will create unnecessary administrative and regulatory barriers to patients’ access to new medicines introduced in Europe. 

The failure to agree on a predictable, efficient, and non-duplicative system is a missed opportunity, coming at a time when science is radically changing treatment paradigms. Now, more than ever, Europe needs to speak with a coherent voice on clinical evidence in the best interests of patients and our healthcare systems. 

Since the HTA Regulation was proposed in 2018, industry has consistently advocated for a system that effectively reduces duplication of clinical assessments and ensures that joint assessments are used by all the EU member states in their own process of HTA. 

EFPIA acknowledges the work of the Members of the European Parliament in advocating for a stronger EU voice and added value of the Regulation through provisions with regards to the uptake of joint clinical assessments. We support the use of safeguards to ensure that joint assessments cannot simply be ignored. 

Beyond the approval of the final compromise, the collective focus should be on ensuring effective implementation of the framework in a well-resourced system. We believe the HTA Regulation should be a launchpad for more systematic, scientific and evidence-driven joint work to advance the speed, quality and efficiency of decision making to foster faster, more equitable access to medicines for patients across Europe. Industry stands ready to constructively engage in the debate around the practical implementing details to ensure a robust EU-level system that delivers quality outputs for the benefit of patients.