EFPIA statement on today's meeting of EU Health Ministers
In line with many of the views shared by Member States at today’s video conference of Health Ministers, EFPIA welcomes the proposals from the Commission to strengthen Europe’s capacity to prepare and respond to public health threats, including through strengthening the capacity of the EMA and the ECDC as well as the proposal to set up an EU Health Emergency Response Authority (HERA).
Discussions on the EU Pharmaceutical Strategy were not open to the public. We remain concerned that, although the Strategy contains a number of proposals that will benefit the European research, manufacturing and bio-preparedness eco-system, the overall impact of the Strategy will be to put Europe further behind other regions of the world in generating medical innovation. That means patients in Europe will have to wait longer to access the latest diagnostics, treatments and vaccines. Reducing disparities, delays and barriers to access is a goal we share; finding collaborative solutions based on shared understanding of the root causes would be more effective and less damaging to innovation than trying to use incentives and regulations that were designed to support research and development or assess safety and efficacy.
In light of the inclusion of the Commission Proposal for a European Regulation on HTA at today’s meeting, EFPIA, expresses its strong concerns over the risk that the compromise pursued by the EU Member States will inevitably lead to an inefficient system of joint clinical assessments and further delay access for patients. At a time when science is radically changing treatment paradigms, a well-functioning European capacity for joint assessments is essential. 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.
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 assessments will not facilitate more efficient access, it will delay it further. It will create unnecessary administrative and regulatory barriers to patients’ access. Under these circumstances, it may be best to delay the implementation of a permanent process for the joint production of clinical assessments until all parties have established sufficient trust in the quality of joint work on clinical assessments and can formally commit to the undisputed use of it in national decision-making processes. Until such a point of trust in joint clinical assessments is 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.”
The current compromise emerging risks leading to a cumbersome, siloed and un-balanced process with unreasonably numerous opportunities for disagreement and delays. In order to preserve the spirit of enhanced EU level collaboration on joint clinical assessment, aiming to streamline evidence requirements, reduce duplication and divergence of assessment outcomes and improve predictability, it is of utmost importance that the process leads to high-quality joint clinical assessment reports and their de-facto use by decision-makers at national level.