The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published a statement expressing its concerns over the current proposal for joint clinical assessments.
In a press release, EFPIA makes clear they believe that the current form of the Commission Proposal for a European Regulation on HTA risks compromising its ability to achieve its objectives. They say:
“EFPIA…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.”
EFPIA’s position has been, and continues to be, that a centrally-administered system which harmonises data requirements and removes duplication is the ideal outcome, and that the original proposed joint HTA achieves this. The current proposal is based around collaboration on a project basis.
The statement is of high relevance now, as the proposed Regulation is due to be discussed at the December meeting of the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO).
Read the full EFPIA press release here.