Commission proposal for a European regulation on HTA


29 November 2019 - 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.

Read EFPIA press release

Michael Wonder

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Michael Wonder