Date: 16/02/2016

Purpose of the meeting

DG SANTE was invited to the EFPIA Working Group on HTA. The purpose of the meeting was EFPIA-REAto present the EU activities on HTA and to discuss the possible ways of HTA collaboration in the area of relative efficacy (REA) in view of the upcoming new Joint Action 3 on HTA.


The biggest concern for EFPIA members is that the Joint REAs are so far not reused at national level, thereby it is important and urgent to have clear re-use criteria and aim at replacing parts of the national reports. EFPIA also called for an early scientific dialogue between regulators, HTA bodies and industry to determine evidence requirements and data needs. On Timing/Process it was considered essential that the joint REA report is issued around or shortly after marketing authorisation in order to avoid delays in market access, for this support of companies to enable timely access to data by HTA bodies is essential. The experience gained in regulatory scientific advice shall be used possibly to align processes and timelines, interaction with companies is important during the process. On methodologies: it was considered important to adopt EUnetHTA methodologies as the “golden” standard and create convergence on national requirements and methodologies.
EFPIA companies are generally committed to support Joint Action 3 , the concerns is more on how this can be done, therefore clarity and transparency on the process and the outcome of the cooperation is essential to attract more interest.

Follow up

European Commission asked EFPIA to share some ideas on: the re-use criteria, possibly as position paper form the Working Group or EFPIA; on HTA long term vision; share executive summary of the EFPIA studies on the topics.

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