EMA and the EUnetHTA 21 consortium set priorities for their collaboration Share

April 26, 2022

April 12, 2022

The European Medicines Agency (EMA) and the European Network for Health Technology Assessment (EUnetHTA) 21 consortium have published a PDF icon joint work plan until 2023. The focus of the plan is to prepare, from a methodological and operational perspective, for the coming into application of the Regulation on Health Technology Assessment (EU) 2021/228 in January 2025 after a 3-year implementation period.

The work plan continues the close collaboration between EMA and Health Technology Assessment (HTA) bodies in Europe, which began in 2010 through consecutive EUnetHTA Joint Actions of which the last one concluded in May 2021. This collaboration has demonstrated many synergies between regulatory evaluation and HTA along the lifecycle of a medicine and aims to facilitate patients' access to medicines in the European Union.

Following the award of a service contract to the EUnetHTA 21 consortium to support the continuation of the EU cooperation on HTA, the European Commission invited EMA and EUnetHTA 21 to establish a joint work plan to be carried out during the transition phase in order to deliver on key areas of their collaborative work.

Priority areas in the EMA / EUnetHTA 21 joint work plan include joint scientific consultation for robust evidence generation, generation of patient-relevant data / information to support decision making, and methodologies to engage patients and healthcare professionals. Activities related to the delivery of the service contract will be given high priority and will be actioned by EUnetHTA 21.

The European procedure for joint scientific consultation by HTA bodies in parallel with scientific advice by EMA, previously known as parallel scientific advice or parallel consultation or Early Dialogue, has recently been relaunched. This procedure provides a platform for medicine developers to discuss their plans for evidence generation for a medicine throughout its life span with both regulators and HTA bodies, including plans for post-licensing evidence generation.

The work plan also aims to facilitate information exchange between regulatory assessors and HTA bodies on products of mutual interest, including advanced therapy medicinal products (ATMPs). Earlier engagement between regulators and HTA bodies should support the uptake of innovation in healthcare systems for the benefit of patients across Europe.

Note

The EUnetHTA 21 consortium had been awarded the service contract for the provision of joint health technology assessment (HTA) work supporting the continuation of EU cooperation on HTA by the European Health and Digital Executive Agency (HaDEA). The contract will run for 24 months, and until 16 September 2023. EUnetHTA 21 work will build on the achievements and lessons learned from the EUnetHTA Joint Actions and focus on supporting a future EU HTA system under the Regulation(EU) 2021/2282. The EUnetHTA 21 joint consortium is led by ZIN (The Netherlands) and includes the following HTA agencies: AEMPS (Spain), AIFA (Italy), AIHTA (Austria), GBA (Germany), HAS (France), INFARMED (Portugal), IQWIG (Germany), KCE (Belgium), NCPE (Ireland), NIPN (Hungary), NOMA (Norway) and TLV (Sweden).

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