The European Medicines Agency (EMA) and the European Network for Health Technology Assessment (EUnetHTA) 21 consortium have published a
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.