European collaboration between regulators and health technology assessment bodies Joint work plan (2021-2023) between EMA and European HTA bodies facilitated through EUnetHTA21
Close collaboration between EMA and the EUnetHTA 21 consortium aims to support preparing for the coming into application of the new Health Technology Assessment (HTA) Regulation
EMA and the previous European Network for Health Technology Assessment (EUnetHTA), which was established through consecutive Joint Actions of which the last one concluded in May 2021, started their collaboration in 2010 based on recommendations from the High-level Pharmaceutical Forum ,with the aim to harness synergies between regulatory evaluation and health technology assessment (HTA) along the lifecycle of a medicine. A first EMA-EUnetHTA work plan was established for the years 2012-2015 and a report on the outcomes of this joint work published in April 2016. Subsequently, a second joint work plan for the years 2017-2021 was agreed and a report published in June 2021.
Following up on the achievements through such cooperation and the mutual trust and understanding developed through this joint technical work, EMA and EUnetHTA at their last bilateral during Joint Action agreed to establish a list of priority areas for future collaboration between regulators and HTA at European level to continue future collaborative work. The overall goal of such collaboration is to improve efficiency and quality of processes, whilst respecting the respective remits of different decision makers, and ensure mutual understanding and dialogue on evidence needs, to facilitate access to medicines for patients in the European Union.
Subsequent to the award of the “Service contract for the provision of joint Health Technology Assessment (HTA) work supporting the continuation of EU cooperation on HTA” to the EUnetHTA21 consortium, the European Commission has invited EMA and EUnetHTA21 to establish a joint work plan for delivering on the previously identified priorities. Deliverables on HTA side will either be actioned by EUnetHTA21 if related to their service contract delivery, or alternatively through individual HTA bodies from the consortium or beyond, who are from a European (EU/EEA) Member State and express interest to participate. In the latter situation, individual HTA bodies represent their own position and not the views of EUnetHTA21. In addition, all deliverables part of EUnetHTA21 will be subject to a public consultation, to which EMA is invited to participate.
EMA and the EUnetHTA21 secretariat will keep an oversight of all activities.