HTA: the HAS, a lead player in the European cooperation for health technology assessment
As part of the forthcoming adoption of a new European Regulation on Health Technology Assessment (HTA), the HAS and 12 other national agencies united within the EUnetHTA21 consortium (European Network of HTA 21), won a call for tenders launched by the Commission to strengthen European collaboration. In parallel, the president of the HAS, Prof. Dominique Le Guludec, was elected co-chair of the Heads of Agencies Group (HAG) on September 29. This group will set the strategic guidelines for HTA. The HAS thus reaffirms its long-standing commitment to European cooperation for the assessment of health technologies and aims to position itself as a methodological benchmark.
For many years, the establishment of a common assessment of health technologies has been a major challenge for the European Union. To advance collaboration in this area, the European Parliament and the Council of the European Union are preparing to adopt, at the end of this year, a European Regulation on the common assessment of these technologies - the implementation of which will come into effect in 2024, three years after its entry into force. This interval should allow Member States to adapt their national procedures according to the provisions of the regulation, but also to put in place - at European level - the framework necessary for the proper carrying out of joint evaluations.
To this end, the European Commission launched a call for tenders in February 2021 to work on the divergences identified during previous collaborations and to set up a common methodological basis. The tender will provide for the carrying out of 2 joint evaluations on medicinal products and 4 on medical devices to test the new methodological approaches developed.
The HAS is given a leading role within the EUnetHTA21 consortium
A pioneer in European cooperation in health technology assessment, the HAS responded to this call for tenders in association with 12 other national agencies within the EUnetHTA21 consortium.
On September 23rd, the European Commission announced that it had selected the EUnetHTA21 project submitted in May of 2021 and is committed to 2 years’ worth of funding, at the height of three million euros.
The HAS is called upon to play an active role in this project. It will participate in the development of methodological guides and the design of the common evaluation procedure for high-risk medical devices. It will also participate in the development of joint evaluations (medical devices and drugs) and scientific advice to industry. The HAS is also involved in governance, by serving as vice-chairman of the executive committee and chairmanship of the committee responsible for ensuring the consistency and quality of deliverables.
The 13 agencies of the EUnetHTA 21 consortium
· G-BA (Gemeinsame Bundesausschuss), Germany,
· IQWIG (Institute for Quality and Efficiency in Health Care), Germany,
· AIHTA (Austrian Institute for Health Technology Assessment), Austria,
· KCE (Belgian Health Care Knowledge Centre), Belgium,
· AEMPS (Agencia Española de Medicamentos y Productos Sanitarios), Spain,
· HAS (Haute Autorité de santé), France,
· NIPN (National Institute of Pharmacy and Nutrition), Hungary,
· AIFA (Italian Medicines Agency), Italy,
· NCPE (National Centre for Pharmacoeconomic), Ireland,
· NOMA (Norwegian Medicines Agency), Norway,
· ZIN (National Health Care Institute), Netherlands,
· INFARMED (National Authority of Medicines and Health Products), Portugal,
· TLV (Dental and Pharmaceutical Benefits Agency), Sweden.
Prof. Le Guludec elected co-chair of the Heads of Agencies Group (HAG)
Professor Dominique Le Guludec, President of the HAS, participated on September 29 in the launch of the Heads of Agencies Group (HAG), which brings together heads of national health technology assessment agencies. A strategic body, the HAG, is called upon to set guidelines for European cooperation, with the EUnetHTA21 Consortium and the Coordination Group of the new HTA regulation which will be set up in early 2022. Elected to preside the group is Professor Rui dos Santos Ivo, President of the Portuguese agency INFARMED. Prof. Le Guludec and Dr Trygve Ottersen, Executive Director of the Norwegian Institute of Public Health NIPHNO, are the two co-chair.
These new responsibilities are linked to several years of consistent investment of HAS teams in this area, positioning France as a benchmark in the field of health technology assessment methods. European cooperation within the framework of the Consortium and the HAG aims to improve the quality and standardization of the evaluation of medicinal products and medical devices which will in future be carried out jointly, at the level of the European Union, with the objective of promoting access to innovative health products in the interests of patients.
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