Special European HTA Regulation
The new European Regulation on Health Technology Assessment (HTA-r) 2021/2282, which comes into force on 12 January 2025, marks a important step towards the creation of a harmonised system for health technology assessment in the European Union.
The main objective of this regulation is to facilitate patients' access to effective and safe treatments by promoting a coordinated and transparent approach between the different member states.
In our Special Issue, we have used our expertise to analyse the implications of the new European HTA Regulation and disclose its details.
The document provides a comprehensive overview of the procedures, deadlines and responsibilities of the actors involved in the new HTA system.
Publication by the European Commission of the first of the 'Implementing Acts', the Joint Clinical Assessment (JCA) of medicinal productsthe main element of the cooperation system, kicked off a series of updates.
Joint clinical evaluation focuses exclusively on the relative clinical value of a new health technology compared to one or more appropriate comparators or the standard of care.
This focused approach ensures that decisions are based on solid clinical evidence. And it is important to emphasise that the JCA does not evaluate the price or cost-effectiveness of the technology.
The Role of Stakeholders in the HTA Process
The health technology assessment process involves various stakeholders. The coordination group and its subgroups play a key role in the management and conduct of JCAs.
The participation of HTD, patient organisations and experts is crucial to ensure a transparent and effective process.
A Solidarity Pact between EU Countries
The new HTA Regulation represents a pact of solidarity between the 27 countries of the European Union: aims to improve the quality of health services, reduce health inequalities and promote the general well-being of the European population. The procedures and responsibilities of the actors involved are clearly outlined in the regulation, emphasising the importance of a coordinated and transparent approach.
The implementation of the HTA-r recommendations represents an important opportunity for all actors involved. We at Pharma Value are ready.
Our knowledge has been deepened over the months. Already last year we gave some information about the new HTA Regulation with the Poster presented at the 62nd AFI Symposium7 to 9 June 2023 in Rimini and throughout the year we provided updates through the Pharma Value LinkedIn page.
Accompanying the HTA Regulation
Thanks to the knowledge gained from reading official documents and networking with some key players, they use their expertise to analyse the implications of the new European HTA Regulation and disclose its details, Pharma Value has initiated a accompanying pathway to the HTA Regulation and how this impacts on the EU marketing authorisation procedure in EMA and the pricing and reimbursement procedure in AIFA.
If you would like to receive further information and request our advice write to us.
