The European Health Technology Assessment (HTA) landscape has long been characterised by heterogeneity in the clinical evaluation of health technologies after they receive market authorisation. This leads to inconsistency in decision-making which originates from the fact that while the European Commission grants marketing authorisations at the central level with validity across the EU, decisions about pricing, reimbursement, relative clinical effectiveness and national launch are the competency of the individual member states.
While previous initiatives, such as the voluntary joint actions under the European Network for Health Technology Assessment (EuNetHTA), aimed to foster collaboration across member states, they were not developed with the purpose of fully unifying the process. The introduction of the EU HTA Regulation (HTAR) marks a transformative shift, introducing earlier and more coordinated efforts between EU member states in the clinical assessment of an HTA dossier across Europe.
ProPharma recognised this European HTA transformation early. With decades of experience in the HTA field, particularly in the HTA assessments and procedures under the EuNetHTA, the company has developed tools and capabilities that meets the evolving needs of Health Technology Developers (HTDs). These solutions support HTDs in pursuing a Market Authorisation while simultaneously navigating the organisational and competency shifts as required by the new European HTAR.
The Rise of Joint Clinical HTA Assessments on a European Level
EU cooperation on HTA has a long history, leading to the legislative proposal for the HTAR. This history includes the EUnetHTA Joint Actions and the HTA Network. EUnetHTA Joint Actions were the scientific and technical components of EU cooperation on HTA, funded under the EU Health Programmes. They began with the development of joint clinical HTA activities in 2010–2012 and, building on these successes, led to increased uptake by national HTA bodies from 2016 onwards. The HTA Network connected national authorities and bodies responsible for HTA and provided strategic guidance and policy orientation for scientific and technical cooperation.1
This evolution of the EU cooperation on HTA has therefore been a gradual and strategic journey, culminating in the adoption of the HTAR. This reflects years of collaborative effort to harmonise HTA practices across member states and improve the efficiency and consistency of clinical evaluations.2
With the adoption of the HTAR (and the associated Implementing EU Regulation 2024/1381, the first legal framework for a unified, EU-centric review process for HTA was established, while leaving the final responsibility for pricing & reimbursement decisions to the individual EU Member States.4
The regulation officially entered into force on January 11, 2022, with full application for new oncology medicines and Advanced Therapy Medicinal Products (ATMPs) going through a centralised European Market Authorisation Approval (MAA), starting January 12, 2025. By 2030, this framework will eventually apply to all new health technologies.5
