Il Parlamento Europeo adotta il regolamento su Health Technology Assessment
The European Parliament has formally adopted the Regulation on Health Technology Assessment (HTA), which will make it mandatory for centrally authorised medicinal products and selected medical devices to undergo joint clinical assessment at the EU level.
The legislation will first apply to cancer medicines and Advanced Therapy Medicinal Products (ATMPs) starting from January 2025, expanding to cover Orphan Medicinal Products (OMPs) in 2028 and finally to cover all centrally authorised medicinal products in 2030.
The European Commission (EC) has published a Q&A document which provides an overview of the Regulation and the next steps.
Over the next 3 years, the Commission is tasked with developing detailed procedural rules and the methodology that will be used for EU HTA processes. This will involve setting up a Stakeholder Network, where EU trade associations will be represented and given the chance to become involved in transversal EU HTA activities:
- Guidance for the interaction between Health Technology Developer and HTA (for Joint Scientific Consultations and Joint Clinical Assessments)
- Guidance and template for the interaction with patient representative, healthcare professional and other experts
- Guidance for identifying and handling conflict of interest (COI) and declaration of interest (DOI) and EUnetHTA confidentiality agreement (ECA) forms
The methodology is being prepared by the EC’s service provider EUnetHTA21, and several deliverables and public consultations are foreseen over the next 2 years.
A full overview of the upcoming methodological guidance and corresponding stakeholder consultations is listed in the attachment below.