The European Commission has published a draft Regulation on Health Technology Assessment (HTA), focusing on joint scientific consultations for medicinal products for human use and how developers can receive early guidance on the evidence and data needed to carry out a joint clinical assessment of their product. This initiative aims to enhance collaboration between EU Member States to assess new health technologies and provide guidance to developers, facilitating clinical approval and market entry across the EU.
Developers can request joint consultations via an IT platform, in parallel with the European Medicines Agency’s (EMA) scientific advice, ensuring timely and aligned outcomes from both HTA bodies and the EMA. The regulation also foresees the inclusion of relevant experts in the consultations, including patient representatives and stakeholders with expertise in the therapeutic area. Notably, the European Reference Networks for rare and complex diseases, along with their respective European patient advocacy groups and the portal for rare diseases and orphan drugs, are specified as sources for compiling the experts' list.
The proposed regulation fosters a more structured dialogue between experts, regulators, and developers, streamlining the regulatory process and ensuring that patients across Europe can access new treatments safely and efficiently. This is particularly important for therapies targeting complex conditions, such as rare diseases.
The draft act is currently open for public consultation until 29 October and can be accessed here.