Following the Public Consultation on the draft implementing act on the joint scientific consultations on medicinal products for human use under the Health Technology Assessment (HTA) Regulation, the BioMed Alliance has shared a response on the proposal. The aim of the initiative was to establish clear procedural rules for health technology developers when it comes to receiving early guidance that is required for conducting a joint clinical assessment of products.
The BioMed Alliance welcomes the proposed implementing regulation for joint scientific consultations on medicinal products under Regulation (EU) 2021/2282. Healthcare professionals and researchers agree that HTA should have a strong scientific basis, and the Alliance would therefore like to offer the following remarks and suggestions for consideration:
- Expert Selection: High-quality HTA requires the participation of top experts from diverse fields. European medical societies can help identify these experts, ensuring that only those with the most relevant, specialized knowledge are included.
- Timely Information Sharing: Medical societies require clear timelines and prompt information sharing to accommodate experts’ busy schedules.
- Conflict of Interest Management: A balanced approach to managing Conflict of interest, acknowledging that experts may be involved in various initiatives with different stakeholders, including industry and institutions.
Check out the response in the attachments below.