Stakeholders are bracing for the European Union’s upcoming Health Technology Assessment Regulation (HTAR), set to unify health technology assessments across the EU within the next year. There’s widespread concern about the readiness of stakeholders and the complexity of the administration involved.
The Health Technology Assessment Regulation will establish a Joint Clinical Assessment (JCA) to standardize the evaluation of the clinical effectiveness of drugs and medical devices across the EU’s 27 Member States. This aims to eliminate the current inconsistencies in how these assessments are conducted.
At the DIA Europe 2024 conference in Brussels, a gathering of scientific, healthcare, patient advocacy, and regulatory professionals, Maya Matthews from the European Commission highlighted the groundbreaking nature of this initiative, stressing the collective effort to act as a unified Europe. Matthews pointed out the objective of generating evidence-based reports to help Member States make faster reimbursement decisions.
European Stakeholders Urged to Prepare for New Health Technology Assessment Regulations
The regulation will initially apply to cancer drugs and other advanced therapy medicinal products in the first quarter of 2025, with plans to include all drugs with a Marketing Authorization from the European Medicines Agency by 2030. However, a poll indicated that many stakeholders are still unprepared for the changes.
Michael Berntgen from the European Medicines Agency emphasized the urgency of preparing for the new procedure, particularly for products that will be submitted for initial marketing authorization after January 2025. Similarly, Inka Heikkinen from the EFPIA Health Technology Assessment Working Group urged stakeholders to begin preparations immediately, regardless of their filing timeline.
Streamlining Healthcare Innovation in Europe: Concerns and Calls for Extended Preparation Time
Concerns have been raised about the JCA procedure’s potential to create redundancies and add administrative burdens. While the JCA aims to streamline the process and facilitate quicker access to medical innovations, the ultimate decision on national reimbursement remains with individual countries.
The industry is also worried about the short timeline for dossier preparation, suggesting that more than the allocated 90 days are needed to ensure quality submissions.
The regulation represents a significant step towards simplifying access to medical products and devices in Europe, aiming to attract investment and focus on patient-centered innovation. Stakeholders are calling for urgent action to address these concerns and ensure a successful transition to the new regulatory framework.
Resource: Euractiv, March 21, 2024
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