European Commissions draft implementing regulation on Joint Scientific Consultation
Lightning Health
Global market access consultancy supporting the life cycles of health technologies
The European Commission (EC) has recently published the draft implementing regulation on Joint Scientific Consultation (JSC) for the EU joint Health Technology Assessment process. This new framework presents notable changes that could significantly impact the way in which scientific advice is integrated into healthcare decision-making across Europe.
Structured Request Periods
The Coordination Group will set the dates for JSC request periods each year by the 30th November, with at least two request periods scheduled annually.
Impact to manufacturers:?This structured timeline allows manufacturers to better plan their submissions, but may also create competition for limited slots, especially if HTA agencies face capacity challenges.
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Criteria for JSC Selection
The selection of candidates for JSC will focus on drugs addressing unmet medical needs, those that are first in class, or have a potential impact on patients and public health. Furthermore, priority will be given to medicines with significant cross-border relevance and those contributing to Union-wide clinical research.
Impact to manufacturers: R&D efforts should focus on innovative therapies that align with these criteria, as these will have a higher likelihood of being selected for joint consultation, accelerating time to market.
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Expertise and Consultation
When a drug is chosen for a JSC, stakeholders with relevant expertise (particularly those covering multiple EU member states) will be consulted. Stakeholders may come from various sources, including patient advocacy groups, European reference networks, and the European Medicines Agency. The JSC Subgroup is encouraged to seek input from various organisations to ensure that diverse perspectives are considered during the consultation process.
Impact to manufacturers:? Manufacturers can expect more comprehensive consultations, but must be prepared for potentially complex, multi-country perspectives that could lengthen the consultation process.
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Broad Participation
Invitations to JSC meetings will be extended to a range of participants, including health technology developers, individual experts, and staff from the HTA secretariat. This broad participation aims to foster a comprehensive dialogue on the innovative therapies being assessed.
Impact to manufacturers: The inclusion of various stakeholders can lead to more robust feedback, however manufacturers may need to increase investment in cross-functional representation to effectively engage in these meetings.
The new framework holds promise of a more unified approach to scientific consultation across the EU, which could ultimately benefit manufacturers. However early preparation, resource management, and strategic alignment with the new framework will be essential to leverage the benefits of JSCs.
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