Draft EU HTA regulation implementing act sets out rules for joint scientific consultations
The fourth implementing act has been released, with the European Commission seeking feedback on the proposed rules joint scientific consultations.
With the Regulation (EU) 2021/2282EN on health technology assessment (HTAR) coming into effect January 2025, the European Commission is ramping up its advice to stakeholders looking to participate in the process. Aimed at reducing duplication across member states and ensuring faster access to innovative treatments, HTAR introduces joint clinical assessments (JCAs) for new medicines and high-risk medical devices. The regulation also provides a framework for joint scientific consultations (JSCs), allowing developers to receive early guidance on the clinical evidence and data required for JCAs.
Previous acts, now formally adopted following a public consultation period, have established the procedural rules for JCAs of medicinal products, assessing and managing conflicts of interest and cooperation between the Member State Coordination Group on Health Technology Assessment (HTACG) and the European Commission (EC) with the European Medicines Agency (EMA). The fourth draft implementing act, titled “Health technology assessment – Joint scientific consultations on medicinal products for human use”, provides details on how developers can engage with EU-level experts to obtain advice on ahead of formal JCA of their product. Future acts are imminent and will provide clarification around JCAs of medical devices and JSCs on medical devices and in vitro diagnostic medical devices.
The EC’s initiative on JCSs facilitates collaboration between health technology developers and the HTACG on the development plans for medicinal products. The consultations aim to streamline the preparation of JCAs by offering developers guidance from the HTACG “on the information, data, analyses and other evidence that are likely to be required from clinical studies” JCAs. JSCs may also be conducted in parallel with scientific advice from the EMA, thus synchronized timing and document submission to both bodies is required.
To ensure legal clarity for developers, the regulation mandates the establishment of deadlines and a minimum number of request periods for consultations. The HTACG is required to set these request periods by 30 November each year, coinciding with the adoption of its annual work program. At least two request periods for consultations must be provided each year. Developers are also allowed to submit updates on their amended development plans no later than 10 days before the formal JSC meeting. Further guidance is expected to clarify the exact timetable for each consultation process.
JSCs meetings will include a broad range of stakeholders, such as JSC assessors, health technology developers, clinical and patient experts, as well as other relevant experts in the disease or therapeutic area. If a JSC is held concurrently with the EMA’s scientific advice, EMA representatives will also participate in the discussions.
The public consultation period for the draft act is open for 4 weeks and feedback is sought by October 29, 2024.