European Commission progresses EU HTA Regulation with second adopted implementing act

The European Commission has adopted the second implementing act under the EU Health Technology Assessment (HTA) Regulation, establishing rules for information exchange related to joint clinical assessments and joint scientific consultations in the context of health technology assessments.

With the EU Health Technology Assessment (HTA) Regulation set to take effect in just a few months, the European Commission has adopted its second implementing act, further advancing the regulatory framework. This act establishes procedural rules for cooperation between the Member State Coordination Group on Health Technology Assessment (HTACG) and the European Medicines Agency (EMA), focusing on information exchange related to joint clinical assessments (JCAs) and scientific consultations (JSCs) for medicinal products, medical devices, and in vitro diagnostics.

The second act, Health technology assessment – cooperation with the European Medicines Agency, was adopted after public consultation involving stakeholders such as patient organizations, societies, pharmaceutical/medical device companies, analytics/technology providers and individuals. It outlines key procedural elements to facilitate effective collaboration between the HTACG and EMA, with support from the HTA secretariat. It focuses on the planning and forecasting of JCAs and JSCs, aiming to create a more coordinated and transparent assessment process across the EU.

The act also addresses the selection of patients, clinical experts, and other specialists for involvement in assessments and consultations, ensuring the right expertise is used. It provides guidance on managing horizontal scientific and technical issues, crucial for harmonizing assessment methodologies and ensuring consistency across member states. Additionally, the act outlines processes for secure information exchange, emphasizing the protection of sensitive data shared among the EMA, HTA secretariat, and the Coordination Group. It includes provisions to maintain confidentiality when sharing information with Coordination Group members, subgroups, and other relevant stakeholders.

Under the EU HTA Regulation, the phased implementation of JCAs will begin in January 2025, starting with oncology drugs and advanced therapy medicinal products (ATMPs). By 2028, the scope of the JCA process will expand to include orphan drugs, with the final phase of the JCA rollout expected by 2030, at which point all healthcare interventions, including medical devices and other medicinal products, will be covered by the joint assessment framework.

Next steps

This implementing act is the second of six acts expected by the end of 2024. The first act, outlining the timelines and procedural steps for conducting JCAs, was adopted in May 2024.

Status of the six implementing acts under the EU HTA Regulation

With the timeline for JCAs rapidly approaching, the European Commission must move quickly to finalize the implementing acts, particularly those affecting oncology drugs and ATMPs. Any delay risks leaving pharmaceutical companies and stakeholders uncertain about the process, giving them little time to prepare. Companies will need to rapidly adapt to new procedural requirements, align their strategies for JCAs, and be ready for the changes ahead. Timely preparation is crucial to avoid delays in patient access to these innovative treatments.