The European Medicines Agency (EMA) is gearing up to support the implementation of the new regulation on health technology assessment (HTAR), formally known as Regulation (EU) 2021/2282, which becomes applicable on January 12, 2025. The regulation represents a significant step forward in improving and accelerating patient access to novel medicinal products within the European Union.
Access to a centrally authorized medicine in the EU is a two-step process. First, the EMA performs a regulatory assessment to authorize the medicine for use in patients. Second, health technology assessment (HTA) bodies evaluate the medicine to assist EU member states in decisions regarding its use, pricing, and reimbursement levels. These decisions take into account the health technology’s impact on the sustainability of the healthcare systems.
“EMA welcomes the new HTA regulation and is ready to do what it takes to support the European Commission and the Member States in its successful implementation. While our role is supportive, the new regulation will enable our collaboration across decision-makers reinforcing efforts to improve access to medicines for all patients in the EU. In our network strategy to 2028, facilitating the path to accessibility of new medicines for patients is a priority and the framework for cooperation and the exchange of information between regulators and HTA bodies provided by the new rules will help galvanise our efforts,” said EMA’s Executive Director, Emer Cooke.
The regulation also establishes an EU framework for assessing selected high-risk medical devices, aiding national authorities in making more informed and timely decisions about pricing and reimbursement. EMA will be supporting the implementation of the legislation in three key areas:
- Joint Clinical Assessments (JCAs): The EMA will help the HTA Coordination Group conduct these assessments. This involves determining the relative clinical effectiveness and safety of new health technologies compared to newer or existing technologies. The EMA will provide relevant information derived from its own regulatory assessments.
- Joint Scientific Consultations (JSCs): The EMA will collaborate with the HTA Coordination Group in offering scientific advice to technology developers. This is intended to facilitate the generation of evidence that meets the needs of both regulatory bodies and HTA entities.
- Information Exchange: The EMA will share information about upcoming applications and future health technologies, which will assist with planning and future trends identification.
The regulation recognizes the value of collaboration between regulators, who assess the benefits and risks of medicines, and HTA bodies, who then compare their effectiveness to existing products. This builds upon the long-standing cooperation between EMA and HTA bodies, which was established in 2023 with the European Network for Health Technology Assessment (EUnetHTA).
To prepare for the regulation’s implementation, the EMA has been working closely with the European Commission, EU Member States, and a range of stakeholders, including the pharmaceutical industry, healthcare professionals, patients, and academia.
The new rules will initially apply to new active substances for treating cancer, as well as all advanced therapy medicinal products (ATMPs). These rules are scheduled to be extended to orphan medicinal products in January 2028 and to all centrally authorized medicinal products by 2030. Selected high-risk medical devices will also be assessed under the HTAR starting in 2026.
When the EMA receives submissions for marketing authorization applications for medicinal products included in the scope of JCAs, it now has a legal obligation to notify the European Commission – which acts as the secretariat for the HTA Coordination Group (HTACG). This ensures that procedures are correctly followed and that joint work is produced in a timely and transparent way. The Agency began identifying such applications in June 2024.
Based on expected marketing authorization applications to EMA and submission plans from health technology developers, the HTACG estimates that it will need to conduct 17 JCAs for cancer medicines and 8 JCAs for ATMPs in 2025. Note that cancer-related ATMPs are included in the cancer medicines count. The actual number of JCAs will depend on the formal submissions received by EMA. Guidance for companies on declaring products in the scope of JCA can be found on EMA’s website.
Additionally, the EMA now has a legal obligation to provide information from ongoing regulatory assessments. Details about the information to be exchanged will be developed in collaboration with EMA’s Committee for Human Medicines and the JCA subgroup. It is important to note that both the HTA assessment and the benefit-risk assessment for a particular medicine continue to be performed independently within their specific remits and according to their respective legal frameworks.
In February 2025, the HTACG will launch the first request period for JSCs. During this period, developers can indicate if they wish to request parallel JSCs with EMA. The future processes for parallel JSC are built on experience from the initial piloting in 2008 and further process improvements over time. This year, the HTACG plans to initiate 5 to 7 joint scientific consultations for medicinal products and 1 to 3 joint scientific consultations for medical devices.
