EMA is ready to support the implementation of the new regulation on health technology assessment (HTAR) (Regulation (EU) 2021/2282) when it becomes applicable on 12 January 2025.
The regulation is an important step forward in accelerating and widening access to new medicines. In the European Union (EU), a centrally authorised medicine is accessible to patients when it has first gone through regulatory assessment by EMA and is authorised for use in patients, and secondly been evaluated by health technology assessment (HTA) bodies to help Member States take decisions about the use, price and reimbursement level of a new health technology taking into account its 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."
The regulation also creates an EU framework for the assessment of selected high-risk medical devices to help national authorities to make more timely and informed decisions on the pricing and reimbursement of such health technologies.
EMA will support the implementation of the new piece of legislation in three areas. It will:
The regulation recognises the value of cooperation between decision-makers, namely regulators who evaluate the benefits and the risks of medicines and HTA bodies who then assess their effectiveness compared to existing products. It builds on the longstanding cooperation between EMA and HTA bodies, developed with the European Network for Health Technology Assessment (EUnetHTA) until September 2023.
EMA has been supporting the preparation for the implementation of the regulation by working closely with the European Commission, EU Member States, and stakeholders representing the pharmaceutical industry, healthcare professionals, patients and academia.
The new rules will initially apply to new active substances to treat cancer and to all advanced therapy medicinal products (ATMPs). They will be expanded to orphan medicinal products in January 2028, and to all centrally authorised medicinal products as of 2030. Selected high-risk medical devices will also be assessed under the HTAR as of 2026.
EMA now has a legal obligation to notify the European Commission, which serves as the secretariat to the HTA Coordination Group (HTACG), ensuring that procedures are followed and joint work is produced in a timely and transparent manner when it receives submissions for marketing authorisation applications for medicinal products in the scope of JCA. From June 2024, the Agency started identifying such applications.
Based on anticipated marketing authorisation applications to EMA and health technology developers' submission plans, the HTACG estimates that it will need to conduct 17 JCAs for cancer medicines and 8 JCAs for ATMPs in 2025. 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.
EMA also has a legal obligation to provide information from ongoing regulatory assessments. The details to be exchanged will be developed together with EMA’s committee for human medicines and the JCA subgroup. The HTA assessment and the benefit-risk assessment on a particular medicine continue to be performed independently within their respective remits and following their respective legal frameworks.
In February 2025, the first request period for JSC will be launched by the HTACG. In this context, developers can indicate whether they wish to request parallel JSC with EMA. The future processes for parallel JSC have been built based on experience gathered since the initial piloting in 2008 and the iterations of process improvement performed over time. This year, the HTACG is planning to initiate 5 to 7 joint scientific consultations for medicinal products and 1 to 3 joint scientific consultations for medical devices.
The HTA Regulation established the Coordination Group on Health Technology Assessment (HTACG) composed of Member States’ representatives, mainly from HTA authorities and bodies. The European Commission provides the secretariat to the HTA Coordination Group (HTA secretariat).