On Sunday, 12 January, the Regulation on Health Technology Assessment (HTA) will take effect, enhancing access to innovative health technologies for patients across the EU. This regulation establishes a framework for assessing health technologies, such as medicines and medical devices, fostering collaboration among EU Member States. It aims to help national authorities make informed decisions on pricing and reimbursement, thereby streamlining the process for developers and ensuring faster patient access to effective products.
“I welcome the start of application of the new EU rules on Health Technology Assessment. European patients need quicker access to innovative and lifesaving medicines and medical devices and we are one step closer to making this a reality,” Olivér Várhelyi, Commissioner for Health and Animal Welfare, said.
“We must now ensure that these rules are fully put into practice across the EU – to make better use of available resources, to ensure faster entry into the market for pharmaceuticals with lower costs, less red tape and faster administrative procedures to get them included into the reimbursement schemes. This is central for a strong European Health Union that delivers for citizens and strengthens the EU’s competitiveness,” the Commissioner added.
Health technology assessment summarises essential information about the medical, social, economic, and ethical issues related to health technologies. The European Commission proposed the HTA Regulation on 31 January 2018, adopted in December 2021 and will be applicable from 12 January 2025.
During the transitional period, the Commission and Member States have established a governance structure and preparatory documents for effective implementation. The new rules will introduce a single EU-level submission file for joint clinical assessments, reducing duplication and improving scientific quality across the EU.
Starting on 12 January, the rules will first apply to applications for new cancer medicines and advanced therapy medicinal products (ATMPs). They will extend to orphan medicines in January 2028 and cover all new medicinal products by 2030. Selected high-risk medical devices will also be assessed starting in 2026. This new framework replaces previous EU-funded cooperation while respecting Member States’ responsibilities in managing their health services.
