Swedish Agency for Health Technology Assessment and Assessment of Social Services
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What is HTAR?
The regulation aims to help ensure that patients in the EU have better access to innovative healthcare technologies, such as medicines and medical devices. It will ensure that our resources are used efficiently and strengthen the quality of HTA across the EU.
HTAR will contribute to a transparent and inclusive framework by an EU collaboration of HTA agencies for joint clinical assessments and joint assessments of the scientific evidence that forms the basis for companies’ applications for reimbursement of their products, such as the high-cost threshold. The regulation also aims to reduce duplication of work for national HTA authorities as well as companies and to ensure the long-term sustainability of HTA cooperation within the EU.
HTAR will enter into force on 12 January 2025. The period between 2025 and 2030 is an interim period. After 2030, the agencies shall be able to comply with the new law.
SBU participates in this work
On behalf of Sweden, Swedish Agency for Health Technology Assessment and Assessment of Social Services (SBU), The Swedish Dental and Pharmaceutical benefits Agency (TLV) and the Swedish Medical Products Agency (LV) participate in the work with HTAR.
SBU is also a member of of HTAR’s Coordination Group together with the Dental and Pharmaceutical benefits Agency (TLV). Six different Implementing Acts will be formulated and approved in 2024, that is, before HTAR comes into force.
Read more about the EU Commission’s regulations on HTA:
Regulation on Health Technology assessment - European Commission (europa.eu)
