Networks and Initiatives
AIHTA is actively engaged in European and international HTA networks and initiatives. Through collaboration and knowledge exchange with partner institutions, the Institute contributes to the further development of scientific methodologies, promotes the harmonisation of assessment approaches, and strengthens the quality of evidence-based decision-making.
These include, among others:
HTAR: The EU HTA Regulation
Since January 2025, the EU Health Technology Assessment Regulation (HTAR) has been in force.
Through the HTAR, EU Member States are collaborating more closely than ever before to jointly assess medicinal products and certain medical devices submitted for market authorisation. These assessments examine the effectiveness and safety of new treatments in comparison with existing therapies. The outcomes of these Joint Clinical Assessments provide a basis for national HTA processes and subsequent decisions on the reimbursement and funding of medicinal products and certain medical devices within individual Member States.
The objectives of the HTAR are:
- To promote patient access to innovative health technologies
- To replace multiple national clinical assessments with a shared clinical evidence assessment
- To improve the quality, transparency and consistency of HTA assessments across Europe
- To support national decision-making processes
Implementation is taking place in phases:
- Since January 2025, cancer medicines and advanced therapy medicinal products (ATMPs) have been assessed jointly.
- Since January 2026, medical devices have been selected on a regular basis for assessment. The focus is on high-risk devices (Classes IIb and III, such as mechanical ventilators, cardiac pacemakers and implants) as well as Class D in vitro diagnostic medical devices.
- From 2028, additional product categories are expected to be included, including medicines for rare diseases (orphan drugs).
- From 2030, all medicinal products submitted to the European Medicines Agency (EMA) under the centralised marketing authorisation procedure are expected to be covered by the HTAR.
In addition to joint clinical assessments, the HTAR also encompasses joint scientific consultations, the early identification of emerging health technologies (horizon scanning), and voluntary cooperation among Member States in other areas.
Within the framework of the EU HTA Regulation, AIHTA contributes both to European cooperation and to national implementation. The Institute participates in Joint Clinical Assessments (JCAs) and supports the implementation of the Regulation in Austria. It also prepares evidence-based decision support for national assessment procedures, particularly in the area of hospital medicines. Furthermore, AIHTA contributes its scientific expertise to the further development and application of common HTA methodologies at the European level.
In November 2025, AIHTA started its first Joint Clinical Assessment of a medicinal product at EU level, in collaboration with another EU Member State.