After months of negotiations, the EU Parliament and Council have reached a political agreement on the proposed Health Technology Assessment (HTA) regulation. HTA involves the systematic assessment of the effects, costs and benefits of medicines, medical devices and tests, and aims to inform decision-making on market access and clinical guidelines. Currently, HTA processes are performed by around 50 different HTA agencies based in different Member States. The new regulation on HTA will create a framework for greater collaboration between Member States on clinical assessment and scientific consultations for new health technologies. Member States will still be responsible for assessing non-clinical aspects of HTA (e.g. economical, ethical, and social concerns) and will ultimately decide on pricing and reimbursement based on national criteria.
It is hoped that this framework will help accelerate access to new medicines and support Member States in meeting unmet clinical needs, boosting innovation and improving competitiveness of the EU healthcare sector. The regulation will now have to be formally adopted by the EU Council and Parliament before it can enter into force.
https://ec.europa.eu/commission/presscorner/detail/en/ip_21_3142
