REGULATION (EU) 2021/2282 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 15 December 2021on health technology assessment and amending Directive 2011/24/EU aims to harmonize European legislation in the field of health technology assessment.
The Regulation will apply to all Member States from 12 January 2025. Until then the European Commission will:
- set up the Coordination Group. The Commission will soon invite Member States to nominate their members and the first meetings of the Coordination Group is tentatively scheduled for mid-2022;
- establish the Stakeholder Network;
- adopt the necessary implementing and delegated acts; and
- facilitate the development of methodology for joint HTA work by the Coordination Group as required by the Regulation.
This Regulation establishes:
- a support framework and procedures for cooperation of Member States on health technologies at Union level;
- a mechanism which lays down that any information, data, analyses and other evidence required for the joint clinical assessment of health technologies is to be submitted by the health technology developer only once at Union level;
- common rules and methodologies for the joint clinical assessment of health technologies.
The Regulation shall not affect Member States’ competence to draw conclusions on the relative effectiveness of health technologies or to take decisions on the use of a health technology in their specific national health context. It shall not interfere with the exclusive national competence of Member States, including those for national pricing and reimbursement decisions, or affect any other competences which concern Member States’ management and delivery of health services or medical care or the allocation of resources assigned to them.
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