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Regulation on Health Technology Assessment Finally Adopted

  • 15/12/2021
  • Articles

On 13 December 2021, the European Commission welcomed the adoption of the Regulation on Health Technology Assessment (HTA) following its approval by the European Parliament in second reading (see, attached European Commission press releases). The Regulation on HTA had cleared its last major legislative hurdle on 9 November 2021 when it was endorsed by the Council of the European Union (see, Van Bael & Bellis, Life Sciences News & Insights of 12 November 2021).
 
HTA is defined in the Regulation as “a multidisciplinary process that summarises information about the medical, patient and social aspects and the economic and ethical issues related to the use of a health technology in a systematic, transparent, unbiased and robust manner”.  The Regulation creates collaborative structures and procedures that allow Member States to carry out joint clinical assessments, effect joint clinical consultations and identify jointly emerging health technologies. Additionally, the Regulation offers scope for voluntary cooperation in adjacent areas. At the same time, the Regulation respects a delicate balance with Member State competencies in core areas such as pricing and reimbursement, but also decision-making on the use of health technologies and the management and delivery of health services and medical care.
 
While the Regulation on HTA is now scheduled to enter into force in January 2022, it will not apply until January 2025. In practical terms, this means that no joint work among Member States pursuant to the Regulation will occur before the first quarter of 2025. The long interim period will be used to set up the organisational framework contemplated by the Regulation on HTA and to adopt a series of implementing measures. The first meeting of the yet to be established Coordination Group of Member State representatives is scheduled to convene in June 2022.  

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