Publication of Regulation on Health Technology Assessment

• 22/12/2021
• Articles

The Official Journal of the European Union publishes today the Regulation on Health Technology Assessment (HTA) (Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU; see, attached copy). The publication follows the Regulation’s approval in second reading by the European Parliament on 13 December 2021 and its endorsement by the Council of the European Union on 9 November 2021 (see, Van Bael & Bellis Life Sciences News & Insights of 15 December 2021 and 12 November 2021).
 
While the Regulation on HTA will enter into force on 11 January 2022, i.e., “the twentieth day following that of its publication in the Official Journal of the European Union” (see, Article 36(1) of the Regulation), it will only apply from 12 January 2025 (see, Article 36(2) of the Regulation). As noted earlier, 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. In practical terms, no joint work among Member States pursuant to the Regulation will occur before the first quarter of 2025.