Council of EU Approves Health Technology Assessment Regulation
On 9 November 2021, the Council of the European Union (Council) gave its green light for the adoption of the proposed Regulation on Health Technology Assessment (HTA) (the Regulation). Attached are a copy of the text as approved by the Council (See, first attachment) and the Council’s accompanying statement of reasons (See, second attachment). Raising subsidiarity concerns, Bulgaria and Poland issued statements indicating that they are unable to support the proposed Regulation (See, third attachment) and, therefore, abstained from voting.
With the Council’s approval, the Regulation’s legislative process is nearing completion. This process was initiated in January 2018 when the European Commission first issued its proposed Regulation (See, Van Bael & Bellis Life Sciences News & Insights of 1 February 2018 and 8 October 2018). The Regulation now just requires a final vote by the European Parliament to become law. This step is expected to be a formality. Pursuant to its Article 36, the Regulation will start to apply three years after its entry into force (which will happen 20 days after the Regulation’s publication in the EU Official Journal).
HTA is a technique to evaluate the medical, social, economic, organisational and ethical issues of a health technology, including medicines, medical devices and medical interventions. The main purpose of conducting an assessment is to inform policy decision-making. In practical terms, the Regulation envisages the following four avenues of cooperation:
- joint clinical assessments;
- joint scientific consultations in response to requests for advice from the life sciences sector;
- identification of emerging health technologies (known as “horizon scanning”); and
- voluntary cooperation in areas outside the scope of mandatory cooperation.