Medical research – Image Pixabay
(BRUSSELS) – New health technology rules, adopted Monday, will allow vital and innovative health technologies – innovative medicines, medical equipment and treatment methods – to be more widely available.
The Regulation on Health Technology Assessment (HTA) is designed to ensure efficient use of resources, to strengthen the quality of HTA across the EU, and save national HTA bodies and industry from duplicating their efforts, reassure business and ensure the long-term sustainability of EU HTA cooperation.
The adoption was welcomed by the European Commission. “I am very pleased that today, after years of hard work, new rules to ensure that patients have better access to innovative medicines and medical devices will soon be a reality in the EU,” said Health Commissioner Stella Kyriakides.
“With COVID-19, we have seen the importance of producing safe and efficient treatments and medical devices for all Europeans. The new rules will secure inclusiveness and transparency in the assessment process and increase predictability for Member States’ authorities and for the industry. Member States will be able to take more timely and evidence-based decisions on patient access to innovative technologies within their healthcare systems.”
The Regulation will apply from January 2025, but the implementing work starts now, including the setting up of the necessary governance structure and preparatory documents to ensure effective application from this date.
The Regulation supersedes the current system of EU-funded project-based cooperation between Member States on health technology assessment by introducing a permanent framework for joint work that will also cover joint scientific consultations, the identification of emerging health technologies, and voluntary cooperation, as well as work on joint clinical assessments.
The Regulation is to enter into force 20 days after its publication in the Official Journal of the EU. The Regulation provides for a delayed application of three years, during which the 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.
Adoption of Regulation on Health Technology Assessment - background guide
More innovative health technologies for patients (europa.eu)
