A new harmonised regulation on health technology assessment has been adopted across the EU. 

The European Commission welcomed the regulation, a deliverable of the EU Pharmaceutical Strategy, which will apply from January 2025.

Work to implement the new rules will start immediately, including the setting up of the necessary governance structure and preparatory documents to ensure effective application.

The Regulation on Health Technology assessment (HTA) supersedes the current system of EU-funded project-based cooperation between member states on by introducing a permanent framework for joint work that also covers joint scientific consultations, the identification of emerging health technologies, and voluntary cooperation, as well as work on joint clinical assessments.

It will enter into force 20 days after its publication in the Official Journal of the EU.

WHY IT MATTERS

The new regulation aims to allow vital and innovative health technologies - such as innovative medicines, certain medical devices, medical equipment and prevention and treatment methods - to be more widely available.

It is also intended to ensure the efficient use of resources, 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 LARGER CONTEXT

Earlier this year, industry association Med Tech Europe raised concerns that the new regulation could interfere with regulatory assessments conducted under the Medical Device Regulation (MDR), which came into application in May 2021.

ON THE RECORD

EU commissioner for health and food safety, Stella Kyriakides, said: “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. The Regulation on HTA is a key deliverable of the European Pharmaceutical Strategy and an important building block for a European Health Union and our work to deliver concrete benefits to citizens in the area of health.  

“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. 

“Now health experts, the producers, and most importantly of all – patients, will have a new framework that will help us to address unmet medical needs and facilitate access to innovative medicines and some high-risk medical devices.  This is about patients and improving access to life saving innovative technologies. It is also about building a new way of cooperating on health in the EU.

“Its implementation will be crucial not only in order to reach the objectives of EU's Pharmaceutical Strategy and Europe's Beating Cancer Plan, but also to enhance coordination at EU level in the field of health.”