14 May 2021

The COVID-19 pandemic is pushing health systems across the EU to their limits. For people living with diabetes (PwD) the pandemic has meant delays in diagnosis, disruptions in prevention and screening programmes as well as difficulties in accessing their care. Much of this has highlighted the existing weaknesses of healthcare systems across Europe.

A robust legal framework on Health Technology Assessment (HTA) can help strengthen care and equip healthcare systems to respond better to future crises, while also addressing unmet needs.

The Commission has adopted its legislative initiative on HTA in 2018. The Parliament followed suit by tabling amendments and finalising its position in 2019. After three years of discussions in the Council, Coreper agreed on a mandate. The first interinstitutional trilogue took place on 26 April 2021 and the next one is scheduled for end of May. Given the long-awaited step forward in the stalled negotiations, health technology providers, healthcare systems and patient community alike expect an ambitious agreement to be reached.

The HTA proposal provides for joint work in four areas:

• Joint clinical assessments to determine the most innovative technology with the most impact for patients.
• Joint scientific consultations to facilitate the communication between health technology developers and HTA authorities.
• Horizon scanning of emerging health technologies to ensure early identification of the best ones.
• Continuing voluntary cooperation in areas outside of compulsory work.

To make sure the HTA framework fulfils its objectives, Member States must incorporate the results of joint clinical assessments into their national processes. To avoid duplication of efforts on the national level, joint clinical reports must be legally binding and only complemented by additional clinical evidence when the national context requires.

Another pre-requisite for an improved HTA framework will be to enhance the role of patients and patient representatives, including people living with diabetes and other conditions as well as civil society at large in all decision-making processes and treat them as equal partners in the process. Inclusive and transparent joint consultations should include people living with diabetes and other conditions as they are the best placed to make decisions concerning their care. Patients should be engaged throughout the life cycle, starting with early dialogue, through to the writing of the reports and the re-assessment stage.

To this end, the final HTA framework must have a legal status, be ambitious in its scope, truly increase the value of cooperation and avoid nationally minded influence. The regulation is an important building block towards the creation of a European Health Union, and if properly implemented will benefit patients, healthcare sector and industry alike.