EU Regulation on Health Technology Assessment (HTA): MedTech Europe remains highly sceptical about the added value for health systems and citizens

Posted on 01.07.2021

30 June 2021 – MedTech Europe – the European trade association for the medical technology industry including diagnostics, medical devices and digital health – takes note of today’s decision by the Council of the European Union, endorsing the text of the future Regulation on Health Technology Assessment (HTA).

Our industry supports EU legislation whenever it provides a demonstrated added value. Having engaged throughout the legislative process for this file, MedTech Europe remains unconvinced that the elements of this Regulation relevant to the medical technology sector will positively improve patient access across Europe, inform funding of innovation or resolve the challenges faced by social security systems across Europe.

Unless the specificities of medical technologies are fully recognised in the upcoming implementation stage, we regret this Regulation will only create another ‘layer’ of EU bureaucracy to be overcome, rather than enable all European citizens to access the many benefits of our sector’s innovations.
The market access processes for medical technologies and pharmaceuticals function differently, and HTA plays a very specific and limited role (if any) in the Member States’ financing and investment decisions on medical technology.

In that regard, MedTech Europe does acknowledge and welcome:

• the possibility to have a medical technology-specific composition of the future coordination group,
• the possibility for medical technology-specific methodologies to be developed and applied, and
• the clarification that future joint clinical assessments should neither delay nor interfere with the CE marking of medical technologies, nor delay their market access.

Having followed more than 10 years of EU-level cooperation via EUnetHTA, our industry has yet to witness substantial improvements in citizens’ timely access to medical technology innovations, or in Member States’ ability to conduct joint clinical assessments. The notion that this work can positively transform healthcare systems across Europe and render them more sustainable is not supported by real-life experience or evidence. We therefore remain very sceptical about the overall added value of EU-level work on HTA in accelerating access to needed medical technologies.

Enhanced cooperation at EU level can only improve this situation if notable changes are made to how the Member States conduct and use HTA to drive their national financing and investment decisions on with regard to medical technology innovation.

“This Regulation will create a new regime of joint clinical assessments on medical technologies, without establishing a clear purpose for conducting such assessments at EU level,” Serge Bernasconi, CEO of MedTech Europe commented. “If future joint clinical assessment reports have any chance to truly enable greater patient access to medical technology innovation, it will be critical to arrive at clear and common ground, with all Member States, on the purpose for such EU-level work. It will also be critical for these assessments to be conducted at an appropriate time, when the real-world evidence needed to do the job properly is available. Establishing this purpose and timing is a case-by-case decision, needing to be tailored to each medical technology. Failure to do this, correctly and consistently, will be detrimental to patients who depend on the life-saving and life-transforming benefits of medical technology innovation,” he said.

With the future implementation of this Regulation starting soon, Europe enters a critical new chapter that will truly reveal whether the Regulation’s stated goals are met in practice for the benefit of patients. Despite its many concerns, MedTech Europe remains committed to continue engaging in this process, both with the EU Institutions and with Member States, to promote proper observance of our sector’s specificities, and to improve citizen and health system access to the benefits of medical technology innovation.