The new law adopted on Wednesday aims to avoid duplicating national assessments to determine a medicine’s added value that help EU countries decide on pricing.
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MEPs highlight that there are many barriers to accessing medicine in the EU, the main ones being the lack of new treatments for certain diseases and the high price of medicines, which in many cases do not have added therapeutic value.
Health professionals, patients and institutions need to know whether or not a new medicine or a medical device is an improvement. Health technology assessments (HTA) therefore seek to identify their added value, comparing them with other products.
The new law aims to boost cooperation between member states in the field of HTA, by laying out the procedure for member states to carry out voluntary joint assessments. Provisions cover aspects such as rules for sharing data, setting up coordination groups, avoiding conflicts of interest among experts, and publishing the results of the joint work.
HTAs are under the exclusive competence of member states. However, multiple countries carrying out parallel assessments, under diverging national laws, may result in a duplication of requests and increase the financial and administrative burden on health technology developers, say MEPs.
This burden acts as a barrier to the free movement of health technologies and the smooth functioning of the internal market, and delays patients’ access to innovative treatments.
Soledad Cabezon Ruiz (S&D, ES) said: “This new law is a good step towards improving European citizens' access to medicine and health technologies. It will improve the quality of health technologies, inform research priorities and eliminate unnecessary duplication. Also, it has the potential to make the health system more sustainable”.
The report was adopted with 576 votes to 56 and 41 abstentions. MEPs will enter into negotiations for a first reading agreement with EU ministers once they set their own position on the file.
The EU says that the term 'health technologies' refers to medicines, medical devices, and medical procedures and measures for prevention, diagnosis and treatment.
Medical device industry body MedTech Europe issued a statement welcoming the regulation, but added that it would need to prove it could have a positive impact on market access.
"In the end, any new EU HTA regulation on medical technologies needs to prove that it would positively impact decisions on access to innovative technologies of value for patients and health systems. Any new regulation should not create an extra layer of assessments nor duplicate any elements already answered by the new Medical Device and In Vitro Diagnostic Regulations that are currently being implemented. This is because the role of CE marking is to demonstrate safety, performance, & a clinical benefit whereas HTA’s role is to assess the relative effectiveness of a technology compared to the current standard of care.
"Three key areas must be well addressed to make EU HTA collaboration on medical technologies relevant for access to patients and healthcare systems: the focus on the collaboration between groups of Member States which share the same assessment needs, the clear distinction between the role of CE marking and HTA, and the need for an appropriate phase-in of medical technology into the new HTA regulatory framework.
"For Council discussions, we suggest considering a more refined use of the transition period. HTA assessments for medical technologies should phase-in after the new regulatory systems for medical devices and in vitro diagnostics are fully implemented and operational. This will allow for the availability of real-life effectiveness data for innovative products that are evaluated for HTA."