- national pricing and reimbursement of medicines a national competence
- results in duplication of assessments for a single new medicine
- legislation will facilitate joint assessments, saving costs and time
- boosts cooperation in health technology assessment
The new law aims to avoid duplicating national assessments to determine a medicine’s added value that help EU countries decide on pricing and reimbursement.
MEPs highlight that there are many barriers to accessing medicine and innovative technologies 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 medical device is an improvement. Health technology assessments (HTA) therefore aim to identify their added value, comparing them with other products.
The new law therefore 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 report is a good step towards improving European citizens' access to medicine and health technologies. The regulation 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 legislative report was adopted with 40 votes to 3, with 2 abstentions. It will be put to a vote by the full House during its 1-4 October plenary session in Strasbourg.
Health technologies encompass medicines, medical devices, and medical procedures and measures for prevention, diagnosis and treatment. Health technologies are an innovative sector, part of an overall market for healthcare expenditure that accounts for 10% of EU GDP.