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Boost for joint European assessment of medicines

Boost for joint European assessment of medicines

Photo Rodrigo Senna

(STRASBOURG) - A new law adopted by the European Parliament on Wednesday aims to avoid duplicating national assessments to determine a medicine's added value that help EU countries decide on pricing.

At their plenary session, MEPs drew attention to the many barriers to accessing medicine and innovative technologies in the EU, with 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 seek to identify their added value, comparing them with other products.

The new law aims to boost cooperation between EU 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.

While HTAs are under the exclusive competence of member states, MEPs say 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.

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.

"This new law is a good step towards improving European citizens' access to medicine and health technologies," said rapporteur Soledad Cabezon Ruiz MEP: "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".

MEPs will now enter into negotiations for a first reading agreement with EU ministers once they set their own position on the file.

Further information, European Parliament

Adopted text will be available here (click on 03.10.2018)

Briefing: Strengthening EU cooperation on health technology assessment

Procedure file

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