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Parliamentary questions
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7 March 2019
E-000008/2019(ASW)
Answer given by Mr Andriukaitis on behalf of the European Commission
Question reference: E-000008/2019

The Commission is aware of the concerns regarding shortages of pharmaceutical products for human use. Shortages are a serious problem that can affect many patients across the EU. The main reasons for shortages include manufacturing problems, quotas from industry, legal parallel trade, or economic reasons such as the price of medicines, which falls under the competence of the Member States.

The Commission has not carried out an impact assessment on shortages but held a meeting with experts from EU countries on 25 May 2018. The meeting was a response to calls from the co-legislators to monitor the obligation of marketing authorisation holders to ensure continuous supply of medicines as laid down in EU legislation.

The Commission published a summary of Member States’ measures to ensure continuous supply, including national measures addressing shortages(1). A meeting document on the obligation of continuous supply to tackle shortages, including the general principles to be considered by Member States planning to introduce restrictions on the supply of medicines at risk of shortage, was agreed at the meeting(2). The European Medicines Agency and Heads of Medicines Agencies network are also working on various measures to address this problem, including improving the reporting of shortages of medicines(3).

(1)https://ec.europa.eu/health/sites/health/files/files/committee/ev_20180525_summary_en.pdf
(2)https://ec.europa.eu/health/sites/health/files/files/committee/ev_20180525_rd01_en.pdf
(3)http://www.hma.eu/522.html

Last updated: 7 March 2019Legal notice