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Parliamentary questions
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15 May 2019
E-001463/2019(ASW)
Answer given by Vice-President Katainen on behalf of the European Commission
Question reference: E-001463/2019

Shortages of pharmaceutical products are a serious problem that can affect many patients across the EU. The Commission is aware of the concerns regarding shortages of pharmaceutical products for human use. The 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.

As a response to calls from the co-legislators to monitor the obligation of continuous supply laid down in EU legislation(1), the Commission held a meeting with experts from EU countries on 25 May 2018.

After the meeting, the Commission published a summary of Member States’ measures to ensure continuous supply, including national measures addressing shortages(2). At the meeting, a document was also agreed to assist Member States to implement and enforce the obligation of continuous supply(3).

The European Medicines Agency and Heads of Medicines Agencies network are working on measures to address this problem, including agreeing a definition of a shortage and improving the reporting of shortages of medicines(4).

The Commission also addresses issues of access and availability through the Pharmaceutical Committee, the Expert Group on Safe and Timely Access to Medicines for Patients(5) and by supporting relevant projects and initiatives via the EU Health Programme(6).

Generally speaking, the organisation and delivery of health services and medical care and the pricing and reimbursement decisions that closely influence access to medicines are a Member State competence. The Commission, however, closely follows this issue and analyses the effectiveness, accessibility and resilience of health systems as part of the European Semester(7).

(1)Article 81 of Directive 2001/83/EC.
(2)https://ec.europa.eu/health/sites/health/files/files/committee/ev_20180525_summary_en.pdf
(3)https://ec.europa.eu/health/sites/health/files/files/committee/ev_20180525_rd01_en.pdf
(4)http://www.hma.eu/522.html
(5)https://ec.europa.eu/health/documents/pharmaceutical-committee/stamp_en
(6)For instance https://webgate.ec.europa.eu/chafea_pdb/health/projects/664317/summary
(7)https://ec.europa.eu/info/business-economy-euro/economic-and-fiscal-policy-coordination/eu-economic-governance-monitoring-prevention-correction/european-semester_en

Last updated: 16 May 2019Legal notice