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Parliamentary questions
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23 August 2019
Answer given by Mr Andriukaitis on behalf of the European Commission
Question reference: E-002284/2019

The Commission is aware of the growing concerns regarding shortages of medicines and patient care. The reasons for shortages include manufacturing problems, industry quotas, legal parallel trade, or economic reasons such as the price of medicines, which falls under Member States competence.

According to EU legislation, marketing authorisation holders must, other than in exceptional circumstances, inform Member State authorities at least two months before they withdraw their product from the market either permanently or temporarily, including the reasons for the withdrawal(1). There is also an obligation of continuous supply to cover the needs of patients for medicines placed on a specific EU market(2).

Following a meeting with Member States in 2018, the Commission published a summary of Member States’ measures to ensure continuous supply, including national measures addressing shortages(3). A paper on the obligation of continuous supply to tackle shortages was also agreed with Member States(4). The Commission is currently reflecting on possible additional ways to address shortages of medicines.

Furthermore, in specific circumstances, the deliberate creation of medicines shortages, for example in the sense of a refusal to supply, may constitute an infringement of both European and national competition rules.

The Commission and/or national authorities are closely following this issue and can further investigate and take enforcement measures in individual cases.

(1)Article 23a of Directive 2001/83/EC
(2)Article 81 of Directive 2001/83/EC

Last updated: 28 August 2019Legal notice