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Parliamentary questions
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27 November 2018
E-004939/2018(ASW)
Answer given by Mr Andriukaitis on behalf of the European Commission
Question reference: E-004939/2018

1. 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(1). A recent study on the economic impact of pharmaceutical incentives on innovation, availability and accessibility has also examined the reasons for selective market launches of medicines(2).

The Commission facilitates exchanges between Member States on shortages of medicines. A meeting with Member State experts on 25 May 2018 addressed shortages of medicines and clarified the obligation for industry and wholesalers to ensure a continuous supply of medicines(3). The Heads of Medicines Agencies/European Medicines Agency task force on availability of authorised medicines for human and veterinary use(4) continues to work to address shortages of medicines and market access in the Member States.

2. According to EU legislation, companies lose their marketing authorisation if they do not place their products on the market in a Member State within three years(5). There is, however, no obligation to market medicines in a particular or all Member State(s) and no criteria to define ‘commercial interest’.

Marketing authorisation holders must inform Member States’ authorities at least two months in advance if they plan to withdraw their product from the market either permanently or temporarily, including the reasons for the withdrawal(6).

(1)https://ec.europa.eu/info/business-economy-euro/economic-and-fiscal-policy-coordination/eu-economic-governance-monitoring-prevention-correction/european-semester_en
(2)https://ec.europa.eu/docsroom/documents/29521
(3)https://ec.europa.eu/health/documents/pharmaceutical-committee/ev_20180525_en
(4)http://www.hma.eu/522.html
(5)Article 24(5) of Directive 2001/83/EC.
(6)Article 23a of Directive 2001/83/EC.

Last updated: 27 November 2018Legal notice