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Parliamentary questions
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22 March 2018
E-000365/2018(ASW)
Answer given by Mr Andriukaitis on behalf of the Commission
Question reference: E-000365/2018

Shortage of medicines is a significant problem which affects many patients and represents a threat for the health of patients and the well-being of all citizens. This is part of the broader problem of access to medicines.

The Commission has noticed that shortages are mainly driven by manufacturing problems or economic reasons such as the level of reimbursement of medicines which is under the competences of the Member States.

Nevertheless, the legislation obliges marketing authorisation holders and wholesalers to ensure appropriate and continued supply within the limits of their responsibilities(1). The Commission is collecting information on the national measures introduced to implement this obligation.

In total, 22 responses to this questionnaire were received between December 2017 and January 2018. A preliminary review of the responses indicates differences in the implementation of the continued supply obligation but also additional measures introduced in the Member States. For example, public service obligations on wholesalers to have a permanent stock to allow daily supply of the region they serve, mandatory reserves for supply of critical medicines and lists of essential/critical medicines for which export is forbidden.

The Commission will prepare a detailed report on the response for discussion with the Member States in the Pharmaceutical Committee and an expert group later in 2018. The Commission will also liaise with the Heads of Medicines Agencies/European Medicines Agency's Joint Task Force on availability of medicines. The EU and its Member States actively contribute and support the discussions and work on shortages of medicines at the World Health Organisation.

(1)Article 81 of Directive 2001/83/EC on the community code relating to medicinal products for human use.

Last updated: 23 March 2018Legal notice