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Parliamentary questions
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21 February 2020
Answer given by Ms Kyriakides
on behalf of the European Commission
Question reference: E-004370/2019

EU medicines legislation requires companies to ensure continuous supply of marketed medicines and to notify competent authorities two months before any temporary or permanent interruption of supply(1). EU legislation does not, however, oblige companies to maintain medicines on the market should they decide to withdraw. Member States are responsible for the enforcement of the legislation.

The Commission addresses issues of availability through the Pharmaceutical Committee, the Expert Group on Safe and Timely Access to Medicines for Patients(2) and will launch a study on shortages under the EU Health Programme(3). The Commission also analyses the effectiveness, accessibility and resilience of health systems, including spending on medicines, as part of the European Semester(4).

In addition, a study was launched with support of the EU Health Programme on the ‘Accessibility of pharmaceutical care and trends in pharmaceutical spending’(5). This study will, amongst others, look into patterns of market withdrawals. I n addition, the Commission follows the Heads of Medicines Agencies/European Medicines Agency Task Force work to address shortages of medicines and improve coordination between Member States.

The Commission will also launch a Pharmaceutical Strategy to ensure Europe’s supply of affordable medicines to meet patients’ needs. The strategy will aim to deliver a future-proof pharmaceutical policy to address all levels of the value chain, from research and development to authorisation and access of patients to medicines.

The strategy will also be addressing the issue of dependency of the pharmaceutical industry on the manufacturing capacities of, and the supply of starting materials and active pharmaceutical ingredients from third countries.

(1)Articles 23a and 81 of Directive 2001/83/EC
(3)For instance https://webgate.ec.europa.eu/chafea_pdb/health/projects/664317/summary
(4) https://ec.europa.eu/info/business-economy-euro/economic-and-fiscal-policy-coordination/eu-economic-governance-monitoring-prevention-correction/european-semester_en
(5)See under heading 8.13: https://ec.europa.eu/health/sites/health/files/funding/docs/wp2019_annex_en.pdf
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