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Parliamentary questions
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6 June 2019
E-001417/2019(ASW)
Answer given by Mr Mimica on behalf of the European Commission
Question reference: E-001417/2019

Protecting people exposed to low quality medical products requires a holistic approach that strengthens pharmaceutical systems both globally and locally, tackling issues such as adequately resourced health systems, the regulatory framework and its enforcement, quality manufacturing and distribution, and the availability of qualified health workers.

The EU promotes access to medicines in developing countries through a health-in-all-policies approach and various initiatives, programmes and financial support. The Renewed Partnership on Strengthening pharmaceutical systems(1) aimed to improve the quality and availability of pharmaceutical supplies including safety and quality of medicines. In particular the EU MEDISAFE(2) project supports the fight against the production and trafficking of falsified medicines and pharmaceuticals in Eastern and Central Africa. The EU also provides support to the World Health Organisation (WHO) to work on access to medicines that includes the prevention, detection and response to sub-standard and falsified products.

Furthermore, the EU contributes to global initiatives that provide quality assured medicines such as the Global Fund to fight Aids, Tuberculosis and Malaria, Gavi, the Vaccine Alliance, the United Nations Population Fund, and supports partner countries’ bilateral health programmes on medical product quality. The EU and Member States also play an active role in the WHO Member State mechanism on substandard and falsified medicines(3), with WHO supporting countries through its activities on medicines quality assurance(4).

In order to help fight the dissemination of counterfeit medicines, the EU prepares a biannual Report on the protection and enforcement of intellectual property rights in third countries(5) and the Counterfeit and Piracy Watch List(6). The EU also has cooperation programmes with China, South-East Asia and Latin America(7) among others to reduce the import of such medicines.

(1)EU/AP/WHO Renewed Partnership on Strengthening pharmaceutical systems and improving access to quality medicines in 15 African countries 2012-2017: https://www.who.int/medicines/areas/coordination/renewed_ecacpwho/en/
(2)2018-2021 www.cbrn-coe.eu/Projects/TabId/130/ArtMID/543/ArticleID/201/Project-66-MEDISAFE-–-Combating-illicit-traffic-and-enhancing-the-safety-of-medicines-in-Eastern-and-Central-Africa.aspx
(3)https://www.who.int/medicines/regulation/ssffc/en
(4)https://www.who.int/medicines/areas/quality_safety/quality_assurance/en/
(5)Report on the protection and enforcement of intellectual property rights in third Countries, SWD(2018) 47 final.
(6)http://trade.ec.europa.eu/doclib/press/index.cfm?id=1952
(7)https://ipkey.eu/en

Last updated: 13 June 2019Legal notice