On August 29, 2018, the task force set up by European Union (EU) regulators to better address potential problems with medicines' supply and to avoid shortages has published its work programme for the coming years 2018/201. Improving the availability of human and veterinary medicines authorized in the EU is a key priority of the EU Network. The work programme lists actions for regulators and industry alike to ensure the availability of medicines for the benefit of patients in the EU. The work programme covers centrally and nationally authorised products, both for human and veterinary medicines, in the following cases:
- when medicines are authorised but not marketed (or no longer marketed);
- when medicines authorised and marketed are affected by supply-chain disruptions that directly affect their availability. Such disruptions may occur due to problems with good manufacturing practice (GMP), good clinical practice (GCP), good distribution practice (GDP) or quality defects.
The task force is a working group which has been set up by the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA), with representatives from the European Commission and interested national competent authorities, the chairs of the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) and Veterinary (CMDv), the GMP/GDP Inspectors Working Group, the Working Group of Communication Professionals (WGCP) and the European Surveillance Strategy Working Group (ESS WG).
The task force will develop and coordinate actions for better prevention, identification, management of and communication on issues that can affect the availability of medicines, in order to improve continuity of supply of human and veterinary medicines across Europe. Details about groups and agreed actions are:
- Thematic working group 1 - Marketing authorisations: This group looks at ways to minimise supply disruptions and avoid shortages by facilitating authorisation and marketing of medicines using the existing regulatory framework.
- Thematic working group 2 - Supply chain disruptions: This group focuses on strategies to improve prevention and management of shortages caused by disruptions in the supply chain.
- Thematic working group 3 – Communication: This group focuses on improving timely access to up-to-date information on availability issues, for all actors within the network as well as users of medicines. The group looks at ways to enhance interactions and communication with stakeholders as well as improving collection and sharing of information between regulatory authorities and pharmaceutical industry.
Key priorities of the task force include:
- looking at ways to minimise supply disruptions and avoid shortages by facilitating approval and marketing of medicines using the existing regulatory framework (e.g. using work sharing and reduced timetables when possible);
- developing strategies to improve prevention and management of shortages caused by disruptions in the supply chain (e.g. developing guidance for companies on reporting of shortages);
- encouraging best practices within industry to prevent shortages;
- improving sharing of information and best practices among EU regulatory authorities to better coordinate actions across the EU;
- fostering collaboration with stakeholders and enhancing communication of supply problems to EU citizens2.
Note - The task force will organize a multi-stakeholder workshop on 8-9 November 2018, to gather stakeholders' perspectives on how to address availability issues and to include their input into the deliverables of the task force. It will bring together all stakeholders impacted, including patients, consumers, healthcare professionals, industry, wholesalers/distributors, parallel distributors, academia and regulators.
Footnote
1 http://www.ema.europa.eu/docs/en_GB/document_library/Work_programme/2018/08/WC500254439.pdf
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