European Union Task Force Publishes Guidance Tackling Medicine Shortage Issues
A European Union task force set up to address medicine supply problems published on 4 July 2019 two documents on the subject as follows:
- Guidance on detection and notification of shortages of medicinal products for Marketing Authorisation Holders in the Union (EEA) (“Document 1” - attached); and
- Good practice guidance for communication to the public on medicines’ availability issues (“Document 2” - attached).
The task force was established by the European Medicines Agency (“EMA”) and the Heads of Medicines Agencies (“HMA”), with representatives from the European Commission and national competent authorities, the chairs of the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) and Veterinary (CMDv), the Good Manufacturing Practices/Good Distribution Practices Inspectors Working Group, the Working Group of Communication Professionals (“WGCP”) and the European Surveillance Strategy Working Group (“ESS WG”).
Document 1 offers guidance to the pharmaceutical industry to facilitate the detection and early notification of medicine shortages to competent authorities. The guidance is based on a common EU definition of the term ‘shortage’ which is said to occur when supply does not meet demand at a national level. In that definition, the notion of supply refers to the total volume of stock of the individual medicinal product that is placed on the market by the Marketing Authorisation Holder. Demand relates to the request for a medicinal product by a healthcare professional, veterinarian or patient in response to a clinical need.
On the basis of this definition, Document 1 explains the issues that form the subject of notification; the party responsible for the notification; the time of notification; the bodies that should be notified; and the information which a notification should cover. Document 1 also contains a handy proposed template for shortage notification. The guidance and template will be implemented in a pilot phase which is currently scheduled to start in the last quarter of 2019.
Document 2 is addressed to EU national competent authorities and EMA and lays out principles and examples of good practices for communication on shortages to the public, including patients and healthcare professionals. The guidance is based on a survey carried out by the task force in all EU Member States to collect information on how issues related to shortages and availability of medicines are measured and communicated to the public.
Significantly, in presenting the guidance, EMA described medicine shortages as a “a key public health priority for the EU network”. At the same time, EMA also acknowledged that medicine “[s]hortages and availability problems are complex with no quick solutions”.
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