Insights & news

European Union Task Force Publishes Guidance Tackling Medicine Shortage Issues

  • 08/07/2019
  • Articles

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”.

Attachments:

Key contacts

Related practice areas

Related insights

Sign up for updates
    • 15/07/2019
    • Articles

    Belgium - Request for Premiums and Benefits by Hospitals from Suppliers of Medicines and Medical Devices in Public Procurement Proceedings

    The Federal Agency for Medicines and Health Products (“FAMHP”) has recently come out against hospitals requesting premiums and benefits from firms participating in tender proceedings for the supply of medicines and/or medical devices. According to FAMHP, that practice is not only prohibited by Article 81 of the Law of 17 June 2016 on Public Procurement, but may also run foul of Article 10 of the Law of 25 March 1964 regarding Medicines. At issue is the widespread practice indulged in by hospitals to ask prospective suppliers of medicines or medical devices to take care of unrelated goods and services such as the supply of educational materials and software for patient management or to pay for outreach activities organised by the hospitals. Article 81 of the Law of 17 June 2016 on Public Procurement provides in relevant part that the award criteria of a request for tenders should be connected to the subject of the public procurement procedure. For its part, Article 10 of the Law of 25 March 1964 regarding Medicines prohibits firms, subject to exceptions, from offering or providng benefits in cash or in kind to specific healthcare professionals and institutions in connection with the prescription, administration or supply of medicines or medical devices. Similarly, healthcare professionals and institutions are banned from soliciting or receiving such benefits. Based on a combined reading of these provisions, FAMHP maintains that it is not possible to offer or request free additional services with the supply of medicines or medical devices. According to FAMHP, additional services have to (i) come at a price; or (ii) and this is a puzzling addition, “have to present a cost which expressly forms part of the price of the goods”. Importantly, the services have to present a connection with the goods supplied. FAMHP indicates that this implies that outreach activities or additional software are “not admissible”. It adds that “free competition” should be guaranteed at all times and that a hospital should be able to justify the use of a specific award criterion. In other words, the hospital does not benefit from discretionary powers when crafting and then implementing a procurement procedure. Attached are a circular letter of FAMHP on the subject as well as an opinion delivered earlier this year by the committee for public procurement, an advisory body, which informed the point of view of FAMHP.

    Read more
    • 12/07/2019
    • Articles

    Slovakia Final Member State To Benefit From EU-US Mutual Recognition Agreement For Inspections of Manufacturing Sites For Human Medicines

    Slovakia has become the 28th and final EU Member State to be given the powers to carry out good manufacturing practice (“GMP”) inspections at a level equivalent to that prevailing in the US (see attached press release). On 11 July 2019, the US Food and Drug Administration (“FDA”) confirmed Slovakia’s status under the Mutual Recognition Agreement (“MRA”) governing GMP inspections of manufacturing sites for human medicines between the EU and the US. For their part, EU Member States have been able to rely on inspection results produced by the FDA since 1 November 2017. Pursuant to the MRA, the EU and the US now fully recognise inspections of manufacturing sites for human medicines carried out in each other’s territories. Separately, the batch testing waiver existing under the MRA will also start to apply. As a result, qualified persons in pharmaceutical firms based in Europe will no longer be required to carry out the quality controls when these have already been run in the US. The EU and US will continue implementation work for the MRA in hopes of extending its scope to a range of additional products, including veterinary medicines, human vaccines and plasma derived medicinal products.

    Read more

Subscribe to our updates

Please select the practice areas you are interested in: *