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Focus on Regulation

HMA-EMA’s work programme on availability of authorised medicines for human and veterinary use includes measures for Brexit

On 23 August 2018, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA), the network of the National Competent Authorities in the European Economic Area (EEA), published the work programme of their joint task force regarding the availability of authorised medicines for human and veterinary use.

The HMA-EMA task force was created to develop and coordinate actions on the availability of human and veterinary medicinal products authorised in the EU. It establishes links with existing working groups and ensures that any activities related to the availability issues in their field are reflected in their respective work programmes.

The present work programme includes a number of actions and deadlines concerning how the HMA-EMA task force plans to address the problem of shortages of medicinal products in the EU. This includes potential shortages that could occur as a result of the UK’s withdrawal from the EU. These actions were agreed in February 2017 but were only published in the course of August 2018.

Lack of availability of medicinal products in the EU either because the products are not marketed or due to supply disruptions has been identified by the EMA and HMA as an area of a great concern. According to the work programme, shortages of medicinal products can have a significant impact not only on the supply chain but also ultimately on healthcare systems and on end-users.

The HMA-EMA task force has set itself a deadline for the fourth quarter of 2019 to encourage accelerated procedures by mutual recognition to extend marketing authorisations to countries where companies would not normally seek marketing authorisation. By that time, the task force also intends to facilitate and promote the use of multilingual packages to enable the transfer of medicinal products with the appropriate translation of the package leaflet to EU Member States that are experiencing shortages, in particular smaller markets. The task force also plans to review the existing procedure for withdrawal of medicinal products in the EU and explore the need for a transition period to allow better planning for any disruptions.

One action of the work programme has already been completed. The HMA-EMA task force has already facilitated the approval of generics and biosimilars through the implementation of joint evaluation (work sharing) and shortened timetables for renewals of marketing authorisations and variation applications.

Other key actions for the task force include development of a concept of reportable shortages by agreeing an EU-wide definition of “shortage” of medicinal products, development of guidance for companies on reporting of shortages, and steps to encourage them to develop best practices to prevent shortages.

Concerns have been expressed regarding the supply of medicinal products in the EU after the UK leaves the EU. As part of the work programme, the HMA-EMA task force has prepared actions to avoid potential risks of shortages resulting from Brexit. The task force intends to provide practical guidance concerning the implementation of required regulatory changes following Brexit, including change of the “reference Member States” for mutual recognition and decentralised authorised products. The task force will also monitor the implementation of these regulatory changes and take steps to minimise disruption of the supply of medicinal products and avoid shortages as a result of Brexit. Planned steps include a review of existing guidance documents for competent authorities regarding how best to manage and minimise the impact of shortages, including the shortages that may arise as a result of Brexit.