As many voices in Europe are getting louder about the increasing threat of medicines shortages, the European Medicines Agency and the Heads of Medicines Agencies task force on improving the availability of medicines in Europe just released its 2019/2020 work programme. Working groups tasked to tackle specific issues as well as a multi-stakeholder workshop in November are being set up.

The joint initiative of the European Medicines Agency (EMA), and the Heads of Medicines Agencies (HMA) was established to look specifically into medicinal products that are authorised but not marketed or no longer marketed, and supply chain disruptions directly preventing the availability of authorised and marketed products, according to the task force webpage.

The task force released its 2019/2020 work programme [pdf] dated 23 August (Work programme of the HMA/EMA task force on availability of authorised medicines for human and veterinary use) which includes the establishment of three working groups.

According to the work programme those groups will work on: Marketing authorisations, supply disruptions, and communication.

For example, the group on marketing authorisations will look into reviewing existing procedure for withdrawals of medicines, to include the need for a transition period to allow better planning for any disruptions. The group is also expected to see how to encourage accelerated procedures by mutual recognition to extend marketing authorisations to countries where companies would not normally seek marketing authorisation, and identify potential supply issues for medicines due to the United Kingdom’s withdrawal from the EU.

The group on supply disruptions is tasked with developing the concept of reportable shortages by agreeing on an EU-wide definition of medicine shortage, develop guidance for companies on reporting of shortages, and encourage best practices within industry to prevent shortages.

The group focused on communication will have, for example, to define ways “to give access to the public to clear and useful information on medicine availability problems and supply disruptions across the EU,” according to the work programme.

The work programme also includes the organisation on 8-9 November of a multi-stakeholder workshop to gather stakeholders’ perspectives on how to address availability issues and to allow their contribution to the deliverables of the task force, for example when to report shortages.

Image Credits: EMA.