Shortages and availability of medicines
Improving the availability of medicines authorised in the EU is a key priority for the European medicines regulatory network. In 2016, to better address potential problems with the supply of medicines, EMA and the HMA established a joint task force. Since its creation, it has developed and coordinated actions to facilitate the prevention, identification, management of and communication about shortages.
In 2019, the task force launched the Single Point of Contact (SPOC) system to improve information sharing on important shortages of medicines between Member States, EMA and the European Commission. This platform allows Member States to share information on availability problems with medicines as well as information on medicines that could be used as an alternative and are available in other Member States. This could help prevent and better manage shortages.
Its operation is currently being piloted (in two phases) to fine-tune operational aspects prior to full implementation in 2020. The first phase of the pilot, which ran from April to August 2019, tested the functioning and usefulness of the information exchange in the SPOC system. During this phase, 52 notifications of shortages were circulated within the SPOC network. During phase one of the pilot, 24 Member States made use of this system to share information on shortages. A second phase is foreseen for 2020, during which additional responsibilities of the SPOC system will be tested to further improve the handling of shortages.
REPORTING AND COMMUNICATING SHORTAGES
In July 2019, the task force published guidance for MAHs on detecting and reporting medicine shortages (Guidance on detection and notification of shortages of medicinal products for MAHs in the Union) and guidance to NCAs and EMA on good practices in communicating to the public on medicines’ availability issues (Good practice guidance for communication to the public on medicines’ availability issues).
Both documents lay the foundations for an improved and harmonised EU approach in reporting of and communication on medicine shortages and availability issues. These are key deliverables of the task force which have undergone extensive consultations with stakeholder groups, including at a multi-stakeholder workshop in November 2018. They are listed in the work programme of the task force for 2018-2020, which was updated in 2019.
Brexit-related guidance
The uncertainties regarding the date and terms of the UK’s withdrawal from the EU led to concerns about the impact on the supply of medicines if the UK should leave the EU without a withdrawal agreement (a ‘no-deal scenario’). EMA, the European Commission and Member States prepared a series of guidance documents to help companies take the necessary regulatory steps to enable continued supply of their medicines in the EU for the benefit of patients. The guidance is based on the assumption that, in January 2021, the UK will become a third country where EU laws will cease to apply. In March 2019, EMA and HMA published a questions-and-answers document for patients, healthcare professionals and the general public on the preparatory work that EU authorities have been doing to prevent medicine shortages due to Brexit.