A European Union (EU)-wide task force on medicines supply shortages has set a deadline at the end of 2018 to identify potential supply issues arising from Brexit.
The Task Force on Availability of Authorised Medicines (TF AAM) has been set up by the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) to develop and coordinate actions for better prevention, identification, management and communication of supply issues.
The TF AAM has published its programme of work for the next 2 years. The work programme lists actions for regulators and industry alike to ensure the availability of medicines for EU patients. Key among its priorities is the potential negative effect of Brexit. By the end of 2018, the task force expects to have developed practical guidance on the regulatory changes required following Brexit.
A dedicated paediatric task force is now being established to specifically improve information exchange on availability issues of paediatric formulations. Efforts are also underway to facilitate the supply of medical radioisotopes by promoting work-sharing and reduced timetables. Existing procedures for product withdrawals, including the need for a transition period to allow better planning.
The task force is hosting a multi-stakeholder workshop on 8-9 November 2018 to gather stakeholders’ perspectives on how to address availability issues. It will bring together all stakeholders impacted, including patients, consumers, health care professionals, industry, academia and regulators.