On 1-2 March, the European Medicines Agency (EMA) convened a multi-stakeholder workshop on the topic of medicines shortages and withdrawals, bringing together representatives from patient and healthcare professional organisations, national medicines authorities, industry and academia. Medicines shortages and withdrawals can have severe clinical consequences for patients, increasing anxiety and impacting their quality of life. Improving the availability of medicines authorised in Europe is therefore a key priority for medicines regulators across the continent. In 2016, EU regulators established a Taskforce to develop and coordinate actions for better prevention, identification, management of and communication on issues that can affect the availability of medicines.
This Taskforce, which brings together representatives from the Heads of Medicines Agencies (HMA) and EMA, works to improve continuity of supply of human and veterinary medicines across Europe. The workshop was designed to inform key stakeholders about Task Force activities on medicines shortages and availability, providing an opportunity for participants to share their perspectives on these important topics and identify ways to collaborate on actions to improve outcomes for patients. During the workshop, which was opened by the EMA Executive Director, Emer Cooke, representatives from the Taskforce, EMA and national medicines authorities explained how they work collaboratively to identify, mitigate and address medicines shortages. Representatives from the European Commission were also present, highlighting EU initiatives for identifying and preventing public health emergencies.
There were several presentations and interventions from organisations which are members of the Patients’ and Consumers’ and Healthcare Professionals’ (HCP) Working Parties. Ancel.la Santos from BEUC (European Consumer Organisation) outlined the results of a recent survey that examined the impact of shortages on patients, which showed that almost 30% experienced a worsening of symptoms, and high levels of anxiety. BEUC and other organisations emphasised the need for more preventive actions, stronger sanctions, and greater transparency in communicating to patients and HCPs about shortages. Video recordings of the workshop sessions and presentations are available on the EMA website:
