Medicine shortages

 Medicine shortages can occur for many reasons, such as manufacturing difficulties or problems affecting the quality of medicines that can impact on patient care.

In the EU, most medicine shortages are dealt with at national level by national competent authorities. However, EMA can be involved in certain situations, for example when a medicine shortage is linked to a safety concern or affects several Member States.

In December 2016, a task force on the Availability of Authorised Medicines for Human and Veterinary Use was set up by the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA).

Since April 2019, the task force has been running a pilot programme on establishing a single point of contact (SPOC) network to improve information sharing between Member States, EMA and the European Commission on important medicine shortages of human and veterinary medicines and to coordinate actions to help prevent and manage shortages. This includes information sharing on alternative medicines that are available in other Member States. The first phase of the pilot ran from April to August 2019 to test the functioning and usefulness of the information exchange via the SPOCs. During this phase, 24 Member States used the SPOC system and circulated 52 notifications of shortages. The task force plans to run a second phase of the pilot in 2020, to test the criteria for identifying cases deserving EU-wide coordinated action and for network alerts of upcoming public communications that could have a high impact on patients.

In July 2019, EMA and HMA published a guidance for marketing authorisation holders on detecting and reporting medicine shortages. The guidance is based on a survey on how issues related to shortages and availability of medicines are measured and communicated to the public in EU Member States, which was carried out by the HMA / EMA Task Force on the Availability of Authorised Medicines for Human and Veterinary Use.

In September 2019, the European Commission invited HOPE together with other European stakehold-ers for the first meeting on that issue.

In July 2020, Parliament’s environment and public health committee adopted a report on medicine shortages calling for European health “independence” by securing supplies, restoring local drug manufacturing and ensuring better EU coordination of national health strategies.

The report by the environment and public health committee identifies three areas for action:

  • A return to EU independence, securing supplies of medicine and equipment
  • Stronger EU coordination, complementing national measures to guarantee affordable and high-quality health services
  • Closer cooperation between EU countries