EFPIA statement on Medicine Shortages in Europe
Drug shortages are a growing source of concern and industry is taking every possible step in our capacity to minimise the impact of shortages for patients. The causes of shortages are understood to be multifactorial, including problems in production, global consolidation of manufacturing, unintended impacts of pricing and tendering policies, as well as problems within the supply chain. Industry remains committed to ensure appropriate and continued supplies of medicines to pharmacies and persons authorised or entitled to supply medicines to the public so that needs of patients are met.
Industry is currently working with EMA and Heads of Medicines Agencies in order to ensure effective implementation of the EMA/HMA guidance on detection and notification of shortages, which should enable all EU competent authorities to receive harmonised information about any potential disruption or interruption of supply at very early stage.
As an Industry, we are keen to ensure that all possible sources of information are being used in order to provide additional intelligence about the root causes and drivers of shortages, including identification of bottlenecks in the supply chain. In this respect EFPIA recommends that the data stored in the interoperable network of national repositories being set up in the context of the Falsified Medicines Directive (Directive 2011/62/EU) and its Delegated Regulation 2016/161/EU on safety features be used for the monitoring of shortages. The data stored in the National Medicines Verification Systems could provide useful intelligence regarding the number of packs being supplied by manufacturers on the various EU markets as well as on the level of stocks present in the supply chain at country level, and therefore facilitate shortages detection and mitigation. The use of the repositories systems for the monitoring of shortages would benefit from further discussion between National Competent Authorities and relevant supply chain stakeholders, but the ambition is to use every tool available to protect patient safety and public health.