Pharma says FMD data could help manage drug shortages

A pharma industry trade body has called for the data stored within the EU’s medicine verification system to be harnessed to monitor medicine shortages.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) says it is working with the European Medicines Agency (EMA) and heads of regulatory authorities in Europe to make sure that national agencies get information about any potential disruption or interruption of supply at very early stage.

The move comes as the threat of a no-deal Brexit looms ever larger, and as medical and pharma leaders have warned that the UK’s contingency planning – such as laying on additional ferry capacity – is likely not sufficient to guarantee there will be no shortages after 31 October.

It’s a problem that affects the UK and the EU27 equally, as 45 million patient packs are supplied from the UK to other European countries each month, while another 37 million flow in the opposite direction, according to the Association of the British Pharmaceutical Industry (ABPI).

A recent report from the House of Commons Exiting the EU Committee suggested that the disruption caused by a no-deal Brexit would increase the risk of falsified medicines entering the supply chain, particularly if the UK is excluded from the medicines verification framework.

“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,” says the organisation.

In particular, the data stored in the National Medicines Verification Systems (NMVSs) 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,” it adds.

The trade body says that the causes of shortages are multifactorial, including problems in production, global consolidation of manufacturing, unintended impacts of pricing and tendering policies, as well as issues within the supply chain.

“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,” says EFPIA.