Out of stock

The causes of shortages are multifactorial, including production issues, global manufacturing consolidation, unintended effects of pricing and bidding policies, and active ingredient supply issues and regulatory constraints. The innovative pharmaceutical industry is committed to ensuring an adequate and continuous supply of medicines to pharmacies and those licensed or authorized to supply medicines to the public in order to meet patient needs.

Through EFPIA, the industry is currently working with the EMA and the heads of the medicines agencies to ensure effective implementation of the EMA/HMA guidance on shortage detection and reporting, which should enable all competent authorities in the EU to receive harmonized information on any potential disruption or interruption of supply at a very early stage.

As an industry, we want to ensure that all possible sources of information are used to provide additional information on the root causes and drivers of shortages, including the identification of bottlenecks in the supply chain. In this regard, EFPIA recommends that data stored in the interoperable network of national repositories set up under the Falsified Medicines Directive (Directive 2011/62/EU) and its Delegated Regulation 2016/161/EU on safety devices be used for shortage tracking. Data stored in national medicines verification systems could provide useful information regarding the number of packages provided by manufacturers in different EU markets as well as the level of stocks present in the supply chain at the national level, and thus facilitate the detection and mitigation of shortages. The use of repository systems to monitor shortages would benefit from further discussion between national competent authorities and supply chain stakeholders, but the ambition is to use all available tools to protect patient safety and public health.