EFPIA statement on the European Commission's Communication on addressing medicine shortages in the EU
EFPIA shares the objectives set out in the Commission’s Communication on addressing medicine shortages in the EU. Shortages cause harm to patients and immense concern to their families and clinicians. Although only 4% of shortages occur in the innovative medicines sector, recognising their impact, we are fully committed to working together to manage, mitigate and eradicate them where possible.
EFPIA particularly welcomes the structural measures to address the industrial dimension of medicines shortages in the medium and long term. In this respect, we applaud the Critical Medicines Alliance which should provide a genuine platform for national authorities, industry, civil society, the Commission and EU agencies to develop coordinated action against shortages and provide structural solutions rather than treating symptoms.
Shortages can arise for many different reasons such as manufacturing issues or a lack of capacity associated with long investment lead times. They can result from stronger and/or unexpected demand due to public health emergencies or poor forecasting. Solutions need to be fit for purpose targeting the specific root causes of shortages. Any measures aimed at mitigating shortages in the immediate and short term should be proportionate and provide efficient, workable solutions that serve public health needs.
For example, in a period of supply constraints imposing stockpiling obligations in some EU countries will simply translate into more shortage in others. It would go against the spirit of the EU voluntary solidarity mechanism foreseen to alleviate acute shortages.
Similarly, the EC legislative proposal asking for prevention plans for all medicines or 6 months notification of shortages will divert limited resources (from both authorities and industry) from where they are needed and could lead to unintended consequences such as panic buying while at the same time might not help to address the real issues.
To fully deliver the actions included in the Communication, EU Institutions and Competent Authorities need to include industry in the design and implementation of new processes as well as share information on the likely demand for medicines as early as possible.
The failure to utilise the information stored in the European Medicines Verification System (EMVS) remains a missed opportunity to mitigate and manage shortages that could be readily implemented. The system provides real time data on the quantities of individual medicines in the supply chain at Member State level, even down to the exact number of boxes dispensed in national pharmacies and hospitals or the number of boxes of individual medicines that have been exported or imported. The data provides the most complete picture of the root causes of shortages, where and how shortages occur in Europe, and is our best chance to pre-empt, plan and mitigate their impact on patients. Not including this powerful resource in the Commission’s series of actions leaves a gaping hole in our collective efforts to protect patients from shortages of medicines across Europe.