Medicine shortages: EFPIA proposals for action
Last month, the European Commission published its Staff Working Document on how to ensure resilient supply chains of medicines. The report is the outcome of a structured dialogue between the Commission and stakeholders from across the medicines supply chain, including EFPIA. We welcome the report underlining that collaboration and partnership are key to supply chain security: avoiding shortages is a shared goal of all stakeholders.
Our industry’s ability to ensure the safe supply of medicines to patients across Europe came into sharp focus during the early stages of the COVID-19 crisis. Almost overnight, borders closed, export restrictions were put in place and air freight options simply vanished. Despite an exponential increase in the demand for some medicines, the research-based pharmaceutical industry was able to increase capacity, in some cases by as much as 300-400%, and manage supply issues to the point that not a single EFPIA member reported disruption to supply during that extremely challenging period.
While the COVID-19 pandemic faded, the medicines supply chains have been confronted to new considerable challenges linked to the war in Ukraine and the energy crisis. To fulfil their mission to deliver medicines to patients in need into war-torn Ukraine, companies had to seek alternative routes via humanitarian organizations and the Ukrainian Ministry of Health. Challenges persist with lengthening delays of supplies of various components or packaging materials and, despite the overall resilience shown by the research-based industry’s supply chains, shortages could happen. When they do, they will inevitably lead to frustration and worry for patients, their families and clinicians when they are dependent on an essential medicine.
That is why we are committed to keep building on the reliability of the supply of the pharmaceutical sector for the future. The EFPIA proposal for action puts forward 9 concrete proposals underpinned by 5 principles to help protect patients across Europe from the impact of shortages across the wider medicines supply chain:
- A harmonised EU prevention and mitigation system, based on a standard definition of a shortage, and an interoperable IT European monitoring/notification system: this requires agreement on a harmonised, workable definition of a shortage and the development of a European state-of-the-art, interoperable IT monitoring/prevention tool.
- Increased transparency and understanding of patient demand, through timely (current and forward looking) epidemiological data: the use of European Medicines Verification System (EMVS) will provide increased transparency in the overall supply chain.
- A risk-based approach focussing on critical products / critical shortages leading to the implementation of targeted shortage prevention plans (SPP) for critical products through a collaborative process, and the management of safety stocks on a risked-based approach.
- Increased flexibility through the enactment of regulatory mitigation measures for shortages.
- Maintenance of resilient global supply chains through the strengthening of EU resilience building on the very strong existing EU manufacturing and R&D footprint while keeping the benefits of global open supply chains, and where appropriate, targeted incentivisation for diversification of supply chains (without discrimination and in compliance with international law).
The forthcoming revision of the EU pharmaceutical legislation provides a unique opportunity to simplify, harmonise and modernise the current system relying on the use of new technologies to better understand and anticipate demand as well as to strengthen supply chain resilience, all of which will help to anticipate and address shortages. Our blend of proposals relying inter alia on the use of digital technology will help ensure patients across Europe get the medicines they need. They will support Europe’s economic recovery and increase resilience in the face of future health crises. If the EU is ready to set an ambition for global leadership in pharmaceutical innovation, then our industry is ready to work with the EU and Member States to make it a reality.