Our industry’s ability to reliably provide 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. I am proud to say that 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 percent, and manage supply issues to the point that not a single EFPIA member reported disruption to supply of finished products during that extremely challenging period.
Nevertheless, we should never underestimate the frustration and worry for patients, their families, and clinicians when the medicines they depend on are not available in their hospital or pharmacy. The early phase of the pandemic did see disruption in the supply of medicines from other segments of the industry, as well as difficulties for patients in accessing our medicines due to challenges in the distribution of products after they left our factories.
That is why we are committed to building on the reliability of the innovative pharmaceutical sector for the future. As an active participant in the EU Structured dialogue on security of medicines supply, we have continued to offer solutions to help protect patients across Europe from the impact of shortages across the wider medicines supply chain. Avoiding shortages is a shared goal of all stakeholders. However, medicines supply chains are complex, with many actors involved, and a disruption can occur at any point of the chain. We need the active, coordinated engagement and support of all of them to address issues and minimize any negative impact on patient access. Supportive and agile regulators are also essential to achieving this goal.
The starting point to address medicines shortages is to use all the available evidence to understand the extent and root causes of the problem. European citizens deserve a state-of-the art, interconnected shortages monitoring system. The good news is that both the technology and the data already exist within the European Medicines Verification System (EMVS) data repositories. By using this data to monitor medicine shortages, we can go a long way to really understanding the root causes of shortages, and then find solutions that ensure medicines reach patients where and when they need them.
A harmonized EU definition of medicine shortages, and greater clarity on when a shortage should be notified to the authorities, would help minimize any negative impact on patient access. This should take a risk-based approach — with a focus on critical products with a high medical need, or those with a sensitive supply chain.
Supply readiness and proactive pandemic preparedness planning were crucial to quickly scaling up manufacturing during the pandemic.
Supply readiness and proactive pandemic preparedness planning were crucial to quickly scaling up manufacturing during the pandemic. Looking ahead, policies should ensure that all manufacturers have prevention plans in place for the most relevant products. This should focus on a limited number of critical products of major therapeutic interest, and avoid unintended negative consequences limiting supply of medicines in other countries.
In addition, very practical measures like flexible national labeling requirements, or electronic Patient Information Leaflets, would allow a more flexible allocation of products across the EU. Using these tools can enhance our ability to prevent and mitigate the impact of medicines shortages, allowing authorities to anticipate and act in partnership with the relevant actors in the pharmaceutical supply chain.
Our industry is investing heavily in manufacturing at the cutting edge of science and innovation — from modular manufacturing to cell-based and mRNA technologies, as well as greener techniques. There are significant benefits to ensuring the right policy framework is in place to support that investment happening here in Europe as it is a strong basis to avoid shortages of medicinal products in the future.
Maintaining diverse global supply chains that have shown their resilience time and time again, not least during the COVID-19 pandemic is vital.
So what does the policy framework look like to drive innovative manufacturing and support medicine supply in Europe? Maintaining diverse global supply chains that have shown their resilience time and time again, not least during the COVID-19 pandemic is vital. Considering the EU is the largest exporter of medicines in the world, with a global market share of 63.8 percent (€383 billion), we must avoid blunt instrument policies like ‘reshoring’ that would put this incredibly successful model at risk. Particularly as the research-based, innovative sector already sources 76 percent of its active pharmaceutical ingredients (APIs) from within Europe, a nuance that is often overlooked in discussions around policy responses to supply issues.
Recent events have underlined that resilience begins with research. Creating an environment that fosters and supports innovation, including in manufacturing, is the first and most important step to supply chain resilience in the future. Europe owes its limited international dependency on APIs and finished medicines to its historical leadership in pharmaceutical research and innovation. Research and development leads to innovation; and innovation leads to first-mover advantage in advanced production. This is the cycle that supports over 800,000 direct jobs in Europe’s pharmaceutical sector. But this dynamic is changing fast. In the 1990s, Europe was the primary destination for pharmaceutical R&D investment; this position has moved to the U.S. coupled with intense competition from China, other parts of Asia, Switzerland and the U.K. Unless the EU acts now through the review of the pharmaceutical legislation to create a pro-innovation policy framework, it is likely that production will follow the same trajectory as R&D investments.
Instead, taking the right measures to strengthen medicines supply will support Europe’s economic recovery through a vibrant pharmaceutical sector. They will protect and promote patient health through reliable supply and the adoption of new technologies. And they will increase resilience in the face of future health crises. If the EU is ready to set an ambition for global leadership in pharmaceutical innovation through its pharmaceutical strategy, then our industry is ready to work with the EU and member countries to make it a reality.
