Ensuring the supply of medicines to patients in Europe – POLITICO
Our industry’s ability to reliably deliver medicines to patients across Europe has come to the fore during the early stages of the COVID-19 crisis. Almost overnight, borders were closed, export restrictions were put in place, and air freight options were simply gone. I am proud to say that despite an exponential increase in the demand for certain drugs, the research-based pharmaceutical industry has been able to increase its capacity, in some cases by as much as 300-400 percent, and manage the supply problems to the point that not a single member of EFPIA reported an interruption in the supply of finished products during this extremely difficult period.
Nonetheless, we should never underestimate the frustration and concern of patients, their families and clinicians when the medications they depend on are not available in their hospital or pharmacy. The initial phase of the pandemic saw disruptions in the supply of medicines to other segments of the industry, as well as difficulties for patients to access our medicines due to problems with the distribution of products after they left. our factories.
This 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 continued to deliver solutions to help protect patients across Europe from the impact of shortages across the medicine supply chain. Avoiding shortages is a goal shared by all stakeholders. However, drug supply chains are complex, with many players involved, and disruption can occur at any point in the chain. We need the active and coordinated commitment and support of all to resolve issues and minimize any negative impact on patient access. Supportive and agile regulators are also essential to achieve this goal.
The starting point for addressing drug 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 shortage monitoring system. The good news is that the technology and the data already exist in the data repositories of the European Medicines Verification System (EMVS). By using this data to monitor drug shortages, we can go a long way to truly understand the root causes of shortages, and then find solutions that ensure drugs get to patients where and when they need them.
A harmonized European definition of drug shortages and greater clarity as to when a shortage should be notified to the authorities would help to minimize any negative impact on patient access. This should take a risk-based approach – focusing on critical products with a high medical need, or those with a sensitive supply chain.
Supply readiness and proactive pandemic preparedness planning have been crucial in rapidly scaling up manufacturing during the pandemic. Going forward, 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 the supply of drugs in other countries.
In addition, very practical measures such as flexible national labeling requirements or electronic patient information brochures would allow a more flexible distribution of products across the EU. Using these tools can improve our ability to prevent and mitigate the impact of drug shortages, enabling authorities to anticipate and act in partnership with relevant players in the pharmaceutical supply chain.
Our industry invests heavily in manufacturing at the cutting edge of science and innovation – from modular manufacturing to cellular and mRNA technologies, as well as greener techniques. There are significant benefits to ensuring that the right policy framework is in place to support this investment taking place here in Europe, as it is a solid foundation for avoiding drug shortages in the future.
So what does the policy framework look like to stimulate innovative manufacturing and support the supply of medicines in Europe? It is vital to maintain various global supply chains that have shown their resilience time and time again, especially during the COVID-19 pandemic. Given that the EU is the largest exporter of medicines in the world, with a global market share of 63.8% (383 billion euros), we must avoid the policies of harsh instruments like ‘relocation’ which would endanger this incredibly successful model. Especially since the innovative research-based sector already sources 76 percent of its active pharmaceutical ingredients (APIs) from Europe, a nuance that is often overlooked in discussions of policy responses to supply issues.
Recent events have underscored that resilience begins with research. Creating an environment that fosters and supports innovation, including in the manufacturing sector, is the first and most important step in supply chain resilience going forward. Europe owes its limited international dependence on APIs and finished drugs to its historic leadership in pharmaceutical research and innovation. Research and development lead to innovation; and innovation leads to first-mover advantage in advanced production. This is the cycle that supports more than 800,000 direct jobs in the European pharmaceutical sector. But this dynamic is changing rapidly. In the 1990s, Europe was the main destination for investments in pharmaceutical R&D; this position has shifted to the US coupled with intense competition from China, other parts of Asia, Switzerland and the UK Unless the EU now acts through From revising pharmaceutical legislation to creating a policy framework conducive to innovation, production is likely to follow the same trajectory as investments in R&D.
Instead, taking the right steps to boost drug supply will support Europe’s economic recovery through a vibrant pharmaceutical sector. They will protect and promote the health of patients 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 itself 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 this a reality.