In the face of continuing global geopolitical instability, Europe is increasingly paying attention to its sovereignty, security and resilience.
The availability of vital medicines and vaccines is central to Europe’s health preparedness. As governments across Europe rebuild and learn from the pandemic, policies that can build health resilience and strengthen health systems are coming into focus; The concept of open strategic autonomy is at the top of the EU’s policy agenda.
The EU Medicines Law provides the European Commission with a perfect vehicle to address health resilience, improve patient outcomes and develop strategies to support and develop the scientific sector life as well as research and development (R&D) footprint in the region.
It is important that any focus on self-sufficiency and addressing global supply dynamics does not take away from the goal of promoting a healthy, prosperous and globally competitive Europe.
Build resilience through research
The innovation industry needs conditions that attract investment in R&D for Europe to remain competitive while benefiting from global supply chains and R&D networks.
The innovation industry needs conditions that attract investment in R&D for Europe to remain competitive while benefiting from global supply chains and R&D networks. A resilient manufacturing base starts with ensuring R&D is carried out in the EU.
Europe is competing for investment with the US as well as with emerging countries such as China and Brazil. Worrying trends: in 2002, the US spent $2 billion more than Europe on R&D; today that number is nearly 25 billion. In 2020, Europe had a 19.3% share of global clinical trial activity, down 6.3% from the average of 25.6% over the past 10 years. For advanced therapeutic drug products, clinical trial activity is twice as high in the US and nearly three times as high in China as in Europe.
Europe needs policies to encourage companies to invest in Europe.
Policy solutions need to be carefully targeted to tackle problems without stifling innovation or harming Europe’s competitiveness.
Find the right policy solution for the right problem
No EFPIA member had a shortage of medicines to report to the European Medicines Agency during the pandemic. In fact, only 4% of shortages involve innovative drugs.first
In this context, in the innovation sector, 54% of the active pharmaceutical ingredients (APIs) required for innovators’ drug production in the EU come from the EU itself. That’s 64% if the UK and Switzerland are included. Meanwhile, 15% of APIs come from North America and only 6% from India, 5% from China and 10% from other countries.
Policy solutions need to be carefully targeted to tackle problems without stifling innovation or harming Europe’s competitiveness.
Proposals to reduce by a quarter regulatory data protection, a key part of Europe’s intellectual property (IP), would have the opposite effect.
Proposals to reduce regulatory data protection a significant portion of Europe’s intellectual property (IP) would do the opposite. With the downward trend, we should strengthen intellectual property if we want to close the gap with Asia and the United States
The innovation industry supports practical policies, such as establishing a European list of critical medicines, which can monitor supply chains, production and value, as well as studying the Important medicines to reduce dependence on non-EU countries.
These policies must be designed in close collaboration and with early involvement of manufacturers, to avoid multiple systems operating in parallel and increasing national reserve requirements.
Different parts of the pharmaceutical industry face different problems and require different solutions, as well as a multifaceted approach, addressing the root causes of shortages, including Partners work together to build trust and increase transparency throughout the supply chain.
In a world characterized by global uncertainty and insecurity, diversifying and limiting supply chain constraints will help reduce risk.
In a world characterized by global uncertainty and insecurity, diversifying and limiting supply chain constraints will help reduce risk. That means supporting open global supply chains, creating alliances with strategic partners with shared interests and thereby creating the conditions in Europe for life science manufacturing to flourish.
This will include solidarity agreements between EU countries allowing the transfer of critical medicines while stocks last and consistent use of electronic patient information to accelerate the allocation of supplies to countries. family in need.
Use new data and technology to improve supply chain transparency
Europe is not using the data at its fingertips to manage supplies and mitigate shortages. We need better visibility into drug availability throughout the supply chain in an integrated system.
The European Medicines Verification System (EMVS) database, established in the context of the EU Counterfeit Medicines Directive to prevent and monitor shortages, is vital.
EMVS data has the ability to track when and how medicinal products are introduced into different markets, as well as the rate of consumption at the country level.
Confidential use and analysis of this data by authorities will provide a better understanding of the root causes of shortages, thereby informing appropriate responses to a situation. specific situation.
Data stored in the National Medicines Verification System will provide intelligence on the packages of prescription products supplied by manufacturers in EU countries, the number of packages dispensed in pharmacies country, the number of export and import packages, as well as the existing inventory levels in the supply chain at the country level. Real-time information can be analyzed by detailed time frame as well as by region.
This wealth of data will facilitate detection and mitigation using every available tool to protect patient safety and public health.
This wealth of data will facilitate detection and mitigation using every available tool to protect patient safety and public health.
Improving understanding of patient needs through timely epidemiological data is also important: the European Center for Disease Control can provide modeling data on patient needs and capacity. hospital capacity in member states.
Actions to prevent and mitigate shortages must be clearly distinguished; A one-size-fits-all solution will not succeed. Action will be most effective if organized and coordinated at EU level, avoiding the replication of uncoordinated measures that add complexity to the system. Companies operate global supply chains; A coordinated process between EU countries would be most effective in ensuring they continue to operate smoothly.
Combining these actions will help achieve the shared goals of a competitive and resilient Europe, while ensuring patients continue to have access to the medicines they need, wherever they are in Europe .
- IQVIA, October 2023
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