Faced with continued global geopolitical uncertainty, Europe is paying increasing attention to its sovereignty, security and resilience.
The availability of critical medicines and vaccines is crucial for 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 in focus; The concept of open strategic autonomy is at the top of the EU policy agenda.
EU pharmaceutical legislation provides the European Commission with the perfect tool to address health resilience, improve patient outcomes and develop strategies to support and grow the regional life sciences sector and research and development (R&D) footprint.
It is important that any focus on self-sufficiency and addressing global supply dynamics does not lose sight of the goal of fostering a healthier, more advanced and globally competitive Europe.
Building resilience through research
Innovative industry needs conditions that attract investment in research and development, so that Europe remains competitive while benefiting from global supply chains and research and development networks. A resilient manufacturing base starts with ensuring that research and development is done in the EU.
Europe competes for investment with the US, as well as with developing countries such as China and Brazil. The trends are worrying: in 2002, the US spent 2 billion euros more than Europe on research and development; today that figure is almost 25 billion euros. In 2020, Europe accounted for 19.3 percent of global clinical trial activity, down 6.3 percent, compared to an average of 25.6 percent over the past 10 years. For advanced therapy medical products, clinical trial activity is twice as high in the US and almost three times as high in China as in Europe.
Europe needs policies that will encourage companies to invest in Europe.
Finding the right policy solution for the right problem
No EFPIA member has had a shortage of medicines to report to the European Medicines Agency during the pandemic. Namely, only 4 percent of shortages refer to innovative medicines.1
For context, in the innovative sector, 54 percent of the active pharmaceutical ingredients (APIs) required for the production of original medicines in the EU come from the EU itself. It is 64 percent if the UK and Switzerland are included. Meanwhile, 15 percent of APIs come from North America, and only 6 percent from India, 5 percent from China and 10 percent from other countries.
Policy solutions must be carefully focused on solving problems without hindering innovation or harming European competitiveness.
Proposals to reduce regulatory data protection — an important part of European intellectual property (IP) — for a quarter, it will do the opposite. Given the downward trend, we should strengthen IP if we want to close the gap with Asia and the US
The innovative industry supports pragmatic policies, such as the establishment of a European list of critical medicines, whose supply, production and value chains can be traced, as well as research on the Critical Medicines Act to reduce dependence on non-EU countries.
These policies must be designed in close collaboration with—and with the early involvement of—producers, to avoid multiple systems operating in parallel and duplicating the country’s stockpile requirements.
Different parts of the medicines sector face different problems and require different solutions, as well as a multi-pronged approach, addressing the root causes of shortages, with partners working together to build trust and increase transparency throughout the supply chain.
In a world characterized by uncertainty and global insecurity, diversifying and limiting constraints in supply chains reduces risk. This means supporting open global supply chains, creating alliances with strategic partners with common interests and thus creating the conditions in Europe for life science manufacturing to flourish.
This should include solidarity agreements between EU countries to allow the transfer of critical medicines during shortages and the consistent use of electronic patient data to speed up the allocation of supplies to countries in need.
Using data and new technology to improve supply chain transparency
Europe is not using the data at hand to manage supply and mitigate shortages. We need better visibility of available drug supplies across supply chains, in an integrated system.
The data repositories of the European Medicines Verification System (EMVS), set up in the context of the EU Falsified Medicines Directive to prevent and monitor shortages, are crucial.
EMVS data can track when — and how — drugs are placed on different markets, as well as the rate of consumption at the national level.
The confidential use and analysis of this data by the competent authorities would bring a better understanding of the root causes of shortages, in order to develop appropriate responses to the specific situation.
Data stored in national drug verification systems would provide information on prescription product packs supplied by manufacturers in EU countries, the number of packs dispensed in national pharmacies, the number of packs exported and imported, as well as the level of supply chain stocks at country level. Real-time information can be analyzed by precise time frames as well as by region.
This wealth of data would facilitate detection and mitigation using all available tools to protect patient safety and public health.
Increased understanding of patient requirements through timely epidemiological data is also vital: the European Center for Disease Control can provide data modeling covering patient needs and hospital capacity in Member States.
Actions to prevent and mitigate shortages must be differentiated; one solution for all will not work. The action will be most effective if it is organized and coordinated at the EU level, avoiding the duplication of uncoordinated measures that further complicate the system. Companies run global supply chains; a coordinated process in EU countries would be most effective in ensuring their smooth development.
Taken together, these actions will help achieve the shared goals of a competitive and resilient Europe and ensure that patients continue to have access to the medicines they need, wherever they are in Europe.
- IQVIA, October 2023