In the face of persistent global geopolitical uncertainty, Europe is paying increasing attention to its sovereignty, security and resilience.
The availability of essential medicines and vaccines is essential to Europe’s health preparedness. As governments across Europe rebuild and learn lessons from the pandemic, policies that can build health resilience and strengthen health systems are the focus; the concept of open strategic autonomy is at the top of the EU political agenda.
EU pharmaceutical legislation provides the European Commission with the ideal vehicle to address health resilience, improve patient outcomes and develop strategies to support and grow the life sciences sector and healthcare footprint. research and development (R&D) of the regions.
It is important that any focus on self-sufficiency and global supply dynamics does not lose sight of the goal of fostering a healthier, more prosperous and globally competitive Europe.
Building resilience through research
Innovative industry needs conditions that attract R&D investments, so that Europe remains competitive while benefiting from global supply chains and R&D networks. A resilient manufacturing base starts by ensuring that R&D is carried out in the EU.
Europe competes for investments with the United States, as well as emerging countries like China and Brazil. The trends are worrying: in 2002, the United States spent 2 billion euros more than Europe on R&D; today, this figure stands at almost 25 billion euros. In 2020, Europe accounted for a 19.3 percent share of global clinical trial activity, a decline of 6.3 percent, compared to an average of 25.6 percent over the past 10 years. For advanced therapy medicines, clinical trial activity is twice as high in the United States and almost three times higher in China than in Europe.
Europe needs policies that encourage businesses to invest in Europe.
Finding the right political solution to the right problem
No EFPIA member has had a medicine shortage to report to the European Medicines Agency during the pandemic. In fact, only 4 percent of shortages are linked to innovative medicines.1
As a reminder, in the innovative sector, 54% of the active pharmaceutical ingredients (API) needed for the production of original medicines in the EU come from the EU itself. This represents 64 percent when including the United Kingdom and Switzerland. Meanwhile, 15% of APIs come from North America, and only 6% from India, 5% from China and 10% from other countries.
Policy solutions must be carefully targeted to solve problems without hindering innovation or harming European competitiveness.
Proposals to reduce regulatory data protection — a significant share of European intellectual property (IP) — a quarter of it — will have the opposite effect. Given the downward trends, we should strengthen intellectual property if we want to narrow the gap with Asia and the United States.
Innovative industry supports pragmatic policies, such as establishing a European list of critical medicines, whose supply, production and value chains can be monitored, as well as exploring a medicines law critical to reducing dependence on third countries.
These policies should be designed in close cooperation with – and early involvement of – manufacturers to avoid multiple systems operating in parallel and multiple national storage requirements.
Different parts of the pharmaceutical sector face different problems and require different solutions, as well as a multi-faceted approach, tackling the root causes of the shortage, with partners working together to build trust and increase transparency in the entire supply chain.
In a world characterized by global uncertainty and insecurity, diversification and limiting restrictions in supply chains mitigates risks. This means supporting open global supply chains, creating alliances with strategic partners sharing common interests and thus creating the conditions in Europe conducive to the development of the life sciences manufacturing industry.
This should include solidarity agreements between EU countries that would allow the transfer of essential medicines in the event of stock shortages, as well as the consistent use of electronic patient information to accelerate the allocation of supplies to countries that need it.
Using data and new technologies to improve transparency in supply chains
Europe is not using the data it has to manage supply and alleviate shortages. We need better visibility of available medicine stocks throughout supply chains, in an integrated system.
The European Medicines Verification System (EMVS) data repositories, established in the context of the EU Falsified Medicines Directive to prevent and monitor shortages, are essential.
EMVS data can potentially track when and how drugs are placed in different markets, as well as the rate of consumption nationally.
The confidential use and analysis of this data by the competent authorities would allow a better understanding of the root causes of shortages, in order to develop adequate responses to a specific situation.
Data stored in national medicines verification systems would provide information on boxes of prescription products supplied by manufacturers in EU countries, number of boxes dispensed in national pharmacies, number of boxes exported and imported, as well as the level of stocks present in national pharmacies. the supply chain at the national level. Real-time information can be analyzed by granular 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.
A better understanding of patient demand, through current epidemiological data, is also vital: the European Center for Disease Control can provide modeling data covering patient needs and hospital capacity in Member States.
Actions aimed at preventing and alleviating shortages must be differentiated; a one-size-fits-all solution will not succeed. Action will be more effective if it is organized and coordinated at EU level, avoiding the multiplication of uncoordinated measures adding complexity to the system. Companies manage global supply chains; a coordinated process between EU countries would be most effective in ensuring their proper functioning.
Together, these actions will help achieve the common 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