24.02.2025.
Europe is waking up to its heavy reliance on pharmaceutical imports. While countries like France and Germany are actively working to secure pharmaceutical sovereignty, others remain highly vulnerable. Poland produces 30% of its medicines, while Latvia depends on imports for 95%.
Early this year the Royal Dutch Pharmacists Association (KNMP) reported that over 4.5 million Dutch patients were affected by medicine shortages. Pharmacies spend €220 million annually managing shortages, requiring 2,000 full-time employees dedicated to sourcing alternatives.
Critical and non-interchangeable drugs are particularly impacted, forcing healthcare providers to adjust treatments—often leading to increased costs and reduced efficacy.
A coalition of 19 EU countries, including France and Germany, has been particularly vocal about the need for more decisive action. These nations argue that the
EU must take “drastic steps” to secure its pharmaceutical supply chains and reduce reliance on a handful of manufacturers, primarily in China.
According to official EU data, more than 50% of Active pharmaceutical ingredients (APIs) meeting European standards come from fewer than five global production sites, highlighting the fragility of supply.
How did Europe lose its grasp?
Until the 1950s, Europe was the global leader in pharmaceutical manufacturing. However, from the 1960s onwards, India and China expanded their production capacities to achieve independence from Western suppliers.
Over time, they became highly competitive, exerting price pressure that pushed pharmaceutical manufacturing—including active pharmaceutical ingredients (APIs)—towards Asia.
By 2019, only 36% of API manufacturing sites were in Europe, while 55% were in Asia. In value terms, Europe’s share of global generic API production was just 24%, compared to 66% in Asia (primarily China and India).
By 2021, China introduced 18 new active substances to the global market, nearly matching Europe’s 19.
Today, China dominates the supply of raw materials, key starting materials (KSMs), intermediates, and APIs, while India is a major producer of both APIs and generic finished products.
This dependency creates significant risks, as Professor Ulrike Holzgrabe from Würzburg University starkly warned:
China wouldn’t need an atomic bomb to deal a fatal blow to Europe. Just stopping its supplies of antibiotics would also do the trick.
A global push for pharmaceutical sovereignty
Governments worldwide are taking steps to regain control over medicine production. By 2030, Saudi Arabia intends to increase its share of domestic pharmaceutical manufacturing from 20% to 40% to meet local demand and expand globally. By 2032, its pharmaceutical sector is projected to exceed $10 billion in annual sales, accounting for 37% of the MENA market.
Austria has provided €28.8 million in funding to Sandoz for local amoxicillin production, while Brazil is investing in state-owned pharmaceutical firms to boost domestic supply.
Switzerland is also exploring policy changes to ensure drug affordability and supply stability.
Health security as a priority for the Polish Presidency
Recognizing the urgency of the issue, health security has become a key priority for the Polish presidency of the Council of the European Union.
At the high-level conference “Critical Medicines for Health Security – Current Challenges and Future Directions” in Brussels, health ministers, European Commission representatives, and industry experts gathered to address the issue.
Key discussions revolved around reducing Europe’s reliance on non-EU pharmaceutical imports and strengthening resilience against health crises and military threats.
One of the primary concerns raised was the growing risk of supply disruptions and medicine shortages, exacerbated by geopolitical tensions and economic instability.
- On February 25, 2025, the Alliance for Critical Medicines will publish key recommendations on how to strengthen medicine supply security across the EU.
- Rising risks: The COVID-19 pandemic, the war in Ukraine, and geopolitical instability have exposed the dangers of over-reliance on non-EU suppliers (mainly China and India).
- Investment in local production: Special programs and funding are necessary to incentivize European pharmaceutical companies to produce critical medicines and APIs domestically, ensuring resilience in times of crisis.
- Medicine security as national security: Just as military security is vital for a nation’s defence, securing medicine supply chains is essential for national stability. The Polish presidency underscores the need for Europe to treat medicine security as a fundamental aspect of its defence strategy.
The Critical Medicines Act
To tackle this challenge, the European Commission is developing the Critical Medicines Act, a new legislation aimed at reducing dependency on external suppliers and boosting local production.
This initiative aligns with the broader reform of the EU pharmaceutical sector, focusing on enhancing investment, securing supply chains, and ensuring access to essential drugs during emergencies.
As geopolitical tensions rise and global supply chains become more fragile, ensuring stable access to medicines must remain at the top of the EU’s agenda. The future of Europe’s healthcare system depends on its ability to produce essential medicines within its borders.
SOURCE
https://polish-presidency.consilium.europa.eu/en/news/a-safe-europe-means-safe-medicines/
https://nltimes.nl/2025/01/09/drug-shortages-persist-netherlands-affecting-millions
https://www.europarl.europa.eu/RegData/etudes/STUD/2023/740070/IPOL_STU(2023)740070_EN.pdf https://www.swissinfo.ch/eng/multinational-companies/five-ways-authorities-hope-to-end-medicine-shortages/88784833
https://abm.gov.pl/en/news/173,We-want-more-medicines-to-be-produced-in-Poland.html
https://www.dw.com/en/can-eu-wean-itself-off-essential-drugs-from-china-india/a-68982337
