Challenges in Medicine Supply: A System on the Edge

Since the enactment of the Medicines Supply Shortage Mitigation and Improvement Act in 2023, there has been no significant improvement in the situation regarding drug shortages, according to a recent analysis by a researcher from Worms University. David Francas evaluated data from the Federal Institute for Drugs and Medical Devices (BfArM) to assess trends in medicine supply shortages since 2018.

Francas indicates that the current state of the system is precarious, operating with minimal buffer capacity. He emphasizes that medicine shortages serve as indicators of a system lacking reserves. The study reveals a worrying trend where shortages tend to increase following specific events. For instance, the Valsartan shortage in 2018 was triggered when large batches of the medication produced in China were recalled due to elevated levels of nitrosamines, a carcinogenic substance. Furthermore, the COVID-19 pandemic significantly disrupted global supply chains, underlining the dependency of the pharmaceutical supply on international networks, with two-thirds of active ingredients sourced from China and India.

In addition to isolated incidents, there is a broader, long-term trend indicating an increasing scarcity of medications. Francas' findings show that the number of reported shortages has reached a historically high level. Research indicates that persistent shortages can lead to significant healthcare challenges, including increased mortality rates.

Another critical issue is the growing market concentration within the pharmaceutical industry. Fewer companies hold licenses for essential medications, often due to the declining economic viability of production. This trend is particularly concerning for generic drugs, as the failure of a single manufacturer in a concentrated market can leave the system unable to compensate adequately for the loss.

Despite the introduction of the Medicines Supply Shortage Mitigation and Improvement Act, the overall situation has not seen significant enhancements. Francas points out that the system is lacking in financial resources, and building resilience requires investment.

On a European level, the proposed Critical Medicines Act aims to relocate pharmaceutical production back to Europe, with a budget of EUR80 million allocated for this purpose until 2027. This funding could facilitate the shift of manufacturing of certain active substances from China to Europe. However, establishing and initiating production facilities in Europe tends to be more expensive than in Asia, necessitating long-term subsidies to maintain competitiveness.

While political backing for relocating production has thus far been more theoretical than practical, there are positive developments. The issue of medicine shortages is increasingly recognized at the political level, with several EU health ministers advocating for the use of the EU defense fund to support critical medications. This fund is envisioned to reach a volume of EUR800 billion, as proposed by Ursula von der Leyen. Health ministers argue that Europe's defense capacity could be jeopardized without a reliable supply of essential medications and stress that the safety of the pharmaceutical supply chain should no longer be viewed as a secondary concern.