EU Nations Demand 'Critical Medicines Act'

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Written by Martin Lynch, European News Editor for Industrial Info (Galway, Ireland)--A majority of European Union (EU) nations have banded together to call for a "Critical Medicines Act" that would allow Europe to be less reliant on external suppliers for essential medicines.

Nineteen countries of the 27-nation bloc, including heavyweights Germany and France, are calling for the EU to introduce a similar act to the European Chips Act introduced early last year to protect semiconductor supplies and last month's Critical Minerals Act, designed to secure a more sustainable supply of the minerals essential to its climate, automotive, digital, aerospace and defense sectors. For additional information, see February 21, 2022, article - Europe Enacts 'Chips Act' to Battle Semiconductor Shortages and April 4, 2023, article - Europe Outlines Critical Minerals Act. Both of the previous "critical" acts have resulted in major investment pledges and regulatory changes for their sectors.

Like chips and raw materials, Europe relies heavily on external suppliers and often single-source suppliers for its essential medicines. This has become a growing problem in recent years, and over the past few months, the region has suffered acute shortages of key medicines such as antibiotics, thrombolytics and insulin while others like antipyretics and painkillers were also in short supply. According to the Organization of Economic Development and Cooperation (OECD), shortage notifications increased by 60% between 2017 and 2019. Annual surveys of EU pharmacists show that since the start of reporting in 2019, all EU countries have experienced shortages on a yearly basis with each year worse than the year before.

"The reasons for shortages are complex, and range from unexpected increases in demand to manufacturing and quality issues, factory closures or relocations, bottlenecks in the supply chains, and regulation and reimbursement policies. In several member states, parallel exports, combined with a lack of transparency on supply, cause serious disruptions that have detrimental effects for patients," the group stated. It added that there is now a growing security element to contend with.

"In addition to these problems, the EU is becoming increasingly dependent on imports from a few manufacturers and regions for its medicines supply, adding a security dimension to the question. In 2019, globally more than 40% of APIs were sourced from China. Furthermore, almost all API producers depend on China for intermediate inputs, even if they are located in another country. Next to the geographic concentration, there is also a concentration of manufacturing sites: for more than 50% of APIs globally, less than 5 CEP1 manufacturers exist. As a result, Europe (and the world) depend on a few manufacturers for a large bulk of their medicines supply."

The group recognizes that the EU has taken steps with the creation of the Executive Steering Group on Shortages of Medicines Caused by Major Events (MSSG), which brought together experts from European Medicines Agency (EMA), the European Commission (EC) and the EU member states. "However, considering the complexity of the problems and the risks associated with them, we believe that the EU must take more drastic steps to improve the security of medicines supply". It is proposing the following points of action:

• Installing a voluntary solidarity mechanism within the MSSG to, as a last resort, temporarily alleviate acute shortages in member states
• Establishing a European list of critical medicines whose supply, production and value chains must be monitored
• Exploring a Critical Medicines Act to reduce dependencies for critical medicines and ingredients, particularly for products where there are only a few supplying manufacturers or countries

These three proposals are targeted at the short, medium and long term, the group stated. "Together, they should prevent the worst case scenarios of patients not being properly treated due to empty stocks, and provide a more structural response to the root causes of our problems."

In 2021, when the European Chips Act was enacted, the EC promised 15 billion euro (US$16.5 billion) in additional public and private investment until 2030. This came on top of 30 billion euro (US$33 billion) of public investments that it had already planned. A large portion of that was set aside to advance semiconductor projects while the planning process was fast-tracked in Member States for new grassroot facilities and expansions of existing plants.

While Europe has a thriving and innovative technology research and development sector, its share of the overall global semiconductors production market is less than 10% and is heavily dependent on third-country suppliers. The goal is for the EU to double its current market share to 20% by 2030. Similar concerns pushed through its recent Critical Minerals Act. Demand for key raw materials is projected to increase dramatically in the coming years, and Europe is heavily reliant on imports, often from "quasi-monopolistic third country" suppliers, the EC noted. The European Union is overly dependent on single sources, with more than 90% of its supply of certain minerals coming from a single third country. It has proposed more financial support for mining projects, increased targets for minerals extraction through recycling, more EU-based processing and recycling centers, faster planning processes and a call on Member States to develop national programmes for exploring geological resources.

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