EU plans to share medicines in case of shortage

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Brussels plans for EU countries to share life-saving medicines and take emergency measures to avoid a repeat of the shortages that hit the bloc a year ago.

The European Commission is proposing a voluntary solidarity mechanism requested by France and Germany and an early warning system in the event of a shortage of medicines, according to a draft proposal seen by the Financial Times. If donors do not come forward sufficiently, EU capitals will be allowed to draw on an EU-funded stockpile built up during the Covid-19 pandemic and take other emergency measures.

In December and January, Western countries suffered shortages of antibiotics, including penicillin and amoxicillin, and painkillers such as paracetamol, particularly in medicines used by children.

Among the emergency measures proposed to avoid a repeat of this crisis, the commission could authorize the extension of the shelf life of drugs, speed up the approval of alternative suppliers and support production increases.

Brussels will also encourage joint procurement of medicines from 2024 and exchanges of medicines with countries in the southern hemisphere, where peak winter demand occurs at a different time.

The commission will develop guidance for national stockpiles in 2024 and establish a critical medicines alliance bringing together governments, industry and civil society. The commission declined to comment.

Three-quarters of countries reported worsening drug shortages in 2022, according to an industry survey. The EU manufacturing industry relies heavily on active pharmaceutical ingredients imported from China and India.

Growing demand and disruption to supply chains have been compounded by inflation that has hit the production of generic drugs, which typically sell at much lower prices than brand-name versions.

France is actively encouraging the relocation of supplies of basic medicines, with a giant paracetamol factory opening in the country next year.

The EU is discussing whether to finance more domestic production.

The commission’s proposal is expected to be approved on October 25 and could still change. Initially non-binding, it could lead to a law on critical medicines, with Brussels drawing up a list of vital medicines by the end of the year.

The committee also urges member states and the European Parliament to approve the revision of pharmaceutical legislation proposed in April. It includes taking control of drug production in the event of a public health emergency, requiring shareholders to inform Brussels of supply levels and for manufacturers to give early warnings of shortages.

An analysis by the European Medicines Agency and the Commission found that barring unexpected demand, the EU should avoid an antibiotic shortage this year.

Information available today suggests that while demand over the upcoming winter season does not differ significantly from recent years, the supply of key antibiotics to the EU appears to generally match demand, according to the ‘analysis.

However, this is highly dependent on the industry’s compliance with its legal obligations to ensure supply and its ability to adapt.