Shortages and supply obligations

A shortage of a medicinal product means that a community pharmacy or a hospital pharmacy is unable to dispense it to a patient within a set period. EU law requires the marketing authorisation holder and distributors to ensure appropriate and continued supplies to the market, under Article 81 of Directive 2001/83/EC. The French Public Health Code implements that obligation and strengthens it for medicinal products of major therapeutic interest.

Obligations of exploitant companies

For medicinal products of major therapeutic interest, the exploitant company must draw up a shortage management plan, inform the ANSM as soon as it becomes aware of a risk of shortage and implement alternative solutions. It must also build up a safety stock for the national market, of at least two months for these medicinal products, which the agency may extend to up to four months. Breaches expose the company to financial penalties imposed by the ANSM.

The European framework

Regulation (EU) 2022/123 strengthened the role of the European Medicines Agency in monitoring shortages and managing public health crises, in particular by drawing up lists of critical medicinal products. A broader reform of EU pharmaceutical legislation, which provides for stronger obligations to notify and prevent shortages, was launched by the Commission in 2023.

Shortages and patents

Shortages raise questions about the exercise of exclusive rights. Article L. 613-16 of the French Intellectual Property Code allows a patent to be made subject to an ex officio licence in the interest of public health, in particular where the medicinal product is made available to the public only in insufficient quantity or quality. The risk of shortage may also be invoked, on proportionality grounds, before the court hearing an application for provisional measures against a generic. Finally, magistral and hospital preparations offer a last-resort solution in the event of an acute shortage.

Key points

The obligation of continued supply weighs on the exploitant and on distributors alike, and is stronger for medicinal products of major therapeutic interest. The shortage management plan should be kept up to date, the safety stock calibrated and any risk of shortage reported to the ANSM without delay. In patent litigation concerning an essential medicinal product, the public health argument must be anticipated, whether one relies on it or responds to it.

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This glossary entry is general in scope and does not constitute legal advice.

Dhenne Avocats acts in pharmaceutical patent disputes and on the medicines regulatory questions that accompany them, from the marketing authorisation to the supplementary protection certificate.

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