Wholesaler-distributor and public service obligations

The wholesaler-distributor is a pharmaceutical establishment that buys and stores medicinal products for wholesale distribution, as they are, to community pharmacies and hospital pharmacies. It differs from the depositary, which stores products on behalf of the company without acquiring ownership of them. It is subject to public service obligations, which Directive 2001/83/EC defines as the obligation to guarantee permanently an adequate range of medicinal products to meet the requirements of a specific geographical area and to deliver the supplies requested within a very short time.

Public service obligations

The French Public Health Code specifies these obligations, which are assessed within the distribution territory declared by the establishment.

• holding a range covering at least nine tenths of the presentations of medicinal products marketed in France
• holding stock sufficient to meet at least two weeks’ consumption
• delivering any order within twenty-four hours of receipt
• taking part in an on-call system guaranteeing supply outside working days.

Exports and parallel trade

Wholesalers may resell medicinal products to other Member States, which feeds parallel import and may contribute to supply tensions in France. Companies sometimes respond with supply quotas. The Court of Justice of the European Union accepts that a dominant undertaking may protect its commercial interests by refusing to meet orders that are out of the ordinary, but refusing to fill ordinary orders in order to prevent parallel trade may amount to an abuse of a dominant position.

The wholesaler and patent law

Offering, putting on the market and holding a patented product are acts of infringement. Under French patent law, however, these acts give rise to liability on the part of a person other than the manufacturer only if they were committed knowingly, so that the rule that good faith is irrelevant, which applies to the manufacturer, does not apply to the wholesaler. Notifying the patent, with precise identification of the products, puts the wholesaler on notice.

Key points

The wholesaler-distributor is the link that guarantees the availability of medicinal products throughout the territory, under precise public service obligations. A company should assess the competition law risk of any restriction of deliveries. For a patent holder, a detailed notification of the patent to wholesalers is a useful reflex as soon as an infringing generic enters the supply chain, with the main action directed at the generic manufacturer.

---

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.

Pharmaceutical patents and medicines regulation · Pharma case law · Tell us about your situation