Sale of Medicinal Plants: When Does the Pharmacist Have a Monopoly?

Imagine: you are the owner of a small shop in Aubagne, specialising in the sale of plant-based food supplements. One day, you receive a formal notice from the Order of Pharmacists, accusing you of selling "medicinal products without authorisation". Your heart races: how could plants, which can be found in supermarkets, be medicines? Yet, this is exactly the question the French Supreme Court (Cour de cassation) decided in a judgment of 22 February 2011. This decision, which may seem technical, has very concrete consequences for all actors involved in the sale of health products.

But what distinguishes a simple food supplement from a medicinal product? The answer is not always obvious. Yet the stakes are colossal: free sale or monopoly of pharmacists, authorised or prohibited advertising, liability in case of problems. The Supreme Court provided an essential clarification by recalling that the classification of "medicinal product by function" does not depend on the natural origin of the product, but on its actual properties and its use.

In this article, I will dissect this decision for you, shop owners, herbalists, or simple consumers. I will explain how judges determine whether a product is a medicinal product, and what this changes for you, whether you are in Aubagne, La Ciotat or elsewhere.

The facts: a story like any other

Mr X, a trader based in Aubagne, marketed plant-based capsules, notably Harpagophytum and Ginkgo biloba. These plants, although natural, were listed in the pharmacopoeia (the official register of medicinal substances). The Order of Pharmacists considered that Mr X was encroaching on their monopoly, because these capsules were presented as having therapeutic properties: Harpagophytum for joint pain, Ginkgo for memory. Mr X argued that they were food supplements, not medicines. The dispute was brought before the courts.

The Court of Appeal, at first instance, ruled in favour of the pharmacists. It classified the capsules as "medicinal products by function" (i.e., products which, without being officially declared as medicines, act as such). Mr X then appealed to the Supreme Court, arguing that plants could not be medicines because they are natural. The Supreme Court dismissed his appeal, upholding the Court of Appeal's decision.

This dispute illustrates a classic conflict between freedom of trade and the protection of public health. The pharmaceutical monopoly is strict: only pharmacists may dispense medicines. But where is the line drawn? This decision established precise criteria.

The reasoning of the court — explained

The Supreme Court relied on Article L. 5111-1 of the Public Health Code, which defines a medicinal product. But note: this text distinguishes between "medicinal product by presentation" (a product presented as treating a disease) and "medicinal product by function" (a product which, even if not presented as a medicine, has pharmacological properties). In short, a product can be considered a medicinal product even if its label does not say so, provided it acts on the body in a significant way.

The judges examined several criteria: the composition of the product (the capsules contained concentrated plant extracts), its method of use (high dosage, capsules), its pharmacological properties (the glucosides of Harpagophytum have a demonstrated anti-inflammatory effect), and the risks associated with its use (possible drug interactions). In other words, just because it is a plant does not mean it is harmless. A medicinal plant, used in high doses, can have effects as powerful as a synthetic drug.

This reasoning is consistent with European case law, which tends to broaden the notion of medicinal product to protect consumers. In this case, the Supreme Court did not create new law, but recalled the importance of a case-by-case assessment. What few people know is that this decision was made in the context of criminal proceedings for illegal practice of pharmacy. Mr X risked a fine and imprisonment. Fortunately for him, only a civil conviction was imposed.

What this changes for you — concretely

If you are the owner of a natural products store in La Ciotat, this decision directly concerns you. You must check that the products you sell are not classifiable as medicinal products by function. For example, St. John's Wort capsules dosed at 900 mg, presented for "boosting morale", could be reclassified as a medicinal product. The consequences: you could be prosecuted for illegal practice of pharmacy, with penalties of up to 2 years' imprisonment and a €30,000 fine. Additionally, you will have to stop selling and destroy the stock, a significant financial loss.

For consumers, this decision is a guarantee. If you buy a product that turns out to be an unauthorised medicinal product, you are exposed to health risks. The decision protects you by requiring that these products be dispensed by a pharmacist, who can advise you on contraindications. For example, Ginkgo biloba can interact with anticoagulants. A pharmacist will warn you; a supermarket seller may not.

If you are a tenant of a commercial lease, check your lease: some clauses prohibit the sale of medicinal products. If your activity evolves towards reclassified products, you could be in breach. undefined, I have encountered cases where traders had to renegotiate their lease or change their activity following a similar decision. Better to anticipate.

Four tips to avoid this type of dispute

• Check the composition of your products: If a plant is listed in the pharmacopoeia and your product contains a significant dose of its active ingredients, have it analysed by an expert to determine whether it can be classified as a medicinal product by function.
• Adapt your communication: Avoid any therapeutic claims on your labels or website. Do not say "relieves pain" but "contributes to general well-being". A simple change of wording can tip the classification.
• Consult a lawyer specialising in pharmaceutical law: Before launching a new product, have a legal audit carried out. The cost (a few hundred euros) is negligible compared to the risks of litigation.
• Ensure traceability: If you import plants, check that your supplier complies with standards. In the event of an inspection, you must be able to justify the origin and quality of your raw materials.

Further reading: related case law and developments

This decision is part of a consistent line of the Supreme Court. Already in 2005, in a judgment (No. 04-85.238), it classified a propolis-based product presented as strengthening the immune defences as a medicinal product. The trend is clear: judges are becoming increasingly strict on the classification of medicinal products by function, especially since EU Directive 2001/83/EC harmonised the definition.

However, a more recent decision of the CJEU (2017, Case C-387/16) nuanced: a product may be classified as a food supplement if it is presented as such and if its pharmacological properties are not significant. In other words, not everything is a medicinal product. A case-by-case analysis is required, which the 2011 judgment confirms.

For the future, an increase in litigation can be anticipated, as the boundaries between food supplements and medicinal products are blurred. The health authorities (ANSM) regularly publish lists of authorised or prohibited plants. Stay informed, as the regulations evolve quickly.

Checklist before acting

• Does my product contain a plant listed in the pharmacopoeia? Yes → Go to the next question. No → Low risk, but check claims.
• What is the dosage of active ingredients? If the dosage is higher than that recommended for a food supplement, high risk of classification as a medicinal product.
• Is my product presented as having a therapeutic effect? If yes, it is a medicinal product by presentation, prohibited without a marketing authorisation.
• Have I consulted a lawyer lawyer? If not, do so before any launch.

Are you in a similar situation? A first 30-minute consultation with Maître Zakine (€45) can save you months of proceedings — and often much more. Book an appointment →