Medicinal Product by Presentation: Medicinal Plants and the Pharmacy Monopoly

Imagine: you are in Moissac, and you sell on the local market herbal teas made from plants you have picked in your garden. You present them as "remedy for insomnia" or "to relieve joint pain." Without knowing it, you could be prosecuted for illegal practice of pharmacy. This question arises every day for herbalists, local producers and even large retailers.

But what exactly is a medicinal product? The law distinguishes between a medicinal product by presentation (the product is presented as having curative properties) and a medicinal product by function (it actually has a pharmacological effect). Medicinal plants are at the heart of this debate: some are listed in the pharmacopoeia and their sale is reserved for pharmacists, unless they are sold as is, without processing.

The decision of 5 May 2009 of the Court of Cassation (No. 07-88.599) recalls that judges must examine each product on a case-by-case basis, taking into account its composition, its properties, its method of use and the risks to health. A lesson for all those who handle plants for therapeutic purposes.

The facts: a story like many everyday

Mr. X, owner in Montauban, operated a natural products business. He sold capsules, herbal teas and plant extracts, including echinacea, ginseng and St. John's wort. On the packaging, health claims: "boosts immune defences", "helps fight fatigue", "promotes nervous balance".

The Order of Pharmacists filed a complaint for illegal practice of pharmacy. According to them, these products were medicinal products by presentation and by function, and their sale without a pharmacist violated the pharmaceutical monopoly. Mr. X argued that his products were food supplements, not medicinal products, and that the plants used were liberalised (authorised for free sale) by the regulations.

The Court of Appeal acquitted Mr. X, holding that the products were not presented as medicinal products and that the plants did not have sufficient medicinal properties. The Order of Pharmacists appealed to the Court of Cassation.

The reasoning of the court — dissected

The Court of Cassation censured the appeal judgment. It recalled that to classify a product as a medicinal product by presentation, it must be verified whether it is presented as possessing curative or preventive properties. For a medicinal product by function, it is necessary to examine its composition, its pharmacological (action on the body), immunological (action on the immune system) or metabolic (action on metabolism) properties, scientifically established, its method of use, the extent of its distribution, the consumers' knowledge of it and the risks to health.

In other words, the lower courts must carry out a case-by-case analysis of each product. In this case, the Court of Appeal had not investigated whether the products were presented as curative, nor carried out this detailed analysis. It had also failed to check whether the plants listed in the pharmacopoeia fell outside the monopoly of pharmacists (which is only the case if they are sold as is, without processing).

What few people know: the European pharmacopoeia classifies certain plants as medicinal, but their free sale is possible if they are sold raw, unprocessed. As soon as they are presented as having a therapeutic effect, or are processed (capsules, extracts), the monopoly revives.

The Court of Cassation did not rule on the merits; it referred the case back to another Court of Appeal for it to redo its work properly. This is called a judgment of cassation with referral.

What this changes for you — concretely

For landlord owners: If you rent premises to an herbalist or a seller of natural products, ensure that his activity is legal. Otherwise, you could be involved in proceedings for complicity in illegal practice of pharmacy. In Montauban, a landlord had to repay €15,000 in damages after renting to a plant seller without checking his authorisations.

For tenants: If you run a plant business, check that your products comply with the regulations. A simple change of labelling can turn a food supplement into an illicit medicinal product.

For purchasers: Before buying a business selling natural products, have the products audited by a lawyer lawyer. A conviction for illegal practice of pharmacy can lead to administrative closure and fines of up to €375,000.

For co-owners: If a co-owner rents his unit to a seller of medicinal plants, the syndic can act to stop an illegal activity that harms the reputation of the building.

Four tips to avoid this type of dispute

• Tip No. 1: Have your claims analysed. Before writing on a product "relieves headaches" or "boosts immunity", ask a lawyer whether this constitutes a presentation as a medicinal product. Even an implied claim may be considered.
• Tip No. 2: Distinguish liberalised plants from plants subject to monopoly. The list of liberalised medicinal plants is fixed by decree. If you sell a plant not on the list, you must be a pharmacist or under his responsibility.
• Tip No. 3: Do not process the plants. Sale in its natural state (whole or fragmented dry plant) is free, but as soon as you make a capsule, mother tincture or extract, you enter the pharmaceutical monopoly.
• Tip No. 4: Document your sources. Keep purchase invoices for plants, technical data sheets and analyses. In the event of an inspection, you will be able to prove that your products are food supplements and not medicinal products.

Further reading: related case law and developments

The Court of Cassation had already ruled on the subject in a judgment of 14 November 2006 (No. 05-86.755), where it had held that plant capsules presented as "slimming" were medicinal products by function. The trend is therefore constant: judges are strict on the pharmaceutical monopoly, especially when health claims are involved.

Since this 2009 decision, European regulations on health claims (Regulation EC No. 1924/2006) have strengthened the requirement for scientific evidence. Courts are increasingly attentive to the perception of the average consumer. What this means for the future: sellers of natural products will have to be even more careful in their communication.

Checklist before acting

• Q: Can I sell chamomile herbal teas indicating "to promote sleep"?
  A: Yes, if chamomile is a liberalised plant and you sell it as is. But the claim "promotes sleep" is a health claim that could be considered a medicinal presentation if it is too precise. It is better to say "traditionally used for...".
• Q: What should I do if I receive a formal notice from the Order of Pharmacists?
  A: Do not reply alone. Contact a lawyer specialising in pharmaceutical law. You can negotiate a settlement or challenge the classification.
• Q: What are the risks in case of conviction?
  A: Up to 2 years' imprisonment and a fine of €375,000 for illegal practice of pharmacy. The court may also order the closure of the business and confiscation of the products.
• Q: Can I sell nettle capsules without being a pharmacist?
  A: No, if the nettle is processed into capsules, it is a preparation that falls under the pharmaceutical monopoly. Only a pharmacist can dispense them.
• Q: Can an herbalist sell medicinal plants?
  A: The herbalist diploma no longer exists in France. Only pharmacists can sell medicinal plants, unless they are liberalised and sold as is. In practice, very few plants are liberalised.

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