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Advertising for medicines is strictly regulated under the Medicines Act: for prescription medicines, you are not allowed to advertise to the public; for over-the-counter medicines, you are permitted, but under strict conditions. If you violate the rules, you risk hefty fines — one retail chain was fined more than 190,000 euros. Below, you can read which rules apply and where the boundaries lie.
Why are there rules for pharmaceutical advertising?
Advertising for medicines affects both the pharmaceutical industry and the consumer. The rules must guarantee that such advertising is fair and responsible, protect the public against misleading information, and prevent inaccurate or incomplete advertising from harming health. The legal framework is set out in the Medicines Act, which distinguishes between prescription medicines and over-the-counter medicines.
Rules for advertising prescription medicines
For prescription medicines, the Medicines Act is clear: no advertising is permitted directed at the general public (the consumer). However, advertising is permitted directed at healthcare professionals, such as doctors. Such advertising must comply with the Code of Conduct for Pharmaceutical Advertising, which requires, among other things, that:
- the advertisement meets the standards of good taste and decency;
- Vague terms and superlatives are avoided.
Inducements are prohibited: for example, you may not pay for a doctor's conferences or continuing education to encourage them to prescribe a medication more frequently. There are some exceptions, such as gifts of low value that are useful in the practice of the profession. TODO_VERIFY: the precise limits and amounts for permitted inducements may change — check the current code of conduct and regulations.
Rules for advertising of over-the-counter medicines
For over-the-counter medicines (without a prescription), the law allows more: advertising directed at the general public is permitted. However, strict requirements apply here as well. For instance, the advertisement must:
- make clear that it concerns a medicine;
- contain instructions for use;
- not be aimed at children;
- not suggest that the remedy is better than other medicines.
Heavy fines for unlawful advertising
Those who violate the rules can face hefty fines. For example, retail chain Holland & Barrett received two fines totaling more than 190,000 euros (ECLI:NL:RBAMS:2022:7416). The chain sold a medicine without a license and advertised it, including by allowing the posting of product reviews.
By presenting the product as a means to prevent joint pain, the judge ruled that it was a medicine and not a dietary supplement. The advertising for it was therefore in violation of the rules.
The Ministry of Health imposed the fines; the Amsterdam District Court ultimately reduced them by 25%.
Frequently Asked Questions
Am I allowed to advertise a prescription medicine?
Not directed at the public. Advertising for prescription medicines may only be directed at healthcare professionals and must comply with the Code of Conduct for Pharmaceutical Advertising.
When is a product considered a medicine?
This applies, among other things, when you present it as a means to prevent or treat a condition. In that case, the rules for medicines apply, even if you intended it as a supplement.
Am I allowed to display customer reviews for a health product?
Caution: allowing assessments can be seen as advertising for a medicinal product, as in the Holland & Barrett case. Have this assessed if you have doubts about the status of your product.
What are the risks of a violation?
Substantial fines and potential enforcement. In the example mentioned, it involved more than 190,000 euros in fines.
Legal assistance with advertising?
The law imposes many requirements on advertising, partly to protect consumers and ensure fair competition. Disputes can arise quickly, for example in comparative or health-related advertising. We advise on planned communications and assist you in legal proceedings.
View our expertise in advertising and health law, or schedule a no-obligation intake consultation.
