2. European Legislation – Directive 2001/83

1. European Legislation – Directive 2001/83

1.2. Advertising to the general public

Article 88

1)  Member states shall prohibit advertising to the general public of medicinal products:

  • available on prescription only,
  • containing psychotropic or narcotic substances.

2)  medicinal products may be advertised to the public when they are intended for use without the intervention of a medical practitioner (non-prescription medicinal products or over-the-counter (OTC)).

3)  Member states may ban the advertising of products that are reimbursed.

4)  Vaccination campaigns are an exception, when approved by competent authorities. [An exception for vaccine products is grounded in the fact that member states encourage individuals to get vaccinated in the interest of collective public health.]

5)  Member states shall ban Television advertising for medicinal products and medical treatment available only on prescription (accd. to Article 14 of Directive 89/552/EEC).

6)  Member states shall prohibit direct distribution of medicinal products to the public by the industry for promotional purposes.

Article 89

1)  The advertisement to the general public should:

a)  make clear that the message is an advertisement, and that it concerns a specific medicinal product.

b)  contain at a minimum the following information:

      • the name (and generic name of the active substance) of the product,
      • the information for correct use, and
      • an express and legible invitation to carefully read the instructions on the package leaflet and/or on the outer packaging.

2)  If used solely as a reminder Member States may decide that the advertising of a medicinal product to the general public, includes only the name of the product or its international non-proprietary name, or the trademark.

Article 90

Advertising shall not contain any material with misleading messages by:

giving the impression that a medical consultation or surgical operation is unnecessary;

• suggesting that the effects of taking the medicine are guaranteed, are unaccompanied by adverse reactions or are better than, or equivalent to, those of another treatment or medicine;

• suggesting that the health of the subject can be enhanced by taking the medicine;

suggesting that the health of the subject could be affected by not taking the medicine (except in relation to authorised vaccination campaigns);

• exclusively or principally addressing children;

• referring to a recommendation by scientists, health professionals or celebrities;

• suggesting that the medicinal product is a foodstuff, cosmetic or other consumer product;

suggesting that the safety or efficacy of the medicinal product is due to the fact that it is natural;

presenting case histories that could lead to erroneous self-diagnosis and refrain from using improper, alarming or misleading terms or pictorial representations to make recovery claims or disease representations

To note:

Direct-to-Consumer advertising (DTCA)[1] of prescription medicines refers to the marketing and advertising of pharmaceutical products directly to consumers as patients, as opposed to specifically targeting health professionals. It is only completely legal in New Zealand and the United States, but subject to regulations regarding the balanced disclosure of a prescription's benefits in comparison to its risks. [2]

[1] Direct-to-consumer advertising; Wikipedia

[2] Can direct-to-consumer advertising of prescription drugs be effectively regulated? Joel Lexchin, David B Menkes, New Zealand Medical Journal Vol 132 No 1496: 7 June 2019
Can direct-to-consumer advertising of prescription drugs be effectively regulated? - PubMed (nih.gov)
Prescription Drug Advertising, FDA website, Content current as of: 07/08/2019