Advertising of medical products in Norway

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Newsletter

Published 14 June 2021
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As medical products concern the health and even life of patients the Norwegian legislator has made strict requirements for the advertisement thereof. The specialized lawyers from our life science practice group have assisted many companies assessing and forming the advertisement of their medical products. Therefore, in this month’s newsletter we give you an introduction on the dos and don’ts on this topic.

In the last decade, the life sciences sector has experienced a dizzying growth, leaving behind remarkable new discoveries addressing previously unmet medicals needs and improving the life quality of humans all around the world. However, in order to communicate this to the public, not only knowledge of the legal framework is required, but also finesse and creativity. Usually when companies exaggerate and overpromise their products, this makes them loose their credibility. When doing so with medical products this may also not only have serious legal consequences but potentially affect the lives of patients. Consequently the challenge is to make complex scientific information understandable for the public while balancing with the legal requirement that any advertisement for medical products must be strictly factual based and objective. There are special requirements when advertisement is addressed towards health personnel, however, in this newsletter we will solely focus on advertisement towards the public.

Which products are allowed to advertise for?

Advertisement of medical products is governed by Chapter 13 of the Norwegian Regulation on Medical Products. In order to be allowed to advertise a medical product, the product needs to comply with four basic requirements:

  1. It must have obtained marketing authorization in Norway;
  2. It must be a non-prescription product;
  3. It cannot contain psychotropics or narcotics (as classified by the UN-convention); and
  4. Except for authority approved vaccination campaigns, the product must exclusively be recommended for illnesses or symptoms that normally would not require examination or treatment by a professional.

Companies who are members of the Norwegian pharmaceutical industry organization Legemiddelindustrien (LMI) will further be subject to LMI’s industry rules (available here). The rules may be a useful source of guidance and examples also for non-members.

What kind of advertisement of medical products towards the public is allowed?

Given the potential serious consequences, the list of what kind of advertisement is allowed is much shorter than the list of what is not. Provided the advertisement does not trigger any of the explicit prohibits (see next topic), advertisement is allowed as long as the advertisement promotes a rational use of the product by objectively presenting it without exaggerating its effect. However, as it is easier to manoeuvre around explicit prohibits, this general legal requirement is often not easy to interpret the boundaries of, and one of the main reasons advertisements are considered in breach of the legal regulations.

In addition, it must be clear from the advertisement, that it is in fact an advertisement, and that the product in question is a medical product.

Apart from the more general requirements, the Norwegian Regulation on Medical Products also requires that the following information is included in the advertisement:

  1. The name of the medical product including its active substance;
  2. All information required for the correct use of the medical product, including the method of use, important precautions and warnings; and
  3. A call to carefully read the package and the leaflet.

What kind of advertisement of medical products towards the public is forbidden?

The counterpart to the main legal requirement (objective presentation of the medical product without exaggerating effect) is that the advertisement is forbidden if it is misleading in any manner.

As these two rules often go hand in hand, and together provide the overall framework, the Norwegian Regulation on Medical Products also contains a long list of detailed prohibitions. Thus, advertisement of medical products is forbidden if it:

  1. mentions any serious illness (i.a. tuberculosis, sexually transmitted diseases, cancer or other tumor diseases, chronic insomnia, diabetes or other metabolic disorders);
  2. contains misleading illustrations or play on strong effects;
  3. is associated with samples, objects, gifts, prizes or any other kind of reward;
  4. gives the impression that a medical consultation, or contact with health personnel is superfluous;
  5. implies that the effect of the medical product is guaranteed or claims that it is without side effects;
  6. claims that the medical product in question is as good as, or better, than any other treatment or medical product;
  7. implies that a patient’s health can be better by using the medical product or may be impaired by not using it;
  8. directed exclusively or mainly towards children;
  9. refers to or contains recommendations from health personnel or scientist, or any other person who, by virtue of their reputation, may encourage the use of the medical product;
  10. implies that the medical product is comparable with food, cosmetic or other common commodity;
  11. implies that the medical product’s safety or efficacy is due to the fact that it is from nature;
  12. by the use of description or detailed show case of a disease misleads viewers to wrongly diagnose themselves; or
  13. in an excessive, intimidating or misleading manner refers to claims of healing effect or illustrates changes in the human body (or parts thereof) which are the consequence of a disease, injury or of the medical product in question.

Consequences of breach

Advertisement of medical products is constantly supervised by the Norwegian Medicines Agency (NMA), which, in case of breach, has the authority to impose a ban on the advertisement or fees on the company. However, unless it is a particular serious breach, the NMA will as a starting point impose amendments necessary for the advertisement to comply with the legal requirements.

Companies who are members of LMI have the opportunity to submit their contemplated advertisement to the council Rådet (incorporated by LMI together with the Norwegian medical association to supervise the LMI industry rules) to receive a binding opinion.

In a recent case from March 2020, the NMA imposed amendments on Pfizer’s commercial for Viagra on three grounds:

  1. Unlike any other over the counter medical product Viagra requires mandatory guidance from a pharmacist. This warning was not included in Pfizer’s commercial, and the advertisement did therefor, according to the NMA not met the requirement that is has to contain all information necessary for the correct use of the medical product, including the method of use, important precautions and warnings.
  2. The just mentioned requirement was also neither met with regard to the information actually contained in the advertisement. According to the NMA, the font used in the advertisement was too small, which made it challenging for the target group (elder men) to obtain all necessary information.
  3. The missing and hard readable information in combination with the use of images and songs made the advertisement, according to the NMA, misleading and exaggerating the medicinal value of Viagra.