Pharmaceutical advertising regulation and medical device advertising in Norway

1.1 Medicines

The primary legal regulations are:

• The Medicines Act, Act No 132 of 4 December 1992, (Lov om legemidler m.v. (legemiddelloven), Chapter 7
• The Medicines Regulation, Regulation No 1839 of 18 December 2009 (Forskrift om legemidler til mennesker (legemiddelforskriften)), Chapter 13
• The Marketing Act, Act No 2 of 9 January 2009 (Lov om kontroll med markedsføring og avtalevilkår mv. (markedsføringsloven)) 

1.2 Medical devices

Primary legal regulations are:

• The Medical Devices Act, Act No 37 of 7 May 2020, (Lov om medisinsk utstyr), implementing the following regulations into Norwegian law:
  • Medical Devices Regulation (EU) 2017/745 (MDR), and
  • In Vitro Diagnostics Medical Devices Regulation (EU) 2017/746 (IVDR).
• The Medical Devices Regulation, Regulation No 1476 of 9 May 2021, (Forskrift om medisinsk utstyr)
• The Marketing Act, Act No 2 of 9 January 2009 (Lov om kontroll med markedsføring og avtalevilkår mv. (markedsføringsloven)) 

2.1 Medicines

In addition to the legal regulations by the Norwegian authorities, the Association of the Pharmaceutical Industry in Norway (“LMI”) has written rules for the marketing of medicines. The rules apply to communication between manufacturers/suppliers and healthcare professionals or the general public. Although the LMI rules only technically applies to members of LMI, it does create a certain norm to which Norwegian HCPs (and their employers, as the case may be) are likely used to.

LMI has also made reference to the Code of Practice issued by the International Federation of Pharmaceutical Manufacturers and Associations (“IFPMA”) in 2019 and endorse these guidelines. Furthermore, they also refer to the European pharmaceutical industry association EPFIA and their code of practice.

In addition, the consumer authority has issued a guidance document related to marketing of cosmetic procedures in social media and on the internet.

2.2 Medical devices

To our knowledge, there are no such other legal regimes that govern the advertising of medical devices. 

3.1 Medicines

When applying for a marketing authorisation an applicant may use a national procedure; a mutual recognition procedure; a decentralised procedure; or a centralised procedure. We will describe only the national procedure.

A pharmaceutical company must apply for a marketing authorisation in order to sell and advertise a medicinal product on the Norwegian market, or in the EEA in general. In Norway the Norwegian Medical Products Agency (“NMPA”) is responsible for providing authorisations. The authorisations are granted pursuant to the The Medicines Regulation Chapter 2 – 9.

The product's quality, safety and (medical) efficacy must be demonstrated before NMPA issues an authorisation. In order for an authorisation to be issued there must a risk-benefit analysis. An authorisation will not be issued unless there is a positive risk-benefit balance. The documentation requirements are often extensive.

3.2 Medical devices

There is no direct requirement of an approval from Norwegian authorities in order to market medical devices. However, it follows from the Medical Device Act that before marketing of medical devices, there should be a marking in accordance with Norway’s international requirements. If a medical device is not marked in accordance with CE-requirements, it cannot be promoted as a medical device.

Devices that are labelled with the CE-mark can be advertised in the internal market, including Norway. The CE-marking is a declaration form the manufacturer that the product is in accordance with applicable rules or regulations. For certain risk classes of medical devices, there is a need for a conformity assessment by a notified body before the medical device can be marketed. The notified body will assess whether the medical device complies with the set standard of safety requirements. 

Yes. The distinction plays an important role. While advertising of over-the-counter medicines to the general public is permitted, advertising of prescription-only medicines to the general public is prohibited. 

5.1 Medicines

For prescription medicines, advertising to the public is illegal pursuant to Section 13-4 of the Medicines Regulation.

Marketing towards the public is only allowed when the medicines is recommended for illness or symptoms which do not require examination or treatment by a doctor. The advertising should not be misleading or deceptive. Advertisements should encourage a sensible use of the medicine by providing an unbiased presentation. The unbiased presentation should not overstate the product’s attributes.

The marketing of non-prescription medicines cannot mention serious illnesses. Where marketing towards the public is legal it should be clear that it is marketing. There are several information requirements and prohibitions related to the information that can be conveyed to the public, pursuant to the Medicines Regulation Section 13-6.

There is also an exemption from the prohibition for vaccination campaigns or if something else follows from Article 14 of Directive 89/552/EC. 

5.2 Medical devices

Advertising of medical devices is permitted in Norway. For medical devices, there is no distinction between advertising that is aimed at healthcare professionals and the general public.

Advertising for medical devices must be objective, correct and provide precise information about the device. It must also be in accordance with the instructions from the producer, with regards to its purpose, correct application and precautions. 

Under MDR and IVDR, which are both implemented into Norwegian law, Article 7 prohibits the use of text, names, trademarks, pictures and figurative or other signs that can mislead the user regarding the device’s intended purpose, safety, and performance by:

• Ascribing functions and properties to the device which the device does not have;
• Creating a false impression regarding treatment or diagnosis, functions or properties which the device does not have;
• Failing to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose;
• Suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.

Claimed characteristics of a medical device must be documented. NMPA can intervene if a medical device does not have the ascribed effect.

In addition, the Marketing Act sets general rules for advertising with regards to medical devices sold to the general public. It also sets out rules for the sales between commercial operators. These rules are administered by the Norwegian Consumer Authority. 

6.1 Medicines

For advertising targeted at health care personnel there are strict rules. These marketing rules are found in the Medicines Act and in the Medicines Regulation Chapter 13.

Advertising is only allowed for medicines that have been authorised for marketing in Norway.

As a general rule, the advertising of medicines should not be misleading or deceptive. Advertisements should encourage a sensible use of the medicine by providing an unbiased presentation. The unbiased presentation should not overstate the product’s attributes.

The main restrictions applicable to the advertising of medicines are stipulated in Sections 13-7 and 13-8 of the Medicines Regulations. Under Section 13-7, promotional materials aimed at health care professionals must include specific information (please refer to question 7.1). Furthermore, according to Section 13-8, all promotional materials aimed at health care professionals must

• Accurately reproduce citations, tables, and other illustrations from medical journals or scientific publications, providing correct references and precise citations.
• Utilize content solely from medical journals and scientific publications that have undergone peer review. Additionally, scientific publications must have been published.

Under Section 13-10, it is prohibited to offer gifts, economic benefits, or advantages to the health care professional during the promotion of medicinal products.

Under Section 13-11, there are various restrictions on distributing free samples to health care professionals.

The Medicines Regulations also regulate the distribution of free samples and prohibit producers from offering gifts to health care professionals in the context of promotional activities, in Section 13-11.

The surveillance of marketing of medicinal products is done by NMPA. If the rules and regulations are not followed this can lead to fines or coercive fines. 

6.2 Medical devices

There is no distinction between advertising aimed at healthcare professionals and the general public. Please refer to question 5.2. for general restrictions applicable to advertising of medical devices. 

7.1 Medicines

Under the Medicines Regulations Sections 13-7 and 13-8, any advertisement directed at health care professionals for a medicinal product must include the following information:

Relevant and comprehensive information consistent with the approved summary of product characteristics by the Norwegian Medicines Agency.

• Dispensing regulations pertaining to the medicinal product,
• Price details, and
• Information regarding pre-approved reimbursement.
• The date the material was created or last revised.

The advertisement may alternatively be promoted as a reminder advertisement (reminder) and must then only contain the name of the medicinal product, active substance and the name of the marketer.

The provided details should be precise, up-to-date, verifiable, easily accessible to the recipient, and complete enough that the recipient can make up his own mind of the therapeutic value of the pharmaceutical. The information must be plain, factual balanced and objective.

7.2 Medical devices

Before medical devices are placed on the market, sold or put into use, they must be labelled in accordance with the requirements of international agreements, especially Regulation (EU) 2017/745, the Medical Devices Regulation.

MDR and IVDR article 7 provide restrictions on the claims that may be used in the labelling, instructions for use, and advertising. It is forbidden to use text, names, trademarks, pictures and figurative or other signs that may mislead the user or patient with regards to the intended purpose, safety and performance of the device. 

8.1 Medicines

According to the Medicines Regulations Sections 13-5 and 13-6, and the LMI guidelines, the following information must appear in advertisements directed to the general public.

Promotional materials for Medicinal Products should be plain and factual. They should promote sensible use. Promotional materials must not give a misleading or exaggerated image of a Medicinal Product’s properties and medicinal value.

Advertising to the general public shall be designed in such a way that it is clear that it is advertising and that the medicinal product being advertised is clearly identified as a medicinal product. Promotional materials must not lead to use of the Medicinal Product that is not medically justified.

The following information should always be included in Promotional materials aimed at the public:

1. the name of the Medicinal Product together with the name of the active ingredients (generic names).
2. information necessary for the correct use of the Medicinal Product, including area of application and important precautions/warnings.
3. a recommendation to the user to carefully read the packaging and package insert.

8.2 Medical devices

For medical devices, there is no distinction between advertising that is aimed at healthcare professionals and the general public, as there is for pharmaceutical advertising. Please refer to section 7.2.

However, general marketing legislation applies to claims regarding consumer products.

According to the general marketing legislation, is not permitted to:

• Mislead customers with false or exaggerated information.
• Attribute functions and properties to the equipment that it does not have.
• Create a false impression of the device's ability to treat.
• Fail to disclose possible side effects and complications.
• Suggest a use of the device other than that for which it is intended.

All documentation of a Medicinal Product’s properties and effects must refer to the product’s SmPC or a valid scientific reference (cf. LMI guidelines subsection 7.7). References are not required for mandatory information that is included in the ad or technical facts (e.g., marketing authorization, pack sizes, strengths or formulations)

Valid references in advertising are the SmPC or scientific work that is accessible to the recipient of the advertising. Scientific work must, if used as reference, be peer reviewed and published. When referring to scientific work, including reference to visual representations, quotations, tables and illustrations from these, clear references must be given to where they can be obtained.

A company's internal research reports do not meet the requirement for valid references.

Scientific is understood as systematic, methodical and critical investigation, study or research which employs scientific methods. Scientific method normally requires that the scientific assertions are publicly and intersubjectively verifiable.

It is permissible to use official statements or reports published by Norwegian or joint-European pharmaceutical authorities as references. For example:

• European Public Assessment Report (EPAR)
• Norwegian Pharmaceuticals Handbook for Healthcare Professionals
• Official Norwegian or joint European (EU/EEA) treatment guidelines

Patient cases, fictitious or real, can be used to describe the disease and treatment of the relevant patient group. Any mention of Medicines must comply with the approved SPC, cf. section 4.2, And with the Rules in general. Patient cases should not be used to make claims about the properties or medicinal value of medicines.

When presenting sales figures and market shares, Farmastat or similar may be used as references. The premise used as a basis for the calculation must be clearly shown and a robust and verifiable calculation, which can be demonstrated on enquiry, must exist.

When using data from non-interventional trials/registered trials or similar, it must be clearly marked that these are not results from randomized controlled trials/pivotal trials and all necessary provisos must appear in the Promotional material.

There should be no biased focus on (individual) findings from supplementary trials. 

Comparative advertising is permitted, subject to the conditions set out in the Comparative Advertising Directive.

Comparative Advertising must not be misleading and must be based on comparable and relevant properties of products. Both the advertiser’s own and the competitor’s preparations must be presented in a balanced, fair and objective manner. 

There are few specific provisions for advertisement on the internet or in social media, as the rules on content, formal requirements, access restrictions, etc. applies regardless of the platform used, be it website/webpage, blog, podcast, app, etc

For websites, it is recommended that there be a clear division (preferably in the form of tabs) between pages for the public and those for Healthcare Professionals.

The website should clearly show the cross-over from pages designed for public to those meant for Healthcare Professionals only.

Delimitation should be done in the form of a "pop up" or other clear marking that the content is reserved for healthcare professionals, through words such as HCP’s "only" or other suitable synonyms.

Advertising for prescription-only Medicinal Products is allowed only on websites clearly marked “for Healthcare Professionals only”, or with words to that effect. 

The Norwegian Medical Products Agency monitor compliance with most aspects of medicines and medical products, including advertisement to both HCPs and the general public. Additionally, the Norwegian Consumer Authority monitor compliance with all advertisements directed at the general public.

Competitors can inform the authorities in cases of non-compliance. Competitors cannot themselves bring court actions against unlawful advertising in general; only the authorities may bring court proceedings and claim for injunctive relief.

In cases of non-compliance and depending on the severity of the breach, NMPA can inform the manufacturer of the breach and their duty to ensure compliance. If the breach is not rectified, NMPA are entitled (and likely) to impose fines.

However, when the unlawful advertising constitutes a breach of good business practice among traders, competitors may bring court action. Such breaches may consist of advertisement containing misleading information regarding a competitor’s product, or unlawful copies of a competitor’s product or advertising material. The Comparative Advertising Directive also applies.

I.e., The Marketing Act section 26 prohibits the use of incorrect or misleading representation (including advertising) which is likely to influence the demand or supply of a product. In such cases, competitors may be entitled to compensation for damages resulting from the infringement.

Furthermore, to the extent that non-compliance pertains to claims under Article 7 MDR / IVDR, criminal sanctions of up to two years imprisonment are available. 

We have no indications of any developments in the near future.