Pharmaceutical advertising regulation and medical device advertising in Sweden

1.1. Medicines

Provisions concerning advertising of medicines are stipulated in the Medicinal Products Act (2015:315). Supplementary provisions to the Medical Products Act are stipulated in the Medical Products Agency Regulations (LVFS 2009:6) on marketing of medicinal products for human use.

Further, general rules concerning advertising are stipulated in the Marketing Practices Act (2008:4). Such general rules also apply to advertising of medicines.

Provisions concerning advertisement of medicines via television are stipulated in the Swedish Radio and Television Act (2010:696). 

1.2. Medical devices

There are no Swedish laws regulating advertising of medical devices, but such regulation follow from the directly applicable Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (“MDR”) and in Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices (“IVDR”).

Additionally, the general rules concerning advertising stipulated in the Marketing Practices Act (2008:4), also apply to advertising of medical devices. 

2.1. Medicines

The Ethical Rules for the Pharmaceutical Industry (“LER”) stipulates provisions concerning advertising of medicines. Such rules are not legally binding but are considered by Swedish courts to reflect good practice.  

2.2. Medical devices 

Swedish Medtech, which is the association for Swedish medical technology organisations, has published several guidelines and regulatory codes which member organisations of the association are subject to (e.g. Swedish Medtech’s Business Code and Agreement on Collaboration Regulations). The guidelines and regulatory codes include provisions on advertising. A member organisation acting in violation of the guidelines or business codes may be subject to warnings, reprimands or in case of severe violations, be excluded from the association.  

Advertising of medicines for human use to the general public and healthcare professionals require that the advertised medicine in has been approved for sale. In the absence of such approval, the advertising is prohibited (the Medicinal Products Act, Chapter 12, Section 1). 

There are no specific licenses/approvals/fees required for advertising of medical devices required under Swedish law.  

Yes.  Advertising of prescription-only medicines is generally prohibited, except for advertising for vaccination of humans against infectious diseases, (the Medicinal Products Act, Chapter 12, Section 1). Advertising of over-the-counter medicines is permitted but must comply with certain rules (see question 5 and 6 below regarding such rules).

5.1.  Medicines 

With regard to advertising of over-the-counter medicines to the public, restrictions are stipulated in in the Medical Products Act. According to the Medical Products Act, the advertising must be clearly indicate that the communication constitutes advertising and that the product is a medicinal product. Additionally, the content of such advertising shall not be designed in such a manner that it encourages use of medicines which is harmful or otherwise inappropriate, or to discourage people from seeking appropriate treatment (the Medicinal Products Act, Chapter 12, Section 2). 

The Medical Products Act also stipulates general restrictions with regard to advertising of medicines that apply to advertising of medicines to the public. For example, advertising of medicines cannot be directed towards children (the Medicinal Products Act, Chapter 12, Section 1),  must promote appropriate use of the product through a presentation that is up-to-date, factual and balanced, cannot be misleading and must also comply with good marketing practice (the Medicinal Products Act, Chapter 12, Section 2). 

Additionally, the general requirements that advertising under the Marketing Practices Act apply. According to such rules, the advertising cannot, for example, be misleading, aggressive and must comply with good marketing practice (The Marketing Practices Act Section 5 and 8).   

5.2. Medical devices

As described in the answer to question 1.2, there are no specific Swedish laws concerning advertising of medical devices. Instead, such regulation  follow from the MDR and IVDR. According to article 7 in MDR and IVDR, the following is prohibited in advertising of medical devices:

• 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; and,
• suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out. 

As mentioned in the answer to question 1.2, advertising of medical devices is also subject to the general rules concerning advertising under the the Marketing Practices Act. According to such rules, the advertising cannot, for example, be misleading, aggressive and must comply with good marketing practice (The Marketing Practices Act Section 5 and 8).

6.1. Medicines 

Please see the answer to question 5.1., the Medical Products Act provides general restrictions with regard to advertising of medicines. Such restrictions also apply to advertising of medicines to healthcare professionals. Additionally, advertising of medicines to healthcare professionals is also subject to the rules stipulated in the Marketing Practices Act (the Marketing Practices Act Section 5 and 8). 

Restrictions regarding the supply of samples of medicines to healthcare professionals are further stipulated in LVFS 2009:6. According to the regulation, free samples of medicines may be provided to persons authorised to prescribe medicines. Samples of prescription-only medicines must however be covered by the prescriber's authorisation. Samples of non-prescription medicines may be provided to a person who is authorised to operate an outpatient pharmacy and to the pharmacy manager of the outpatient pharmacy. Lastly, samples of non-prescription medicines may be provided to a pharmacist appointed by a healthcare provider at a hospital pharmacy (LVFS 2009:6 Section 11). Supply of samples of medicines to other healthcare professionals than those listed above, is prohibited (LVFS 2009:6 Section 12).

The supply of samples of medicines to healthcare professionals must be carried out with great restraint and solely if the following conditions are met (LVFS 2009:6 Section 13):

• Only a limited number of samples of each medicinal product may be provided for each recipient.
• Each supply of samples shall be subject to a written, dated and signed order from the recipient.
• A thorough check shall be performed to ensure that the recipient is authorised to prescribe or distribute the medicine. Orders shall be retained so that they can be made available in case of future inspections by the Medicinal Products Agency.
• The sample cannot be larger than the smallest packaging
• available on the market.
• Each sample shall be labelled with the text "free sample of medicinal product, not for sale" or any other wording of equivalent meaning.
• Each sample shall be accompanied by a copy of the summary of the characteristics of the product. 

Medicines which classifies as narcotics according to the Medicinal Products Agency's regulations (LVFS 2011:10), may not be provided as samples of medicines (LVFS 2009:6 Section 14). 

6.2. Medical devices

Please see the answer to question 5.2. The restrictions stipulated in MDR, IVDR and the Marketing Practices Act also apply to advertising of medical devices to healthcare professionals. 

According to Swedish Medtech’s guidelines for gifts aimed at healthcare professional companies within the medical devices industry, gifts may solely be offered to healthcare professionals under certain circumstances. Such gifts must relate to the practice of the healthcare professional, benefit the patients and be of nominal value. There is no exact value limit, but whether a gift is of nominal value must be assessed on a case-by-case basis, considering how the gift is perceived by the health care professional.

There are also restrictions when offering product samples for marketing purposes. According to the guidelines from Swedish Medtech, such product samples should only be given to the extent necessary to evaluate the product in question. Additionally, the products sample should be given to a healthcare institution and not directly to an individual health care professional. 

7.1. Medicines

In pursuance of the Medicinal Products Act, advertising of medicines must include information that is of particular importance for the general public and for healthcare professionals (qualified to prescribe or supply the medicine). Furthermore, according to LVFS 2009:6, advertising of medicines directed at prescribers and other healthcare professionals must be sufficiently detailed so that the healthcare professional can form an opinion about the therapeutic value of the medicine in question. Additionally, essential information from the summary of product characteristics (“SmPC”) and classification of the medicine must be included in the advertising. 

In the LER rules, there is a more detailed regulation regarding the information that must be included in advertisements directed to healthcare professionals. The following information must appear in such advertisements: 

1. the name of the medicine, 
2. its dosage form and, if required, its strength, 
3. its active ingredients, specified by generic name which must be positioned close to the medicine
4. where this first appears as a headline or eyecatcher, 
5. a balanced statement of the medicine’s characteristics (this description shall contain required particulars about the pharmacological group or other accepted group affiliation, together with indication or area of indications),
6. warnings or restrictions as regards the use of the medicine, 
7. the name of the manufacturer or of his representative (including contact details),
8. a clear statement about the year of publication of the information or, in the case of information provided on the internet, the date when the site was most recently updated, as well as designation that makes it possibly to identify the information without difficulty, information about the date on which the summary of product characteristics was compiled or reviewed,
9. the status of the product (e.g. prescription-only or over-the-counter),
10. the status of the product regarding benefits system (e.g. EF or F)
11. a reference to fass.se for further information. 

7.2. Medical devices

Generally, there are no specific Swedish information requirements regarding advertisements of medical devices directed to the general public. However, article 7 in the MDR and IVDR states that an advertiser must inform the user or the patient associated with the use of the device in line with its intended purpose. Furthermore, according to the general rules of the Marketing Practices Act, all material information must be included in any marketing (including advertisements of medical devices). What constitutes material information must be assessed on a case-by-case basis, taking into account whether the information influence or is likely to influence the recipient’s ability to take a well-founded commercial decision. 

8.1. Medicines

In pursuance of the Medicinal Products Act, advertising of medicines must include information that is of particular importance for the general public and for healthcare professionals (qualified to prescribe or supply the medicine). This provision is further specified in LVFS 2009:6 and the LER rules. According to LVFS 2009:6 and the LER rules, the following information must appear in advertisements directed to the general public:

1. the name of the medicine and the common (i.e. generic) name, if the medicine contains only one active ingredient,
2. information necessary to enable proper use of the medicine (such as the need to contact healthcare for diagnosis prior to treatment or if the treatment is not effective within a certain period, restrictions for children and pregnant women, limitations on the duration of treatment, and necessary warnings or limitations). 
3. an invitation to carefully read information given in the package information leaflet (the invitation must be explicit and easily legible),
4. the name of the manufacturer or of his representative (including contact details), 
5. Information about the year of publication, or in the case of advertising on the internet, the fate when the site was most recently updated. 
6. a clear recommendation to consult a physician before using the medicine (provided it is a non-prescription medicine that is effective against disease or symptoms of a disease that require contact with physician for diagnosis or treatment). 

8.2. Medical devices 

Generally, there are no specific Swedish information requirements regarding advertisement of medical devices directed to the general public. However, article 7 in MDR and IVDR states that an advertiser must inform the user or the patient associated with the use of the device in line with its intended purpose. Furthermore, according to the general rules of the Marketing Practices Act, all material information must be included in any marketing (including advertisements of medical devices). What constitutes material information must be assessed on a case-by-case basis, taking into account whether the information influence or is likely to influence the recipient’s ability to take a well-founded commercial decision.

There are no explicit provisions on how scientific data may be referred to in advertisement regarding medicinal products in the Medicinal Products Act or LVFS 2009:6. However, the Medicinal Products Act states that all marketing must be up-to-date, factual and balanced. 

The LER rules contain more specific provisions on how “documentation” (i.e. written or visual presentations containing reports on scientific facts and discoveries) may be cited. Such documentation must be cited in a balanced and fair way, which, among other things, means: 

1. that results of a study, which are contradicted by another study, may not be cited without reservation, and that results that have been refuted must not be used;
2. that a study may not be cited in such a way that it could convey an incorrect or misleading impression of the nature, scope, implementation or importance of the study;
3. that comparisons between different medicinal products or alternative treatments should be expressed in such a way as to make clearly evident their statistical validity;
4. that the report of a study should not be cited or abstracted in such a way that the citation or abstract gives an inaccurate or misleading impression of the contents of the reports and the conclusions stated therein; 
5. that information containing quotations, numerical data, diagrams, images, including graphics, illustrations, photographs or tables taken from a scientific study be correctly reproduced (except when adaption or alteration is required in order to satisfy applicable rules, in which case it must be clearly evident that adaption or alteration has been made).

There are no explicit provisions on how scientific data may be referred to in advertisement regarding medical devices. In pursuance of article 7 in the MDR, IVDR and the general prohibition on misleading advertising in the Marketing Practices Act, scientific data and reports may not be cited in a way which could mislead consumers about the significance of the data or reports or otherwise mislead the consumers.

10.1. Medicines 

Yes. The general provision in the Medical Products Act, provides that marketing of medicines must be up-to-date, factual, and balanced also applies to comparative advertising. Additionally, the LVFS 2009:6 states that advertising of medicines directed to the general public may not include claims that the medicine in question is superior to, or equivalent to, the effect of any other treatment or medicine. 

The LER rules also contains rules for comparative advertisements of medicines. According to the LER rules, comparisons between effects, active ingredients, costs of treatment, etc. must be presented in such a way that the comparison as a whole is fair. The object(s) included in the comparison must be selected in a fair way, be relevant, and be presented objectively and truthfully. More specifically, the requirement for a fair comparison means: 

1.  that the objects included in the comparison must be clearly specified and (if required for the sake of clarity) the complete name and generic designation of the compared medicinal products should be stated;
2. that the facts which the comparison is intended to clarify and the limitations in the comparison must be stated (in a non-misleading way); 
3. that the comparison of properties of synonymous medicinal products, or of medicinal with the same indications, must give a comprehensive and fair picture of the compared properties; 
4. that comparison of certain properties must not induce incorrect or misleading conclusions regarding properties not covered by the comparison.

Additionally, it should be noted that any comparison must also comply with the general rules on comparative advertising as set out in the Marketing Practices Act (see our response to question 10.2 to learn more about these rules).

10.2. Medical devices

There are no specific rules for comparative advertising regarding medical devices, which means that the general rules in the Marketing Practices Acts apply. According to the Marketing Practices Act, an advertiser may, in its advertising, directly or indirectly refer to a competitor’s business and/or products provided the comparison is: 

1. not misleading; 
2. relates to products that fulfil the same need or are intended for the same purpose;
3. objectively refer to essential, relevant, verifiable and distinctive characteristics of the products;
4. does not cause confusion between the advertiser and the competitor or between their products, trade marks, company names or other marks; 
5. does not discredit or derogate the competitor’s business, relationships products, trade mark, company names and other marks; 
6. in the case of products with a designation of origin, at all times relates to goods with the same designation; 
7. does not take unfair advantage of the competitor’s reputation associated with the trade mark, company name or other distinguishing marks of the competitor or their designation of origin; and
8. does not portray a product as an imitation or copy of a product bearing a protected trade mark or company name. 

No. However caution is advised when advertising prescription-only medicines on the internet and social media. As stated in our response to question 4 above, it is not permitted to advertise such medicines to the general public. In our view, it is probable that advertisements on the internet and in social media are deemed to be aimed at the general public (since the general public normally can access and view such advertisements). Hence, such advertising could contravene the Medicinal Products Act.

It should also be noted that, according to the Medicinal Products Act, any advertisement of medicines aimed at the general public must be presented in such a way that it is clear that the product at hand is a medicine and that advertising is involved. Additionally, the Marketing Practices Act states that the advertisement must clearly indicate who or what company is responsible for the advertisement. 

A similar disclosure-requirement exists in relation to medical devices. According to the Marketing Practices Act, all advertisements must be designed and presented in such a way that it is clear it includes advertising. Furthermore, the advertisement must clearly indicate who or what company is responsible for the advertisement 

12.1.  Medicines 

The Swedish Medicinal Product Agency is the regulatory body regarding the marketing of medicines and medical devices. It is responsible for monitoring that all such marketing adheres to the advertisement provisions set out in the Medical Products Act, LVFS 2009:6, MDR, IVDR and the Swedish Act (2021:600) with Supplementary Provisions to the EU’s Regulations on Medical Devices and the regulations issued under the act.

The Swedish Consumer Agency (“CA”) is responsible for enforcing the general advertising rules, as set out, inter alia, in the Marketing Practices Act. In so far as the marketing of medicines and medical devices involves these rules, the CA also serves as a regulatory body.

The main sanctions in case of non-compliance are prohibitive injunctions under conditional fines and fines. 

A prohibitive injunction under a conditional fine means that the company is prohibited from using certain advertisement claims in the future. If the company does not comply with the prohibition, the fine can be imposed. Pursuant to the Swedish Act on Penalties of Fines, a conditional fine shall be set at an amount which in consideration of the known financial circumstances of the addressee and other circumstances can be presumed to induce the addressee to adhere to the prohibitive injunction. The conditional fine usually amounts to SEK 1,000,000. 

A fine (market disruption fee) may be imposed for violations of the Marketing Practices Act. The amount of such fee can range from SEK 10,000 to 4% of the trader’s annual turnover in the preceding financial year, depending on the severity of the violation.

The MPA has the authority to issue regulations stipulating that entities who violate the marketing rules set forth in Article 7 of the MDR and IVDR to pay a fine (sanction fee). The amount of such a sanction fee may not exceed SEK 100,000,000. However, we are not aware that the MPA have issued any regulations of this kind. 

The Information Review Board (“IGN”) and the Pharmaceutical Evaluation Board (“NBL”) monitors that companies in the pharmaceutical industry adheres to good industry practices in their marketing activities. IGN and NBL have the power to issue sanction fees of up to SEK 500,000 against member companies of LIF that violates the LER rules.

The EU Artificial Intelligence Act (“EU AI Act”), expected to be adopted by legislative bodies within the EU, includes obligations for AI systems that qualify as medical devices. These AI systems will be classified as “high risk” and will be subject to strict requirements. The provisions in the EU AI Act will be directly applicable in every member state, including in Sweden.