The primary framework regulating the advertising and promoting of medicinal products in Sweden consists of the following laws, regulations and self-regulatory codes.

The rules on advertising in the EU Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use have been implemented in Sweden by the Medicinal Products Act (SFS 2015:315) (Sw. Läkemedelslagen) and regulations issued by the Swedish Medical Products Agency (MPA) on marketing of medicinal products for human use (Sw. Läkemedelsverkets föreskrifter (LVFS 2009:6) om marknadsföring av humanläkemedel, ‘LVFS 2009:6’).

The central provisions on advertising of medicinal products, such as the requirements for advertisements to be up to date, accurate, balanced and not misleading, and adhere to good marketing practices (Sw. god marknadsföringssed), are outlined in the Medicinal Products Act; meanwhile, LVFS 2009:6 provides detailed provisions that clarify and expand upon these central provisions of the Medicinal Products Act.

Furthermore, general provisions applicable to advertising of all products and services, including advertising of medicinal products, are found in the Marketing Practices Act (2008:486) (Sw. Marknadsföringslagen). Under the Marketing Practices Act, all marketing activities must be compatible with good marketing practices and fair towards consumers and the industry. The Marketing Practices Act also contains specific rules on misleading advertising, comparative advertising and special offers.

Moreover, the Radio and Television Act (SFS 2010:696) (Sw. Radio- och tv-lagen) prohibits the advertisement of medicinal products through teleshopping, which involves purchasing medicinal products advertised on television via phone or the internet. The Act also imposes restrictions on the sponsorship of television advertisements. Further, the Act bans product placement and other forms of advertising for prescription-only (Rx) medicinal products.

In addition to statutory regulations, the advertising of medicinal products is governed by a self-regulatory code called the Ethical Rules for the Pharmaceutical Industry (LER). This code is issued by the Swedish Association of the Pharmaceutical Industry (Sw. Läkemedelsindustriföreningen, LIF), the trade association representing the Swedish pharmaceutical industry.

Other codes of practice that apply to advertising in general also apply to advertising of medicinal products, such as the International Chamber of Commerce’s Advertising and Marketing Communications Code (‘ICC Rules’).

The Swedish self-regulatory code LER applies to the following entities:

• LIF member companies;
• the Association for Generic Pharmaceuticals and Biosimilars in Sweden (Sw. Föreningen för Generiska läkemedel och Biosimilarer) and its member companies;

• the Association of Smaller Life Science Companies (Sw. Innovativa Mindre Life Sciencebolag) and its member companies; and
• the Association for Clinical Research Organisations active in Sweden (Sw. Branschorganisationen för CRO-företag) and its member companies.

Companies bound by LER are contractually obligated to comply with LER and decisions by LIF’s two disciplinary bodies: the Information Examiner Committee (Sw. Informationsgranskningsnämnden, IGN), and the Information Practices Committee (Sw. Nämnden för bedömning av läkemedelsinformation, NBL). Additionally, companies bound by LER are accountable for all activities carried out on their behalf by an intermediary and must both ensure that their affiliate companies (for example, parent companies or sister companies) observe and comply with LER in the event of activities on the Swedish market or targeted at the Swedish market, and enjoin business partners in licensing agreements and the like to comply with LER.

Furthermore, LER is widely acknowledged by the entire pharmaceutical industry, including non-LIF members. Also, although LER and decisions of IGN and NBL are not legally binding, Swedish courts typically apply them as standards for fair and ethical marketing.

The concept of advertising of medicinal products in LVFS 2009:6 corresponds to the definition provided in EU Directive 2001/83/EC, and includes “any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products”, such as the following:

• advertising of medicinal products to the general public or healthcare professionals (HCPs);
• visits by medical sales representatives to HCPs; and
• supply of samples.

The phrase “any form” suggests that the definition of advertising of medicinal products is wide. The definition of marketing practice under the Marketing Practices Act is even wider and includes “advertising and other measures in the course of business activities which are intended to promote the sale of and access to products including a trader’s actions, omissions or other measures or behaviour before, during or after sale or delivery of products to consumers or traders”.

A distinction is made between information-sharing and advertising. Whether a specific activity (for example, an interaction, statement or communication) is considered information-sharing or advertising is determined on a case-by-case basis. One key factor in the assessment is the purpose of the activity. An interaction without promotional purpose indicates information outside the scope of the advertising regulations, while an interaction with promotional purpose indicates information within the scope of the regulations.

Depending on the relevant circumstances, patient leaflets and patient support programmes can qualify as advertising if the information has a promotional purpose and, for example, can be seen as promoting the prescription, supply, sale or consumption of medicinal products.

Under LVFS 2009:6, there are several activities that expressly fall outside the definition of advertising, such as the labelling and accompanying package leaflets and correspondence, possibly accompanied by material of a non-promotional nature, needed to answer a specific question about a particular medicinal product. Furthermore, objective and informative announcements and reference material relating to, for example, package changes, adverse-reaction warnings as part of general drug precautions, trade catalogues and price lists, fall outside the definition of advertising, on the condition that they include no product claims. Also, information regarding human health or diseases such as disease awareness campaigns fall outside the definition of advertising, on the condition that there is no reference, not even indirect, to medicinal products.

Press releases regarding medicinal products are partly covered by LIF’s guideline “Use of Digital Channels According to the Pharmaceutical Industry’s Ethical Guidelines” (Sw. Användande av digitala kanaler utifrån Läkemedelsbranschens etiska regelverk), and are permitted under specific restrictions.

Generally, press releases must be directed at journalists and news editors. Pharmaceutical companies must not link to, share or distribute press releases with the general public or with HCPs, nor should the employees or representatives of pharmaceutical companies share them on social media.

For publicly listed pharmaceutical companies subject to market disclosure rules, press releases may be distributed through their own investor relations channels. However, the content of such press releases must adhere to the aforementioned limitations, with the utmost caution applied to those containing information about Rx medicinal products.

Since journalists and news editors are the intended audience for press releases, the content should be tailored accordingly, with the news story taking precedence. Specifically, a press release must be of general newsworthiness, contain minimal references to product names or active substances, and include only the brief and balanced information necessary to convey the news.

Since journalists and news editors are part of the general public and press releases are often publicly available online, press releases can also be considered advertising of medicinal products targeting the general public. The key criterion is whether the press release, considering, among others, its overall content and purpose, is deemed to have a predominantly commercial message or non-commercial message. As advertising of Rx medicinal products to the general public is prohibited, a press release which contains any information about Rx medicinal products requires strict caution.

Comparative advertising is allowed, provided it complies with the requirements outlined in the general provisions in the Medicinal Products Act and the Marketing Practices Act. Comparative advertisement must not discredit other companies or other medicinal products. Furthermore, when advertising to the general public, it is prohibited to claim that a medicinal product is superior to or equivalent to another treatment or medicinal product.

In addition to the Medicinal Products Act and the Marketing Practices Act, LER includes specific guidelines for comparing medicinal product information directed at the general public and HCPs, covering aspects such as a medicinal product’s effects, active ingredients or treatment costs. In general, these comparisons must not mislead the recipient and must be presented in such a way that the comparison as a whole is fair, relevant, objective and truthful. This entails that:

• the objects included in the comparison are clearly specified;
• the facts which the comparison is intended to clarify and the limitations inherent in the comparison are stated in a way that the comparison is not likely to mislead;
• comparisons of properties of synonymous medicinal products, or of medicinal products with the same indications, must give a comprehensive and fair picture of the properties compared; and
• the comparison of certain properties does not induce incorrect or misleading conclusions regarding properties not covered by the comparison.

Providing information on unauthorised medicinal products or unauthorised indications will generally be deemed to constitute advertising. As all advertising of medicinal products must be in conformity with the approved Summary of Product Characteristics (SmPC), providing information on unauthorised medicinal products or unauthorised indications will generally be prohibited.

Individual correspondence, accompanied by non-promotional material if necessary, is not considered advertising if it is necessary to address a specific enquiry about a medicinal product. Therefore, a pharmaceutical company is permitted to respond to a specific question from an HCP about an unauthorised medicinal product or unauthorised indication. However, the response must not exceed the scope of the query.

During a scientific conference directed at HCPs, providing information on unauthorised medicinal products or unauthorised indications is generally prohibited. However, as detailed in 2.2 Information or Advertising: Disease Awareness Campaigns and Other Patient-Facing Information, information can fall outside the scope of advertising if, depending on the relevant circumstances, the information does not have a promotional purpose. It can be possible to provide such information during scientific conferences but, due to the broad interpretation of advertising (see 2.1 Definition of Advertising), such information should be shared with great caution.

LER used to stipulate specific conditions under which information regarding unauthorised medicinal products and unauthorised indications could be provided at international scientific congresses held in Sweden. However, following a judgment by the Administrative Court of Appeal in Stockholm on 27 September 2021, case no. 546-21, this exemption has been removed.

Providing information to HCPs on unauthorised medicinal products or unauthorised indications will generally be deemed to constitute advertising and prohibited. However, if the information is provided by way of individual correspondence following an unsolicited query from an HCP, it can fall outside the scope of advertising and thus be permitted. See 3.1 Restrictions on the Provision of Information Concerning Unauthorised Medicines or Indications.

Providing information to healthcare institutions on unauthorised medicinal products or unauthorised indications to assist with their preparation of budgets, etc, will generally be deemed to constitute advertising and prohibited.

However, as detailed in 2.2 Information or Advertising: Disease Awareness Campaigns and Other Patient-Facing Information, objective and informative announcements and reference material relating to, for example, trade catalogues and price lists fall outside the definition of advertising and can be permitted to be sent to HCPs at healthcare institutions, provided they include no product claims. Furthermore, if the information is provided by way of individual correspondence following an unsolicited query, it can also fall outside the scope of advertising and be permitted to be sent to HCPs at healthcare institutions – see 3.1 Restrictions on the Provision of Information Concerning Unauthorised Medicines or Indications.

Compassionate use programmes, which allow the use of unauthorised medicinal products for patients with diseases lacking satisfactory authorised therapies, are permitted under strict conditions, with MPA as the competent authority.

There are no specific rules governing the publicising of compassionate use programmes or other early access forms. Given the broad interpretation of advertising (see 2.1 Definition of Advertising), there is a risk that providing information regarding a medicinal product in a compassionate use programme or other forms of early access will constitute advertising of unauthorised medicinal products or indications, which, as detailed in 3.1 Restrictions on the Provision of Information Concerning Unauthorised Medicines or Indications, is prohibited. Each situation must be assessed individually to determine compliance.

Advertising Rx medicinal products to the general public is prohibited under the Medicinal Products Act, with the exception of marketing campaigns concerning vaccination against human infectious diseases.

However, certain non-commercial information on Rx medicinal products, more specifically information that does not constitute advertising, can be provided to the general public, for example, information intended to facilitate the safe, effective and correct use of medicinal products such as patient aid materials that are intended to be handed to patients by HCPs. Such information can also be given through the website fass.se.

Pharmaceutical companies can also provide information on a pre-approved website they administer, as long as it has undergone pre-examination and pre-approval by LIF (so-called “pre‐approved website”). Companies adhering to LER can apply for this pre-approval. However, users must seek out the information themselves, and the company cannot actively market the website.

Advertising over-the-counter (OTC) medicinal products to the general public is allowed, but it must comply with the general requirements of the Medicinal Products Act and the Marketing Practices Act, as well as the specific requirements outlined in LVFS 2009:6. The general requirements include, among others, that all advertisements must be up to date, accurate, balanced and not misleading, and must align with or be derived from the SmPC.

Advertising OTC medicinal products to the general public must, according to LVFS 2009:6 and LER, include at least the following:

• the name of the medicinal product, as well as the common name if the medicinal product contains only one active substance;
• the information necessary for correct use of the medicinal product;
• necessary warnings or limitations applicable to its use;
• an express, legible invitation to read carefully the instructions on the package leaflet or on the outer packaging;
• its dosage form;
• relevant contact details;
• a clear statement about the year of publication or, in the case of information on the internet, the date when the site was most recently updated; and
• if the advertising concerns an OTC medicinal product that is effective against a disease or symptoms of a disease that require contact with an HCP for diagnosis or treatment, a clear recommendation to consult an HCP before using the medicinal product.

The price of an OTC medicinal product can be included but there is no strict requirement to do so.

In addition to specifying the information that must be included, LVFS 2009:6 also outlines information that must not be included when advertising OTC medicinal products to the general public. The prohibition list includes any information that:

• gives the impression that a medical consultation or surgical operation is unnecessary, in particular by offering a diagnosis or by suggesting treatment by mail;
• suggests that the effects of taking the medicinal product are guaranteed, are unaccompanied by adverse reactions or are better than, or equivalent to, those of another treatment or medicinal product;
• suggests that a person’s health can be enhanced by taking the medicinal product;
• suggests that a person’s health could be affected by not taking the medicinal product (not applicable to vaccination campaigns for infectious diseases);
• refers to any recommendation by scientists, HCPs or persons who are neither of the foregoing but who, because of their celebrity, could encourage the consumption of medicinal products;
• suggests that the medicinal product is a foodstuff, cosmetic or other consumer product;
• suggests that the safety or efficacy of the medicinal product is due to the fact that it is natural;
• could, by description or detailed representation of a case history, lead to erroneous self-diagnosis;
• refers, in improper, alarming or misleading terms, to claims of recovery; or
• uses, in improper, alarming or misleading terms, pictorial representations of changes in the human body caused by disease or injury, or of the action of a medicinal product on the human body or parts thereof.

The pharmaceutical companies’ ability to interact and collaborate with patients/the general public, user organisations and interest groups such as patient organisations is governed by LER, which outlines specific restrictions and formalities that must be observed to ensure ethical and compliant engagement. Such interactions can involve joint activities related to disease information (such as meetings), research, training, the development of patient support programs, the creation of informational and educational materials, joint opinion formation and market studies. If possible, it is advisable to initially contact a relevant organisation when collaborating.

The framework also extends to collaborations with individual patients who are not affiliated with any organisation, as well as with individuals related to the patient.

All collaboration must take place in a responsible and meaningful manner, and in such a manner that the parties’ independence from one another is not jeopardised or questioned. The chosen collaborative projects cannot comprise an overwhelming share of the patient organisation’s activity or economy.

Furthermore, as a general rule, all collaborations must be regulated in written agreements. The agreement must be signed by both parties and clearly state, among other things, the purpose of the project, information about financing, and each party’s rights and obligations. The agreement must always be readily available for a third party, and information about the collaboration must also be available in LIF’s database on collaborations (Sw. LIFs Samarbetsdatabaser) for the duration of the project. All projects are made publicly available for three years before they are automatically removed from publication. Any consultation involving an individual patient or related party (such as a lecture, advisory board participation or other forms of consultation in their capacity as a patient or related party) is published in an equivalent manner, ensuring that no personal data is disclosed.

Moreover, collaboration must be transparent, and all informational materials and invitations must clearly indicate that the initiative is a collaborative project.

Economic and other forms of support can only be provided for specific projects. A pharmaceutical company is prohibited from offering economic or other support that:

• aims to fund the organisation’s routine and ongoing operations, or any other work which would give rise to a situation of dependency for the organisation;
• leads to the organisation’s inability to continue its activities after the collaboration agreement ends; or
• exceeds the costs associated with the collaborative activities.

Furthermore, pharmaceutical companies are not allowed to pay for travel and accommodation for meetings or conferences for individual participants, nor should such expenses be requested by individual participants or patient organisations. Any meeting organised by a pharmaceutical company must relate to the pharmaceutical company’s area of business. It is not permitted for pharmaceutical companies to offer participants in meetings a fee, nor are participants entitled to request or receive a fee for their participation.

Consultations are subject to specific rules under LER. For example, LER provides that:

• a written agreement must be established between the representative’s organisation and the pharmaceutical company, outlining the amount of remuneration for the assignment (which must be reasonable in relation to the scope of the assignment) and how it is paid;
• the number of consultants should not be higher than necessary for the project;
• there must be a legitimate need for the assignment;
• the purpose of the consultation cannot be to educate or unduly influence the consultant;

• the consultant can only talk about his or her own or a relative’s disease and possible care, and not about specific medicinal products, treatments or vaccinations (in other words, not a patient testimonial) if the assignment is to provide a lecture/patient story to HCPs or the general public;
• the consultation cannot be part of an incentive to choose a specific medicinal product;
• the pharmaceutical company can only cover travel, lodging and accommodation expenses related to the consultation assignment, provided these costs are moderate. No additional benefits, compensation or gifts are permitted; and

• it is recommended to include an obligation for the organisation/the individual consultant to disclose, when making public statements about a topic that is related to the assignment, that the consultant has performed consultancy assignments for the company.

Informational and educational materials, aids and patient support programmes are also subject to specific rules under LER.

Product-neutral informational and educational materials and aids can be distributed if the material:

• is of low value (currently SEK450 incl. VAT); and
• contains relevant information to the general public/patient about, for example, a disease.

When it comes to product-neutral patient support programmes, various types can be offered to patients, for example, materials, applications, lectures and support, with the primary goal of ensuring patient safety and enhancing the patient’s ability to manage his or her illness.

A product-specific patient support programme for a Rx medicinal product can only be offered to patients who have been prescribed the product, which is ascertained by the relevant healthcare institution providing information about the patient support programme.

Advertising of medicinal products targeting HCPs must, according to LVFS 2009:6, include all essential information consistent with the SmPC and the classification of the product. All information must be exact, up to date, possible to verify, and complete enough to enable the recipient to form his or her own opinion about the therapeutic value of the medicinal product in question. Any quotations, tables or other material from medical or scientific journals that are used must be cited in a truthful way and include the source. Additionally, any document provided to HCPs must include the date that the document was drafted or revised.

Furthermore, under LER, information concerning medicinal products for which the relevant SmPC is available at any time via fass.se must, in the event the SmPC is not reproduced, contain at least the following information:

• the name of the medicinal product;
• its dosage form and, if required, its strength;
• its active ingredients, specified by generic name which must be positioned close to the name of the medicinal product where this first appears as a headline or eyecatcher;
• a balanced statement of product characteristics: this description must contain required particulars about pharmacological group or other accepted group affiliation, together with indication or area of indications;
• required warnings or restrictions as regards the use of the medicinal product;
• relevant contact details;

• a clear statement with information about the year of publication or, in the case of information on the internet, the date when the site was most recently updated;
• information about the date on which the SmPC was compiled or reviewed;
• the status of the product (for example, Rx or OTC);
• the product’s status relating to the Swedish system of subsidies for medicinal products, and if the medicinal product is included in the system of subsidies, the sales price for the subsidised packages (which can be stated by a reference to fass.se according to the bullet point below), as well as clear indication of any limitations in a decision by the Swedish Dental and Pharmaceutical Benefits Agency (Sw. Tandvårds- och läkemedelsförmånsverket) (TLV) to include the product in the system of subsidies; and
• a reference to fass.se for further information.

Advertising can refer to data on file or data generated from other clinical studies that are not included in the SmPC. However, certain conditions must be observed: the additional information must supplement the SmPC by confirming or specifying the information it contains. Furthermore, this supplementary information must be consistent with the details provided in the SmPC.

Combination products, which consist of medicinal products with companion or complimentary diagnostics, including those that are not included in the SmPC, are not subject to any explicit rules. Instead, the general rules for advertising of medicinal products and medical devices apply, including the general rule that all advertising of medicinal products must be in conformity with the approved SmPC and the general prohibition on providing information regarding unauthorised medicinal products or unauthorised indications.

Advertising of companion diagnostics products is not subject to any explicit rules. Instead, the general rules for advertising, including advertising of medical devices, apply.

A reprint of a journal article, with information about human health or diseases, is not considered advertising if there is no direct or indirect reference to medicinal products. The same applies to correspondence with non-promotional material needed to respond to a specific query from an HCP about a medicinal product. However, it is important to note that journal articles about unauthorised medicinal products or unauthorised indications can be considered advertising and prohibited.

Furthermore, LER allows for the distribution of informational and educational material to HCPs if the material is of low value (currently SEK450 including VAT), is directly relevant to the HCP’s professional practice, and directly benefits patient care.

The ability of medical science liaisons (MSLs) to discuss scientific information concerning unauthorised medicinal products or unauthorised indications with HCPs in any given situation will be contingent on a case-by-case assessment. Providing information on unauthorised medicinal products or unauthorised indications will generally be deemed to constitute advertising and prohibited. However, as detailed in 2.2 Information or Advertising: Disease Awareness Campaigns and Other Patient-Facing Information, 3.1 Restrictions on the Provision of Information Concerning Unauthorised Medicines or Indications and 3.3 Provision of Information to Healthcare Professionals, the information can also fall outside the scope of advertising if the information is purely informational and does not have a promotional purpose, or by way of individual correspondence following an unsolicited query from an HCP.

Advertising of medicinal products does not require prior authorisation from or notification to a regulator. All marketing material for a medicinal product must, however, be in conformity with its SmPC and the SmPC is subject to approval.

Furthermore, under LER, pharmaceutical companies must send so-called ‘statutory copies’ of new, up-to-date medicinal product information (for example, publications, advertisements, invitations, mailings, commercial films, or information on websites) to IGN in order for IGN to carry out its task of monitoring the market.

Pharmaceutical companies generally achieve compliance with medicinal product advertising rules by employing specific personnel and implementing structured procedures.

The holder of a marketing authorisation for a medicinal product (Sw. Innehavare av försäljningstillstånd) (MAH) must, under the Medicinal Products Act, employ a scientifically competent function to monitor information relating to the medicinal product.

Furthermore, a pharmaceutical company (or its representative in Sweden) must, under LER, employ an Information Officer in marketing ethics (Sw. Informationsansvarig marknadsetik) (IMA). The IMA must be appointed from the executive staff and must complete specific training in marketing law arranged by LIF. The IMA is the company’s liaison officer in ethical matters related to informational and marketing activities. Additionally, the IMA must approve all marketing materials relating to medicinal products before it is taken into use and, among other things, certify that the material satisfies the applicable rules and regulations, corresponds with the SmPC, and is a fair and truthful presentation of facts.

Advertising medicinal products on the internet is regulated by several technology-neutral laws and guidelines, including the Medicinal Products Act, the Marketing Practices Act, LVFS 2009:6 and LER. These regulations apply to all advertising directed at the Swedish market, including advertising on the internet. Consequently, the same requirements and restrictions that apply to other forms of medicinal product advertising also apply online. Websites featuring medicinal product information must clearly identify it as such and specify the intended target audience, whether HCPs or the general public, with the presentation tailored accordingly.

Additionally, LIF has issued guidelines that further clarify advertising of medicinal products online, addressing both the presentation of medicinal information, in “Information from IGM on Medicinal Information on the Internet” (Sw. Information från IGM om läkemedelsinformation på internet), and the use of digital channels in compliance with LER, in “Use of Digital Channels According to the Pharmaceutical Industry’s Ethical Guidelines” (Sw. Användande av digitala kanaler utifrån Läkemedelsbranschens etiska regelverk).

Companies are required to restrict access to web pages containing information that advertises Rx medicinal products or other information intended for HCPs. This is because such products can only be advertised to HCPs. The control mechanism commonly used is any form of self-verification where the visitor confirms that he or she is an HCP. However, it is not definitively settled whether such system would be accepted if challenged in a Swedish court.

Companies are allowed to provide disease awareness information and materials to the general public online. The condition is that this information must not include any reference, even indirect, to medicinal products. Such information falls outside the definition of advertising – see 2.2 Information or Advertising: Disease Awareness Campaigns and Other Patient-Facing Information.

There are no explicit rules governing virtual scientific meetings. Instead, the general rules for scientific meetings apply, including those on sponsorship and providing informational and educational material detailed in 9. Gifts, Hospitality, Congresses and Related Payments. Pharmaceutical companies are allowed to sponsor scientific meetings or congresses and virtual attendance by HCPs, but they must adhere to these general rules. However, when it comes to the provision of meals, specific provisions apply and a meal can only be offered if a company representative is present at the meeting where the meal is provided.

Advertising medicinal products on social media is regulated by several technology-neutral laws and guidelines, including the Medicinal Products Act, the Marketing Practices Act, LVFS 2009:6 and LER. These regulations apply to all advertising directed at the Swedish market, including advertising on social media platforms. Consequently, the same requirements and restrictions that apply to other forms of medicinal product advertising also apply online. See 7.1 The Advertisement of Medicinal Products on the Internet.

According to guidelines issued by LIF on how digital channels can be used in compliance with LER, “Use of Digital Channels According to the Pharmaceutical Industry’s Ethical Guidelines” (Sw. Användande av digitala kanaler utifrån Läkemedelsbranschens etiska regelverk), social media is generally directed towards the general public. Therefore, great care should be observed if Rx medicinal products are advertised in social media to ensure the advertising is directed solely towards HCPs. Pharmaceutical companies are responsible for all content in their social media channels, which means they must review all comments made in response to the pharmaceutical company’s post and remove a comment if it, for example, includes information about Rx medicinal products targeting the general public.

Employees of pharmaceutical companies should be cautious when using social media as it can be difficult for visitors to distinguish between personal and professional posts. LIF recommends that employees always act as representatives of their companies and adhere to LER when on social media. This is because the use of social media by employees can give rise to liability for the pharmaceutical company if their posts are perceived as official communications.

The anti-bribery and anti-corruption legislation relevant to interactions between pharmaceutical companies and HCPs or healthcare organisations (HCOs) is primarily outlined in the Swedish Criminal Code (1962:700) (Sw. Brottsbalken). These provisions apply broadly to all interactions between pharmaceutical companies and HCPs/HCOs and include the following key points:

• an employee or contractor cannot receive, accept a promise of, or request an undue advantage for the performance of their employment or commission (taking of a bribe);
• a person cannot give, promise or offer such an undue advantage (giving of a bribe); and
• a business operator who supplies money or other assets to a person representing the business operator in a particular matter cannot, through gross negligence, promote giving of a bribe, gross giving of a bribe, or trading in influence (negligent financing of a bribe).

The rules apply to individuals. However, the rules can also result in a corporate fine for a company if a person employed by the company engages in a criminal offence and the company did not do what is reasonably required to prevent the offence, or the person committing the offence holds a qualified position in the company.

The rules apply to both the public and private sectors. However, in the public sector, there are additional restrictions under the Criminal Code. Accordingly, it is prohibited for a person to receive, accept a promise of, or request an undue advantage to influence a decision or action taken by another in the exercise of public authority or public procurement. Similarly, it is prohibited to give, promise or offer someone such an undue advantage, which is considered trading in influence.

The rules apply to benefits provided to both individuals and organisations, with specific considerations for the public sector as outlined.

The provision of benefits or inducements to HCPs or HCOs is generally discouraged, and several regulatory codes complement the Swedish Criminal Code in this regard.

LER sets out rules governing all interactions between pharmaceutical companies and HCPs/HCOs, including rules regarding inducements. These rules include strict guidelines on inducements and generally prohibit gifts to HCPs or HCOs. See 9. Gifts, Hospitality, Congresses and Related Payments.

Furthermore, the Swedish Anti-Corruption Institute (Sw. Institutet Mot Mutor) has issued the Code to Prevent Corruption in Business (the ‘IMM Code’). The IMM Code is generally more stringent than the anti-bribery provisions in the Swedish Criminal Code. It broadly prohibits providing certain forms of benefits deemed improper and any benefits to individuals who exercise public authority or are involved in public procurement decisions.

These self-regulatory controls apply to benefits provided to both individuals and organisations.

Pharmaceutical companies are generally prohibited from providing, offering or promising gifts to HCPs. However, LER provides specific exceptions to this prohibition:

• Informational and educational materials: These can be provided if their total value does not exceed SEK450 (incl. VAT), and the materials are directly relevant to the recipient’s practice and directly beneficial to patient care.
• Items of medical utility: These can be provided for the purpose of educating employees and for the care of patients, provided their total value does not exceed SEK450 (incl. VAT), and the items must not be those routinely used in the recipient’s business.

It is important to note that informational and educational materials, as well as items of medical utility, must never be supplied, offered or promised as an incentive for HCPs to recommend, prescribe, purchase, supply, sell or administer medicinal products.

Regarding hospitality, LER sets out detailed rules. Pharmaceutical companies are generally not allowed to pay for travel or accommodation for HCPs. However, pharmaceutical companies are allowed to offer meals in connection with scientific meetings under certain circumstances and subject to monetary limits. At time of writing (February 2025), the value of lunch must not exceed SEK350 (incl. VAT) per person and the value of dinner must not exceed SEK950 (incl. VAT) per person.

Pharmaceutical companies can provide samples of medicinal products that have been authorised for sale in Sweden to HCPs, but there are, under LVFS 2009:6, strict restrictions in place:

Samples of Rx medicinal products can only be provided to a person authorised to prescribe the medicinal product.

Samples of OTC medicinal products can be provided to:

• persons with a pharmacy authorisation and the person responsible for medicinal products in the pharmacy;
• other retailers authorised to sell medicinal products; and
• pharmacists of hospital pharmacies which are appointed by the HCO.

Moreover, providing samples of medicinal products must be done with great restraint and can only take place under the following conditions:

• only a limited number of samples of each medicinal product can be provided to the same recipient each year;
• each delivery of a medicinal product sample requires a written, dated and signed request from the person ordering the sample;
• a careful examination of the recipient must be made to ensure that the recipient is authorised to prescribe or dispense the medicinal product;
• requests must be saved to enable display at the next inspection by MPA;
• no medicinal product sample can be larger than the smallest package size available on the market;
• each medicinal product sample must be marked with the text ‘free medicinal product test, not for sale’ or any other wording having the same meaning; and
• each sample must be accompanied by a copy of the SmPC.

LER imposes even stricter rules, allowing at most one sample per product per year to the same person. Additionally, samples of Rx medicinal products can only be provided for products considered “new”, meaning they have been publicly available for less than two years. New strength or dosage forms without a new indication do not qualify as new products.

Samples of medicinal products must never be used as an incentive to recommend, prescribe, purchase, supply, sell or administer specific medicinal products.

An HCP’s employer is responsible for its employees’ training and development of skills and carries the responsibility for related costs. However, pharmaceutical companies can sponsor scientific meetings or congresses and the attendance of HCPs at these events, but there are extensive restrictions under LER. Sponsorship must comply with LER’s six fundamental principles, ensuring trust, transparency, mutual benefit, proportionality, moderation and clear documentation.

Additional key restrictions and requirements for sponsoring scientific meetings or congresses under LER include:

• pharmaceutical companies can only offer meetings or sponsor events that are connected to the company’s business operations, meaning the company must have products or conduct research in the relevant therapy area;
• the scientific and vocational programme must form the main part and purpose of the relevant meeting;
• pharmaceutical companies can only contribute to costs for venues, lecturers, study material, moderate meals and similar that is necessary for the execution of the meeting;

• meals, if offered, must be served in connection with the meeting, with, at time of writing (February 2025), lunch not exceeding SEK350 (incl. VAT) per person and dinner not exceeding SEK950 (incl. VAT) per person);
• alcohol consumption must be limited and can only be served in connection with meals. Spirits must never be offered and non-alcoholic alternatives must always be available;
• pharmaceutical companies cannot pay for travel, accommodation or registration fees, nor can these be requested by individual participants;
• participants cannot be offered remuneration by pharmaceutical companies and participants cannot receive or request remuneration for attending; and
• recreational activities cannot be funded by pharmaceutical companies.

Regarding selection of location and venue, meetings outside Sweden or the Öresund region are permissible only if the majority of the participants come from other countries than Sweden, or if the corresponding knowledge or experience is unavailable there. The location and venue for the meeting must be reasonable for the meeting’s purpose, avoiding high season or exclusive locations and venues, such as ski resorts during winter or locations hosting major international events concurrently.

The LER guidelines and restrictions detailed above also apply to the attendance of HCPs at events taking place abroad, with the exception of monetary limits for meals. According to the Host Country Principle in EPFIA’s Code of Practice, local monetary limits for meals take precedence over LER.

Pharmaceutical companies cannot organise or sponsor cultural, sports or other non-scientific events in relation to scientific conferences. However, simple social activities, such as background music or local performances at the venue in connection with the conference, are permissible if they are not organised, requested or paid for by the pharmaceutical company.

Pharmaceutical companies can provide grants or donations to healthcare institutions, and these are subject to strict restrictions under LER. Such grants and donations must not be linked to past, present or potential future use, recommendation, sale or prescription of the donor’s products or services, nor should they serve as an inducement to recommend, prescribe, purchase, supply, sell or administer specific medicinal products.

Additional restrictions and requirements under LER include:

• grants and donations cannot be offered or requested to fund the internal or regular activities of healthcare institutions, nor can they be used to finance recreational activities; and
• grants and donations to healthcare institutions are only allowed if they support research and development.

Typically, there is no difference between monetary donations and donations of equipment or services; all donations must adhere to these guidelines.

Pharmaceutical companies are generally prohibited from offering rebates or discounts to HCPs, as LER restricts the provision of gifts, which extends to rebates and discounts.

Regarding healthcare institutions, an agreement between the Swedish Government and the Swedish Association of Local Authorities and Regions prohibits Swedish regions from entering into agreements with pharmaceutical companies for rebates or discounts on medicinal products within the Swedish benefits system.

Therefore, offering rebates or discounts to HCPs or healthcare institutions is effectively restricted.

Pharmaceutical companies can pay for services provided to them by HCPs (employees and management), by way of consultation (for example, assignments within research, education, conferences, product development and advisory bodies). However, these payments are subject to extensive restrictions under LER to prevent them being considered improper inducements.

All interactions with HCPs must comply with LER’s six fundamental principles, ensuring trust, transparency, mutual benefit, proportionality, moderation and clear documentation.

Additional key restrictions and requirements for pharmaceutical companies paying for services provided to them by HCPs under LER include:

• consultations and assignments must not serve as an incentive to recommend, prescribe, purchase, supply, sell or administer specific medicinal products;
• there must be a legitimate need for the assignment;
• the assignment must be agreed upon in writing between the HCP, his or her employer and the pharmaceutical company;
• the agreement must require the HCP to disclose his or her consultancy or part-time employment with the pharmaceutical company when expressing public opinions, verbally or in writing, on a topic related to the assignment;
• the agreement must specify the tasks to be performed and how remuneration is regulated;
• the remuneration must be reasonable in relation to the work’s content and the time spent;
• apart from covering costs for travel, food and accommodation (as applicable), no other benefits, remuneration or gifts are allowed; and
• compensation for work carried out as part of normal work duties must be paid to the employer.

Employer consent is required when a pharmaceutical company engages an HCP as a consultant. See 9.7 Payment for Services Provided by Healthcare Professionals.

Pharmaceutical companies are required to disclose details of transfers of value to HCPs or healthcare institutions under LER. This is a regulatory requirement and includes disclosing any direct or indirect transfers of value that are made to or for the benefit of the recipient, such as donations, sponsorships, remunerations for consultation and assignments, and reimbursement of expenses.

Additional key requirements under LER when disclosing transfers of value include:

• disclosures must be made annually, covering a full calendar year. Pharmaceutical companies are strongly recommended to report by the last weekday in May and must do so by 30 June at the latest. The information must remain publicly accessible for three years;
• pharmaceutical companies must document the details of transfers of value and retain these records for at least five years after each reporting period ends;

• disclosure must follow a template created by LIF (Appendix 1 to LER);
• disclosure can either be performed via LIF’s co-operation database, or on the pharmaceutical company’s website with a link to the report in LIF’s co-operation database;
• disclosure must be made in Swedish, but pharmaceutical companies are encouraged to also provide the information in English; and
• depending on the situation, disclosure can be made on either an individual or aggregate level.

Exceptions to the disclosure obligation apply to meals served in connection with meetings and informational and educational materials as well as items of medical utility which do not have to be disclosed.

These transparency requirements also apply to foreign companies. Under LER, a pharmaceutical company must disclose transfers of value according to the national code of the country where the recipient has its principal place of business or seat. If the recipient has its principal place of business or seat in another European country than Sweden, and the pharmaceutical company cannot disclose the transfer of value through a group member in the recipient’s country, the company must disclose the transfer of value according to LER. This implies that even companies without products on the market must comply with these requirements if they are bound by LER and engage in transfers of value to recipients in applicable jurisdictions.

The enforcement of rules on advertising of medicinal products and inducement involves several bodies.

Regulatory Authorities

• MPA acts as the supervisory authority under the Medicinal Products Act and LVFS 2009:6.
• The Swedish Consumer Agency oversees compliance with the Marketing Practices Act.

Self-Regulatory Authorities

• IGN and NBL are self-regulatory bodies operating under LER.

Courts

• The Administrative court in Uppsala, the Administrative Court of Appeal in Stockholm and the Supreme Administrative Court handle appeals of MPA decisions.
• The Patent and Market Court, the Patent and Market Court of Appeal and the Supreme Court enforce marketing practices under the Marketing Practices Act.
• Prosecutors and general courts (District Courts, Courts of Appeal and the Supreme Court) enforce anti-bribery and statutory rules on inducements.

These bodies collectively ensure compliance with the rules governing advertising of medicinal products and inducements.

Pharmaceutical companies can initiate proceedings against competitors for advertising infringements. They have several options:

• A company can bring a case before the Patent and Market Court for various advertising infringements, such as unfair advertising.
• A company can report violations of the Medicinal Products Act or LVFS 2009:6 to MPA, which can then issue a prohibitive injunction against the competitor.
• A company can report a competitor’s breach of good marketing practices under LER to the disciplinary bodies IGN and NBL, with IGN serving as the first instance and NBL the appellate body for most types of cases.
• A company can report a competitor’s violation of the Marketing Practices Act to the Swedish Consumer Agency, which can then issue a prohibitive injunction.

Regulators and courts can impose several sanctions on pharmaceutical companies that violate medicinal product advertising rules and inducement regulations:

Medicinal Products Act Violations

These often result in a prohibitive injunction with conditional fines. MPA can also issue provisional orders and injunctions to take corrective measures, both of which can be subject to fines.

Marketing Practices Act Violations

These can lead to a prohibitive injunction with conditional fines. Additional sanctions can include market disruption fees ranging from a minimum of SEK10,000 to a maximum of 4% of the trader’s annual turnover in the financial year before the infringement ceased or when the writ of summons was served, as well as damages to third parties.

NBL and IGN Jurisdiction Violations

These can result in a disciplinary fee of up to SEK500,000.

Anti-Bribery and Criminal Violations

These can lead to criminal sanctions against individuals and corporate fines. The maximum corporate fine is SEK10 million for small companies and SEK500 million for large companies.

Procedures before the self-regulatory bodies IGN and NBL can occur simultaneously and in parallel with proceedings in the Swedish courts. Decisions from IGN and NBL are contractually binding, whereas judgments from Swedish courts are legally binding.

The courts operate independently from IGN and NBL, but courts can consider IGN and NBL rulings as expressions of fair and ethical marketing. See 1.2 Application and Influence of Self-Regulatory Codes on the Advertisement and Promotion of Medicines.

In recent years, there have been notable enforcement trends in advertising of medicinal products.

Cases before IGN and NBL have frequently addressed the boundaries of what qualifies as advertising under LER, particularly concerning whether press releases constitute advertising (including advertising of unauthorised medicinal products or unauthorised indications) or are merely informational non-commercial messages. Many press releases have been deemed advertising, underscoring the importance of carefully designing a press release to ensure compliance with the regulatory framework.

Similarly, MPA has focused on the boundaries of advertising for medicinal products. MPA has issued several prohibitive injunctions with conditional fines against companies for advertising products that MPA classify as medicinal products contrary to the companies’ claims that the products classify as other types of products, such as cosmetic products.

Another enforcement trend is MPA’s scrutiny of advertisements for products containing cannabidiol (CBD). MPA has imposed multiple conditional fines on companies for advertising CBD products in violation of prohibitive injunctions.

An additional enforcement trend is the increased focus on bribery and corruption cases, as evidenced by a rise in indictments from 38 in 2020 to 77 in 2022, and 96 in 2023.

The rules for advertising veterinary medicinal products are generally similar to those for human use, as both fall under the Medicinal Products Act and regulations issued by MPA. Most enforcement bodies relevant to human medicinal products also apply to veterinary medicinal products. However, the regulatory framework for veterinary medicinal products is less extensive and detailed compared to that for human medicinal products.

The self-regulatory enforcement body for veterinary medicinal products is the Veterinary Industry Nordic (ViNordic). Among other things, ViNordic’s Marketing Board can issue fees of up to SEK45,000 for violations of advertising rules, or SEK75,000 for repeated violations, based on complaints from ViNordic member companies, certain other parties trading in veterinary medicinal products, and MPA.