Pharmaceutical Advertising 2020

Last Updated March 02, 2020

Norway

Law and Practice

Authors



Advokatfirmaet GjessingReimers AS is a boutique IP and tech law firm with 11 employees (six partners) and considerable experience within all areas of IP, technology law and life science. The life sciences team includes four partners who advise clients on contentious and non-contentious matters. The team provides legal services to Norwegian and foreign pharmaceutical companies, biotech companies, medical device companies and food enterprises, as well as patient organisations and government institutions. The firm's specialist expertise includes competition and market access, patent litigation, intellectual property, public procurement, marketing law, and medicinal products. GjessingReimers has in-depth knowledge of regulatory law and practice and of the co-operation between the competent authorities within the EEA, as well as the European Commission and the European Medicines Agency. The firm's knowledge also covers national and EU-regulatory requirements on pricing and reimbursement of medicinal products, on advertising and on the regulatory requirements applicable to wholesalers and pharmacies.

Advertising of medicinal products in Norway is governed by the Act on medicinal products of 4 December 1992 and by Chapter 13 of the Medicines Regulation of 18 December 2009. In addition, the Marketing Control Act of 9 January 2009 provides more general rules relevant to advertising of medicinal products.

Norway is a member of the European Economic Area (EEA). Hence, Norwegian rules on advertising should be in accordance with Articles 86 to100 of Directive 2001/83/EC.

Pharmaceutical advertising is also regulated by the self-regulatory code provided by the Pharmaceutical Industry Association (“the LMI Code”), which is based on the rules of the Act on medicinal products, Chapter 13 of the Regulation, Directive 2001/83/EC and the rules of the European Federation of Pharmaceutical Industries and Associations (EFPIA).

In the autumn of 2018, the Norwegian Medicines Agency (NoMA) published a hearing concerning the Norwegian advertising rules – mainly to further harmonise those rules to Articles 86-100 of the Directive 2001/83/EC. As the outcome of this process is not clear this chapter is based on the existing legal framework. 

According to Chapter 2 of the LMI Code, it applies to its Member Companies, defined as any enterprises that are members of LMI, Member Companies of the EFPIA (which, according to the EFPIA Code, are obliged to follow Norwegian regulations) and other companies that have agreed to follow the LMI Code. Furthermore, the rules of the Code apply in Norway. The Code also applies outside Norway when the Member Company is addressing Norwegian healthcare professionals. For foreign companies with authorisation in Norway, the authorised representative in Norway is responsible for compliance with the Code. The responsibility of the authorised representative in Norway also applies when information/interaction is administered/managed by a department outside Norway. The LMI Code is binding upon the above subjects.

According to Section 13-2 of the Medicines Regulation, advertising of medicinal products means any form of written and verbal description, picture, as well as handouts of free samples of medicinal products for humans and animals, including herbal medicinal products, which are designed with the purpose of increasing the sale or use of a medicinal product. 

NoMA has, in its administrative practice, interpreted the definition of advertising broadly. Hence, from a practical point of view, information provided by a pharmaceutical company is generally considered advertising.

However, according to Section 13-1, second section of the Medicines Regulation, the labelling, the package leaflet (PIL) or the summary of product characteristics (SmPC), which are approved as part of the marketing authorisation, fall outside the scope of the rules on advertising. The same applies to the dissemination of technical information concerning, inter alia, prices and packaging sizes, provided they are not connected to indications or the SmPC. Finally, a company's information relating to human health or diseases, provided that there is no reference, even indirect, to medicinal products falls outside the scope of the rules on advertising.

There is no express exemption for patient support programmes, and those are in practice considered to be advertising. The provision concerning the labelling, the PIL and the SmPC should be interpreted in the light of the Court of Justice of the European Union’s judgement in case C-316/09. Hence, a faithful reproduction of the packaging of the medicinal product, and a literal and complete reproduction of the PIL or the SmPC approved – not accompanied by any additional element which supports its classification as advertising - should be complied with to avoid that the information is classified as prohibited advertising. Furthermore, the information above should be made available through a pull service requiring active research steps by the internet user – ensuring that a person will not be unwillingly confronted with that information.

As mentioned above, pharmaceutical company may refer to health or diseases if not linked directly or indirectly with referral to a medicinal product. Traditionally, NoMA has considered disease awareness campaigns as advertising. However, in 2014, NoMA to some extent opened up for disease awareness campaigns under strict conditions set out in specific NoMA guidelines. Information on health or diseases is not considered as advertising if the information is given on pharmaceuticals group level – within the Anatomical Therapeutic Chemical (ATC) classification system level 1 and 2 – and in accordance with specific criteria established by NoMA.

According to NoMA, the information should not highlight information about the treatment options. The information may however refer to different treatment options; the use of medicinal products can be mentioned as an option among several different treatment options. It is not allowed to mention brand name or specific active substance; the information shall not promote the use of one or more specific medicinal products. The information must support that the healthcare professional in cooperation with the patient decides which treatment should be provided given the individual patient's needs.

As information about diseases with only one or a few alternative medicinal products for treatment may draw attention to a specific medicinal product – regardless of whether it is referred to or not. Under such circumstances, NoMA highlights that it is particularly important that the information does not focus on treatment, but on health, disease and information on where to seek advice.

The information should be accurate, up to date, verifiable, sufficiently comprehensive, balanced and easy to understand. NoMA further requires the information to be precise, correct and adapted to the public. All printed material must be dated and updated.

Knowledge of new important disease or health information should be implemented in and replace previous releases. For information available on the web, the provider should make every effort to ensure that all information at all time is updated and dated. All information should contain a reference to medical literature or other reliable and professionally quality-assured scientific sources. The information should cover all the main characteristics of a given disease and not just a few selected aspects. The format of the information must be adapted to the quality requirement and not vice versa.

The information should not describe disease in such a way that it creates unnecessary concern. The handling of the disease should be presented in a balanced and correct manner. Nor should the information over focus on certain risk factors, but must place risk factors into a comprehensive risk scenario for disease. The production should not unfairly emphasise special treatment possibilities or a need to seek medical treatment.

The language used should give the information in a simple, easily understandable manner and have a suitable design. Finally, the entity providing the information must be clearly stated.

There is no provision expressly prohibiting press releases. As a starting point, it is allowed to inform about the activity of the pharmaceutical company. However, taking into account the broad definition of advertising of medicinal products in Norway, press releases focusing on medicinal products are likely to be considered advertising.

According to Chapter 11 of the LMI Code, Member Companies must exercise particular caution to avoid that a press release being seen as advertising. If the press release mentions the product’s name or active substance, the Code recommends that it concerns news item having significant general newsworthiness. The mention of a product name or active substance should be kept to a minimum – only factual and brief information about the medicinal product should be provided. The media should be the target group for the press release and sent to or made available to a group of journalists or the media with a view to it being journalistically evaluated and treated prior to publication.

We are not aware that NoMA has assessed whether press releases in accordance with the above LMI Code are considered to be advertising and/or otherwise comply with the advertising rules.

According to Section 13-6 of the Medicines Regulation and Chapter 7 of the LMI Code comparative advertising for over-the-counter (OTC) medicines is prohibited. 

There is no ban on comparative advertising for prescription-only medicines. Chapter 8 of the LMI Code provides that the advertisement must not be misleading and must be based upon comparable and relevant properties of the products. Both the company’s and the competitor’s product must be described in a balanced, fair and objective way.

In addition, the Marketing Control Act and the Regulation on comparative advertising provides that factual claims must be substantiated. Relevant documentation may be results from clinical trials.

According to Section 2 of the Regulation on comparative advertising, comparative advertising means any advertising that directly or indirectly refers to a competitor or products or services offered by a competitor.

Section 3 of this Regulation provides that comparative advertising shall only be accepted when:

  • it is not misleading;
  • it compares products that meet the same needs or are intended for the same purpose;
  • it compares objectively one or more of the qualities of the products or services that are concrete, relevant, demonstrable and representative, including the price;
  • it does not discredit the trade mark, trade name or other characteristics, product, service, enterprise or situation of the competitor;
  • goods with a designated geographical origin shall only be compared with goods with the same designation;
  • it must not take unfair advantage of the reputation of a competitor’s trade marks, trade name, other characteristics or designated geographical origin;
  • it must not present the product or service as an imitation or copy of another product having a protected trade mark or trade name; and
  • it does not lead to confusion in the trade, between the advertiser and a competitor or between the advertiser’s or competitor’s trade mark, trade name or other characteristics, products or services.

Section 13-3 of the Medicines Regulation provides that advertising is only allowed for medicinal products that have obtained a marketing authorisation. As NoMA interprets the definition of advertising broadly; in general, it is not allowed to provide information on unauthorised medicines.

With regard to unauthorised indications, Section 13-3 of the Medicines Regulation requires that advertising must comply with the SmPC, as approved by NoMA. As unauthorised indications are not included in the SmPC, advertising is not allowed.

Section 13-1 of the Medicines Regulation provides that the requirements relating to advertising are also applicable with regard to conferences, meetings and other sales-promoting activities. Hence, a pharmaceutical company cannot provide information on unauthorised medicines or unauthorised indications during a scientific conference directed at healthcare professionals.

To send information on unauthorised medicines or unauthorised indications to healthcare professionals will only be allowed if the information is not considered to fall under the definition of advertising. Taking into consideration that NoMA has, in its administrative practice, interpreted the definition of advertising broadly, the sending of information on unauthorised medicines or unauthorised indications to healthcare professionals will not be allowed.

Providing healthcare institutions with information on unauthorised medicines or unauthorised indications will as a starting point be contrary to advertising rules.

However, prior to the granting of a marketing authorisation, in the health technology assessment procedure for reimbursement, companies can provide NoMA with product data – upon request – in accordance with Chapter 14 of the Medicines Regulation. Furthermore, before a marketing authorisation is granted, the company can provide public tender bodies with information necessary to participate in the competition.

Medicinal products without a Norwegian marketing authorisation are made available through compassionate use programmes as provided for in Article 83 of Regulation (EC) No 726/2004. Prescribers may also apply for compassionate use, named patient as provided for in Article 5 of Directive 2001/83/EC, see Section 2-5 of the Medicines Regulation.

The Medicines Regulation does not provide an exemption from the advertising rules for the above-mentioned compassionate use. As those products have not obtained a marketing authorisation, advertising is not allowed. In this respect, companies may not publish information concerning the availability of compassionate use programmes. However, compassionate use programmes approved are published on NoMA’s homepage.

Section 13-5 of the Medicines Regulation prohibits the advertising of prescription-only medicines to the general public. The same provision allows advertising to the general public of over-the-counter medicines.

As mentioned above, advertising is only allowed if a marketing authorisation has been granted. The general principles are that advertising should encourage the rational use of the medicinal product, by presenting it objectively and without exaggerating its properties. The advertising should not lead to the use of the medicinal product that is not medically justified. The advertising should also comply with the SmPC. 

According to Section 13-6 of the Medicines Regulation, advertising directed at the general public should always comprise the name of the product, the active ingredient, necessary information concerning correct application and consumption of the medicinal product and an express invitation to read carefully the instructions on the package leaflet or on the outer packaging.

While advertising directed at the general public can mention the price of the medicine, there is no obligation to include such information.

According to Section 13-5 of the Medicines Regulation, advertising of medicinal products to the general public should not contain recommendations from doctors, dentists, veterinarians or others who, by virtue of their reputation can encourage the use of medicinal products. Furthermore, misleading or improper illustrations shall not be used, and not refer to changes in the human body caused by disease or injury, or of the action of a medicinal product on the human body. It is also prohibited to mention serious diseases such as cancer, sexually transmittable diseases, tuberculosis, chronic insomnia, diabetes, etc.

Section 13-6 of the Medicines Regulation further provides that advertising directed at the general public should not:

  • give the impression that a medical consultation is unnecessary;
  • indicate how patients may perform self-diagnosis;
  • suggest that the effects of taking the medicine are guaranteed or are unaccompanied by adverse reactions;
  • suggest that the medicinal product is better than, or equivalent to, those of another treatment or medicinal product;
  • suggest that the health of the subject could be affected by not taking the medicine;
  • be directed exclusively or principally at children;
  • refer to a recommendation by health professionals or scientists to support the use of a medicinal product;
  • suggest that the medicinal product is a foodstuff, cosmetic or other consumer product;
  • suggest that the safety or efficacy of the medicinal product is due to the fact that it is natural;
  • by a description or detailed representation of a case history, lead to erroneous self-diagnosis; and
  • refer, in improper, alarming or misleading terms, to claims of recovery.

As a starting point, there is no express ban on interactions between patients or patient organisations and the industry. Consultation and sponsorship with patients or patient organisations by pharmaceutical companies may, however, fall under the definition of advertising.

If the interaction is considered advertising, the activity will be contrary to the prohibition to advertise prescription-only medicines to the general public.

According to Chapter 27 of the LMI Code, under specific conditions the following interaction with patient organisations are expressly allowed – under specific conditions:

  • patient directed co-operative project;
  • purchase of advertisements and stands; and
  • providing of services to a pharmaceutical company.

Exclusivity agreements between a patient organisation and a pharmaceutical company are not allowed. Furthermore, a Member Company cannot require to be the sole funder of a patient organisation project.

The collective income from the pharmaceutical industry should not exceed 15% of the patient organisation’s annual budget. According to the LMI, the 15% limit comprises income from patient-directed co-operative projects, purchases of advertisement and stands and providing of services to the pharmaceutical industry.

Section 13-3 of the Medicines Regulation provides that advertising directed at healthcare professionals should encourage the rational use of the medicinal product, by presenting it objectively and without exaggerating its properties. The advertising should not lead to the use of the medicinal product which is not medically justified. The advertising should also comply with the SmPC as further defined by the Court of Justice of the European Union (CJEU) in case C-249/09, see 5.2 Reference to Data Not Included in the Summary of Product Characteristics.

According to Section 13-7 of the Medicines Regulation, advertising directed at healthcare professionals should always comprise the following:

  • name of the medicinal products, dosage form and strength;
  • name of all active substances. This information must be in a clear font and be given a dominant display;
  • name of the marketing authorisation holder (and eventually the manufacturer);
  • therapeutic indications;
  • contraindications;
  • adverse reactions, precautions for use and interactions;
  • dosage;
  • package size(s);
  • prescription class, provisions for prescription and delivery and
  • approved price per date and provisions for reimbursement.

Advertising directed at healthcare professionals may also be provided as a reminder, in which case it could contain solely the name of the medicinal product, generic name of the active substance and the name of the marketing authorisation holder.

Section 13-7 of the Medicines Regulation provides that internal research reports are not accepted as a scientific source for advertising. Therefore, advertising cannot refer to data on file.

Advertising directed at healthcare professionals may refer to clinical studies that are not included in the SmPC. The information must, however, be in accordance with the SmPC as further defined by CJEU in case C-249/09.

In this respect, NoMA has held that, based on the ruling of the CJEU, it must be considered whether the information is contrary to the SmPC – and thus not in accordance with the SmPC.

If it is not contrary to the SmPC, it must be considered whether it supplements what is stated in the SmPC by verifying or specifying the information. The information provided must not distort the content of the SmPC and it must promote the rational use of the medicinal product through objective presentation and without exaggerating its properties. The information should not be misleading and be accurate, relevant, verifiable and sufficiently detailed to enable the recipient to form a personal opinion on the therapeutic value of the medicinal product. 

In addition, the clinical study must be presented in scientific material accessible to the receiver of the advertising, eg, professional journals, reference books and published congress reports. Furthermore, journals that are not professionally quality assured (referee) are not accepted as a scientific source for claims presented in advertising.

Referring to combination products or companion diagnostics that are not included in the SmPC may be considered contrary to the advertising rules. NoMA may consider the combination marketed as a fixed combination as defined in Article 10b of Directive 2001/83 – or another medicinal product – not holding a marketing authorisation. Furthermore, the reference to combination products or companion diagnostics must be in accordance with the SmPC. If it is not contrary to the SmPC, it must supplement what is stated in the SmPC by verifying or specifying the information, see case C-249/09, see 5.2 Reference to Data Not Included in the Summary of Product Characteristics.

Companies may provide reprints of journal articles to healthcare professionals. No specific rules apply and, as a result, the content of the journal article must comply with the advertising rules as described above.

Considering the broad definition of advertising of medicinal products in Norway, Medical Science Liaisons (MSLs) proactively discussing scientific information on unauthorised medicines or indications with healthcare professionals is considered contrary to the advertising rules.

However, according to Chapter 22 of the LMI Code, unauthorised medicines or indications may be discussed in Advisory Board meetings in which external healthcare professionals participate. In order to set up an Advisory Board, strict conditions apply. In this respect, Advisory Board meetings should not be arenas for (covert) marketing or the pre-launching of new medicinal products or indications and should be set up only if there is a genuine need for external expertise. Hence, in practice, MSLs may not proactively discuss scientific information on unauthorised medicines or indications with healthcare professionals.

There are no requirements concerning prior approvals of advertising from the regulator. According to Section 13-11 of the Medicines Regulation, companies are obliged to inform NoMA of their advertising activities. Furthermore, Chapter 29 of the LMI Code provides that all advertising material should be submitted to LMI. In practice, advertising material is submitted to an LMI database accessible to NoMA.

Section 13-11 of the Medicines Regulation provides that the marketing authorisation holder shall establish a scientific service responsible for information about medicinal products that he or she places on the market and designate a person responsible for the information provided.

The responsible person must submit a copy of written advertising to the authorities, ensure that the company's advertising activities comply with the advertising rules, ensure that the company’s sales representatives have been adequately trained and fulfil the obligations imposed upon them, supply the authorities or bodies responsible for monitoring advertising of medicinal products with the information and assistance they require to carry out their responsibilities, ensure that the decisions taken by the authorities or bodies responsible for monitoring advertising of medicinal products are immediately and fully complied with and ensure that advertising material is stored for at least two years.

Further requirements are imposed on the companies in Chapter 29 of the LMI Code. Companies must implement procedures for the authorisation of materials and activities to comply with both laws and self-regulatory codes.

Furthermore, the responsible person must be a physician, pharmacist (Cand Pharm) or other person with equivalent expertise – if approved by the LMI.

Advertising materials must not be used unless approved by the company’s scientific service. Materials must be re-approved within pre-defined intervals to ensure continued compliance with the rules on advertising.

Member Companies should have an internal control system and should have an overview of all scientific or non-scientific programmes at meetings. Internal control documentation must be kept with the Member Company for at least two years while all approvals should be kept together with final versions of approved material for at least three years.

The general provisions governing advertising of medicinal products apply to advertising on the internet. To ensure compliance with the advertising rules, the general public and healthcare professionals shall be directed to different parts of the website of the company.

In its administrative practice, NoMA has held that all mandatory information must appear in the same field of vision. This practice bans the use of banner advertisements. Further requirements are imposed on the Member Companies by Chapter 5 of the LMI Code. Websites containing information concerning health and disease, mainly directed at the general public, cannot have separate sections for healthcare professionals or hyperlinks to other sites providing information directed at healthcare professionals

It should also be clearly stated when the user leaves a website owned, operated or controlled by one Member Company, or when they are being linked to a website not owned, operated or controlled by the Member Company.

The general provisions governing advertising of medicinal products apply to advertising on social media.

According to Chapter 5 of the LMI Code, Member Companies must monitor comments and other information provided by the users of the company’s social media and make necessary changes. Unless access to a site is technically limited to healthcare professionals, the site may only contain information that may be provided to the public. The Member Company must also clearly indicate who is responsible for the information, including discussions and comments posted on the page, regardless of the author of the individual posts. Member Companies must inform its users of the rules that apply to comments or to sharing of information on the company’s sites and also inform that published messages and comments are monitored.

According to NoMA’s administrative practice, companies are not required to include access restrictions on websites containing advertising or other information intended for healthcare professionals.

However, in order to comply with the advertising rules NoMA requires that the main website only contains information that may be provided to both the public and healthcare professionals. A neutral main website containing company information is recommended.

Websites advertising prescription-only medicines should be clearly separated from websites meant for the general public. NoMA also recommends that access to a healthcare professional should be based on active confirmation from the user that he or she is a healthcare professional.

Companies are allowed to provide disease awareness information to patients online. The information must comply with the conditions disclosed in 2.2 Difference Between Information and Advertising.

Section 387 and 388 of the Criminal Code of 20 May 2005 provides criminal liability for acts falling under the definition of corruption. Corruption is defined in Section 387 as demanding, receiving or accepting an offer, for him or herself or someone else, for an undue advantage in connection with a position, office or assignment, or giving or offering an undue advantage in said connection. Position, office or assignment includes public officials and also employees of private entities. There is no requirement of intent in the wording of Section 387.

There are no formal differences between the public and private sector. However, in general, it is assumed that public officials are subject to a stricter norm than individuals working in the private sector.

The maximum sentence is three years’ imprisonment. Section 388 provides for a maximum of ten years imprisonment for gross corruption. Whether an act amounts to gross corruption shall be based on an assessment of several factors, such as inter alia if a public official is involved, if there is a breach of a specific duty connected to the position and the value of the undue advantage.

Corporate criminal liability can be established if the conditions in Section 27 of the Criminal Code are met, the main requirement being that the act is performed on behalf of the corporation. It is not a requirement that the actual person having committed the act is known or identified.

Section 13-7 of the Medicines Regulation provides that, where medicinal products are being promoted to persons qualified to prescribe or supply them, no gifts, pecuniary advantages or benefits in kind may be supplied, offered or promised to such persons unless they are inexpensive and relevant to the practice of medicine or pharmacy.

In the same respect, the LMI Code Chapter 14 concerning professional gifts, Chapter 15 concerning meetings arranged by a Member Company, Chapter 16 concerning meetings arranged by third parties, Chapter 18 concerning hospitality, Chapter 19 concerning grants and donations, Chapter 20 and 21 concerning professional services agreements, Chapter 24 concerning free medicinal samples and Chapter 27 concerning co-operation with patients and patients organisations – in all these areas benefits or other inducements must not be offered in order to unduly influence a decision to recommend, prescribe, buy, give, sell or administer a medicinal product. These prohibitions on inducements to prescribe apply both to individuals and to organisations.

Section 9 of the Health Personnel Act provides that healthcare professionals are prohibited from accepting any payment or benefit capable of influencing the person’s official services in an improper manner. In addition, Section 387 and 388 of the Criminal Code of 20 May 2005, relating to bribery, will apply to both the giver and the health personnel receiving gifts. 

The above provisions do not ban pharmaceutical companies from offering gifts to healthcare professionals entirely. However, Chapter 13 of the LMI Code provides for stricter rules and bans all gifts to healthcare professionals, including, for example, flowers and pens. Branded pens and notepads of insignificant value can be made available to healthcare professionals in connection with company-initiated meetings. If the company-initiated meeting is held at the healthcare professional's workplace, company branded pens and notepads cannot be made available. However, practical non-branded meeting equipment such as pens and notepads of a insignificant value can be made available to the participant.

The ban on gifts do not hinder the distribution of advertising material such as direct mailing and brochures. The LMI Code also allows the distribution of memory sticks – labelled with the company’s name and logo. This requires that the content complies with the advertising rules and the stick does not have a disproportionate capacity not reflecting a reasonable balance between the information material needs and available alternatives (with less capacity).

Furthermore, in accordance with Chapter 14 of the Code some professional gifts may be offered to healthcare professionals: The distribution of information and education material to healthcare professionals is allowed if the material is of minor value, of direct professional importance to medical treatment or pharmacist practices and of direct benefit for the treatment of patients.

The distribution of items of medical utility to healthcare professionals is allowed if the device is of minor value, distributed for the purpose of promoting education of healthcare professional and patient care, of direct professional importance to medical treatment or pharmacist practices and to direct benefit for treatment of patients. The item should not offset costs that would otherwise be routinely incurred by a healthcare professional. The item may contain company name and logo, while no brand name and hallmark may be added. Brand name and hallmark may however be added to the item of medical utility where these are part of the function or purpose of the device, typically “dummies” (eg, empty inhaler) if the item is labelled “For demonstration” and “Does not contain active substance”.

The distribution of information and educational material or items to healthcare professionals to be passed on to a patient is permitted if the material is of minor value.

LMI’s board has decided that “minor value” currently means NOK400 or less. Value is calculated at market price, that is, the current cost of buying the item (including VAT). The rules do not have any annual cap or further limits for distribution.

Furthermore, the ban on gifts does not hinder pharmaceutical companies from offering hospitality (meals, travel and board) to healthcare professionals at events organised by them, and at work meetings in connection with consultancy services and clinical trials. However, strict conditions apply, see Chapters 15 to 18 of the LMI Code. 

All hospitality must be reasonable and necessary. Limit for lunch at HCPs workplace is NOK244, and the same limit applies to meals at promotional meetings with at least 45 minutes of professional program. Limits for meals at promotional meetings with at least 90 minutes of professional program is NOK930, and NOK1,329 for promotional meetings with at least seven hours of professional program. All rates are inclusive of drinks and VAT, and exclusive of any tips.

If a Member Company is covering travel and/or overnight stays, the professional programme must be of a minimum duration of five hours per day excluding the day of travel, for which the requirement is at least three hours, unless this is not feasible due to the travel schedule.

However, for health care professionals working in public hospitals, pharmaceutical companies are not permitted to finance travel and board expenses. Hence, such expenses should be covered by the individual health authority (hospital), while modest catering in connection with professional meetings may be offered by the pharmaceutical company.

Chapter 16 of the LMI Code provides that pharmaceutical companies are not allowed to sponsor attendance by healthcare professionals to scientific meetings or congresses arranged by third parties abroad. Furthermore, pharmaceutical companies are not allowed to sponsor attendance by healthcare professionals to scientific meetings or congresses arranged by a healthcare association in Norway.

Pharmaceutical companies are allowed to provide healthcare professionals with samples of a medicinal product under conditions provided for in Section 13-8 of the Medicines Regulation.

Samples may only be provided to physicians, dentists, veterinarians and fish health biologists in response to a written and signed request by the above-mentioned healthcare professional. Samples of prescription-only medicinal products may only be distributed to individuals who may prescribe the product in question. The medicinal product must have marketing authorisation.

In the course of one year, only one sample of the specific medicinal product may be distributed to each healthcare professional. If the medicinal product has approval for different forms or strengths, one sample of each form and strength may be provided. Each sample shall be no larger than the smallest presentation on the market.       

Each sample shall be labelled “free medical sample – not for sale”, and a complete SmPC must follow the sample. Samples of medicinal products in prescription class A or medicinal products containing substances classified in accordance with international conventions as psychotropic substances or narcotics cannot be distributed. The pharmaceutical company must keep a record of all samples provided for two years.

Chapter 24 of the LMI Code provides for additional limitations. The provision of free samples cannot have as its sole purpose to be used in patient care. Furthermore, it is not permitted to provide samples for more than two years after a medicinal product was introduced on the Norwegian market. If a new strength or pharmaceutical form is introduced in connection with a new indication for a medicinal product, samples may be provided in the following two-year period for those packages.

Pharmaceutical companies are allowed to sponsor scientific meetings or congresses. In that respect, Chapter 16 of the LMI Code provides for specific conditions, which have to be fulfilled.

The meeting must be arranged by a health organisation or another legal entity. The professional content of the event must be governed by an independent scientific committee or equivalent, and the Member Company cannot influence the professional content of the event. The Member Company shall not provide practical or administrative assistance for the performance of the event. More than one Member Company shall be invited to participate in the financing of the event.

The main purpose of the event should be the professional update of the participants. The event cannot, however, be part of physicians approved and counting continuing education. The event should take place in a restricted area so that only healthcare professionals are exposed to the company’s advertising/stands. The event must comply with the hospitality requirements and requirements for professional programme, venue, meals, coverage of expenses as provided for in Chapters 15 and 18 of the LMI Code. Agreements on the purchase of advertisements or events at third-party events shall be made in writing.       

If the event is arranged by a healthcare professionals association – which is a non-profit association of healthcare professionals who have a common interest, matter or discipline they want to promote – pharmaceutical companies can only sponsor if the event has obtained a “concept approval” from the LMI in accordance with the rules provided for in Chapter 16 of the LMI Code. The requirement for concept approval does not apply to international congresses and international meetings in Norway approved by EFPIA.

According to Chapters 16 and 18 of the LMI Code, pharmaceutical companies are not allowed to organise or sponsor cultural, sports or other non-scientific events in relation to scientific conferences.

According to Chapter 19 of the LMI Code, pharmaceutical companies can only provide grants or donations to or healthcare organisations defined as any legal entity which provides health assistance or patient treatment, such as a health enterprise, doctor’s practice, etc, which is a research or teaching institution within medical, biological or other health-related disciplines such as a university or another institution of learning, through which health professionals provide health services, or which is an association of health professionals that is a non-commercial organisation of Healthcare Professionals having a common interest, subject or discipline they wish to promote.

Hence, providing grants or donations to individuals is not permitted. This does not preclude a Member Company from allowing healthcare professionals to attend professional meetings arranged by that company in compliance with Chapter 15 of the LMI Code.

Grants and donations may only be provided if the purpose is to contribute to medical research or better patient care and must have a clearly defined purpose. Grants and donations must not be provided to support general business operations of a healthcare organisation and can only be granted upon application from the healthcare organisation describing the purpose, how the grant or donation is intended to be used and a budget.

The support must be defined in a written agreement between the Member Company and the healthcare organisation before it is granted/paid and this must clearly define the purpose of the grant or donation. Both the application and the agreement must be signed by the general manager/CEO or other person authorised to represent the healthcare organisation.

The same rules apply to both monetary donations and donations of equipment or services.

As a starting point, there is no express ban hindering pharmaceutical companies giving rebates or discounts to healthcare professionals or healthcare institutions.

However, in general, pharmaceutical companies cannot sell medicinal products directly to healthcare professionals or healthcare institutions. Furthermore, Section 6 of the Medicines Act prohibits giving rebates that are not determined at the time of sale of a medicinal product. Hence, volume-based rebates, where the size of the discount depends on future sales, are considered not to be compliant with Section 6.

It is possible to pay for services provided by healthcare professionals. Chapter 21 of the LMI Code provides that it is permitted to use healthcare professionals as consultants for services such as speaking at and chairing meetings, involvement in clinical and other scientific studies, training of own personnel, participation at advisory board meetings and participation in market research where such participation involves remuneration. However, the arrangement that covers the genuine consultancy must, to the extent relevant to the particular arrangement, fulfil all of the following criteria:

  • a legitimate need for the services has been clearly identified in advance of requesting the services and entering into arrangements with the prospective consultants;
  • the criteria for selecting consultants are directly related to the identified need and the persons responsible for selecting the consultants have the expertise necessary to evaluate whether the particular healthcare professionals meet those criteria;
  • the number of healthcare professionals retained is not greater than the number reasonably necessary to achieve the identified need;
  • a written contract or agreement is agreed in advance of the commencement of the services that specifies the nature of the services to be provided and the basis for payment of those services;
  • the contracting company maintains records concerning the services provided by consultants;
  • results from provided services shall only be used in accordance with the agreed contract/agreement;
  • the hiring of the healthcare professional to provide the relevant service is not an inducement to recommend, prescribe, purchase, supply, sell or administer a particular medicinal product; and
  • the compensation for the services is reasonable and reflects the fair market value of the services provided.

According to the LMI Code, healthcare professionals employed in a business shall make his or her employer aware of any consultancy assignment, the nature of the assignment and the agreed fee. However, healthcare professional’s services in an Advisory Boards and the like must be approved by the employer. Responsibility for clearance lies with the employee.

There is no legal requirement in Norwegian law to disclose details of transfers of value to healthcare professionals or healthcare institutions.

However, Chapter 26 of the LMI Code provides that all pharmaceutical companies must annually disclose details of transfers of value to healthcare professionals or healthcare institutions in accordance with the EFPIA’s Disclosure Code.

The transparency requirements apply to all Member Companies, and thus also to foreign companies, see 1.2 Application and Legal Value of Regulatory Codes.

The obligation to disclose details of transfers of value relates to actions such as grants, donations, registration fees, fees for service and consultancy, etc. Hence, the transparency requirements apply to Member Companies that do not yet have products on the market.

NoMA is responsible for enforcing the rules on advertising and inducement of the Medicines Act and the Medicines Regulation.

The self-regulatory Board of the Norwegian Medical Association (NMA) and the Association of the Pharmaceutical Industry in Norway relating to information on medicinal products enforces the rules on advertising and inducement for members of the LMI, Member Companies of the EFPIA, which are obliged to follow Norwegian regulations, and other companies who have agreed to follow the LMI Code. The LMI Code is binding upon the above subjects.

Decisions of NoMA may be appealed to the Ministry of Health and Care Services. Decisions may also be the subject of a civil action before the regular courts.

Companies can file a complaint to NoMA for a competitor's infringements of the advertising rules.

Companies can also initiate proceedings against competitors before LMI’s self-regulatory board concerning infringements of the LMI Code. The self-regulatory board can impose fines of up to NOK300,000.

If a company has a legal interest, it may also refer the matter to the regular courts. This might be the case if a competitor’s infringements of the advertising rules have an impact on their product.

If a company violates medicines advertising rules, NoMA can stop the further publication of an advertisement. It may also impose a general advertising ban stopping all advertising for a certain medicinal product for a certain period, or introduce a permanent ban. To our knowledge, a nine-month general advertising ban is the longest ban handed down by NoMA. NoMA may also request the company to provide a corrective statement to all who received the illegal advertising.

In 2018, Parliament adopted a bill providing the competent authorities with competence to hand down infringement penalties. However, further regulations will have to be adopted by the Ministry of Health and Care Services prior to implementation of this system. A public hearing on those regulations may be expected within 2020.

NoMA can launch infringement procedures regardless of any previous assessment of the Board of the NMA and the Association of the Pharmaceutical Industry in Norway relating to information on medicinal products; decisions taken by the Board do not prevent the courts from addressing the same issues.

In 2015 and 2016, NoMA actively enforced the rules regarding pharmaceutical advertising in Norway. In this period, a significant number of administrative decisions were handed down concerning infringements of the advertising rules. Some of these decisions included imposing general advertising bans on a medicinal product prohibiting any advertising of the product for a period of up to nine months. Decisions taken by NoMA are published on NoMA’s home page.

In May 2016, NoMA imposed a general nine months’ full advertising ban against any advertisements for a particular medicinal product. The company, represented by Felix Reimers, appealed the decision to the Ministry of Health and Care Services and in parallel submitted to the Oslo Court of Execution and Enforcement a request for a preliminary injunction (PI).

In August 2016, the Court granted the injunction, as it found that it was likely that the decision would be declared invalid. In that regard, the Court held that the threshold to impose a general advertising ban was quite high – and that it was a condition that the company had been given an opportunity to adjust its practice to make it compliant with the position of NoMA.

In a decision of December 2016, the Ministry held NoMA’s decisions invalid, for the reasons on which the Court had relied in the PI decision. In addition, the Ministry noted that NoMA had failed to provide guidance to the company and to give a reasonable opportunity to influence the decision before it was made. As the company’s express willingness to comply with NoMA’s position had not taken into consideration, it was held that the matter had not been sufficiently clarified. A further consequence was that the decision was not proportionate, since less burdensome measures would have achieved the same purpose, namely the protection of public health. After the Ministry lifted the above-mentioned advertising ban, only two administrative decisions have been published. The first concerning a private hospital’s marketing of a medicinal product not holding a marketing authorisation in Norway; the second concerning advertising of OTC emergency contraception not considered to be objective. This indicates that there has not been any significant enforcement action in the past three years.

Advokatfirmaet GjessingReimers AS

Grev Wedels plass 7
P.O. Box 678 Sentrum
0151 Oslo
Norway

+47 222 75 222

post@gjessingreimers.no www.gjessingreimers.no
Author Business Card

Law and Practice

Authors



Advokatfirmaet GjessingReimers AS is a boutique IP and tech law firm with 11 employees (six partners) and considerable experience within all areas of IP, technology law and life science. The life sciences team includes four partners who advise clients on contentious and non-contentious matters. The team provides legal services to Norwegian and foreign pharmaceutical companies, biotech companies, medical device companies and food enterprises, as well as patient organisations and government institutions. The firm's specialist expertise includes competition and market access, patent litigation, intellectual property, public procurement, marketing law, and medicinal products. GjessingReimers has in-depth knowledge of regulatory law and practice and of the co-operation between the competent authorities within the EEA, as well as the European Commission and the European Medicines Agency. The firm's knowledge also covers national and EU-regulatory requirements on pricing and reimbursement of medicinal products, on advertising and on the regulatory requirements applicable to wholesalers and pharmacies.

Compare law and practice by selecting locations and topic(s)

{{searchBoxHeader}}

Select Topic(s)

loading ...
{{topic.title}}

Please select at least one chapter and one topic to use the compare functionality.