Pharmaceutical Advertising 2020

Last Updated March 02, 2020

Iceland

Law and Practice

Authors



LEX Law Offices is one of Iceland´s leading law firms, providing clients with comprehensive services over a wide range of transactional, corporate and commercial issues, as well as most other aspects of Icelandic law. The firm, founded in 1959, is one of the largest law firms in Iceland with close to 50 lawyers in its practice. The firm provides legal services to the life sciences industry, successfully combining in-depth knowledge of transactional, corporate, commercial, regulatory, competition and intellectual property matters. The firm´s dedicated team advises on all aspects and stages of the life cycle of products, from research and development through to manufacturing and marketing. LEX is recognised for its expertise in compliance matters and offers its clients valuable advice on all regulatory matters, including clinical trials, marketing authorisation procedures, pricing and promotions. The firm provides its clients with tailored advice on developing and implementing comprehensive compliance programs. Among LEX´s clients are both large domestic and international pharmaceutical companies as well as start-ups and other entrepreneurial companies.

The advertising of medicinal products in Iceland is governed by a combination of legislation and self-regulatory codes of practice. The principle legislation is the Medicinal Products Act No 93/1994 (the Medicinal Products Act). The relevant secondary legislation includes Regulation No 980/2016 on Pharmaceutical Advertisements (the Pharmaceutical Advertisements Regulation), Regulation No 560/2018 on Postal and Online Sale of Pharmaceuticals (the Postal and Online Sale of Pharmaceuticals Regulation), and Regulation No 545/2018 on Marketing Authorisations for Proprietary Medicinal Products, their Labelling and Package Leaflets (the Marketing Authorisations Regulation).

In addition, general laws concerning advertising and commercial practices apply to the advertisement of medicinal products, including Act No 57/2005 on the Surveillance of Commercial Practices and Marketing (the Act on the Surveillance of Commercial Practices and Marketing). Further, the Icelandic Medicines Agency (the IMA) has published guidelines on pharmaceutical advertisement, dated 25 April 2018 (the Guidelines).

Lastly, Frumtök, the Icelandic association of the pharmaceutical industry, has published a self-regulatory code on communications between healthcare professionals, healthcare organisations, and patient organisations (the Ethics Code). The Ethics Code is an Icelandic version of a code adopted by EFPIA, the European Federation of Pharmaceutical Industries and Association on 27 June 2019. In cases of discrepancy between the Icelandic version and the English version, the English version (published by EFPIA) applies in Iceland. In December 2017, Frumtök adopted an addendum to the Ethics Code which applies to communication with healthcare professionals and the advertisement of prescription medicinal products.

The Ethics Code applies on a wide basis in Iceland. The Icelandic Medical Association, the Icelandic Federation of Trade, and the Icelandic Federation of Trade and Services, have voluntarily agreed to be bound by the Ethics Code, in addition to Frumtök’s member companies.

However, as Icelandic legislation does not refer to this self-regulatory code, the Ethics Code does not apply to companies or individuals that are not members to any of these four associations, or have not by other means voluntarily agreed to be bound by the code. To conclude, the Ethics Code has no legal implications but is binding for the above-mentioned parties, which have agreed to be bound by it.

Icelandic legislation, ie, the Pharmaceutical Advertisements Regulation, has a broad definition of what constitutes a pharmaceutical advertisement. According to the Regulation, the term includes any advertising or promotional activity, whether written or oral, sponsored, directly or indirectly, by the holder of a marketing authorisation aiming to promote the prescription, supply, sale, or consumption of medicinal products, in the form of images, supply of medical samples, or promotional events and meetings.

The general principle in Iceland is that all pharmaceutical advertisements are prohibited, pursuant to Article 13 of the Medicinal Products Act. As previously mentioned, Icelandic legislation provides for a broad definition of the term pharmaceutical advertisement. However, it should be noted that the following does not fall under the scope of the definition of advertisements:

  • writings on the inner and outer packaging of the medicinal product and on the package leaflet;
  • information which is necessary to answer inquiries on specific medicinal products and does not include advertising or promotional activity;
  • notifications or correspondence regarding packaging changes, warnings on side effects, product- and pricelists, provided that no benefits of the medicinal product are asserted;
  • information on health or diseases, provided that no medicinal product is referenced, neither directly nor indirectly;
  • notifications on medicinal products from the public authorities, eg, notifications published on the IMA’s website;
  • patient leaflets, given to a patient by his doctor or by a pharmacy, which include general information on diseases and the use of medicinal products, provided that the leaflets are not intended for public distribution or made with the purpose of increasing the prescription, delivery, sale, or use of medicinal products; and
  • pharmacies' advertisements concerning their services, prices of over-the-counter pharmaceuticals, and general discounts.

From the exceptions mentioned above, information, such as disease awareness campaigns, is not considered pharmaceutical advertisements, provided that there is no direct or indirect reference of a certain medicinal product.

Likewise, information, such as patient’s leaflets, which include general information on diseases and the use of medicinal products, given to patients by a doctor or a pharmacy, are not considered as advertisements, provided that the leaflets are not intended for public distribution or made with the purpose of increasing the prescription, delivery, sale, or use of medicinal products. All information in such leaflets, however, needs to be in accordance with an authorised summary of the product's characteristics (SPC) and the IMA shall receive a copy of the leaflet.

Discussing a specific medicinal product in a patient support program is generally considered an advertisement if the discussion is sponsored directly or indirectly by the holder of the marketing authorisation and if it is aimed to promote the prescription, supply, sale, or consumption of the medicinal product in question.

In Icelandic legislation in general, when evaluating whether the providing of information is considered advertising, no distinction is made between advertisements and information directed at different target groups. However, Icelandic legislation includes extensive derogations from the general prohibition of pharmaceutical advertisements. These derogations distinguish between advertisements directed at healthcare professionals and advertisements directed at the general public. Icelandic legislation defines healthcare professionals as doctors, dentists, nurses, pharmacists, pharmacy technicians and students of these fields. The general public is defined as all individuals who are neither healthcare professionals nor veterinarians.

According to Article 15 of the Medicinal Products Act, prescription medicinal products may be promoted among the health professions prescribing or distributing medicinal products, by such means as will make it unlikely that such advertisements will reach the general public. Furthermore, comparative advertising is strictly prohibited in advertisements directed to the general public but permitted under certain circumstances in advertisements directed at healthcare professionals, see 2.4 Comparative Advertising. Moreover, when an advertisement is directed to a healthcare professional, Icelandic legislation puts forward a more detailed demand regarding which information must be included then what applies in advertisements directed to the general public, see 4.2 Information Contained in Advertising to the General Public. and 5.1 Restrictions on Information Contained in Advertising Directed at Healthcare Professionals. Lastly, Icelandic legislation prohibits multiple statements in advertisements directed to the general public, as discussed in 4.2 Information Contained in Advertising to the General Public.

Icelandic legislation does not provide for any special provisions on press releases regarding medicinal products. Therefore, such press releases must be examined with regards to the general provisions on advertisements to the general public and to healthcare professionals.

Comparative advertising is prohibited in pharmaceutical advertisements directed to the general public. However, comparative advertising is permitted, under certain conditions, in pharmaceutical advertisements, directed at healthcare professionals, pursuant to Article 12 of the Pharmaceutical Advertisement Regulation.

The conditions for such comparative advertisements are as follows:

  • first, that the advertisement provides clear information on which medicinal products are being compared. Unclear or indirect comparison is, therefore, prohibited;
  • second, the compared medicinal products must have the same field of application in order that they can be objectively compared; and
  • third, the information provided shall only be based on the authorised SPCs of the compared medicinal product.

Pursuant to Article 3 of the Pharmaceutical Advertisements Regulation, it is prohibited to advertise medicinal products that do not have a marketing authorisation in Iceland. Taking into consideration the broad scope of Icelandic legislation’s definition of pharmaceutical advertisements, it will generally be prohibited to provide information on unauthorised medicinal products.

Additionally, pursuant to Article 4(1) of the Pharmaceutical Advertisements Regulation, all pharmaceutical advertisements shall be in accordance with the applicable SPC. Pursuant to Article 59(2) of the Marketing Authorisations Regulation, the SPC of a medicinal product is issued together with the marketing authorisation. Therefore, information, considered to be advertisements, on unauthorised medicinal product do fulfil this requirement, and for this reason such providing of information is prohibited.

Lastly, the Ethics Code establishes that only authorised medicinal products can be promoted and that the promotion must be in accordance with the SPC.

Scientific conferences fall under the scope of pharmaceutical advertisements if they are directly or indirectly sponsored by the marketing authorisation holder. Conferences are directly mentioned in the definition of pharmaceutical advertisements. The information provided during a scientific conference will therefore generally be considered an advertisement, provided that other conditions are met, as discussed in 2.2 Difference Between Information and Advertising. Since advertising of unauthorised medicinal products is prohibited, it is not allowed to provide information on unauthorised medicinal products during a scientific conference directed at healthcare professionals.

However, the Ethics Code states that, under certain conditions, it is permitted to provide information on medicinal products, which are authorised in other countries, at international scientific conferences held in Iceland. The conditions for providing such information are, that the provided information clearly states that the medicinal product has not been authorised in Iceland, in which countries the pharmaceutical has been authorised, and that an explanatory statement indicating that registration conditions differ internationally is attached to any references to the prescribing information authorised in a country or countries where the medicinal product is authorised.

Proactively providing information on a certain medicinal product generally falls under the broad definition of pharmaceutical advertisement. As mentioned in 3.1 Restrictions on Provision of Information on Unauthorised Medicines or Indications, advertisements of unauthorised medicinal products are prohibited, even if they are directed towards healthcare professionals. For this reason, providing information proactively on unauthorised medicinal products is always prohibited.

However, when information on unauthorised medicinal product is sent reactively it must be assessed on a case-by-case basis. Article 2(2)(b) of the Pharmaceutical Advertisements Regulation, states that information necessary to reply to inquiries on specific medicinal products, and does not include advertising or promotional activity, is not considered pharmaceutical advertising. For this reason, information which only includes a reply to such a question will therefore not be considered an advertisement. 

The sending of information concerning unauthorised medicinal products to healthcare institutions, is, generally, considered a pharmaceutical advertisement and falls under the prohibition of advertisements of unauthorised medicinal products.

On the other hand, notifications and correspondence related to amendments of package, warning on side-effects and on price and product lists is not considered an advertisement provided that no statements are made on the benefits of the medicinal product. As discussed in 3.3 Provision of Information to Healthcare Professionals, the same applies to information which is necessary to reply to inquiries on specific medicinal products and which does not include advertising or promotional activity. Therefore, if no excess information is provided and the information is sent as a response to an inquiry, or if the provided information only concerns the above-mentioned issues, it will not be considered an advertisement and is allowed. 

The Marketing Authorisations Regulation provides that the IMA can allow exemptions from the requirement of a marketing authorisation for compassionate use reasons. However, no provisions are to be found in the legislation on advertisements of such programs. As medicinal products that do not have marketing authorisations cannot be advertised under Icelandic legislation, the availability of such programmes cannot be published.

Advertisements of prescription medicinal products to the general public are prohibited. The IMA can however permit advertisements in connection with a vaccination campaign approved by the Minister for Health. Advertising of non-prescription medicinal products to the general public is however permitted subject to the requirements set forth in the Medicinal Products Act, the Pharmaceutical Advertisements Regulation and the general Act on the Surveillance of Commercial Practices and Marketing.

Advertisements of medicinal products directed at the general public are subject to both general and specific requirements. The general requirements apply to all advertisements of medicinal products, ie, both advertisements that are directed at the general public and advertisements that are intended for healthcare professionals.

The general requirements that all advertisements of medicinal products must fulfil are laid down in Article 4 of the Pharmaceutical Advertisements Regulation. Firstly, the advertisements must provide correct and professional information on the product in question and all information provided in the advertisement must be in accordance with the SPC. Secondly, the advertisement must display the product in an impartial matter and without exaggerating its qualities, ie, advertisements of medicinal products may not include subjective adjectives, such as excellent, wonderful or fantastic, and must in no way be misleading. Finally, pharmaceutical advertisements must be put forward in a way so the target group of the advertisement in question can easily read, hear, or in other ways receive the information it conveys.

An advertisement of a medicinal product directed at the general public must be straightforward and set forth in an unequivocal manner. Indirect advertisements, such as advertisements in the form of an editorial review or an interview, are prohibited, unless they include an explicit reference informing that the coverage is sponsored by the holder of the marketing authorisation. Furthermore, comparative advertisements are prohibited for medicinal products. Finally, there are detailed requirements on the content of advertisements of medicinal products directed to the general public, as described below in 4.2 Information Contained in Advertising to the General Public.

As previously mentioned, advertisements directed towards the general public must meet certain requirements regarding their content, in addition to the other general and specific requirements mentioned in 4.1 Main Restrictions on Advertising to the General Public.

The price of a medicinal product may be mentioned in an advertisement, but there is no requirement to that end. However, advertisements of medicinal products directed at the general public, must include the following minimum information:

  • the name of the medicinal product and, if it only contains one active substance, the international non-proprietary name (INN) must also be included;
  • the medicinal product’s dosage form;
  • the medicinal product’s indication; and
  • all necessary information for the correct usage of the product.

In addition, a notification has to appear, which encourages the consumer to read all information on the packaging and in the leaflet carefully before using the product in question and to ask a doctor or a pharmacist in case further information on risk or side-effects is needed. The notification must include a reference to additional information on the medicinal product featured on the website www.serlyfjaskra.is. The information above shall be provided through the same medium as the advertisement.

However, if an advertisement is only meant to bring attention to the name of a medicinal product, the Pharmaceutical Advertisements Regulation provides an exception for advertisements that only display the name of the product in question.

Under the Pharmaceutical Advertisements Regulation, an advertisement of a medicinal product directed at the general public must not contain any material that:

  • states that it is unnecessary to seek the advice of a doctor or a veterinarian;
  • suggests that it is unnecessary to have surgery;
  • implies that the effects of the medicinal product are guaranteed, that there are no side-effects or that the results of the product are better or as good as from another product;
  • notwithstanding vaccination campaigns, implies that the health of a consumer may improve by using the medicinal product in question;
  • suggests that the health of a consumer may deteriorate by not using the product;
  • is exclusively or principally directed at children;
  • is endorsed by scientists, healthcare professionals or celebrities;
  • suggests that the product is foodstuff, a cosmetic or another consumer product;
  • implies that the safety or efficacy of the medicinal product is due to the fact that it is natural;
  • could by its description or reference to specific case story lead to erroneous self-diagnosis;
  • refers in an indecent, alarming or misleading manner to statements of recovery; and
  • displays in an indecent, alarming or misleading manner pictorial representation of alterations to the human or animal body, or parts thereof, as a result of disease or injury or as a result of using the product.

Icelandic legislation does not include provisions which regulate the interactions between pharmaceutical companies and patient organisations. The rules described above would however apply. Interactions could in many cases be considered an advertisement, and if so the general and specific restrictions, on advertisements, directed to the general public apply. See 2.2 Difference Between Information and Advertising regarding the difference between information and advertising.

However, the Ethics Code contains special provisions, concerning interactions between pharmaceutical companies and patient organisations. The Ethics Code states that the independence of patient organisations must be assured, the interactions between patient organisations and pharmaceutical companies must be based on mutual respect, and the views and decisions of each party should have equal value. Furthermore, patient organisations must neither agree to promote prescription medicinal products, nor may a pharmaceutical company request such service from a patient organisation. The aim and scope of any collaboration should be transparent, and all support, be it financial or non-financial, must be disclosed, and the amount, purpose and description of the support laid out in a contract.

Moreover, pharmaceutical companies may not try to affect the content of a patient organisation’s material, to serve their own commercial interests. However, pharmaceutical companies may correct inaccuracies, and even contribute material written from a fair and balanced scientific perspective, at the request of the patient organisation.

Analogous to advertisements directed at the general public, advertisements directed at healthcare professionals are subject to the general requirements mentioned in 4.1 Main Restrictions on Advertising to the General Public and the specific requirements set forth in Article 10 of the Pharmaceutical Advertisements Regulation.

Prescription medicinal products may only be advertised to healthcare professionals. All information in advertisements of medicinal products directed at healthcare professionals must be consistent with the SPC. An advertisement must moreover include the following minimum information:

  • the name of the medicinal product, its potency and dosage form;
  • the name of all active substances displayed in a prominent manner;
  • the name of the marketing authorisation holder;
  • agreed indications and contra-indications regarding the use of the medicinal product;
  • information on what animal species the medicinal product is intended for and if applicable, the relevant deadline for product utilisation;
  • a clear and highly readable reference to further information on side effects, warning and other important matters being available at www.serlyfjaskra.is, the IMA’s website, or a specific notification referencing www.serlyfjaskra.is;
  • the date of the latest SPC;
  • if the marketing authorisation was granted with a reservation regarding the prescribing healthcare professional needing to be familiar with certain educational material or make the educational material known to the patient, a clear indication to that end is required;
  • prescription authorisations and dispensing groups;
  • permissible maximum retail price;
  • the reimbursement for patients; and
  • clear instructions on how to contact the holder of the marketing authorisation or their representative, who provides information on the medicinal product.

Furthermore, all information provided in advertisements directed at healthcare professionals shall be highly readable, precise and as up to date as possible. Moreover, the reader must be able to verify the information and the information provided must be detailed enough for the healthcare professional in question to be able to form his or her own opinion on the therapeutic value of the product. If quotations, tables, or other illustrative material, taken from a medical journal or other scientific work is included, it must be accurately reproduced, and the precise source of the information must be referenced. Lastly, there are certain restrictions on comparative advertisements as covered in 2.4 Comparative Advertising.

In general, all information provided in an advertisement of a medicinal product must be in accordance with SPC. There is no special provision derogating from this principle. However, as stipulated in 5.1 Restrictions on Information Contained in Advertising Directed at Healthcare Professionals, there are provisions which assume that advertisements can include references to additional material in advertisements. Accordingly, it can be assumed that referencing data which is not included in the SPC, is permitted, provided the information is in accordance with the information provided in the SPC.

Icelandic legislation does not include provisions concerning references to combination products in advertisements of medicinal products. However, as mentioned in 5.2 Reference to Data Not Included in the Summary of Product Characteristics, all information in such advertisements must be consistent with the information provided in the SPC.

Icelandic legislation does not restrain the exchange of medical and scientific information. Providing reprints of journal articles would rarely be considered advertising and, therefore, is allowed provided no medicinal product is explicitly referenced, either directly or indirectly, as discussed in 2.2 Difference Between Information and Advertising.

Furthermore, in cases where the reprint was sent at the healthcare professional’s request it could also fall under the derogation from the definition of an advertisement excluding information necessary to answer inquiries on specific medicinal products and does not include advertising or promotional activity. However, the sender must be careful not to attach any promotional material to the article.

Additionally, reprints of journal articles are often of financial value, and are therefore considered a gift. In such cases the distribution also must comply with the rules on gifts, as discussed in 9 Gifts, Hospitality, Congresses and Related Payments.

Icelandic legislation is scarce, regarding Medical Science Liaisons (MSLs). However, Article 14(1) of the Pharmaceutical Advertisements Regulation, states that representatives of the marketing authorisation holder, which promote pharmaceuticals in person, shall receive appropriate training from their employer, and have sufficient professional knowledge to be able to provide as detailed information as possible, on the medicinal product they are promoting.

Furthermore, the Ethics Code states that all pharmaceutical companies shall ensure that all their employees who communicate with healthcare professionals, pharmacies, hospitals and other healthcare institutions to promote medicinal products, have sufficient knowledge of the relevant laws and secondary legislation.

Moreover, the pharmaceutical companies shall ensure that their employees:

  • follow the applicable laws, regulations, and codes of conduct;
  • show responsibility and morality in their work;
  • make the SPCs accessible to everyone they visit;
  • alert the pharmacovigilance representative of all information they receive on the use and safety of a medicinal product;
  • ensure that the frequency, timing, or length of their promotional meetings with healthcare professionals does not cause discomfort; and
  • do not use incentives or misleading ways to schedule meetings or presentations, and always explicitly state their identity and that of their employer.

Considering that representatives of pharmaceutical companies must follow applicable laws, regulations, and codes of conduct, they are not permitted to give information on unauthorised medicinal products, unless provision of the information is not considered advertising.

Advertisements of medicinal products are not subject to prior notification or authorisation from the IMA. However, for the IMA to be able to perform their regulatory obligations, marketing authorisation holders must keep a file of all advertisement and other promotional material, published in the last two years and provide the IMA access to it upon request.

The file must contain information on the target group for each advertisement, how it was published and distributed, an overview of the media where it was published and the time period of display. 

Furthermore, pursuant to Article 16(4) of the Medicinal Products Act, if holders of marketing authorisations, or their agents, convey general information on diseases and the use of specific medicinal products to patients by means of brochures, the IMA shall receive copies of such brochures.

Notwithstanding the documentation requirements mentioned in 6.1 Requirements for Prior Notification/Authorisation, there are no specific arrangements pharmaceutical companies must make in order to ensure compliance with the rules on medicinal advertising.

The general rules on advertising of medicinal products apply to the advertisements displayed on the internet and/or social media. There are no special provisions in the Medicinal Products Act or secondary legislation regarding online advertisements. Furthermore, the Postal and Online Sale of Pharmaceuticals Regulation refers to the Medicinal Products Act and states that the same rules apply to online and postal pharmacies.

There are no special provisions regarding advertisements of medicinal products on social media. Therefore, the same rules as apply to the use of social media in this regard as to other platforms. As advertisements published on social media are as a rule directed to the general public, only non-prescription medicinal products can be advertised on social media. The conditions discussed in 4 Advertising to the General Public must accordingly be met.

Even though there are no provisions in Icelandic legislation requiring access restrictions on websites containing advertisements of medicinal products directed at healthcare professionals, an advertisement on an open website would generally be considered to be directed at the general public but not healthcare professionals and therefore have to comply with the relevant restrictions discussed in 4 Advertising to the General Public. Accordingly, the responsibility rests with the company in question to ensure that advertisements intended for healthcare professionals do not find their way to the general public.

As previously stated, no special provisions apply for advertisements of medicinal products or information published or distributed online. Pursuant to Article 16(4) of the Medicinal Products Act, marketing authorisation holders are permitted to distribute general leaflets on diseases and the use of certain pharmaceuticals, provided that all information in the leaflet is in accordance with the SPC, and the IMA receives a copy of the leaflet. Disease awareness information leaflets published and distributed online are, therefore, exempt from the pharmaceutical advertisement ban, analogous to traditional printed leaflets, provided other conditions are met.

Pursuant to Article 264a of the Icelandic Penal Code, bribery in the private sector is punishable by fines or up to six years imprisonment. The provision applies to executives or other employees who accept gifts or other gains they are not entitled to, for their own advantage or others, and in return act or fail to act, in accordance with their professional duties. It is also punishable to offer such gifts or advantages, by fines or up to five years imprisonment. Pursuant to chapter II. A of the Icelandic Penal Code, legal entities can also be held criminally liable for violations of Article 264a.

Furthermore, since the provision states that the gift or advantage may be for the recipient’s gain or others, bribing an employee with a gift or advantage, which would benefit the company he or she works for or controls, would also be punishable under the provision.

Regarding the public sector, the provision explicitly states that it applies to both privately held companies and companies within the public sector. Furthermore, since the Icelandic healthcare sector is in part publicly run, possible recipients include public officials. In such cases, Article 109 of the Icelandic Penal Code applies. Violation of Article 109 has the same penalty as violations of Article 264a. The main difference is that Article 109 also prohibits indirect bribing, eg, giving anyone who states they have influence over public officials, gifts, or other advantages, with the aim of making the recipient use his or her influence. 

Finally, the promise or provision of benefits with the aim to increase the sale of a certain medicinal product may constitute as unfair commercial practices, as defined in the Act on the Surveillance of Commercial Practices and Marketing. Such activities can therefore also be subject to administrative fines under the said Act.

As discussed in detail in 9 Gifts, Hospitality, Congresses and Related Payments, gifts to healthcare professionals and organisations are subject to various limitations, both according to Icelandic legislation and the Ethics Code.

Even though the ban on gifts in the Medicinal Products Act and secondary legislation only applies to healthcare professionals, the Ethics Code also applies to healthcare officials, healthcare organisations and patient organisations.

As a rule, the Pharmaceutical Advertisements Regulation, prohibits the offering of gifts, money, or other benefits to healthcare professionals, unless the gift is of “insignificant value” and is connected to the healthcare professional’s practice. The term “insignificant value” is not further clarified in the Regulation. Further, hospitality in connection with events must always be confined with the purpose of the event and can only be provided to doctors, dentists, veterinarians, nurses, pharmacists, pharmacy technicians and students in these professions. Finally, healthcare professionals may not request any prohibited gifts or benefits.

According to the Ethics Code, the rules on gifts are even stricter. According to Article 11 of the Ethics Code, all personal gifts to healthcare professionals, healthcare organisations and patient organisation representative, either directly or indirectly, are prohibited. The providing or offering cash, cash equivalents or personal services is also prohibited according to the code.

According to the Icelandic appendix to the EFPIA code on the promotion of prescription-only medicines to, and interactions with, healthcare professionals, the transmission of informational or educational material to healthcare professionals is permitted provided it is “inexpensive”, directly relevant to the practice of medicine or pharmacy, and directly beneficial to the care of patients. Further, items of medical utility aimed directly at the education of healthcare professionals and patient care can be provided if they are “inexpensive” and do not offset routine business practices of the recipient. According to the appendix, “inexpensive” means that the total value of the material or equipment must not exceed ISK3,000 per item. 

Pursuant to Article 17 of the Medicinal Products Act and Article 16 of the Pharmaceutical Advertisements Regulation, it is permitted to provide a healthcare professional with free samples of medicinal products, but the following requirements must be fulfilled:

  • the sample is of a newly authorised medicinal product being promoted;
  • the samples do not contain narcotic drugs or psychotropic substances;
  • samples can only be provided to doctors, dentists and veterinarians, and only to the extent that they are authorised to prescribe the product;
  • the sample can only be provided once a written, dated and signed request from the doctor, dentist or veterinarian at hand;
  • only one sample per year can be provided;
  • the sample may not be larger than the smallest package marketed;
  • the sample shall be labelled “free medicinal product sample – not for sale or use”;
  • enclosed with the sample shall be the SPC; and
  • no samples of unauthorised medicinal products may be provided.

The Ethics Code does not contain any further rules regarding the providing of samples to healthcare professionals, but simply refers to the above provision of the Pharmaceutical Advertisements Regulation.

Icelandic legislation does not provide for any specific restrictions on sponsorship of scientific meetings or congresses, other than the rules on gifts described above.

The Ethics Code includes numerous conditions relating to the sponsorships of scientific meetings or congresses. First, it must be clearly noted in the event invite if a pharmaceutical company is sponsoring the event. Second, the place of the scientific meeting or congress may not be known for extravagance or entertainment facilities, such as Michelin restaurants, golf or ski resorts, or spas. Third, a written contract must be made concerning every healthcare professional’s trip to an event abroad sponsored by a pharmaceutical company. In addition, travel days should take aim of the dates of the conference, and if the healthcare professional needs to travel on different days for a specific reason, the healthcare professional should take care of all expenses which stem from such change, including amendment fees and travel insurance. Moreover, it is neither preferable nor appropriate for a healthcare professional to travel with a spouse or other guests. Lastly, entertainment expenses shall be both reasonable and moderate, ie, healthcare professionals should fly on economy class, accommodation should not have more than four stars, dinners should not be held at Michelin star restaurants or other renowned places and the sponsor should neither organise nor pay for entertainment activities outside of the conference or meeting schedule.

The Ethics Code additionally states that pharmaceutical companies cannot organise or sponsor events outside of their home country unless most of the invitees are from outside of its home country and, given the countries of origin of most of the invitees the location of the relevant resource, or expertise that is the object or subject matter of the event, it makes greater logistical sense to hold the events in another country.

According to the Ethics Code, the maximum cost for breakfast, lunch and dinner at such sponsored events is ISK4,000 for breakfast, ISK6,000 for lunch and ISK15,000 for dinner.

Icelandic legislation does not provide for any specific restrictions on sponsorship of cultural, sports or other non-scientific events, other than the rules on gifts already described.

The Ethics Code prohibits pharmaceutical companies from sponsoring or organising entertainment events, including cultural, sports or other non-scientific activities in relation to scientific conferences.

Icelandic legislation does not provide for any specific rules regarding grants ore donations to healthcare professionals or healthcare institutions, other than the rules on gifts described above.

According to Article 12 of the Ethics Code, donations or grants to healthcare organisations or patient organisations are prohibited unless they are made for the purpose of supporting healthcare, research, or education. Furthermore, the donations must be documented and kept on record by the donor and the donation cannot constitute an inducement to recommend and/or prescribe, purchase, supply, sell, or administer specific medicinal products. Lastly, the Ethics Code states that a pharmaceutical company cannot demand to be the sole funder or sponsor of a healthcare institution or patient organisation or any of its programmes.

The Ethics Code prohibits all donations and grants to individual healthcare professionals.

Icelandic legislation does not provide for any specific rules regarding rebates or discounts to healthcare professionals or healthcare institutions, other than the rules on gifts described. The general prohibition on gifts discussed above will, as a rule, entail that rebates and discounts cannot be provide to healthcare professionals or healthcare institutions.

Icelandic legislation does not contain any provisions on the payment for services provided by healthcare professionals. 

According to the Ethics Code, payments for services provided by healthcare professionals are only allowed if the following conditions are fulfilled:

  • a written contract is made in advancement of the commencement of the services;
  • the need for the services has been identified and documented before reaching out to the healthcare professional;
  • 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 a particular consultant meets those criteria;
  • the number of consultants hired is in accordance with the identified need;
  • the contracting company maintains records concerning, and makes the appropriate use of, the services provided by consultants;
  • the engagement of consultants to provide relevant service is not an inducement to recommend and/or prescribe, purchase, supply, sell or administer a particular medicinal product; and
  • the reimbursement for the services is reasonable and reflects the fair market value of the services provided.

Icelandic legislation does not require any prior authorisations or notifications in relation to any of the activities described in 9 Gifts, Hospitality, Congresses and Related Payments.

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

The Ethics Code does contain a requirement to disclose details of transfers of value. In addition, each member’s disclosure report is published on Frumtök’s website.

According to the Ethics Code, pharmaceutical companies must disclose the amount of every transfer of value that can reasonably be allocated to one of the following categories;

  • donations and grants;
  • contribution to costs related to events; and
  • fees for service and consultancy.

Further, each member must disclose the identity of the healthcare professional who received the donation and the amount he or she received.

The transparency requirements of the Ethics Code apply to all member companies, which comprise all companies which are members of Frumtök, member companies of the EFPIA, which according to the EFPIA code are obliged to adhere to Icelandic regulations, and other companies that have agreed to follow the Ethics Code. The transparency requirements also apply to member companies that do not yet have products on the market.

The IMA is the surveillance authority responsible for enforcing the rules on pharmaceutical advertisements described.

The Consumer Agency is the surveillance authority responsible for enforcing the Act on the Surveillance of Commercial Practices and Marketing. According to Article 17 of the Pharmaceutical Advertisements Regulation, the IMA shall notify the Consumer Agency if it considers that a pharmaceutical advertisement violates chapter II of the Act on the Surveillance of Commercial Practices and Marketing.

Cases regarding non-compliance with the provisions on bribery in the General Penal Code are investigated by the police and may result in a criminal case before the Icelandic Courts.

Companies can notify the IMA if they suspect that their competitors are violating the advertisement rules set out in the Medicinal Products Act and secondary legislation. Decisions by the IMA may be referred to the Minister of Health under the provisions of the Public Administration Act. The Ministry’s decisions can be brought before the Icelandic Courts.

According to Article 18 of the Medicinal Products Act, the IMA shall refer decisions on advertisements of medicinal products to the Icelandic Competition Authority in cases where there are reasons to suspect that an advertisement of a medicinal product violates provisions of the Competition Act No 44/2005.   

Additionally, matters regarding advertising infringements may be referred to the District Courts in Iceland, provided that legitimate interest is shown. 

Lastly, member companies to Frumtök can send a complaint to Frumtök, if they consider other member companies to be in violation of the ethics code. Frumtök appoints a committee to handle such disputes.

According to Article 18 of the Medicinal Products Act, the IMA may ban advertisements that do not comply with regulatory conditions. In addition, the IMA can order the withdrawal of specific advertisements that provide false or inadequate information on medicinal products. The IMA may also require that the advertiser publishes corrections or additional information in a comparable manner.

The penalties that can be imposed due to non-compliance of the advertising rules and rules on inducements in Iceland are reprimands, fines and imprisonment. Repeated or major violations are punishable with imprisonment for up to two years. Attempted violation or complicity in violations of the Act are also punishable.

Additionally, the IMA has numerous of other measures to force companies to comply with the Act, such as to:

  • issue a reprimand;
  • issue a reprimand, allowing a suitable time limit for rectification;
  • impose per diem fines; and
  • halt or limit the activities or use in question, including seizing products and ordering destruction.

Violations of the Act on the Surveillance of Commercial Practices and Marketing are punishable by fines up to ISK10 million.

Although member companies may send a complaint to Frumtök, as discussed in 11.1 Enforcement Bodies, Frumtök cannot take any measures following a violation of the Ethics Code, except publishing their decision on their website.

Procedures initiated with Frumtök can be filed in parallel with any proceedings before the IMA, the Ministry of Health or other agencies. Frumtök’s decisions are neither binding for the Icelandic courts nor administrative authorities. However, they might take such decisions into consideration when interpreting vague concepts of law, such as unfair market practices.

There are no recent enforcement trends in relation to advertisements of medicinal products in Iceland and no significant publicly known changes in enforcement action in the field.

LEX Law Offices

Borgartún 26
105 Reykjavík
Iceland

+354 590 2600

lex@lex.is www.lex.is
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Law and Practice

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LEX Law Offices is one of Iceland´s leading law firms, providing clients with comprehensive services over a wide range of transactional, corporate and commercial issues, as well as most other aspects of Icelandic law. The firm, founded in 1959, is one of the largest law firms in Iceland with close to 50 lawyers in its practice. The firm provides legal services to the life sciences industry, successfully combining in-depth knowledge of transactional, corporate, commercial, regulatory, competition and intellectual property matters. The firm´s dedicated team advises on all aspects and stages of the life cycle of products, from research and development through to manufacturing and marketing. LEX is recognised for its expertise in compliance matters and offers its clients valuable advice on all regulatory matters, including clinical trials, marketing authorisation procedures, pricing and promotions. The firm provides its clients with tailored advice on developing and implementing comprehensive compliance programs. Among LEX´s clients are both large domestic and international pharmaceutical companies as well as start-ups and other entrepreneurial companies.

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