Advertising of medicinal products is governed by the Act on Medicinal Products of 4th December 1992 and by the appurtenant Regulation on medicinal products of 18th December 2009. In addition to these rules, the Association of the Pharmaceutical Industry (LMI) has provided several codes of practice for its members. Most notably are the Rules for marketing of medicinal products, which is largely based on EFPIA's Code on the promotion of prescription-only medicines to, and interactions with, healthcare professionals.

To ensure that its members follow the Codes as well as the Regulation, LMI and the Norwegian Medical Association in cooperation formed the Board relating to information on medicinal products (the Board) in 2000. The Board acts as a self-regulated supervisory body for all the members. The purpose is to ensure that the relationship between physicians and the pharmaceutical industry is based on transparency and integrity, and that the relationship does not progress by means that undermines the trust of neither physicians nor the pharmaceutical industry.

The Board publishes its decisions on a regular basis. A synopsis of the recent decisions follows:

Advertising of Mycamine®

MSD (the complainant) reported an advertisement for Mycamine® published in a member's bulletin, alleging that the advertisement was in violation of the rules of marketing of medicinal products.

The complainant stated several objections towards the advertisement.

Firstly, that the advertisement was accompanied by a text which resembled the one in Felleskatalogen (a reference book of medicinal products), but which was not in accordance with this text, nor with the Summary of Product Characteristics (SPC). The complainant argued that the text of the advertisement was altered to encourage use outside the approved indication and also giving a misleading view of the medical value of the medicinal product.

Secondly, the complainant stated that the defendant (Astellas) previously had been reported and fined for omitting the text of the approved indication.

Thirdly, the advertisement contained a sentence that Mycamine® was the "Most used echinocandin in the world". The complainant alleged that the underlying reference was unpublished and also not in line with the rules. Therefore it was impossible to evaluate the claim.

The defendant alleged that their circumscription of the text represented the wording and interpretation of the European Medicines Agency's scientific evaluation of Mycamine®.

With regards to the claim "Most used echinocandin in the world", the defendant stated that the requirement of the rules are that abilities or effects must be documented by scientific publications. The claim did not refer to abilities or effects, and could therefore not be documented by such publications.

According to the Board, the SPC stated that Mycamine® should only be used when other fungicides are not appropriate. The Board found that the advertisement went beyond the approved indications of the SPC. The Board also commented the lack of compliance of the text of the advertisement compared to Felleskatalogen, in spite of the advertising using the format of Felleskatalogen. The Board also stated that important information from the SPC regarding safety had been rewritten and de-emphasized. In the view of the Board, the advertisement was misleading, and the Board considered it serious that important information would not be perceived by the prescribing physician.

Astellas was fined 150 000 NOK (appr. € 20 000).

Advertising of Xeplion®

 The Norwegian Medicines Agency (the complainant) reported an advertisement for Xeplion® published in a magazine for healthcare professionals. One of the statements in the advertisement was that Xeplion was approved for reimbursement.

The complainant alleged that the advertisement was in violation of the rules for marketing, since the advertisement did not contain information about reimbursable use, reimbursement codes and the conditions for reimbursement for the indications mentioned in the advertisement. Nor was information about reimbursement mentioned in the SPC which accompanied the advertisement.

The complainant also alleged that the SPC which accompanied the advertisement used a text font that was too small, making it practically impossible to read for most people. As such, important information about safety was not communicated to the reader. Therefore, the complainant alleged that the advertisement was not balanced with regards to benefits and risks.

The defendant (Janssen-Cilag) stated that both the lack of information regarding reimbursement and the small size of the font were errors, and stated that the advertisement had been withdrawn.

The Board noted that the defendant had admitted both errors, and agreed that information about reimbursement should be mentioned in the advertisement. The Board also noted that information about reimbursement was not present in the SPC.

Janssen-Cilag was fined NOK 30.000 (appr. € 4 000).

Advertising of Pradaxa®

 The Norwegian Medicines Agency (the complainant) reported an advertisement for Pradaxa® published in a magazine for healthcare professionals. A statement in the advertisement said that Pradaxa® was approved for reimbursement from 1st January 2013.

The complainant alleged the advertisement to be unlawful due to the fact that no decision for reimbursement of Pradaxa® had been issued yet. The Agency had previously recommended reimbursement for Pradaxa® to the Ministry of Health and Care, which in turn had proposed that Pradaxa® should reimbursable, but no final decision was made, nor had the Ministry instructed the Agency to finalize the application for reimbursement from the defendant (Boehringer Ingelheim). There was therefore no guarantee that Pradaxa® would be reimbursable from 1st January as stated in the advertisement.

The defendant admitted that the formulation of the statement was imprecise, but alleged that the statement did not promote use outside the reimbursable conditions. Furthermore, the defendant showed that the Agency itself had also published that Pradaxa® might be reimbursable in a newsletter.

The Boards stated that in accordance with the rules, information of reimbursement shall not be disclosed before the decision is final and the conditions for reimbursement are known. Boehringer Ingelheim was fined NOK 10.000 (appr. € 1 300).

Advertisment of Qutenza®

 Pfizer (the complainant) reported an advertisement of Qutenza®, alleging that several issues in the advertisement were in violation of the rules for advertising.

The first issue was a statement which claimed that Qutenza® offered "Prolonged pain relief without systemic adverse effects".

The complainant stated that the SPC stated several systemic adverse effects, and that the statement therefore was in violation with the approved SPC.

The defendant (Astellas) alleged that the first statement was not intended to mislead, but to promote the understanding of the problems of medical treatment for neuropathological pain. The local treatment and the underlying mechanism implied several advantages compared to conventional systemic treatment and the systemic adverse effects associated with conventional treatment. The complainant admitted that the statement was imprecise and that this would be rectified in the future.

The second issue for the complainant was a brochure called "Administration guidance to the prescribing physician for Qutenza®". The complainant pointed out that important information regarding adverse effects and precautions was missing, and thus in violation of the rules.

The defendant stated that marketing authorisation for Qutenza® contained a condition of training of healthcare personnel, and that the brochure is a document included in this training. The brochure was a regulatory document approved by the Norwegian Medicines Agency, and as a regulatory document it was exempted from the rules of advertisement.

The third issue raised by the complainant was an invitation for a meeting regarding bladder control. On the backside of the invitation the logos of several products marketed by the complainant were listed.

The complainant alleged that the listing of the products and the meeting were connected, and as such, the listing of the products could not be regarded as "reminders", and thus not be excluded from the requirements. Since the text from the Felleskatalogen was not present, the listing of the logos was therefore in violation of the rules.

The complainant also pointed that the statement "Treatment of pain without systemic adverse effects" was used in the invitation, and referred to the previous considerations for the first issue.

The defendant disputed the allegations, and also stated that the invitation had been used several times without reactions from anyone.

The Board found the statement regarding no systemic adverse effects to not to be in line with the SPC, and thus sided with the complainant in the first issue.

With regards to the second issue, the Board stated that under condition that the brochure was a part of a risk management plan as alleged by the defendant, the rules of advertisement was not applicable for this document.

For the third issue, the Board stated that the invitation contained a medical statement, in this case a wrong statement. For medical statements in invitations for meetings the rules for ordinary advertisement must be followed.

The Board considered it "severe" that the defendant repeatedly had claimed that its product was without systemic adverse effects, and fined Astellas NOK 100 000 (appr. € 13 000).

Advertisement of Galvus® and Eucreas®

 MSD (the complainant) reported advertisements for Galvus® (vildagliptin) and Eucreas® (vildagliptin and metformin) to the Board alleging the advertisements to be in violation with the Regulation and LMIs Rules for marketing of medicinal products.

The advertisement contained several statements regarding the active substance of Galvus® (vildagliptin). According to these statements, vildagliptin:

1. Had significantly better reduction of HbA1c compared to other DPP4-inhibitors.

2. Had reduction of HbA1c at similar levels as GLP-1-analogs.

3. Had significantly better reduction of HbA1c than metformin or sulphonylurea

All of these statements were stated to be based on a publication referring to a retrospective database analysis.

Regarding the first statement, the complainant referred to that the publication claimed the differences were in accordance with available literature. The complainant alleged that the publication's view at this point was, at best, discussable, and that several other articles claimed no difference in effect or safety between various DPP-4 inhibitors.

Regarding the second statement, the complainant referred to a clear opinion of the specialist environment that GLP-1 analogs reduce HbA1C better than DPP-4 inhibitors.

Regarding the third statement, the complainant referred to the SPC, which described the results of several studies comparing vildagliptin with metformin or sulphonylurea. The advertisements impression of significantly better effect was in contradiction to the data stated in the SPC.

The complainant also had several comments regarding the publication. The publication claimed that the data suggested that vildagliptin had stronger reduction of HbA1C than DPP-4 inhibitors and GLP-1 analogs, and that these data were in agreement with data from randomized clinical trials. The complainant alleged that this conclusion was surprising, as they were not aware of any randomized clinical studies that conclude with significant differences in the reduction of HbA1C between different DPP-4 inhibitors, but that there were studies between GLP-1 analogs and DPP-4 inhibitors in favor of GLP-1 analogs.

The defendant (Novartis) referred to that the Board allows the use of register studies in comparative advertisement with the Board, but that this use must be done with caution.

The defendant alleged that the results of the publication were fully described in the advertisement, and that the advertisement did not offer a misleading nor misrepresenting view of the study. Nor did it offer exaggeration of the properties or medical value of the drug.

The defendant also made several comments regarding the underlying study. The complainant also alleged that register studies are an important supplement to the scientific data from controlled studies especially for new medicinal products.

The Board commented that the authors of the publication did not conclude with significant differences, but that the results indicate efficiency and a safety profile similar to other comparable substances. The advertisement presented the results without the reservations of the underlying study.

The Board showed that use of register studies is allowed, also for comparative advertisements, but that such use must be cautious. In this particular instance the defendant should also have included underlying randomized clinical studies which constitute the basis of the approval of the product. Those studies did not give the same result, and the advertisement was therefore suited to mislead physicians.

The defendant was fined NOK 50 000 (appr. € 6 700).

About the authors:

Inga Kaasen is an attorney-at-law and partner at the Norwegian law firm Grette. She also holds a PhD. in biotechnology. She is the leader of Grette's Life Sciences team, and has extensive experience with patent disputes, pharmaceutical law, IP transactions and R&D agreements.

Håkon Austdal is an associate at the Norwegian law firm Grette. He also holds a Bachelor of Pharmacy. He is a member of Grette's Life Sciences team, working with patent disputes and pharmaceutical law.

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