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Roche at odds with ENLI in illegal marketing-case

The Ethical Committee for the Pharmaceutical Industry has fined Roche’s Danish unit for breaking the committee’s rules for drug commercials directed at healthcare personnel. Roche questions the sentence but refrains from appealing against the decision. “We have noticed the decision,” says Roche’s Head of Communication.

Does a verbatim repetition of a public authority’s evaluation of a drug seem like a health claim?

Yes, according to the Ethical Committee for the Pharmaceutical Industry (ENLI). A new ruling from the committee fines the Danish unit of the drug group Roche DKK 30,000 (nearly USD 4,800) plus VAT for offending against the ethical rules for pharmaceutical companies’ advertising to health professionals.

According to ENLI, Roche has used therapeutic instructions from RADS – the Danish Council for the Use of Expensive Hospital medicines, whose assignments were undertaken by the Danish Medicines Council from January 1, 2017 – to present the company’s non-small cell lung cancer (NSCLC) therapy Tarceva extra favorably.

“We can conclude that we in this case, do not agree with ENLI’s interpretation of the Promotion Code section 7.05,” says Morten Wiberg, Head of Communication in Roche, to MedWatch.

Roche: a verbatim repetition

The case is based on a Roche advertisement from August.

In the advertisement entitled “New RADS therapeutic instructions and drug recommendation for non-small cell lung cancer”, Roche stresses RADS’s assessment that 90 percent of the population can be treated with Tarceva and that RADS recommends Tarceva as first-line treatment in the indication.

This is, according to Morten Wiberg, merely a neutral and factual information in accordance with the Promotion Code section 7.05.

“In Roche’s response to consultation from September 4, 2017, we stress that our letter to the hospital dispensaries included a verbatim repetition of RADS’ therapeutic instructions for NSCLC. Those instructions are made by NSCLC specialists and members of the RADS committee. In the material, Roche does not mention anything about being first choice or the effect of our drug,” he explains and adds:

“Therefore, Roche assesses that the terms, notions and choices or words in RADS’ therapeutic instructions are a correct description of the practice of the oncological treatment.”

Price and effect play a role – that won’t do

However, ENLI is certain that Roche has acted against the rules stipulating that apart from SPC (summary of product characteristics required by the EU Commission before marketing of a drug, ed.), you can only use scientifically based research as documentation for information about a drug.

“Roche has made an advertisement based on a RADS instruction and this is not legal. The Roche advertisement is solely based on the RADS instruction and does not include information from, for instance, the SPC or other scientific studies. Therefore, Roche uses RADS as its primary source for the ad and this is not in accordance with the rules,” says Rikke Thomassen, head of secretariat in ENLI, to MedWatch.

According to her, ENLI’s guidelines specify that a pharma company can only use instructions and recommendations from RADS – now the Medicines Council – as neutral information for the purpose of advertisement.

This is because drug recommendations from RADS and the Medicines Council not only describe the effect of the drug but also whether the effect matches the price.

“In the end, the recommendations are based on what price agreement the drug group has made with Amgros (the Danish regions’ pharmaceutical procurement service, ed.). And when price plays a role, you cannot use the recommendations as primary source for commercials, like Roche did,” she says.

Disagrees but does not appeal

But the head of secretariat’s arguments are lost on Roche.

“We can conclude that we in this case, do not agree with ENLI’s interpretation of the Promotion Code and its guidance,” says Morten Wiberg and refers to Roche’s response to consultation in which the company admitted that the message of the advertisement is based on the RADS instructions as the primary source.

“But RADS’ therapeutic instructions just refer to Tarceva as a treatment option in this indication so we do not think that the material emphasizes the actual recommendation of the drug. On the contrary, we are dealing with a balanced and loyal repetition of RADS’ instructions,” he adds.

However, Rikke Thomassen from ENLI stands firm.

“ENLI does not deny that Roche has repeated the RADS information in a verbatim manner. But in this case, ENLI assessed Roche’s advertisement material to be a health claim. The RADS information was the main message of the advertisement and this information included a recommendation of the drug. Thus, our ruling is correct,” she says.

Despite its disagreement with the committee, Roche chose not to appeal against the decision.

“Roche has noted ENLI’s ruling but we do not want to appeal. We have briefed relevant employees and in the future, we will ensure that marketing material referring to instructions, decision or the like from the Medicines Council, RADS, or KRIS is sent to ENLI for preliminary approval,” says Morten Wiberg.

MedWatch has asked to see the advertisement in question but Roche did not wish to hand it over.

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English edit: Ida Løjmand

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