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Marketing Regulations

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While pharmaceutical companies in Sweden and the United Kingdom claim to police their own marketing practices, when it comes to promoting products, a long list of violations tells a different story, according to a recent study by three researchers from the University of Lund, Sweden.

The researchers, Anna V. Zetterqvist, Juan Merlo and Shai Mulinari, analyzed data from 2004-2012 pertaining to complaints about marketing violations, who made them as well as the conclusions from any investigations. Sweden and the UK often are cited for their effective self-regulation programs, according to the report.

But the data told a different story. “The prevalence and severity of breaches testifies to a discrepancy between the ethical standard codified in industry Codes of Conduct and the actual conduct of the industry,” the authors noted.

Altogether, overseeing bodies ruled that 536 Swedish and 597 UK cases violated conduct codes, the equivalent of an average of more than one incident every week for each country.

No medical evidence

A majority of the cases had to do with misleading promotions; that is, there was no medical evidence for some of the claims about drugs. Other violations involved marketing prescription drugs, which the European Union bans.

“Nearly 20 percent of the violations were ‘especially serious,’ involving transgressions such as pre-license or off- label promotion, or the marketing of prescription drugs directly to patients, both illegal practices in the European Union,” noted Mulinari, one of the study’s authors. “However, it is important to point out that these are the cases that have been identified, and we just don’t know how much more unethical marketing is out there but is never reported.”

Much of the activity around identifying deceptive marketing practices pertaining to drugs and issuing significant penalties have taken place in the U.S., Mulinari added.

A balancing act

Attorney Amund Brede Svendsen, a partner in the Norwegian law firm Grette, which largely serves pharmaceutical companies and also handles intellectual property and life sciences’ issues, said it is his impression that pharmaceutical companies take marketing regulations very seriously and are eager to be compliant. “Companies strive to adhere to every regulation, but at same time want to market their products effectively and strongly, and often it is a balancing act.”

Among the issues with which companies wrestle are whether they are exaggerating the medical value of a drug, claiming their drug is better than a competitor’s, asserting a medication has a wider area of use than is set out in its marketing application or are suggesting that patients will suffer if they don’t use their drug, Svendsen said. “Issues about the interaction between the companies and health care personnel, even veterinarians and dentists; those appear to be the more contentions ones. Clients ask, ‘Can we do this? Can we claim to do this?’ There are areas where the case law and practice are not fully developed. “

Companies often get frustrated because it can be hard to predict the outcome when practices are challenged, according to Svendsen. “There is always the possibility that an individual case will have a different decision.”

Per Thomas Thomassen, a special advisor at Grette, noted that this lack of predictability, combined with the regulatory authority’s ability to impose a total, albeit time-limited, advertising ban on a particular medicinal product, if it finds the pharmaceutical company has violated the regulations on advertising, is taxing. This could encourage the pharmaceutical industry, or some companies, to challenge the authority’s use of sanctions. The regulations on advertising of medicinal products are fully harmonized within the European Economic Area, which includes the EU, Iceland, Norway and Liechtenstein, and there should not be any latitude for national regulatory authorities to make decisions that overstep the European regulations, Thomassen added.

More efficient regulatory responses

More independent oversight, swifter responses to violations and financial penalties that make companies wince are needed to reduce violations, as well as more efficient regulatory responses in parallel with prosecution in severe cases, as takes place in the U.S., Mulinari continued. “Currently, in Sweden, like in many other countries, the fines for transgressions are very low relative to the financial power of pharmaceutical companies,” Mulinari said. “In Sweden, fines are designed to cover the expenses of the self-regulatory system.” Drug company activities require meticulous oversight, including pre-screening promotional material and actively monitoring promotional information, he said, and regulators need to view marketing transgressions as a public health threat rather than a nuisance.

“But even if regulatory bodies had the capacity and the willingness to provide oversight, they face the major challenge of how to acquire knowledge about dubious marketing tactics,” Mulinari added. “This information remains unavailable to those outside the companies, including regulators.”

While it is difficult to say if deceptive marketing practices are on the rise, concerns about them are, according to Mulinari. “There is a growing body of international scientific literature on the deceptive marketing practices used by some pharmaceutical companies, and the potentially highly negative impact that this has on patient health,” he said.

Photo of: Amund Brede, Shai Mulinari and Per Thomas Thomassen, Grette. 

Photographer Grette: Per Kristian Lie Lowe

 

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