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June 28, 2015

Drug promotion: does self-regulation work?

Many countries trust industry-appointed bodies to self-regulate the marketing and promotion of drugs, but is that trust well-placed? A recent study suggests violations are common under self-regulation, while proponents argue that these cases are simply proof that the system is catching misconduct.

By Chris Lo

pills

While all countries are in agreement on the need for the rigorous regulation of pharma promotion, different countries adopt different approaches to achieving the goal. In the broadest sense, there’s a split between governments that adopt an in-house approach to regulating promotion, as with the Food and Drug Administration (FDA) in the US, and those that delegate the responsibility to pharma associations or multi-stakeholder groups, as is the more common method in Europe.

The motivation for establishing a self-regulating system for pharma product promotion is primarily pragmatic – industry associations have the relevant expertise and willingness to establish voluntary codes of practice that set standards for ethical marketing activities and have the authority (usually through self-regulatory bodies that are independent of the associations themselves) to levy sanctions against companies that are found in violation of that code. This takes the regulatory burden away from state health departments, saving the government staff and financial resources.

Both approaches have their proponents and critics, but in reality relatively little study has gone into the comparative efficacy of government regulation and industry self-regulation of pharma promotion.

Lund University study finds breaches aplenty

One recent study by researchers at Lund University in Sweden took a long look at the application of self-regulation of pharma promotion. Along with the general lack of study in the area, one of the motivations for the study cited by the researchers was the relative lack of large-scale marketing scandals among the self-regulating countries of Europe when compared to the US, which has seen a number of high-profile settlements over illicit market practices in the last few years, including GlaxoSmithKline’s landmark $3bn settlement for infractions including providing kickbacks to doctors and promoting drugs for off-brand applications.

For many, the relative scarcity of major pharma marketing scandals like this in Europe is an indication that self-regulation is working just as it should. But the study, published in February in PLOS Medicine journal, draws the opposite conclusions. After studying the self-regulatory systems of Sweden and the UK, two countries deemed to be examples of effective self-regulation, the researchers found that between 2004 and 2012, there were 536 code breaches in Sweden and 597 violations in the UK, an average of more than one marketing breach a week in both countries.

Breaking down the numbers, the majority (58%) of code violations in the time period were due to misleading claims, with other common misconduct including failures to comply with undertakings (23%), pre-licensing or off-label promotion (18% and 5% respectively) and illicit promotion of prescription drugs directly to the public (15%). Around 20% of these breaches were deemed to be serious by the self-regulating entities of each country (the Pharmaceutical Industry’s Information Examiner in Sweden and the Prescription Medicines Code of Practice Authority in the UK).



The US is one of the only countries in the world that allows big pharma to advertise prescription drugs directly.


The report picks out seven major pharma firms – Pfizer, Novartis , Bayer , GlaxoSmithKline, Novo Nordisk , Eli Lilly and AstraZeneca – that were ruled in serious breach of code on at least 10 separate occasions during the eight-year time span.

One regulatory failing identified in the study was rather toothless financial penalties – average charges for violations were €447,000 in Sweden and €765,000 in the UK, which represents 0.014% and 0.0051%, respectively, of the annual revenues of the fined companies in each country. This compares unfavourably with average fines that equate to 0.8% of revenues in the US’s state-regulated system, according to the Pharmaceutical Journal.

Other issues included a lack of active monitoring for breaches (especially in the UK), too little publicity of company misconduct and the need to vet promotional materials before they are disseminated.

For the report’s lead author Dr Shai Mulinari, the findings unearth the sheer frequency of violations under these two self-regulating systems and offer a counterpoint to those who claim that industry codes of practice provide an effective deterrent to underhanded behaviour in marketing. "There is clearly a discrepancy between the ethical rules and what companies are actually doing," he said after the study’s publication.

State oversight vs. self-regulation: the wrong conversation?

Mulinari and fellow Lund University researcher Anna V. Zetterqvist have been studying the regulation of European pharma promotion for some time now. Their 2013 study into misleading advertising for antidepressants in Sweden was similarly critical of the self-regulation, and even went so far as to suggest that if self-regulatory flaws were not addressed, "many countries may want to reconsider the current balance between self-regulation and legislative control with government oversight".

There was no such recommendation in the broader 2015 study. Speculating on the reason for the more moderated tone would be unfair without speaking to the authors (Dr Mulinari and Lund University have not responded to requests for comment at the time of writing). Nevertheless, perhaps debating the relative merits of government oversight and industry self-regulation is the wrong conversation.

"One regulatory failing identified in the study was rather toothless financial penalties."

After all, the large number of violations highlighted as a problem by the study are held up as a positive sign by industry groups. The European Federation of Pharmaceutical Industries and Associations argued that the frequency of rulings is "testimony to the efficiency of these self-regulatory systems that misconduct is indeed identified".

A spokesman for the Association of British Pharmaceutical Industry, meanwhile, had this to say in a statement to the Wall Street Journal: "The commitment of the UK pharmaceutical industry to a complaints system that is as open as possible and that publishes full details of cases, demonstrates the seriousness with which the industry takes its responsibilities under self-regulation." Industry associations have also pointed out, not unreasonably, that the Lund University study focuses only on the number of violations and not the full extent of promotional materials, compliant and non-compliant, making it impossible to see what proportion of these materials were in breach.

When two parties in a debate can take the same data and come to opposite conclusions, the discussion is arguably more ideological than evidence-driven, and therefore of limited use in terms of driving the refinement and reform of marketing oversight. State oversight and self-regulation both have their flaws, but these flaws often overlap; the FDA is also unable to pre-approve pharma marketing materials and advertisements, for example.

The real-world case studies of industry and state regulation prove that neither system is perfect, and if government or self-regulatory bodies are found wanting, the focus should be on ongoing reforms to address issues in areas such as transparency, enforcement, deterrence and monitoring – one of the study’s more disturbing findings, for example, is that only 0.2% of complaints in the UK came from active monitoring, surely a result of British companies only being obliged to submit materials upon request, rather than as a matter of course.

So long as independent bodies appointed by the industry can be trusted to act in the best interests of public health, rather than the health of the industry itself, then the only debate is how best to refine pharma promotion standards and penalise those who fail to live up to them.

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