AN analysis of the prevalence and severity of breaches of codes of conduct in the pharmaceutical industry in the UK and Sweden prompted me to review data in Australia.
The PLOS Medicine analysis of complaints, complainants and rulings regarding drug promotion in the UK and Sweden between 2004 and 2012 revealed the discrepancy between the ethical standards codified in industry codes of conduct and the actual conduct of the industry.
For comparison, I reviewed data from annual reports of the Medicines Australia Code of Conduct.
The PLOS Medicine paper revealed that over the 9-year study period, Swedish authorities received 952 complaints of which 56% were in breach of the country’s rules on medicines promotion. In the UK there were 933 complaints with 64% in breach. The corresponding data for Australia for the same period is 362 complaints with 53% in breach of the rules.
In Sweden 47% of complaints came from active monitoring by self-regulatory bodies compared with 0.2% in the UK. In Australia the figure is 27%.
Economic sanctions and costs imposed on companies averaged A$660 000 a year in Sweden, A$1.114 million in the UK and $740 000 in Australia.
Serious violations of codes were judged to have occurred in 19% and 17% of complaint determinations in Sweden and the UK, respectively. My analysis showed that, here, 6% were considered serious by Medicines Australia.
All the data showed a decline in the number of complaints received over recent years but there is no way of knowing if this represents a real improvement in compliance, complainant fatigue or changing monitoring strategies.
There are many problems with studies that make country comparisons, particularly because no standard denominator exists. Sweden, the UK and Australia each have different systems of code coverage, complaint handling, breach recording, promotion monitoring, sanctions for violations and different populations. For example, the Swedish data relates to the promotion of prescription and over-the-counter drugs whereas in the UK and Australia data apply only to prescription drugs.
There are also marked differences in the source of complaints. In the UK many more complaints come from health professionals and individuals than in Sweden or Australia.
All these self-regulatory bodies perform some form of monitoring but this varies as to what is assessed and what is reported.
Code violations detected by the Medicines Australia monitoring committee were not reported publicly until 2008 when, stimulated by the Australian Competition and Consumer Commission (ACCC), educational events were scrutinised for the first time. This resulted in an all-time high of 83 complaints received in 2007‒2008.
However, none of the three countries’ self-regulatory bodies appear to monitor the behaviour of pharmaceutical representatives, which account for around half of the industry’s promotional spend and have been found to be problematic.
Economic sanctions and the costs reported also differ between countries. In Australia, fines imposed are publicised but not the cost of corrective advertising or letters to doctors. The average fine imposed by Medicines Australia between 2009 and 2013 was $44 000, with the maximum fine at $200 000.
The economic sanctions imposed in all counties represent a very small fraction of the sales of the product promoted, let alone the annual sales revenue of the companies concerned, and are particularly small when compared with the fines imposed by US Department of Justice.
Yet, even in the US, the large fines have not deterred repeated violations.
In an industry trying to maximise sales there must be a temptation to stretch or cross code boundaries. The number of complaints reported to authorities is likely to underestimate unethical behaviour, especially given the limitations of monitoring and lack of support for internal whistleblowers.
Ongoing egregious conduct by some sections of the pharmaceutical industry highlights the need for more policies to improve corporate behaviour.
In Australia, the ACCC has demanded improvements in the Medicines Australia code, imposing a condition on the latest code to ensure all transfers of value between industry and health care practitioners are publicly reported. Ironically, other industry associations such as the Generic Medicines Industry Association and the Australian Self Medication Industry have opted out of ACCC code authorisation and thus are not subject to imposed conditions.
Other policies suggested include monitoring the interaction between drug representatives and medical practitioners, more substantial fines for severe code breaches, greater encouragement of internal whistleblowers and, as implemented in Italy, requiring companies to contribute a percentage of promotional expenditure to fund independent research.
All ideas worth serious consideration but, given the current Australian Government’s focus on deregulation, it seems unlikely such policies will be implemented in the near future. Meanwhile, a “No Advertising Please” campaign encourages individual action.
Dr Ken Harvey is adjunct associate professor in the School of Public Health and Preventive Medicine, Monash University. He represented the Consumer Health Forum on the previous government’s Working Group on Promotion of Therapeutic Products and Medicines Australia’s Transparency Working Group and Code Review Panel.
Dr Harvey’s analysis is available on request to firstname.lastname@example.org.