News that Pfizer is paying $2.3 billion in the US to settle a marketing case has prompted a call for changes in the way Australia does business from Dr Ken Harvey, Adjunct Senior Research Fellow in the School of Public Health at La Trobe University.
He writes:
The New York Times report says: “Prosecutors said that they have become so alarmed by the growing criminality in the industry that they have begun increasing fines into the billions of dollars and will soon start charging doctors individually as well.”
Not in Australia unfortunately!
This topic was aired on ABC Radio “World Today” program today. The transcript hasn’t added my interview but I made the point that Pfizer Australia has had 17 complaints against Medicines Australia self-regulatory Code of Conduct upheld during 2005-09. Although one of these complaints received the maximum fine of $200,000, over this time the fines only averaged $50,000. There is no evidence that such fines have reduced Code violations by Pfizer or other member companies.
Somewhat different to the $2.8 billion fine imposed on Pfizer by U.S. regulators!
Which is why Choice (Australian Consumers Association) and others wanted Medicines Australia to increase the maximum fine for Code transgressions to $1 million in submissions to the recent Code review. Not surprisingly, this was rejected by MA who then went on to make a token increase in fines of $50,000 only taking the maximum fine to $250,000.
Currently, Australia has a variety of complex and convoluted co-regulatory systems to control unethical therapeutic claims and promotional practices depending upon the type of product (innovator and generic prescription, over-the-counter and complementary medicines, therapeutic devices, food and cosmetics) and the media in which claims are made. There are different standards and gross inconsistencies between various Codes of Conduct, their complaint processes, timeliness, transparency, sanctions, monitoring and effectiveness.
I have suggested to the Australian Competition and Consumers Commission (ACCC) that it is time this craziness was simplified and unified by creating one Code applicable to all therapeutic claims and promotional practice; one complaint (and appeal) process, one monitoring process and one set of effective sanctions, including corrective advertising orders and fines related to the sales income of the product and company involved.
The process should be overseen by government, funded by industry (using a moiety of product registration fees), and administered by an independent committee representative of all stakeholders. The system should have a legislative base in the Therapeutic Goods Act and/or regulations and be capable of being enforced. South African legislation provides a model of such a broader system (involving all types of medicines), see here.
This would be in line with the 2007 World Health Assembly Resolution WHA 60.16.5 on Rational Use of Medicines which urged member states to,
“Enact new, or enforce existing, legislation to ban inaccurate,
misleading or unethical promotion of medicines, to monitor
promotion of medicines, and to develop and implement programmes
that will provide independent, non-promotional information about
medicines”.
