“Medicines Australia (MA) is an industry association whose members represent multinational, research-based pharmaceutical companies such as Pfizer, GlaxoSmithKline and CSL. Their self-regulatory code of conduct governs the promotion of prescription drugs and the relationship of industry to health professionals.”
Consequently, MA recently held a Code of Conduct Consumer Review Workshop (one of three held in different cities) on behalf of CHOICE (Australian Consumers Association) in late March. Consumer representatives and several MA staff, representatives from the pharmaceutical industry on the MA Code Review Committee and others participated.
Background
As a recent article explained, the code of conduct “refers to relevant legislation, such as the Therapeutic Goods Act 1989, which states that prescription drugs must not be promoted to health professionals.” The code is “the oldest and most detailed of four self-regulatory codes that deal with the promotion of medicines to health professionals.”
The Generics Medicines Industry Association (GMiA), the Australian Self-Medication Industry Association (ASMI) and the Complementary Health Care Council of Australia (CHC) have their own codes. As do a number of other industry associations involved with therapeutic devices and diagnostics.
Despite these measures, the author noted that there “are concerns about the multitude of self-regulatory codes produced by the therapeutic goods industry” because “there are great variations in their provisions, sanctions, administrative procedures and transparency and, most importantly, they do not apply to non-members who are often the worst offenders.”
As a result, the Australian government set up a “Working Party on Therapeutic Promotion” in 2010 “with the aim of achieving uniformity among the codes and addressing the problem of non-members.” The author noted, however, that the government did not “adopt the most important recommendation of the working party – that compliance with an appropriate code should be a condition of marketing for all sponsors of therapeutic goods.”
Meeting on Australian Industry Codes
Participants during the workshop, which the author attended, “expressed concern about the code review process. Submission to the review (available on the MA website) was open to all and consumers appreciated the additional opportunity to attend public workshops. But MA and its code were not well known in the community, which limited input.”
Participants expressed that it had been their experience in making previous codes “that it often took many years (and several code revisions) to make changes.” For MA to make changes to its codes, a 75% vote is required (and some larger companies had more votes than others). Participants noted that this “self-regulation was self-serving and could only endorse the lowest common denominator of member ethical standards.”
The sanctions imposed for Code offences were another concern. Participants noted that the maximum fine of $250,000 (or $300,000 for multiple code breaches) was “hardly an effective deterrent to a large multinational pharmaceutical company and the average fine imposed (around $50,000) could easily be written off as a tax deduction.”
Consumers in the workshop “were not convinced that the ‘shame’ of being found in breach of the code provided any real deterrent as some companies have repeatedly violated the code over the years.” This is not much different than the process seen in the U.S., in which pharmaceutical companies are currently under second, third and sometimes fourth corporate integrity agreements (CIAs).
The workshop also discussed “product familiarization programs, patient support programs and starter packs (free product samples for doctors).” While some considered these to be “mere marketing strategies aimed at getting doctors to prescribe the latest and most expensive drugs,” others believed they served a useful purpose. For example, some noted that patient-support programs “can assist patient compliance with reminders and other strategies, while free product samples could be helpful for needy patients or to see if side effects may be a problem.”
However, some participants were concerned “that free starter packs didn’t just target the indigent and were often not the drug of choice for the patients’ condition.” Others indicated that starter packs “lacked accompanying important information and labelling provided by pharmacists.” In addition, all participants “agreed on the need for greater transparency about such programs so the benefits being advocated could be evaluated.”
Conclusion
In the end, “MA was commended for monitoring promotion, (which many other industry associations do not) and the recognition that complaints usually only represent the tip of the unethical promotional iceberg.” Consequently, participants “suggested that MA also monitor the activities of medical representatives as they represent a significant proportion of the promotional budget and research has revealed concerns.”
The author noted that “There was support for much greater transparency in the relationship between industry and health professions,” with some even suggesting that the provisions of the Physician Payment Sunshine Act should be incorporated in the code.” The author pointed out that there is already public support for this measure by some drug companies and the Australian Medical Association.
While we wait to see the final regulations for the Sunshine Act, which Congress has asked the Centers for Medicare and Medicaid Services (CMS) to produce this year, the Drug Information Association (DIA) will be holding a session on the Sunshine Act in anticipation of the final regulations to discuss implementation. The panel will be moderated by John F. Kamp, JD, PhD, Executive Director of the Coalition for Healthcare Communication and includes several prominent physician-industry collaboration experts.