Consumer input in Medicines Australia’s code of conduct review

TRANSPARENCY AND MEDICINE – A series examining issues from ethics to the evidence in evidence-based medicine, the influence of medical journals to the role of Big Pharma in our present and future health.

Today Ken Harvey presents a report from a recent workshop hosted by the pharmaceutical industry body for public input in their code of conduct review.

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.

The code refers to relevant legislation, such as the Therapeutic Goods Act 1989, which states that prescription drugs must not be promoted to health professionals. It’s 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.

The Australian government supports self-regulation and compliance with MA’s code on the promotion of products (but not on the relationship with health professionals) is a condition of marketing approval for prescription (but not other) drugs.

Nonetheless, there are concerns about the multitude of self-regulatory codes produced by the therapeutic goods industry. 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.

In 2010, the government set up a “Working Party on Therapeutic Promotion” with the aim of achieving uniformity among the codes and addressing the problem of non-members.

Regrettably, the government didn’t 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.

The current MA code of conduct revision should be seen in this context.

Consumer workshop

I attended MA’s Code of Conduct Consumer Review Workshop (one of three held in different cities) on behalf of CHOICE (Australian Consumers Association) in late March. Eleven other consumer representatives and several MA staff, representatives from the pharmaceutical industry on the MA Code Review Committee and a lawyer who’d been commissioned by the St James Ethics Centre to oversee the process at the request of MA, were there.

Participants 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.

There was concern that these opportunities were merely token gestures and issues raised wouldn’t be addressed. Individuals who’d been involved in previous code reviews agreed; it’d been their experience that it often took many years (and several code revisions) to make changes.

MA spokespeople pointed out that it was an association of members; that a 75% vote was required to get changes incorporated (and some larger companies had more votes than others). Ultimately, they said, the system only worked if members agreed to go along with it.

This led to comments that 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. The maximum fine of $250,000 (or $300,000 for multiple code breaches) is 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 were not convinced that the “shame” of being found in breach of the code provided any real deterrent; some companies have repeatedly violated the code over the years.

There was debate over industry product familiarisation programs, patient support programs and starter packs (free product samples for doctors). 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; patient-support programs, for instance, 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.

There was also concern that free starter packs didn’t just target the indigent; they were often not the drug of choice for the patients’ condition. And that they lacked accompanying important information and labelling provided by pharmacists.

All agreed on the need for greater transparency about such programs so the benefits being advocated could be evaluated.

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. It was 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.

There was support for much greater transparency in the relationship between industry and health professions. And it was suggested that the provisions of the US Physician Payment Sunshine Act should be incorporated in the code. There’s already public support for this measure by some drug companies and the Australian Medical Association (AMA).

Medicines Australia deserves congratulations for hosting the workshop and it will be interesting to see if the concerns raised get incorporated into the revised code. If not, ACCC’s authorisation of the code will provide another opportunity for public input.

This is the fifteenth part of Transparency and Medicine. You can read previous instalments by clicking the links below:

Part One: Power and duty: is the social contract in medicine still relevant?

Part Two: Big debts in small packages – the dangers of pens and post-it notes

Part Three: Show and tell: conflicts of interest undeclared for clinical guidelines

Part Four: Eminence or evidence? The ethics of using untested treatments

Part Five: Don’t show me the money: the dangers of non-financial conflicts

Part Six: Ghosts in the machine: better definition of author may stem bias

Part Seven: Clearing the air: why more retractions are good for science

Part Eight: Pharma’s influence over published clinical evidence

Part Nine: Insight into how pharma manipulates research evidence: a case study

Part Ten: Why data from published trials should be made public

Part Eleven: Open disclosure: why doctors should be honest about errors