A row broke out in Australia late last week after the government rejected an official recommendation that drugmakers should follow an industry code of practice before their medicines can be listed on the Australian Register of Therapeutic Goods. The decision, which was part of a review of the Therapeutic Goods Administration, was met by harsh criticism from consumer and industry groups alike.

In explaining its move, the government responded by saying its “preference is to maintain an emphasis on self-regulation and strongly supports industry’s initiative to harmonize their codes of conduct to incorporate the…high-level principles” suggested by the Working Group on Promotion of Therapeutic Products, which was issued last March (read here and this is the government response).

“From time to time, examples are highlighted of industry offering inducements to health professionals to promote products,” the government writes in its response. “This has the potential to influence clinical decisions on grounds other than the best interests of the patient. Strong and enforceable industry codes of conduct are effective in limiting unethical behaviour, but there needs to be consistency across industry codes in terms of their requirements, application, enforcement and penalties. This is currently lacking. There are also concerns that non-members of industry associations may not be bound by industry codes…”

“Further changes will be considered if it is found that there is a need to provide greater encouragement to non-members of industry associations to nominate and sign up to an appropriate industry code, including the TGA seeking notification of a sponsor’s nominated code of conduct at the point of including a product on the ARTG,” they added in their reply, which was reported by Pharma Times.

Nonetheless, Carol Bennett, chief executive the Consumers Health Forum of Australia, said in a statement that the government has missed an opportunity “to protect consumers from the cowboys in the industry who choose not to participate in voluntary codes of conduct.” She also told ABC Radio that “it does tend to indicate that the real client, if you like, is the industry, not the Australian consumer. And really, the whole purpose of the regulatory body, the TGA, is to serve the interests of Australian consumers” (read here).

Equally perturbed was Brendan Shaw, ceo of Medicines Australia, the industry trade group, who called the government response “very disappointing. This was a rare opportunity for stakeholders across the health sector to implement important regulatory reform which was identified by Government as a gap in industry self-regulation…” he said in a statement.

“There is no reason why Medicines Australia member companies should be required to adhere to one standard while non-members adhere to a less standard. We need to make sure our member companies are not disadvantaged by doing the right thing. There needs to be a level playing field that applies to all companies - not just those who choose to belong to Medicines Australia. Appropriate standards of conduct must apply across the board.”

In defense, Catherine King, the Parliamentary Secretary for Health, told ABC Radio that the government “is certainly not frightened to do so. But we want to give the industry time to get its act together to get those codes aligned. We also want to give the opportunity for them to actually get some of the non-members into those codes.

“In terms of promotion to health professionals; it has largely been this place that it’s been self-regulatory. What we have said is that we think there is room for improvement in that self-regulatory approach. So they need to improve their codes of conduct and look at seeing, non-members to become and sign up to those codes.”

“We then are saying, if we need to go further and get the TGA to seek that people need to sign on or nominate a particular code of conduct that they’ll comply with when they’re listing or registering goods, therapeutic products, we’ll do that. But we’re going to do a staged approach to it. We want to actually get the codes right first.”