Australia's government has rejected official recommendations that drugmakers should be required to comply with an industry code of conduct before their products can be listed on the Australian Register of Therapeutic Goods (ARTG).
The decision - which has been condemned by industry and consumer groups - forms part of the Gillard government's response to seven separate reviews of the national health care products regulator, the Therapeutic Goods Administration (TGA), undertaken over the last 18 months.
These reviews have highlighted a number of concerns to consumers, health professionals and the regulated industry, and the government says it will introduce a comprehensive package of reforms of the TGA.
One of the reviews was undertaken by the Working Group on Promotion of Therapeutic Products, a panel of industry, health professional and consumer representatives chaired by Anne Trimmer, who heads the Medical Technology Association of Australia. In its report, the Working Group called for a requirement that all sponsors listing products on the ARTG must comply with an industry code of conduct.
However, the government has not accepted this proposal, saying that its "preference is to maintain an emphasis on self-regulation" and initiatives to harmonise the various industry codes of conduct.
The professional relationship between health care practitioners and companies is governed by industry and professional codes of conduct, not by government regulation, the government points out. A number of the industry's associations have codes of conduct and practice, and while these can be effective at limiting unethical behaviour if they are strong and enforceable, they currently lack consistency in terms of requirements, application, enforcement and penalties, it says. There are also concerns that non-members of industry associations may not be bound by such codes.
Ministers say they plan to deal with these issues by strengthening self-regulation and harmonisation of the various 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 add.
But Brendan Shaw, chief executive of the research-based industry group Medicines Australia, said it was "very disappointing" that the panel's call for a consistent ethical standard across the sector between members of industry associations and non-members had not been accepted.
"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," said Dr Shaw. "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," he said.
And Carol Bennett, chief executive the Consumers Health Forum of Australia (CHF), said 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."
Speaking on ABC radio, Parliamentary Secretary for Health Catherine King said the government "is certainly not frightened" of doing more to force drugmakers to sign up to codes of practice in future, but it wants to take a staged approach and get the codes right first.
"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," said Ms King.
- In its response to the reform proposals, Australia's Generic Medicines Industry Association (GMiA) said it was "disappointed" by the government's statement that a "modest increase" in TGA fees and charges paid by the industry will be required to deliver the changes.
"This is not only an abuse of the Australian Government Cost Recovery Guidelines, it also marginalises the importance of these activities and potentially constrains the TGA from properly delivering public information," said the GMiA's chief executive, Kate Lynch.