The Parliamentary Secretary for Health, Mark Butler, last week launched two related initiatives at the National Medicines Policy Partnership Forum: a position paper on the promotion of therapeutic goods and a consultation paper on advertising arrangements.
The former was produced by the Regulatory Policy & Governance Division of the Department of Health and Ageing, while the latter was produced by the Regulatory Reform Section of the Therapeutic Goods Administration (TGA).
Dr Ken Harvey, Adjunct Senior Lecturer in the School of Public Health, La Trobe University, has some major reservations about the proposed reliance on industry self-regulation, insufficient focus on the promotion of so-called “lower-risk” complementary medicines and medical devices to the general public, and proposals to refer all all complaints about “efficacy” to the TGA “when this organisation has a proven track record of non-responsiveness and non-transparency”.
Harvey has prepared a detailed response to both papers, which Croakey is happy to forward to interested readers. Here is the summary of his response:
“While many of the measures proposed have merit, I have the following major concerns:
• A reliance on industry self-regulation (which has proven to be weak and self-serving);
• Apparent failure to involve other stakeholders, especially consumers and health professionals, in developing the common high level set of Code principles proposed;
• The focus on the promotion of so-called “higher-risk” medicines and medical devices to health practitioners which ignores the fact that most of the problems in this area come from the promotion of “lower-risk” complementary medicines and medical devices to the general public.
In addition, the current Code of Conduct of the Complementary Healthcare Council of Australia is arguably the weakest and least transparent of all industry Codes but this problem is ignored;
• The suggestion of referring all complaints about “efficacy” to the TGA when this organisation has a proven track record of non-responsiveness and non-transparency in complaint handling (although they do keep promising to do better).
The Consumers Health Forum and others have proposed that the current complex and convoluted co-regulatory system for therapeutic promotion would be better simplified and unified by creating one overarching principles-based Code applicable to all therapeutic claims and promotional practices supported by one monitoring process, one complaint (and appeal) 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 system should be funded by government and administered transparently by an expert independent committee representing the therapeutic goods sector, the advertising industry, consumers, healthcare professionals and government. Specific panels could deal with promotional activities targeting health professionals on the one hand and consumers on the other.
The system should have a legislative base in the Therapeutic Goods Act &/or regulations and be capable of being enforced. This would meet the requirements of the 2007 World Health Assembly Resolution (60.16.5) on Rational Use of Medicines that urged Member States (including Australia) to: ‘Enact new, or enforce existing, legislation to ban inaccurate, misleading or unethical promotion of medicines and to monitor promotion of medicines’.”
Update, 8 July: Carol Bennett of the Consumers Health Forum has sent in this response:
“The Consumers Health Forum has long championed the need for an ethical and transparent code covering both the promotion and advertising of therapeutic goods in Australia. Whilst the position papers released by Parliamentary Secretary Mark Butler do not go as far as we might want towards this goal, they do put industry on notice that if it doesn’t put its own house in order, the Government could legislate to do just that.
Health consumers have been calling for action in this area for many years, as they’ve watched a range of questionable products advertised and marketed in misleading ways. Examples include products in areas like weight loss and sexual health being promoted as ‘miracle cures’ with little or no evidence to support their claims.
CHF acknowledges that some industry groups have made strong efforts to improve regulation of their own sectors.
However, too many organisations and shonky operators are able to escape scrutiny, which is why we have argued for a strong, enforceable, transparent and overarching code that would apply to prescription, over the counter, generic, complementary medicines and medical devices. This is an important way of building consumer confidence in an industry that has been marred by incidences of misleading claims.
Health Consumers look forward to being at the table and having their say as well as reporting on our views of how the new promotion and advertising arrangements are going.“