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TGA faces some questions over Sigma cruise

Sue Dunlevy did this story about Sigma, a generic drug manufacturer, wanting to take GPs and pharmacists on a luxury cruise visiting Italy, Malta, Corsica and Monte Carlo.  Former Victorian premier Jeff Kennett is billed as the keynote speaker at the conference advertised in the Australian Doctor magazine. The story was also picked up here.

Dr Ken Harvey, Adjunct Senior Research Fellow in the School of Public Health at La Trobe University, is reliably quick off the mark on these matters.  He’s already submitted a complaint to the Medicines Australia Code of Conduct Committee and has also sent the letter below to Mark Butler, the Parliamentary Secretary for Health. The letter is reproduced with Harvey’s permission.

Dear Mr Butler,

Re: Sigma Mediterranean Conference for GPs and Pharmacists; TGA and Ethical Codes of Conduct

I have attached advertisements and appended media coverage about this event which appears to breach Section 6.2 (hospitality), 6.4 (sponsorship) and 6.6 (venue) of Medicines Australia Code of Conduct.

However, Sigma, not being a member of Medicines Australia, has argued in the past that they are not subject to the provisions of Medicines Australia Code regarding such matters. I have also been told that the Therapeutic Goods Administration (TGA) supports Sigma’s view.

TGA’s letter of marketing approval requires the promotion of all prescription products (whether member or non-member) to comply with the requirements of the Medicines Australia Code of Conduct. In addition, the Therapeutic Goods Act 1989 notes that advertisement, in relation to therapeutic goods, includes any statement, pictorial representation or design, however made, that is intended, whether directly or indirectly, to promote the use or supply of the goods.

Clearly, the purpose of Sigma organising and promoting a 10-day Mediterranean cruise for doctors and pharmacists (with only one and a half days educational content) is to promote the use and supply of their products.

It seems self-evident that Medicines Australia Code should apply to this event and I cannot understand why the TGA has adopted a contrary view.

I should be grateful if, on my behalf, you could ask the TGA for an explanation of their ruling.

This Sigma event is yet another example of inconsistencies and double standards of Australian co- regulatory systems aimed at controlling unethical promotional practices.

Currently, Australia has a variety of complex and convoluted co-regulatory systems to control unethical therapeutic claims and promotional practices depending upon the type of product (innovator and generic prescription, over-the-counter and complementary medicines, therapeutic devices, food and cosmetics) and the media in which claims are made.

There are different standards and gross inconsistencies between various Codes of Conduct, their complaint processes, timeliness, transparency, sanctions, monitoring and effectiveness (see also: Harvey K. A review of proposals to reform the regulation of complementary medicines. Aust Health Rev 2009: 33(2); 279-285. )

In addition, the different jurisdictions involved in therapeutic claims made for “nutraceuticals” (functional foods) and “cosmaceuticals” (cosmetics) create additional problems.

It is time that this mess was simplified and unified by creating one Code applicable to all therapeutic claims and promotional practice; one complaint (and appeal) process, one monitoring 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 process should be overseen by government, funded by industry (using a moiety of product registration fees), and administered by an independent committee representative of all stakeholders. The system should have a legislative base in the Therapeutic Goods Act &/or regulations and be capable of being enforced. South African legislation provides a model of such a broader system (involving all types of medicines).

In May 2007, Australia (and other member states) adopted World Health Assembly Resolution WHA 60.16.5 on Rational Use of Medicines. This urged member states to, “Enact new, or enforce existing, legislation to ban inaccurate, misleading or unethical promotion of medicines, to monitor promotion of medicines, and to develop and implement programmes that will provide independent, non-promotional information about medicines”.

I have proposed (to the recent National Medicines Policy Forum) that the National Medicines Policy Committee set up a working party to consolidate the multiple existing Codes into a single Code and draft suitable enabling legislation.

I should be grateful for your response to this proposal which, I believe, would be a practical demonstration of Australian commitment to WHA Resolution 60.16.5.

Yours sincerely,
Dr Ken Harvey

• Croakey will keep you posted on any responses to Ken Harvey’s letters

Related Posts

Comments 1

  1. Simon Burrow says:

    This is not the first time that this has happened. API and Symbion are just as guilty. WHat a charade – it’s all about business gathering. Money that could be spent elsewhere. And guess who’ll be leating about margins in the Guild negotiations? The wholesalers, who else.

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CRANAplus conference 2014
Cultural Solutions - Healing Foundation forum 2014
Lowitja Institute Continuous Quality Improvement conference 2014
National Suicide Prevention Conference 2014