By Chris Arblaster, PHD, , ASMI (Australian Self-Medication Industry) - Healthcare Products
SubscribeAustralian and New Zealand are engaged in an experiment with wide-ranging implications for both markets, the region and international harmonisation efforts more generally.
Currently, more separates Australian and New Zealand markets than just the Tasman Sea. Though efforts in recent years have lessened the differences between scheduling and other regulatory issues, the two countries maintain two regulatory agencies and two systems of advertising controls.
Companies endure separate processes for bringing products to market, for packaging and labelling and other requirements. Among the interesting points of difference are that New Zealand allows direct to consumer advertising of prescription medicines while Australia does not and that complementary medicines are not currently handled similarly by both jurisdictions.
All that is available for discussion and potentially could change under a proposal now open for consultation.
The Trans-Tasman Therapeutic Goods Agency Project involves New Zealand and Australia giving consideration to establishing a joint agency to regulate therapeutic goods (medicines, medical devices, and complementary medicines) in both countries.
The goal of the project is to create a new agency that will replace the Therapeutic Goods Administration (TGA) in Australia and Medsafe in New Zealand. New legislation for both countries would set out what controls would apply to what therapeutic goods.
Industry Associations in both countries enjoy productive relationships with their respective regulatory agencies and are among the key consultation partners. The Australian Self-Medication Industry (ASMI) and the Non-Prescription Medicines Association of New Zealand (NMA) have been actively consulted since the initial stages of the proposal.
Whenever sovereignty is at stake or particular sector sees the possibility of losing some positive element in the current system, there is of course anxiety. Many ongoing concerns over the Joint Agency were adequately addressed at a recent New Zealand stakeholder meeting by Juliet Seifert (ASMI Executive Director and current Chair of the Therapeutic Goods Advertising Code Council, TGACC), Judith Brimer of the TGACC, Graham Peachy of the TGA and other key stakeholders.
The new arrangements would draw on the best features of the New Zealand, Australian and international approaches. The proposed joint agency is an enormous opportunity to take advantage of our combined markets while paving the way for future harmonisation efforts beyond Australia and New Zealand. A treaty would set out broad enduring principles for the agency. As the consultation paper describes, “The Agency would regulate therapeutic products using a risk-management approach, in which the degree of regulatory control would be proportional to the risk associated with the use of the product.”
This formal consultation document is now available, and comment on the proposals by New Zealand and Australian officials is sought. The consultation document provides information on the establishment and governance of the agency, and the regulatory framework that would apply to medicines, medical devices and complementary healthcare products.
The paper can be downloaded from www.jtaproject.com/papers.htm
ASMI will be conducting significant consultation with its members over the proposals before the official closing date for submissions on Friday, 2 August 2002.
If plans continue to stay on track, a joint agency could be a reality in 2004, marking unprecedented cooperation leading to real gains for industry as these markets merge.
Graham Peachey of TGA and Stewart Jessamine of Medsafe will give a joint presentation on the proposal to the annual conference of ASMI on 12 September 2002 in Sydney. Those interested in the conference are directed to www.asmi.com.au/events.htm.