Trans-Tasman harmonisation… a bridge too far

On 20th November 2014, Ministers for Health in Australia and New Zealand announced that work on a mutual therapeutic products regulator would cease. Although stalled on numerous occasions since negotiations commenced in 1999, this long-winded attempt at harmonising Australia's regulatory and registration authority, the Therapeutic Goods Administration (TGA), with Medsafe, its New Zealand counterpart, was reaffirmed as recently as June 2011 with formation of an Australia New Zealand Therapeutic Products Agency (ANZTPA).

The arrangement had promised cheaper and more readily available medicines, and smaller regulatory burdens for pharmaceutical and medical technology industries. It had potential to reduce duplication through adoption of common dossiers for product registration (thereby accelerating registration processes) and to address inconsistencies in Australia's regulatory system to conform to best practice principles agreed by the Council of Australian Governments (COAG).
 
The Ministers have now offered some benign remarks about continued cooperation "where there are mutual benefits". This must be interpreted in the context of conspicuous differences between Australian and New Zealand regulatory environments. New Zealand's relatively liberal attitude towards new technologies and deregulation of prescription medicines may ultimately have proved irreconcilable with the bureaucratic, insular and risk averse disposition of Australia's TGA as well as cumbersome arrangements administered through the Advisory Committee on Medicines Scheduling that ultimately reserves poisons scheduling responsibility to States and Territories.
 
Other examples of possible obstacles include New Zealand's greater emphasis on industry self-regulation and freedom to directly advertise prescription medicines to consumers. Australia limits non-prescription advertising to an approved list of just 10 ingredients. Unscheduled, low risk 'therapeutic goods' to which Australia's pervasive advertising controls apply include such innocent items as medicated soaps and some toothpastes.
 
New Zealand's progressive approach to switching medicines with established safety profiles from prescription to non-prescription contrasts with Australia's caution towards innovation.
 
Between 2003 and 2013 New Zealand proved a world leader in non-prescription switches yielding consumer gains by offering improvements on existing non-prescription medicines or effective non-prescription therapies where none previously had existed. This has created greater scope for self-care and personal health accountability than in Australia.
 
Abandonment of ANZTIPA seems hard to reconcile with the Australian Government's declared agenda for deregulation and competitiveness and represents a symbolic blow to a long standing agenda for closer economic cooperation between Australia and New Zealand.
 
Even more bewildering (to New Zealand especially) was the announcement on 24 October, 2014 that the Australian Government would independently review the TGA's regulatory framework for medicines and medical devices. This seemed to cut across years of past negotiation devoted to Trans-Tasman harmonisation.
 
Indeed, the impending review's Discussion Paper canvasses precisely the issues that would have been the substance of lengthy negotiation with New Zealand. An underlying justification for the new review is examination of "how international risk assessments might be better utilised within the Australian system" so as to fulfil its "innovation and competitiveness agenda". This could involve TGA acceptance of prior European or United States certification of medicines and medical technologies.
 
As worthy and unexceptionable as such goals may be, it is incomprehensible why they could not have been pursued concurrently with Trans-Tasman harmonisation.

David Gadiel is a Senior Fellow at the Centre for Independent Studies.