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ANZAC spirit fails drug test

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Hopes to make drugs in Australia and New Zealand cheaper and more quickly available have been dealt a blow after the Federal Government announced that plans to bring the regulation of drugs and medical devices across the Tasman under a single umbrella have been abandoned.

In an unheralded development that has also dented efforts to increase trans-Tasman co-operation and economic integration, Australian Health Minister Peter Dutton and his New Zealand counterpart Dr Jonathan Coleman have jointly announced agreement to “cease efforts” to establish a joint therapeutic products regulator.

The announcement brings to an abrupt end 11 years of work, after the two countries jointly committed in 2003 to the establishment of the Australia New Zealand Therapeutic Products Agency to oversee the regulation of medicines and medical devices across the two jurisdictions.

The decision comes despite the fact that both governments reaffirmed their commitment to the Agency as recently as last year, when the-then Prime Minister Julia Gillard and NZ Prime Minister John Key issued a statement reiterating their commitment to the ANZTPA.

At the time, the prime ministers said the agency “should provide for efficient and cost-effective regulation of medicines and medical devices…[as well as] a trans-Tasman centre of regulatory excellence for positioning Australia and NZ therapeutic producers in the regional and global market place”.

In 2011, the countries agreed to a three stage approach over a period of up to five years that would see the scheme operational by mid-2016.

The decision to axe the project is a blow to efforts to increase economic co-operation and integration between Australia and New Zealand, given that the ANZTPA was to have been the first fully joint trans-Tasman regulator.

It raises doubt about the prospects for success of other attempts to achieve some form of trans-Tasman harmonization.

In their joint statement, Mr Dutton and Dr Coleman said the decision to abandon the project was taken “following a comprehensive review of progress and assessment of the costs and benefits to each country of proceeding”.

“Each country will now proceed with its own domestic therapeutics regulatory reform program, but we remain open to future co-operation activities,” the ministers said.

The Abbott Government has already initiated a review of Australia’s therapeutic goods regulatory regime amid industry complaints the system is too bureaucratic, costly and slow.

A particular gripe is that sponsors are required to conduct tests and provide evidence for products that have already been approved for use by regulators in other countries, particularly in Europe and the US, and the review will consider automatic approval for therapeutic goods already accepted by credible regulators offshore.

Despite abandoning the ANZTPA project, the ministers said their two countries would “continue to co-operate on the regulation of therapeutic products where there are mutual benefits for consumers, businesses and regulators in each country”.

Adrian Rollins