RMI

Trans Tasman regulation hits rough waters

It's crunch time for decisions over the proposed joint regulatory scheme, the Australia New Zealand Therapeutic Products Authority, and it looks like the Government might not have the numbers to get it through the legislative process.

While the innovative medicines industry supports the concept, it shares some of the concerns that have been raised in Wellington. The proposals do need to be critically examined to ensure that we avoid burdensome bureaucracy and expensive compliance costs.

But, the implications of not going ahead are serious for patients and the innovative medicines industry alike.

"The bottom line for New Zealand is that the cost of regulation 'is what it is'. To fund an adequate service New Zealand businesses would be faced with charges comparable with those proposed for the joint agency anyway – but without the advantage of access to the larger Australian market," Dr Pippa MacKay, chair of the Researched Medicines Industry Association suggested.

Fee increases of the magnitude required to go it alone would inevitably have an impact on access to prescription medicines in New Zealand. The New Zealand market is very small and access to the market is significantly limited by current reimbursement policies.

It may not, therefore, be ultimately commercially viable to bring many of the new innovative products available in other countries to New Zealand.

Why do we need a joint agency? Can't we go it alone?

New Zealand, like many countries, is finding it difficult to independently provide full evaluation, control and audit functions to international standards.

Medsafe struggles to cope with volumes and the increasing complexity of pharmaceuticals. Further, its performance record is poor. The average time from submission to approval of new medicines (2005 figures) was over three years (1,100 days), and this is not improving.

Medsafe is about to introduce new charges, which are, in some cases, as high as an eight-fold increase. Yet it is making no commitment to improvements in performance and timelines.

"Logic suggests there will be a marked reduction of applications for registration of new medicines, which will in turn, further reduce New Zealanders' access to new and innovative medicines," Pippa MacKay said.

"Add to this the fact that currently medical devices and complementary medicines are not actively regulated in New Zealand i.e. they are only examined if a problem arises once they are in the market.

"From a public health and safety perspective this is unacceptable," she said.

A way forward?

While there are objections from various quarters regarding the detailed plans, or lack of them, for the joint regulator, in general there is support for the overall concept of improved medicines regulation and acknowledgement that New Zealand will have real difficulty in going it alone.

A way out of the impasse might be for government to wait until January until the finalised rules and processes for the new agency are available. Supporting the legislation without sighting these is a big ask for a number of players.

What's the best solution for New Zealand?

If sovereignty is important for New Zealand the 50:50 partnership proposed with Australia is the best deal we could possibly ever expect. It gives NZ an equal say in all decisions and the option to veto anything that we are not happy with.

Together, Australia and New Zealand can provide sufficient critical mass to ensure world-class evaluation, control and audit functions. A common regulatory regime would also provide access to a greater pool of scientific expertise. In turn these factors would provide consumers with rapid access to new and innovative medicines. Most importantly, New Zealanders will be assured that all therapeutic products, including complementary medicines and medical devices, will be safe, effective and of the highest quality.

Compliance costs associated with the joint agency will be cost-neutral or better for businesses already operating trans-Tasman as they will only incur one set of regulatory fees and associated costs instead of two.

The partnership will mean that businesses currently operating only in New Zealand will face increased compliance costs. But they could then potentially target a market of 24 million, rather than just the four million in New Zealand.

This newsletter is published on behalf of the
Researched Medicines Industry Association of New Zealand
The views and opinions expressed in this publication
are not necessarily those of the RMI.

For further information:
The Researched Medicines Industry Association Inc
PO Box 10447 Wellington
Phone 04 499 4277

http://www.rmianz.co.nz/

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