Too Much Red Tape

The Right Prescription is most concerned with the Government’s proposed Australian/New Zealand Single Joint Agency to regulate medicines, medical devices and dietary supplements. Increasing harmonisation with Trans-Tasman regulations under CER is generally supported, particularly when trade barriers and business costs are reduced.  Regrettably the current proposal with regard to dietary supplements and medical equipment has the reverse effect.

Red tape, bureaucracy and unwieldy regulations permeate our health sector.  While some regulatory frameworks are necessary, all too often they fail to achieve their intended purpose - with some serving no good purpose whatsoever. Red tape reduces efficiencies, imposes unnecessary costs and reduces the quality of services while frustrating all concerned.

Dietary Supplements

In New Zealand dietary supplements are not treated as drugs but rather as foods – a status confirmed in the Dietary Supplements Regulations 1985.  The United States followed the New Zealand lead in 1994 with the passage of the Dietary Supplement Health and Education Act, which also treats supplements as foods. In 1995 public consultation on the new Act was held and some 850 submissions clearly indicated that the public did not want access to supplements restricted, nor for them to be classified as drugs, nor to pay higher prices for regulation.

The question has to be asked – what is the problem and where is the mischief?  Officials cannot show one case of a death resulting from the taking of dietary supplements.   Ordinary food is far more likely to cause harm – yet the Government proposes to make consumers pay for a strict and expensive regime for dietary supplements that bears no relation to the risk (or lack of risk) they pose.

Australia has been out of step with world thinking in this area since it implemented its Therapeutic Goods Administration in 1991.  Australia has worked for the past 10 years to export its system around the world without takers.  According to the International Committee of the American National Nutritional Foods Association, Australia is viewed internationally as having the most draconian regulatory regime for dietary supplements in the world.  Why would we want to adopt such a system?

The Australian system works as a positive list where all herbs, vitamins, minerals and other nutritional ingredients must be registered and placed on an approved list before it can be sold. The application form for a new substance is 14 pages long and costs NZ$5,725 just to lodge the form.  If the application includes clinical or toxicological data, evaluation of this costs a minimum of a further NZ$5,725.

Where is the evidence that Americans or New Zealanders are at risk from their relatively light-handed regulations?  Where is the evidence that Australians are safer after paying huge fees to their bureaucracy? A good example of the restrictive nature of the Australian regime is colostrum.  This is a derivative of the New Zealand diary industry, and exported all around the world in capsule form. 

A New Zealand Company commands 80% of the lucrative USA market but it is effectively banned in Australia because its supplier has so far been unable to get it on the official list.  Unquestionably the New Zealand consumer will get a rough deal under the Government’s proposal and New Zealand suppliers of dietary supplements will be driven to the wall. 

We have a very healthy, vibrant and growing dietary supplements industry in this country with a lot of further growth potential (including for exports). If the Government proceeds with the proposal then this growth will be truncated, consumers will lose choice because some 40% of our dietary supplement market is imported from third countries principally the USA and Canada and many of them will likely be knocked out of the market by the Australian regulations, or more likely the manufacturers will not be prepared to meet the unnecessary strident Australian registration and labelling conditions for such a small market.

Surely it would make more sense for us to allow New Zealanders unfettered access to products that have passed the credible standards of regulators such as the US Food and Drug Administration or similar agencies.  Why compromise with an Australian system that shuts out competition and restricts consumer choice for no good reason?.

• The Australian regime protects vested business interests, mainly in Australia.
• The Australian regime creates expense and red tape for dietary supplements even for those that have passed the test of credible agencies such as the US Food & Drug Administration.
• The Australian regime creates non-tariff barriers against us.  It reduces competition, increases prices and reduces consumer choice.

The Right Prescription is of the view that we should be reducing red tape and compliance costs within the health sector, not adding further layers of it.

Pending Legislation

Government intends to release a discussion document soon with more details about New Zealand’s adoption of the Trans-Tasman Therapeutic Goods Agency proposal.  We predict that because of the contentious nature of this proposal it may now be put on the back burner until after the General Election.  If returned to office however it seems the Labour Government has made the commitment to go down this path, which would be disastrous for consumers and suppliers of dietary supplements in New Zealand.

We urge all New Zealanders who support freedom of choice to make submissions on this discussion document.  We must oppose any proposal that increases costs or restricts choices without good reason.

- Written by
- ACT New Zealand Health Spokesperson: M.P. Ken Shirley
- edited by Jacqui Leeden