New medicines body draws criticism

Australia and New Zealand?s plans to establish a joint medicines authority has drawn widespread criticism, especially in New Zealand where it is feared the $140 million complementary medicines and food supplements industry will be devastated.

The new agency will replace Australia?s Therapeutic Goods Administration (TGA) and New Zealand?s Medicines and Medical Devices Safety Authority, and will operate similarly to the Food Standards Authority.

But critics fear it will restrict the range of permitted goods and forcing it to adhere to pharmaceutical manufacturing principles, as required in Australia. They say New Zealand will lose control of its regulations to Australia, and that the government has ignored a report from a year-long inquiry that found there was no need to regulate food supplements as drugs.

Pros and cons
Amy Adams, a spokesperson for the dietary supplements industry?s educational body, the NZ Health Trust, said the move was a massive blow to the industry. ?We have evidence showing this will cost consumers choice, increase compliance costs and see New Zealand jobs disappear,? she said. ?We feel really betrayed by the New Zealand government throughout this whole process.? Ms Adams said the TGA had been a ?spectacularly unsuccessful? bureaucracy.

New Zealand?s Health Minister, Trish Worth, said the single agency would expand drug regulations in New Zealand to complementary medicines and medical devices. ?This is all about quality, public safety and standards. We require standards for the food we sell ... we require standards for pharmaceuticals and medical devices. And one of the hard lessons I learned this year (from the mass Pan Pharmaceuticals recall due to impropriety) was that the public demanded standards and regulations for complementary healthcare.?

Critics noted there had never been a death from a food supplement in New Zealand and that the Pan incident took place in Australia.

Allan Crosthwaite, a spokesperson for the Complementary Healthcare Council of Australia, said smaller manufacturers would be hardest hit by the new laws when they came into effect in mid-2005.

?These firms import small volumes of therapeutic goods from countries such as America and under the new scheme the US companies will have to meet certain GMP standards to manufacture for New Zealand,? he highlighted. ?Most US companies will not be interested in supplying New Zealand because the cost of obtaining a GMP license will far out-weigh the benefits of supply, so a lot of the little importers will be wiped out.?

Change is inevitable
Despite this, Crosthwaite said regulatory change was inevitable and warned the fall-out was being greatly exaggerated.

?There is a great deal of misinformation floating around and it is causing enormous angst. New Zealand stores have indicated that they will lose 30 per cent of their products. The Australian and New Zealand governments have not done a good job of informing the industry and public in New Zealand of the facts. The trend all over the world is toward improved regulatory provisions for complementary healthcare; the US is currently consulting on GMP requirements and other countries are considering improved legislation. Australia has built a good reputation for quality and safety worldwide and our industry has benefited from this reputation. Harmonisation would hopefully open many exporting opportunities.?

The Australian supplements industry was pushing for a division in the new body to deal with complementary healthcare, he noted. ?The problem is a lot of the decision-makers for our industry sector do not have a background in herbal medicine—they have been trained in a sickness-orientated model rather than a wellness model. We?d like to see an office of complementary medicine that is staffed by experts in our field. Perhaps now is the time for the industry to get recognised as a separate sector within the Australian healthcare system and not as the poor cousin to the prescription medicine industry.?

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