KEY POINTS:
Dr Graham Sharpe's opinion is, well, sharp. A small but loud sector of the pro-vitamin lobby has hijacked a bill which would have benefited patients with better, faster access to new medicines.
They did so "by telling lies", says the president of the New Zealand Society of Anaesthetists. The lobbyists shouted the loudest, the media largely focused on them, missing the real point, and opposition politicians gave in to point scoring.
Sharpe and others believe what is left is a big mess. He is talking about the now postponed Therapeutic Products and Medicines Bill, legislation which would have allowed a joint Australian and New Zealand therapeutic products agency to go ahead.
The authority would have regulated prescription medicines for both countries and, for the first time in this country, regulated the complementary health industry.
And, boy, does the complementary health industry need to be regulated, says Sharpe.
Some in the pro-vitamin lobby went ballistic about the bill. They went on marches, chanted and spent big money on an advertising campaign which suggested natural health businesses would go bust and products would disappear. New Zealand, they said, would be dictated to by Australian bureaucrats.
What the public heard less about was another reason why a transtasman arrangement is so important. This has to do with New Zealand's small population size - and drug companies.
The legislation was about a lot more than vitamins, says Sharpe. Without a joint agency it will be more difficult for a country of New Zealand's size to access new and improved drugs, some vital to anaesthetists and other doctors trying to save lives.
Anything from break-through cancer drugs to improved arthritis medication may be harder to get.
Sharpe is not alone in his dismay. The New Zealand Medical Association, which represents doctors and patients, has condemned the failure of the legislation. The drug companies are not happy - and neither are people from within the natural health industry who supported the regulation of their industry.
Michelle Beckett from Natural Products New Zealand, for example, took on the protesters, going to the Advertising Standards Authority with a list of complaints about misleading, deceptive and scaremongering advertisements.
Two days ago, she won on all counts. Beckett believes many of the protesters have vested interests in natural health products and were simply against any regulation.
But regulation would ensure natural products of the highest quality with ingredients true to their label, she says. Any company that had a problem with that should not be in business.
In the advertising campaign the protesters claimed, among other things, the Government was trying to "outlaw vitamins". Not true, says Beckett.
"One of the big pieces of misinformation out there was that hundreds if not thousands of products were going to disappear from the shelves."
How could this be true? she asks, given that Australia has more than 16,000 natural health products on the market and 80 per cent of products on the shelves in New Zealand pharmacies and supermarkets are already sold across the Tasman.
She is pleased her complaint has been upheld but says it is too little, too late for the public.
The doctors and the drug companies want urgent action. The joint agency may not have been the perfect vehicle but would have addressed a number of concerns.
New Zealand already has a regulatory authority, Medsafe. When a company wants to put a new drug on the market they must apply to Medsafe for registration.
On average it takes three years for registration to come through, then companies must wait to see if Pharmac will fund the drug.
Medsafe is widely criticised as under-resourced and under-funded. Last year, fees went up from $16,000 to $122,000 per registration. Drug companies say they are having to think hard about whether to bother licensing drugs here, given a market of around 4 million people. It makes more sense commercially to register through a joint agency with Australia and reach a market of more than 20 million people.
Dr Pippa MacKay, who represents the drug companies, says since the fee hike there has been a 70 per cent drop in products being filed by the drug companies.
This means a lot of innovative and useful products are not coming on to the market in New Zealand because of the existing regulatory framework.
"Why we need Australia is because our regulatory authority is not able to manage on its own.
"We are too small and the skills you need to do the sort of evaluations we need are not easy to find."
New Zealand, like the rest of the world, has a shortage of experts who can evaluate new drugs.
Earlier this year Merck, Sharp & Dohme had to make a decision about whether to register a new HIV drug. Managing director Alister Brown won't name it but says it is a new class of HIV treatment for people for whom everything else has failed.
In the end, they decided to file the product and an "accommodation" with Medsafe was reached over the filing fee. The drug is only needed by a few hundred people and the registration cost high for little return - but those people really need it.
The company had considered delaying in case the transtasman agency went ahead, then simply waiting until the drug was registered in Australia, he says.
"I would imagine other companies have had to make calls on drugs and have waited in the assumption there would be a transtasman agency. So there's already been a delay if you like, probably for the last 12 months with a lot of companies simply not filing their drugs," says Brown.
Those companies will now have to decide whether to bother. For Merck Sharp & Dohme, the issue will be recurring. They have three or four new cancer drugs in the pipeline and "this will be a dilemma, I can tell you, when they get to the point where we're ready to file them", says Brown.
He worries about what will happen and how difficult it will be to get a solution that gets broad political support: "Going with a joint transtasman agency was not a bad solution."
Experts also point out that although Australia is a lot bigger than us, the agency was to have had a minister from each country heading it.
Cameron McIver, chief executive of the Medical Association, says New Zealanders will miss out without the agency. The process is slow, cumbersome and extremely expensive. New Zealand, he says, will slip further behind.
Dr Sharpe says doctors here will find it increasingly hard to provide the same level of care to patients as their counterparts in Australia and he blames a small number of complementary health lobbyists.
Sharpe says the industry needs to be regulated. He is not joking when he says some products have been found to have traces of human remains - "ground up human bone" - and arsenic. Not many, but without regulation of products we will never know what is in them.
He is angry with Sue Kedgley of the Green Party who opposed the bill, saying she is ignorant, and says the National Party opposed the bill purely for political expediency.
Interesting, he says, that the idea for a joint agency emerged out of a review of CER (Closer Economic Relations) in the 1990s - under National.
Asked why the medical professionals did not win the argument, Sharp says it is not easy. When he spoke at a select committee earlier this year representing more than 400 anaesthetists, "I got the same time as some health provider selling bee pollen."
The lobbyists are sticking by their claims. Health Freedom New Zealand, which ran the advertising campaign, still has on its website, "NZ Govt moves to outlaw vitamins."
Patrick Fahy, who says he wrote the organisation's response to the advertising complaint, is not repentant. Neither is he jumping for joy that the bill has failed.
The legislation has not been dumped, he says, it has simply been put aside until Labour can get the numbers to pass it. "We may have won the battle, or a battle, but we certainly haven't won the war and I can assure you I won't be giving up on this."
Fahy talks a lot about sovereignty, concerned that Australians would dictate to New Zealand.
"I don't want some bloody bureaucrat telling us how to run our affairs. They can't run their own affairs over there; Australian health statistics are worse than our own."
If Medsafe did not have the resources to do the job properly then "get rid of them and let's put some people in there that can do the job".
The medical professionals would say this was exactly what a transtasman agency would have been able to do. The irony is, they say, that the Government has made it clear it will still regulate complementary products one way or another.
And the double irony is that by keeping the current struggling system, New Zealand will likely see a rubber stamping of decisions made elsewhere, in Europe and America - and Australia.
