Industry chief: ‘Once-in-a-lifetime opportunity to slash the red tape’

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Put simply, Carl Gibson said too much public money was being spent on treating serious medical conditions that could be prevented if only Australians were encouraged to boost their own day-to-day health through the use of natural medicines and supplements. This made sense because, after all, prevention is better—and far cheaper—than cure.

Twelve months later, as the chief of the newly named Complementary Medicines Australia (CMA), he believes his message has been heard by a fresh government, itself elected just as Gibson was settling into office in Canberra.

Deregulation nation​

“From a year ago, we are in a different landscape​,” he says. “We were calling for an advocacy agenda for a system to move to wellness. We’re starting to see that now, but it’s up to us to capitalise on it​.

“The government has announced that it will deregulate complementary medicines and it’s going to set up a review to get the answers and craft what needs to be deregulated. This shows that our industry does carry a great deal of weight in the political circles of Canberra, as well as within the regulatory system​.” 

The benefits of deregulation are compelling. As if to echo Gibson’s sentiments, the Australian Self-medication Industry (Asmi), which represents consumer healthcare products, has just released a Frost & Sullivan report which put the net economic benefit of using complementary medicines in Australia at A$3bn (US$2.6bn).

“That’s potentially A$3bn off our health bill each year. It’s no wonder the government is keen to talk to us about our deregulation agenda​,” says Gibson, an Englishman who cut his teeth in political campaigning before turning towards regulation and advocacy.

Now CMA seems to have the ear of the government, it is pushing for a three-pronged assault to reform Australia’s notoriously strict regulatory system, its areas of priority being deregulation of ingredient approvals, advertising and manufacturing complexity.

“We call it ‘light touch, right touch’ for complementary medicines, though I must make it absolutely clear it’s not soft touch. We truly believe that we need to be regulated, but regulated appropriately for complementary medicines—regulated for the low-risk nature of the products we promote, manufacture and sponsor​.”

Relaying the framework​

Somehow the regulator, the Therapeutic Goods Administration (TGA), which as we reported earlier this week was blamed by a former CHC president, Professor Ian Brighthope, for stifling innovation and development within the industry when it was created through a government Act in 1989, also appears to be on side.

“We had to do a fair bit of pushing to get complementary medicines included in the review​,” says Professor John Skerritt, the TGA’s chief. “That may be surprising, but we have been strongly supportive of complementary medicines to be part of it, which might come as news to some. The evaluation is starting right now, so it’s important for the industry to engage​.”

Although Skerritt acknowledges that a form of deregulation is necessary, he is protective of the Australian framework’s reputation for safety and its drive to maintain quality.

“The message is often circulated that Australia is one of the strictest regulatory environments in the world of complementary medicines. We certainly have a strong regulatory framework and there are some regulators that don’t. But having the high quality required in our regulatory environment is of commercial benefit​.”

While largely agreeing with Skerritt’s assessment, Gibson’s focus in on finding the right formula that allows Australia’s complementary healthcare companies to maintain their reputations on the world stage while also allowing them to flourish in areas where the system has been holding them back. For example: reform of the current system of advertising pre-approval, one of his organisation’s three pillars for reform.

“Pre-approval of advertising is the most complex issue I’ve ever dealt with in my life, and I used to work in nuclear power​,” says Gibson. “Last year, you could market for food; this year, you can’t. Last year, you could market for osteoporosis in advertising; this year you can’t. Last year you could talk about restless legs; this year, it’s not allowed in advertising. What’s gone wrong with the world? it’s too complex​!

“We are making some reforms, so companies will start to see their advertising go through quicker, more efficiently, and our panel now has the ability to give approval for advertising with conditions​.” 

This never used to be the case: companies were told either their advertising was acceptable or it wasn’t. But still, Gibson thinks it’s a step in the right direction, but there’s still more on the advertising agenda.

“You have to take a step back and ask, what’s the point? Why are we unique as a low-risk product industry; why do we have this unique and quite odd pre-approval system in operation? Why are we guilty until proven innocent? So one of our key recommendations is that advertising is completely reformed​.”

‘The PM gets it’​

It has traditionally taken between 16 months and two years for companies to secure approval for a new ingredient. Last week, Prime Minister Abbot was damning about a system that allows this level of inefficiency. 

Announcing the government’s review of complementary health regulations, he said: “Businesses often have to undertake a regulatory approvals process to use or sell products in Australia that duplicates a process that has already occurred in other developed countries. This adds to costs and provides little or no additional protection​.

“As an important first step, the government will enable Australian manufacturers of medical devices the option of using European Union certification in place of TGA certification. This will place Australian manufacturers on the same footing as overseas competitors​.”

This is exactly what Gibson has been calling for: “The prime minister gets it. He says the best contention is that if [an ingredient is] safe somewhere else, why do we need to test it again. Why do we need to gold-plate the regulation​?

“It’s the access to new ingredients that invigorates our market; it’s the lifeblood of the products coming through to our consumers, so it’s absolutely key that we fast-track those products through​.”

Things rarely happen quickly or predictably in government, especially in the complex world of regulations, which is why Gibson knows it would be an error to slow down despite the significant strides towards reform. As a result, he is rallying industry players to get involved and maintain the level of pressure CMA has been applying since his arrival.

“When the TGA talks about the need for third-party conformity assessment, they also need examples. Just because somebody has done something elsewhere, the TGA doesn’t automatically know about it. ​

“They have to be shown international precedents before they can provide evidence for minister to sign off on. So if anyone has any knowledge of third-party conformity in other countries, we need to know about it​.”

Gibson believes the industry is now facing a “once-in-a-lifetime opportunity​” to develop a regulatory system that will encourage and promote complementary medicines to thrive, rather than maintaining the current pharmaceutical model that he says constrains its growth.

“And anyone who wants to get involved in the deregulation agenda, I urge them to do so as it’s absolutely critical to our industry to get rid of all that red tape​.”