Regulatory reform will come, but don’t expect the world to change

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“I won’t be as bold to say it’s a once-in-a-generation move, but it will set the agenda through to 2020. That’s a fairly long period​,” said Professor John Skerritt, the head of the Therapeutic Goods Administration, which oversees complementary medicines. 

Often considered as the industry’s bête noir, the TGA has over the last 25 years overseen one of the world’s strictest regulatory systems even if many industry players complain of a byzantine approach to what they say is effectively a low-risk segment.  

Regulatory support​

However, Skerritt admitted the TGA had to do a “fair bit of pushing​” to get complementary medicines included in the government’s ongoing review of Australian bureaucracy, and was at pains to point out that the regulator was on the side of companies while ensuring that the consumer is still well covered.

“This may be surprising to hear, but we have been strongly supportive of complementary medicines to be part of [the upcoming review]​,” Skerritt said. “But whether or not you like it, it is not a review of the TGA. It’s a review of the regulatory framework, and a number of other reforms will be ticking along in parallel​.”

Prime Minister Tony Abbott has committed his government to embark on a swingeing drive to cut red tape, and last week it was announced that the complementary health industry would be one of the beneficiaries of a process to level the playing field by making approvals more straightforward for local players to attain.

“This is an important part of the government’s plan to cut red tape and foster a lower-cost, business-friendly environment with less regulation​,” Abbott announced.

“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​.”

Differentiation the key​

Skerritt believes it is important to differentiate between simple remedies and much more involved products that require closer attention.

“We do have lo look at low-risk complementary medicines. When I talk to regulators in other countries, most of them have a separate framework for high-risk herbal medicines that have some quite active pharmacological substances in them—let’s remember where most medicines in medical practice first came from; they came from plants​. 

“Most countries treat these differently from, say, bog standard fizzy vitamin B and C. Should Australia treat them differently? Quite possibly. If we did, it would enable the regulator to focus more on the high-risk herbal products​.”

It is hard to be loved as a regulator and it’s easy to be misunderstood, especially when you are expected to be all things to all players. According to Skerritt, companies believe the TGA has on hand every piece of available published research, though this is not the case.

For example, companies will sometimes expect the regulator to go out and look for overseas studies, which aren’t necessarily available. The key is working together, Skerritt believes.

Working in partnership​

“We need the industry to help us access information from other countries and regulators, rather than expecting us to go and get it​. Often, for intellectual property reasons, the company has to bring it to us, so we need to work closely with the industry​. 

“I’m a real advocate for aligning with international requirements; they are very variable but let’s work with overseas ingredients groups and work together on what they have, rather than doing it all by ourselves​.”

Even though the Therapeutic Goods Act was approved in 1989, and the TGA’s principles are well established, it is still possible to improve the way a regulator looks at its industry, says Skerritt, with the key being to improve the process and interpretation of guidelines, for which the government has now given the green light in its red tape review.

“We aren’t going through a full-on regulatory revolution, but there is a quiet revolution happening. We want to work together with the industry to build on the momentum​.” ​

Each day this week, FoodNavigator-Asia will be looking at elements of Australia’s complementary health industry, and assessing its progress in the face of a regulatory system that might well be trimmed to deliver greater innovation. Tomorrow, we will look at hemp, and how some producers are managing to go to market in spite of the current system.​