Australia: Nicotine Inhaler Testing the Law

Source from:  Tobacco Reporter 04/25/2016

Following a decision by the Federal Court, Australia's national drug regulator will have to decide whether a nicotine inhaler offered by British American Tobacco's Nicovations Australia may be sold over the counter.

According to a story in the Sydney Morning Herald, Nicovations last year applied to register its Voke inhaler with the Therapeutic Goods Administration (TGA) as an over-the-counter drug.

But the TGA declined to consider the company's application, saying it had incorrectly used the form for an over-the-counter medicine instead of for a prescription medicine. The TGA argued that the inhaler could be considered only as a potential prescription medicine because it contained nicotine, which is classified as a dangerous poison in Australia.

So Nicovations took the TGA and the Secretary of the Department of Health, Martin Bowles, to the Federal Court where judge Alan Robertson quashed the TGA's decision. He ordered both the secretary and the administration to "determine [the company's] application according to law" and to pay Nicovations' costs.

Robertson declined to rule on whether the nicotine in the inhaler should be treated as a dangerous poison. "These are technical or scientific questions and they need to be decided in accordance with the statutory scheme, in the first instance, by the secretary and then, if necessary, by a reviewable decision of the minister and on external merits review by the Administrative Appeals Tribunal," he said.

Towards the end of last year, the UK's drug regulators gave the go-ahead for Voke to be sold as a quit smoking aid, making it the first such product to be given a drug license in the UK, where it can now be prescribed on the state-funded National Health Service for patients trying to give up smoking. Enditem