A recent Australian case (http://www.austlii.edu.au/au/cases/cth/FCA/2016/394.html) has touched on the tricky area of nicotine containing products, this time in the guise of product known as the Voke Inhalator, which contained 0.43mg of nicotine in a pressurised inhalation can. The supplier of the product was seeking to register the product as an OTC product, but our regulator, the Therapeutic Goods Administration (TGA), refused to consider the application, on the basis that the wrong form had been used.
For those who follow the realm of nicotine-based products, and adjacent things such as electronic cigarettes, the underlying issue of regulatory categorisation is of great ongoing interest.
The Federal Court of Australia overturned the decision by the TGA to refuse to consider the application of Nicovations Australia for the Voke Inhalator.
The Therapeutic Goods Act (the Act) requires an application for registration of a therapeutic good to be in accordance with a form approved by the Secretary to the Department of Health (or a delegate). Once an application has been made, the application must be evaluated by, in practice, the TGA under section 25 of the Act. Nicovations applied for registration of the Voke Inhalator using the form that the TGA specifies for over-the-counter products. The TGA decided that, because of the presence of nicotine (a schedule 4 restricted product), the Voke Inhalator could not be an OTC product and declined to evaluate the application. Nicovations stated that the product fell within the exception to nicotine contained in the Poisons Standard (which does not schedule nicotine if it is indicated for tobacco cessation and prepared for oromucosal use). Nicovations sought judicial review of the TGA’s decision.
Nicovations alleged that it had requested registration using “a form” approved in writing under section 23 of the Therapeutic Goods Act, albeit, arguably, the wrong form. Nicovations asserted that, in this instance the requirements of the Act were satisfied, meaning that the TGA had to accept, and evaluate, the application. The failure to use the correct form were, in the arguments of Nicovations, matters that should be considered and determined as part of the evaluation, and not from a preliminary screen. The TGA argued that because Nicovations had used the incorrect form, it was not made on a form approved by the Secretary in writing under section 23 of the Act, and was therefore not an application made in accordance with the Act.
Justice Robertson was required to determine whether or not Nicovations had made a complying application. The parties also requested the judge to decide whether or not the Voke Inhalator should be correctly categorised as an over-the-counter medicine or a scheduled poison. The judge determined that the assessment of the correctness of Nicovations’ contention that the product was an over-the-counter drug ought not to be made at the time of correctness of the form, but rather required evaluation under section 25. There was, Justice Robertson stated, “nothing flowing from [Nicovations’] use of the approved form it used, to prevent the determination of the application”. The application might still have failed as not being an over-the-counter product, but this required an evaluation.
However, Justice Robertson declined to make a decision as to whether the Voke Inhalator should be allowed to be registered as an over-the-counter product, stating that this was a “technical or scientific question…to be decided in accordance with the statutory scheme”.
The decision should not be taken as having major implications for sponsors of most products. The fact that there is a stated, specific exception to nicotine being a scheduled poison suggests that ordinary applications will still require the correct form to be used. This is confirmed by Justice Robertson’s statement regarding the potential failure of the application.
