On the move: The transfer of Drugs between Schedules
In brief: Earlier this year, amendments to the Therapeutic Goods Regulations 1990 (Cth) (the Regulations) had the effect of allowing certain drugs which were previously available only as prescription medications, to become available as over-the-counter (OTC) medications, (for example, the morning-after pill, Postinor-2). Other drugs which were once available only from pharmacies, are now commercially available in supermarkets (such as Ibuprofen, an anti-inflammatory analgesic). Michael Seifried, lawyer, reviews the legal issues that surround the regulation of scheduled drugs
Introduction
The Therapeutic Goods Act 1989 (Cth) (the Act) is the principal legislation for the regulation of therapeutic goods in Australia. The Australian Register of Therapeutic Goods (ARTG), provides that all drugs manufactured for supply in this country must be either:
- 'registered' – which include both prescription (high risk) and non-prescription (low risk) drugs; or
- 'listed' – those that are considered a lower risk to consumers than registered drugs or drugs manufactured for export only;
in the ARTG, unless specifically exempted or excluded. The classification of drugs into one class or another, however, is not static – and as the examples above indicate, prescription drugs may become OTC medications (or vice versa) and drugs may also be shifted between the various schedules.
The means by which the movement of drugs from one part of the ARTG to another is achieved by a combination of legislative and regulatory means.
The regulatory framework
The Act provides for the Regulations to prescribe the ways in which 'listed' drugs may be transferred from one part of the ARTG to another.
The Regulations allow a manufacturer or sponsor to apply to transfer a 'listed' drug to the part of the ARTG for 'registered' drugs.
Such an application is a two stepped process. First, such applications must be made to the Secretary of the Department of Health and Aged Care. Then, the Secretary may refer the application to the National Drugs and Poisons Schedule Committee (the NDPSC) (which is comprised of members of State and Territory Governments as well as a panel of technical and industry experts).
In exercising its powers, the NDPSC must consider the toxicity and safety of a substance, the potential hazards of using the substance and the potential for its abuse as well as a number of other factors listed in the Act. The decisions of the NDPSC are contained in the Standard for the Uniform Scheduling of Drugs and Poisons (the SUSDP) relating to the classification of drugs and poisons into Schedules for inclusion into the legislation of the various States and Territories. Although these Schedules have no force in Commonwealth law, they are recommended for inclusion into the various State and Territory legislation, such as the Therapeutic Goods (Victoria) Act 1994.
The manufacturer or sponsor may also apply to have drugs transferred between Schedule 4 (prescription only drug) to Schedule 3 (non-prescription drug for supply by a pharmacist). In this way, Postinor-2 was rescheduled from a Schedule 4 (prescription only drug) to a Schedule 3 (non-prescription drug for supply by a pharmacist).
Conclusion
Decisions of the NDPSC must follow a process of public consultation, as prescribed by the Regulations. In relation to Postinor-2, for example, a large number of submissions were received in relation to the application to have that drug rescheduled from Schedule 4 to Schedule 3. However, recent media speculation has suggested that the Federal Government may yet decide to reclassify Postinor-2 as a Schedule 4 drug.
It is therefore important to be alert not only to the fact that drugs can be transferred or rescheduled upon application, but also to be aware of the procedures by which submissions in relation to those applications can be made to the NDPSC.
For further information, please contact:
- Richard HamerPartner,
Melbourne
Ph: +61 3 9613 8705
Richard.Hamer@allens.com.au