Complementary Medicine Section established

In recognition of the growing use of complementary medicines in the Australian community, TGA has established a new section to provide technical and secretariat support to the Complementary Medicines Evaluation Committee (CMEC). The Government has directed that CMEC be established to provide expert advice on complementary medicine. The section will also provide policy and technical advice on complementary medicines. The Complementary Medicine Section, which will be headed by Laurayne Bowler, will take over the functions of the Alternative Medicine Unit from the Listing, Treaties and Alternative Medicine Section. This Section will now be known as the Listing, Treaties and Export Section.

OTC Drug Evaluation - Transfer from Victoria to Canberra

The 1996 "Review of the Evaluation Process for Registrable Non-Prescription Drug Products" recommended that the responsibility for evaluation and the conduct of the Medicines Evaluation Committee (MEC) should be transferred to the TGA during 1997. The contract between the Victorian Department of Human Services (VDHS) and the Commonwealth was finalised on 30 June 1997 and the Therapeutic Goods Unit (TGU) of the VDHS has been wound up. From 1 July 1997, the newly restructured OTC Drug Evaluation Unit within the Chemicals & Non-Prescription Drug Branch (CNPDB), TGA, will be responsible for evaluation of registered OTC products and the establishment of a new Secretariat for the MEC.

In announcing the successful transfer of these activities, the Acting Director of the CNPDB, Ms Laurayne Bowler, commented that the Victorian evaluation unit was to be commended, as it had done a very professional job of evaluation and support for the MEC for many years. However, the shift back to the Commonwealth would facilitate greater consistency across the TGA and moves towards trans-Tasman harmonisation of drug controls.

The transition from Victoria to Canberra has run smoothly. The TGA OTC Drug Evaluation Unit commenced evaluation of all new applications from 1 April 1997 and in winding down, the Victorian TGU achieved its contractual objective to present evaluations of all applications submitted to it by the TGA to the MEC, at least once, by 30 June 1997. Unresolved applications will be finalised in due course by the TGA Unit, which has commenced the transfer of the MEC drug files to the TGA registry. At transfer, there were 86 outstanding applications for registration, the majority of which are awaiting company responses.

Medicines Evaluation Committee

To ensure a seamless transfer, the Victorian MEC will continue under State legislation until September, to allow time for the establishment by the Minister of a Commonwealth transitional committee. The new MEC will be established as a statutory committee under the Therapeutic Goods Act 1989 during 1998.

OTC Drug Evaluation Unit

The OTC Evaluation Unit has been restructured and expanded with new professional officers. The new staffing profile consists of:

The new evaluators have commenced a period of intensive on-the-job training in all aspects of OTC drug evaluation. Dr Maxine Stevens, a former senior evaluator in the TGU in Melbourne, will assist with formalised training sessions during late July. To assist in maintaining target times during this transition period, temporary external contracts have been let to several of the previous TGU staff.

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Mevinphos under review

The Chemicals and Non-Prescription Drug Branch recently assessed all available public health information including toxicology studies, dietary exposure information, medical case reports, scientific papers from the open literature and submissions from the public, on the insecticide mevinphos, as part of the National Registration Authority's (NRA) Existing Chemicals Review Program. The NRA's review also included assessment of the environmental and occupational health and safety aspects associated with mevinphos use in Australia. The TGA found that the potential for public exposure to mevinphos is low, as there are no registered uses for mevinphos in or around the home and mevinphos is already in a restrictive poisons schedule - Schedule 7 - of the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP).

At the completion of the review process, the NRA concluded that mevinphos posed an undue hazard to users who mix, load and apply the chemical, based on the acute toxicity of mevinphos. As a result, the NRA recommended that most registered uses of mevinphos be cancelled, with a complete phase-out of registrations by December 1998.

Prior Informed Consent Scheme

The Prior Informed Consent Procedure is an international program requiring countries which take national action to ban or severely restrict a chemical on health or environmental grounds to notify this action. This information on the action taken, and the reasons for the action, are supplied to a Secretariat which is jointly run by the United Nations Environment Programme (UNEP) and the Food and Agriculture Organisation (FAO). When notifications have been received, and the evidence of the health or environmental concerns has been considered, the chemical may be placed on an international list. Countries then have the opportunity to notify whether they wish to continue to receive the chemical or not. This scheme is currently voluntary, however negotiations are underway to draft and agree to a legally binding arrangement.

Pharmaceuticals are currently exempt from this procedure in its current draft form. This means that banning a pharmaceutical for health related reasons would not require a notification of control action, and would not lead to international control on the export of the chemical.

An officer from the Chemicals and Non-Prescription Drugs Branch attended the third Intergovernmental Negotiating Committee meeting for the development of a legally binding instrument in Geneva in May, as part of the Australian delegation. This meeting clarified the positions of the major participants, however did not make significant progress towards negotiated text. Importantly, there was no further work on the exemptions list, and it is therefore not yet confirmed that pharmaceuticals will be exempt from the scope of this legally binding procedure. The fourth negotiating meeting is due to be held in late October.