TGA's future directions

In my experience as an oncologist, Shadow Health Minister and now Parliamentary Secretary to the Minister for Health, the Therapeutic Goods Administration never stands still for long. While this perpetual motion is partly a natural function of being Australia's drug and device evaluation agency, it is also a credit to the staff who strive for the best possible practices.

As many of you would be aware, the major challenges currently keeping the TGA especially active include a review of the Therapeutic Goods legislation, harmonisation with the European community on device evaluation and the holding of an Alternative Medicines Summit. To update you on the review, KPMG Management Consulting has been appointed to undertake the review with senior consultants Kath Schofield and Ken Baxter leading the review team. I have requested that the team report back by the end of the year. A reference group has also been established to assist the review process and with membership from the whole spectrum of parties interested and involved in medicines, I am confident that positive recommendations will flow from this considerable pool of expertise.

As an aside, while in New Zealand recently undertaking activities in relation to the Australia New Zealand Food Authority, I took the opportunity to meet with my New Zealand counterparts Mrs Jenny Shipley, Minister of Health, and her Assistant Ministers Mrs Katherine O'Regan and Mr Maurice Williamson. While no formal discussions have begun or firm undertakings taken, we discussed the issue of harmonisation of therapeutic goods between our two countries and all agreed that such a course could be advantageous and deserved serious consideration.

This activity and the other major challenges I have mentioned are, of course, undertaken while the hectic schedule of usual TGA business continues. The effort and input from staff into all of these processes are appreciated and valued and I would encourage you all to assist where possible as the TGA moves forward in its important role assisting in the health and safety of the Australian community.

Senator Bob Woods

Alternative medicines summit

Major steps towards removing unnecessary barriers preventing ill people accessing alternative medicine have been taken at an Alternative Medicines Summit held in Canberra on 16th October.

"Today's summit has provided us with the first real baseline to determine the position in the community in terms of people with illnesses accessing the alternative medicines they believe they need," Senator Woods said. "The Government's policy parameters for alternative medicine was considered in detail and it is clear that steps can be taken to achieve our aim of removing unnecessary obstacles to alternative treatments. Today's landmark step is a cooperative effort by consumers, industry, practitioners and Government and places us on a path to a world-class, effective and workable regulatory system."

A full report will appear in the next issue of TGA News.

TGA regulatory review

Earlier this year, Senator Woods, the Parliamentary Secretary to the Minister for Health and Family Services, announced that he had commissioned a review of Australia's current approach to the regulation of medicinal products.

Terms of Reference agreed by Senator Woods, after consultation with a range of industry and consumer stakeholders, require that the Review report by end December 1996 with recommendations on means of improving the speed, effectiveness and cost-efficiency of the current approach. Senator Woods had indicated that the Review should recognise the high priority the Government places on protecting the health and safety of the public and on freeing Australian business from unnecessary or unduly complicated regulatory requirements. In particular, the Review will investigate:

1. Restrictions on advertising of medicinal products*;
2. Increased use of medicinal evaluation reports and decisions from overseas regulatory agencies in countries with comparable regulatory standards with a view to enhancing medicinal product approvals through-put;
3. Options for the regulation of orphan drugs;
4. Approval processes for alternative medicines with a view to ensuring any inappropriate existing impediments are removed;
5. Export arrangements to remove any unnecessary regulatory obstacles for Australian manufacturers and exporters while maintaining appropriate standards for Australian exports.
6. Appropriate mechanisms for stakeholder input to - the regulatory process;
7. The food-medicinal products interface.

*Medicinal products means therapeutic goods other than devices

A team of consultants from KPMG Management Consulting has been appointed to undertake the Review of TGA. KPMG were appointed to this task following a selective tender process conducted by Senior Executive Officers of the Department of Health and Family Services. The selection panel considered proposals from five independent consultancy teams.

The KPMG team is headed by Ms Kath Schofield, KMPG's National Director Health Industries Group and comprises Professor Don Birkett from the School of Medicine, Flinders University and Mr Ken Baxter, Director of Management Consultancy, KPMG, Sydney. A Secretariat has been established within the Department to provide support to the consultancy team.

As stakeholders involved with these aspects of TGA's work will appreciate, many individuals and organisations have already made a considerable effort to address many of the issues of relevance to this Review, through submissions and input into recent related inquiries. To capitalise on this effort, the Secretariat is, where possible, accessing existing submissions, such as those prepared in the context of the Industry Commission Inquiries into Packaging and Labelling and the Pharmaceutical Industry. These are being used to initially inform the Review.

Existing information is being supplemented where necessary and appropriate. For example, stakeholders have been invited to submit further relevant information and the Consultants are gathering information on the policy, legislative and administration frameworks operating in other relevant countries in respect of the Terms of Reference.

In all instances stakeholder input will be integral to the review process, which will result in a report detailing a range of options on issues addressed in the Terms of Reference.

A key mechanism for ensuring stakeholder input into the Review is the Reference Group established by Senator Woods to provide day to day expert advice to the consultant and to act as a sounding board in respect of options under consideration.

Senator Woods has asked Mr Ian Lindenmayer to Chair the Reference Group and has agreed the following composition for the Group: Dr Janice Hirshorn Director, Policy and Strategy Development, Australian Pharmaceutical Manufacturers Association Inc); Ms Juliet Seifert (Executive Director, The Proprietary Medicines Association of Australia); Mr Ian Spencer (Nutritional Foods Association of Australia (NFAA); Professor Terrance Campbell (Department of Clinical Pharmacology and Chair of the Royal Australasian College of Physicians - Therapeutics Committee); Dr Kerry Bone (Lecturer in Herbal Medicine, practising herbalist and member of Traditional Medicines Evaluation Committee and member of the National Herbalists Association); Mr Andrew Wood (on behalf of Senator Woods' Office and TGA); Professor Stephen Leeder (President, Public Health Association); Ms Janne Graham (Consumers' Health Forum of Australia Inc); Mr John Woods (Executive Director, Cosmetics, Toiletries and Fragrances Association of Australia); Mr John Bronger (National President, Pharmacy Guild of Australia); and Dr Giselle Cooke (Health Network Australia).

While the Reference Group will be an important source of informed opinions and ideas, the Consultants are expected to draw advice and information from a wide variety of sources and are liaising with a wide range of organisations and individuals with an interest in the Review.