Complementary medicines regulatory reforms

In December 1998, a Working Party of industry, consumer and government representatives was established under the Chairmanship of Senator Grant Tambling to consider the regulation of complementary medicines by the Therapeutic Goods Administration.

Over a period of weeks, the working party developed a reform package which has been endorsed by all bodies. These reforms will be implemented through legislation and amended regulations, major policy reforms, new administrative procedures to facilitate advice and consultation, and information initiatives.

Legislative amendments

The legislation underpinning the reform package passed through the Senate on 11 March 1999 and the House of Representatives on 25 March 1999. The legislation was proclaimed on 1 April 1999.

Senator Tambling officially launched the reform package including the new Office of Complementary Medicines in late April.

Major policy reforms

The existing advertising controls for low risk complementary healthcare products have been the subject of criticism from a number of areas. To address this concern the Therapeutic Goods Advertising Code will be reviewed by the Therapeutic Goods Advertising Code Council (TGACC) with the assistance of the Complementary Medicines Evaluation Committee (CMEC). The review process commenced in March 1999.

Post Market Vigilance will play an increasingly important role in the regulation of complementary medicines. A more streamlined pre-market assessment process for low risk complementary healthcare products will allow early market access. A more targeted, transparent and rigorous post-marketing vigilance program will be implemented to ensure public health and safety.

Another element in the reform package was the issue of fees and charges by the TGA for complementary medicines. Industry has been concerned that sponsors of new substances entered onto the Australian Register of Therapeutic Goods (ARTG) currently must pay the cost for evaluation of those new substances. The "free rider" effect has been an issue for this sector. This means that any sponsor who subsequently wishes to list or register a product containing that substance benefits by not having to pay the initial evaluation costs. The complementary medicines industry has agreed to devise a new framework for fees and charges which does not penalise responsible manufacturers and suppliers of complementary healthcare products from entering products and new substances on the Australian Register of Therapeutic Goods (ARTG).

Advice & consultation

An Office of Complementary Medicines (OCM) has been established within TGA. The Director of the OCM, Dr Fiona Cumming, commenced work on 8 February 1999. Arrangements are being made to improve linkages with industry, consumers and other interest groups. Staff are being recruited to complement existing skills, knowledge and experience.

A high level Complementary Healthcare Consultative Forum (CHCF) will be established to promote Government and industry dialogue on complementary healthcare policy, trade, research and other issues as they arise. Membership will be drawn from industry, practitioners, consumer groups, Commonwealth and State governments. The Forum will be chaired by Senator Grant Tambling.

The Complementary Medicines Evaluation Committee (CMEC) has been made a statutory expert committee under the Therapeutic Goods Act 1989 with an expert advisory panel to be called upon as and when required. In addition to evaluating new substances, the CMEC will consider the level and quality of evidence to support claims in the marketplace, and the level and quality of evidence to support the safety of long term continuous use of complementary medicines.

Definitions

Legislative and regulatory amendments will be made to help identify and define complementary medicines.

The broad definition of therapeutic goods will be revised to exclude goods for which a Food standard exists and goods that have a tradition of use as a food in the form in which they are presented. This change will provide greater clarity at the food/medicine interface and provide more certainty for industry and consumers alike.

New administrative arrangements

A new Electronic Lodgement Facility (ELF) will enable faster and easier access for low risk complementary healthcare products onto the Australian Register of Therapeutic Goods by using new technology and more streamlined regulatory requirements.

A new approval process for low risk or "Listable" substances will enable Gazettal of decisions by the Minister in the Commonwealth Gazette rather than relying on the more formal and cumbersome amendment of Regulations under the Therapeutic Goods Act. This will result in a quicker, more responsive process.

The Director of the OCM, Dr Fiona Cumming,
and Senator Tambling

A Section 30 notice under the Therapeutic Goods Act 1989 tells sponsors that there is an error and/or omission in an application. New systems will be put into place to help sponsors minimise mistakes and omissions, avoid the threat of cancellation of approval, and remove unnecessary delays to marketing approval.

Section 7 of the Therapeutic Goods Act 1989 helps identify whether or not a product is a therapeutic good. Improved administrative arrangements will be put in place to enable decisive and timely action to provide greater clarity and certainty for sponsors, regulators and consumers.

More information

If you would like to know more about the Office of Complementary Medicines and/or Australia's Therapeutic Goods Administration, browse the TGA website (Complementary Medicines <http://www.tga.gov.au/cm/cm.htm>).