Vol. 22 No. 3 June 2002

I have just read a policy statement issued by the Australian Medical Association. It reminded me of similar positions published by the American and the New Zealand Medical Associations. At its heart is the problem for the orthodox medical establishment posed by the wide public acceptance of “unorthodox” medicine. For years the establishment was held in such esteem that it felt safe to ignore alternative medicine or make dismissive statements whenever comment was sought on the subject. Now, however, it can no longer cling to this position and so is assuming an attitude of conciliation. I think the establishment’s view may be summarised like this:

Complementary medicine is okay so long as it comes up with evidence of efficacy and safety to a degree comparable with that asked of mainstream medicine. Which, in reality, means it must undergo a conversion to orthodoxy to be acceptable. And beside, who will pay for this exhaustive process?

Government-appointed bodies must be set up to vet unorthodox medicine. These bodies must have heavy representation from people who know little about alternative medicine. It is unthinkable that the practitioners of alternative medicine might have sufficient integrity and intelligence to decide such things for themselves and become autonomously self-regulating.

GPs, medical students, etc, should be taught about alternative medicine so that they as “true medical professionals” can advise their patients on other therapies – no matter how superficial their knowledge of such things may be.

The concept of integrated medicine, like in China where practitioners of Western medicine and traditional medicine cooperate, is too hideous to contemplate and must never be mentioned.

A lot of these attributes are demonstrated in the current moves to form an Australian and New Zealand joint policy on the regulation of therapeutic goods. A paper entitled “Draft consultation paper on establishment, governance and a proposed regulatory framework for a trans- Tasman therapeutic goods agency” – prepared jointly by the Therapeutic Goods Administration (Australia) and Medsafe (NZ) – was released on 17 December 2001.

Consternation reigned among the natural health people here who saw the text, because its content was very different from what they had been led to believe. I reproduce here sections that I think apply to homœopathic medicines, potentised beyond being poisonous or requiring prescription:

Functions and scope of the trans-Tasman Agency
The Agency would be responsible for ensuring the quality, safety, efficacy and timely availability of therapeutic goods supplied in or exported from Australia and/or New Zealand. The goods to be regulated by the Agency would include prescription medicines, over-the-counter (OTC) medicines, complementary medicines (including dietary supplements other than food type dietary supplements) and medical devices.
The Agency would provide structures and mechanisms to regulate therapeutic goods using a risk management approach.

Complementary medicines would be categorised as high-risk, medium-risk or low-risk complementary medicines. High- and medium-risk complementary medicines would be subject to premarket evaluation. Low-risk complementary medicines would be granted a marketing authorisation on the basis of selfcertification by the sponsor and validation of key requirements by the Agency.

Medicines intended only for export from Australia or New Zealand (but not from Australia to New Zealand or vice versa) would be granted an export-only licence.

Some therapeutic goods and kinds of goods would be exempted from specified regulatory requirements.

Post-market activities would be undertaken in relation to all of the above types of goods, commensurate with the assessed risk associated with their use.

There would be provision for either country to “opt-out” of a regulatory decision in pre-agreed and extraordinary circumstances. The regulatory activities undertaken by the Agency would include:

evaluating and assessing therapeutic goods for safety, quality and efficacy.
maintaining a database, or register, of therapeutic goods that are licensed for supply in one or both jurisdictions or are for export only.
granting, refusing, varying, suspending and revoking product licences authorising the supply of goods in one or both jurisdictions; licences to export from one or both jurisdictions (applies to export only good); licences to manufacture therapeutic goods in Australia or New Zealand.
evaluating substances for inclusion in a list of substances that may be included in low-risk medicines or complementary medicines.
Complementary medicines
Further work will be done on terminology and the definition of “complementary medicines”. For the purposes of this paper, the term “complementary medicine” has been used to describe those complementary healthcare products that are, or are represented to be, for therapeutic use and that do not meet the definition of medical device.

Also, for the purposes of this paper, complementary medicines are those medicines consisting wholly or principally of a substance that has a clearly established identity and a tradition of use and/or a history of tradition of use. These substances would be defined in the legislation.

It is anticipated there would be a process by which the list of substances permitted for inclusion in a low-risk complementary medicine could be expanded prior to start-up of new legislation. This would enable complementary medicines currently on the New Zealand market to be categorised as low-risk complementary medicines after the substance has been assessed for quality and safety. A safety assessment would be required to be done before a new substance could be added to the list.

Risk-based approach to the regulation of complementary medicines
A risk-based approach would apply to the regulation of complementary medicines. Complementary medicines would be classified as high, medium or low risk complementary medicines, depending mainly on the substances they contain and the indications/claims made about them.

Low-risk complementary medicines would generally be granted a product licence on the basis of electronic assessment and sponsor self-certification. The Agency would undertake audits of these goods to check that the certifications made by the sponsor were correct.

In the Green Party Complementary Health Newsletter of March 2002, Sue Kedgley, the Green Party Health Spokesperson, gives vent to strong objection to the proposed plan. She says:

“Under the proposal the Government would transfer control of dietary supplements, such as herbs and vitamins, to a new trans- Tasman body which would be located in Australia, set up under Australian law, staffed primarily by Australians and which would most likely adopt the current Australian regulations which treat dietary supplements as medicines.

“The proposed agency has far more sweeping powers than even the Australia New Zealand Food Authority (ANZFA). ANZFA evaluates and makes recommendations on food, food labels, ingredients, etc, but does not regulate and license individual food products. “By contrast, the Therapeutic Goods Agency would have complete control over the importation, manufacture, licensing and registration of all dietary supplements used in New Zealand and Australia. Any supplement that was imported into or manufactured in New Zealand would have to be registered and licensed with the TGA. Manufacturers would only be permitted to use ingredients that had been approved by the TGA, and it could cost as much as $10,000 for a new substance to be added to the list

“The Managing Director of the proposed Agency (almost inevitably an Australian) would have extensive delegated powers to make and change rules relating to dietary supplements. The only way a New Zealander could challenge any decision the TGA had made would be through an expensive judicial review in the High Court which could cost an estimated $20,000.

“Handing over the control of such an important industry to a trans-national agency dominated by Australians is absurd. Can you imagine Australians allowing control of their medicines, medical devices, and dietary supplements to shift to New Zealand? Absolutely not!”

In response to the MP’s impassioned protest Robin Boldarin, a spokesperson for Annette King, the Minister of Health, said:
“There is no intention to place dietary supplements and natural medicines under the Medicines Act . . . no intention to adopt the current Australian Therapeutic Goods Act in New Zealand.

“The New Zealand and Australian Governments have agreed to investigate establishing a trans-Tasman agency to regulate medicines, medical devices and health care products for Australia and New Zealand. If the joint agency proceeds, new legislation will be required in both countries. This would replace the Medicines Act in New Zealand and the Therapeutic Goods Act in Australia. It would not come into force until 2004 at the earliest …

“Under new legislation, all products used for therapeutic purposes would be regulated according to risk associated with their use . . . regulatory controls would be significantly less stringent than those applied to prescription medicines, in recognition of the different levels of risk.

“Manufacturers would need to have a quality system in their factory and there would need to be a screening process for new ingredients to ensure they are safe for short and long term use. “An expert committee with members who are knowledgeable about herbal and complementary health products will provide advice on the safety of ingredients. Companies will be able to make truthful claims about the health benefits of their products on labels and in advertisements.

“Dietary supplements and other complementary health care products will continue to be available from herbalists, supermarkets, health food stores and other retail outlets.”

There is so a great difference in view between these two camps I think we will have to wait till the proposed legislation is open to submissions from those interested.

The Homœopathic Society is particularly concerned that legislation such as this should define “homœopathic” in a manner it finds acceptable, and does not leave a loophole allowing all the current bogus stuff labelled “homœopathic” to continue to be available.

Bruce Barwell