1. That there is no intention to adopt the current Australian Therapeutic Goods Act in New Zealand.

Comment: The Draft Consultation Paper tabled by Medsafe 17^th December 2001 would indicate that there is every intent to adopt Australian regulations administered by a majority Australian presence at the decision making level.

Question: Can you explain your comment in view of Medsafe’s apparent support for the Draft Discussion Paper? If there is no intent on behalf of officials to pursue major elements included in the paper why then was it distributed in the first place?

2. That work is in progress to identify an appropriate regulatory framework for complementary healthcare products.

Comment: The Ministry has had some twelve years or more to introduce a sensible framework to upgrade Dietary Supplement Regulations. The proposed Health and Therapeutic Products Bill appears to have been scuttled by the Ministry.

Question: Can you account for the failure of the department’s officials to properly manage this legislation so that the Dietary Supplement Regulations serve both the public and industry and that both cease to live in an archaic Dietary Supplement Regulatory environment?

3. The reference to best regulatory practice that will adequately protect consumer health and safety.

Question 1: Can you supply verifiable documentation that supports regulatory controls of the nature outlined in the Draft Consultation Paper December 2001. In support of this question can you make available data regarding safety based on sound verifiable studies published in the medical literature?

Question 2: The proposal proposes to include dietary supplements as medicines. Can you provide risk analysis comparative data between medicines (for which there is ample precedent) and dietary substances?

4. It is proposed that an expert committee with members who are knowledgeable about herbal and complimentary products will provide advice on the safety of ingredients.

Comment: The discussion paper indicates that Australians will dominate the advisory committee and that there is no provision for New Zealand industry or public representation.

Question: Given the content of the Draft Discussion Paper regarding assurances of transparency and fairness with soundness in governance how would you respond to the proposal not to include both industry experts and public representation on decision making committees?

5. Consumers have a right to receive adequate, truthful information to enable them to choose wisely and use products safely.

Comment: The cost to public health and therefore Government is significant based on tired, inappropriate legislation that restricts the "right of individuals to know" and industry to provide. There is sound medical evidence available that would indicate there is presently in place, and an intention to reinforce the iron curtain approach to the provision of truthful information by industry and other sources to the public.

Question: Given the absurd and entrenched regulatory environment of the TGA which is reflected in the proposal how can you possibly assure New Zealanders as per your letter, that contrary to the American experience you can deliver a "right to know" information environment? (Example: court action by Pearson et al against the FDA ( Pearson vs Shalla 11) on the public’s "right to know" regarding the benefits of folate supplementation).

6. That the proposed legislation is not being influenced by multinational pharmaceutical companies.

Comment: The EU directive on Dietary Supplements on the 12^th March last was pushed through in the face of strong EU public opposition. (Reportedly 400 million votes against). Members of the supervisory boards of pharmaceutical companies are sitting on the European Commission (Example: Commissioner Bolkenstein). There is evidence that the genesis of Codex and its on-going decision making process is to a significant extent driven through elements of the pharmaceutical industry,

Question: Can you provide documentation to verify your statement?

Finally: your reference to "the need for public access to product and health information" is commendable if in fact that is the intent of the proposed legislation. The requirement to "ensure safety" must be supported and "appropriate standards of production control" need to be implemented and followed.