JUST PUBLISHED!!!

Uploaded to the New Zealand Parliament website on February 26, 2023.

The complete report (PDF) is available here.

NB. There was one error in the original submission. Therefore, a Supplementary Submission has been forwarded to the Health Select Committee (March 13,2023). We stated the word proportionate was mentioned far more times than it had been mentioned (PDF here).

AT A GLANCE.

The PSGR propose that the Bill is unfit for purpose and must be discarded. The principles and rules in the omnibus bill fail to entrench democratic norms of accountability and transparency that prevent misconduct and abuse of power. The Bill is not structured adequately to:

Recognise much greater risk from medical interventions over the product lifecycle.
Take account of financial bias (conflicts of interest) by Sponsors and overseas institutions.
Provide obligations and resourcing at high level to assist the Regulator with independent scrutiny, as drug and device safety and efficacy claims cannot be accepted at first glance.
Demand that the Sponsor and Regulator transparently discloses information sources and data.
Demand that the Regulator takes account of non-industry data throughout the product life cycle and that these requirements are structured at high level in the bill.
Make clear accountability and transparency requirements for market authorisation.
Make clear principles and rules for post-market surveillance and adverse event monitoring.
Steward off-label use in the public interest (appropriate to long-understood safety signals).

The Therapeutic Products Bill is an unsuitable regulatory instrument for dietary and nutritional products:

The Regulatory Impact Statement and the Bill’s content demonstrate that there is no scientific expertise regarding the benefits of nutrients and human physiology in the bill’s drafting.
The documents suggest that risk benefit considerations will and cannot take account of dosage and prescribing differences between clinical drugs with toxicological action and dietary and nutritional supplements with largely known toxicities. For example, nutrient intake not only concerns tolerance, but involves an intention to redress nutrient deficiencies.
The absence of feedback loops between nutritional scientists and between practitioners of nutrition and herbal medicines demonstrate an authoritarian and non-consultative approach.
The absence of scientific expertise implies that there is no capacity to recognise the potential for nutrients to redress large inequities experienced by Māori relating to health and disease.
Due to this technical and scientific ignorance, it is likely that increased regulation will increase barriers to nutrition by restricting supply and by increasing cost.
This may breach the Treaty of Waitangi principle of active protection.

Regulators are in place to ensure the safety of citizens and promote trust.

The purpose of this Bill is to protect personal and community health.
Regulation is in place to prevent abuse of power, i.e., limit the political and financial influence of the regulated industry.
Medical/biotechnological/pharmaceutical industries are markedly more powerful and more resourced than New Zealand regulators, and regulatory capture is a key risk.
Decision-making must be in the public interest and not unduly biased (subservient) to industry.

This omnibus bill focuses disproportionately on food and dietary supplements, and on end stage use by practitioners. It fails to put in safeguards to prevent regulatory capture. The risk of capture increases when a regulator depends on information sourced from large powerful interests, in this case, the medical, pharmaceutical and biotechnological industry.

Our 39-page submission considers issues that we propose have not been adequately considered by the Minister of Health and Cabinet:

[1] POOR LEGISLATION, A TINY REGULATOR & BIG BUSINESS. 5

[2] FAILURE TO CONSIDER ACTIVE PROTECTION OBLIGATIONS TO MĀORI. 9

[3] IMPROVEMENT REQUIRED : Regulatory transparency for market authorisation. 15

[4] IMPROVEMENT REQUIRED: Post-market surveillance and adverse event regulations. 18

[5] IMPROVEMENT REQUIRED: Risk that barriers to off-label use may increase. 21

[6] IMPROVEMENT REQUIRED: Product moratorium orders lack transparency. 21

[7] REGULATORY IMPACT STATEMENT: Unfit for purpose. 22

[8] NATURAL HEALTH PRODUCTS: Requires distinctly different regulatory culture. 25

[9] CONTRADICTORY: THE CLAIM THAT BENEFITS WILL OUTWEIGH THE RISKS. 28

[10] SERIOUS CONFLICTS OF INTEREST ACROSS INTERNATIONAL ‘HEALTH’ ORGS. 29

[11] CASE STUDIES: Protocols may favour toxic drugs and create barriers to nutrition access. 36

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2023 Therapeutic Products Bill

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