Therapeutic Products Bill: Labyrinthine & unaccountable as it exits the starting gate?

No cost benefit analysis, an empty Bills Digest, no RIS, a governance culture that persistently ignores and underfunds diet & nutrition. Cabinet Ministers are letting us down.

Time to read: 11 mins

Yes, I understand the issue of tainted product, of substituted product and of toxicity, and the need to regulate dietary, or food supplements. But sweeping dietary and food ingredients with a long history of known use, in the same legislative framework as these technologies:

• new chemical entity – Compound never regulated or approved (not an active moiety).

• new molecular entity - active moieties (biologically active) not previously approved

• new active substance – new substance, or mixture of isomers which differ from previously authorised.

• new biological entity – contains human or non-human cells, bacteria, viruses, and material derived from those cells or viruses. Can be modified or engineered (including gene-edited).

… is wrong. And from the start, Andrew Little’s Bill downplays the degree to which the safety and risk from new drugs & biologics remain profoundly uncertain. Iatrogenic injury from medical inventions and drugs is far more extensively documented than dietary and food supplements.

The Bill is so messy, so complex that there is not a clear line of sight to understand how and who is responsible, when something goes wrong.

We have some 30 days to submit to the Therapeutic Products Bill.

MAIN POINTS

1. New Zealand is deviating from many (healthier) OECD nations by proposing to regulate food supplements via medicines legislation. Many countries, including the European Union, regulate natural health products that are traditional and herbal medicines, and vitamin and mineral supplements as foods or foodstuffs. They call them food, or dietary supplements.

2. Instead, Cabinet proposes that food supplements with a long history of safe use (and with known toxicity profiles) should be regulated under the proposed Therapeutic Products Bill alongside synthetically derived medicines and biotechnologies that alter genes and gene function.

3. Dietary, or food supplements are currently regulated under the Dietary Supplements Regulations 1985 and under the Food Act 2014. Instead, would become regulated as ‘natural health products’ (NHPs) – inside what is already acknowledged will be gargantuan and highly complex (see 5/288) legislation that is already difficult to understand and negotiate.

4. Cabinet appears to be Trojan horsing confusing standards for high-risk technologies into this legislation without precautionary text. The proposal directly downplays the potential for risk resulting from new technologies including biotechnology (and gene-editing such as Crispr) – which can change gene function. The Bills text very subtly (e.g. See clause 43) refers to biotechnology. This is surprising for novel technologies (biologics) that are historically regarded as high risk.

5. We can see from the accompanying Beehive press release that this Bill is envisaged as a ‘flexible regulatory framework’ that ‘enables New Zealand to take advantage of advances in medicine, such as cell and tissue therapies, emerging gene therapies, and the use of artificial intelligence and machine learning software.’ It’s industry friendly.

6. The proposed NZ Therapeutic Products Bill states that ‘Therapeutic products are divided into 4 types: medicines, medical devices, APIs (active pharmaceutical ingredients), and NHPs (natural health products) (see clause 20). The Bill regulates them differently because, by their nature, they have different benefits and risks.’ (p. 68/288).

7. The principles that define risk are loose and weak: ‘likely benefits of therapeutic products should outweigh the likely risks associated with them, and their regulation should be proportionate to those benefits and risks.’ Perceived risk depends predominantly on information and data supplied by the sponsor (manufacturer), or by other regulators, who may also depend on their sponsors. This distorts how risk will be evaluated.

8. No function authorises independent review of the scientific literature. Thus, any changing profile of risk in the scientific literature is out of scope. The Therapeutic Products Regulator will not conduct independent risk reviews and there is no provision for financial resourcing to ensure the Therapeutic Products Regulator (Part 9) can conduct their own separate review of the scientific literature to independently consider benefits and risks. Information gathering is limited to information from the sponsor or ‘reports, assessments, or decisions made by, or information received from, overseas regulators, overseas organisations, and other entities’ (pp. 132, 229/288).

9. It’s difficult to understand how biotechnologies are regulated. ‘Clause 32 provides for a medicine, a medical device, or an API to be a biologic if it contains human or non-human cells (including whole organs), viruses, and material derived from those cells or viruses.’ (9/288) Biotechnologies are subtly referred to as biologics that are ‘modified, engineered, or otherwise.’ (pp. 86, 91, 94/288)

10. The Bills Digest is empty.

a. No cost-benefit summaries have been provided for a proposed omnibus bill with thousands of pages of associated secondary legislation (see p. 5/288).

b. No survey of (e.g.) OECD nations with better health outcomes have been undertaken to identify what other nations have successfully inserted food supplements into medicines legislation. It appears most (healthier) nations regulate food supplements separately as a foodstuff.

11. New Zealand’s policy, research and education environment in relation to nutrition and dietary sufficiency is poor and under-serviced. Vitamins, minerals and fatty acids play an important role in supporting hormone (including neurotransmitter); metabolic; and (innate and adaptive) immune system function, and in prevention of cancer. This is under-recognised in policy and law in New Zealand.

12. Guy Hatchard has documented past attempts to regulate natural health products, consistent with the content in this Bill. Hatchard draws attention to commonly used herbal ingredients mooted for potential regulation/restriction. We can establish that, rather than New Zealand-based nutritional biochemistry experts making these recommendations, this information comes from the International Coalition of Medicines Regulatory Authorities (ICMRA), a group with historically no practical interest in nutrition, dietary supplements and the role of food in preventing disease.

13. The other major parties support the Bill. However, Dr Elizabeth Kerekere has drawn attention to Māori opposition to Rongoā Māori being captured under this legislation. Food supplements with a long history of understood use, which protect health and prevent and reverse disease should be excluded alongside Rongoā Māori.

GREENWASHING RISK FROM FOREIGN/INVENTED TECH

The Medicines Act 1981 currently defines medicine as a substance that is:

manufactured, imported, sold, or supplied wholly or principally for use as a therapeutically active ingredient in the preparation of any substance’ that ‘achieves, or is likely to achieve, its principal intended action in or on the human body by pharmacological, immunological, or metabolic means.’ While an ‘ingredient’ ‘includes a chemical or biological entity.

The Therapeutic Products Bill explains medicine in clauses 15-22 - because the claim ‘therapeutic’ must be extensively explained. It looks like it was drafted by the pharmaceutical and biotechnology industry because it massages what medical treatments are - obfuscating the fact that biotechnology is a medical treatment (p. 28-32/288)

‘Therapeutics’ is a marketing/rhetorical term which is designed to alleviate or diminish perceived risk that might be signalled through the use of technical terms that clearly iterate that a product is a biotechnology or some other molecular entity. It’s jargon that aims to promote trust, which we now see embedded by Andrew Little and his team, as a regulatory term. It’s greenwashing.

Quick note: Medsafe currently approves medicines, primarily via the Medicines Act 1981 (as well as other legislation). Pharmac’s operations (such as securing medications and maintaining and managing the pharmaceutical schedule) are directed by the Pae Ora (Healthy Futures) Act 2022.

Where is biotechnology inserted in this chart? Biotech (biologics) can be a medicine, a medical device or an API. But similarly, a drug sponsor can apply for a dietary supplement to be regulated as a medicine. It’s quite vague and opaque just how biotechnology will be regulated.

Note: The NZ EPA theoretically also stewards biotechnology, but did not consider (see section (1)) the investigational COVID-19 vaccine (BNT162Bt) to be a biotech, even though it encoded a viral antigen that would be expressed by the vaccine recipient. This sets something of a precedent for future regulatory actions.

Biotechnology comes under the term biologic - another marketable term.

Based on policy and governance over the last two years, there is clear evidence that the New Zealand government downgrades and dismisses dietary nutrition in public health. This is despite extensive scientific evidence base demonstrating how health can be protected - multifactorially (i.e. via multiple pathways which are often not only recognised, but required by the human body). Investment in this research is poor.

Investment in technological and medical innovation are policy priorities. Cabinet policy drives investment in technologies which seeks to cure a single condition - even if this drives further inequity. How? By neglecting the dominant of disease risk in those under 80 years of age - dietary and nutritional poverty, which drives multimorbidity.

NO REGULATORY TEETH

How can risk be understood when the proposed Therapeutic Products Bill does not permit the Therapeutic Products Regulator to independently review the scientific literature? This is where the vast bulk of independent literature, without financial conflicts of interest, is published.

Instead, the Therapeutic Products Regulator will rely on other jurisdictions with similar limitations, where they predominantly rely on data and information submitted by the Sponsor who has a financial conflict of interest in regulatory decisions. (See 13. above).

I’ve documented just how far the government will go to push a biologic, a gene therapy with a largely unknown toxicity profile through regulatory channels; and just how extensively they will avoid reviewing the scientific literature (i.e. accountability) to identify risk pathways. The last 3 years have also shown us the extent to which cheap off-patent, repurposed drugs will be sidelined, and the extent to which nutrition will be ignored. We’ve also seen how norms and values - basic public health ethics, have been swept aside and dispensed with.

This Bill informs us that Cabinet believes that technologies such as the mRNA gene ‘therapy’ used in the pandemic, which contained the directions for the body to code (in an uncontrolled manner) for a cardiotoxic, inflammatory spike protein, should be regulated under the same legislation as vitamin C – ascorbic acid or magnesium.

This big biotech frontier of medicine is new, under-regulated and rife with uncertainty and risk but government communications downplay this, by inferring that biotechnology as a medical therapy to relieve or heal a disorder will be a natural or logical step for healthcare. The production of new biotechnologies vastly outpace any regulatory efforts. Basically, regulators aren’t proactive and autonomous in this arena.

Consider, in contrast, food/dietary supplements with a long history of safe use.

OPAQUE & COMPLEX

We can predict that inserting food supplements into a Medicines Act would naturally increase the complexity of the Act by (theoretically) producing layers and layers of differential understanding on risk.

It would increase the difficulty the public would have in accessing and understanding the applicable legislation and the science and data that supports Regulatory decisions around dietary foodstuffs. Rather than increasing transparency and accountability, it would muddy the policy, legislative and controls arena.

 It would also increase the likelihood that officials and regulators would conflate the toxicological profile of food supplements with a long history of safe use with synthetic medicines for which the body frequently has limited degradation pathways and for which the body has no required daily requirement. Many pathways for drugs, biologics and dietary supplements remain unknown – but when a substance has a long history of safe use, there is a commonsense approach based on judgement. This approach can be over-ridden by technical approaches, particularly in cultures such as New Zealand where dietary health is poorly researched. This is apparent in previous attempts to regulate food supplements, as Guy Hatchard has documented.

And I emphasise – ad nauseum - the government doesn’t call them food supplements, or recognise them as dietary supplements (i.e., supplements that promote dietary sufficiency and prevent disease, unlike allopathic medical drugs.)

Thus, they are called edible (drugs are also edible). Food has been excised from our thoughts.

We can’t pretend that gene therapy is as important as dietary sufficiency for the maintenance of human health. We can recognise though, that the $billion dollar biotech market, with its patents, and projected ownership of gene-edited life forms is a highly lucrative market which is growing at between 13-15% (CAGR). Drug and biotech firms are much wealthier than nutritional supplement firms by an order of magnitude. They have far more extensive power to lobby to reduce regulatory barriers. These not only improve market access, but prevent us understanding what happens when things go wrong.  

This is a signal of market failure – and of the success of big pharma and biotech in ensuring that governments think the way they do.

But the role of the government is to prevent abuse of power, and ensure citizens are safe, so as to promote trust in the governors, by the governed.

FOOD AS BIOLOGICALLY APPROPRIATE MEDICINE

It is exceptionally strange that our government would stick dietary food supplements in the same Act as

‘medicines made from biological components, gene therapies, and advanced cell and tissue therapies.’

Whereas:

• natural health products are traditional and herbal medicines, and vitamin and mineral supplements.

We can see that the Parliamentary drafters have assiduously avoided any reference to the term ‘food’ – nor do they call them ‘dietary supplements’ – they don’t recognise that they promote dietary sufficiency.

Cabinet ignores the fact that the body has a need for nutritional adequacy in order to sustain health, and that modern diets do require supplementation in order to sustain health and prevent chronic disease. In a chronic disease tsunami – pandemic – tragedy - the New Zealand machinery of government, and our health and science systems remain persistently ignorant about food and nutrition. (I’ll justify these claims in a forthcoming article.)

While biotechnology investment is increasing, governments systematically underfund research into the dominant driver of disease – diet and the environment. We know, frequently, that dozens if not hundreds of genes are involved in the development of most chronic disease. We also know that 85-90% of chronic disease is directly caused by environmental exposures, and most commonly, dietary inadequacy and insufficiency. Genes play a small part of disease aetiology, the development of disease. As Rappaport (2018) describes:

the modest effects of heritable genetics suggest that exposures and/or gene–environment interactions are major causal factors

This ignorance creates the perfect void for such (predictably harmful) legislation to be introduced, and an absence of public sector expertise that might challenge it.

(This is why, up until the one-size-fits-all Pfizer-Biontech medical mandate in the pandemic was so strange - ironic. Up until this time, the frontier of medicine promoted, was precision medicine – recognising that each patient will have different vulnerabilities which drive disease, related to dietary inadequacy, microbiome and digestive tract function, as well as heritable traits including SNIPs.)

FOOD SUPPLEMENTS REGULATED SEPARATELY

A quick search reveals that the OECD nations our government admire and respect, don’t do this.

In Europe,  food supplements (including vitamins, minerals, amino acids, essential fatty acids, fibre and various plants and herbal extracts) – are recognised as foodstuffs. Concentrated sources of nutrients, required to correct nutritional deficiencies and maintain an adequate an adequate intake. The legislation recognises the history of safe use of the foodstuff.

Health supplements and traditional medicines are regulated by the food agency in Singapore.

Denmark regulates vitamins, minerals, plant ingredients and concentrated substances such as omega-3 fatty acids and amino acids as food supplements.

Dietary supplements in Sweden are regulated through the Swedish Food Agency’s Regulations on food supplements (LIVSFS 2003:9).

We know we will not see anyone in our legacy media parsing such nuances – that’s not their job anymore.

NO COST-BENEFIT: OMNIBUS BILL & TONNES OF SECONDARY LEGISLATION

This is an omnibus bill ‘a proposed law that covers a number of diverse or unrelated topics.’

Then Cabinet plan to draft a raft of secondary legislation (with brief Parliamentary oversight - like the kid who tastes the toothpaste so their breath will smell clean) will contain the rules (the controls), the nuts and bolts. As they noted:

A very large amount of secondary legislation will need to be made before the Bill comes into force. Much of this will be technical and detailed rules made by the Regulator. As an indication, under the equivalent Australian Commonwealth Act there are approximately 2,500 pages of secondary legislation plus regulations of 100 to 150 pages under each of the Australian State Acts. (p.5/288)

Apparently, the current ‘regulatory arrangement does not provide an appropriate level of assurance that products imported and supplied in New Zealand are safe or made to the appropriate quality standards.’

However, if you attempt to scrutinise the Bills Digest, which should contain Regulatory Impact Statements (RIS), and underlying information which justifies any content in a new Bill – it’s empty.

Therefore, the above claim about an appropriate level of assurance is not justified. We can assume persistent underinvestment in the regulatory environment to support the current Acts which regulate food supplements. Western governments persistently underfund any regulator. This is more likely a policy decision of funding (which is social and political) rather than a technical failure of the legislation. Where is this analysis?

Over the past 3 years, we’ve seen a decline in the production of RIS’s and a complete failure to apply cost-benefit assessments to new policy. Governance requires accountability. Democratic government actively erodes the checks and balances of democracy when they avoid these processes- they stop being transparent and accountable. They also diminish trust relationships when they persistently ignore weighty public submissions protesting new policies which frequently appear to be crafted by offshore owned management consultancies, rather than government officials. We now observe that the terms of reference (the scope for enquiry) of the Royal Commission chops out a bunch of stuff; that results will be published after the election; and that it will be chaired by a lockdown advocate.

These patterns of actions persistently erode norms and processes which protect and uphold democratic representative democracy; instead favouring of governing styles which more closely align with the beliefs, policy aims and goals of the corporate sector.

CAPTURED BY DESIGN – THE THERAPEUTIC PRODUCTS REGULATOR

This section briefly outlines processes which steer regulators to make decisions which persistently favour the regulated institution, rather than public or environmental health.

If we take the pattern or regulators that have been established for the protection of human health, and identify how these other institutions can become ‘captured’ we can estimate trajectories for proposed Therapeutic Products Regulator, which combine to result in an absence of regulatory ‘teeth’. There are many ways this can occur, a good book to read is Professor David Michaels’ The Triumph of Doubt.

Most recently a review on the financial dependency of drug regulators was published in the BMJ. The author, Maryanne Demasi (PhD) has detailed the declining evidentiary standards and shortening approval times of the FDA. If the FDA can’t do it – how can little New Zealand? In fact what is more likely, is that New Zealand will set precedents for weak regulation that can then be emulated by other industry-friendly regulators.

Factors contributing to regulatory capture:

1.     Dependency on industry money. The regulator will be funded through levies or via fees for applications. This produces a form of institutional corruption where the regulator adopts a service culture, or mindset of regulatory employees where they provide a service for a fee. The conflict of interest arises as regulators and industry work to mutual benefit, industry to achieve market access, and regulators can sustain a form of an industry-dependent business model.

2.     Service, not regulatory, mentality. Frequently in this model, a value for service mentality arises where timely and responsive approvals are demanded by industry. The toing and froing between regulators and industry through emails or email communications and shared files, questioning various aspects of applications encourages collegial relations.

3.     Revolving doors. It’s common in this model to observe revolving doors between lobbyists, industry and the regulator agency, where employees transition between institutions. Often lower paid regulatory staff will transition to higher paid private sector positions.

4.     No resources for independent regulatory risk assessment. Regulators depend on the regulated industry to supply the trial information and study data to support their approvals. This may be suitable in early stages when there is little information in the scientific literature (independent information, produced by actors other than the industry with the financial conflict of interest). However as a profile of risk or harm builds, regulator funding, tied to direct application processes, does not empower staff to conduct independent literature reviews to establish a safety or risk profile, and evaluate the cost and benefit of a new drug.

5.     Regulatory staff depend on industry for technical expertise. Industry scientists and staff may often have greater technical and scientific expertise than the regulator. Well-resourced industry actors have greater latitude to influence rules (controls) to ensure that controls reflect industry values and priorities. These controls can often be outdated, or fail to consider real risk, such as off-target risk, or risk observed in the scientific literature. Underfunding of public sector toxicology and nutrition has resulted in an absence of public-sector expert scientists that might provide expertise.

6.     No funding to review international policy or legal cases. Before the pandemic, the pharmaceutical industry had dropped to its lowest point. Pfizer was infamous for the largest settlement in history for pharmaceutical industry fraud. What occurs in court rooms, and in other jurisdictions is important. This is more than the technical details of one pharmaceutical substance. It speaks to how we trust medicine and how we build pharmaceutical medicine into policy.

Please contact me if you find my statements to be incorrect.