Therapeutic Products Bill – The Devil is in the Detail

Citizens are sending in their comments after viewing the 200-page hydra that is the Therapeutic Products Bill, now before Select Committee.

So far, over 30,000 individuals and groups appear to have forwarded their thoughts for consideration.

The central function of this legislation is to protect health, but all indications point to an outstanding level of regulatory capture, before the ink was dry on the draft Bill.

Regulatory capture doesn’t pop up overnight. It is a gnarly mix of weak principles and rules which promote corporate dependency, and ensure financial impotence.

It takes energy and resources to give regulators ‘teeth’. Democracies have to embed obligations in law which require officials to look beyond industry data, and craft laws which provide financial resources separate from user fees to support drug applications.

We can only consider that Health Minister Verrall’s top priority is to get this draft Bill through. To use her medical expertise to assuage political concerns. I’m not confident that Verrall has demonstrated a mindset that can be sceptical of large pharmaceutical and biotechnology industries’ claims of safety and efficacy.

Officials and citizens need to be sceptical of billion dollar industries with histories of misrepresentation and fraud, which include illegal marketing, failure to report safety data.

This Bill does not require the new Regulator to proactively conduct enquiry into the safety and efficacy of products, be it in the scientific literature, or to review court documents following offshore decisions.

It’s not just the unjustified stuffing of nutritional and dietary supplements into the replacement Medicines Act, there’s a lot more on the table.

HARM FROM DRUGS VASTLY OUTSTRIPS HARM FROM NUTRIENTS

The most obvious technical repositioning in this draft Bill is Cabinet, and the Ministry of Health’s action to make nutritional and dietary supplements come under medicines legislation. Somehow these Ministers believe regulated food and dietary supplements should be regulated alongside medical and biological drugs, and medical devices. Even though they stated they would exclude them, in 2018.

Regulatory Impact Statements (RIS)should justify a Bill’s content. The Ministry of Health (MoH) is presumably informing the RIS, but demonstrates no consideration of nutritional and biological knowledge which might guide and inform officials.

Lacking any judgement based on the science in the peer reviewed literature, it appears that food and dietary supplements will be regulated toxicologically, presuming that only so much of a ‘drug’ is possible. No scientific evidence was provided demonstrating the potential for hospitalisation and death from these products. The RIS failed to make any mention of the disproportionately greater iatrogenic risk from medicines, biotechnology (biologics) and devices.

It is unlikely that scientific, historic and cultural practices that underpin issues such as tolerance, what tolerance infers risk-wise, and the issue of nutrient deficiency will be taken into account. Nutrient deficiency can be addressed by recommending higher dosages in order to support optimum health for a person. That ‘stuff’ is way out of scope, and likely irrelevant for the purposes of the legislation.

The logical conclusion of the knowledge gaps is that the medical model will apply to any regulatory management of dietary and nutritional supplements. The Minister claims regulation will be proportionate to risk, but doesn’t define proportionate.

It’s contradictory from the get-go.

I believe that if passed, this legislation would produce grave injustices, including even greater barriers to these nutrients that Pharmac keeps forgetting to fund, and that low-income families, nutrient deficient from poor diets, struggle to pay for.

But it is critical to look even more deeply. Because a lot of what they don’t do is not stated. It’s not obvious.

OMISSION OF OBLIGATIONS MAKES THE BILL DANGEROUS

Yes, the devil is in the detail – that is not there.

The Health Minister and Cabinet have failed to state important obligations in law requiring the proposed Regulator look beyond industry to consider other scientific evidence. They’ve also failed to require that the Regulator disclose the data supplied by industry in support of market authorisation.

Remember, medicines today include biologics, which can be designed to alter gene function, and medical devices which are ‘software and production systems’. Regulatory oversight must be robust.

It’s easier for Regulatory cultures, practices and norms to bend to influence and power when principles and rules are poor or non-existent.

The Therapeutic Products Bill principles opaquely call for ‘benefits to outweigh the risks’. Why is there no guidance on what benefits outweighing risks actually mean?

How can we ever claim that benefits outweigh the risks when nowhere – absolutely nowhere – is the Regulator required to review non-industry data across the product lifecycle. When nowhere in this overarching legislation, are there rules clarifying obligations to ensure transparent reporting of adverse events. This stuff is basic feedback loop (triangulation) stuff, it prevents the Regulator from exclusively navel-gazing at industry-funded data.

Nowhere do the principles require that benefits outweighing risks should take into account basic issues such as the health status and age of an individual. This is public health 101.

REGULATORY CAPTURE ON THE CARDS

When there is little transparency and accountability, when small regulators depend on the big institutions with extensive conflicts of interest as the only source of ‘truth’, capture is more likely.

What is Regulatory capture?

‘the practice whereby private industry professionals or lobbyists overtake regulatory agencies to serve their own interests’

Capture doesn’t just arise from legislation and regulatory processes that directly serves the regulated industry (the Sponsor). Capture arises from the construction of legislation that forgets to literally require regulators look beyond corporate sponsored data, and build in complaint mechanisms when this happens.

The problem is a global one. Nations convene at the regulatory level to exchange information. But the problem is, these drug and device regulators also depend on industry data to arrive at claims of safety and efficacy.

Often, regulators simply depend on industry analysis of their own results, rather than raw data. Did you see any obligation in the Bill preventing these short-cuts? I didn’t.

SECONDARY LEGISLATION – JUST THE TICKET FOR BIG PHARMA

An Act of Parliament provides ‘rails’ to guide the behaviour of officials.

Why did I call this Bill a hydra? It’s an omnibus bill. The Therapeutic Products Bill is an overarching, umbrella piece of legislation. The minute it is approved, officials will set to work to not only change to lots of other related legislation, but produce even more, potentially hundreds, if not thousands of pages as secondary legislation. As the drafters note:

Those hundreds of pages of secondary legislation don’t require Parliament’s assent or public oversight.

That’s why it is critical that the legislation must have impeccable principles, rules and safeguards at the highest level to ensure that the Regulator must be accountable, transparent, and not default (bias) decision-making to favour industry claims. Regulatory rules must ensure officials will not be subservient to the medicines, biotechnology (biologics) and devices industries.

That’s why the Regulator should be required to triangulate the scientific evidence in the independent scientific literature against the claims of the pharmaceutical or biotechnology corporation set to make the big bucks after market authorisation.

If these obligations are not in this legislation, they’re unlikely to be magically inserted downstream.

Lacking overarching obligations, the Bill is drafted in such a way as to privilege large medical, biotechnological and pharmaceutical industries at every turn.

FORGETTING TRANSPARENCY OBLIGATIONS TO PREVENT BIAS

Interestingly, the Health Minister focuses much more on the behaviour of the regulated, rather than their own behaviour. Imagine, preferring to create rules for someone else, and not for yourself.

Many more rules concern downstream regulation, once drugs are approved and in the pipeline; than rules for upstream regulation, rules guiding the MoH’s regulatory behaviour for approving medical drugs and devices. This includes the methods by which the regulator gathers information and judges the acceptable safety, quality and efficacy or performance of therapeutic products across their lifecycle.

The stated purpose of the bill (and future Act) – protect personal and community health involves looking at their internal conduct concerning drug approvals as well as issues once products are released into the marketplace.

More pages have been drafted concerning downstream regulation – manufacture, supply, administration and use of medicines, biotechnology (biologics) and devices.

The Minister and Cabinet, are relatively uninterested in requiring disclosure of the scientific evidence used by the Ministry of Health and the Regulator to arrive at conclusions on the safety and efficacy of drugs.

They haven’t specified which overseas institutions have authority to inform the Regulator on an issue, despite the suggestion that New Zealand should ‘align’ with international decisions.

Nowhere do the principles demand that the overseas institutions that the Regulator co-operates or aligns with, including the World Health Organisation (WHO), should be 100% independent of financial conflicts of interest but is not. WHO partner institutions have overlapping financial conflicts of interest and their licensing agreements remain largely undisclosed.

WE’VE GOT THE CASE STUDY TO PROVE MINISTRY CAPTURE

We’ve just observed how intricately officials depend on industry claims, from the COVID-19 drug approval processes.

We observed Ministers patently ignore the role of natural immunity and the time-limited promise of the mRNA Pfizer/BioNTech gene therapy. Claims of efficacy were based on lower levels of symptoms two weeks post second dose then translated to global mandates. Responsible Minister Hipkins and medical doctor Verrall always understood that the endpoints never promised to prevent transmission of infection.

Verrall co-authored an early elimination strategy paper which set the climate for lockdowns, and her signature is all over the mandate Orders. Ministers Hipkins and Verrall worked closely to require perfectly healthy people to submit to a novel mRNA gene therapy that had never been tested for risk of genotoxicity and carcinogenicity.

Extraordinarily, the trial data for pregnant women still haven’t been released.

The approval process for mRNA Pfizer/BioNTech gene therapy involved the adroit navigation of a mind-blowing range of loopholes in a short space of time. Safety data was hidden from the public, with no line of sight to see whether the Sponsor had fulfilled the obligations in the Gazette.

The mRNA Pfizer/BioNTech gene therapy was a higher-risk biological entity; yet granted a secretive data protection period for five years.

Official Information Act requests that the regulator never reviewed the scientific literature to triangulate any of the Sponsors claims against the published scientific evidence as time progressed.

Our job is to learn from this experience, so as to require our health agencies to protect health.

WHAT WE MUST INSIST UPON

When we see, and we understand, then we can trust. Trust that our families and children will be safe. Trust that the regulator doesn’t rubber-stamp drugs and devices through in a biased fashion.

Abuse of power and misconduct arises when principles and rules are poor. Principles can have a controlled scope and fail to work meaningfully at high level. This has happened in this Bill.

Regulatory transparency and accountability provisions must be inserted in future medicines legislation at high level. When we have transparency, when we see how decisions are made, we can better anticipate and prevent harm.

The stakes are high. Hundreds of pages of secondary legislation will be produced away from public scrutiny.

Abuse of power and misconduct arises when regulators and advisory institutions are deeply networked between each other, but not required to source (uncomfortable) external information.

For scientific evidence requires access to, and scrutiny of, challenging and controversial information, otherwise we have dogma and ideology.

We must help a future medicines Regulator to not be captured in endless cycles of service to the regulated industry. Big pharma and big biotech will use resources and market power to influence decisions. Financial conflicts of interest (COIs) don’t just incentivise risk that study designs will be unfit and study findings distorted. COIs taint industry journals, public research institutions and media independence.

We must insist that the future Regulator will be compelled in law judge risk and benefit based on health and age status. We must insist that the Regulator is restricted from arbitrary decisions which limit access to off-patent drugs with a long history of safe use, and safe off-label prescribing.

The Health Minister and Cabinet must lock in transparent rules and principles for post market surveillance and adverse event reporting.

I’m a trustee of the Physicians and Scientists for Global Responsibility, a 20-year-old charity. And we’ve taken a deep dive into the draft Bill, and sent our paper to the Health Select Committee.

Principles and laws which govern democracies should keep people safe and prevent abuse of power.

None of this is apparent in the Therapeutic Products Bill. It has been captured from the start. We need to toss it out, and start again.

Image credit: Nataliya Vaitkevich

J.R. Bruning is a sociologist (B.Bus.Agribusiness; MA Sociology(Res)) based in the Bay of Plenty, New Zealand. Bruning’s primary research focus is on the relationship between governance, policy, and the production of scientific and technical knowledge for public good. Other writing can be found on JRBruning.Substack.com and at TalkingRisk.NZ.