Gene Technology Bill – Claim 1

CLAIM 1:

“If two overseas regulators approve a GMO medicinal product, NZ must approve it, even if it is controversial or banned somewhere else”

Answer: Yes – If at least two trusted overseas health authorities (for example, the FDA in the U.S. and the EMA in Europe) have approved a medical activity that uses gene technology or similar, then New Zealand’s Regulator must also approve it automatically — called a “mandatory medical authorisation.”

In other words:

If other major countries have already authorised a gene-related medical procedure or treatment for people, New Zealand is required to follow suit — unless one of the listed exceptions applies.

Where is this dealt with in the Legislation?

• Part 2, subpart 5, clause 50

Exceptions:

The automatic approval requirement does not apply if the overseas authorisation is for:

(a) Activities involving animals —

• Treating an animal using gene tech (therapeutic/veterinary use)

• Using gene tech to enable an animal medical device

• Conducting clinical trials (on humans or animals)

(b) Or if the overseas authorisation was made under emergency powers (for example, fast-tracked approval during a pandemic or crisis).

So:

This rule only applies to established medical uses on humans that have gone through normal (not emergency) approval overseas — and not to animal use or trials.

The Regulator still has the power to say no if granting the authorisation would cause an “imminent risk” of:

• Death, serious illness, or serious injury to people, or

• Serious damage to the environment.

So the Regulator must approve unless it’s dangerously unsafe or environmentally destructive.

An important distinction:

What “Mandatory Medical Authorisation” actually means

Despite the word “mandatory”, this clause does not mean that people are forced to take any treatment or product.

The word “mandatory” here refers to the Regulator’s obligation, not the public’s.

So:

“Mandatory medical authorisation” means that the Regulator must approve certain gene-based medical products or procedures if they’ve already been approved by at least two trusted overseas authorities — unless doing so would clearly endanger people or the environment.

It’s about fast-tracking regulatory approval, not forcing uptake.

Does it mean New Zealanders could be required to take something?

No — not automatically.

This section only gives regulatory approval (the legal green light to use or offer the product).
It does not create any power to mandate medical treatments or compel individuals to receive them.

If a future government ever wanted to make a particular medical product compulsory (e.g., as part of a public-health mandate), that would have to be done under separate legislation or emergency powers — not under this clause.

So:

“Mandatory medical authorisation” ≠ “mandatory medical treatment.”

In short

What powers then, does the Gene Technology Bill provide, and what other legislation do Government have that enables actual medical mandates in New Zealand?

Below is a structured explanation showing:
1️⃣ What powers the Gene Technology Bill itself provides (and what it doesn’t),
2️⃣ Which other Acts actually allow for mandatory medical interventions, and
3️⃣ How those powers could or could not interact.

🔹 1. What the Gene Technology Bill covers — and what it does not cover

The Gene Technology Bill is primarily about:

• How gene technologies are regulated, tested, approved, and monitored in NZ.

• Giving a Regulator authority to approve, licence, or restrict products and activities involving gene technology.

It is not a health mandate law.
The Bill:

• Allows the Regulator to approve new medical products (including those based on gene tech).

• Does not give anyone (the Ministry of Health, DHBs, or the Regulator) the power to force or compel any individual to take or use those products.

• Explicitly separates authorisation to supply or use from approval for other purposes (see section 16 of the Bill).

So, “mandatory medical authorisation” means the Regulator must issue an approval — it doesn’t mean the public mustcomply with a treatment.

🔹 2. What laws can enable actual medical mandates in New Zealand

If the Government ever wanted to require medical interventions (for example, vaccinations or testing), it could only do so under other, separate Acts that already exist.

Here are the relevant ones:

⚖️ (a) Health Act 1956

This is the main public-health powers law.

It allows:

• Section 70(1)(f) – a Medical Officer of Health (under ministerial direction) can require people to be isolated, quarantined, or disinfected if they pose a public-health risk.

• Section 70(1)(ea) – they can require persons, places, or things to be disinfected, tested, or treated, if necessary to prevent the spread of a notifiable disease.

✅ However:
These powers can only be triggered during a declared public-health emergency, and only with specific written orders.
They are temporary, reviewable, and subject to judicial oversight.

So while these powers could enforce treatment in certain emergency contexts, they are not automatically invoked by the Gene Technology Bill.

⚖️ (b) COVID-19 Public Health Response Act 2020 (still on the books but largely inactive)

This Act was used during the pandemic to issue vaccine and testing mandates.
Those powers could technically be revived or reused for another declared epidemic.

However, they:

• Require a ministerial order,

• Must be tied to a declared epidemic or emergency, and

• Expire unless renewed by Parliament.

So again, not automatic — only if government and Parliament actively invoke them.

⚖️ (c) Civil Defence Emergency Management Act 2002

Used in wider emergencies, but even here, medical treatment cannot be compelled unless authorised through the Health Act mechanisms above.

🔹 3. How these powers could (or could not) interact

Here’s how the pieces fit together:

So, the Gene Technology Bill alone cannot make anything compulsory for individuals.
Only separate emergency powers could — and even then, with strict limits, transparency requirements, and potential for legal challenge.

🔹 4. In plain summary

• The Gene Technology Bill controls approval and use — not personal mandates.

• Mandatory medical authorisation = Regulator must approve (not “people must take”).

• Actual medical mandates would require other Acts (like the Health Act) to be invoked.

• Those powers can only be used in emergencies and are temporary, reviewable, and contestable.

What this could mean for ordinary New Zealanders

In practice, this could affect the speed and independence of medical approvals in NZ:

1. Faster access to new medical tech
   – New Zealand could quickly allow the use of new gene-related medicines, therapies, or vaccines once they’ve been cleared overseas.
   – This might help bring innovative treatments to patients faster.

2. * Less independent review
   – NZ’s Regulator would have less discretion to independently assess long-term safety or local suitability, since the law requires approval once two overseas authorities have done so.
   – So the NZ review process could become more of a formality.

   1. Red Flag: Less discretion to independently assess long-term safety or local suitability poses risks to

3. Government health policy flow-on
   – Once something is authorised, it becomes lawful to supply or administer it in NZ.
   – This could influence later public-health decisions, like inclusion in vaccination programmes, hospital treatments, or pharmaceutical subsidies — but those are policy decisions, not automatic mandates.

   Let’s unpack this properly — in plain terms and with specific NZ examples of what “less independent review” means and why it could matter.

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   * What “Less independent review” actually means

   Under the Gene Technology Bill, when two or more recognised overseas regulators (e.g., the U.S. FDA, the European Medicines Agency, or Health Canada) have approved a medical product that uses gene technology, NZ’s Regulator must also approve it — without re-evaluating all the data from scratch.

   That means:

   • The NZ Regulator can’t say “we need to redo the full safety testing or require more trials locally”, unless there’s evidence of imminent danger to people or the environment.

   • Their role becomes reactive (checking for obvious immediate risks) rather than proactive (deciding what’s safe or suitable for NZ’s population or ecosystem).

   So, NZ loses part of its independent scientific and contextual judgment, relying instead on the assumption that if it’s safe for large overseas populations, it’s safe here too.

   ---

   Why this can matter for New Zealand — key differences

   New Zealand has unique environmental, population, and cultural contexts that overseas regulators do not account for when approving products.
   Here are several real examples where reduced independent review could pose risks:

   ---

   ⚖️ Example 1 – Environmental gene escape in island ecosystems

   If a gene-edited mosquito, plant, or bacteria is approved overseas for disease control, NZ’s regulator may have to approve it too.
   But NZ’s isolated ecosystem, with many endemic species (like native birds and insects), means:

   • A gene-altered organism could have unintended effects on native species or soil ecosystems.

   • Overseas regulators would not have tested for that, since those species don’t exist outside NZ.

   So, mandatory approval could limit NZ’s ability to apply its traditional “precautionary principle” in biosafety — a key foundation of NZ’s Hazardous Substances and New Organisms (HSNO) framework.

The Precautionary Principle says that if some course of action carries even a remote chance of irreparable damage to the ecology, then you shouldn’t do it, no matter how great the possible advantages of the action may be. You are not allowed to balance costs against benefits when deciding what to do.

⚖️ Example 2 – Genetic therapies interacting with distinct health factors

Gene therapies or mRNA-based treatments could be approved overseas for certain diseases.
But NZ’s ethnic and genetic diversity (particularly Māori and Pacific populations) can affect how genes, enzymes, or immune systems respond to therapies.

For example:

• Some populations have different metabolic or immune profiles that change drug safety or effectiveness.

• Overseas trials may not include Māori or Pacific participants, so side-effect risks could be missed.

If the NZ regulator must approve such a therapy automatically, it may not be able to demand additional local safety trials that account for those differences.

⚖️ Example 3 – Local health system readiness

Suppose a complex new gene therapy (e.g., CRISPR-based cancer treatment) is authorised overseas.
Automatic NZ authorisation means it’s legal to supply here — but:

• NZ may lack specialised equipment, training, or containment procedures that overseas hospitals use.

• Without a pause for local readiness assessment, implementation errors or inequities could occur.

So, it could be “legal” but unsafe in practice if the infrastructure isn’t there.

⚖️ Example 4 – Social licence and informed consent

Some overseas approvals move faster under commercial pressure or emergency conditions.
If NZ automatically mirrors those decisions, local communities may feel excluded from consultation — especially iwi, hapū, or community health advocates who would normally expect to be consulted under the Treaty of Waitangi principles and ethical review processes.

That could erode public trust in biotechnology governance.

In essence

By removing the Regulator’s discretion to fully re-examine safety and local context, the Bill could:

• Reduce NZ’s control over what medical and gene technologies are used domestically,

• Limit local testing or ethical consultation, and

• Increase dependence on overseas scientific and regulatory standards, even when NZ’s risks are different.

🧭 In summary