Public Annotation for FYI Request #32475

### *Legal Advice & Cabinet Papers on Pfizer/Comirnaty Provisional Consent and the Medicines Amendment Act 2021*

**Response received: 18 November 2025 (Ref: H2025073666)**

This OIA sought access to **legal advice, internal correspondence, and risk assessments** surrounding one of the most debated legal issues of the COVID-19 era:

### **Whether Medsafe’s provisional consent for Pfizer’s Comirnaty vaccine (Feb 2021) complied with — or breached — s23 of the Medicines Act 1981**,

and

### **how and why the Government rushed through the Medicines Amendment Act 2021 to retrospectively validate that consent.**

The request also sought Cabinet papers, Crown Law advice, DPMC discussions, and any reports on alternative legal options the Government considered.

---

# 1. Summary of the Ministry’s Response

The Ministry of Health **withheld the entire body of requested material** under:

### **s9(2)(h) — legal professional privilege (LPP)**

This applies to all sought documents involving:

* Crown Law
* Medsafe
* DPMC
* Internal Ministry legal advice
* Risk assessments
* Cabinet-related legal analysis
* Advice on removing “limited number of patients” from s23
* Advice on whether Comirnaty’s provisional consent was *intra vires* or *ultra vires*

The Ministry states that **public interest does not outweigh withholding**.

### Part 4(d) was refused entirely under:

### **s18(g)(i) — information not held**

This relates to:

> Communications with external regulators (e.g., Australia’s TGA) about whether NZ’s provisional consent complied with s23 at the time.

The Ministry says it **holds no such communications** and believes no other NZ agency holds them either.

---

# 2. What Was Withheld — And Why It Matters

### **A. All legal advice about whether Medsafe acted lawfully under s23 (pre-amendment)**

The central controversy:
Section 23 (before May 2021) allowed provisional consent only for:

> “the treatment of a *limited number of patients*”

Pfizer’s rollout, however, involved **the entire eligible population**.
Numerous academics, lawyers, and parliamentarians argued this made the provisional consent **ultra vires** (outside the law).

All internal legal views on this question are withheld.

---

### **B. All Cabinet papers and internal reports on the hurried Medicines Amendment Act 2021**

This Act was passed under urgency on **19 May 2021**.
It:

* Removed the “limited number of patients” wording
* Retrospectively validated existing provisional consents (including Comirnaty)
* Prevented legal challenges or judicial reviews from succeeding

The OIA sought Cabinet papers and justification for this legislation.

Everything is withheld under legal professional privilege.

---

### **C. All internal legal risk assessments (Nov 2020 – June 2021)**

These would likely cover:

* Judicial review risks
* Known defects in s23
* Crown Law’s interpretation
* Medsafe’s concerns
* Risk of the provisional consent being overturned in court

Again, all withheld.

---

### **D. Advice on “alternative options” the Government considered**

This may include:

* Amending legislation **before** granting provisional consent
* Using other emergency or regulatory pathways
* Limiting the initial consent to smaller cohorts
* Seeking additional statutory authority

All withheld under s9(2)(h).

---

# 3. What the Ministry Says It Does *Not* Hold

The Ministry claims it has **no communications** with:

* Australia’s TGA
* Other international regulators

about whether New Zealand’s legal process complied with s23.

This is surprising given:

* Medsafe routinely interacts with TGA and other regulators
* NZ’s approach was unique internationally
* Legal concerns were known and documented publicly in early 2021

Nonetheless, the Ministry’s formal position is that such material **does not exist**.

---

# 4. Public Interest Considerations

The Ministry states it assessed the public interest but concluded that:

* legal privilege
**outweighs**
* the public’s right to understand how and why s23 was interpreted and changed during the largest public-health intervention in NZ history.

The requester, and many members of the public, would note:

### **Public interest is exceptionally high**, because:

* The provisional consent was the legal basis for administering a new biological product to millions of New Zealanders.
* The Government subsequently amended the law under urgency and made the change **retrospective**.
* Several High Court cases depended on interpretations of s23.
* The rushed legislation remains one of the most legally contested moves of the pandemic.

Despite this, the Ministry insists that privilege prevails.

---

# 5. Pattern Compared to Other FYI OIAs (Context)

This OIA fits a clear and consistent pattern seen across multiple FYI requests concerning:

* COVID-19 vaccine regulation
* Medsafe’s legal authority
* Provisional consent processes
* Crown Law involvement
* Cabinet-level decision-making

Similar OIAs have been **widely refused** on the same grounds (s9(2)(h), legal privilege), including:

### **Related FYI Requests**

* **#27368** – Legal basis for provisional consent process
* **#31040** – Medsafe–Crown Law correspondence on Pfizer authorization
* **#30107** – Internal legal risk assessments on COVID-19 regulatory decisions
* **#28314** – Cabinet material on Medicines Amendment Act 2021
* **#29421** – Advice about retrospective validation provisions
* **#26514** – Communications about safety signals and Pfizer consent conditions

Across all, agencies consistently refuse to release:

* legal advice
* risk assessments
* draft Cabinet papers
* legal briefings to Ministers

This request (#32475) is part of that larger transparency issue.

---

# 6. What This Means for the Public Record

At present, due to the Ministry’s complete withholding:

* The public still cannot see any internal legal analysis of the **legality** of Pfizer’s provisional consent under s23.
* No Cabinet-level legal reasoning behind the **retrospective validation** has been released.
* No documentation of **legal risks** identified inside the Ministry or Crown Law is available.
* The Government’s **interpretive reasoning** around the phrase “limited number of patients” remains undisclosed.
* The public cannot confirm whether concerns were raised, debated, or overridden.

This OIA response therefore preserves a large gap in the historical transparency of one of the most consequential legal decisions of the COVID-19 period.

---

# 7. Conclusion

The Ministry’s response confirms:

### ✔ All legal advice, internal correspondence, Cabinet papers, risk assessments, and interpretations of s23 are withheld under legal privilege.

### ✔ Communications with foreign regulators are said **not to exist**.

### ✔ The Ministry does **not** consider public interest to outweigh secrecy.

Given the scale of the policy decisions in question, and the enduring public debate over the Medicines Amendment Act 2021, this OIA joins a long list of similar requests where transparency has been denied.

I asked them for the filenames of the documents pfizer submitted for approval. denied.

I took them to the ombudsman. They said there were so many files and they couldn't possible look through them all.

I said ok then send me the list of files you just found. Ombudsman then said it would be too difficult to search for the relevant files. (even tho they just told me exactly how many relevant files there were)

it's a rigged game mate. this took almost to two years to get a non-answer.