(Government Bill 134—1, David Seymour)
From: Ukes Baha | 17 April 2025
Submitted in response to the call for public submissions on the Medicines Amendment Bill.
I submit this formal opposition to the Medicines Amendment Bill on the grounds that it introduces structural, legal, and ethical risks to New Zealand’s medicines regulatory framework. While the intent to improve efficiency in the medicines approval process may be commendable, the proposed changes compromise essential safeguards, weaken regulatory sovereignty, and place public health at risk by privileging market access over clinical oversight. The Bill enables fast-tracked approvals with insufficient local evaluation, broadens ministerial discretion, and introduces data protection measures that unduly prioritise commercial interests.
Clauses: 22A–22E
The Bill introduces a new mechanism—consent by verification, a process allowing fast-tracked approval of medicines already authorised in certain foreign jurisdictions without full domestic review. Under this provision, the Minister may approve the sale, distribution, and advertising of such medicines provided they have been authorised by two or more recognised regulatory authorities overseas.
Issue: This constitutes a serious relinquishment of New Zealand’s sovereign responsibility to assess medicines within its unique epidemiological, demographic, and socio-cultural context.
New Zealand’s population includes vulnerable groups with distinct pharmacological responses (e.g., Māori and Pacific populations, immunocompromised individuals, and patients with multi-morbidity). Section 22C(1)(b)(v) narrowly exempts medicines requiring “contextualisation” but leaves discretion entirely with the Minister, creating a gap in accountability and scientific rigour.
This also raises serious equity concerns. Fast-tracked approval without adequate contextualisation risks failing Māori and Pacific communities, whose unique health profiles require locally informed scrutiny. Such an approach undermines Te Tiriti o Waitangi obligations of active protection and equitable healthcare provision.¹
Clauses: 22D–22E
The Minister is granted broad rulemaking powers and post-consent authority to amend, suspend, or revoke consent with limited procedural safeguards. While the Bill requires an eight-week consultation period for rules (s22D(2)), this requirement can be circumvented by classifying the change as “minor” (s22D(3)).
Issue: This facilitates executive rulemaking with insufficient checks, weakening the integrity of delegated legislation and bypassing the public’s right to participate meaningfully in the development of secondary regulations.
This is inconsistent with established principles of administrative law and subdelegation control, particularly as outlined in the Legislation Act 2019, which emphasises transparency, reviewability, and proportionality in secondary legislative instruments.
Clause: 23BA
The Bill creates a new “verification protected period” of five years for confidential supporting information submitted under the consent-by-verification pathway.
Issue: This provision extends commercial exclusivity over clinical data for medicines already authorised overseas, without requiring any domestic clinical trial contribution.
This is a de facto data exclusivity regime that exceeds obligations under the TRIPS Agreement (WTO), particularly Article 39.3², which permits protection only against “unfair commercial use.” The provision instead establishes absolute protection, irrespective of public health need or emergency conditions.
Such measures unduly restrict competition, delay the entry of generics or biosimilars, and inflate medicine costs—contrary to the New Zealand Medicines Strategy 2007 and Pharmac’s mandate to ensure cost-effective healthcare access.
Clause: 29A
This clause exempts certain “funded alternative medicines” from standard approval pathways if listed by Pharmac due to shortages of consented medicines.
Issue: This creates a parallel distribution route for unconsented medicines, reliant solely on funding agency endorsement, without adequate pharmacovigilance requirements.
While supply constraints require flexibility, bypassing Medsafe’s evaluation risks compromising patient safety, and may breach informed consent obligations under the Code of Health and Disability Services Consumers’ Rights 1996 (Rights 6 and 7³).
These shortcuts further risk widening disparities for underserved groups, particularly Māori, whose trust in the system depends on culturally safe and evidence-based care — a responsibility affirmed under Te Tiriti o Waitangi.
Clause: 29B
This clause requires manufacturers and importers of unapproved medicines to report monthly data after supply, with name-based traceability only on request.
Issue: This is retrospective accountability, not pre-distribution assurance. The burden of oversight is shifted from proactive regulation to reactive monitoring, increasing the risk of harm and systemic failure.
This Bill, in its current form, reflects a deregulatory ideology that prioritises commercial expedience over clinical caution, and ministerial authority over democratic process. It weakens New Zealand’s medicines safety framework, undermines Medsafe’s scientific independence, and introduces intellectual property protections that are disproportionate and anti-competitive.
Accordingly, I urge Parliament to oppose the Bill in its entirety, or at minimum, require significant amendment, including:
New Zealand’s medicines framework must serve the people first — grounded in science, transparency, and the right to safe and informed care. This Bill, by contrast, serves speed over safety, discretion over democracy, and commercial interest over public trust.
Ukes Baha
Public Health Advocate | Counsellor | Policy Analyst
ukesbaha.com