New ‘Rule of Two’ Speeds Up Medicine Approvals, Expanding Kiwis’ Access to Treatments

“Faster access to medicines has always been a priority for patients,” Minister Seymour said following the Bill’s third reading.

New Zealanders will now have faster access to life-saving medicines thanks to the passing of the Medicines Amendment Bill, which introduces the ‘Rule of Two’ — a new streamlined approval process that allows medicines already approved in two recognised international jurisdictions to be approved domestically within 30 days.

Associate Health Minister David Seymour hailed the legislative milestone as a transformational change that will remove bureaucratic delays, improve access to treatments, and bring New Zealand’s regulatory system in line with global best practices.

A Game-Changing Step for Patient Access

“Faster access to medicines has always been a priority for patients,” Minister Seymour said following the Bill’s third reading. “For many New Zealanders, pharmaceuticals are a matter of life and death — or the difference between a life of pain and suffering or living freely. This change will increase access to medicines by introducing a streamlined verification pathway. People will access new treatments more quickly.”

Under the new framework, if a medicine has already been approved by any two of seven trusted overseas regulators — Australia, the United States, Canada, the United Kingdom, the European Union, Singapore, or Switzerland — New Zealand’s Medsafe can issue approval within 30 days, without repeating the entire evaluation process.

The reform was a commitment outlined in both the ACT–National and National–NZ First coalition agreements, underscoring the Government’s focus on efficiency and improved healthcare outcomes.

Learning from the Past

Seymour pointed out that the COVID-19 pandemic revealed the limitations of New Zealand’s previous approach to medicine approvals. “During Covid, it was embarrassing that Kiwis had to wait for medicines other countries already had. Living in New Zealand should never be a disadvantage. I’m fixing that,” he said.

He compared the change to vehicle imports, noting, “New cars are acceptable for the New Zealand market if they meet at least one of several foreign standards. We are applying the same principle to medicines. If trusted jurisdictions have already done the work and verified the product’s safety, we won’t delay access by duplicating the process.”

The efficiency gains are expected to reduce approval times by several months. Seymour cited a recent example of an asthma treatment that could have been approved by the end of 2022 under this system but was only cleared 16 months later, in May 2024.

A Broader Strategy to Strengthen the Health System

The Medicines Amendment Bill complements a wider set of reforms aimed at modernising New Zealand’s pharmaceutical system and improving the responsiveness of Pharmac and Medsafe.

Key actions already taken by the Government include:

• Allowing Pharmac to assess funding applications simultaneously with Medsafe’s regulatory review.

• Allocating Pharmac its largest-ever budget of $6.294 billion over four years, with an additional $604 million uplift to strengthen its negotiating and funding capabilities.

• Ensuring patient voices are formally integrated into Pharmac’s funding decisions.

• Reintroducing pseudoephedrine for sale in pharmacies to improve access to effective cold and flu treatments.

• Funding 66 new medicines, benefiting over 200,000 New Zealanders within the first year of implementation.

• Requiring Pharmac to consider the broader societal impacts of funding decisions, not just cost.

“These reforms demonstrate our commitment to ensuring that the regulatory system for pharmaceuticals is not unreasonably holding back access,” Seymour said. “This will lead to more Kiwis being able to access the medicines they need to live fulfilling, healthy lives.”

Aligning with International Standards

The introduction of the ‘Rule of Two’ places New Zealand among a growing number of countries adopting mutual recognition of medicine approvals from trusted partners. This model reduces duplication, saves time and resources, and ensures patients benefit sooner from medical innovations that have already been rigorously tested abroad.

For pharmaceutical companies and healthcare providers, the change is expected to encourage greater investment and faster introduction of new therapies into the New Zealand market, creating a more dynamic and patient-centred system.

A Step Toward Smarter Regulation

The Government sees the passage of the Medicines Amendment Bill as part of a broader regulatory modernisation agenda. Minister Seymour described it as a “common-sense efficiency that costs nothing but helps Kiwis in need.”

“This is about making sure our rules serve people — not the other way around,” he said. “By trusting global science and streamlining our own systems, we can get better outcomes for patients faster, without compromising safety.”

The change reflects a decisive shift toward evidence-based, internationally aligned regulation — one that aims to transform the way New Zealand approves, funds, and delivers medicines for its people.