Hon David Seymour
Associate Minister of Health

Associate Health Minister David Seymour is welcoming Cabinet’s decision to enable medicines to be approved in less than 30 days if the product has approval from two recognised overseas jurisdictions.  

This change is included in the Medicines Amendment Bill (the Bill), which amends the Medicines Act 1981. The pathway will be in operation by early 2026.

The policy will start with Australia, the United States, Canada, the United Kingdom, the European Union, Singapore and Switzerland, as recognised countries. These are the main countries Medsafe currently recognises.

“Faster access to medicines has always been a priority of mine. For many New Zealanders, pharmaceuticals are life or death, or the difference between a life of pain and suffering or living freely,” Mr Seymour says.

“This change will increase access to medicines for Kiwis by introducing a streamlined verification pathway for medicines. People will access new treatments more quickly. This is committed to in the ACT-National and National-NZ First coalition agreements.

“Cabinet has agreed to give the responsible Minister powers to regulate the Rule of Two. That means I will be outlining the proposed regulatory pathway for industry and the public to feedback on via the Select Committee process. This system should be as straightforward as possible to allow New Zealanders the greatest level of access to innovative medicine possible.

“New cars are acceptable for the New Zealand market if they meet at least one of several foreign standards. We can apply the same principle to medicines, if other jurisdictions have already done the work and can ensure the products’ safety, we don’t need to delay patient’s access by doing the exact same tests,” Mr Seymour says.

“This is a common-sense efficiency that costs nothing. It helps Kiwis in need. It can shave months off the approval process. A perfect example of this was with a treatment for asthma which could have been approved by the end of 2022 under this pathway, but was not approved until 16 months later in May 2024.

“This Government is making medicines access a priority because it leads to better patient outcomes. So far, we have:

• Changed Pharmac’s process so it can assess a funding application at the same time as Medsafe is assessing the application for regulatory approval
• Allocated Pharmac its largest ever budget of $6.294 billion over four years, and a $604 million uplift to give Pharmac the financial support it needs to carry out its functions - negotiating the best deals for medicine for New Zealanders
• Made patient voice a crucial consideration in Pharmac’s funding decisions
• Put pseudoephedrine back on the shelves of pharmacies

“We’re committed to ensuring that the regulatory system for pharmaceuticals is not unreasonably holding back access. It will lead to more Kiwis being able to access the medicines they need to live a fulfilling life.”

Notes: 

Draft criteria for regulatory pathway rules will likely relate to ensuring that:

• manufacturing sites associated with product have evidence of Good Manufacturing Practice (GMP) compliance which is valid to Medsafe’s satisfaction,
• if a product is a generic or biosimilar prescription medicine, the innovator or reference product is identical to that approved for New Zealand

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