New legislation aimed at reducing barriers to new medicines and speeding up public access to treatments not previously available in New Zealand passed its first reading in April. The Medicines Amendment Bill (Bill) would amend the Medicines Act 1981 to provide a verification pathway for medicines to be approved for distribution in New Zealand if they have been approved by two recognised overseas jurisdictions. Initially, these jurisdictions would include those currently recognised by Medsafe: Australia, the United States, Canada, the United Kingdom, the European Union, Singapore and Switzerland. Where an applicant can demonstrate a product has approval from two of these jurisdictions, Medsafe would not need to carry out a full assessment, and the product could be approved within 30 days. Associate Health Minister David Seymour’s press release stated, “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.” From his first reading address, the time saving attributed to this change would see what currently takes 400 working days to approve reduced to 30 working days. The Bill’s Regulatory Impact Statement cites research, comparing the registration of medicines across 20 OECD countries, which showed that between 2011 and 2020 New Zealand ranked last for the approval of modern medicines. However, a primary reason given for this, is the length of time taken after Medsafe approval, for medicines to be funded by Pharmac. Prior to this funding, the size of our market is too small to be a priority for pharmaceutical suppliers. The Opposition, who supported the Bill’s first reading, touched on the funding issue as one needing to be addressed to ensure the approved medicines then become widely available; an issue they will be following in their support of the Bill. To set out the detailed processes for the verification pathway and requirements for applications, the Bill would create a power for the Minister of Health (Minister) to make secondary legislation (rules). Before making rules, the Minister would be required to consult the relevant organisations or bodies representative of those likely to be affected; except where a change is minor. Changes to a number of prescribing rights would also be made to enable more types of prescribers to prescribe unapproved medicines. Currently, only medical practitioners can prescribe these ‘off label’ alternatives, for example, where due to a shortage the approved medicine is not available. This ability would be expanded to include nurse practitioners. Pharmacists, registered midwives, dentists, dieticians, and optometrist, would also be able to prescribe unapproved medicines within their scope of practice. The Bill, which had good cross-party support to select committee, is before the Health Committee with their report due 11 August 2025.
