Written by Niamh Henwood
The New Zealand Government introduced the Medicines Amendment Bill to the House of Representatives on the 31st of March this year, with the aim of improving and streamlining access to medication, both for patients and medical professionals.
But what is the bill amending? How will access be improved and streamlined? What stage is the bill currently at? And what will this mean for you, either as a member of the public or a medical professional?
What is the Medicines Amendment Bill actually amending?
The Medicines Amendment Bill is amending the Medicines Act 1981 to improve access to medicines. The Medicines Act 1981 regulates medicines, related products and medical devices used in New Zealand. It also ensures that all medicines and medical products used in New Zealand are safe and effective (Ministry of Health, n.d.).
The Act specifically defines what medicine is and sets out requirements for the approval, classification, manufacture, sale, distribution, advertising, prescribing and dispensing of medicines, along with the approval of related products. It also sets out the requirements for licensing in the medicine distribution chain, including wholesalers and pharmacies. The Ministry of Health regulates the Act, along with Medsafe (the New Zealand Medicines and Medical Devices Safety Authority), and has done so since 1981 (Ministry of Health, n.d.).
The bill is proposed to amend some of the practices outlined in the Act, with the intent to improve overall access to medication for patients and improve the process of approving medications to be used in New Zealand. It will also amend some of the membership requirements for the Medicines Classification Committee, which advises the Ministry of Health on medicine classification, in the hopes of modernising the committee.
What will actually change?
Under the proposed changes, the usual process of pharmaceutical companies requesting approval for medications to be used here in New Zealand will be streamlined into a verification process that will hopefully allow medicines to be approved in less than thirty days. Currently, with some variation depending on the risk level of the medication, it can take months for approval (Seymour, 2025). This is due to Medsafe requiring large amounts of in-depth data for accurate assessment, and occasionally, additional data being required (Medsafe, 2019). The new process would allow medications that have been approved for use in at least two recognised overseas jurisdictions, such as Australia, Canada, the E.U., the U.S or the U.K., to bypass parts of the process and achieve approval within thirty days.
The changes also aim to increase prescriber rights by adjusting current regulations. For example, nurse practitioners will be allowed to prescribe replacement medication within their scope of practice. In some cases, there can be short supplies of approved medications, and it may be necessary for a replacement medication to be prescribed to a patient. However, not all medical professionals can prescribe the necessary replacement. The changes will allow certain medical professionals to prescribe replacement medications, covered by Pharmacare. Among these will be dentists, registered midwives, dietitians, pharmacists and optometrists, aiming for more effective access for patients requiring replacement medication (Brown & Seymour, 2025).
Finally, the membership requirements for the Medicines Classifications Committee are to be modernised, allowing for more flexible requirements and bringing the Committee to a similar operating standard as other Committees working under the Act (Parliamentary Counsel Office, 2025). As the Committee advises the Ministry of Health on the classification of medicines, the modernisation will likely aim for the Committee to allow more flexible classifications, potentially to further expedite medicine approval for use in New Zealand.
What stage is the Bill currently at?
The Medicines Amendment Bill was officially introduced to Parliament on the 31st of March this year. The bill subsequently passed the first reading and was referred to the Health Select Committee for public submissions (Doak, 2025). These public submissions closed on the 19th of May, and the Committee will now convene to go through these submissions and compile any common complaints, concerns or inquiries to create a report for the House, including recommending any changes to the bill. The report is currently due on the 10th of August, after which the bill will go to the second reading (New Zealand Parliament, 2025).
What does this mean for the public?
Overall, this bill is intended to increase patients’ access to medicines, both through faster approval processes and increased prescribers. If the bill is to come into law, the approval of long-awaited medicines could be expedited, hopefully allowing patients waiting for these medications to access them far earlier than typically expected. Patients could also expect easier and faster prescriptions of replacement medication in the scenario of a medication shortage.
A key point to keep in mind is medicines will still go through due process in terms of approval, but if they have already been approved in two recognised overseas jurisdictions, the process will be expedited, without weakening the approval process. The goal is to keep safe practices while improving the process. This is partly what the Health Select Committee report is for: to catch any possible weaknesses and loopholes before the Bill passes into law. Watch for the report in August to learn of any possible changes or improvements recommended to the House regarding the Bill.
Key Takeaways
- The Medicines Amendment Bill is a bill aiming to amend the Medicines Act 1981.
- The process of medicine approval for use in New Zealand by Medsafe will be streamlined and improved via a new verification process.
- Prescriber rights will be increased for medical professionals, allowing more to prescribe replacement approved medication in their relevant fields, in the case of a shortage.
- The membership requirements for the Medicines Classification Committee will be modernised, and will bring the Committee to the same standard of work as other committees working under the Medicines Act 1981.
References
Brown, S., & Seymour, D. (2025, April 8). Expanding prescriber rights will increase access to medicines. New Zealand Government. https://www.beehive.govt.nz/release/expanding-prescriber-rights-will-increase-access-medicines
Doak, A. (2025, May 8). Medicines Amendment Bill – Health Committee calls for submissions. Dentons New Zealand. https://www.dentons.co.nz/en/insights/alerts/2025/may/8/medicines-amendment-bill-health-committee-calls-for-submissions
Medsafe. (2019, September 12). Medsafe’s evaluation and approval process. New Zealand Medicines and Medical Devices Safety Authority. https://www.medsafe.govt.nz/Consumers/Safety-of-Medicines/Medsafe-Evaluation-Process.asp
Ministry of Health. (n.d.). Medicines Act. New Zealand Government. https://www.health.govt.nz/regulation-legislation/medicines-legislation/medicines-act
New Zealand Parliament. (2025, April 14). Medicines Amendment Bill: Bill history. https://bills.parliament.nz/v/6/bfaa07b4-837c-425e-0d57-08dd6ff875cc?Tab=history
Parliamentary Counsel Office. (2025, May 9). Medicines Amendment Bill. New Zealand Parliament. https://www.parliament.nz/en/pb/sc/make-a-submission/document/54SCHEA_SCF_BFAA07B4-837C-425E-0D57-08DD6FF875CC/medicines-amendment-bill
Seymour, D. (2025, April 8). Rule of Two for faster access to medicines. New Zealand Government. https://www.beehive.govt.nz/release/rule-two-faster-access-medicines
