The Medicines Act, legislation from 1981, sets out requirements for the approval, classification, manufacture, sale, distribution, advertising, prescribing and dispensing of medicines, along with licensing requirements for the medicine distribution chain, including wholesalers and pharmacies. Importantly, it also details ownership rules for pharmacies.
The previous government replaced the Medicines Act with the Therapeutic Products Act (previously the Therapeutic Products Bill) in July 2023, with most provisions in the Act intended to come into force on 1 September 2026.
Consultation on this draft Bill and previous proposed replacement legislation was a significant piece of advocacy for us.
The TPA retained existing Medicines Act ownership provisions which require pharmacies to be majority owned by pharmacists. We strongly supported this, however raised concerns around future risks to retaining pharmacist ownership (based on the Ministry of Health’s regulatory impact statement and analysis). This followed the draft Bill in 2019 including two options for pharmacy ownership, status quo and open ownership, following our successful advocacy with the government to reverse their initial position of unrestricted pharmacy ownership.
We raised concerns about the definition of dispensing in the draft Bill, as this only described the supply of a medicine. We were concerned about the risk of splitting dispensing into supply and advice, so detailed all parts of the dispensing process and the importance of these in our submission. The TPA was updated to reflect this by including an example of dispensing that includes providing advice.
In May 2024, the new coalition government formally announced it would repeal the Therapeutic Products Act. The Therapeutic Products Act Repeal Bill was subsequently introduced with submissions closing in July 2024.
While the government acknowledges that the current Medicines Act is out of date, they believe the TPA is not the solution and would have over-regulated some products and imposed unnecessary costs on consumers, businesses and exporters.
The government intends to “develop a modern, risk proportionate regulatory regime for medicines and medical devices, and a separate modernised regime for natural health products”. Until new legislation is passed, the Medicines Act continues to apply.
We are monitoring this repeal work closely, with new government policy proposals currently in development for a Medical Products Bill.
The government has issued drafting instructions for the new Bill, saying it should cover medicines and medical devices, recognising the regulatory differences between the two, and that the legislation should support improved health outcomes for all New Zealanders by enabling timely access to safe, high quality, and effective medical products, providing cost-effective assurance that medical products meet acceptable standards of safety, quality, and efficacy or performance, and enable medicines and medical devices to be classified according to risk.
Overarching principles of the Bill are expected to focus on the ideas that:
- regulation should be proportionate to benefits and risks, and support timely access to medical products
- the likely benefits of medical products should outweigh their likely risks
- regulation should recognise differences between product types, including medicines and medical devices
- regulation should, where possible, be harmonised with international good practice, enabling reliance on assessments and decisions by trusted overseas regulators
- the regulatory system should support innovation, competition, economic growth, and exports in a way that maintains New Zealand’s reputation as a producer of high-quality products.
Under the Bill, products will generally be registered with, or approved by, a medical products regulator before they are supplied in New Zealand. The process for obtaining approval will vary according to the nature and risk of the product. The lowest risk products will either be exempt from the approval requirement or approved following registration and a declaration that the product meets relevant standards.
The Bill will be flexible so that innovative products can be assessed appropriately over time without primary legislation needing to be amended. This approach is consistent with comparable countries.
The Bill will introduce pathways for professions to gain or expand prescribing and other powers in relation to medicines. We will be advocating for further scope of practice changes for community pharmacists and look forward to better understanding the proposed legislative enablers for pharmacist prescribing and the new opportunities this presents for members.
A cabinet paper proactively released states that by the end of March 2025, further approvals will be sought relating to the regulation of pharmacies.
This remains an active piece of sector advocacy work for us and a key strategic priority, particularly maintaining our successful retention of majority pharmacy ownership and effective control provisions, as well as the updated definition of dispensing to avoid the unbundling of dispensing into separate supply and advice components.
We will keep members updated as this work progresses.