The much anticipated Therapeutic Products Bill was introduced to Parliament on 30 November 2022. The Bill will replace the significantly outdated Dietary Supplements Regulations 1985 and most of the Medicines Act 1981, and is the outcome of a reform programme that started with the Therapeutic Products and Medicines Bill in 2006.
The purpose of the Bill is to promote and improve the health of all New Zealanders by providing for the acceptable safety and quality of medicines, active pharmaceutical ingredients (APIs), medical devices, and natural health products across their lifecycle. The Bill also provides for the efficacy of medicines and APIs, and the performance of medical devices.
The Bill is a substantial rewrite of the draft Therapeutic Products Bill that was released for consultation in 2018. The new Bill reflects broad sector feedback on the previous draft Bill, the health and disability system reforms, changes to health technology, and lessons learnt from the Covid-19 response.
In particular, the Bill provides for:
- The establishment of a new Regulator who will have a range of enforcement powers. While the Regulator will be appointed by the Director-General of Health, the Regulator will exercise their powers independently of the Director General and Minister of Health (although may be subject to general policy directions issued by the Minister)
- A market authorisation regime - All therapeutic products will have to have market authorisation before they can be imported into, supplied in, or exported from New Zealand (unless an exception provided for in the Bill applies). The process and extent of the new Regulator's evaluation of a product before it can be authorised will depend on the type of product, and the type of market authorisation sought from the sponsor of the product
- The regulation of natural health products (NHPs), which are essentially products that have a therapeutic purpose and contain nothing else except natural product ingredients, or specified additives or formulation aids. NHPs include herbal remedies, vitamins and other supplements. Importantly, the Bill regulates the types of health benefit claims that can be made about NHPs. The pathway to obtain market authorisation is less onerous for NHPs (it is primarily a self-declaration pathway), and market authorisation is not required for low concentration NHPs
- A more robust regulation regime for medical devices - Medical devices are defined broadly, and for the first time in New Zealand, include products that consist only of software that has a therapeutic purpose (such as computer-aided detection software that performs image processing to help detect breast cancer)
- More extensive post-market obligations on those who obtain market authorisation for therapeutic products (sponsors), including the requirement for sponsors to have a robust surveillance and response system for their products, to conduct surveillance of various matters including the product's safety and quality, and respond to any issues identified
- A prohibition on inducements - Pharmacy operators, and suppliers of therapeutic products are prohibited from giving benefits to health practitioners (eg doctors and dentists) or veterinarians with the intention of inducing such practitioners to make decisions that products are appropriate for patients or to give favourable advice about products to patients. There is also a prohibition on a health practitioner or veterinarian from accepting or asking for such a benefit
- Clearer export requirements - The Regulator will be able to issue export authorisations for products that do not meet criteria for the product to be supplied in New Zealand (this will allow New Zealand suppliers to export products to other countries even though the products are not permitted to be sold in New Zealand)
- A more robust offences and penalties regime - In particular, there are graduated criminal offences, strict liability offences, infringement offences and a civil pecuniary penalty regime
- Crown organisations to be criminally liable if they commit an offence under some sections of the Bill. This would apply to any Crown agencies that are involved in the supply chain of therapeutic products, including sponsoring and supplying products
- The chief executive of the Ministry of Health will have the power to make an "emergency arrangements notice" in specified circumstances, which would allow a person or class of persons to do something that would otherwise contravene a restriction in the Bill (such as the requirement to have market authorisation, or a licence or permit to carry on a controlled activity). This would permit the importation or supply of a medicine or vaccine that was urgently required to address a pandemic or natural disaster.
Similar to the current legislation, the new Bill includes types of therapeutic purposes, specifies that particular activities cannot be carried out without a licence or permit unless provided for in the Bill, and restricts advertising of therapeutic products. However, those requirements have been modernised and updated.
The Bill does not change the restrictions on pharmacy ownership currently in the Medicines Act 1981. Rather, all provisions of the Medicines Act will be repealed except the pharmacy ownership provisions. The Medicines Act will then be renamed as the Pharmacy Ownership Act 1981. Interestingly, the interpretation of the current statutory requirements and restrictions on granting pharmacy licences is one of the issues that is being litigated in a judicial review between New Zealand Independent Community Pharmacy Group and Te Whatu Ora - Health New Zealand & Ors (CIV-2022-485-011). The judgment was reserved and is expected next year. It will be interesting to see what the outcome of that case is, and whether the outcome results in any changes to the pharmacy ownership requirements during the Select Committee process.
Consideration of rongoā Māori
Prior to the introduction of the Bill, some rongoā Māori health workers were concerned that the Bill would restrict their ability to provide services to whānau. Although the Bill does not provide a specific exemption for rongoā Māori health workers, to the extent that rongoā Māori health workers supply or use NHPs, the requirements in the Bill relating to NHPs will apply. Importantly, an NHP practitioner (as defined in the Bill) can manufacture an NHP without a New Zealand authorisation for a client, and supply that NHP to the client if the client consults the practitioner about their health needs, and other specified criteria are met.
In addition, the Bill makes it clear that:
- The Regulator, Minister and any other person exercising power under the Bill must be guided by the principles, which include that the regulation of therapeutic products should support innovation, including opportunities for Māori, and the choice of, and equity of access to, therapeutic products for Māori and other population groups
- The Regulator's functions include engaging with Māori and other population groups in a manner that reflects their needs and aspirations in relation to therapeutic products
- The Regulator must ensure that they have the capacity and capability to understand and give effect to the principles of te Tiriti o Waitangi/the Treaty of Waitangi, and understand and take into account mātauranga Māori and Māori perspectives in relation to therapeutic products.
A new workstream has been established within the Ministry of Health to consider how rongoā might be protected in legislation. According to the Associate Minister for Health (Māori), Peeni Henare, the new workstream will analyse the bill “to identify any gaps and opportunities to protect rongoā Māori, assure whānau safety, and ensure access to the export market for practitioners”.
Next steps
The Select Committee process will provide an opportunity for people to have their say on the Bill. It is expected that the Bill will have its first reading next week, and that the Select Committee will call for submissions soon, with a relatively short period of consultation.
Also, as part of the rongoā workstream, the Ministry of Health is currently planning to engage with Māori partners and stakeholders between February and March 2023. In addition, various regulations and rules will need to be drafted and put in place to complete the regulatory regime, which will provide further opportunities for consultation.
If enacted, the legislation will come into effect when an Order in Council is made to bring it into force, or on 1 September 2026 at the latest.
If you have any questions about the Bill, please contact a member or our health team.
Updated 10 February 2023
The Select Committee process has begun. The consultation period has been extended twice with submissions now being accepted until 5 March 2023.
