The Therapeutic Products Act 2023 (Act) will come into force on 1 September 2026 (unless an earlier date is chosen by the Government). The Act consolidates the rules relating to all therapeutic products, replacing the Medicines Act 1981 and the Dietary Supplements Regulations 1985. All health practitioners who prescribe the use of therapeutic products should ensure they are up to date on the Act before it comes into effect.
What is covered
The definition of a therapeutic product is wide-ranging, covering products that are intended for use in, on, or in relation to humans for a therapeutic purpose, products that are intended for use as an active ingredient of a medicine, and any products that are specified in regulations.
Therapeutic products are divided into four types:
- medicines, which include pain relief available at supermarkets (such as paracetamol), vaccines, chemotherapy medicines, and patient-specific genetic treatments;
- medical devices, including products ranging from tongue depressors and bandages to implantable devices (such as pacemakers), cell-phone-based diagnostic software, and robotic surgery machines;
- active pharmaceutical ingredients (APIs), which are the active ingredients of medicines; and
- natural health products (NHPs), which include products such as vitamin and mineral supplements, herbal remedies, animal extracts, probiotics, enzymes, and essential fatty acids.
The Act provides for the regulation of all therapeutic products, to ensure that they are of acceptable quality and safety, that medicines and APIs are of acceptable efficacy, that medical devices have acceptable performance, and that the health benefit claims of NHPs are substantiated.
Providing therapeutic products – market authorisation
Most medicines, medical devices, or NHPs will not be able to be imported, supplied, or exported unless they have a market authorisation (which will be issued by the Therapeutic Products Regulator), or there is a specific licence or permit. However, some products, such as medicines that require compounding, custom-made devices, and low-concentration NHPs may be exempt from this requirement.
Medicines that are currently consented under the Medicines Act 1981 will automatically receive a market authorisation under the Act. Other products, including medicines that are currently provisionally approved and medical devices will have temporary authorisations, and will need to obtain a full market authorisation.
The Act will regulate who can carry out controlled activities involving therapeutic products. These controlled activities include cover various aspects of a health practitioner’s role, including:
- prescribing and dispensing medicines;
- administering medicines and using medical devices; and
- conducting clinical trials.
There are a range of strict requirements and constraints in relation to those controlled activities. Health practitioners will be permitted to:
- supply a medicine or medical device by non-wholesale supply (including by exporting it to a recipient who is ordinarily resident in New Zealand) if it is a general-sale medicine or medical device that has a standard authorisation or provisional authorisation (whether supplied for an authorised indication or an off-label use);
- supply a medicine or medical device by non-wholesale supply (including by exporting it to a recipient who is ordinarily resident in New Zealand) if:
- it is a prescription medicine or a pharmacist medicine and they are a prescriber for it;
- in the case of a pharmacy medicine or a medical device, it is relevant to a health service that forms part of the practitioner’s scope of practice;
- it is supplied to their own patient or to a patient of, and at the request of, another health practitioner who would be allowed to supply the medicine or device;
- in the case of a medicine that requires compounding, it is lawfully compounded; and
- in the case of a medicine or device that does not have a standard authorisation or provisional authorisation for any indications, the special-case requirement is complied with.
- prescribe, administer, or dispense a medicine (whether or not it has a market authorisation or is supplied for an authorised indication or off-label use), if:
- they are a health practitioner prescriber for that medicine;
- they prescribe, administer, or dispense it to their own patient or to a patient of, and at the request of, another health practitioner prescriber for the medicine;
- the patient is in New Zealand or is ordinarily resident in New Zealand; and
- in the case of a medicine that does not have a standard authorisation or provisional authorisation for any indications, the special-case requirement is complied with;
- import a medicine or medical device that does not have a market authorisation if it is imported for the purpose of supplying or administering it to a patient to whom they are allowed to supply or administer it and the special-case requirement is complied with;
- supply by wholesale supply a medicine or medical device if they have possession of it for the purpose of carrying on a different controlled activity, and the recipient is a pharmacist, health practitioner, or veterinarian;
- take a post-production step in the manufacture of the medicine or device (such as packing or labelling it) if taking the step is reasonably necessary to enable that supply;
- produce a medical device using a device production system if the device is relevant to a health service that forms part of the practitioner’s scope of practice and they produce it for their own patient or a patient of, and at the request of, another health practitioner whose scope of practice covers the device; and
- issue standing orders for medicines with a standard authorisation or provisional authorisation.
A person who works for a health practitioner may also supply a pharmacy medicine with a standard authorisation or provisional authorisation to a patient of the health practitioner if the health practitioner could supply it, there is an authorised indication for it, and the worker is acting under the general supervision of the health practitioner.
Health practitioners will be able to carry on a controlled activity (including prescribing, supplying and administering) with a medicine or medical device that does not have a market authorisation if a special-case requirement is met.
The special-case requirement obliges the health practitioner to be satisfied that there is no authorised medicine or medical device that is suitable to meet the clinical needs of the patient (whether as an authorised indication or an off-label use), is immediately available or could be obtained within a reasonable period, and is reasonably affordable to the patient or their whānau. Health practitioners will also need to be satisfied that it is appropriate to carry on the activity with the medicine or device being sought.
Additional regulations may be drafted to provide criteria to determine how affordability and appropriateness are to be assessed.
Penalties for a breach of the Act for an individual can be imprisonment for a term not exceeding five years and/or a fine not exceeding $200,000, and for a company a fine not exceeding $1 million.
Civil penalties, for contravening specific provisions in the course of a business or undertaking, and for the purpose of making a commercial gain or avoiding a commercial loss, can result in having to pay the greatest of whichever of the following are applicable:
- if the conduct constituting the contravention was a transaction, the consideration for the transaction;
- if the contravention resulted in the person making a commercial gain or avoiding a commercial loss, three times the amount of the gain made or loss avoided as a result of the contravention (if it can be ascertained);
- if the person is an individual, $250,000; and
- if the person is not an individual, $2,000,000.
What happens now?
There are still a few years before the Act comes into force and replaces the Medicines Act. Closer to that time regulations will be released and will give more details about the new regime, and we will provide information about those when they are available. In the meantime, health practitioners should take some time to understand future obligations about prescribing and supplying medicines.
If you have any questions about how the Act may affect your business, or about health sector laws generally, please contact a member of our health law team.
You can read the other related articles here:
- The Therapeutic Products Act 2023 – key information for pharmacists
- The Therapeutic Products Act 2023 – key information for manufacturers of medical devices
Disclaimer: The content of this article is general in nature and not intended as a substitute for specific professional advice on any matter and should not be relied upon for that purpose.