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. It will be important for all pharmacists to be aware of how the Act will affect them and their pharmacies before the Act come into force.
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 pharmacist’s role, including:
- wholesale and non-wholesale supply;
- dispensing medicines;
- administering medicines and using medical devices; and
- carrying on a pharmacy business.
There are a range of strict requirements and constraints in relation to those controlled activities. Pharmacists will be permitted to:
- compound medicines, either upon receipt of a prescription or in advance if they believe that they might receive a prescription for the medicine and it is reasonable to produce the medicine in anticipation;
- dispense a medicine in accordance with a complying prescription;
- 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);
- it is a prescription medicine, and they supply it in accordance with a complying prescription to the patient for whom it is prescribed;
- it is a pharmacist medicine, and they supply it either in accordance with a complying prescription or after they have determined that it is appropriate;
- it is a medicine that does not have a market authorisation, but they supply it in accordance with a complying prescription; or
- it is a medical device that does not have a market authorisation, but they supply it to a specific patient at the request of a health practitioner;
- import a medicine or medical device for the purposes of the above supply if it is for a specific patient (whether or not it has a market authorisation or is supplied for an authorised indication or off-label use);
- 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; and
- 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.
A pharmacy worker working in a pharmacy business may also do any of the above if they carry on the activity in a way that the pharmacist is allowed to do, and under the supervision of a pharmacist.
The Medicines Act 1981 will be retained only to the extent that it relates to pharmacy ownership, and will be renamed the Pharmacy Ownership Act 1981. The current requirements for pharmacy ownership are not changing.
This means that all pharmacies will still require majority ownership by one or more pharmacists, who must be in effective control of the pharmacy. Pharmacists will also continue to be prohibited from holding a majority interest in more than five pharmacies at once.
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, pharmacists should take some time to understand future obligations about dispensing medicines and any additional steps that may need to be taken around NHPs sold in the pharmacy.
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 health practitioners
- 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.