The Therapeutic Products Act 2023 (Act) replaces the Medicines Act 1981 and the Dietary Supplements Regulations 1985. The Act was passed by Parliament in July, and will come into force on a date appointed by the Governor-General by Order in Council, or at the latest by 1 September 2026.
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.
Similarly, therapeutic purposes are wide-ranging, including:
- preventing, diagnosing, monitoring, alleviating, treating, curing, or compensating for a disease, ailment, defect, or injury;
- influencing, controlling, or preventing human conception, and testing for human pregnancy;
- investigating, replacing, modifying, or supporting part of a human’s anatomy;
- supporting or sustaining human life;
- providing vitamin, mineral, or other human nutritional supplementation; and
- disinfecting medical devices.
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.
Although therapeutic products are products intended for human use, the Act also controls veterinary activities that involve the use of human medicines or medical devices for animal patients.
Providing therapeutic products – market authorisation
Under the Act, therapeutic products (other than APIs) will be regulated by means of market authorisations, issued by the Therapeutic Products Regulator. In general, a medicine, medical device, or NHP cannot be imported, supplied, or exported unless it has a market authorisation, 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 allowed to be imported, supplied, or exported without them having a market authorisation.
Once a product has a market authorisation, the person to whom the authorisation was issued (known as the sponsor) is responsible for ensuring that the product conforms to the authorisation and meets the applicable product standards. The sponsor will also have ongoing obligations in relation to post-market surveillance, record-keeping, record keeping, and reporting.
Medicines that are currently consented under the Medicines Act 1981 will automatically receive a market authorisation under the Act. Other products, including provisionally approved medicines and all medical devices that were lawfully supplied in New Zealand before the Act comes into force will have temporary authorisations, and between two and five years in which to seek market authorisation.
Controlled activities
The Act will regulate who can carry out controlled activities involving therapeutic products. The controlled activities are:
- manufacturing;
- wholesale and non-wholesale supply;
- exporting;
- prescribing and dispensing medicines;
- administering medicines and using medical devices;
- conducting clinical trials; or
- carrying on a pharmacy business.
Those who are permitted to carry out those activities include pharmacists, health practitioners, veterinarians, product sponsors, people who manufacture custom-made devices (such as prostheses), and NHP practitioners. Regulations may also allow other classes of people to carry on controlled activities.
Every person in the supply chain for therapeutic products must comply with an extensive set of rules. These rules will include:
- when, where, how, and by whom the activity is carried on;
- the equipment and materials used;
- suitable quality control and assurance processes; and
- having procedures in place to deal with expired or recalled items.
Special-case requirements
Doctors 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 doctor 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. Doctors 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
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.
Special thanks to Partner Ron Arieli for preparing this article. 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.
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.
