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Government introduces Therapeutic Products Bill

Government introduces Therapeutic Products Bill

The Government has introduced the Therapeutic Products Bill to Parliament. The Bill will replace the outdated Medicines Act and other legislation, and is intended to create a flexible, responsive regulatory regime covering the entire range of products with therapeutic uses, and “enable New Zealand to take advantage of advances in medicine, such as cell and tissue therapies, emerging gene therapies, and the use of artificial intelligence and machine learning software”. It is an extensive Bill, covering a very wide range of issues and being over 200 pages in length.

The Bill is due to have its First Reading in Parliament before Christmas and will be referred to the Health Select Committee for public submissions.

Products covered

A therapeutic product is any product that is intended for use ain, on, or in relation to humans for a therapeutic purpose, defined as:

  • preventing, diagnosing, monitoring, alleviating, treating, curing, or compensating for a disease, ailment, defect, or injury:
  • influencing, inhibiting, or modifying a human physiological process:
  • testing the susceptibility of humans to a disease or an ailment:
  • influencing, controlling, or preventing human conception:
  • testing for human pregnancy:
  • investigating, replacing, modifying, or supporting part of a human’s anatomy:
  • investigating a human physiological process:
  • supporting or sustaining human life:
  • providing vitamin, mineral, or other human nutritional supplementation:
  • maintaining or promoting human health:
  • disinfecting medical devices:
  • a purpose connected with a purpose referred to in paragraphs above

Therapeutic products are divided into 4 types: medicines, medical devices, APIs (active pharmaceutical ingredients), and NHPs (natural health products) (see clause 20).

A therapeutic product is a medicine if it achieves its principal intended action by pharmacological, immunological, metabolic, or genetic means, unless it is an API or NHP. Clause 23 provides for 4 primary classes of medicines: prescription medicines, pharmacist medicines, pharmacy medicines, and general sale medicines. All medicines will be in 1 of these classes.

A therapeutic product is a medical device if it achieves its principal intended action by means other than pharmacological, immunological, metabolic, or genetic means (see clause 24). Any therapeutic product that is not a medicine, API, or NHP is a medical device. This includes a vast array of products from tongue depressors and bandages to implantable devices, diagnostic software, and robotic surgery machines.

Activities covered

The Bill regulates who can carry on various activities with therapeutic products. For medicines and medical devices, controls are imposed on, among other, manufacturing, wholesale and non-wholesale supply, exporting, and conducting a clinical trial with the product. Additional controls are placed on the use of medicines, including prescribing, com‐ pounding, dispensing, and administering. Manufacturing and exporting a natural health product in the course of business are controlled activities, as is carrying on a pharmacy business. While advertising is not a controlled activity, the Bill allows the regulator to impose restrictions on advertising of therapeutic products. The Bill does allow direct to consumer advertising of therapeutic products.

The Bill provides that therapeutic products must receive a market authorisation before they can be imported into, exported from, or supplied in New Zealand. Significant penalties attach to the unlawful importation, supply, or export of therapeutic products.

Market authorisations are required for natural health products imported into, supplied in, or exported from New Zealand in the course of business. Reflecting their generally lower-risk, natural health products will be evaluated against different standards than those for medicines and medical devices. The Bill allows the Regulator to issue an export authorisation for a product that does not meet one or more criteria for a product supplied in New Zealand. This is intended to support the export of safe, quality products from New Zealand to overseas markets that have different requirements for therapeutic products.

New Regulator

The Bill establishes a Therapeutic Products Regulator. The Regulator will be a public servant appointed by the Director-General of Health within the Ministry of Health, headed by an independent statutory officer, with a wider remit than the medicines regulator Medsafe. The Regulator will exercise their powers under the Bill independently of the Director General of Health and the Minister of Health

The new regulator will be responsible for ensuring the safety, quality and efficacy of regulated products across their lifecycle. It will design and implement proportionate, risk-based market authorisation pathways to support the timely availability of therapeutic products. Its functions will include, in addition to market authorisation, licensing controlled activities, post-market surveillance, compliance and enforcement.

Replacing current legislation

The Bill will repeal most provisions of the Medicines Act 1981, except those relating to pharmacy ownership, and revokes the regulations made under that Act. The Bill does not disturb current regulatory arrangements relating to medicinal cannabis or drugs controlled under the Misuse of Drugs Act 1975, or psychoactive substances controlled under the Psychoactive Substances Act 2013. The Dietary Supplements Regulations 1985 under the Food Act 2014 will also be revoked, as they currently regulate edible natural health products.

Next steps

Once the Bill has passed its first reading, which is expected to be on one of the four remaining sitting days of this year’s Parliament, it will go to the Health select committee, which will call for public submissions. Capital is able to assist clients who wish to make a written and/or oral submission to the committee.

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