Legislation to modernise the way medicines, medical devices and natural health products are regulated has been introduced in Parliament today.
The Therapeutic Products Bill replaces the Medicines Act 1981 and Dietary Supplements Regulations 1985 with a comprehensive regulatory regime that is fit for the future.
Health Minister Andrew Little said the Bill will give New Zealanders peace-of-mind about the safety, quality and efficacy of the medicines, medical devices (such as COVID-19 test kits) and natural health products they are using.
“Quality medicines and medical devices are essential for a well-functioning health system, and consumers need to know the natural health products they’re buying off the shelf are safe,” Andrew Little said.
“The Therapeutic Products Bill is a flexible regulatory framework for how therapeutic products are manufactured, prescribed, imported, advertised, supplied and exported, and makes the regulation of clinical trials more robust.
“It enables 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. Having risk-proportionate approval systems will improve access to necessary and life-saving medicines, such as vaccines in a pandemic.
“Consumer safety sits at the heart of the Bill, so the community will be better protected from goods and gadgets that make unfounded or misleading therapeutic claims.
“Having a modern set of laws and regulations that line up with international practices will also help our medicines and natural health products industries to export to the world.
“The Therapeutic Products Bill has been more than a decade in the making and, alongside the Pae Ora (Health Futures) Act, will contribute to building a health system New Zealanders expect and deserve,” Andrew Little said.
The Therapeutic Products Bill is the result of more than a decade of policy work. It incorporates what has been learned from consultation on the Natural Health and Supplementary Products Bill that was introduced in 2011 before being discontinued, as well as the regulation of therapeutic products policy proposals released in April 2016.
The Bill is expected to have its first reading in Parliament before Christmas and will be referred to the Health Select Committee for detailed examination including public and industry submissions.
Natural health products
The Therapeutic Products Bill will regulate natural health products, but in a separate category from medicines and medical devices.
Natural health products are intended to support, promote or maintain health in some way, so are in the category of ‘therapeutic products’.
However the rules applying to natural health products will reflect the fact that they are generally lower risk than medicines and medical devices.
The Bill will ensure market standards for the quality of products (such as Vitamin C tablets) in the places they are already supplied, such as supermarkets.
The Bill establishes a new regulator within Manatū Hauora – Ministry of Health, headed by an independent statutory officer, with a wider remit than the medicines regulator Medsafe.
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.
Additional resources will be made available to setup the new regulatory regime while ensuring the day-to-day work of Medsafe continues efficiently. The new regulator have the same ability as Medsafe to recover costs through fees, charges and levies, which will be set after consultation with the relevant sectors, professions and individuals it regulates.
The Bill also includes a range of modern enforcement tools allowing for a graduated and proportionate response to breaches, including tiered criminal offences, strict liability offences, improved infringement notices and a civil pecuniary penalty regime.