Therapeutic Products Bill introduced to modernise medical devices

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.

(With Inputs from New Zealand Government Press Release)