6/12/2022·2 mins to read
New legislation set to modernise medicines sector
Not long after the introduction of the ambitious Pae Ora (Healthy Futures) Act, Parliament has introduced another significant piece of legislation in the health care sector to round out 2022.
The Therapeutic Products Bill, introduced to Parliament on 30 November, aims to modernise how medicines, medical devices and natural health products are regulated.
The Bill replaces the Medicines Act 1981 and the Dietary Supplements Regulations 1985, which have struggled to keep pace with the dynamic medical environment and international standards. The Bill endeavours to provide a comprehensive and risk-proportionate framework for the regulation of therapeutic products. It also aims to give New Zealanders assurances about the safety, quality, and performance of such products. Hon Andrew Little, Minister of Health, expressed that “consumer safety sits at the heart of the Bill” and that the public will be “better protected from goods and gadgets that make unfounded or misleading therapeutic claims.”
Products captured by the Bill
The Bill is extensive - coming in at almost 300 pages, more than double the length of the Medicines Act. The length is explained by the fact that two distinct types of products are captured by the Bill - medical products and natural health products.
The Bill will regulate how medical products are manufactured, tested, imported, promoted, supplied, and exported. It also makes the regulations applying to clinical trials more robust. The scope of products covered by the Bill is wide - medicines from paracetamol to cell therapies, and medical devices from tongue depressors to implantable pacemakers, are all captured.
Natural health products (such as vitamin C tablets) will also be regulated, but in a separate category to medical products. The rules applying to natural health products will reflect that such products are generally lower risk that medicines and medical devices. The Bill will set market standards for the quality of natural health products in places where they are supplied, such as supermarkets.
Penalties, enforcement and a new regulator
The Bill also establishes a new regulator within Manatū Hauora | Ministry of Health. The Therapeutic Products Regulator will have a wider remit than the current medicines regulator, Medsafe, and will be responsible for designing and implementing market-authorisation pathways for the availability of therapeutic products. Other functions will include licensing controlled activities, post-market surveillance, compliance and enforcement. The Bill also provides a wider range of modern enforcement mechanisms, including harsher criminal penalties and greater fines.
Parliament has previously attempted to repeal and replace the Medicines Act that was introduced over 40 years ago. In 2006 and 2011, similar bills concerning therapeutic products were introduced, but both were discontinued. This is clearly an attempt by Parliament to adopt the learnings from those unsuccessful bills.
This Bill is the result of more than a decade of policy work. The Bill incorporates feedback from consultation with the sector in recent years. It has also considered the current health and disability system reforms, new technology advances, and lessons from the Covid-19 response. Integration with the Pae Ora (Healthy Futures) Act is an important consideration as the Bill will endeavour to operate as part of a transformed health and disability regime. Hon Little appears confident that this new Bill is “fit for the future”.
“Fit for the future”: do you agree?
The Bill is expected to have its first reading in Parliament before Christmas. Following this, the Bill will be referred to the Health Select Committee, and during this stage, public and industry submissions will be invited. While the date for submissions has not yet been announced, we anticipate it to be in quarter one next year.
If you are likely to be affected by the Bill, we encourage you to make a submission. If you would like assistance with preparing a submission, please contact one of our experts.
Special thanks to Madeleine Holmes for her assistance in writing this article.