Monday, February 26, 2024

New Bill to reduce regulation of therapeutic goods

Plans to exempt many small-scale Natural Health Product (NHP) manufacturers and rongoā practitioners from regulation under the Therapeutic Products Bill have been announced by Minister of Health Ayesha Verrall and Associate Minister of Health (Māori Health) Peeni Henare.

“I would like to thank the thousands of submitters on this important Bill. The feedback received by the Committee has shaped the changes we are proposing and will ensure the legislation is robust and fit for the future,” Dr Verrall said.

“The changes announced today recognise that the Bill as originally drafted went too far. For example, particular concerns were raised that the regulatory regime for NHPs wasn’t risk proportionate, and the costs may drive small producers of NHPs out of business.

“A number of NHP producers operate out of their homes and produce only a small quantity of goods. These are often sold locally, for example at farmers’ markets.”

The Bill is intended to support product safety, but regulation needs to be proportionate to risk, the Minister said.

“While NHPs aren’t risk-free, I’m comfortable that the evidence available suggests these products don’t pose a significant public health risk,” she said.

“Under changes to the Bill the Government is proposing to make, small-scale NHP producers won’t need to obtain a product authorisation or manufacturing licence from the new Regulator where their products are made and supplied in-person to customers in New Zealand. Product authorisation will still be required for imported NHPs.”

It is also proposed that in most cases Government will not regulate rongoā in the new regulatory system.

Associate Minister Henare says Māori will retain determination around what rongoā means to them, and who is a rongoā practitioner.

“I rongo mātou. We have listened to what Māori have told us. It is now proposed that in most cases Government will not regulate rongoā in the new regulatory system. That means whānau will continue to use and manage rongoā just as they have for generations,” he said.

“We are serious about protecting rongoā and rongoā practitioners. Proposed changes to the Bill will also ensure rongoā activities and services operating from marae continue as usual.”

The cases in which regulation will apply is when products are made for commercial wholesale or commercial export. Most rongoā practitioners do not operate in this way so the change will not affect their day-to-day practice, the Associate Minister said.

“It is important for the Crown to ensure mātanga rongoā can access the export market if they choose to and protect rongoā from those that might abuse it. For example, people who aren’t practitioners may try to market a product as rongoā which is not recognised or endorsed by mātanga rongoā, and in so doing, cause harm to rongoā and mātauranga Māori,” Mr Henare said.

The Government will establish an advisory committee of rongoā experts and Māori health leaders to implement the new provisions in the Bill. Members will be appointed by the Minister of Health, Associate Minister of Health (Māori) and Minister for Māori Development, in consultation with other Ministers and health agencies.   

“We recognise Māori have their own systems in place to regulate rongoā, and these will continue to be used to ensure the oranga of whānau and Māori communities.”

“We also acknowledge government doesn’t have the expertise to protect rongoā in a way that upholds mātauranga Māori. That’s why we’re establishing a committee to take on that protection role and guide the implementation of the Bill.”

The Government and Health Select Committee also heard the public’s concerns about the Bill’s ban on personal importation of prescription medicines. The Select Committee will recommend changes to the Bill to allow personal importation, with appropriate safeguards.

“I know this is a major issue for a number of people and I welcome the proposed changes that will enable New Zealanders to import prescription medicines. I also want to provide reassurance that Government has never had any intention to restrict GiveaLittle pages around unfunded drugs,” Minister Verrall said.

The Government will introduce a Supplementary Order Paper (SOP) amending the Bill to remove many of its obligations in relation to small-scale NHP producers and rongoā practitioners. The details of the small-scale NHP producers’ exemption will be set out in secondary legislation, to be made after the Bill passes.

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