Photo: 123RF
Legislation to ensure medicines approved in similar countries overseas also get approval in New Zealand has passed in Parliament.
It passed with support from all parties other than the independent MPs Tākuta Ferris and Mariameno Kapa-Kingi.
The bill also enables the advertising of unapproved medicines at medical conferences - a change the government had to legislated after legal experts rubbished the coalition's claims the ban on advertising had already been lifted.
The Medicines Amendment Bill was a commitment in National's coalition agreements with both ACT and New Zealand First.
It enables medicines to receive approval from the minister within 30 days if they have been approved by two or more overseas regulators that meet specified criteria.
These include that the group or person:
- Is a regulator of medicines
- Operates in a regulatory framework similar to New Zealand's, with a similar decision-making process
- Has a formal framework for co-operation with the Director-General of Health
- Uses international guidelines and standards consistent with New Zealand's approach
- Conducts their business and releases reports in English.
The Health Minister will have the power to add regulators to the approved list through regulatory change - without having to change the law - if they meet these requirements.
The minister can equally remove regulators deemed to no longer meet the requirements.
Australia, the United States, Canada, the United Kingdom, the European Union, Singapore and Switzerland are the initial jurisdictions .
Medicines that are "identical in all material respects" to approved medicines could also be approved.
The bill also expands who can prescribe medicines to nurse practitioners, midwives, dentists, and optometrists, so long as the medication falls within their scope of practice.
Pharmacist prescribers were also added to a list of those who can prescribe unapproved medicines.
Health Minister Simeon Brown and Associate Health Minister David Seymour on Wednesday hailed the passage of the bill, saying in a statement it would increase access to medicines with a "common-sense efficiency that costs nothing".
"It helps Kiwis in need. It can shave months off the approval process. A perfect example of this was with a treatment for asthma which could have been approved by the end of 2022 under this pathway but was not approved until 16 months later in May 2024."
Other changes - brought in after the public consultation stage at select committee - will enable advertising of medicines at medical conferences and trade shows, along with the ability for pharmacists to have a financial stake in a business they prescribe from.
Legal experts in August warned advertising unapproved medicines at conferences remained a criminal offence despite Ministers Brown and Seymour having welcomed "confirmation" the rules had been changed.
The ministers welcomed the changes around medical conferences, saying it was cutting red tape and estimated to generate $90 million in revenue over the next few years.
"Prohibition was introduced in response to the perceived risk that pharmaceutical companies may attempt to circumvent formal medicine approval processes. The Ministry for Regulation investigated this. They found the overly cautious approach was out of step with other recognised jurisdictions. The government acted fast to fix it," the ministers said.
Brown said the change would make it easier for healthcare professionals to keep up with the latest innovations in health products and medicines.
Labour's Health spokesperson Ayesha Verrall said those changes had already been debated as part of the previous government's Therapeutic Products Bill, which the coalition subsequently scrapped - and suggested that meant plans to overhaul the wider approvals regime were in question.
"It appears that having repealed the Therapeutic Products Bill, promised a new Medicines Act, David Seymour doesn't want to wait for that to make these changes... The Medicines Act is from 1981, that is how outdated our medicines regulation is in New Zealand. We support this bill and the modernisations and small changes to our regulatory system that is in here but our entire regulatory system is out of date," she said.
"The fact that this bill has had this addition to it suggests to me that medicines regulation in New Zealand is in big trouble."
She also criticised the ability for the Medicines Classifications Committee members to be appointed by the Minister rather than the Director-General.
Ferris and Kapa-Kingi - who were absent from Parliament - lodged their dissenting votes using the Green Party (which voted in favour of the bill) as a proxy.
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