The Therapeutic Products Act will be repealed before the end of 2024.
The Minister responsible, Hon Casey Costello, is planning to develop two
pieces of legislation to replace the TPA – one to cover Natural Health
Products and another to deal with medicines and medical devices.
Ms. Costello is looking towards a lasting and robust solution that
appropriately balances oversight and efficiency.
The coalition government has confirmed that the Therapeutic Products Act will be repealed before the end of this year, and Natural Health Products will be covered by legislation away from the Medicines Act and medical devices.
In the first week of May, the Natural Health Alliance met with the Associate Minister of Health, Casey Costello, who is responsible for the repeal and replacement of the Therapeutic Products Act 2023. Four members from Medsafe and the Ministry of Health were also present, as well as Parliamentary staff from Ms. Costello’s office.
We were strong in our approach: Natural Health Products are not synthetic chemicals and therefore not a pharmaceutical product; there must be a legislative and regulatory framework that ensures the long-term protection of natural health products away from bureaucratic tinkering. The Food Act and the Dietary Supplement Regulations have allowed the natural health products industry to flourish and grow while at the same time ensuring consumers are protected, and that must be our starting point.
The over-riding issue for the NHA is what comes next and how are we able to implement a robust and durable legislative and regulatory framework. We reminded the Minister that the Ministry of Health (Medsafe) had targeted natural health products for almost 30 years, continually pushing for increased regulations around sale and manufacture that ultimately aims to class these food products as pharmaceuticals. And while this had failed at every attempt so far, in our view it makes no sense to continually revisit these attempts each time a new government is elected with a different ideology on health policy.
We further stated that the NHA disagreed with the Ministry’s assertion that there are “safety” concerns to such an extent that New Zealand requires an entirely new regulatory system, such as the Therapeutic Products Act.
We are therefore very pleased to see that, a week after our meeting, Ms. Costello’s office issued a media release that mirrors our viewpoint on the protection of natural health products. Ms. Costello confirms the repeal of the Act will occur this calendar year. “To provide certainty to industry, consumers and practitioners the TPA will be repealed in full. It is my intention that the repeal Bill passes before the end of the year.”
She writes: “The current Medicines Act is out of date, but the TPA was not the solution. It would have over-regulated some products and imposed unnecessary costs on consumers, businesses and exporters.”
The Minister reiterates in her media statement that the government is listening to the concerns of industry and consumers. “Industry groups considered their products would be over-regulated, particularly lower risk products, such as some natural health products. Consumers, importers and practitioners, told us that over-regulation could make these products more expensive or unavailable and I am not confident the Act would have improved approval times for new medicines.”
The Minister’s full statement can be read here: https://www.beehive.govt.nz/release/therapeutic-products-act-be-repealed
During question time in Parliament on Thursday 9 May, Ms. Costello went even further and said she is planning to develop two pieces of legislation to replace the TPA – one to cover Natural Health Products and another to deal with medicines and medical devices. This will be the next phase of policy work and engagement in our industry.
I will be calling our members personally over the next few weeks to explore a range of options and how you can assist in this next phase to ensure our industry’s future.
All in all, the NHA is pleased with the way this is tracking. We are confident that we have a Minister who is listening to the concerns of the natural health products industry and is not captured by Big Pharma or the bureaucracy. Although we must remain vigilant and engaged to ensure we achieve the right outcomes.
The gauntlet has been laid down. It’s now up to our industry to meet that challenge.
She writes: “The current Medicines Act is out of date, but the TPA was not the solution. It would have over-regulated some products and imposed unnecessary costs on consumers, businesses and exporters.”
All in all, the NHA is pleased with the way this is tracking. We are confident that...