Associate Health Minister Casey Costello announced this month that the Therapeutic Products Act 2023 (TPA) will be repealed later this year, and work will begin on two new regimes – one for medicines and medical devices, and another for natural health products.
Ms Costello’s repeal announcement doesn’t come as a surprise. The new coalition Government’s 100-day plan, which was revealed in November last year, listed “begin work to repeal the Therapeutic Products Act 2023” as one of the Government’s 49 agenda items, so swift action was expected.
The big question now is how long it will take for the new regime to be developed. The TPA was a long time coming, so we may have a while to wait.
Why is the TPA being repealed?
The Government has acknowledged that the current regulatory framework for therapeutic products is out-of-date, but it does not consider that the TPA is the answer.
The TPA was introduced under the previous Labour Government amidst strong opposition. This was largely due to concerns of over-regulation, particularly in respect of lower risk products such as natural health products, and concerns about possible cost increases for consumers, businesses, and exporters.
The Government argues that repeal of the TPA in full would provide more certainty to industry and consumers and afford an opportunity for the development of a more modern, risk-proportionate regime. The Government says it wants legislation that will “streamline the way in which new medicines are approved and ensure that regulation supports innovation in health and medical products and economic growth”.
What does the repeal mean for businesses and consumers?
While the TPA received Royal assent on 26 July 2023, most of the provisions of the TPA were only intended to come into force on 1 September 2026. Because of this long lead time, businesses have been continuing to operate under existing laws, including the Medicines Act 1981, the Dietary Supplements Regulations 1985 and the Sunscreen (Product Safety Standard) Act 2022. Following the repeal of the TPA, these existing laws will continue to apply.
So, for now (and likely the foreseeable future), it’s business as usual.
When can we expect to know more?
The Government has announced that it will kick off its consideration of proposals for new legislation later this year. As part of this process, Government will be engaging with key stakeholders, so we expect there to be opportunities for consumers, industry and practitioners to have their say along the way.
If the TPA (which was several years in the making) is anything to go by, we may have a while to wait before we have a new regulatory regime in place. Whether pursing two separate regimes – one for medicines and medical devices and the other for natural health products – will speed up the process remains to be seen. Industry developments, including medical technology advancements, mean that pressure to replace the current, out-dated regime is likely only to increase.
We will continue to keep a close eye on developments in this space. Organisations within the therapeutic products sector should stay attuned to any opportunities to engage with the legislative process in the coming months (and years).
If you have any questions about the current therapeutic products regulatory regime – including the Medicines Act 1981, the Dietary Supplements Regulations 1985 or the Sunscreen (Product Safety Standard) Act 2022 – or you would like to discuss any aspect of this article, please get in touch.
