Associate Minister for Health Casey Costello confirmed yesterday that, after repealing the Therapeutic Products Act (TPA), the Government will start working on a new regulatory regime for medicines and medical devices, and a separate regime for natural health products (NHPs). Work will start later this year.
The repeal of the TPA was a commitment of the coalition Government, which believes that the Act would have imposed over-regulation and unnecessary costs on consumers, businesses and industry. Ms Costello said that the proposed new legislation will be modern and risk-proportionate, and will support innovation and economic growth. She also commented that the new regime "needs to back our innovators" and "to provide timely access to new and promising therapies."
The news that the Government will regulate NHPs separately from medicines and medical devices will come as no surprise to those who watched the TPA's journey through the legislative process last year. What remains to be seen is whether structuring the regulation as two separate bills will make it easier to get both of those bills through the House.
The Medicines Act 1981 is long overdue for replacement, and the health sector will be watching closely to see how any new legislation addresses modern questions relating to therapeutic products. How to protect patient safety without unduly stifling innovation in a context of accelerated technological change, how to ensure New Zealand is sufficiently aligned with our major trading partners, and how the costs of increased regulation will borne by market participants will all be significant issues for the Government to address.
We will continue to keep a close eye on developments in this space. In the meantime, we encourage pharmaceutical, medical device and dietary supplement businesses and organisations to start considering how to take advantage of another chance to influence the shape of the regulation.
This article was co-written by Aisling Weir (special counsel), Catherine Miller (special counsel) and Michael Finucane (senior solicitor).
