Table of Contents
Summarised by Centrist
Parliament has passed the Medicines Amendment Bill, enabling the Health Minister to approve a medicine within 30 days if at least two comparable overseas regulators have already cleared it.
The initial list includes Australia, the US, Canada, the UK, the EU, Singapore and Switzerland. Regulators can be added or removed by regulation. Medicines “identical in all material respects” to approved products can also be cleared quickly.
The bill passed with support from National, Labour, ACT and NZ First. Independent MPs Tākuta Ferris and Mariameno Kapa-Kingi opposed it (via proxy).
Ministers Simeon Brown and David Seymour say the change will speed access “at no cost,” citing an asthma treatment they argue could have been approved 16 months sooner under this pathway.
The law now permits advertising of unapproved medicines at medical conferences and trade shows. The government estimates about $90m in conference revenue from related changes.
Pharmacists may hold a financial stake in businesses they prescribe from; pharmacist prescribers are also added to those who can prescribe unapproved medicines.
Prescribing powers are expanded to nurse practitioners, midwives, dentists and optometrists (within scope).
Labour’s Ayesha Verrall backed the bill but warned New Zealand’s broader medicines regime remains outdated after the coalition scrapped the Therapeutic Products Bill, and criticised shifting appointments to the Medicines Classifications Committee from the Director-General to the Minister.
