New Zealand To Create New Regulator Under Therapeutic Product Reform Bill
Executive Summary
After 10 years in the making, draft legislation for modernizing how medicines and medical devices are regulated in New Zealand has been introduced in parliament for debate.
A new regulator in New Zealand with a wider remit than the current medicines regulator, Medsafe. Keeping pace with rapid advances in health technologies including gene, cell and tissue therapies. And staying aligned with international practices.
These are just some of changes proposed in the newly published Therapeutic Products Bill, a piece of draft legislation that has been 10 years in the making and which seeks to modernize the way in which medicines, medical devices and natural health products are regulated in New Zealand.
The bill was introduced in parliament on 30 November and is expected to undergo its first reading before Christmas. It will be referred to the Health Select Committee for detailed examination including public and industry submissions, according to the government.
Once finalized, the bill will replace the Medicines Act 1981 and Dietary Supplements Regulations 1985 with a “comprehensive regulatory regime that is fit for the future,” said health minister Andrew Little.
The bill takes on board sector feedback to consultation undertaken in recent years, as well as advances in health technology changes and also lessons from COVID-19, the government noted.
It will regulate how products are manufactured, tested, imported, promoted, supplied, and exported. This will include providing better oversight of gene, cell and tissue therapies and medical devices. These products are currently not fully regulated in New Zealand.
The new scheme will align with international best practice and will be future proofed with the flexibility to ensure effective control over new technologies, the government said. “Having a modern set of laws and regulations that line up with international practices will also help our medicines and natural health products industries to export to the world,” Little noted.
The bill also proposes introducing modern enforcement tools.
New Regulator
The new regulator proposed in the bill would be established within the Ministry of Health (Manatū Hauora). It would be headed by an independent statutory officer, with a wider remit than Medsafe.
“The new regulator will be responsible for ensuring the safety, quality and efficacy of regulated products across their lifecycle,” said Little. “It will design and implement proportionate, risk-based market authorisation pathways to support the timely availability of therapeutic products. Its functions will include, in addition to market authorisation, licensing controlled activities, post-market surveillance, compliance and enforcement.”
Additional resources are to be made available to set up the new regulatory regime while ensuring the day-to-day work of Medsafe continues efficiently, the minister said. The new regulator would have the same ability as Medsafe to recover costs through fees, charges and levies, “which will be set after consultation with the relevant sectors, professions and individuals it regulates.”
The bill also includes a range of modern enforcement tools allowing for a graduated and proportionate response to breaches, including tiered criminal offences, strict liability offences, improved infringement notices and a civil pecuniary penalty regime.