The New Zealand government has introduced the Therapeutic Products Bill which is intended to replace the existing medicines, medical devices and dietary supplements regimes. The Bill covers the manufacture, testing, import, promotion, supply and export of therapeutic products (which has an expanded definition that includes medical devices, gene therapies and natural health products, together with pharmaceuticals) and is the most significant reform of this sector in New Zealand since the 1980s. In terms of next steps:

1. The Bill is open for submissions until 5 March 2023 (at 11:59pm NZDT); and
   
   
2. There is a reasonably high chance it will pass before the next New Zealand General Election at the end of 2023. We anticipate it will be several years before the legislation is in full force, but the Bill proposes a backstop commencement date of 1 September 2026.

Summary of proposed changes

• Therapeutic products: there are new definitions of therapeutic product and therapeutic purpose that expand the scope of the current regulatory regime to include:
  • Medical devices;
  • Natural health products, including vitamin and mineral supplements; and
  • Treatments involving biological components, gene therapies and advanced cell and tissue therapies.

In the case of medical devices, this will represent a significant shift to largely align with international practice. The proposed regime distinguishes between medical devices, depending on the degree of personalisation and how medical devices are produced (see cls 24-27).

• Therapeutic Products Regulator: the Bill will establish a new Therapeutic Product Regulator within Manatū Hauora | Ministry of Health, empowered to implement and oversee an effective regulatory regime (see Pt 9). The Regulator will be headed by an independent statutory officer, with a wider remit than the current medicines regulator, Medsafe. Regulation will focus on two areas: Market authorisation requirements and controlled activities (discussed below). The Regulator will also administer a new risk-proportionate market authorisation process, and exercise a range of compliance and enforcement powers (also discussed below).
  
  
• Introduction of Pre-Market Authorisation: the Bill will require pre-market authorisation for all therapeutic products prior to import, supply or export in New Zealand. This will impact medical devices most significantly, which are currently subject to notification regime only.

Products currently consented under the Medicines Act will automatically receive a market authorisation under the proposed legislation. Other products that were lawfully supplied in NZ before any new legislation commences will have a transition period of 2 to 5 years in which to seek market authorisation.

Market authorisations for both medicines and medical devices will be issued following an evaluation by the Regulator of a product's safety, quality, and efficacy or performance. The Bill empowers the creation of risk-proportionate approval pathways (allowing for no market authorisation in certain low-risk situations) and the setting of relevant product standards.

Natural health products will also be subject to market authorisation but subject to different evaluation process, which reflects the lower-risk.

• Licencing/controlled activities: individuals seeking to undertake a controlled activity with a therapeutic product will need to apply to the regulator for a licence or permit. Controlled activities are outlined in Pt 3 of the Bill and include manufacturing, wholesale and non-wholesale supply, exports and clinical trials. Additional controls are placed on the use of medicines, including prescribing, compounding, dispensing and administering. Manufacturing and exporting a natural health product are subject to separate controls. (see Pt 5 for Licences and Permits).

The Bill also provides for broad regulation-making power to allow other classes of individuals to engage in controlled activities, for example, surgeons to retrieve a whole organ for immediate transplantation. This provides flexibility to allow the regulatory regime to develop and evolve.

• Advertising and prohibited conduct: misrepresentation, health benefit claims and advertising will be governed by Pt 6 of the Bill (as opposed to under New Zealand consumer laws). The Regulator will oversee this and has power to impose restrictions on advertising, along with ordering certain remedies. These include recall, directions orders and advertising remediation orders.
  
  
• Regulation of natural health products: natural health products will be regulated in a separate category from medicines and medical devices, which reflects the generally lower risk profile. The Bill will also regulate 'health benefit claims' made in relation to a product, which is currently only regulated under consumer law such as the Fair Trading Act 1986.
  
  
• Enforcement: the Bill will introduce a range of enforcement tools, including tiered criminal offences, strict liability offences, improved infringement notices and a civil pecuniary penalty regime: see Pt 8.  This is intended to allow for graduated and proportionate responses to breaches.

Areas we expect will remain largely the same are:

• Direct to consumer advertising

The Bill allows direct to consumer advising of therapeutic products, which is the status quo. However, the Minister expressly invited submissions on this point, noting the Bill does not change the current policy settings but acknowledging some controversy in advertising.

• Cannabis and Psychoactive substances

Similarly, the Bill does not amend the regulatory amendments relating to medical cannabis or drugs controlled under the Misuse of Drugs Act 1975 or Psychoactive Substances Act 2013.

The Bill has now been referred to the Health Select Committee, with submissions due by 9 February 2023. There is a high chance the Bill will pass before the next General Election at the end of 2023. We anticipate it will be several years before the legislation is in full force, but there is a backstop commencement date of 1 September 2026.

Further information about the Bill can be access through this link, along with relevant government papers here.

Please feel free to contact Emma Moran to discuss further.