Member Feedback For NHPNZ TPB Submission

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Member feedback for NHPNZ’s submission on the Therapeutic Products Bill (204-1)

Natural Health Products NZ (NHPNZ) encourages all members to make a submission on the Therapeutic Products Bill (TPB) directly to the Health Select Committee.  In addition, the association will make a submission on behalf of the sector.  This form is for members to provide their feedback to NHPNZ on the TPB so that we can best represent the views of the sector in the Natural Health Products NZ submission. (More info about member submissions follows.)

Download the Feedback Form here (.xls)

(best viewed from your laptop)

Who can use this form?

  • This form is to capture the feedback of NHPNZ members – full, associate, or retail.
  • The feedback may be collated within your organisation and relayed to NHPNZ by one person, or you may like to delegate separate Sections of the TPB to team members and reply individually.

When is the deadline?

  • Please provide your feedback via this form ASAP.  The hard deadline has been removed, but keep in mind that we will need time to collate the feedback, seek further clarification if necessary, and incorporate members’ views into the Natural Health Products NZ submission.
  • You can complete and send this form more than once.  So if you think of something else after sending, just complete it and send again.
  • (The deadline for all submissions to the Health Select Committee has been extended to 5 March 2023.)

Send the completed form to: [email protected]

Guidance for writing your submission:

More information about the Bill and historical documents can be found on our website under REGULATORY RESOURCES (member login required for some pages).

This is a critical stage in the establishment of modern, fit-for-purpose regulations for the New Zealand natural health products industry.  

Thank you for participating so that we can continue to enable this vibrant and growing sector.

Overview information for the Bill

 
Natural Health Products NZ (NHPNZ) has sought and received legal advice on the TPB.  The overview from this advice is in the box below.  The Board is analysing the full report and will incorporate it into both the NHPNZ submission, and into guidance for member submissions. 

Natural Health Products NZ’s Government Affairs team have been working intensively with officials and ministers over the past year (and in fact many, many years before), with our primary objectives being to achieve a modern, fit-for-purpose regulatory regime that:

  • Assures safety and quality in a risk proportionate manner
  • Enables appropriate, evidence-based health claims that fully inform consumers about the function of products
  • Removes export barriers by demonstrating New Zealand has world-class regulatory, compliance and audit systems
  • Enables the industry to expand faster, innovate, employ more people and contribute more to the economy, especially in the regions
  • Makes it harder for non-compliant products to be marketed and sold here

This Bill goes a long way to achieving this and is a very successful outcome thus-far for the industry and our Members’ ongoing contribution to that effort.  But as we’ve said, the devil is in the detail, so your feedback now (and once we have the rules and regulations that will follow on from the Bill) is of utmost importance, so our work continues with vigour.

Therapeutic Products Bill – Analysis for Natural Health Products New Zealand


Overview

The Therapeutic Products Bill (“Bill“) was introduced to Parliament on 30 November 2022 and had its first reading on 14 December 2022.  The Bill has now been referred to the Health Committee, with submissions due on 15 February 2023, and the report to the House of Representatives due on 14 June 2023.

The Bill intends to establish a new regulatory regime for therapeutic products, which includes natural health products (“NHPs“).  In particular, the Bill regulates the manufacturing, testing, promotion, supply, import and export of therapeutic products.  The two key components of the new regulatory regime are market authorisation requirements, which regulate which therapeutic products may be imported into, supplied in, or exported from New Zealand, and a licensing regime which regulates how those therapeutic products can be dealt with.  The Bill also establishes a new Therapeutic Products Regulator (“Regulator“) that would be responsible for ensuring the safety, quality, and efficacy of regulated products across their lifecycle.  Its functions would include issuing market authorisations, licensing controlled activities, post-market surveillance, and compliance and enforcement.

There is still a significant amount of detail that needs to be determined in secondary legislation to be made under the Bill.  The explanatory note of the Bill notes that the equivalent legislation in Australia, the Therapeutic Goods Act 1989, has approximately 2,500 pages of secondary legislation.  There are two key types of secondary legislation that the Bill provides for: rules that would be made by the Regulator and would largely be more technical and detailed, and regulations that would be made by the Governor-General on the recommendation of the Minister.  The making or recommending of secondary legislation would only occur following consultation with affected parties.

It will be some years before the new regime comes into force.  Given the current timeframe and the Government’s commitment to progress the Bill in this parliamentary term, we expect that the Bill would be passed by Parliament before the 2023 general election.  Cabinet Papers suggest that once the Bill has passed it will take another 12 to 24 months to develop detailed regulations to complete the regulatory scheme.  Accordingly, the Bill will not enter into force until an Order in Council is made to bring it into force, with a backstop date of 1 September 2026. 

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