Therapeutics Products Bill update June 13th 2023

The report on the Therapeutic Products Bill has now been released and the next step is that the second reading will take place later this month. This report is extremely disappointing to say the least. Many outstanding submissions were made and the report demonstrates that they have heard what we’ve said, but have chosen to ignore much of it. While many platitudes are made in the report itself these are not adequately reflected in the amendments recommended to the bill and fundamentally in law it’s the bill that will hold, not the report.

To recap on some of our concerns from a homeopathic perspective, we raised the following:

  • We recommended against regulation of natural health products in alignment to international standards as New Zealand presents a unique landscape – while they are making some exceptions regarding Rongoā Māori, they are ignoring the rest and will want to align with international standards.
  • Our recommendations with regard to homeopathic preparations and low concentration NHPs have been completely ignored. The only amendment made was in the spelling: Low-concentration natural health products (the hyphen has been added in!).
  • A license will still be required to import low-concentration NHP (clause 69)
  • We can still create Personalised NHPs, but we can only dispense with a consultation. (clause 112) But the government has announced they plan to ‘exempt many small-scale NHP manufacturers and Rongoā practitioners from regulation under the TPB, so there seems to be some sort of contradiction here.
  • The fines have been lowered from $200K to $100K and max 1 year imprisonment (not 5) for individuals and a fine not exceeding $500K (down from $1Mill) and the report stresses that this is a maximum! It is still a major concern under clauses 252 and 253, which suggests this could happen where advertisements do not meet advertisement requirements.
  • No changes to the Regulatory body, some minor modifications have been made to supposedly strengthen the details around the regulator to create the impression that appropriate people are included in consultation where relevant, and to ensure independence, but the devil will still be in the detail when the rules are formed. The changes put forward look very negligible and will not have the desired impact. We proposed a more light touch approach to NHP to reflect the much lower risk associated with NHPs.
  • The most concerning aspect is that we are still not allowed to use remedies that derive from human or animal origin – no acknowledgment has been made of there being none of the substance in the homeopathic remedy. (clause 31 and 32)

A small comfort is that National and ACT are opposing this bill, so all is not lost but remember they are still the minority at the moment. National have stated in their opposition they “see no compelling evidence for substantive and significant or serious harm from natural health products” and they believe “this bill is a complete overreach”. They also oppose the Direct to Consumer Advertising (DTCA). ACT similarly considers this bill to be an overreach. Interestingly independent MP Dr Elizabeth Kerekere who sits on the select committee is also opposed to this bill.

The government steps from here will be:

  • Second Reading (next stage) - the House debates the Health Committee report and votes on the Bill. Expected later this month. If the vote is successful, the Bill moves to a debate of the committee of whole House.
  • Committee of whole House – the House considers the Bill in detail. Ministers and MPs can propose changes, which may be published before the debate in a Supplementary Order Paper (SOP). The House then votes on the Bill, including any proposed changes.
  • Third Reading - final debate and vote in the House. If successful, the Bill is passed.
  • Royal Assent - the Bill is signed by the Governor-General and becomes an Act.
  • Commencement – even after a Bill is signed by the Governor-General, some or all of the provisions may not come into force until a later date. Currently, most of the provisions in the Bill are intended to commence in 2026, allowing time for public and sector consultation on secondary legislation. Transition periods for products currently in-market will also start from commencement.

In overall terms, homeopathy is probably less affected than other modalities, however we have a big problem with regard to our sarcodes, nosodes and matridonals should this bill go through.

Note: Ministers and MPs can propose changes still and these will be published before the House has its final debate in Parliament, so there is no further call for a submission. You can however raise awareness around the bill and get your MPs to take action and vote against the bill – this needs to extend beyond National and ACT though since they are likely already on board. Petitions are also an option! Remember this is an election year – put pressure on. We strongly encourage you to take action on this if you want to continue to have access to the full range of homeopathic remedies.

Sonia Pechner
NZ Homœopathic Society volunteer team