Kia Ora

Welcome to the latest edition of our newsletter.

We can confirm the Therapeutic Products Bill was introduced to Parliament today. You can read the Minister of Health’s media release here.

This is a significant milestone which we’ve been working towards for a long time. Thanks to everyone who has helped along the way. We know that the Bill is in better shape for taking on board sector comments.

We have some key updates to share with you, including the following:  

• the new regulator
• cost recovery model
• offences and penalties framework
• natural health products (NHPs)
• rongoā Māori interests
• pharmacy ownership rules
• direct to consumer advertising of prescription medication (DTCA-PM).

The new regulator will be a branded business unit within Manatū Hauora, led by an independent statutory officer. The regulator will cover a broader scope of products and activities, and it will design and implement proportionate risk-based market authorisation pathways to support access to safe and effective therapeutic products.

The regulator will have a modern and flexible suite of enforcement tools, including civil pecuniary penalties.

It will be funded through fees, charges, and levies. It’s expected that some Crown funding will also help meet costs associated with the new regulatory regime.

In terms of pharmacy ownership rules, given the changes underway with the health and disability system reforms and the ongoing COVID-19 response, the current rules restricting pharmacy ownership are being maintained.

Following a review of available evidence, the Government has also decided to continue to permit DTCA-PM, subject to current controls. The relevant Cabinet Papers on the above issues are now available on our website.

We acknowledge that many of you will have a view on these decisions. There will be an opportunity to have your say at Select Committee stage.

Today, the Government also announced a new workstream to consider how rongoā Māori can be appropriately scheduled in legislation so rongoā Māori is protected, patient safety is assured, and export market access is protected. You can read the media release here.

Please forward our newsletter to any of your colleagues who would be interested and look out for our next update.  If you want to get in touch with the team, you can email us at: therapeuticproducts@health.govt.nz

Ngā mihi
Therapeutics Policy Team

Introduction of the Bill

You can read the Therapeutic Products Bill here. To follow the progress of the Bill and receive notifications click here.

Here’s a quick summary of the stages the Bill will go through:

• Introduction - the Bill is made available for the House to consider.
• First Reading - MPs debate and vote on the Bill.
• Select Committee - receives submissions on the Bill, holds public hearings, and prepares a report on the Bill, including recommending changes.
• Second Reading - the House debates the Select Committee report and votes on the Bill.
• 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.

For more information on the legislative process, click here.

New regulator

Medsafe has operated as an effective regulator, ensuring COVID-19 vaccines and therapeutics used in New Zealand are suitably safe and effective, and providing trusted and quality advice.

However, the current Medicines Act does not provide it with the modern regulatory tools needed to ensure comprehensive access to safe and effective therapeutic products.

To balance a high degree of independence with the need for efficiency and cohesion within the health system, the new regulator will be a branded business unit within Manatū Hauora. An independent statutory officer will be appointed by the Director General of Manatū Hauora to head the unit and they will work independently of the Director General and the Minister of Health.

As part of the new regime, the new regulator will cover a broader scope of products and activities. In addition to medicines, the regulator will be responsible for medical devices and natural health products, biologics (e.g., gene and tissue therapies) and clinical trials (among other controlled activities).

The new regulator will be responsible for ensuring the safety, quality, and efficacy of regulated products across their lifecycle. Its functions will include market authorisation, licensing controlled activities, post-market surveillance, and compliance and enforcement.

Once Parliament passes the Bill, it will not come into force immediately. We will need to build the new regulator and develop secondary legislation before the Bill commences. This will start in 2023 and will take a number of years to put in place.

Cost recovery

To ensure the regulator is sustainable, the Bill will allow the regulator to recover its costs through fees, charges and levies.

Fees, charges and levies will be determined following consultation with the sectors, professions and individuals regulated under the Bill.

This consultation will take place before the Bill commences and will apply an ‘open book’ approach to fee setting. This will mean that charges are efficient and effective, and stakeholders will have visibility over the costs that underpin the charges they pay.

Offences and penalties

The Bill includes a range of modern enforcement tools that include tiered criminal offences, strict liability offences, improved infringement notices and a civil pecuniary penalty regime. This will allow for graduated and proportionate responses to breaches.

The civil penalty regime is intended for contraventions that are engaged in for commercial and profit-driven reasons, but which do not warrant the full stigmatising effect of a criminal prosecution.

Natural health products (NHPs)

As you know, the Bill will provide for a modern, comprehensive and flexible regulatory regime for NHPs, as well as medicines and medical devices.

NHPs are categorised as a therapeutic product in the Bill because they are intended to have a therapeutic purpose. They will be regulated as a separate category to medicines and medical devices.

While there are many similarities between NHPs and other therapeutic products there are also distinct differences. NHPs are also varied in their risk profiles and the Bill needs to allow for that.

The Bill is designed to ensure there is a clear distinction between NHPs, medicines, foods and cosmetics. Regulations applying to NHPs will reflect that they are generally lower risk than medicines and medical devices.  

The regime for NHPs will include:  

• a list of permitted NHP ingredients (to be developed in secondary legislation). 
• a general requirement that most NHPs obtain a ‘market authorisation’ before being imported into, supplied in or exported from New Zealand. Applying a risk-proportionate approach, market authorisation of NHPs will be via a self-assessment/declaration pathway. This is a less onerous process than for medicines or medical devices, but still allows the regulator to take appropriate safety action (e.g., recalls). 
• an authorisation for natural health practitioners to manufacture and supply NHPs to their clients as part of a health consultation.  
• provisions for making ‘health benefit claims’ which relate to maintaining and promoting health, nutritional supplementation such as vitamin and mineral supplements, and the relief of symptoms. There will also be the potential for the regulator to develop pre-authorised claims for other therapeutic purposes, where those claims are substantiated.  
• provisions that will support exports and innovation through exemptions to meet requirements in importing countries, and improved export certifications.  
• identified boundaries between this regime and the schemes for foods, cosmetics, medicines and medical devices.  

In early November, we held two stakeholder hui’s on NHPs to give people an update on the Bill. It was great to see so many people from across different groups come together, such as importers, exporters, manufacturers, health practitioners and academics.

Rongoā

The Government today also announced a new workstream to consider how rongoā might be appropriately scheduled in legislation. Under Te Tiriti o Waitangi, the Crown has an obligation to actively protect rongoā.

‘Rongoā’ is not mentioned or referred to in the Bill. However, because of the inclusion of NHPs in the Bill, aspects of rongoā are captured through definition.

This new rongoā workstream will explore the interface of the Bill and rongoā. It will also explore whether rongoā matters are being addressed through other government work programmes. Rongoā practitioners, whānau and stakeholder groups will have the opportunity to share their views through targeted engagement led by Manatū Hauora. 

Manatū Hauora will provide advice to the Minister in April 2023.

Pharmacy ownership

There are longstanding restrictions in New Zealand on who may own a pharmacy.

We acknowledge the strong interest of stakeholders on this issue, and the differing views on pharmacy ownership rules.

Given the significant changes underway with the health and disability system reforms and the ongoing COVID-19 response, the pharmacy sector does not need further change. The removal of restrictions on pharmacy ownership would create additional uncertainty and disruption for the sector in the short term.

Maintaining the status quo does not affect the ongoing provision of safe and effective medicines and other therapeutic products to New Zealanders.

The new therapeutic products regulatory regime will still enable innovation in how and where services will be provided, such as mobile pharmacies reaching remote areas, pharmacists visiting rest homes, or working as part of a multi-disciplinary healthcare team in the community. 

The Bill also provides new mechanisms that will enable improvements around e-prescribing and a new regime for access to unauthorised medicines to meet a patient's clinical needs. This will help address some of the inequities in the system.  

DTCA-PM

Advertising for medicines, medical devices and medical treatments in New Zealand is managed through government regulation and self-regulation by industry and professional organisations.

The current combination of government regulation and self-regulation has shown it's effective, with only minimal enforcement action needed.

The Bill contains an enhanced status quo. It continues to allow well-regulated, direct to consumer advertising of prescription medicines (DTCA-PM) and will provide the regulator with more modern and effective enforcement tools to control advertising of all therapeutic products.

This includes advertising remediation orders and significantly increased penalties, a new provision for infringement notices, and a broader definition on what constitutes an advertisement.

In reviewing whether to maintain the status quo on DTCA-PM, the Government noted that such advertising (if regulated appropriately) can result in more awareness of health conditions and earlier detection of diseases. It can also support increased literacy and better relationships between prescribers and patients. Previous research involving GPs, reported doctors were confident they could resist patient pressure to prescribe clinically inappropriate or unnecessary medicines.