Kia Ora

Welcome to the latest edition of our newsletter.

We’re making good progress with the drafting of the Bill, working with the Parliamentary Counsel Office (PCO). Last month PCO provided further redrafts of the Bill for us to consider. It’s an exciting time - seeing it all come together.

In this newsletter we’ve highlighted the market authorisation process, which is how medicines, medical devices and natural health products will come into the New Zealand market. We’ll be making sure that access to clinically necessary medicines will be made available where required.

We’ve been looking at how best to embed The Treaty of Waitangi | Te Tiriti o Waitangi in the Bill. Our engagement with a range of stakeholder groups has continued, particularly in the rongoā Māori space with Te Kāhui Rongoā.

We’re also working closely with our colleagues in Te Aka Whai Ora – Māori Health Authority and Te Whatu Ora – Health New Zealand.

We’ll be continuing our engagement with stakeholders throughout the next few months as we head towards introduction of the Bill later this year.

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

Engagement

Last month we held the last of a series of workshops with Te Kāhui Rongoā, a rongoā practitioner representative body. The focus of the workshops was to discuss options for the recognition and protection of rongoā Māori to the extent rongoā Māori is affected by the Bill.

We’re grateful to everyone who has contributed to this mahi, we know it’s the beginning of a long conversation.

The Ministry recently held a hui with Māori clinicians and health providers to update them on the Bill and to seek feedback on how we propose to reflect Te Tiriti in the Bill. A further hui is planned for August.

At the end of June, we also presented to the Medical Technology Association of New Zealand (MTANZ) annual Healthtech conference in Auckland and fielded a number of questions on the regulation of medical devices (and software as a medical device) under the Bill.

Market authorisation

Under the Bill, therapeutic products will require an authorisation from the regulator before they can be imported and supplied in New Zealand. Usually, this authorisation will follow an evaluation by the regulator of information supplied by the product manufacturer or supplier. 

The Bill will enable the regulator to design flexible, risk-proportionate pathways for applicants to seek product approval. Each pathway will be designed to achieve an optimal level of regulatory oversight, taking into account the need to provide for patient safety and timely accessibility of products. These pathways provide a framework that will address the specific nature of the product and the circumstances.

Risk based regulation: regulation of therapeutic products must be proportionate to the risks they pose. In authorising a therapeutic product, the regulator must be satisfied that the likely benefits of the product outweigh the likely risks.

The Ministry envisages two main forms of authorisation for medicines and medical devices: standard authorisation and provisional authorisation.

Standard: this pathway will be the default entry point for market authorisation for the majority of therapeutic products. An applicant provides a comprehensive set of clinical and other data to support their application for product approval. The regulator may consider and rely on information and decisions by other recognised overseas regulators.

Expedited: a shorter version of the full evaluation where, for example, evidence of overseas approvals by comparable regulators may be relied on. The regulator will be able to establish expedited pathways for standard and provisional authorisations – depending on factors such as the novelty of a product’s mode of action, decisions by recognised overseas regulators, the intended patient population group, and contextual matters such as a public health emergency or if the product is intended to treat a rare condition. 

Provisional authorisation: will be available for occasions where there is not a full suite of clinical safety and efficacy data, but importation and supply of a product is justified for public health benefits (eg. during a pandemic or for rare conditions). In this case, the regulator may grant ‘time-limited’ authorisation. It is intended that, after a period of time, sufficient clinical data will be available to support an application for a standard authorisation.

Self-assessment/declaration: a pathway for low risk products, enabling applicants to make a declaration of compliance with specific requirements and standards. Products include for example, where substance/ingredients have been pre-approved, lower risk medical devices, sunscreens and natural health products.

Special access: the usual process of getting market authorisation may not always be possible (ie. global supply chain disruptions, discontinuation of authorised products or clinical needs for a particular patient). We recognise that legitimate access to products that have not been approved is necessary to deliver timely patient care in some cases. 

The Bill intends to enable health practitioners, via the Bill and secondary legislation, to prescribe, supply and, where necessary, for licenced suppliers to import essential but not yet authorised therapeutic products for patients under their care. This will be achieved via standing authorisations for health practitioners initiating or prescribing products for patients under their care, and through a licensing regime that supports the sourcing, importation and supply of unauthorised medicines and medical devices.

Robust special access arrangements will be balanced with the timely and equitable provision of necessary medicines with the Bill’s product safety objectives, including minimising the risk that counterfeit or contaminated or ineffective products are imported and supplied in New Zealand.

Medical devices

As with medicines, in determining the most suitable product authorisation pathway for medical devices, the regulator will consider the product’s risk.

Authorisation for the lowest risk products may be via a self-assessment/declaration pathway. This will be a more robust process than the current requirement for medical device sponsors to enter a device’s details in the Web Assisted Notification of Devices (WAND) database. Intermediate and higher-risk medical devices will require an evaluation by the regulator.

Software as a medical device (SaMD) - under the Bill, software would generally be considered as a medical device if it is intended to be used for a therapeutic purpose. SaMD is often referred to as standalone software that can function on a laptop, smartphone or tablet intended for therapeutic purposes.

Software in a medical device (SiMD) - a type of software integrated in a hardware medical device. For example, embedded software or firmware in a cardiac pacemaker. This software is considered a necessary component for the pacemaker to achieve its intended function and will be assessed as part of the conformity assessment of that hardware medical device.

It is not our intention that patient and workflow management software applications will be regulated under the Bill.

As with other medical devices, there will be a pre-market conformity assessment required for SaMD before it can be supplied in New Zealand.

Likewise, the Bill will impose requirements of sponsors in relation to any ‘major or minor changes’ they make to their software.

The Bill provides for high-level definitions of major and minor change requirements: major changes would include any changes that affect the product’s intended use and modifications made to critical aspects of the product’s performance. For SaMD, this could mean adding new patient population as an intended use of the device. Adding a new language option or making ‘look and feel’ type of changes would usually be considered minor. 

Detailed rules that define what is ‘major or minor’ will be set out in secondary legislation, and there will be an opportunity for stakeholders to have their say during the development of these rules. 

Software developers are considered manufacturers of medical devices in the Bill.

As software technology is still quite new to international regulators, we are watching our counterparts closely as we develop our approach on how to regulate the design, development and deployment phases of the software development cycle.

At a glance...

When can I provide feedback?

There will be an opportunity for people to have their say when the Bill reaches Select Committee stage, expected to be early next year.

There will also be further opportunities during the consultation on the regulations.

Contacting the team

If you’d like to get in touch, please email therapeuticproducts@health.govt.nz.

If you know anyone who would be interested in receiving these updates, please forward this email on and they can subscribe via the Ministry of Health website. 

If you no longer wish to receive these updates, please use the unsubscribe button at the bottom of this email.