Kia Ora
Welcome to the latest edition of our newsletter.
Our top priority remains the drafting of the Therapeutic Products Bill. We’ve been working at pace with the Parliamentary Counsel Office (PCO) on this.
It’s a complex piece of legislation. The Bill has almost doubled in size due to the feedback on the exposure draft, the health system reforms, lessons from COVID-19 and the need to include regulation of natural health products (NHPs).
The purpose of the Bill is to protect, promote and improve the health of all New Zealanders by providing for acceptable safety, quality and efficacy of medicines and medical devices, and acceptable safety and quality of NHPs.
In preparing the Bill, we’re taking care to ensure it is future-looking, flexible and sensitive to the needs and aspirations of all New Zealanders, including Māori, Pacific peoples and the disabled community.
We’ve been working closely with our colleagues in Te Aka Whai Ora – the Māori Health Authority - on how best to reflect the principles of the Te Tiriti o Waitangi in the Bill. We’ve been mindful of how the principles apply across all sectors and activities covered by the Bill.
We’ll be continuing our ongoing engagement with stakeholders as we head towards the introduction of the Bill to Parliament in late 2022.
In this newsletter, we’ve highlighted some of our key engagements and give an overview of how the Bill applies to post market activities, biologics, and clinical trials. We’ve also provided an update on NHPs and the establishment of our implementation team.
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
Members of the team attended the Natural Health Products New Zealand (NHPNZ) annual summit in Napier in August. The team gave a presentation on the Bill and fielded a number of questions. It was a great opportunity to catch up with a number of NHP stakeholders.
The team spoke about the Bill and NHPs at the Ministry for Primary Industries led Food and Beverage Forum in August.
We also met with nuclear medicine technologists from the Australian and NZ Society of Nuclear Medicine and discussed the future regulation of radiopharmaceuticals under the Bill.
Additionally, we held a second hui with Māori clinicians and health providers to update them on the Bill and to seek feedback on how we can best reflect the principles of Te Tiriti in the Bill.
Natural health products (NHPs)
In the NHPs space, we’re planning a small, targeted stakeholder hui on NHPs and the Bill for early November.
There has been a lot of work going into the drafting provisions for NHPs in the Bill. It’s worth remembering that the Bill will just set up the framework for a NHP regulatory regime. There is still considerable work to occur to further clarify how the regime will work in practice, most of which will be set out in subsequent regulations.
Post market regulation
The Bill will regulate activities across a therapeutic product’s lifecycle - this includes product development, pre-market activities (such as clinical trials and manufacturing), and the authorisation of the product for import, supply or export. Once a product is authorised, it will also be subject to regulation. This is called ‘post market regulation’.
Post market regulation of therapeutic products has two purposes:
- ensuring products remain safe and meet required quality and efficacy/ performance standards.
- compliance and monitoring (such as product standards and any conditions of a product’s market authorisation).
The Bill mandates the monitoring and reporting of safety issues for both the regulator and sponsor. Consistent with international practice, the sponsor, as the market authorisation holder, will have special responsibilities under the Bill.
The regulator and product sponsor will be responsible for managing the risks of a therapeutic product and taking appropriate steps to deal with any issues identified, including:
- putting in place a surveillance system for monitoring, collecting, analysing, and investigating information on product safety, quality and efficacy/ performance.
- an action system where:
- the regulator is responsible for ensuring compliance and undertaking enforcement or regulatory actions such as issuing recall notices.
- the sponsor is responsible for carrying out preventative and corrective actions (at their own initiative or in response to a request or direction from the regulator).
As with the Bill as a whole, the specific post market requirements for any given therapeutic product will be proportionate to the benefit and risks of the product.
Implementation workstream
An implementation team at Manatū Hauora - Ministry of Health has been established to work alongside the policy and legislative teams, and Medsafe.
The implementation team will be responsible for a multi-year programme to design and build the new therapeutics regulatory regime.
The new regulator will oversee more products and activities than Medsafe. It will be responsible for ensuring the safety, quality and efficacy of regulated products across their lifecycle.
It will also design and implement proportionate and risk-based market authorisation pathways to support the timely availability of therapeutic products and NHPs.
Biologics
Biologics is an umbrella term for all therapeutic products containing cells and tissues. Biologics have not been previously regulated through a consistent approach.
As biologics include advanced therapies, such as gene therapies, these products are often at the forefront of medical discovery which gives rise to unique safety and product standard issues.
Under the Bill, biologics may be regulated as a medicine or medical device, depending on the mode of action. For example, a gene therapy is likely to be regulated as a medicine, while a skin-graft or donated organ might be regulated as a medical device.
Calling biologics medicines or medical devices is not intended to undermine the cultural, ethical and spiritual significance of tissues or organs, and the Bill will sit alongside existing regimes governing the collection and use of human tissue – ie. the Human Tissue Act 2008 and the Human Assisted Reproductive Technology Act 2004.
As with other therapeutic products, biologics will be authorised under the market authorisation framework established by the Bill. Authorisation pathways will be established by the regulator in secondary legislation and tailored to the risks associated with the product, how it is collected and used.
For example, biologics which are minimally manipulated (including blood, whole organs and skin grafts), may not need to be authorised by the regulator before they can be transplanted. However, regulatory controls will provide assurance of the safety and quality of the tissue once they are removed from the donor.
Substantially manipulated or engineered biologics, such as advanced medical gene therapies, will follow market authorisation pathways for their manufacture. These pathways will be tailored to product risk profiles and proposed uses. This 'tiered control' approach is used by countries that are comparable with New Zealand, including Australia, the European Union, Canada and the UK.
The therapeutic product regulatory regime for biologics will run in parallel with other regulatory approval processes, including approval through the Environmental Protection Authority for all genetically modified organisms under the Hazardous Substances and New Organisms Act 1996 which is also being revised. As mentioned above, product standards will also be aligned with other regimes regarding the ethical, cultural and spiritual aspects of human cells and tissues.
Genomics
Genomic medicine is an interdisciplinary medical specialty involving the use of genetic sequence information. Genomic technology is rapidly expanding in testing, sequencing and genetic modification techniques (such as CRISPR) and may give rise to new treatments and interventions.
‘Precision medicine’ or ‘personalised medicine’ is a clinical application of genomic medicine that develops targeted prevention or treatment for a particular genomic outcome determined by diagnostic genetic testing.
Products involved in genomic medicine intended for a therapeutic purpose will be regulated under the Bill through their appropriate product categories. For example, gene therapies and advanced cell-based therapies (such as CAR-T personalised cancer treatments) are defined as ‘biologics’ and will be regulated as medicines, as their effect on the body is through a pharmacological, immunological, metabolic or genetic mode of action. Genetic testing kits used at home or in a clinical setting will likely be regulated as medical devices.
Under the Bill, these products will be assessed by the regulator in a risk-proportionate manner to ensure safety, quality and efficacy of genomic medicines for market authorisation. New and bespoke pathways will be designed for novel genomic medicines, and their clinical trials will be regulated as a controlled activity requiring a licence or permit. The Bill will provide a clear pathway to market and clinical use for these novel therapies.
Clinical trials
Clinical trials play an important role in establishing the safety and efficacy of new medicines. They help drive innovation in health technologies and can also provide time-limited access to novel medicines, although there are rigorous ethical and consent requirements that must be followed.
The Bill proposes to regulate clinical trials of medicines and medical devices as a controlled activity. Individuals seeking to conduct a clinical trial on a medicine or medical device will be required to obtain a licence or permit, in parallel with any ethics approval process.
These will be streamlined, risk-proportionate processes to ensure greater oversight of safety and efficacy for novel therapies or high-risk products, without increasing unnecessary administrative burden for sponsors.
The Bill’s definition of clinical trial is internationally aligned and is not intended to capture non-interventional trials (such as observational trials relying on retrospective analysis of patient records). Likewise, pre-trial activities such as participant recruitment, and post-trial activities such as epidemiological data analysis, are not included but will be subject to ethical oversight by the relevant committees.
After the Bill is enacted, existing approved clinical trials under the Medicines Act will be authorised to continue for up to 12 months before applying for a new licence or permit to extend the trial.
Existing unapproved clinical trials lawfully being carried out at commencement will be authorised for up to six months to allow time for the individual or organisation with responsibility for the trial to apply for a licence or permit.
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.
Ministry of Health - Therapeutic Products
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