We have fascism with a toothy smile (Jacinda Adern) and fascism with a scowl (Andrew Little)
The scowling Minister, Andrew Little does not much care for freedom of choice or democracy but he LOVES regulation
Legislation to modernise the way medicines, medical devices and natural health products are regulated has been introduced in Parliament today.
The Therapeutic Products Bill replaces the Medicines Act 1981 and Dietary Supplements Regulations 1985 with a comprehensive regulatory regime that is fit for the future.
Health Minister Andrew Little said the Bill will give New Zealanders peace-of-mind about the safety, quality and efficacy of the medicines, medical devices (such as COVID-19 test kits) and natural health products they are using.
“Quality medicines and medical devices are essential for a well-functioning health system, and consumers need to know the natural health products they’re buying off the shelf are safe,” Andrew Little said.
“The Therapeutic Products Bill is a flexible regulatory framework for how therapeutic products are manufactured, prescribed, imported, advertised, supplied and exported, and makes the regulation of clinical trials more robust.
“It enables New Zealand to take advantage of advances in medicine, such as cell and tissue therapies, emerging gene therapies, and the use of artificial intelligence and machine learning software. Having risk-proportionate approval systems will improve access to necessary and life-saving medicines, such as vaccines in a pandemic.
“Consumer safety sits at the heart of the Bill, so the community will be better protected from goods and gadgets that make unfounded or misleading therapeutic claims.
“Having a modern set of laws and regulations that line up with international practices will also help our medicines and natural health products industries to export to the world.
“The Therapeutic Products Bill has been more than a decade in the making and, alongside the Pae Ora (Health Futures) Act, will contribute to building a health system New Zealanders expect and deserve,” Andrew Little said.
The Therapeutic Products Bill is the result of more than a decade of policy work. It incorporates what has been learned from consultation on the Natural Health and Supplementary Products Bill that was introduced in 2011 before being discontinued, as well as the regulation of therapeutic products policy proposals released in April 2016.
The Bill is expected to have its first reading in Parliament before Christmas and will be referred to the Health Select Committee for detailed examination including public and industry submissions.
Natural health products
The Therapeutic Products Bill will regulate natural health products, but in a separate category from medicines and medical devices.
Natural health products are intended to support, promote or maintain health in some way, so are in the category of ‘therapeutic products’.
However the rules applying to natural health products will reflect the fact that they are generally lower risk than medicines and medical devices.
The Bill will ensure market standards for the quality of products (such as Vitamin C tablets) in the places they are already supplied, such as supermarkets.
The Bill establishes a new regulator within Manatū Hauora – Ministry of Health, headed by an independent statutory officer, with a wider remit than the medicines regulator Medsafe.
The new regulator will be responsible for ensuring the safety, quality and efficacy of regulated products across their lifecycle. It will design and implement proportionate, risk-based market authorisation pathways to support the timely availability of therapeutic products. Its functions will include, in addition to market authorisation, licensing controlled activities, post-market surveillance, compliance and enforcement.
Additional resources will be made available to setup the new regulatory regime while ensuring the day-to-day work of Medsafe continues efficiently. The new regulator have the same ability as Medsafe to recover costs through fees, charges and levies, which will be set after consultation with the relevant sectors, professions and individuals it regulates.
The Bill also includes a range of modern enforcement tools allowing for a graduated and proportionate response to breaches, including tiered criminal offences, strict liability offences, improved infringement notices and a civil pecuniary penalty regime.
Look at the Orwellian language of this from legal firm, Buddle Findlay. Where they mean ill health they say ‘health’
9 December 2022
The much anticipated Therapeutic Products Bill was introduced to Parliament on 30 November 2022. The Bill will replace the significantly outdated Dietary Supplements Regulations 1985 and most of the Medicines Act 1981, and is the outcome of a reform programme that started with the Therapeutic Products and Medicines Bill in 2006.
The purpose of the Bill is to promote and improve the health of all New Zealanders by providing for the acceptable safety and quality of medicines, active pharmaceutical ingredients (APIs), medical devices, and natural health products across their lifecycle. The Bill also provides for the efficacy of medicines and APIs, and the performance of medical devices.
The Bill is a substantial rewrite of the draft Therapeutic Products Bill that was released for consultation in 2018. The new Bill reflects broad sector feedback on the previous draft Bill, the health and disability system reforms, changes to health technology, and lessons learnt from the Covid-19 response.
In particular, the Bill provides for:
- The establishment of a new Regulator who will have a range of enforcement powers. While the Regulator will be appointed by the Director-General of Health, the Regulator will exercise their powers independently of the Director General and Minister of Health (although may be subject to general policy directions issued by the Minister)
- A market authorisation regime – All therapeutic products will have to have market authorisation before they can be imported into, supplied in, or exported from New Zealand (unless an exception provided for in the Bill applies). The process and extent of the new Regulator’s evaluation of a product before it can be authorised will depend on the type of product, and the type of market authorisation sought from the sponsor of the product
- The regulation of natural health products (NHPs), which are essentially products that have a therapeutic purpose and contain nothing else except natural product ingredients, or specified additives or formulation aids. NHPs include herbal remedies, vitamins and other supplements. Importantly, the Bill regulates the types of health benefit claims that can be made about NHPs. The pathway to obtain market authorisation is less onerous for NHPs (it is primarily a self-declaration pathway), and market authorisation is not required for low concentration NHPs
- A more robust regulation regime for medical devices – Medical devices are defined broadly, and for the first time in New Zealand, include products that consist only of software that has a therapeutic purpose (such as computer-aided detection software that performs image processing to help detect breast cancer)
- More extensive post-market obligations on those who obtain market authorisation for therapeutic products (sponsors), including the requirement for sponsors to have a robust surveillance and response system for their products, to conduct surveillance of various matters including the product’s safety and quality, and respond to any issues identified
- A prohibition on inducements – Pharmacy operators, and suppliers of therapeutic products are prohibited from giving benefits to health practitioners (eg doctors and dentists) or veterinarians with the intention of inducing such practitioners to make decisions that products are appropriate for patients or to give favourable advice about products to patients. There is also a prohibition on a health practitioner or veterinarian from accepting or asking for such a benefit
- Clearer export requirements – The Regulator will be able to issue export authorisations for products that do not meet criteria for the product to be supplied in New Zealand (this will allow New Zealand suppliers to export products to other countries even though the products are not permitted to be sold in New Zealand)
- A more robust offences and penalties regime – In particular, there are graduated criminal offences, strict liability offences, infringement offences and a civil pecuniary penalty regime
- Crown organisations to be criminally liable if they commit an offence under some sections of the Bill. This would apply to any Crown agencies that are involved in the supply chain of therapeutic products, including sponsoring and supplying products
- The chief executive of the Ministry of Health will have the power to make an “emergency arrangements notice” in specified circumstances, which would allow a person or class of persons to do something that would otherwise contravene a restriction in the Bill (such as the requirement to have market authorisation, or a licence or permit to carry on a controlled activity). This would permit the importation or supply of a medicine or vaccine that was urgently required to address a pandemic or natural disaster.
Similar to the current legislation, the new Bill includes types of therapeutic purposes, specifies that particular activities cannot be carried out without a licence or permit unless provided for in the Bill, and restricts advertising of therapeutic products. However, those requirements have been modernised and updated.
The Bill does not change the restrictions on pharmacy ownership currently in the Medicines Act 1981. Rather, all provisions of the Medicines Act will be repealed except the pharmacy ownership provisions. The Medicines Act will then be renamed as the Pharmacy Ownership Act 1981. Interestingly, the interpretation of the current statutory requirements and restrictions on granting pharmacy licences is one of the issues that is being litigated in a judicial review between New Zealand Independent Community Pharmacy Group and Te Whatu Ora – Health New Zealand & Ors (CIV-2022-485-011). The judgment was reserved and is expected next year. It will be interesting to see what the outcome of that case is, and whether the outcome results in any changes to the pharmacy ownership requirements during the Select Committee process.
Consideration of rongoā Māori
Prior to the introduction of the Bill, some rongoā Māori health workers were concerned that the Bill would restrict their ability to provide services to whānau. Although the Bill does not provide a specific exemption for rongoā Māori health workers, to the extent that rongoā Māori health workers supply or use NHPs, the requirements in the Bill relating to NHPs will apply. Importantly, an NHP practitioner (as defined in the Bill) can manufacture an NHP without a New Zealand authorisation for a client, and supply that NHP to the client if the client consults the practitioner about their health needs, and other specified criteria are met.
In addition, the Bill makes it clear that:
- The Regulator, Minister and any other person exercising power under the Bill must be guided by the principles, which include that the regulation of therapeutic products should support innovation, including opportunities for Māori, and the choice of, and equity of access to, therapeutic products for Māori and other population groups
- The Regulator’s functions include engaging with Māori and other population groups in a manner that reflects their needs and aspirations in relation to therapeutic products
- The Regulator must ensure that they have the capacity and capability to understand and give effect to the principles of te Tiriti o Waitangi/the Treaty of Waitangi, and understand and take into account mātauranga Māori and Māori perspectives in relation to therapeutic products.
A new workstream has been established within the Ministry of Health to consider how rongoā might be protected in legislation. According to the Associate Minister for Health (Māori), Peeni Henare, the new workstream will analyse the bill “to identify any gaps and opportunities to protect rongoā Māori, assure whānau safety, and ensure access to the export market for practitioners”.
The Select Committee process will provide an opportunity for people to have their say on the Bill. It is expected that the Bill will have its first reading next week, and that the Select Committee will call for submissions soon, with a relatively short period of consultation.
Also, as part of the rongoā workstream, the Ministry of Health is currently planning to engage with Māori partners and stakeholders between February and March 2023. In addition, various regulations and rules will need to be drafted and put in place to complete the regulatory regime, which will provide further opportunities for consultation.
If enacted, the legislation will come into effect when an Order in Council is made to bring it into force, or on 1 September 2026 at the latest.
If you have any questions about the Bill, please contact a member or our health team.