Background
A new regulatory framework for therapeutic products is currently being considered by the New Zealand Parliament’s Health Select Committee. If passed, the Therapeutic Products Bill (Bill) will replace the Medicines Act 1981, the Dietary Supplements Regulations 1985 and Medsafe, and will govern the manufacturing, testing, promotion, supply, import and export of therapeutic products. Therapeutic products include medicines, medical devices, active pharmaceutical ingredients, and natural health products (NHPs).
The Bill has been developed in response to concerns that existing legislation does not provide adequate coverage of many products used in modern health care delivery and that there is no appropriate level of assurance that NHPs are safe or made to particular quality standards. This includes a lack of regulatory oversight with regards to health benefit claims made by NHPs. The Bill seeks to address these issues by introducing what is described in the explanatory notes as “a risk-proportionate approach” to regulation and requires therapeutic products to meet certain standards before they can be marketed and sold to the public.
Therapeutic Products Regulator
The Bill replaces Medsafe with the Therapeutic Products Regulator (Regulator). The Regulator will oversee the efficacy, safety and quality of therapeutic products and will have a wide range of compliance and enforcement powers, which are to be exercised independently from the director General of Health and Minister of Health. Examples of the Regulator’s powers include issuing market authorisations, granting licences, carrying out post-market surveillance, and the ability to recall products if they do not meet relevant standards.
Licencing and Market Authorisation
The Bill introduces a licensing requirement for anyone carrying out a “controlled activity” involving therapeutic products. The Bill sets out a list of activities that may constitute a “controlled activity”, including the manufacturing, exporting and supply of medicines and medical devices, conducting clinical trials, and manufacturing or exporting NHPs.
Therapeutic products will also require market authorisation before they can be imported into, exported from, or supplied in New Zealand. The Bill provides some limited exceptions to this rule such as products that fall in the category of “low-concentration NHPs”. The process for obtaining market authorisation will involve a rigorous assessment of, among other things, the product’s safety, quality, and efficacy and any health benefit claim will need to be substantiated.
Under the Bill, standards vary between medicines, medical devices and NHPs, as NHPs are generally considered to be lower risk. Once a product receives approval, the person who has been granted market authorisation (referred to as the “sponsor”) will have ongoing responsibilities such as ensuring the product meets relevant standards, as well as record keeping and reporting obligations.
Regulation of NHPs
One of the more topical changes being introduced is the regulation of NHPs, which will be regulated under a separate category. Broadly speaking, NHPs are products that are used for “therapeutic purposes” and derived from natural sources, such as plant material, minerals, or animal extracts. The Bill sets out a schedule with examples of NHP ingredients that would trigger compliance and regulates the types of health benefit claims that can be made. Some examples of products that may be captured include those that promote human health, herbal remedies, vitamins, and dietary supplements.
Penalties
The Bill introduces a range of civil and criminal penalties for non-compliance. Depending on the nature and circumstances, a breach may result in an infringement notice, fine or even imprisonment. Civil penalties include fines of up to $250,000 for individuals and $2 million for non-individuals. Criminal penalties for individuals include imprisonment for up to 5 years and a fine not exceeding $200,000 for individuals, and for non-individuals a fine not exceeding $1 million.
Moving forward
The regulatory overhaul will impact many businesses facing unfamiliar regulatory hurdles and compliance for the first time. As a starting point, a case-by-case analysis of products is recommended to determine whether products are likely to be captured. Whilst there will be a transitional period to allow businesses to comply, for those businesses dealing with therapeutic products, now is the time to become familiar with the regulations and plan accordingly.
