The New Proposed Therapeutic Products Bill
28th February 2019
OK, so this may appear a little dry – actually very dry! However, the new proposed Therapeutic Products Bill is important as it could have far reaching effects for many of us: Scientific Officers and Laboratory Workers, Physicists, Radiation Therapists, MITs, Pharmacists, Physiologists, Biomedical Engineers, CSSD technicians and anyone undertaking clinical trials just to name a few.
Out with the old, in with the new?
The Ministry of Health (MOH) has published a draft Therapeutic Products Bill, intended to replace the outdated Medicines Act 1981, and is requesting feedback on the drastic changes projected for therapeutic products regulation.
The Medicines Act 1981 currently regulates medicines and medical devices in New Zealand. The efforts made to reconstruct the Medicines Act have been long standing – dating back to the late 80s. The Therapeutic Products Bill has finally taken form aiming to bring New Zealand therapeutic products regulation into the 21st century and in-line with international approaches. There is still a significant amount of work to be done. We will not be witnessing the actual implementation of this proposed regulatory scheme for another two years or more – that is, if the Bill passes.
Overview of the proposed Therapeutic Products Bill
Unlike the Medicines Act, the Bill itself lacks details – the specifics will be defined in the subordinate legislative instruments (i.e. regulations and rules) instead. This is termed ‘principles-based’ legislative framework. Regulations and rules are easier to maintain and update as they do not need to go through the full parliamentary process. This allows for a more flexible approach to regulating therapeutic products in contrast to the rigid and prescriptive structure of the Medicines Act. It also raises potential concerns about how easily changes can be made and accountability issues. The proposed scheme allows for various approval pathways depending on the product in question and surrounding circumstances.
Currently, the Minister of Health and Director-General of Health hold the regulatory powers. Under the new scheme, the ‘regulator’ will hold this responsibility, independent of the Minister of Health. The form of the ‘regulator’ is yet to be decided – this is obviously going to be important.
The proposed Bill covers a broader range of therapeutic products (than the current legislation) which are split into four different categories:
a) Medicines – this definition now includes cells and tissues and radioactive medicines.
b) Medical Devices – covers a comprehensive range of products – ranging from simple, minimal risk products such as tongue depressors and bandages to complex, high-risk products such as heart valves, orthopaedic joints and diagnostic equipment such as CT scanners and X-ray machines as well as in-vitro diagnostic tests and software used for a therapeutic purpose.
c) Active Medicinal Ingredients – Also referred to as active pharmaceutical ingredients. These are defined separately to medicines so that they can undergo a less scrutinised approval process.
d) Type-4 Products – these are defined as therapeutic products that do not conform to the definition of medicine or medical device. This category was created with the vision that the Therapeutic Products Bill will stay in place for another 30+ years and therefore will need to cater to novel therapeutic products that are yet to be encountered.
It should be noted that natural health products (including rongoā Maori and dietary supplements) are excluded from this new legislation.
The regulation of therapeutic products is achieved via two mechanisms:
1. Product approval – which is a prerequisite for importing or supplying therapeutic products.
2. Authorisation requirement for undertaking specific activities involving therapeutic products – termed as ‘controlled activities’. Examples of controlled activities include but are not limited to:
• Conducting clinical trials
• Carrying on a pharmacy business
• Compounding & dispensing
The authorisation of controlled activities can be provided for by provisions in the Act or regulations, a licence or a permit. Some products, based on their risk-profile, can be declared to be approval – exempt; meaning that a product approval is not required for the importation or supply of such products. Examples include – whole blood collected by NZBS, and custom-made devices by, or for, an individual clinician for the sole use of a particular patient.
Significant changes to the current approach
Cell and Tissue
Under the new scheme, cells and tissues will be included and regulated under the umbrella term of ‘medicines’: look out Laboratories! Based on the European approach, cells and tissues are further differentiated into ‘minimally manipulated’ and those that have been substantially manipulated. The latter being referred to as ‘engineered cells and tissues’. Minimally manipulated cells and tissues are approval – exempt products, whereas engineered cells and tissues will require product approval. The processing, preservation, storage or distribution of cells and tissues will be controlled activities requiring authorisation in the form of a licence.
The proposed scheme will have a tremendous effect on the medical devices sector. The new legislation places pre- and post- market controls across the lifespan of medical devices – a monumental change. Medical devices will require:
• Product approvals prior to importation and supply
• Compliance with standards for safety and performance – termed ‘essential principles’
Manufacturing a medical device will be a controlled activity requiring authorisation. Medical devices will be allocated a risk class based on international classification rules. The level of regulatory monitoring will be determined by the risk classification of the medical device. The Bill also specifies periodic conformity assessment procedures – the nature of which will also be driven by the risk classification for the device.
Conducting clinical trials of therapeutic products (including cell and tissue and medical devices) will be a controlled activity under the new scheme. This controlled activity will require authorisation (i.e. a licence) as well as the requirement of obtaining ethics approval. In contrast to the Medicines Act, approvals for clinical trials may be granted without seeking advice from the Health Research Council.
Access to unapproved therapeutic products
Section 29 of the Medicines Act allows supply of unapproved medicines under the instruction of a medical practitioner for a named individual. The new scheme, mirroring the United Kingdom, requires a Special Clinical Needs Supply Authority (SCNSA) for the supply of an unapproved therapeutic product. This would also apply if an approved therapeutic product is used for an off-label purpose. This is done to ensure that consideration is given and recorded so that unapproved products are only prescribed under special clinical circumstances. Health practitioner prescribers are able issue SCNSA for unapproved medical devices and off-label use of approved medicines within their scopes of practice. However, only medical practitioners can issue a SCNSA for unapproved medicines – subsequent prescriptions can be made by health practitioner prescribers for the ongoing use of SCNSA issued unapproved medicine.
Post market surveillance of safety and efficacy is currently the recommended practice, but it is not underpinned by legislation. Under the new scheme, there will be detailed requirements for monitoring, reporting and risk management of approved therapeutic products. The regulator will also have an obligation to ensure that a safety-monitoring system is in place.
Pharmacy licensing and ownership
The proposed Bill is attempting to increase accessibility to pharmacy services by allowing for different distribution and supply models. These models include mobile pharmacies and providing pharmacy services (involving the supply of medicines) outside of fixed premises e.g. at a rest a home or Marae.
Under the Medicines Act, a pharmacist is required to hold a greater than 50% share of capital and to be in effective control of the pharmacy (in reference to community pharmacies). The bill is seeking feedback regarding the possible options for further clarifying or changing this pharmacy ownership model.
How will the proposed Bill impact your role in the Health Sector? Have your say…
The consultation process for the Bill ends on 18 April 2019. View the full copy of the therapeutic products regulatory scheme: consultation document.
APEX is currently preparing a response on behalf of the professional groups that are likely to be impacted by the change. Please email us your views and the intensity of the impact the proposed therapeutic Bill is likely to have on your line of duty.
Additionally, you can provide your own feedback.