The Government wishes to protect the public’s health by ensuring that therapeutic products in New Zealand are safe and effective, and meet quality and performance standards.
To this end, the Ministry of Health recently invited submissions on a draft Therapeutics Products Bill.
The Council made extensive submissions on the draft Bill as its proposals will potentially impact on oral health practitioners, their practice and regulation. Prior to making our submissions we discussed key areas of concern with our colleagues at the Pharmacy Council and sought legal advice to confirm our understanding on the various provisions.
The Bill proposes a modern and cost-effective regulatory scheme for therapeutic products in New Zealand. Once enacted the draft Bill will replace the the Medicines Act 1981.
The new scheme will cover a broader range of therapeutic products used in health care in New Zealand. It will cover medicines, active ingredients of medicines, medical devices and type 4 products—a new category established for future innovative therapeutic products.
Our submission focused on the areas that impact oral health practitioners most directly and is summarised below.
The most significant impact of the proposed Bill for oral health practitioners will be the regulation of medical devices. Therapeutic product regulation in New Zealand has not included medical devices previously.
Our primary concern is that dental appliances commonly designed, made, used and imported by oral health practitioners may become regulated as “medical devices” under the new regulatory scheme proposed by the Bill.
We are concerned that the new proposed regulatory scheme for medical devices may compromise patient access if the products become more expensive due to increased regulatory compliance.
Product approval processes for such a vast number of devices will take time and require specialised expertise, availability of which may be limited in New Zealand. This could adversely impact the availability of these devices that could compromise patient care.
We have no evidence of systemic risk to patient safety or harm resulting from the use of dental appliances or equipment under the current regulatory framework. We rely on the practitioner’s ethical and professional obligations to ensure patients receive the appropriate quality of treatment and to ensure patient safety is central to the practitioner’s treatment plan.
We strongly encouraged a pragmatic and staggered approach using a robust risk framework to clearly identify and prioritise those medical devices that require immediate regulatory intervention.
Dental appliances (both fixed and removable) are likely to fall within the Bill’s definition of therapeutic products and there appear to be various provisions which could direct the regulatory requirements for them. Each of these options have different compliance obligations and would change the current approach by oral health practitioners who prescribe, use, supply, design, manufacture, repair or import dental appliances.
The various activities involved in creating, sourcing and fitting the dental appliance for each patient occur in premises that are diverse in nature and scale, such as dental laboratories, private dental practices, hospitals, and often overseas and involve both registered and unregistered people.
We requested further discussions with the Ministry staff on the proposed legal and regulatory framework envisaged for dental appliances, to better understand the potential obligations for oral health practitioners.
With the broad definition proposed for medical devices and in the absence of the supporting regulations and details about the risk-proportionate approach that will be used, we are concerned about the potentially large number of medical devices that could be caught in the new regulatory scheme.
For this reason, we have asked the Ministry to clarify whether they anticipate that dental devices, equipment, materials and software used by oral health practitioners would fall under the new regulatory scheme. And if so, which products.
We highlighted the broad range of dental equipment, all with different risk profiles that might be subject to the proposed scheme including dental chairs and lights, instrument trays, mouth rinse, examination mirrors, retractors, cameras, protective equipment, blow torches, and more invasive or higher risk instruments such as x-ray machines, pluggers, scalers, lasers, burs, curets, forceps, files, and scalpels.
Authority to prescribe is removed from the Medicines Act by the draft Bill and will sit within the respective scopes of practice—set by the health regulators. As with any scope changes, the health regulator must consult on the proposed changes with its stakeholders, and prescribing provisions within a scope must be approved by the Minister of Health. No consultation will be needed to make the necessary scope changes for those who are already authorised under the Medicines Act to prescribe medicines.
This change will not alter dentists and dental specialists’ rights of prescribing, or which medicines and quantity they can prescribe, within their scope of practice.
The permission for oral health therapists and dental therapists to administer certain medicines, with or without a standing order, will also remain unchanged. However, the authorisation of this will likely be removed from the medicine classification’s schedule and sit in another legislative instrument.
Provision for standing orders remain—the detailed requirements will be developed later, as regulations or rules.
The draft Bill proposes that health practitioner prescribers can supply the medicine they prescribe to their patients, within their scope of practice, without requiring a pharmacy licence or other dispensing obligations.
The Bill further proposes staff working under health practitioner prescribers can supply category 3 medicines to patients, subject to the health practitioner’s scope of practice and under general supervision (not yet defined). We do not consider non-trained and non-registered staff should supply or dispense category 3 medicines to patients.
Although we support increasing access to medicines, the Council believes the same professional and ethical standards across all health practitioners who supply and dispense medicines should be applied.
We expressed concern about potential regulatory overlap between the regulator established under the Bill and other existing health regulators. This overlap is of concern on assuring and managing issues of professional competence and conduct of registered health practitioners as it relates to prescribing, supply and dispensing related activities.
We believe clearly differentiating regulatory powers is essential to protecting public safety and avoiding regulatory overlap or gaps.
Consultation on the draft Bill has now closed. The Ministry of Health will analyse the feedback and provide advice to the government based on the consultation outcomes. The draft Bill will be amended as required before it is submitted to parliament.
We will continue to monitor the progress of the Bill and engage with the Ministry further on the issues we have raised. If required, Council will make further submissions to the select committee during the parliamentary process.
We encourage all practitioners to review our submission and the information available on the Ministry’s website. You may have already made submissions to the Ministry of Health on the Bill during the consultation period.
Please contact us if you have any comments or areas of concern about this proposed legislative change.