This article was contributed by Alice Tseng (left), a patent and regulatory partner at Smart & Biggar, with associate Chen Li (right).
Canadian regulators and payers across the country have been actively taking steps to manage the evolving COVID-19 crisis. This article highlights some of the key regulatory changes and guidance instituted, and spans regulatory pathway developments to clinical trials to pharmacy scope of practice to reimbursement issues. The developments are intended to facilitate the review and availability in Canada of health products to help diagnose, treat, prevent or mitigate COVID-19 diseases as well as to minimize disruption to the Canadian healthcare system.
Federal Developments - Health Canada
Health Canada is showing tremendous flexibility in facilitating the supply of COVID-19 related products. COVID-19 Health Product Industry is a helpful page to access some of Health Canada’s numerous guidance documents as well as product information updates. Many of the guidance documents address regulatory pathway issues for in-demand products, such as applicable standards, how to fast-track approval, simplified regulatory requirements and regulatory requirements (e.g. labelling) that are not being enforced. The documents and information available cover a range of products, including diagnostic tests; vaccines and treatments; personal protective equipment (“PPE”) such as masks, medical gowns and medical gloves; hand sanitizers and disinfectants; and ventilators.
The guidance extends beyond typical regulatory pathway information and also includes communications about the use of 3D printing and reprocessing for certain PPE. See 3D printing and other unconventional manufacturing of PPE in response to COVID-19, as well as Notice – Important Regulatory Considerations for the Reprocessing of Single Use N95 Respirators during the COVID-19 Response. The notice contemplates two separate reprocessing strategies for single use N95 respirators: (1) sterilization devices that are manufactured and sold to reprocess N95 respirators, and (2) companies who reprocess and distribute N95 respirators to healthcare facilities.
On March 30, 2020, pursuant to subsection 30.1(1) of the Food and Drugs Act, Health Canada made an Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 (the “March 30 Interim Order”), which addresses the exceptional importation of drugs, medical devices, and foods for a special dietary purpose in relation to COVID-19. The March 30 Interim Order allows certain drugs and devices that do not fully meet regulatory requirements to be imported and sold in Canada. Only drugs and medical devices on the List of Drugs for Exceptional Importation and Sale and List of Medical Devices for Exceptional Importation and Sale (“designated drugs” and “designated medical devices,” respectively) are eligible.
At this time, only drugs that meet the criteria for Tier 3 drug shortages, including certain drugs used for intubation (e.g. neuromuscular blockers, sedatives and narcotic analgesics), salbutamol metered dose inhaler and hydroxychloroquine, can be designated drugs. A Tier 3 shortage is a shortage that has the greatest potential impact on Canada’s drug supply and health care system, in terms of low availability of alternative supplies, ingredients or therapies.
In contrast, for medical devices, there is no requirement to meet any shortage criteria in order for a product to be considered a designated medical device.
In line with the general trend towards transparency, Health Canada is also publishing, in real-time, COVID-19-related applications, approvals and shortages. Below is a snapshot of what is available:
For non-diagnostic devices, Health Canada publishes a list of medical devices authorized pursuant to the March 18 Interim Order (Medical devices for use against coronavirus (COVID-19): List of products authorized under Interim Order).
In contrast, for diagnostic devices, both the devices authorized as well as the applications for authorization are published (Diagnostic devices for use against coronavirus (COVID-19).
To facilitate the conduct of clinical trials while allowing self-isolation of participants and deployment of healthcare personnel to other duties, Health Canada has provided guidance on Management of clinical trials during the COVID-19 pandemic: Notice to clinical trial sponsors. For ongoing clinical trials during the pandemic, sponsors are directed to, among various suggestions and requirements, discuss with local research ethics boards whether it is in the best interest of a participant for them to continue as per the study protocol or to halt their participation; consider risks and risk mitigation strategies related to the use of any immunosuppressive agent; properly document protocol deviations; evaluate alternative methods for safety assessments (e.g. phone contact, virtual visits); consider shipping clinical trial investigational products directly to patients in appropriate circumstances; and consider suspending recruitment or placing the study on hold where necessary.
Regulators and payers in the provinces have likewise been actively trying to facilitate and manage health care supply and services for patients. Some examples are as follows:
Scope of Practice
Pharmacists in Canada have a broad scope regarding the type of controlled acts they can engage in. The specific scope varies by province but includes:
COVID-19 has accelerated the further expansion of the scope of practice of pharmacists in most provinces and loosened some existing requirements. For example, Québec Bill 31, An Act to amend mainly the Pharmacy Act to facilitate access to certain services, assented to on March 17, 2020, allows Québec pharmacists to prescribe and administer vaccines and, in emergency situations, certain other medications. However, “emergency situation” is interpreted very narrowly – this refers to life-threatening situations where drugs like salbutamol or epinephrine are required, as opposed to the pandemic generally.
Additionally, the Collège des médecins and the Ordre des pharmaciens (i.e. the regulators for physicians and pharmacists respectively in Quebec) have relaxed conditions relating to the expanded scope of practice first implemented through Bill 41, An Act to amend the Pharmacy Act (in force since 2015), such that, as of March 16, 2020, and until further notice, Québec pharmacists may:
These amendments bring the scope of practice of Québec pharmacists more into alignment with that of pharmacists in most other provinces. Expanded scope of practice for pharmacists is especially important during the pandemic since patients may not be able to see their physician as easily, as many physicians no longer routinely see patients in-person.
In many provinces, a physician typically writes a prescription on paper, which the patient then brings to a pharmacy to obtain the medication. The physician can also telephone or fax a prescription to a pharmacy. Though e-prescribing may be permitted legally, in practice, there are many barriers such that e-prescribing is not widely used (at the community pharmacy level) in most provinces, unlike many foreign jurisdictions.
Currently, however, regulators are showing flexibility, as the physical transfer of paper from person-to-person is not ideal and many physicians are working from home without a fax machine. The Ontario College of Pharmacists, for example, issued a policy on Emailed and Faxed Prescriptions - Temporary Method for Transmitting Prescriptions via Unsecure Email During COVID-19 stating that, although phone, fax and secure e-prescribing should be used wherever possible, unsecure e-mail may be used temporarily (but not for narcotics) if the physician has the patient’s consent to use unsecure e-mail and certain other requirements are met.
Temporary Exemptions for Controlled Substances
Activities involving controlled substances are typically regulated more strictly than activities involving drugs that are not controlled substances. For example, depending on the province, a pharmacist’s scope of practice may permit the extension (i.e. renewal) of a prescription but, previously, such scope of practice would exclude the ability to extend a prescription for a controlled substance. Now, however, to enable Canadians to access controlled substances for medical treatments (e.g. treatment of substance use disorders and chronic pain) while adhering to social distancing or self-isolation guidance, Health Canada has issued certain temporary exemptions for prescriptions of controlled substances under subsection 56(1) of the federal Controlled Drugs and Substances Act.
Accordingly, if permitted by the applicable provincial scope of practice rules, there is temporarily no longer a restriction against the following activities with respect to controlled substances (narcotics, controlled drugs and targeted drugs):
Cancer Care Ontario Funding
Cancer Care Ontario (“CCO”), the public payer for injectable cancer treatments in Ontario, has developed interim funding measures in recognition that patients may have limited access to surgery, radiation, systemic therapy delivery, diagnostic imaging, and interventional procedures during the pandemic. Below are just a few of the interim policies.
30-Day Supply of Prescription
To minimize the risk of drug shortages and prevent unnecessary stockpiling, the Ontario Minister of Health issued Notice: Ontario Drug Benefit (ODB) Program Changes and Guidance for Dispensers during the COVID-19 Public Health Emergency, recommending pharmacists dispense no more than a 30-days’ supply of medication, subject to their professional judgment in exceptional cases with appropriate documentation. Temporary changes were also made to allow a dispensing fee for each 30-day supply to be claimed even if a greater quantity must typically be dispensed.
The 30-day supply limit has not been welcomed by some patients, in part, because they may incur increased costs as a result of more dispensing fees and co-payments. However, it is not just the public payer in Ontario recommending a 30-day supply – many other associations and regulators have also taken such positions, including the Canadian Pharmacists Association, which issued a statement on COVID-19 and the responsible allocation of medications to patients.
As the COVID-19 crisis unfolds, Canadian regulators and payers are developing innovative strategies and relaxing existing regulatory requirements to address unforeseen issues and to assist patients, health care professionals and industry in dealing with this unprecedented situation. The changes and guidance highlighted in this article provide an overview of the Canadian regulatory landscape in the face of the COVID-19 public health emergency.