Below we highlight life sciences regulatory developments related to COVID-19.
Amendment to the Food and Drugs Act under Bill C-13
On March 25, 2020, the Federal Government enacted the COVID-19 Emergency Response Act. This Act amends the Food and Drugs Act and grants the Governor in Council new powers to make regulations requiring persons to provide information to the Minister of Health.
Regulations made pursuant to the amendment may also relate to preventing shortages of therapeutic products in Canada.
Finally, the amendment also broadens the Minister’s power to make the Food and Drug Regulations applicable to products intended for export.
See: Full text of Bill C-13 (PDF)
Amendment to the Patent Act under Bill C-13
Bill C-13 also amends the Patent Act to oblige the Commissioner of Patents on the application of the Minister of Health, to authorize the Government of Canada and any person specified in the application to make, construct, use and sell a patented invention to the extent necessary to respond to the public health emergency described in the application.
Drugs and medical devices which treat COVID-19, including notably ventilators, are the targets of this amendment.
An authorization shall have a term of no more than one year after the authorization is granted, and no authorization may be issued after September 30, 2020.
Bill C-13 provides that the patent holder can seek an order from federal court to stop any abuses of the authorization and provides for royalties to be paid to patent holders.
See: Full text of Bill C-13 (PDF)
Expedited Access to Disinfectants, Masks and Swabs
Health Canada is expediting access to supplies of hand sanitizers, disinfectants, personal protective equipment (such as masks and gowns) and swabs to help limit the spread of COVID-19.
In particular, Health Canada has relaxed regulatory requirements for these health products; allowing for the sale of authorized products even if there are superficial deviations from Health Canada requirements such as bilingual labelling or different packaging.
Furthermore, Health Canada will also allow the sale of these health products even where they are not authorized in Canada so long as they have been authorized in a jurisdiction with a regulatory framework similar to that of Canada.
Importers who have an appropriate Establishment Licence who intend to take advantage of this measure must notify Health Canada. Companies who do not have the requisite licence may submit an application for expedited review.
Clarification regarding Hard Surface Disinfectants and Hand Sanitizers
On March 26, 2020, Health Canada issued a list of hard surface disinfectants that it considers likely to be effective for use against coronavirus, and clarified its criteria for making indirect efficacy claims for SARS-CoV-2 in relation to these products.
The announcement also includes a list of authorized hand sanitizers, along with reminders regarding proper hygiene.
In addition, Health Canada issued a reminder, through its cosmetics distribution list that hand sanitizers do not qualify as cosmetics under the Food and Drugs Act; rather they are considered drugs or natural health products depending on their composition.
Expedited Access to Diagnostic Tests
Health Canada has also issued an Interim Order to help ensure quicker and more flexible approval of the importation and sale of medical devices that are necessary for Canada’s response to COVID-19.
This notably includes expedited access to COVID-19-related medical devices for use by healthcare providers, including diagnostic test kits.
This Interim Order may also help ensure Canadian access to other marketed COVID-19-related medical devices used to treat, mitigate or prevent COVID-19, as necessary.
Relaxed Regulatory Requirements for Devices
The Minister of Health has issued an Interim Order respecting the importation and sale of medical devices for use in relation to COVID-19.
Device manufacturer may be exempt from certain regulatory requirements if:
- The Minister determines that there is an urgent public health need for the importation or sale of the device;
- the manufacturer of the device has filed with the Minister an application for the authorization of importation or sale of the device in a form established by the Minister;
- the Minister has issued the authorization; and
- the authorization has not been cancelled.
In particular, manufacturers may be exempt from complaint handling and mandatory problem reporting. For the sake of clarity, manufacturers must still comply with the provisions related to distribution records and recalls.
The order further provides for an application process for COVID-19 medical devices in which certain information need not be submitted if the device is authorized by a foreign regulatory authority.
Plan to Fight the Coronavirus with Science
The federal government has pledged $275M in funding for coronavirus research and medical countermeasures; $192 has been earmarked for large-scale industrial research projects including the development of therapeutic antibodies and plant-based vaccines. Other initiatives include support for government and academic vaccine research and development, and for early-warning technology developed by a Toronto-based startup.
False Claims regarding COVID-19 Treatments
Health Canada is cracking down on false or misleading claims regarding COVID-19.
In particular, Health Canada has issued warning letters respecting products ranging from hand sanitizers to Chaga mushroom blends.
The regulator continues to monitor websites and online retailers and is encouraging the public to stop using any products that claim to prevent, treat or cure COVID-19.
A restrictive permit for graduating residents
Physician certification and qualifying examinations had to be postponed due to the current extraordinary situation concerning the COVID-19 pandemic. However, given the need to increase the presence of medical personnel in the field, the Collège des médecins du Québec will issue restrictive permits to graduating residents.
This permit will only authorize residents to practise professional activities in the discipline in which they completed their postgraduate training. The permit will be valid until June 30, 2021 and is not renewable except in case of further postponement or cancellation of exams.
Chloroquine and hydroxychloroquine Prescriptions
Many pharmacists and physicians were issuing prescriptions for chloroquine or hydroxychloroquine to treat or prevent COVID-19. Based on the current situation in Quebec and the scientific data currently available, these prescriptions are considered inappropriate and not indicated.
Measures are currently being put in place to ensure that these prescriptions are maintained for those who use these drugs chronically and to maintain a reserve for hospitalized patients.
A request to limit paper prescriptions made by three professional orders
The Collège des médecins du Québec, the Ordre des pharmaciens du Québec and the Ordre des infirmières et infirmiers du Québec have joined together to issue an opinion asking that their members limit the use of paper prescriptions.
Three alternatives were recommended to replace the usual method:
- Verbal transmission to the pharmacist
- Facsimile transmission
- Electronic transmission using the Dossier Santé Québec
This measure was introduced to reduce transmission of Covid-19 in the community and to allow patients to stay at home.
See: Message du Collège des médecins du Québec, de l’Ordre des pharmaciens du Québec et de l’Ordre des infirmières du Québec (French only) and COVID-19 : Trois ordres professionnels en santé demandent à leurs membres de limiter l’utilisation des ordonnances papier (French only)
Increased prescribing ability for pharmacists
Due to the pandemic, pharmacists have been instructed to dispense prescription drugs for only a 30-day supply to avoid shortages.
In addition, pharmacists’ prescribing authority has increased; they can now prescribe non-prescription drugs when a situation requires it and administer vaccines and can administer drugs in an emergency situation.
The Collège des médecins and the Ordre des pharmaciens have agreed to relax certain terms relating to the professional activities of pharmacists in order to optimize their activities during this pandemic period. The objective of these measures is to minimize the number of medical consultations for matters that can be managed by other health professionals.
The various changes are as follows:
- Pharmacists can extend prescriptions beyond the maximum periods provided for by law;
- Pharmacists may prescribe medication for all minor conditions if the initial diagnosis by the physician was made within four years;
- Unless the physician expressly requires it, pharmacists no longer have to communicate to the physician the information concerning the extension, adjustment or substitution of a drug; and
- Finally, in the event of an out-of-stock situation, pharmacists can substitute the drug with another drug from another therapeutic subclass if necessary.
Other Provincial Measures
Pharmacist Dispensing Limits
The provinces have issued guidance or notice to pharmacists and recommending a limit to a 30-day supply when filling and refilling prescriptions to help reduce the potential strain on the drug supply chain. However, in some cases, pharmacists’ may, if necessary, dispense additional supplies to at-risk patients so that they do not have to go to a pharmacy or clinic if they do become sick. See for example:
Nova Scotia - Prescription refills limited to 30-day supply
New Brunswick - relief on co-pays during COVID-19 outbreak
On March 21, 2020, in response to the province’s pharmacists’ regulatory body policy capping prescription refills to a 30-day amount, the New Brunswick government introduced a policy to ease the financial strain on patients. Effective on March 21st, patients are only responsible for the initial co-payment on a prescription fill or refill. Thus, a patient with a 90-day prescription will only have a co-payment for the first 30-day fill.