Health Canada regulates, evaluates and monitors pharmaceuticals pursuant to the Food and Drugs Act (FDA) and its associated regulations. It regulates controlled substances under the Controlled Drugs and Substances Act (CDSA) and its associated regulations. The Cannabis Act is the legislative framework for controlling the production, distribution, sale and possession of cannabis in Canada.

Medical devices are regulated under the FDA and the Medical Devices Regulations (MDR), administered by Health Canada.

The distribution of pharmaceuticals and medical devices is regulated federally and by territorial/provincial legislation and regulatory bodies, such as provincial colleges of pharmacy and public drug benefit formularies.

Health Canada has various internal complaint/appeal resolution processes to challenge its decisions. Once those internal resolution processes have been exhausted or where a decision is not subject to such resolution processes, a party with standing may challenge a Health Canada decision by filing an application to the Federal Court of Canada for judicial review.

Health Canada classifies health products into certain categories, such as drugs and medical devices. With respect to drugs, Health Canada further classifies products into subcategories such as controlled substances, biologic products, prescription drugs and non-prescription drugs.

Medical devices are categorised by Health Canada according to risk: Class I is the lowest perceived risk, while Class IV is the highest. The classification determines the type of submission and information that must be filed with Health Canada for marketing approval and post-market surveillance.

Health Canada regulates clinical trials/investigational testing of pharmaceuticals and medical devices through the FDA and its regulations.

Health Canada must authorise all clinical studies of authorised and unauthorised pharmaceuticals, biologic drugs and medical devices before they begin, with limited exceptions.

To perform a drug clinical trial, the sponsor must submit a clinical trial application (CTA) to Heath Canada. The sponsor must also have a Research Ethics Board (REB) Attestation and complete certain Qualified Investigator Undertaking forms and a Clinical Trial Site Information form. For biologics, Health Canada also requires that the lot release information is provided by the CTA sponsor/manufacturer before its use in the trial. A CTA is not required for phase IV clinical trials. If the CTA is approved by Health Canada, a No Objection Letter (NOL) will be issued.

To perform medical device investigational testing, the sponsor must submit an investigational testing application (ITA) to Health Canada. The ITA approval process is required for trials involving the use of all unlicensed Class II, III and IV medical devices. REB approval must be obtained prior to study initiation. An ITA is not required for Class I (low risk) medical devices, nor is it required for conducting a study using a licensed device according to its licensed indications for use. Under the MDR, only manufacturers and importers can apply for authorisation. If the ITA is approved by Health Canada, a Letter of Authorisation will be issued.

In 2019, Health Canada launched its Public Release of Clinical Information initiative. Since then, Health Canada has developed a Clinical Trials Database (CTD), which provides certain publicly available information on phase I, II and III clinical trials of human pharmaceuticals and biological drugs. The information provided in the database includes drug name, medical condition, study population, study start/end dates and trial status. However, the database is not a registry and does not contain comprehensive information about each trial. The CTD also does not include information on clinical trials in healthy volunteers (eg, bioavailability/bioequivalence trials) or phase IV trials.

In addition, after a final regulatory decision, the following information (with certain exceptions) in respect of clinical trial and medical device applications will no longer be considered confidential business information and will be publicly available through Health Canada:

• clinical summaries; and
• reports and supporting data of clinical trials in support of a drug submission and clinical trials or investigational testing in humans in support of any Class III or Class IV medical device application.

Health Canada will not release individual patient records and clinical case report forms to the public.

Online tools and systems to support clinical trials may be used so long as they comply with applicable requirements (privacy, confidentiality, informed consent, etc) and good clinical practices. For example, the sponsor should ensure that online tools conform with their established requirements for completeness, accuracy, reliability and consistency of intended performance.

Two federal privacy laws set out how federal government institutions and certain businesses must deal with personal information, including personal health information. The Personal Information Protection and Electronic Documents Act (PIPEDA) addresses the personal information handling practices of federal government departments, including Health Canada, and the Privacy Act regulates private businesses’ data protection practices. Many provinces and territories also have laws that deal specifically with the protection of personal information, including health information. Whether data constitutes personal health information depends on several factors.

Personal data resulting from clinical trials is generally considered to be confidential, although in certain scenarios the sponsor and other agencies will have access to such information, including patient-identifiable information, for analytical purposes. If the data is de-identified or anonymised, then it is generally not considered confidential.

Data can be transferred to a third party or an affiliate so long as the transfer is in accordance with all applicable privacy requirements, contractual agreements and informed consents.

A database containing personal or confidential data may be subject to contractual and statutory obligations, including certain security and privacy measures. For example, Ontario’s Personal Health Information Protection Act requires custodians to take reasonable steps to ensure the personal health information they hold is always protected and secure.

In general, classification decisions are made by the appropriate group at Health Canada upon the submission of required information or an application for market authorisation. In instances where a product could be classified in multiple ways, such as drug/device combination products, classification requests can be sent to the Office of Science within the Therapeutic Products Directorate of the Health Products and Food Branch at Health Canada for guidance.

Product classifications are based on the FDA and its associated regulations. The classification criteria are generally based on the product composition, product purpose and intended use, as well as product format and representations (eg, labelling claims and indications).

Health Canada is responsible for the review and approval of new drug submissions (NDS), including those for biologic drugs.

To obtain marketing authorisation for a biologic drug (innovator or biosimilar), a manufacturer must file an NDS with the Health Products and Food Branch at Health Canada. The submission must include preclinical and clinical results to support the safety, efficacy and quality of the biologic. Given the nature of biologics, Health Canada requires more detailed chemistry and manufacturing information than it does for other drugs. An on-site evaluation may be conducted at the manufacturing site, and samples may be subject to evaluation through a lot release programme overseen by Health Canada to ensure the consistency of the manufacturing process.

A manufacturer can request a brief consult with the Biologic and Radiopharmaceutical Drugs Directorate of Health Canada to discuss the details of their submission and any areas of concern prior to filing.

Health Canada will issue a notice of compliance (NOC) and Drug Identification Number (DIN) upon satisfactory completion of the NDS review. The approval process typically takes one to two years. However, there are regulatory mechanisms for expediting the approval process in some cases.

While there is no specific requirement to renew market authorisations for pharmaceuticals, a manufacturer of a drug must notify Health Canada each year before October 1st that the drug is still on the market and that all information previously provided is accurate and up to date.

The MDR require every manufacturer of a medical device to inform Health Canada each year before November 1st that the information contained in their licence application is accurate. Manufacturers of licensed Class II, III and IV medical devices are also charged an annual fee. Failure by the manufacturer to renew the licence application may result in cancellation of the licence.

There are circumstances when a marketing authorisation can be revoked – eg, failure to comply with the FDA or its regulations. Typically, Health Canada will attempt to work with manufacturers to obtain compliance before a suspension or revocation is issued.

To obtain marketing authorisation for a drug, a manufacturer files an NDS with Health Canada, including preclinical and clinical data to support the safety, efficacy and quality of the product, as well as manufacturing details. Health Canada will issue an NOC and DIN upon satisfactory review of the NDS. This approval process generally takes one to two years but there are certain mechanisms to expedite the process in some cases. If the manufacturer changes the strength, format/dosage form or indications, etc, of the drug, then a Supplemental New Drug Submission (SNDS) must be approved by Health Canada.

Generic drugs are approved through an abbreviated new drug submission (ANDS) and are based in part on comparisons to the brand-name reference product. Supplemental abbreviated new drug submissions (SANDS) are required for certain product changes (eg, packaging, labelling) or new indications. As with an NDS, an applicant for an ANDS or SANDS will receive an NOC upon approval by Health Canada, subject to any patent issues.

Medical devices are categorised and regulated by Health Canada according to risk: Class I indicates the lowest perceived risk, while Class IV indicates the highest perceived risk. The classification determines the type of submission and information that must be filed with Health Canada for the device to be approved for marketing.

Generally, marketing authorisations can be transferred from one entity to another in situations where the only change to the product is the manufacturer’s name, such as in a merger, buyout or other corporate restructuring. In such cases, a submission to Health Canada for each affected drug product must be filed, with supporting documentation.

Healthcare professionals may access drugs and medical devices not currently authorised for sale in Canada through the Special Access Program (SAP) to treat patients with serious or life-threatening conditions where conventional treatments have failed, are unsuitable or are not available in Canada.

In certain situations, an NOC with conditions may be granted by Health Canada with the condition that the sponsor undertakes additional studies to verify the clinical benefit of the drug.

For drugs, manufacturers are required to report all information related to serious adverse drug reactions (ADRs) that occurred in Canada and all serious, unexpected ADRs that occurred outside of Canada to the Canada Vigilance Program of the Marketed Health Products Directorate of Health Canada within 15 calendar days of receiving or becoming aware of the information. Manufacturers must prepare an annual summary of ADRs and serious ADRs during the previous 12 months.

For medical devices, records relating to complaints and incidents must be maintained by the manufacturers/importers and must be provided to Health Canada with an incident report if the medical device was sold in Canada and if the incident:

• occurs within Canada;
• occurs outside Canada for a Class I medical device;
• relates to a failure of the device or a deterioration in its effectiveness, or any inadequacy in its labelling or directions for use; and
• has led to the death or a serious deterioration in the state of health of a patient, user or other person, or could do so if it were to recur.

The requirement to report an incident that occurs outside Canada does not apply unless the manufacturer has indicated to a regulatory agency in the country in which the incident occurred that it intends to take corrective action, or unless the regulatory agency has required the manufacturer to take corrective action.

In addition, certain holders of medical device authorisations in Canada must also notify Health Canada of certain foreign risks – ie, a Medical Device Licence (MDL) holder for a Class II to IV device, a Medical Device Establishment Licence (MDEL) holder that imports a Class II to IV device, and a holder of an ITA for a Class II to IV device.

For drugs, Health Canada has a Submissions Under Review (SUR) list for new active substances (pharmaceuticals and biologics with active ingredients not approved in Canada) as well as SNDSs for new uses.

There are four SUR lists:

• NDSs currently under review;
• SNDSs currently under review;
• NDSs formerly under review; and
• SNDSs formerly under review.

For NDSs/SNDSs currently under review, the list includes:

• the medicinal ingredient(s);
• the month/year the submission was accepted for review; and
• the therapeutic area populated with the WHO Anatomical Therapeutic Chemical Code.

For any submission that was accepted into review on or after 1 October 2018, the SUR list also includes the company name and submission class (eg, extraordinary use submission; new active substance; biosimilar; review under priority review; review under NOC with Conditions; review under submissions relying on third party data; aligned review with a health technology assessment organisation; and COVID-19 use).

For NDSs/SNDSs formerly under review, the SUR list includes:

• the medicinal ingredient(s);
• the month/year the submission was accepted into review and concluded;
• the therapeutic area based on the WHO Anatomical Therapeutic Chemical Code; and
• a hyperlink to the regulatory decision summary or cancellation.

There is a separate list for generic drug submissions (ANDS) accepted for review on or after 1 October 2018.

There is no corresponding publicly available list of medical device submissions. However, the Medical Devices Bureau at Health Canada maintains a list of all licensed Class II, III and IV medical devices marketed in Canada, as well as a list of active MDEL.

Confidential Business Information (CBI) is defined in the FDA as business information:

• that is not publicly available;
• in respect of which the person has taken measures that are reasonable in the circumstances to ensure that it remains not publicly available; and
• that has actual or potential economic value to the person or their competitors because it is not publicly available, and its disclosure would result in a material financial loss to the person or a material financial gain to their competitors.

Health Canada has discretionary authority to disclose CBI about a therapeutic product (including prescription, non-prescription drugs and medical devices) without notifying the person to whose business the information relates or obtaining their consent, if the purpose of the disclosure is related to the protection or promotion of human health or public safety and the disclosure is to:

• a government;
• a person from whom the Minister seeks advice; or
• a person who carries out functions relating to the protection or promotion of human health or the safety of the public.

Health Canada may also disclose CBI about a therapeutic product without notifying the person to whose business the information relates or obtaining their consent, if it believes that the product may present a serious risk of injury to human health.

Personal information in records considered for disclosure by Health Canada will be protected in accordance with federal privacy legislation and applicable provincial/territorial privacy laws.

Health Canada monitors the marketing of drugs and medical devices and takes necessary enforcement actions to prevent the illegal marketing of products. It may take various types of enforcement action to address any such illegal activity, including imposing fines, undertaking activities related to the seizure, detention and forfeiture of products and recommending criminal charges, where appropriate.

In addition, physicians and healthcare professionals are required to adhere to provincial/territorial legislation and to meet their respective professional standards in handling drugs and medical devices.

Health Canada has the authority to take appropriate enforcement measures regarding the importation and sale of counterfeits. This responsibility is also shared with other provincial/territorial regulators, government bodies and healthcare professionals.

The sale of counterfeit health products also violates Canada’s Criminal Code. As such, cases of suspected counterfeit health products are also referred to the Royal Canadian Mounted Police (RCMP) and the Canadian Border Services Agency (CBSA), where appropriate. The CBSA assists Health Canada with the administration and enforcement of regulated goods at the border.

With respect to pharmaceuticals, the Food and Drug Regulations (FDR) require that an establishment engaged in fabricating and packaging/labelling drugs (among other activities) holds a drug establishment licence (DEL) issued by the Minister of Health. The process involves submitting an application, along with a prescribed fee payment, setting out certain required information.

It takes Health Canada approximately 250 days to consider the application, verify good manufacturing practices (GMP) compliance and determine whether to issue an establishment licence. An initial on-site inspection of the establishment will be performed during that period.

Once issued, a DEL authorises an establishment to perform one or more of the regulated activities (eg, fabricate, package/label) in respect of one or more categories of drugs (eg, pharmaceuticals, vaccines, biologics).

The FDR also require that drugs are fabricated in accordance with certain GMP. An establishment that holds a DEL is subject to inspection by the Minister of Health to verify compliance with GMP.

In order to maintain the DEL, the holder of the licence must submit an application to Health Canada before April 1st of each year for the review of their licence.

For medical devices, an MDEL is required for most classes of medical devices. The application for such a licence is submitted to Health Canada along with a prescribed fee payment. In order to maintain the MDEL, the holder of the licence must submit an application to Health Canada before April 1st of each year for the review of their licence.

A DEL is required (with some exceptions) to import, distribute and wholesale a drug. A completed application setting out certain required information, such as evidence of GMP, along with a prescribed fee payment, must be submitted to Health Canada. A licence review application must be submitted each year before April 1st by companies that hold a valid DEL.

Provincial/territorial drug legislation also applies to the wholesale distribution of drugs, including regulations issued by Colleges of Pharmacy and Pharmacy Boards.

For medical devices, an MDEL is required (with certain exceptions) for distributing medical devices in Canada. The application for an MDEL is submitted to Health Canada along with a prescribed fee payment. In order to maintain the MDEL, the licence holder must submit an annual review application to Health Canada before April 1st. Manufacturers of Class II, III or IV medical devices also require an MDL to import or distribute their medical devices in Canada, and such licences must be annually renewed before November 1st.

Pharmaceuticals are classified at both the federal and provincial/territorial levels.

Health Canada classifies drugs into certain categories, such as controlled substances, biologic products, prescription drugs and non-prescription drugs. Controlled drugs listed in the schedules to the CDSA are not on the Prescription Drug List, but their prescription status is conferred by their respective regulations.

A drug with a prescription status at the federal level requires a prescription in all provinces/territories.

When a newly marketed drug is given a non-prescription (over the counter/OTC) status or is removed from the Prescription Drug List by Health Canada, the conditions of sale are determined at the provincial/territorial level. The National Drug Scheduling Advisory Committee (NDSA) reviews the submission and categorises the drug into National Drug Schedules that have been adopted to some extent by the provinces/territories, except Quebec, as follows:

• Schedule I drugs require a prescription and are provided by a pharmacist;
• Schedule II drugs are available only from the pharmacist and must be retained within an area of the pharmacy where there is no public access, but do not require a prescription;
• Schedule III drugs can be sold from the self-selection area of the pharmacy operated under supervision of the pharmacist, but do not require a prescription; and
• unscheduled drugs can be sold without professional supervision.

The import and export of pharmaceuticals and medical devices is regulated under the FDA and its associated Regulations. Some health products have additional restrictions placed on them by other Acts, such as the CDSA.

The Medical Devices Directorate at Health Canada helps to ensure the safety, effectiveness and quality of medical devices sold in Canada. It works with other agencies, such as CBSA, to prevent the importation and exportation of medical devices that do not comply with the FDA and the MDR.

An importer of authorised pharmaceuticals and medical devices must have an establishment licence. Unauthorised drugs may be imported into Canada under certain conditions, such as when authorised under a clinical trial in Canada. Controlled substances have additional restrictions under the CDSA. For prescription drugs, the importer must (with certain exceptions) be a practitioner, drug manufacturer, wholesaler or pharmacist.

Anyone who imports a medical device into Canada must also meet the applicable requirements of the FDA, including the following:

• for Class I devices, the importer must have a valid MDEL, unless exempted;
• for Class II, III or IV devices, the device must be licensed by having an MDL and the importer must have a valid MDEL, unless exempted; and
• for all medical device classes, the importer must ensure that the company from which they import has an MDEL that cover the appropriate licensable activities, unless exempted.

Generally, the importation of pharmaceuticals and medical devices requires prior authorisations. However, there are certain exceptions for importers. Unlicensed medical devices and drugs may be imported through a request by a healthcare professional to the Special Access Program (SAP). Certain drugs may also be imported to address urgent public health needs through the Access to Drugs in Exceptional Circumstances regulatory pathway.

Upon entry into Canada, declaration forms must utilise the Harmonized Commodity Description and Coding System (HS) codes and provide information required by Health Canada. Such importations are subject to regulations issued by CBSA and Health Canada.

Canada is a member of the World Trade Organization and has free trade agreements with 51 different countries. Canada also has several Mutual Recognition Agreements with other countries (eg, EU, Switzerland, Australia, the UK) covering the GMP compliance programmes for drugs/medicinal products.

In Canada, the Patented Medicine Prices Review Board (PMPRB) is governed by the Patent Act and the Patented Medicines Regulations, and ensures that rights-holders do not sell patented medicines in Canada at an excessive price.

The PMPRB only has jurisdiction if there is a patent or certificate of supplemental protection pertaining to the medicine sold in Canada. It takes a very broad view of its regulatory powers. Rights-holders who are subject to the jurisdiction of the PMPRB (ie, patentees and Certificate of Supplementary Protection holders) must submit pricing information on a prescribed basis.

If the PMPRB has jurisdiction, it will review the prices at which the medicine is sold in any market in Canada to determine whether it is excessive. In doing so, it is empowered to consider several factors, including the price at which the medicine is sold in certain other countries, the price at which medicines in the same therapeutic class are sold, and the size of the market in Canada.

The price of generic medications is also regulated by some provinces. For example, in Ontario, regulations made under the Ontario Drug Benefit Act provide that generic medications will only be reimbursed by the public plan at a certain percentage of the price for the interchangeable innovative product. The permitted percentage depends on the dosage form (oral solid versus other) and the number of other generic versions on the market. In addition, certain designated molecules have lower percentage caps on their pricing.

Similar restrictions do not exist for medical devices.

The PMPRB may consider domestic and international prices of the same medicine in other markets. As of 1 July 2022, the comparator countries are Australia, Belgium, France, Germany, Italy, Japan, the Netherlands, Norway, Spain, Sweden and the United Kingdom (PMPRB11). As the PMPRB develops new pricing guidelines, new drugs with a list price above the Median International Price for the 11 comparator countries will remain “under review” until the new guidelines are in place. New drugs with a list price below the Median International Price will be deemed “reviewed”.

The price of a medical device does not generally depend on its price in other countries.

Provincial health insurance plans reimburse the cost of some pharmaceuticals and medical devices in an outpatient setting. Some individuals (eg, indigenous people, military members and federal penitentiary inmates) are covered by federal plans. The eligibility requirements and coverage vary depending on the plan.

Public hospitals cover the cost of most medications/medical devices for inpatients.

Cost-benefit analyses are often applied in determining the reimbursement price of pharmaceuticals and medical devices on public and private drug benefit formularies. The specific rules vary by payor.

Many provinces and territories have implemented switching policies for generic drugs and biosimilars. Such interchangeabilities are governed by specific provincial/territorial regulations and by rules adopted by provincial/territorial colleges or boards.

Health Canada has specific rules for medical apps. Software is deemed to be a medical device when the following conditions are met:

• it is intended to be used for one or more medical purposes as outlined in the definition of device in the FDA; and
• it performs these purposes without being part of a hardware medical device (ie, it is not necessary for a hardware medical device to achieve its intended medical purpose).

Health Canada generally interprets “medical purposes” to be those intended:

• to acquire, process or analyse a medical image, or a signal from an in vitro diagnostic device or a pattern/signal from a signal acquisition systems or imaging device; or
• for the purpose of supporting or providing recommendations to healthcare professionals, patients or non-healthcare professional caregivers about the prevention, diagnosis, treatment or mitigation of a disease or condition.

The practice of telemedicine is regulated at a provincial/territorial level. The Colleges of Physicians and Surgeons in each province/territory also have policies regarding the practice of medicine, including telemedicine.

Generally, physicians may provide medical services through a mobile device if they follow the obligations and policies set by the Colleges and any applicable privacy legislation.

There are no special rules for the online promotion or advertising of drugs and medical devices in Canada. The promotion and advertising of such products, whether by print, broadcast or internet, is regulated under the FDA and associated regulations. Only medical devices and prescription drugs that have been authorised for sale by Health Canada may be advertised legally in Canada. Additional regulatory restrictions apply for prescription drugs and opioids.

Market authorisation holders and advertisers can obtain advertising pre-clearance through various independent agencies, such as the Pharmaceutical Advertising Advisory Board.

Electronic prescriptions are regulated primarily at the provincial/territorial level. For example, the Saskatchewan College of Pharmacy, relying on Health Canada’s policies and provincial legislation, provides that an electronic prescription is equivalent to the written format and is acceptable if certain requirements are met. Health Canada has said that electronic prescriptions are permissible if they achieve the same objective as a written prescription.

Online sales of drugs and medical devices are permitted and regulated under the FDA. Additional requirements for the online sale of drugs have been set by some provinces/territories.

Regulations and policies regarding the creation, maintenance, retention and destruction of hard copy medical records typically extend to electronic health records. Additional requirements for electronic health records may apply at the provincial and territorial level.

The Patent Act and its regulations, including the Patent Rules and the Patented Medicines (Notice of Compliance) (PMNOC) Regulations, govern patent protection in Canada. Canadian jurisprudence is also a source of patent law (eg, double patenting).

To be patentable, an invention must claim new, useful and non-obvious subject matter. There are no specific patentability requirements for pharmaceuticals or medical devices; however, various issues commonly arise in patent cases involving pharmaceuticals and medical devices, including whether the patent claims are directed to a method of medical treatment (not patentable) or are ambiguous, lack utility, or are invalid on the basis of anticipation, obviousness, insufficiency of written description or double patenting.

The PMNOC Regulations create a linkage regime that ties the approval of subsequent entry products (generics, biosimilars) to the patent status of the brand-name reference product.

The pricing of patented medicines is regulated by the PMPRB pursuant to the Patent Act and the Patented Medicines Regulations.

Patent protection is available for new uses of known compounds, so long as they satisfy the requirements of patentability and are directed to new, useful and non-obvious subject matter. Methods of medical treatment and surgery are not considered to be patentable subject matter, whereas claims to the use of a vendible product are permitted. This distinction often turns on whether a specific dosage amount and/or specific administration is recited in the claims.

A new dosage regimen or use of a medicine in selected patient population may be patentable if it satisfies the requirements of patentability and does not require the exercise of skill and judgement by a physician such that it is considered a method of medical treatment.

Any activity that interferes with the full enjoyment of the monopoly granted by the patentee is an infringing activity. This can include both direct and indirect infringement by way of inducement. Three factors are required to establish indirect infringement:

• the act of infringement must have been completed by the direct infringer;
• the completion of the act of infringement must be influenced by the act of the alleged inducer to the point that, without the influence, direct infringement would not take place; and
• the influence must knowingly be exercised by the inducer.

In Canada, a patentee or licensee may obtain a Certificate of Supplementary Protection (CSP) pursuant to the Patent Act and Supplementary Protection Regulations. CSPs provide a maximum of up to two additional years of patent-like protection for eligible patent claims directed to pharmaceutical products. To be eligible for a CSP, the patent must pertain to a medicinal ingredient or a combination of medicinal ingredients contained in a drug that is authorised for sale. The additional protection begins on the 20-year expiration date of the patent, provided it remained in force at that time. The CSP allows for the continued rights of the patentee; however, third parties are permitted to make, construct, use or sell the medicinal ingredient or combination of ingredients for export from Canada. Only one CSP is available for a given medicinal ingredient or combination.

The Patent Act gives the court the authority to declare that a CSP application is invalid or void. However, only CSP applicants that have a CSP application of the same priority may commence such a proceeding.

Infringement of a pharmaceutical or medical device patent includes any act that interferences with the full enjoyment of the monopoly granted by the Patent Office. This can include direct and indirect infringement by way of inducement.

A party can bring an action for a quia timet injunction in situations where it can be established that the anticipated infringing activity is imminent. There is a stringent test for such injunctions, and they are rarely granted.

The PMNOC Regulations also effectively allow for quia timet patent actions by permitting a patent owner to prevent the sale of unapproved biosimilars or generic drugs for up to two years.

There are several exemptions to patent infringement in Canada in relation to pharmaceuticals and medical devices. Section 55.2 of the Patent Act permits the use of a patented invention to obtain governmental regulatory approval, and Section 55.3 further permits experimental use. There is also a common law exemption from infringement for experimental use.

The Patent Act also permits 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 a public health emergency. A compulsory licence issued under such conditions may be active for up to one year. The Commissioner of Patents has the authority to grant a compulsory licence in certain cases of patent rights abuse.

An action for patent infringement may be brought by the patentee and all persons claiming under the patentee pursuant to Section 55(1) of the Patent Act. A person claiming under the patentee is someone who obtained rights to use the patented invention from the patentee – eg, exclusive and non-exclusive licensees. The patentee must be a party to any infringement action such that if they decline to be named as a co-plaintiff, they must be named as a defendant, or mise en cause under Quebec law.

The presumptive remedy for patent infringement is damages. However, the court may allow the patentee to elect an accounting of the infringer’s profits in some cases. The court also has jurisdiction to issue a permanent injunction and require the delivery up or destruction of any infringing goods.

The typical litigation process requires the patentee (or any person claiming under the patentee) to serve and file a Statement of Claim alleging one or more acts of infringement. Actions can be filed in the Federal Court of Canada or in the superior court of the province where the alleged infringement took place. The defendant may respond by serving and filing a Statement of Defence alleging non-infringement and/or patent invalidity as a common defence. The defendant will also typically allege by counterclaim that the patent is invalid (this relief may only be sought in the Federal Court). The defendant may also bring several preliminary motions, including a motion to strike and/or motion for summary judgment.

The PMNOC Regulations allow a subsequent-entry manufacturer (generic, biosimilar) to allege that patent(s) listed on a register against the brand-name reference product are not valid and/or would not be infringed by the manufacture, use or sale of the subsequent-entry product in Canada. Upon receipt of such an allegation, the patent owner may commence an infringement action against the subsequent-entry manufacturer in the Federal Court. By commencing an action, Health Canada’s decision on whether to approve the subsequent-entry product is frozen for 24 months or until the disposition of the action in Federal Court, whichever is earlier. There are certain scenarios whereby a subsequent-entry manufacturer may launch its product “at risk”, including instances in which the patentee waives its right to a 24-month stay.

The sale of counterfeit pharmaceuticals and medical devices is governed primarily by the Customs Act, the Combating Counterfeit Products Act (CCPA), the Trademarks Act, the Patent Act, the Copyright Act and the Criminal Code. Counterfeit health products and associated activities also constitute violations of the FDA and its Regulations.

Through the CCPA, registered copyright and trade mark owners may obtain assistance from the CBSA by filing a Request for Assistance (RFA) for border officials to detain commercial shipments suspected of containing counterfeit goods. The RFA is valid for two years and can be renewed before expiry. Once an RFA is filed, the CBSA can provide information to the RFA holder in respect of shipments and samples of the suspect goods.

If counterfeit goods are discovered, customs officers are permitted to temporarily detain them for a period of five days in the case of perishable items, and ten working days for non-perishable items, and to provide information to the IP rights-holder about the items detained. To extend the detention period, the IP rights-holder must bring a court action to enforce the prohibitions on counterfeit goods and provide notice of the legal proceeding to the Minister before the detention period expires.

In addition, health products are examined for compliance at the border or at a Canadian establishment during compliance verifications or inspections. If the Health Products and Food Branch Inspectorate suspects or confirms counterfeit health products, then Health Canada may take several types of enforcement action, including notifying the RCMP, recommending the refusal or seizure of imports at the border, or ordering the removal or destruction of imports at the border, as well as seizure and detention, forfeiture and destruction.

Under the FDR, Health Canada must approve a drug’s proposed brand name. This process is distinct from the trade mark registration process conducted by the Canadian Intellectual Property Office. Both processes deal with the potential for consumer confusion, but Health Canada also examines the name from a health and safety perspective. A review of marks pursuant to the Trademarks Act is conducted based on the likelihood of confusion with another mark as to the source of origin.

Health Canada’s approval for medical device names is not required.

There are no specific restrictions for parallel importation under the Trademarks Act. However, there are certain labelling and language requirements under the FDR for drugs and under the MDR for medical devices being imported into Canada.

Certain trade dress or non-traditional marks can be protected under the Trademarks Act and at common law. Pursuant to the Trademarks Act, the requirements for non-traditional trade marks (eg, hologram, moving image, scent, taste, colour, shape, mode of packaging good and/or texture) will depend on the nature of the trade mark and will be subject to examination by the Trademarks Office for distinctiveness.

Unregistered trade dress may also be protected under the tort of passing off at common law. Generally, there are three necessary elements to establish passing off:

• the existence of goodwill or reputation in the trade mark;
• deception of the public due to misrepresentation; and
• actual/potential damage.

Canada provides eight years of data exclusivity for an “innovative drug” that contains a medicinal ingredient not previously approved and that is not a variation of a previously approved medicinal ingredient such as a salt, ester, enantiomer, solvate or polymorph. Data protection applies to chemical drugs and biologics.

Canada will not issue market authorisation for a drug based on a comparison, either direct or indirect, to an innovative drug for eight years from the issuance date of the innovative drug’s first market authorisation. In addition, manufacturers that seek approval on the basis of a comparison are prohibited from filing a submission for a copy of that innovative drug until six years have elapsed since the first market authorisation.

The data protection period may be extended by a further six months if, within the first five years of the eight-year period, the results of paediatric clinical trials designed and conducted for the purpose of increasing knowledge of the use of the drug in paediatric populations are also submitted and found acceptable.

Health Canada made various interim orders (IOs) to establish a temporary regulatory pathway for drugs and vaccines related to COVID-19 to expedite the authorisation thereof. Following these temporary measures, amendments to the FDR were introduced to facilitate the review, authorisation and oversight of COVID-19 drugs and vaccines.

On 22 February 2023, the Regulations Amending the MDR (Interim Order No 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19) was adopted to facilitate access to medical devices related to COVID-19. This created a permanent regulatory framework for COVID-19 medical devices while also maintaining most of the flexibilities introduced by earlier IOs for devices on the List of Medical Devices for an Urgent Public Health Need in Relation to COVID-19 (UPHN list).

On 3 January 2024, the Regulations Amending the Medical Devices Regulations (Medical Devices for an Urgent Public Health Need) came into force. These regulations were introduced to broaden the COVID-19 medical devices framework to apply to other medical conditions that present, or are the result of, a significant risk to public health in Canada, and require immediate action to deal with the risk.

Other IOs were adopted to prevent or ease shortages of drugs and medical devices by allowing the importation of foreign drugs and medical devices that met similar high quality and manufacturing standards as Canadian-approved products, in addition to other provisions. Another IO authorised the Minister of Health, under certain conditions, to compel anyone who sells drugs to provide information about shortages or potential shortages of that drug related to COVID-19. These provisions have since been incorporated into the amended FDR.

Health Canada adopted special measures to assist with the running of ongoing clinical trials as a result of the pandemic. Sponsors were required to document any measure they took to reduce the risk of COVID-19 infection. If the physical site for visits changed, trial participants were required to consent to the transfer of any identifiers from the original site to the new site. Additional guidelines for the management of ongoing clinical trials included:

• consideration of safety monitoring measures;
• informing study participants of any changes to the study and monitoring plan; and
• identification of all participants affected by a COVID-19 study disruption with a unique participant identifier.

The interim IOs were replaced by the Clinical Trials for Medical Devices and Drugs Related to COVID-19 Regulations, which came into effect on 27 February 2022 and are intended to facilitate the regulatory pathway for clinical trials for drugs and medical devices related to COVID-19. The regulations are expected to remain in force until additional measures under Canada’s Clinical Trials Modernization Initiative plan are adopted. Applicants for COVID-19 drug trials can apply for authorisation under either the FDR or the Clinical Trials for Medical Devices and Drugs Related to COVID-19 Regulations; trials under the latter are subject to modified requirements. Similarly, applicants for COVID-19 medical device trials can apply for authorisation under either the MDR or the Clinical Trials for Medical Devices and Drugs Related to COVID-19 Regulations.

IOs regarding the sale of drugs for use in relation to COVID-19 were put in place temporarily to facilitate the emergency approval of COVID-19-related drugs, including prescription and non-prescription pharmaceuticals, radiopharmaceuticals and biologic products. The FDR were subsequently amended to allow for modified requirements that facilitate the regulatory process for new COVID-19 drugs to receive an NOC through the NDS regulatory pathway. The amendments maintain some of the earlier mechanisms from the IOs, thus continuing to facilitate the approval of COVID-19-related drugs.

Similarly, IOs were put in place regarding the sale of medical devices for use in relation to COVID-19. On 22 February 2023, Health Canada introduced the Regulations Amending the Medical Devices Regulations (Interim Order No 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19), which provide for accelerated access to, and approval of, COVID-19 medical devices that have an urgent public health need. On 3 January 2024, the Regulations Amending the Medical Devices Regulations (Medical Devices for an Urgent Public Health Need) were introduced to broaden the COVID-19 medical devices framework to apply to other urgent public health needs.

Health Canada introduced several temporary measures to provide greater regulatory flexibility for drug establishment licensing and GMP during the pandemic. This included accelerated regulatory pathways and modified schedules for Health Canada inspections related to drugs manufactured in Canada and abroad. The FDR were subsequently amended to allow for modified requirements that facilitate the regulatory process for new COVID-19 drugs. COVID-19-related DEL applications submitted under the amended Regulations are processed by Health Canada in an expedited manner on a case-by-case basis.

Similar amendments to facilitate the regulatory approval of medical devices, including DELs, were put in place through the Regulations Amending the Medical Devices Regulations (Interim Order No 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19).

IOs respecting the importation of drugs for use in relation to COVID-19 were put in place to facilitate the emergency approval of COVID-19-related drugs, including prescription and non-prescription professional use pharmaceuticals, radiopharmaceuticals, biologics such as vaccines and veterinary drugs. The FDR were subsequently amended to allow for modified requirements that facilitate the regulatory process for new COVID-19 drugs. The amendments maintain some of the mechanisms introduced through the IOs.

Similarly, IOs were put in place regarding the importation of medical devices for use in relation to COVID-19. On 22 February 2023, Health Canada introduced the Regulations Amending the Medical Devices Regulations (Interim Order No 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19), which provide for accelerated access to COVID-19 medical devices that have an urgent public health need.

Many measures have been put in place to accelerate the use of virtual and digital healthcare in light of COVID-19, including the following:

• a Virtual Care Task Force (VCTF) report was released by the Canadian Medical Association, the College of Family Physicians of Canada and the Royal College of Physicians and Surgeons of Canada on 11 February 2020, to provide a framework for expanding the use of virtual care;
• all jurisdictions in Canada revised their healthcare fee codes to facilitate the virtual delivery of care;
• a Virtual Care/Digital Table organised by all levels of government endorsed a policy framework for virtual healthcare services within Canada;
• a Canadian Network for Digital Health Evaluation was created to strengthen Canada’s capacity to evaluate digital health interventions;
• the federal government signed several bilateral agreements with various provinces/territories, including Ontario, to enhance virtual health services at the provincial and territorial level; and
• several provinces and territories also developed virtual care action plans.

The COVID-19 Emergency Response Act was enacted in response to the pandemic and provides that the Commissioner of Patents may, on the application of the Minister of Health, authorise the government of Canada (and any person specified in the application) to make, construct, use and sell a patented invention in order to respond to a public health emergency. Such an authorisation ceases after one year or after the day on which the public health emergency ends, whichever is earlier. The patentee is provided compensation by the government of Canada (or the person specified in the application) but the amount is discretionary, taking into account the economic value of the authorisation and the extent the patented invention is used.

The Patent Act also provides that the Commissioner of Patents may authorise the use of a patented invention by a provincial government or the government of Canada.

To date, there has been no public announcement of a compulsory licence being granted for COVID-19-related treatments in Canada.

Canada did not invoke liability exemptions through the Emergencies Act in response to COVID-19.

Health Canada and other government departments collaborated with the health product industry to provide medical supplies, including manufacturing scale-up and re-tooling of sites.

The federal and provincial/territorial governments made changes and updates to the systems of public procurement due to COVID-19.

At the federal level, the Treasury Board of Canada published a Contracting Policy Notice 2020-1 – Response to COVID-19 on 23 March 2020, which provided that the Board had approved time-limited increases to emergency contracting limits, including that the Minister of Public Services and Procurement had unlimited emergency contracting limits for the research, development, acquisition and deployment of vaccines related to COVID-19 until 31 March 2021. This Notice also set out that Public Services and Procurement Canada (PSPC) was co-ordinating the centralised purchase of specific goods, such as personal protective equipment, on behalf of the federal and provincial/territorial governments. In 2023, the emergency contracting limits were converted to “exceptional contracting limits” (which can be used for emergency contracts) and the PSPC was given a “sustained emergency of national importance exceptional limit” until 31 December 2023.

There were also some changes at the provincial/territorial level. For example, in Ontario, the Coronavirus (COVID-19) Response and Recovery Regulations (O. Reg. 92/20) were introduced under the Supply Chain Management Act. Under this regulation, the Ministry of Government and Consumer Services and the Ministry of Health were designated as the supply chain management entities for the purposes of responding to COVID-19. Quebec also authorised the Minister of Health Services and Social Services to enter into any contracts necessary to protect public health.