Commercialisation of healthcare in Canada: overview
A Q&A guide to the commercialisation of healthcare in Canada.
This Q&A provides an overview of the regulatory framework for the commercialisation of medical products in Canada. It covers the key requirements for manufacturing, advertising and selling drugs, medical devices, biological products and natural health products.
To compare answers across multiple jurisdictions, visit the commercialisation of healthcare Country Q&A tool.
This Q&A is part of the Commercialisation of Healthcare Global Guide. For a full list of jurisdictional Q&As visit www.practicallaw.com/healthcare-guide.
The Food and Drugs Act (FDA) applies to all medical products (that is, drugs, medical devices and natural health products) sold in Canada, whether manufactured in Canada or imported. The FDA and the Food and Drug Regulations (FDA Regulations) seek to ensure the safety of medical products in Canada by governing their manufacture, sale and advertisement.
Health Canada is the department of government with responsibility for national public health, including ensuring that Canadians have access to safe and effective medical products.
Regarding medical products, the FDA and the FDA Regulations are administered by the Health Products and Food Branch (HPFB) of Health Canada. In turn, HPFB is divided into directorates:
The Therapeutic Products Directorate (TPD) has broad authority over pharmaceuticals and medical devices.
The Biologics and Genetic Therapies Directorate (BGTD) is responsible for biologics and radiopharmaceuticals.
The Natural and Non-Prescription Health Products Directorate (NNHPD) is responsible for the review and approval of non-prescription and disinfectant drugs, as well as natural health products.
The Marketed Health Products Directorate (MHPD) monitors the safety, effectiveness and quality of marketed medical products in Canada, including:
Prescription and non-prescription medications.
Natural health products.
The MHPD is also responsible for the post-marketing monitoring, surveillance, adverse event assessment and communication for marketed health products, including:
The HPFB is responsible for the enforcement of the FDA and the FDA Regulations. The Office of Patented Medicines and Liaison is responsible for the:
Administration of the Patented Medicines (Notice of Compliance) Regulations (NOC Regulations).
Maintenance of the Canadian Patent Register.
Determination of the innovative drug status under the data protection provisions of the FDA Regulations.
The Canadian Intellectual Property Office is responsible for the administration and processing of intellectual property rights in Canada, including those related to medical products.
The provincial governments have jurisdiction over, and are responsible for, the funding of all healthcare services. For pharmaceutical coverage, each provincial drug plan sets speciﬁc price and other cost-containment guidelines. The impact of the various regulations at each level of government has resulted in a uniquely Canadian landscape that is sometimes difficult to rationalise on efficiency grounds.
After Health Canada has approved a drug to be sold in Canada, but before these drugs are funded under most public drug plans, a manufacturer must apply to the Canadian Agency for Drugs and Technologies in Health (CADTH) to have its drug reviewed through the Common Drug Review (CDR). CADTH is an independent, not-for-proﬁt national body funded by Canada's federal, provincial and territorial governments. Healthcare decision-makers in Canada are provided by CADTH with credible, impartial advice and evidence-based information about the effectiveness and efficiency of drugs and other health technologies.
The CDR recommends which new non-cancer drugs can be covered under publicly funded drug beneﬁt plans in Canada. All federal, provincial and territory governments take part in this review except the province of Québec.
The pan-Canadian Oncology Drug Review assesses cancer drugs and recommends the drugs that Ontario and other provinces and territories in Canada (except Québec) should fund under their public drug programmes.
Québec has a National Institute for Excellence in Health and Social Services, modelled on the British National Institute for Health and Care Excellence, which evaluates the clinical beneﬁts and costs of medical technologies, drugs and interventions, and develops recommendations and clinical guidelines for the Québec Ministry of Health.
For more information on Health Canada or any of the Directorates see box: The regulatory authorities.
The Food and Drugs Act (FDA) and the Food and Drug Regulations (FDA Regulations) regulate all types of drugs and medical devices. Drugs and devices are defined in the FDA as being manufactured, sold or represented for use in diagnosing, treating, mitigating or preventing a disease or disorder. Therefore, if a medical product, other than a narcotic or controlled drug, does not make any claims in these regards, it does not fall under the scope of the FDA.
Generally, a drug establishment licence (DEL) is required before a distributor is allowed to fabricate an active pharmaceutical ingredient or finished drug. To qualify for a DEL, a manufacturer must show that its operations are conducted following good manufacturing practices, which include among other things clean, sanitary and orderly operating conditions. The Food and Drug Regulations (FDA Regulations) outline extensive requirements to ensure that good manufacturing practices are implemented and followed.
See Question 8.
Drugs must undergo extensive testing and review before marketing in Canada. Pre-clinical laboratory testing to explore the efficacy and safety of a potential new medicine before it is administered to patients is required before a company can ﬁle an application to test the drug on people. Clinical trials conducted in Canada are governed by the Food and Drugs Act (FDA) and the FDA Regulations. Canada has also adopted international and domestic guidelines that identify accepted principles and practices in the conduct of clinical trials, including the ICH Good Clinical Practice Consolidated Guideline.
A sponsor must ﬁle a clinical trial application to obtain authorisation to sell or import a drug for the purpose of conducting a trial. Applications must be ﬁled with Health Canada before conducting clinical trials in phases I, II and III. Submissions must be sent directly to the applicable review directorate:
Pharmaceutical drugs must be sent to the Therapeutic Products Directorate (TPD).
Biological and radiopharmaceutical drugs must be sent to the Biologics and Genetic Therapies Directorate (BGTD).
Authorisation for a phase IV clinical trial (post-marketing surveillance trial) is not required if the trial involves marketed drugs and is conducted within the parameters of an approved notice of compliance (NOC). Anyone wishing to sell a drug to a qualiﬁed investigator to conduct clinical testing in Canada must ﬁle an investigational new drug (IND) submission with the TPD.
The FDA Regulations provide that, with exceptions noted below, no one can sell or advertise a new drug unless the Minister of Health has issued an NOC to the manufacturer of the new drug. A drug can be distributed before receiving an NOC in the following cases:
Where a notice of compliance with conditions (NOC/c) has been issued.
Where the drug is an investigational new drug.
Under Health Canada's Special Access Programme (SAP) for drugs.
In each case, speciﬁed conditions apply to the distribution of the drug.
The issuance of an NOC indicates that the drug meets the required standards for use in humans and that the product is approved for sale in Canada. Essentially, the NOC constitutes the marketing approval of the Minister of Health for the drug product. A manufacturer can obtain an NOC by submitting a new drug submission (NDS) or an abbreviated NDS (ANDS) (or a supplement to either submission). An NDS must be ﬁled for a new, ﬁrst-entry drug product (usually a patented drug product). An ANDS is ﬁled for a subsequent-entry product (a generic drug product) that is the pharmaceutical equivalent of and bioequivalent of a product marketed in Canada under an earlier NOC.
The drug identiﬁcation number (DIN) is a registration number that Health Canada assigns to each prescription and non-prescription drug (and medicinal herb) product marketed under the FDA Regulations. The DIN provides proof that the drug has been evaluated by the TPD and is authorised for marketing and sale in Canada. The DIN is also used as a tracking number to facilitate product recall, inspection and quality monitoring of the drug.
The distinction between ﬁrst and subsequent entry products is important, not regarding the drug approval process, but also for the administration and application of the NOC Regulations enacted under the provisions of the Patent Act. The NOC Regulations seek to prevent infringement of certain pharmaceutical patents while generic pharmaceutical manufacturers apply for regulatory approval to go to market. The NOC Regulations are referred to as the "linkage" regulations because they link two otherwise unrelated legislative schemes:
The Patent Act (the purpose of which is the protection of private patent rights).
The FDA (the purpose of which is the protection of public health and safety).
Essentially, the NOC Regulations prohibit the Minister of Health from issuing an NOC for a generic drug until the relevant patents expire or the court makes a determination that the generic company's allegation of non- infringement or invalidity of the patent in question is justiﬁed. Under data protection provisions contained in the FDA Regulations, companies introducing a drug containing a new medicinal ingredient not previously approved in a drug by Health Canada and not a variation of a previously approved drug are also entitled to an eight-year period of exclusivity. A second entry manufacturer is also prevented from ﬁling a submission for a copy of that innovative drug for the ﬁrst six years of the eight-year period. The data protection period can be extended a further six months if, within the ﬁrst ﬁve years of the protection 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.
An NDS is sent to the TPD's Submission and Information Policy Division and then referred to the appropriate directorate for review. The NDS is considered both an application for a DIN and an NOC submission. The TPD evaluates the submitted data on safety, efficacy and quality and reviews the information that the manufacturer proposes to provide healthcare practitioners and consumers about the drug, including the labels, package inserts and product brochures. If it is concluded that the information contained in the submission establishes the safety, effectiveness and quality of the new drug and the submission meets the requirements of the FDA and FDA Regulations, the Minister of Health provides marketing authorisation by issuing an NOC for the drug.
Alternatively, the Minister of Health can issue an NOC/c. The NOC/c policy at Health Canada has been formulated with the goal of providing physicians and patients with early access to a drug, as well as a means to effectively monitor and report on the safety of the drug through enhanced post-marketing surveillance. The NOC/c policy is restricted to products for serious, life-threatening or severely debilitating diseases or conditions. Diseases considered as serious include:
All other stages of HIV infections.
Amyotrophic lateral sclerosis.
Under the NOC/c policy, a sponsor must commit to pursue conﬁrmatory studies that are acceptable to Health Canada.
Post-NOC, manufacturers must submit to Health Canada on an expedited basis any domestic reports of serious adverse drug reactions or unusual failures in efficacy for new drugs, as well as foreign reports of serious unexpected adverse drug reactions. Annual notiﬁcation to Health Canada that the DIN application has not changed is also required. Manufacturers must also provide a critical analysis of the adverse drug reactions and serious adverse drug reactions of each of their drugs on an annual basis. In addition, manufacturers must inform Health Canada if there has been a signiﬁcant change in the known risks and beneﬁts of a drug.
As well as the NOC/c scheme, there are other exceptions to the general drug approval process that are designed to provide Canadians with access to drugs that have not received an NOC.
Individuals that meet the inclusion criteria can receive access to drugs not approved for use in Canada through participation in an approved clinical trial.
Physicians occasionally also require drugs not approved in Canada to treat patients with a serious or life-threatening illness when other treatments are not available or when existing therapies have failed or are unsuitable. The emergency drug release provisions of the FDA Regulations authorise the sale of an unapproved drug for emergency treatment under certain conditions. The TPD authorises access to such drugs under the SAP. Any decision to authorise or deny a particular request is made on a case-by-case basis.
The FDA Regulations also prohibit a person from importing an unapproved drug into Canada for sale. However, the Inspectorate allows individuals to import a prescription medicine that is not approved in Canada for personal use only (see Question 7).
The abbreviated new drug submission (ANDS) system was designed to create a simpler and more cost-effective process for the approval of generic drugs and to reduce the cost of drugs to Canadian provincial governments and members of the public. The manufacturer of a generic drug only needs to establish that the manufacturer's drug is the pharmaceutical equivalent and bioequivalent of the approved drug of the innovator. The innovator's drug is referred to as "the Canadian reference product". The ANDS does not contain any independent evidence of the safety and effectiveness of the generic drug. Instead, the manufacturer of the generic drug relies on the safety and effectiveness established by the innovator (the manufacturer of the Canadian reference product). Where a particular innovative drug product is not marketed in Canada, the Therapeutic Products Directorate (TPD) considers bioavailability data generated using a non-Canadian reference product.
The Food and Drug Regulations (FDA Regulations) allow a manufacturer to ﬁle an ANDS where, in comparison with a Canadian reference product, four criteria are met:
The new drug must be the pharmaceutical equivalent of the Canadian reference product.
The new drug must be bioequivalent with the Canadian reference product based on pharmaceutical and, where the Minister of Health (Canada) considers it necessary, bioavailability characteristics.
The route of administration must be the same as that of the Canadian reference product.
The conditions of use for the new drug must fall within the conditions of use for the Canadian reference product.
Following a review of the ANDS, the Minister must issue a notice of compliance (NOC) if the submission complies with the FDA Regulations. If the submission does not comply, the Minister must notify the manufacturer. The manufacturer can amend the ANDS or supplement it by ﬁling additional information or material.
Health Canada regulates the manufacture and sale of drugs (see Question 1, Regulatory authorities).
For the advertising of drugs, Health Canada, with the assistance of advertising pre-clearance agencies, administers and directs compliance with the Food and Drugs Act (FDA) and the Food and Drug Regulations (FDA Regulations).
The FDA provides that drug advertising material must not be false, misleading or deceptive. Advertising pre-clearance agencies review and pre-clear advertising material to help the industry ensure compliance with the applicable regulatory provisions and the various Health Canada guidance documents and codes of advertising (for example, the Pharmaceutical Advertising Advisory Board (PAAB) Code of Advertising Acceptance).
Advertising material for all health products directed to health professionals, including prescription and non-prescription drugs, is reviewed and pre-cleared by the PAAB. The PAAB, as well as Advertising Standards Canada, provides advice on messages directed to consumers for prescription drugs and on educational material discussing a medical condition or disease to ensure that they meet the regulatory requirements.
For more information on Health Canada and the PAAB see box: The regulatory authorities.
Foreign marketing authorisations are not recognised. However, Canada has entered into mutual recognition agreements (MRA) for good manufacturing procedures (GMP) with the European Union (EU), the European Economic Area (EEA), Switzerland and Australia.
Canadian companies importing drugs or medical products that fall within the scope of an MRA and that are fully manufactured within a jurisdiction covered by the MRA can beneﬁt from speciﬁed GMP exemptions provided by the MRA, as listed in the Canadian GMP guidelines issued by Health Canada.
Canadian companies importing drugs or medicinal products from a jurisdiction covered by an MRA that is not operational cannot beneﬁt from the speciﬁed GMP exemptions provided by the MRA. The same rationale applies when one or several steps of the drug manufacturing take place in one or more jurisdictions in which the MRA is not operational.
Health Canada has issued a comprehensive policy on imports and exports of medical products (for example, drugs, medical devices and natural health products).
Generally, medical products exported from Canada must meet the relevant requirements of the Food and Drugs Act (FDA) and the Food and Drug Regulations (FDA Regulations). The requirements include, among others, ensuring that products exported are not adulterated, manufactured in unsanitary conditions or manufactured, sold or advertised in a manner that is false or misleading. A medical product can be exported from Canada if it has been fabricated by a Canadian licence holder to a Canadian market authorised formulation or design (DIN).
If the medical product is made in Canada for the sole purpose of export and is therefore not sold for consumption in Canada, the product does not need to be labelled with the Canadian approved product labelling. However, the labelling must indicate that the product is for export only. The manufacturer must also attest that the product is not known to contravene any laws of the importing country. If requested, Health Canada can issue a certiﬁcate (for example, a certiﬁcate of pharmaceutical Products or manufacturer's certiﬁcates) for these products. A medical product made for use in a clinical trial involving human subjects can be exported if it meets the applicable requirements of the FDA and the FDA Regulations for a clinical trial conducted in Canada.
Consumers are encouraged to buy medical products that have received market authorisation from Health Canada. A Canadian who chooses to obtain a medical product from outside Canada that may or may not have been reviewed and market authorised by Health Canada can import either a single course of treatment or a 90-day supply based on the directions for use, whichever is less, of a health product provided that the product does not contain a substance listed in the Prescription Drug List. The medical product must be for:
Their own personal use.
The use of a person for whom they are responsible.
Use on an animal for which they are responsible.
Similarly, visitors to Canada can also bring into Canada (on their person) a single course of treatment or a 90-day supply based on the directions for use, whichever is less, of a health product. The medical product must be shipped or carried in one of the following:
Hospital or pharmacy dispensed packaging.
Original retail packaging.
Packaging with the original label afﬁxed to it which clearly indicates what the health product is and what it contains.
The Food and Drugs Act (FDA) prohibits medical product advertising that is false, misleading or deceptive, or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety (see Question 5). Examples of possible contraventions include messages:
That emphasise only product beneﬁts without including safety information.
Discussing off-label use of a product.
Only drugs that have been authorised for sale in Canada by the Health Products and Food Branch (HPFB) of Health Canada can be advertised. The advertising must not exceed the terms of the market authorisation.
Advertisement includes any representation by any means for the purpose of promoting directly or indirectly the sale or disposal of any food, drug, cosmetic or device. Health Canada has issued guidance documents that explain how Health Canada uses contextual factors to help determine whether a given message is information or advertising. Some messages, depending on the content and the context in which they are disseminated, can be considered non-promotional. These could include:
However, if the message is an advertisement, it must comply with the advertising provisions of the FDA and the Food and Drug Regulations (FDA Regulations).
Any person that promotes the sale of a speciﬁc health product is subject to this legislation, including physicians, when they use their websites or other means for this purpose.
Speciﬁc regulatory provisions exist to limit the type or extent of advertisements of prescription drugs to consumers. For example, prescription drugs cannot be advertised to the general public in relation to speciﬁc diseases. Advertising of narcotic and controlled drugs to consumers is prohibited.
The FDA Regulations prohibit consumer-directed prescription drug advertising beyond the drug's name, price and quantity. This means, for example, that when a prescription drug is advertised by name to consumers, no reference can be made to its therapeutic use or beneﬁts. The FDA Regulations also prohibit the advertising of new drugs that have not been authorised for sale by Health Canada. The advertising of pharmaceutical manufacturers must either be non-promotional in nature or must comply with federal advertising requirements. Under the regulatory framework, Health Canada has permitted two types of prescription drug messages directed to consumers:
Reminder ads, where the name of a prescription drug is mentioned but no reference to a disease state appears in the advertisement, are interpreted as within the name, price and quantity restrictions of the FDA Regulations.
Help-seeking messages, where a disease state is discussed but no reference is made to a speciﬁc prescription drug product, are considered information and not advertising when they meet the criteria outlined in Health Canada policies.
Internet advertising directed at consumers or patients is not treated any differently. Any internet sale or advertising of a medical product that does not comply with the FDA or the FDA Regulations is prohibited.
To monitor medical device distribution from the time of manufacture to use, importers and distributors must obtain an establishment licence. Class I medical device and in vitro diagnostic devices (IVDD) manufacturers must secure a medical device establishment licence (MDEL) if selling directly into Canada and not through a distributor. If the manufacturer is selling through distributors in Canada, then the distributor must also have an MDEL. Both distributors and importers of medical devices and IVDDs, regardless of the device classiﬁcation, must secure an MDEL. Manufacturers of class II, III and IV medical devices and IVDDs do not need an MDEL since they are monitored through the medical device licence (MDL) regime.
See Question 13.
Medical devices are regulated by Health Canada's Therapeutic Products Directorate (TPD) and are subject to the Medical Devices Regulations under the Food and Drugs Act (FDA). The FDA applies to all medical devices sold in Canada, whether manufactured in Canada or imported. The current Canadian regulatory framework is generally aligned with those of the US, the EU, Japan and Australia.
The Medical Devices Regulations (MD Regulations) draw a distinction between IVDD and all other medical devices. Both systems classify devices into one of four risk classes with class I representing the lowest risk and class IV the highest risk. Special rules are included to classify, for example, devices incorporating animal tissues or devices that use recombinant DNA technology in their manufacture.
A set of safety and effectiveness requirements forms the basis of the regulations. These requirements have been modelled on the "essential requirements" of the EU directives. For the majority of devices, demonstration of compliance with these requirements to Health Canada is assessed through a pre-market device licensing requirement. However, all devices must meet these safety and effectiveness requirements, as appropriate.
Before a class II, III or IV medical device can be imported, sold or advertised for sale, a device licence must be obtained from Health Canada. Class I devices are exempt from device licensing requirements. Although manufacturers are responsible for classifying their devices, classiﬁcation is subject to veriﬁcation by Health Canada. The amount of information required to be submitted to obtain a device licence increases the higher the risk class of the device.
Before classifying a device, a manufacturer must ﬁrst determine if the product meets the deﬁnition of a "device" under the FDA. If it is determined that the deﬁnition applies, the manufacturer must then determine whether or not the deﬁnition of "medical device" in the FDA Regulations applies. The definition of "device" in the FDA has recently changed to include in vitro reagents, and a more precise list of exclusion criteria. The deﬁnition in the FDA Regulations excludes devices for use on animals, for which the regulations do not apply.
The classiﬁcation process can be complex, and is dependent on the interpretation of each rule as applied to a given device. The manufacturer is responsible for conducting a self-assessment of the device to determine its class. Where a medical device can be classiﬁed into more than one class, the highest class applies. Guidance from Health Canada is available to assist manufacturers in classifying their devices. The classiﬁcation rules are close to, but not identical with, the European classiﬁcation rules. If the classiﬁcation rules for each jurisdiction were applied to the same group of medical devices, there is a strong likelihood that all but a few would result in equivalent classiﬁcations.
Health Canada has developed a policy on the use of recognised standards in establishing the safety and effectiveness of medical devices which is similar to the European approach and the references in Directive 93/42/EEC concerning medical devices (Medical Devices Directive) to the use of harmonised standards for complying with the essential requirements.
Health Canada, on satisfying itself that the device meets the safety and effectiveness requirements described above, issues a device licence that is subject to annual renewal. This annual renewal requires manufacturers to verify information on the device on ﬁle with Health Canada. Failure to renew a device licence results in its cancellation by Health Canada.
Under the FDA regulations, anyone that imports or sells a medical device in Canada, and any manufacturer of a class I device that does not import or distribute solely through a person who holds an establishment licence, must hold an establishment licence. Retailers, healthcare facilities and manufacturers of class II, III and IV devices are exempt from this requirement. Applications for an establishment licence must be submitted to Health Canada and must contain detailed information as set out in the establishment licence section of the regulations. Health Canada, on satisfying itself that the establishment meets the requirements described in that section, issues an establishment licence. Health Canada can refuse to issue or can cancel an establishment licence.
Medical devices imported or sold in Canada must have labels containing speciﬁc information, related to these devices, that is easily understood by the user. Where the device is too small for this information to be placed on the label, the information must be contained in the directions for use.
Under the MD Regulations, the manufacturers and the importers of devices must also make preliminary and ﬁnal reports to Health Canada concerning any incident involving their device that:
Is related to the failure or deterioration of the device or any inadequacy in the labelling or directions for use.
Has led to a death or serious deterioration in the health of a patient, user or other person.
Could have led to a death or serious deterioration in the health of a patient, user or other person, or could do so were it to recur.
The MD Regulations are supplemented by guidance documents issued by Health Canada, which outline the safety and effectiveness data required for each class of medical device. Licence applications are reviewed by Health Canada staff and licences are issued once all requirements are met. Manufacturers can appeal a decision if licensing is refused, or re-submit applications if additional information is required.
As an exception to the typical licensing process, a special access programme on medical devices allows healthcare professionals to apply for authorisation to use medical devices that are not yet licensed in Canada for emergency use or if conventional therapies have failed, are unavailable or unsuitable. TPD staff review each individual application to assess whether potential risks of using the device outweigh potential beneﬁts.
The Therapeutic Products Directorate (TPD) within Health Products and the Health Products and Food Branch (HPFB) of Health Canada are primarily responsible for the regulation of medical devices.
For more information on the TPD see box: The regulatory authorities.
While the requirements for medical devices that have been licensed or approved in other jurisdictions are the same as for medical devices that have not been licensed or approved in other jurisdictions, considerable effort has been undertaken to harmonise Canada's regulatory requirements with those of the US, the EU, Japan and Australia.
See Question 7. Medical devices when imported by an individual for their own personal use are not regulated under the Food and Drugs Act (FDA) or the Medical Devices Regulations (MD Regulations).
Medical devices can be advertised to the general public. However, messages must not be false, misleading or deceptive, and must not make claims to treat or cure any disease listed in Schedule A to the Food and Drugs Act (FDA) (for example, alcoholism, arthritis, cancer, congestive heart failure, diabetes or obesity). However, there are no such restrictions against advertisements regarding the diagnostic capabilities of a device. Advertising claims must be consistent with Health Canada's authorised indication for the product (for example, as found in the product monograph or product licence).
Biologics are drugs listed in Schedule D to the Food and Drugs Act (FDA). Schedule D includes the:
Names of individual products (such as "insulin").
Product classes (such as "immunising agents" and "monoclonal antibodies").
References to particular sources (such as "drugs, other than antibiotics, prepared from micro-organisms").
Methodology (such as "drugs obtained by recombinant DNA procedures").
The Food and Drugs Regulations (FDA Regulations) contain specific manufacturing requirements for different types of biologic drugs. For example, when manufacturing certain vaccines a manufacturer is restricted to using specific strains of bacteria, and when producing certain types of toxoids, there are prescribed conditions regarding the types of containers that can be used to store the product and prescribed methods by which the storage container must be sealed.
See Question 8.
The Biologics and Genetic Therapies Directorate (BGTD) regulates biologics under the FDA Regulations. Information provided by manufacturers is evaluated to verify that the biologic meets quality, safety and efﬁcacy requirements and that the beneﬁts of the biologic outweigh the risks for its intended use. The information that must be submitted before a biologic receives marketing authorisation is more detailed than for other drugs. As well as the general information, more detailed chemistry and manufacturing information is required to allow the BGTD to evaluate the purity and safety of the product and ensure that it is not contaminated by undesired micro-organisms or another biologic. A notice of compliance (NOC) and a drug identiﬁcation number (DIN) are issued to sponsors when their products are authorised for sale in Canada. After a biologic has received a NOC, the manufacturer must adhere to the BGTD's Lot Release Programme, which sets out risk-based criteria for testing of the product before its release onto the Canadian market. The level of regulatory oversight for biologics in Canada is consistent with that of competent regulatory authorities in other countries.
Over the past few years, as innovator biologic drugs have begun to lose their patents, Health Canada has been developing the regulatory requirements for subsequent entry biologic drugs (SEBs). The term SEB was chosen instead of terms such as "biogeneric" or "generic biologic" to distinguish between the regulatory process and product characteristics applicable to SEBs compared to traditional generic drugs. A notable difference of the market authorisation process for SEBs is that the abbreviated new drug submission (ANDS) regime (see Question 4) that is used for generic drugs is not applicable. As is the case with generic drugs, SEBs enter the market after an identified reference product, but in the case of SEBs there is no claim of pharmaceutical or therapeutic equivalence to the reference product. As such, all SEBs must be approved under an NDS, although the clinical and safety information requirements can be reduced where there is an acceptable reference biologic product.
See Question 5.
Non-Canadian reference products can be used in comparative studies for SEB drug submissions, although Health Canada does not favour this. If a non-Canadian product is used, the submission sponsor is responsible for showing that the product is a suitable substitute for the version of the product approved in Canada, and that the chosen non-Canadian product has sufficient information and data to support the submission. The non-Canadian product must also be from a jurisdiction that:
Has an established relationship with Health Canada.
Formally adopts International Conference on Harmonisation guidelines.
Has similar evaluation and post-market surveillance requirements to Canada.
See Question 7.
See Question 8.
Natural health products
Licences for establishments that manufacture, import or distribute natural health products (NHPs) are required and are based on the attestation by the company that good manufacturing practices (GMPs) are being followed. All Canadian manufacturers, packagers, labellers and importers of NHPs must have site licences. To obtain a licence, sites must:
Maintain proper distribution records.
Have proper procedures for product recalls.
Have proper procedures for the handling, storage and delivery of their products.
Demonstrate that they meet GMP requirements.
See Question 24.
The Natural Health Products Regulations provide a pre-market licensing scheme for NHPs. Pre-market applications must be ﬁled and a licence issued before any NHP can be sold. The requirements do not apply to healthcare practitioners who compound products on an individual basis for their patients, or to retailers of NHPs.
All NHPs must have a product licence before they can be sold in Canada. To obtain a licence, applicants must give detailed information about the product to Health Canada, including:
The licensing scheme and information required depends on the type of natural health product. For example, Health Canada has outlined different pathways for licensing natural health products used as traditional medicines and natural health products making modern health claims. There is also specific guidance provided for the evidence required to be submitted in support of homeopathic medicines. Once Health Canada has assessed a product and decided it is safe, effective and of high quality, it issues a product licence along with an eight-digit natural product number (NPN) or homeopathic medicine number (DIN-HM), which must appear on the label.
The Natural and Non-prescription Health Products Directorate (NNHPD) within the Health Products and the Health Products and Food Branch of Health Canada (HPFB) is responsible for the review and approval of natural health products (NHPs).
For more information on the NNHPD see box: The regulatory authorities.
See Question 7.
The Food and Drugs Act (FDA) prohibits natural health products (NHPs) advertising that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety. However, unlike the advertisement of drugs and devices, the Natural Health Products Regulations allow for the advertisement of an NHP as a preventative, but not a treatment or cure for diseases or disorders.
Health Canada, in collaboration with Advertising Standards Canada, has developed Consumer Advertising Guidelines for Marketed Health Products. These guidelines apply to consumer-directed advertising of non-prescription drugs, including NHPs, for human use. The guidelines are applied by independent advertising pre-clearance agencies that have been endorsed by Health Canada (for example, the Advertising Standards Council). Under the guidelines, therapeutic claims for NHPs must be consistent with the product's terms of market authorisation as listed in the product licence. There are also specific guidelines around the use of terms such as "new", "improved" and "unique". Finally, claims of "safe" and "side effect-free" are unacceptable.
Healthcare remains a top priority for Canadians after decades of debate, signiﬁcant increases in public funding and numerous attempts at reform by the governments, both federal and provincial.
Rising healthcare costs and public funding for the existing system are limiting public investments in other areas that could make Canada a more effective, equitable and successful society (particularly among and between generations). Healthcare costs are rising toward 50% of provincial budgets and are crowding out spending on other government priorities.
The healthcare system needs to be transformed, and the debate over the nature and content of this transformation is gaining momentum. The areas of likely reform include:
Fixing the entry point to the healthcare system so that primary care, not the emergency room, will be the ﬁrst contact point within the healthcare system and the key access point for other health-related services.
More investment in and use of technology in the healthcare system, particularly information and communication technology.
Changes to the compensation system and related labour contracts for healthcare professionals to create the right incentives and improve the alignment with accountability.
Focusing on the state of the health and well-being of Canadians overall.
Building a more transparent and accountable healthcare system with respect to goals, management and performance.
In recent years, governments in Canada and public policy makers have focused on the growing costs of drugs as a percentage of total healthcare spending. Drug costs were forecast to be nearly Can$34 billion in 2014, which was expected to account for approximately 16% of total healthcare expenditure, estimated to be roughly Can$215 billion. Many provincial governments have adopted a new policy to control drug costs by negotiating product listing agreements with both brand name and generic manufacturers that include some form of rebate or discount component. Many provincial governments have also revised policies on the pricing of generic drugs to reduce the prices that governments are prepared to reimburse.
There is a vigorous debate around whether some form of centralised procurement of drugs and medical devices should be instituted. This debate is likely to result in further changes to procurement practices of public sector payers in Canada.
At the same time, corporate and insurance company payers are also becoming increasingly proactive in exploring new strategies to reduce the cost of drugs and devices. Such strategies have included putting restrictions on the reimbursement price of medications and restricting formulary coverage to cheaper generic versions of drugs. As a result, manufacturers of medical products in Canada are likely to face increasing pressure to justify pricing strategies. Brand name drug companies have already started to respond to this pressure by offering payment plans through which they cover the portion of the cost of their drug that is over and above the cost of the generic equivalent and not covered by a patient's other drug payers, either private or public. How this develops remains to be seen.
Other developments in healthcare have come from recent legislative amendments to the Food and Drugs Act (FDA) which create a newly defined term called a "therapeutic product". A therapeutic product is a hybrid term that includes a drug or device or any combination of drugs and devices. The amendments are aimed at strengthening the regulation of therapeutic products and improving the reporting of adverse drug reactions by healthcare institutions, and impose substantial penalties for contravention of the new provisions.
However, natural health products (NHPs) are notably exempt from the new requirements. This fact has not gone unnoticed in the medical community, with some commenting that the amendments will lose much of their effectiveness if those products remain exempt, which suggests that the regulation of NHPs may come under enhanced scrutiny over the coming years.
*With assistance from Rocky Swanson, student lawyer.
The regulatory authorities
Principal responsibilities. This is the primary regulator of healthcare products in Canada.
Therapeutic Products Directorate (TPD)
Principal responsibilities. This is the federal authority that regulates pharmaceutical drugs and medical devices for human use.
Biologics and Genetic Therapies Directorate (BGTD)
Principal responsibilities. This is the federal authority that regulates biological drugs and radiopharmaceuticals for human use.
Natural and Non-prescription Health Products Directorate (NNHPD)
Principal responsibilities. This is the federal authority that regulates natural health products, non-prescription and disinfectant drugs.
Marketed Health Products Directorate (MHPD)
Principal responsibilities. This ensures that the Health Products and Food Branch (HPFB) of Health Canada programmes take a consistent approach to post-market safety surveillance and risk communication.
Pharmaceutical Advertising Advisory Board (PAAB)
Principal responsibilities. This is an independent agency that ensures healthcare product communication is balanced, evidence-based and reflective of best practices.
Justice laws website
Description. This is the Justice Online source of the consolidated acts and regulations of Canada.
Health Canada guidance documents
Description. This is the guidance documents page of Health Canada's website and provides information pertaining to the regulation of the healthcare products discussed in this Q&A.
Jeffrey S Graham, Partner
Borden Ladner Gervais LLP
Professional qualifications. Lawyer, Canada and the United States of America
Areas of practice. Life sciences; biotechnology; pharmaceuticals.
Non-professional qualifications. B.Comm. (Honours Economics), McGill University; BCL and LLB, McGill University; LLB, Cambridge University; LLM, Columbia University
- Acts for life science companies in commercial negotiations, including financial and commercial transactions, research and development, manufacturing and licensing.
- Assists pharmaceutical clients in the listing of products in provincial drug plans, including negotiating drug plans and advising on types of formulary listings.
- Acts for clients in the promotion and distribution of food, drug and natural health products and medical devices, including advising on the appropriate structure for the transaction.
- Provides advice on codes of conduct applicable to manufacturers, distributors and healthcare professionals.
- Advises on good manufacturing practice (GMP) requirements and procedures relating to the production of food, drug, natural health products and medical devices.
- Advises clients in crises, such as recalls of defective or non-compliant products, food contamination, food tampering, fraud on the regulator, diversion of samples, diversion of product to unauthorised purchasers, illegal promotion and counterfeit products.
- Guides clients through the regulatory approval processes with Health Canada, CFIA, CPMA and PMPRB and provincial regulatory agencies.
- Provides assessments and strategic advice on potential challenges with respect to legislative and regulatory changes.
Languages. English, French
Professional Associations/Memberships. Member of the Law Society of Upper Canada; member of the Bar of Ontario; Member of the Bar of District of Columbia.
- Canadian Food and Drug Legislation & Commentary, LexisNexis, Jeffrey Graham (General Co-Editor) 2014/2015.
- Protecting Canadians from Unsafe Drugs Act (Vanessa's Law), Contact Canada, Jeffrey Graham (Author) 2014.
- Commercialisation of healthcare, Jurisdictional Comparisons, Thomson Reuters, European Lawyer Reference, Jeffrey Graham (Co-Editor and Author of Canada Chapter), 2013.
- Espionage: A Legal Perspective, BIO Business (September/October 2011), Jeffrey Graham (Co-Author).
- The 2011-2012 Biotechnology Public Policy Agenda, Biotechnology Focus (September/October 2011), Jeffrey Graham (Author).
- Commercialisation of biotechnology in Canada, Biotechnology Focus (July/August 2011), Jeff Graham (Author).
- The PMPRB - Jurisdictions and the Courts, Contact Canada (November 2010), Jeffrey Graham (Co-Author).
- Our medicine review board is broken; The government should undertake a comprehensive review of the Patented Medicine Review Board, National Post (August 12, 2009), Jeffrey Graham (Co-Author).
- Government of Canada proposes to update regulatory framework for National Health Products, Contact Canada (NHP Directory 2008), Jeffrey Graham (Author).
- End ad paternalism; Patients who can research their conditions on the Web consider outdated laws that direct drug ads only to doctors, National Post (April 17, 2008), Jeffrey Graham (Author).
- Medicare myths; Canada's healthcare system must be reformed to meet the needs of a changing world, National Post ( 14 September 2007), Jeff Graham (Author).
- Ontario bill shackles brand-name drug makers, National Post (27 May 2006), Jeffrey Graham (Toronto) (Co-author).
- Recent Developments of Importance, 2006 Lexpert Directory - ALM Top 500 Guide, Jeffrey Graham (Co-author).
- The Regulation of Stem Cell Research in Canada, Biotechnology Focus (January, 2004), Jeffrey Graham (Co-author).
- Mergers & Acquisitions: Transactions with the North American Biotechnology Sector, 2004 Lexpert/American Lawyer Media, Jeffrey Graham (Co-author).
- Carefully negotiated agreements can increase the potential for success, BioCanada June 2002, Jeffrey Graham (Co-author).
- Legal issues in commercialising Regenerative Medicine, CHARM/BIO 2002, Jeffrey Graham (Co-author).