Regulatory impact analysis statement

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Issues:
Antimicrobial resistance (AMR) is a serious and growing public health threat in Canada and around the world. As more microbes become resistant to antimicrobial drugs (or antimicrobials), these drugs become less effective in preventing and controlling infection. The overuse and misuse of antimicrobials in animals is a contributing factor to the development and spread of AMR. The development and spread of antimicrobial-resistant pathogens in animals can pose serious risks to human health when they are transmitted as food-borne or water-borne contaminants. Antimicrobial-resistant infections are associated with a greater risk of death, more complex illnesses, longer hospital stays and higher treatment costs. Based on available information, close to 80% of the total volume of antimicrobials sold in Canada are sold for use in animals. The Food and Drug Regulations (FDR) currently do not provide the necessary regulatory oversight of antimicrobials for veterinary use to mitigate the risk of AMR.

Description: Amendments to the FDR will improve the regulatory oversight of antimicrobials for veterinary use. The new regulations will require veterinary active pharmaceutical ingredients (APIs) imported or sold in Canada to be manufactured in accordance with good manufacturing practices (GMPs); require persons who import, fabricate, package, label or test veterinary APIs to do so in accordance with an establishment licence (EL); restrict the own use importation of unauthorized veterinary drugs; require manufacturers, importers and compounders of veterinary antimicrobials to provide sales volume information by species; and introduce an alternative, less burdensome pathway for manufacturers to legally import and sell certain low-risk veterinary drugs, known as veterinary health products (VHPs), that could reduce the need for antimicrobials.

Cost-benefit statement: The regulations are anticipated to cost industry and government $41.9 million net present value over 10 years. The quantified costs relate to new GMP and EL requirements that would be levied against persons who import, fabricate, package, label or test veterinary APIs; a requirement to submit sales volume and species data of antimicrobials sold in Canada; and costs to Health Canada relating to new compliance and enforcement activities. The non-quantifiable benefits of the proposed regulations include domestic and international consumer confidence in the livestock and poultry sectors; a reduction of the incidence of antimicrobial-resistant bacteria; a reduction in environmental residues of antimicrobials; and the introduction of alternative products through the new pathway for VHPs.

“One-for-One” Rule and small business lens: Both the “One-for-One” Rule and the small business lens apply to the proposed amendments. The anticipated administrative burden on businesses required to report on sales volume and species sales data is estimated to be $253,011 (constant 2012 dollars) per year, or $633 per company. The small business lens would apply and was considered for the following stakeholder groups: food animal producers, veterinarians, compounding pharmacists, and entities manufacturing or importing VHPs. Veterinarians and pharmacists were identified as saving a significant amount in administrative costs. However, those who wish to compound and manufacture antimicrobials will be required to comply with new associated GMP and EL costs.

Domestic and international coordination and cooperation: The proposed amendments to the FDR are designed to enhance the regulatory alignment of the Department of Health (the Department) with the United States and the European Union.

Background

Antimicrobials

An antimicrobial is a drug that can destroy micro-organisms, including those that can cause disease, or inhibit their growth. In Canada, more than three quarters of antimicrobials are sold for use in animals. (see footnote 2) Of those, approximately 90% are used to promote growth or to guard against disease and infection. Globally, the use of antimicrobials in food-producing animals continues to rise, from just over 63 000 tons in 2010 and to well over 100 000 tons (projected) by 2030. (see footnote 3) In Canada alone, it is estimated that 1.6 million kilograms of antimicrobials were distributed for animal use in 2013. (see footnote 4)

Antimicrobial resistance

Antimicrobial resistance (AMR) is a serious and growing public health threat in Canada and around the world. (see footnote 5) Antimicrobials, such as antivirals, antibiotics, antifungals and antiparasitics, kill most micro-organisms (i.e. viruses, bacteria, fungi and parasites, respectively) or slow their growth. However, those micro-organisms with greater resistance survive and continue to infect their host. AMR is the ability of micro-organisms to resist the effects of antimicrobials. The micro-organisms change in a way that reduces or eliminates the effectiveness of drugs designed to cure or prevent infections and/or disease caused by these micro-organisms. Micro-organisms may be naturally resistant or insensitive to antimicrobials, or may become resistant after being exposed to these drugs. Overuse and misuse of antimicrobials, as well as the use of sub-potent antimicrobials resulting from inadequate quality controls, are the main contributors to the development of AMR. (see footnote 6)

Antimicrobial-resistant infections are associated with a greater risk of death, more complex illnesses, longer hospital stays and higher treatment costs. Recent reports (see footnote 7) (see footnote 8) have shown that infections caused by antimicrobial-resistant bacteria cause at least 2 million illnesses and at least 23 000 deaths annually in the United States. In Europe, about 25 000 patients die each year from drug-resistant bacterial infections. At a global level, deaths attributable to AMR are currently estimated to be 700 000 annually, and could reach up to 10 million by 2050, potentially costing world economies up to US$100 trillion.

Furthermore, the development of AMR has consequences not only for human health, but also for animal health. A reduction in the number of effective antimicrobials available to treat animal diseases can lead to increased animal suffering, higher death rates and, subsequently, economic losses to food animal producers and higher consumer food prices.

Antimicrobial use in animals and antimicrobial resistance

The development of antimicrobial-resistant pathogens in animals can pose serious risks to human health when they are transmitted as food-borne or water-borne contaminants. Furthermore, the overuse and misuse of antimicrobials in animals has helped to accelerate the resistance of micro-organisms to these drugs.

For example, between 2003 and 2011, the Canadian Integrated Program for Antimicrobial Resistance Surveillance (CIPARS) tested 26 428 Salmonella samples from humans exposed to contaminated food products. (see footnote 9) Of these, 28% of the Salmonella strains were resistant to one or more antimicrobials. In 2011, CIPARS observed consistently high levels of resistance to a specific antimicrobial, ceftiofur, in Salmonella isolates found in retail chicken products, as well as in Salmonella causing human infections. (see footnote 10) This antimicrobial resistance was attributed to the use of antimicrobials in chicken hatcheries. Once the use of that particular antimicrobial ceased, a significant decrease in antibiotic-resistant Salmonella was seen in both retail chicken and humans. (see footnote 11)

Domestic and international context

The World Health Organization (WHO) has long recognized the risks to human health resulting from the extensive use of antimicrobials in food-producing animals. The WHO considers that two of the key essentials in combating the development of AMR are assurance of the quality of the drug (i.e. good manufacturing practices [GMPs]) and measures to control the misuse of these drugs. (see footnote 12)

Internationally, regulatory agencies around the world have recognized the dangers of AMR and are taking steps to reduce its occurrence. For example, the United States announced in 2014 a National Strategy for Combatting Anti-Microbial Resistant Bacteria. The U.S. Food and Drug Administration (U.S. FDA) has followed up on this by introducing measures to encourage a more prudent use of antimicrobials in food-producing animals, including the removal of growth promotion claims, requiring greater veterinary oversight and compelling manufacturers to provide data respecting the volume of sales and an estimate of how the products are used. Unlike Canada, the United States and other jurisdictions, including those of the European Union, do not allow the importation of unapproved veterinary drugs for a person’s own use (such as the direct administration to food-producing animals) and require that active pharmaceutical ingredients (APIs) used in the manufacture of veterinary drugs be compliant with GMPs.

In Canada, veterinary drugs in dosage form that are authorized for sale have to meet strict standards, including the requirement to be manufactured according to GMPs. Manufacturing in accordance with GMPs lowers the risk that a drug may be contaminated or adulterated with substances that may cause harm to human or animal health. GMPs also ensure that a drug contains the medicinal ingredient in the quantities necessary to achieve the desired clinical effect. For example, GMPs can reduce the risk of sub-potent antimicrobials entering the market, and thus decrease the possibility of AMR developing from exposure to these drugs. Veterinary drugs in the form of APIs are currently not required to meet GMPs.

However, in the spring of 2015, the Auditor General of Canada released a report on AMR. The Auditor General found that “Health Canada has not taken some important steps needed to promote prudent antimicrobial use in food animals. For example, the Department has not strengthened existing regulations to prohibit farmers from importing unlicensed non-prescription antimicrobials that are important to human medicine for use in their own animals.” (see footnote 13)

In response, on April 18, 2015, Health Canada issued a notice of intent in the Canada Gazette, Part I, informing stakeholders and the public of the Department’s intent to propose amendments to the FDR that will begin to address AMR, including increasing controls at the border.

In October 2015, the president of the Public Health Agency of Canada joined the other G7 health ministers in signing the Berlin Declaration on Antimicrobial Resistance, thereby acknowledging that the emergence of AMR is an increasing global health threat, and committed to pooling national efforts to promote the prudent use of antimicrobials and combat AMR.

Issues

In Canada and around the world, fewer antimicrobials remain effective in preventing and controlling infection as more microbes become resistant in both human and animal settings. The current regulatory oversight of antimicrobials for veterinary use under the FDR does not adequately address the risks to human health. The following are some key areas of concern.

Lack of quality standards for veterinary APIs

Manufacturing in accordance with GMPs can reduce the risk that a drug may be contaminated or adulterated. APIs used in the manufacture of veterinary drugs are currently not required to be compliant with GMPs, as is the case for APIs used in the manufacture of human drugs. This means that the quality of veterinary APIs is less certain and cannot be easily verified. This increases the likelihood that sub-potent APIs or those contaminated with harmful impurities may be introduced into veterinary drugs. If either of these things occurs, it may pose a risk to both animal and human health, both from direct exposure to harmful substances, including as residues in human food, or through the development of antimicrobial-resistant strains of disease causing pathogens introduced into the food supply.

In Canada, establishments that fabricate, package, label, distribute, import, wholesale, or test a drug (with some exceptions, including APIs for veterinary use) must do so in accordance with an EL issued under Part C, Division 1A, of the FDR. The licence application, approval and renewal process allows for the inspection by Health Canada of establishments and processes as a means of confirming compliance with GMP requirements.

Ability for persons to import unauthorized veterinary drugs for own use in food-producing animals

Many antimicrobials that are important to treat humans are freely available for use in animals without veterinary oversight. They may be imported to Canada as APIs or in dosage form without any regulatory oversight, if the importation is not made for the purposes of sale; this is also known as “own use importation” (OUI). This lack of regulatory oversight allows food animal producers to import large quantities of unapproved drugs, and enables these producers to administer such drugs to entire herds.

These drugs have not been authorized for sale in Canada, and consequently, they have not been subject to scientific scrutiny by Health Canada. Although many of these drugs may have been authorized for sale in other jurisdictions, their unregulated use in Canadian food-producing animals can pose a risk to human and animal health. For example, inadequate direction respecting the withdrawal period of a drug could result in higher and potentially unsafe levels of drug residues in the human food supply, and antimicrobials that are not supported by adequate instructions for use or are sub-potent could lead to the development and spread of AMR.

Furthermore, as a substantial number of veterinary APIs can be directly administered to animals without the need to be formulated into a dosage form, some food animal producers may directly import these drugs for use in their business. This activity is driven by economic factors. APIs are less expensive than an authorized drug in dosage form (i.e. a drug that has been issued a drug identification number [DIN] by Health Canada) and are typically available from foreign manufacturers at prices lower than those in Canada. This practice can pose a risk to human and animal health for a number of reasons. APIs imported in this manner are not subject to regulatory oversight; therefore, there are no requirements for labelling the API with instructions for use, reporting adverse drug reactions or recalling an unsafe API — requirements that promote the safe and effective use of a drug.

Lack of information regarding the volume of veterinary antimicrobials sold to facilitate surveillance, prevention and control of AMR

In order to combat the development and spread of AMR, it is important to know at an early stage where resistance is developing and in what species. This type of surveillance is expensive and time-consuming as it involves laboratory analysis of samples, and limited resources may be better focused if geographical areas or species at higher risk were identified and targeted for enhanced surveillance. Sales volume data would be an important tool in maximizing the efficiency of current surveillance programs, as efforts could be focused on more heavily used drugs. Having improved data could also support Health Canada’s ongoing efforts to encourage the prudent use of antimicrobials in food-producing animals. For example, if sales volume data indicates a heavy use of an antimicrobial in a particular species, this could be correlated with resistance information in bacteria of human health importance to determine the need for measures to mitigate risk. Currently, the FDR do not require the reporting of sales volume data.

Restrictive regulatory pathways creating barriers for the availability of approved low-risk health management tools to reduce the need for veterinary antimicrobials

Many low-risk veterinary drugs (also referred to as veterinary health products [VHPs]), which could be used as additional tools for managing the health of animals and could potentially reduce the need to use antimicrobials, have not been authorized for sale in Canada. This is mainly because of the difficulty manufacturers have in generating sufficient scientific data respecting the safety and efficacy of the drug to meet the existing regulatory requirements for a “new drug” (which would require the filing of a new drug submission as per Division 8 of the FDR). Other than the “in human” aspect, many of these drugs meet the definition of a natural health product under the Natural Health Products Regulations (NHPR) and have been approved for sale for use in humans under those regulations. (see footnote 14) However, natural health products for veterinary use continue to be regulated under the more restrictive and burdensome requirements of the FDR.

To provide oversight and facilitate the sale of these types of drugs, the Department has, since 2012, put in place a voluntary non-regulatory pilot program known as the Interim Notification Pilot Program (INPP). The INPP provides Health Canada with a mechanism for determining whether products are likely to pose a risk to health. (see footnote 15) However, the Program is only applicable to low-risk products used in non-food-producing animals, and has the added limitation of being unsupported in regulation. The INPP currently benefits from the use of a list of substances that have been evaluated by Health Canada as safe for use in these types of products. (see footnote 16)

The only other means available for these drugs to be approved for sale is through the Veterinary Drugs Directorate Emergency Drug Release (EDR) program. (see footnote 17) Regulatory authority for EDR is provided by sections C.08.010 and C.08.011 of the FDR, which state that the sale of a drug made under these sections is exempt from all other provisions of the Food and Drugs Act and the FDR. This means that unlike other authorizations, Health Canada has no ability to gather information about the drug or to take actions that could mitigate risks associated with its use. Veterinarians must make an application through the EDR program on an individual basis and the authorization only allows for a small quantity of drugs (in effect, a veterinarian would have to file an EDR application each time he or she wanted to prescribe the drug). This results in a time-consuming and inefficient process both for veterinarians and Health Canada. An example of drugs that continue to be requested through the EDR program are certain calcium supplements that are used in lactating dairy cattle to help maintain calcium levels, so as to reduce the incidence of disease and, subsequently, the need for antimicrobial therapy. These drugs have been the subject of hundreds of individual requests by veterinarians through this program.

Objectives

The overall objective of this proposal is to limit risks to human health by reducing the likelihood of resistance to antimicrobials in humans as a result of the improved regulatory oversight of antimicrobials sold for veterinary purposes.

More specifically, the proposed regulatory amendments are intended to

  • require veterinary APIs imported or sold in Canada to be manufactured in accordance with GMPs;
  • require persons who fabricate, package and label, import or test an API for veterinary use to do so in accordance with an EL;
  • restrict the own use importation of certain unauthorized drugs (including APIs);
  • require manufacturers and importers to provide sales volume information by species for veterinary antimicrobials; and
  • introduce an alternative, more appropriate pathway for manufacturers to legally import and sell low-risk VHPs.

Description

Ensuring the quality of APIs for veterinary use

Similar to the existing provisions for human use APIs, the new regulations would require persons who fabricate, package, label, import or test an API for veterinary use to do so in accordance with an EL. These requirements will also be applied to any person (including veterinarians and pharmacists) who import for the purpose of compounding an antimicrobial for veterinary use that is set out on List A (to be incorporated by reference into the FDR). (see footnote 18)Antimicrobials set out on List A are those that Health Canada has deemed to be important in human medicine, and for which the development of AMR could have an impact on human health. In addition, the regulations will prohibit the import or sale of veterinary APIs that are not manufactured according to GMPs as currently set out in Part C, Division 2, of the FDR. APIs for veterinary use that meet the definition of natural health product in subsection 1(1) of the NHPR would be exempted from these requirements. This will align regulatory oversight for natural health products for veterinary use with that for human use.

Controlling the own use importation of veterinary drugs

Regulatory amendments are needed to eliminate the use of antimicrobials in the form of APIs in food animals and to restrict the use of unauthorized drugs in food animals. Amendments will incorporate by reference into Division 1 of the FDR a list of veterinary drugs (List B (see footnote 19)) that may be imported (but not sold) in Canada despite not being authorized for sale by Health Canada.

The regulations will also prohibit the importation of a drug for the purpose of administering it to an animal that produces food or an animal that is intended for consumption, if its sale would contravene the Food and Drugs Act or regulations, unless the drug is set out in List B. In effect, this would mean that food animal producers will no longer be able to import unauthorized drugs for their own use, other than those drugs that appear on List B. Drugs on List B will be identified by manufacturer, brand name, dosage form, strength and country in which the product has been authorized for sale.

Health Canada is making publicly available helpful and user-friendly support materials that elaborate on the processes for List B and what information the Minister will consider before adding a drug to List B. This information includes the following: evidence that demonstrates the comparability with a drug that has been authorized for sale in Canada, including the dosage form and strength, the route of administration, the existence of a maximum residue limit in the specified species and food commodity; whether the labelled conditions of use fall within the directions for use of the comparable Canadian approved drug; whether the drug is in final dosage form; whether the drug has been approved for sale in a recognized foreign jurisdiction that has a drug approval system comparable to that of Canada; and whether the drug is a medicated premix.

Drugs that contain medically important antimicrobial APIs on List A and prescription drugs will not be considered for inclusion on List B.

Gathering information that supports AMR surveillance

The new regulations will require manufacturers and importers who sell a veterinary drug in dosage form that contains an ingredient on List A and every person who compounds such a drug to provide an annual report to the Minister of Health. The report will identify for each API on List A the total quantity sold or compounded and an estimate of the quantity sold or compounded for each intended animal species.

The information is intended to be correlated against resistance patterns in conducting evidence-based AMR risk analysis. This new provision aims to address the lack of information on the type and volume of veterinary APIs that are being imported or used in Canada. Surveillance would fill existing gaps on antimicrobial sales volume information related not only to antimicrobials being sold and distributed via existing regulated routes but also imported veterinary drugs and APIs.

Facilitating access to VHPs

The new amendments create a pathway to allow for the importation and sale of VHPs (for use in both food-producing animals and companion animals) distinct from the existing drug approval pathways in Part C, Divisions 1 and 8, of the FDR.

Amendments will incorporate by reference into Division 1 a list of VHPs (List C (see footnote 20)). A veterinary health product will be defined in regulation as a drug in dosage form described on List C that is not manufactured, sold or represented for use in the diagnosis, treatment, mitigation or prevention of the disease, disorder or abnormal physical state, or its symptoms. In other words, products making general health claims, such as promoting or maintaining organic functions or the health of an animal, will be considered to be VHPs. Prescription drugs and drugs containing ingredients on List A will not be considered for inclusion on List C. A guidance document indicating the criteria the Minister will consider when amending List C will be made publicly available.

Manufacturers or importers of a VHP will be exempted from Part C, Division 1, related to Assignment and Cancellation of Drug Identification Numbers (C.01.014 to C.01.014.7), Part C, Division 1A (Establishment Licences), and Part C, Division 2 (Good Manufacturing Practices). In addition, the definition of new drug in Part C, Division 8, of the FDR has been amended to exclude VHPs, thereby exempting them from all provisions in Division 8. Manufacturers and importers of VHPs will not be required to obtain DINs or be required to hold an EL. However, GMP requirements of the NHPR apply to these products, and manufacturers and importers will be required to notify the Department at least 30 days before commencing the sale of a VHP. Although not required by regulation, it is Health Canada’s intent to verify that each VHP has been correctly notified.

The new regulations allow the Minister to require the manufacturer or importer of a VHP to provide information if there are reasonable grounds to believe the VHP is no longer safe. The Minister will be able to stop the sale of a VHP if no information is provided, the information provided is insufficient, or the sale of the VHP represents a contravention of the Food and Drugs Act or the FDR. The Minister will be able lift a direction to stop sale if the information provided in response to the request is sufficient, the situation giving rise to the stop sale did not exist, or the situation giving rise to the stop sale has been corrected.

Additionally, the statement “Veterinary Health Product / Produit de santé animale” will be required on the label.

Consequential amendments and changes requested by the Standing Joint Committee for the Scrutiny of Regulations

Amendments to the Establishment Licensing Fees (Veterinary Drugs) Regulations will exempt veterinary APIs from fees associated with the examination of an application for an EL or the amendment of an EL — or the annual review of an EL — that deal exclusively with veterinary APIs. The Department intends to introduce a fee for the examination of an EL application in respect of veterinary APIs under a subsequent proposal and, in doing so, will comply with the requirements set out in the User Fees Act. Pursuing a fee structure for EL examination at a future date allows the Department time to gather a more accurate estimate of the costs associated with this activity and to better align with a future fees structure for the examination of an EL for human APIs (also currently exempted from fees).

The Department will also be taking this opportunity to address a recommendation made by the Standing Joint Committee for the Scrutiny of Regulations (SJCSR) by correcting the French text of the remission provision in the Establishment Licensing Fees (Veterinary Drugs) Regulations. This amendment will better align the text with the English version by removing an inconsistency in terminology. Specifically, the French text in subsection 11(1) is revised to replace the existing reference to “cette somme” with the more appropriate term “ce montant.” The words “une somme” are already used in subsection 11(1) to refer to a different amount, which leads to confusion as to which amount is being referred to.

Regulatory and non-regulatory options considered

The Department has assessed regulatory and non-regulatory options (detailed below), taking into consideration regulatory divergence across provinces and territories, alignment with international regulatory partners, consistency with international standards, level of impact on innovation and competitiveness, as well as appropriate level of oversight.

Option 1: Status quo

For the reasons previously discussed, the status quo does not represent a viable means of achieving the Department’s public health mission and objectives regarding AMR. It would not restrict the uncontrolled importation of unauthorized veterinary drugs for a person’s own use, provide a means of gathering data to support AMR surveillance activities, ensure the quality of veterinary APIs or allow for the legal sale of VHPs and the expansion of their use to food-producing animals.

In addition, the Canadian regulatory framework for veterinary drugs would continue to be inconsistent with the international standards and practices of its trading partners.

Option 2: Non-regulatory initiatives

Under this option, the existing regulatory framework for veterinary drugs would have continued as is under the previous regulations (status quo) with a view to implementing the policy objectives of the regulatory proposal through voluntary means. This option was rejected for several reasons.

Ensuring the quality of APIs for veterinary use

Manufacturing drugs in accordance with GMPs represents a substantive ongoing investment on the part of an API manufacturer. Although many globally based veterinary API manufacturers may already be compliant with GMPs, this is presumed mainly to be a result of more stringent laws already in place in many foreign jurisdictions, including the United States and the European Union. Due to financial considerations, it is unlikely that all manufacturers would voluntarily agree to meeting GMPs. In addition, under a voluntary scenario, Health Canada would be unable to monitor manufacturers to ensure they are compliant with GMPs and take effective action if they are found to be out of compliance.

Controlling the own use importation of veterinary drugs

Consideration was given to establishing a non-regulatory list of unauthorized veterinary drugs (similar to the proposed List B) that Health Canada considered as safe for use in food-producing animals. Health Canada could also be more proactive in educating food animal producers about the risks associated with the use of unauthorized drugs. Although some producers may have chosen to follow Health Canada recommendations, it would be difficult to convince all producers of the risks associated with using products not authorized for sale in Canada when these same products are available on the market in other jurisdictions. Producers that may have been using unauthorized products with good effect may not see the harm in continuing their use. In addition, as the main driver for own use importation is economic, it was presumed that many producers would continue to accept the risks associated with using an unauthorized drug.

Gathering information that supports AMR surveillance

Although gross sales volume data is available through public sources, the level of detail available from this information means that it is of limited use to support AMR surveillance activities. Although consideration was given to requesting more detailed information such as estimates of sales volume by species from manufacturers, importers and compounders of veterinary antimicrobials, the response was not anticipated to be high for a number of reasons, including the administrative burden (although small) that it would place on persons to gather the information and the assumption that many manufacturers may consider this type of information to be confidential and may therefore be reluctant to disclose it voluntarily.

Facilitating access to VHPs

The INPP was intended as a short-term pilot to test the feasibility of an alternate means of providing access to veterinary health products. The program has proven to be successful in that over 600 VHPs have been brought to market under it. This has allowed Health Canada to provide a level of safety oversight to these products as well as gather information about the type of drugs that are being sold and the manufacturers that are active in this field. It has also allowed Health Canada to monitor somewhat the safety of these products through adverse drug reaction reporting, the results of which indicate, as expected, that these products do indeed represent a low level of risk when used appropriately. However, as the sale of the drugs under this program continues to contravene the FDR (specifically subsection C.01.014(1), which prohibits the sale of a drug unless a DIN has been assigned) and as manufacturers have been advocating for the expansion of the program to include food-producing animals, the continuation of the program was considered untenable without a basis in law.

Option 3: Amending the FDR — Selected option

This option will amend the FDR to ensure veterinary APIs imported or sold in Canada are manufactured in accordance with GMPs, restrict the own use importation of certain unauthorized drugs, require manufacturers to provide sales volume information by species for veterinary antimicrobials and facilitate access to VHPs.

This option was chosen because it represents the most efficient and effective approach for improving the oversight of antimicrobials for veterinary use. The regulations will be supported by non-regulatory mechanisms, such as guidance, and collaborative approaches with federal, provincial and territorial partners, industry and other stakeholders that have a role to play in mitigating the risk of AMR associated with antimicrobial use in food-producing animals. This option is preferable because it will result in a more coherent and balanced approach to risk management without imposing an undue burden on stakeholders.

In selecting this option, the Department will achieve the stated objective, within its mandate, of reducing the risks to human health associated with the use of antimicrobials in animals. This option was developed in consultation with stakeholders and takes into account international standards.

A number of variations on the proposed regulatory option were considered. With respect to APIs, consideration was given to applying only the GMP component without the requirement for ELs. It was felt that this would not provide the desired level of oversight and assurance of the quality of APIs and could negatively impact the ability of Canadian manufacturers to export APIs to other jurisdictions where a licensing scheme and inspection component are part of their drug laws.

An import permit system requiring farmers to apply for a permit to import drugs for their own use was considered. However, it was felt that in comparison to the proposal supported by List B, a permit system would impose an unnecessary administrative burden on farmers wishing to import drugs for their own use and would require additional government resources for its administration without providing any additional safety benefit.

For VHPs, consideration was given to having a pre-market application and DIN assignment process similar to what already exists for veterinary drugs in Divisions 1 and 8 of the FDR, which would also allow for the provision of information to support efficacy claims but not to the standard required for a new drug submission under Division 8. It was felt that defining a VHP so as to limit the claims that a manufacturer could make would alleviate the need to conduct a pre-market review of supporting data. Not requiring manufacturers and importers of VHPs to file a pre-market application and wait for a decision from Health Canada allows them to come on market quicker and reduces their administrative burden.

Source : Canada Gazette, Government of Canada

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