Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Sale of a New Drug for Emergency Treatment): SOR/2020-212
Canada Gazette, Part II, Volume 154, Number 21
SOR/2020-212 September 28, 2020
FOOD AND DRUGS ACT
P.C. 2020-681 September 25, 2020
Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to section 30 footnote a of the Food and Drugs Act footnote b, makes the annexed Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Sale of a New Drug for Emergency Treatment).
Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Sale of a New Drug for Emergency Treatment)
Food and Drug Regulations
1 The heading before section C.08.010 of the French version of the Food and Drug Regulations footnote 1 is replaced by the following:
Vente d’une drogue nouvelle pour soins d’urgence
2 Sections C.08.010 and C.08.011 of the Regulations are replaced by the following:
C.08.010 (1) The Minister may issue a letter of authorization to a manufacturer of a new drug authorizing the sale of a specified quantity of the new drug for human or veterinary use to a practitioner, for use in the emergency treatment of an animal or a person under the care of that practitioner, if
- (a) the practitioner provides the following information to the Minister:
- (i) the name of the new drug and details concerning the medical emergency for which the new drug is required,
- (ii) the quantity of the new drug that is required,
- (iii) subject to subsection (2), the information in the possession of the practitioner in respect of the use, safety and efficacy of the new drug,
- (iv) the name and the civic address of the person to whom the new drug is to be shipped, and
- (v) any other information the Minister may request to enable the Minister to determine whether to issue the letter of authorization;
- (b) the practitioner agrees to
- (i) provide a report to the manufacturer of the new drug and to the Minister describing the results obtained following the use of the new drug to address the medical emergency, including information respecting any adverse drug reactions observed by the practitioner, and
- (ii) account to the Minister, on request, for all quantities of the new drug received;
- (c) in the case of a new drug for human use, the person referred to in subparagraph (a)(iv) is a practitioner or a pharmacist; and
- (d) in the case of a new drug for veterinary use, the person referred to in subparagraph (a)(iv) is a practioner, a pharmacist or a person who may sell a medicated feed pursuant to section C.08.012.
(2) Subparagraph (1)(a)(iii) does not apply if the following conditions are met:
- (a) the sale of the new drug has been authorized under subsection (1) to address the same medical emergency on at least one previous occasion;
- (b) the European Medicines Agency or the United States Food and Drug Administration has authorized the sale of the new drug without terms or conditions, for the same use in its jurisdiction; and
- (c) the Minister has not cancelled the assignment of a drug identification number for the new drug under paragraph C.01.014.6(2)(b) or (c) or subsection C.01.014.6(3).
(3) The Minister must not issue a letter of authorization for a new drug that is or that contains a restricted drug as defined in section J.01.001.
(4) The letter of authorization must contain the following information:
- (a) the name of the practitioner to whom the new drug may be sold;
- (b) the name and the civic address of the person to whom the new drug may be shipped;
- (c) the name of the new drug and the medical emergency in respect of which it may be sold; and
- (d) the quantity of the new drug that may be sold to the practitioner to address the medical emergency.
(5) For the purposes of this section, the practitioner is not required to know the identity of the animal or the person under the care of that practitioner at the time the letter of authorization is issued.
C.08.011 (1) Despite section C.08.002, the manufacturer may sell a new drug in accordance with a letter of authorization issued under subsection C.08.010(1).
(2) In the case of the sale under subsection (1) of a new drug for veterinary use that contains an active pharmaceutical ingredient set out in List A and that was not imported under section C.08.011.2, an annual report identifying the total quantity of the new drug that was sold, including an estimate of the quantity sold in respect of each animal species for which the drug is intended, must be submitted to the Minister, in the form established by the Minister, by the manufacturer, if the new drug was present in Canada at the time of sale, otherwise by the practitioner.
(3) The sale of a new drug made in accordance with subsection (1) is exempt from the provisions of the Act and these Regulations other than this section.
C.08.011.1 (1) The Minister may issue a letter of authorization to the manufacturer of a new drug authorizing the holder of an establishment licence to import a specified quantity of the new drug for human or veterinary use, if the following conditions are met:
- (a) the manufacturer provides the following information to the Minister concerning
- (i) the name of the new drug and details concerning the medical emergency for which the new drug will be imported,
- (ii) the quantity of the new drug to be imported,
- (iii) the name of the holder of an establishment licence who will import the new drug,
- (iv) the civic address of the facility where the new drug is to be stored in Canada, and
- (v) any other information the Minister may request to enable the Minister to determine whether to issue the letter of authorization;
- (b) the establishment licence authorizes the importation of a new drug in the same category as the one to be imported; and
- (c) the quantity that is to be imported does not exceed the amount that the Minister determines is likely to be required to address the medical emergency.
(2) The Minister must not issue a letter of authorization for a new drug that is or that contains a restricted drug as defined in section J.01.001.
(3) The letter of authorization must contain the following information:
- (a) the name of the new drug and the medical emergency in respect of which the letter is issued;
- (b) the quantity of the new drug that may be imported to address the medical emergency;
- (c) the name of the holder of an establishment licence who is authorized to import the new drug; and
- (d) the civic address of the facility where the new drug is to be stored in Canada.
C.08.011.2 (1) Despite subsection C.01A.004(1), the holder of an establishment licence may import a new drug in accordance with a letter issued under subsection C.08.011.1(1).
(2) Section C.01A.006 and Divisions 2 to 4, except for the following provisions, do not apply to the importation of a new drug referred to in the letter of authorization:
- (a) sections C.02.003.1 and C.02.004, as they apply to the storage of the new drug by the holder of an establishment licence;
- (b) section C.02.006, as it applies to the storage of the new drug by the holder of an establishment licence;
- (c) subsection C.02.012(1);
- (d) sections C.02.013 and C.02.014;
- (e) section C.02.015, as it applies to the storage and transportation of the new drug by the holder of an establishment licence;
- (f) subsection C.02.021(1), as it applies to the storage of the new drug by the holder of an establishment licence;
- (g) subsection C.02.022(1);
- (h) section C.02.023;
- (i) subsection C.02.024(1);
- (j) section C.03.013; and
- (k) section C.04.001.1, as it applies to the storage of the new drug by the holder of an establishment licence.
C.08.011.3 (1) Despite section C.08.002, the holder of an establishment licence who imports a new drug under section C.08.011.2 may distribute a new drug in accordance with a letter of authorization issued under subsection C.08.010(1).
(2) The holder of an establishment licence who distributes to a practitioner, in accordance with subsection (1), a new drug for veterinary use that contains an active pharmaceutical ingredient set out in List A must submit to the Minister, in the form established by the Minister, an annual report identifying the total quantity of the new drug that was distributed, including an estimate of the quantity distributed in respect of each animal species for which the drug is intended.
(3) The distribution of a new drug made in accordance with subsection (1) is exempt from the provisions of the Act and these Regulations other than this section.
Natural Health Products Regulations
3 (1) The heading before section 103.1 of the French version of the Natural Health Products Regulations footnote 2 is replaced by the following:
Vente d’un produit de santé naturel pour soins d’urgence
(2) The portion of section 103.1 of the the Regulations before paragraph (a) is replaced by the following:
103.1 Section C.08.010 and subsections C.08.011(1) and (3) of the Food and Drug Regulations apply in respect of natural health products except that
(3) Section 103.1 of the Regulations is amended by striking out “and” at the end of paragraph (a) and by adding the following after paragraph (b):
- (c) subsection C.08.010(1) of the Food and Drug Regulations is to be read without reference to the words “or veterinary”; and
- (d) the expression “the Minister has not cancelled the assignment of a drug identification number for the new drug under paragraph C.01.014.6(2)(b) or (c) or subsection C.01.014.6(3)” in paragraph C.08.010(2)(c) of the Food and Drug Regulations is to be read as “the Minister has not, in respect of a natural health product, suspended the product licence under subsection 18(1) or section 19 of the Natural Health Products Regulations or cancelled the product licence under paragraph 20(b) of those Regulations”.
Coming into Force
4 These Regulations come into force on the day on which they are registered.
REGULATORY IMPACT ANALYSIS STATEMENT
(This statement is not part of the Regulations.)
The Food and Drug Regulations (FDR) contain emergency provisions, which can be used in certain circumstances to authorize access to human and veterinary drugs for Canadians in medical emergencies when a drug is not authorized for sale in Canada. These provisions are administered through the Special Access Program (SAP) for human drugs, and through the Emergency Drug Release (EDR) Program for veterinary drugs. In a medical emergency, individual health care providers treating a patient (human or animal) with a serious or life-threatening condition may require new drugs when conventional therapies have failed, are unsuitable or unavailable. These new drugs may not be available in Canada, as manufacturers may not have submitted these drugs to the Canadian market due to its small size. Health Canada is committed to ensuring Canadians have the timeliest access possible to drugs that may be needed in a medical emergency. To continue to meet the needs of Canadian patients and the health care system, changes are being made to the FDR to facilitate access to drugs when a drug is required to treat a patient in a medical emergency where a given drug is unavailable for sale in Canada.
The proposed Regulations that were prepublished in the Canada Gazette, Part I, on May 11, 2019, also contained a proposal for changes to the FDR to facilitate access to drugs to be used by a public health official to address a public or military health emergency, event or incident. Revisions to this element of the proposal are ongoing. Therefore, the project related to the proposed Regulations Amending Certain Regulations Concerning the Sale of Drugs (Public or Canadian Armed Forces Health Emergencies) will proceed separately.
In 2016, Health Canada launched a series of regulatory and policy initiatives to improve the regulatory review of drugs and devices. footnote 3 The intent of the initiative was to adapt to a changing and rapidly evolving health care system and build regulations that adapt to changes in health care delivery, while providing Canadians with faster access to the drugs and medical devices that they need. The plan included renewing the Special Access Program to improve access to products that are not currently authorized for sale in Canada.
The FDR aims to support access to drugs for Canadians, while helping to ensure that all drugs for human and veterinary use are safe, effective and of good quality. The FDR includes detailed provisions requiring drug manufacturers to submit robust safety and effectiveness data to support their drug submissions, should they wish to pursue market authorization in Canada. For manufacturers to obtain this data, most often clinical trials are required, which take years to complete. Market authorization is granted once Health Canada conducts a thorough review and determines that the drug’s benefits outweigh its risks. Recognizing the length of time to bring a drug to market, set against the need to provide access to life-saving medication, the FDR was amended in 1966 to create emergency provisions that permit the sale of unauthorized drugs (drugs not approved in Canada) to provide Canadians with access to human and veterinary drugs in medical emergencies.
These regulatory provisions allow a manufacturer to sell an unauthorized drug to practitioners, footnote 4 including veterinarians, to treat human or animal patients in a medical emergency. The programs that administer these provisions are called the Special Access Program (SAP) [for human drugs] and the Emergency Drug Release (EDR) Program (for drugs for veterinary use). These programs are used by practitioners to request access to unapproved drugs in situations where there is a drug for treating patients with serious or life-threatening conditions when conventional treatments have failed, are unsuitable, or are unavailable. The decision to authorize or deny a request for use of an unapproved drug is made on a case-by-case basis.
How it currently works
The SAP is a widely used 24/7 service, with access provided to 75 000 patients through 5 000 physicians, and with over 16 000 requests per year. footnote 5 One third of all drugs accessed through the SAP are used to treat rare diseases, while many others are used to treat diseases that have a high prevalence in the Canadian population such as cardiovascular diseases (e.g. heart failure, hypertension), neurological disorders (e.g. epilepsy, multiple sclerosis), cancers and microbial infections. On average, there are approximately 500 drugs with active status on the SAP (i.e. drugs that have been authorized in the past year). Drugs considered for authorization by the SAP in accordance with the FDR include pharmaceutical, biological, and radiopharmaceutical drugs as well as natural health products.
The EDR program for veterinary drugs receives between 600 and 1 000 requests per year. Drugs are accessed by veterinarians through the EDR program to treat diseases in a large number of species, including companion animals, food-producing animals, wildlife species and fish. An average of 45 drugs have an active status in the program. To request access to drugs through either the SAP or the EDR program, practitioners submit a request to Health Canada for a drug that is otherwise unauthorized for sale in Canada to treat a patient.
For human and veterinary drugs, the practitioner is required to submit information about the medical emergency, the patient’s medical condition, and information about the use, safety and efficacy of the drug for the medical emergency. Furthermore, after using the drug, practitioners are required to submit a follow-up report to Health Canada on the outcome of the use of the drug.
Practitioners are responsible for ensuring the decision to prescribe the drug is supported by credible evidence. They are also responsible for monitoring and reporting the results of the use of the drug, including any adverse drug reactions. Once the use of the drug is approved by Health Canada, a letter of authorization is sent from the SAP or the EDR program to the manufacturer of the drug, authorizing the sale of a quantity of the drug to a named practitioner. The amount of time that it can take for the drug to reach the practitioner can vary from a couple of days to several months, depending on where the drug is coming from and the type of drug requested. For example, controlled substances take a longer time to arrive in Canada since foreign manufacturers are responsible for ensuring that they meet the regulatory requirements of their own country with respect to the export of drugs to Canada, and they must also obtain an import permit as required under the Controlled Drugs and Substances Act. A manufacturer is under no obligation to sell the requested drug and Health Canada cannot compel a manufacturer to do so.
Drugs authorized through the SAP or the EDR program are meant to be for a limited time to meet specific emergency needs. The programs are not intended as a mechanism to promote or encourage the early use of drugs, to conduct research, or to circumvent the clinical trial or drug review process. Drugs that are authorized for sale under these emergency provisions do not undergo a comprehensive pre-market review, nor are they subject to the same manufacturing and post-market safety requirements as other drugs that a manufacturer would seek approval for the Canadian market through the FDR. For example, the drugs requested through the emergency provisions currently do not undergo a review of good manufacturing practices in Canada (i.e. manufacturing requirements that ensure drugs are produced in sanitary conditions with quality assurance). These are important factors for the practitioner to consider when recommending the use of a drug and in making an appropriate risk/benefit decision in the best interest of the patient.
Challenges with the current regulatory framework
Existing regulatory requirements have served their purpose; however, over the years, practitioners and stakeholders have expressed the following concerns with the program:
- 1. The program is viewed as being burdensome with respect to certain requirements: For each drug request submitted to Health Canada, the FDR requires a practitioner to submit data with respect to the use, safety and efficacy of the drug, despite the SAP or the EDR program having previously authorized the same drug in the past for the same medical emergency. This creates an unnecessary paperwork burden for practitioners. A process that reduces this burden on practitioners will allow practitioners to request a given drug without having to submit data on the drug’s use, safety and efficacy if the drug has been previously authorized through the program and meets certain conditions.
- 2. Lack of clarity concerning when foreign manufacturers can bring a drug into Canada in advance of a request by a practitioner: Certain drugs are frequently requested through the SAP and the EDR program. Manufacturers are aware that certain drugs they produce are frequently requested and used in the Canadian health care system. To account for this, and to reduce the length of time it takes to get a drug from a manufacturer to a practitioner for patient use, foreign manufacturers currently export an unauthorized drug into Canada to be placed in a Canadian affiliate’s facility in anticipation of a request for it by a practitioner and the authorization by the SAP or the EDR program (referred to as “pre-positioning”). Through an exercise of enforcement discretion, Health Canada has, by policy, allowed this by not enforcing the prohibition on import for sale on small individual shipments. Creating a regulatory framework around the practice of pre-positioning will enable certain conditions to apply to manufacturers wishing to pre-position their product in Canada.
The objective of the amendments is to facilitate access to drugs for Canadians by modernizing the emergency provisions in the FDR to arrive at less burdensome processes for drugs accessed through the SAP or the EDR program.
The amendments revise the current emergency provisions of the FDR (Part C, Division 8, sections C.08.010 and C.08.011) to (i) provide a less burdensome process for a practitioner requesting a drug previously authorized through the SAP or the EDR program for use in the emergency treatment of a human or animal patient; (ii) establish a regulatory mechanism for situations when manufacturers wish to import drugs into Canada in anticipation of a request from a practitioner (“pre-position”); and (iii) provide required additional amendments.
(i) Requesting a drug previously authorized through the SAP or the EDR program
The amendments create new requirements that allow a practitioner to submit a request for access to an unauthorized drug without submitting information on the use, safety and efficacy of the drug in certain circumstances — information that is currently required in all circumstances. Specifically, this process will be available when the following criteria, outlined in the amendments, are met:
- The drug has been previously authorized by the SAP or the EDR program for the same medical emergency;
- The drug is authorized for sale without terms and conditions (i.e. without any further restrictions placed on the drug) by the European Medicines Agency or the United States Food and Drug Administration to address the same use for which the drug is requested; and
- Any drug identification number or natural product number previously issued for the drug has not been cancelled for safety reasons.
The following information, currently required to be submitted by the SAP or the EDR program, will still be required:
- the name of the new drug and information concerning the medical emergency for which the new drug is required;
- the quantity of the new drug that is required;
- the civic address of where the drug is to be shipped; and
- any additional information that the Minister of Health (the Minister) may request to enable the Minister to determine whether to issue the letter of authorization.
New sections in the FDR will permit the “pre-positioning” of a drug in Canada by manufacturers in advance of a request for the drug by a practitioner and authorization by the SAP or the EDR program. Through these provisions, a manufacturer will be able to submit a request to the SAP or the EDR program for a letter of authorization allowing for the importation of a given drug by a Canadian drug establishment licence (DEL) holder. footnote 6 The drug will be stored in Canada by the DEL holder, who is prohibited from distributing the drug to a practitioner until a letter of authorization by the SAP or the EDR program is issued allowing the sale of the drug to a practitioner. Pre-positioning allows for a more logistically efficient way for SAP and EDR program drugs to be imported to Canada for potential human or animal use, as they can physically be present in a warehouse in Canada well before a practitioner actually makes a request and an authorization is issued.
Divisions 2 to 4 of the FDR footnote 7 will not apply to the importation of the drug, except for certain provisions relating to good manufacturing practices. For example, a drug will need to be stored in a way that prevents the product from becoming unstable or inactive. The DEL holder will also need to ensure that there is a system of control in place to allow a rapid recall of the drug.
To support the request to pre-position a drug in Canada, the Minister may request the manufacturer to provide any other information to enable the Minister to determine whether to issue the letter of authorization. For example, the Minister may request information that was submitted to a foreign regulatory authority in regard to the monitoring of the safety, efficacy or quality of the drug in that jurisdiction. This information would help to inform the SAP and the EDR program’s decision-making on whether or not a drug should be authorized for pre-positioning, or may provide information that will be important to share with the practitioner who may request the drug, such as safety information. The information would also allow the program to determine if changes to the drug’s safety profile require the SAP or the EDR program to obtain additional information about the drug for the requested use when considering an authorization for pre-positioning.
(iii) Additional amendments
(a) Veterinary drugs accessed through the EDR program with certain antimicrobials will have to be reported
In 2017, requirements for reporting related to certain antimicrobial active pharmaceutical ingredients in veterinary drugs were introduced to the FDR footnote 8 as part of comprehensive efforts to improve stewardship and prudent use of antimicrobials. Specifically, a requirement was introduced that manufacturers, importers and compounders of drugs for veterinary use that contain an active pharmaceutical ingredient on the List of Certain Antimicrobial Active Pharmaceutical Ingredients (List A) are required to provide an annual report for each drug that lists the total quantity sold and an estimate of the quantity sold for each intended animal species. As part of the amendments, Health Canada is expanding the antimicrobial reporting requirement to veterinary drugs authorized under the emergency provisions by the EDR program, which are currently otherwise exempt from all requirements of the FDR.
(b) Drugs may be shipped to community pharmacies, to another practitioner, or to a commercial medicated feed mill
In addition, the amendments will also remove the requirement from the practitioner to submit the names of all institutions in which the drug is to be used, and instead will require information on the location where the drug is to be shipped (the “civic address”) and the name of the recipient. This will allow for the shipment of SAP drugs to a pharmacist or to a practitioner. In turn, this will mean that patients can have access to SAP drugs even outside of an institution such as a hospital or practitioner’s office. Drugs for veterinary use could be shipped to a veterinarian, a pharmacist or a person who may sell a medicated feed pursuant to section C.08.012 of the FDR. This will facilitate access to drugs for patients, particularly in rural communities or in situations where a veterinary drug will be administered through medicated feed, and can help to ensure any delay in the treatment of patients is avoided.
(c) Patient’s identity does not need to be known at time of request
The amendments will specify that it is permissible that the patient’s identity (human or animal) is not known to the practitioner that has submitted a request to the SAP or the EDR program. This provision will capture future use situations where a drug is needed for administration in an emergency by a first responder or in the hospital, such as in an emergency room setting, where the patient may not be known in advance of the emergency. In this scenario, the practitioner will still need to submit the same information to Health Canada to receive a letter of authorization through the SAP or the EDR program as he or she currently does. However, the patient’s identity can be unknown at the time that the request is made.
Targeted consultations with key stakeholders on the changes to the regulatory provisions related to emergency treatment took place beginning in December 2017 and ending in early 2018. Over 130 individuals from across the country participated in the sessions, representing the following groups: physicians, veterinarians, patients, pharmacists, pharmacy technicians, health associations, professional regulatory bodies, drug industry representatives and safety advocates. Additional consultations on the EDR program with key stakeholder groups began in November 2018 and ended in February 2019. Considerable feedback was received through these consultations, including suggestions for areas where improvements could be made to better meet the needs of patients.
For example, respondents commented that the FDR should allow the practitioner to choose a preferred shipment location for a drug accessed through the SAP. In response to this comment, the amendments allow drugs to be shipped to the civic address of the practitioner or pharmacist supplied by the practitioner. In general, respondents supported Health Canada’s proposals to reduce the burden associated with certain requests to the program. Other comments focused on operational improvements that could be made, such as more direct communication with requestors and increased openness about decisions with requestors. Health Canada has taken these comments under advisement as it considers operational improvements to the program; however, these improvements are outside of these regulatory amendments. Veterinary stakeholders were generally supportive of the approach, including pre-positioning.
A document titled Feedback from the Consultation: Renewal of Health Canada’s Special Access Program (SAP) was shared electronically with participants of the consultation. footnote 9
Consultation after prepublication in the Canada Gazette, Part I
The proposed Regulations were prepublished in the Canada Gazette, Part I, on May 11, 2019, followed by a 70-day comment period, ending on July 19, 2019. During the same time period, Health Canada also consulted on a guidance document entitled Draft Guidance Document for Industry and Practitioners on the Special Access Program (SAP) for Drugs.
Ten submissions were received on the proposed regulatory amendments. Respondents included members of the public, professional regulatory bodies, a hospital, and a provincial health organization. Comments were also submitted by animal producer associations and industry.
All comments within the scope of the regulatory amendments are summarized and responded to below. Comments received relating to guidance were considered and addressed as part of the process to finalize the guidance document.
Overall, respondents were supportive of the regulatory amendments, including reduced regulatory burden on practitioners needing to submit a request for access to a drug that has been previously authorized by the SAP or EDR program.
1. Civic address of where a drug can be shipped
One respondent noted that enabling the shipment of SAP drugs to community pharmacies will improve patient safety and timely access. The respondent requested that the Regulations clarify that the location (or “civic address”) of where a drug can be shipped be limited to that of a prescriber’s office, hospital or community pharmacy to allow an opportunity for a health professional to explain the proper use of the drug. The respondent also requested clarification on whether a drug that is pre-positioned could be shipped to a community pharmacy, which they would support.
Health Canada response: Health Canada confirms that this is the intent of the provision and has changed the Regulations to specify that the civic address will be required to be one of a pharmacist or practitioner, and that this individual must be identified by the practitioner. With respect to drugs for veterinary use, this will allow shipments to be made to a practitioner, a pharmacist or a commercial medicated feed mill that mixes and manufactures medicated feed.
2. Compliance for pre-positioning drugs
A respondent noted that it will be important for Health Canada to have a plan to ensure that DEL holders comply with the regulatory requirements for pre-positioning drugs.
Health Canada response: Health Canada will engage in compliance monitoring as part of existing activities, including verifications of letters of authorization for SAP drugs at the Canadian border. Compliance with other requirements of the Regulations will be assessed by inspectors either upon receipt of a complaint or at the request of the SAP program, where non-compliance could impact terms and conditions on the DEL and authorization with the SAP program.
3. Professionals able to request an authorization through SAP
One respondent suggested that pharmacists that have additional prescribing authorizations granted by their provincial professional regulatory bodies be able to request an authorization through SAP for use in emergency treatment.
Health Canada response: The majority of practitioners requesting drugs through SAP are specialized in the field of medicine for the conditions to be treated. Pharmacists who can prescribe in Canada have different scope of prescribing rights varying in different provinces, and are limited to the type of drugs that can be prescribed. As SAP drugs have not undergone regulatory review for the market in Canada, it is practitioners who may request access to drugs through the SAP and who are responsible for ensuring the decision to prescribe the drug is supported by credible evidence to treat a specific medical condition.
4. Retention of samples
An industry respondent shared concerns about cost, feasibility and value of requiring DEL holders to retain a sample of each lot or batch of a drug that is pre-positioned.
Health Canada response: Health Canada has re-evaluated the requirement and agrees that it should be removed as drugs would be imported directly from the manufacturer and the DEL holder would be required to store the drug in a way that prevents the product from becoming unstable or inactive.
5. Drugs for minor species
One respondent commented that the regulatory changes are insufficient to improve access to critical new products, including vaccines, for minor species. The respondent recommended that Health Canada make changes to regulations to increase approvals for new drugs for minor species, including creating distinct standards for these drugs.
Health Canada response: While creating new licensing standards for drugs is outside the scope of this regulatory project, Health Canada agrees that more products are needed to treat minor species. These drugs will continue to be available through the EDR program.
6. Safety of drugs available through SAP
One respondent shared concerns about the safety of drugs available through SAP and the need for more Health Canada oversight.
Health Canada response: Health Canada has designed the SAP and EDR program to only allow access to unapproved drugs that are required to treat patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or are unavailable and where the Minister determines the application requirements have been met. Practitioners who request access to drugs through the SAP and EDR program are responsible for ensuring the decision to prescribe the drug is supported by credible evidence. They are also responsible for monitoring and reporting the results of the use of the drug, including any adverse drug reactions. In response to this comment, a change was made to the Regulations to maintain the Minister’s existing regulatory flexibility to request information from the practitioner with respect to the drug. The proposed amendments presented for consultation had narrowed the ability of the Minister to request information related to the safety and efficacy to be specific to the medical emergency. This has been revised to enable the Minister to be able to request any information in respect of the drug to enable the Minister to determine whether to issue the letter of authorization. This is in recognition that other information may be needed to support the Minister’s decision to authorize the sale of a drug that has not undergone comprehensive pre-market review. A change was also made to a similar provision to allow the Minister to request this information from the manufacturer applying to pre-position a drug.
Modern treaty obligations and Indigenous engagement and consultation
These regulatory changes are intended to facilitate access to drugs not authorized in Canada for all Canadians, including Indigenous peoples. Accordingly, specific consultations with Indigenous peoples were not undertaken. It is anticipated that this change will not have an impact on the Government’s modern treaty obligations.
Health Canada considered regulatory and non-regulatory options.
In the status quo option, Health Canada would continue to administer the current emergency provisions in the FDR. While they have served their purpose, they do not accurately reflect the most efficient way to administer the SAP or the EDR program. For example, this option would not allow Health Canada to reduce the burden that practitioners currently face with respect to the information that they need to provide to Health Canada when they request drugs through the SAP or the EDR program which have been previously approved. In addition, it would not create any exemptions to the prohibitions currently operating against the pre-positioning of drugs by manufacturers.
Under this option, Health Canada would continue to administer the existing emergency provisions of the FDR. The Department would establish processes to fix certain limitations of the current emergency provisions.
Continuing to address the limitations of these provisions through policy-based decisions is not recommended. For example, without a change to the regulations, practitioners would still need to submit data with respect to the use, safety and efficacy of a drug, even if the drug had been previously authorized in the past for the same medical emergency. Health Canada could continue, through policy, to permit the import for sale of small individual shipments of drugs in advance of a request from a practitioner and an authorization by the SAP. As this would be permitted through an exercise of enforcement discretion, regulations rather than policy are required to enable Health Canada to apply certain conditions on the pre-positioning of products in Canada.
Amending the FDR is the recommended option. There is a need for the FDR to specifically address the pre-positioning of a drug in Canada in advance of a practitioner request, and to reduce the administrative burden for practitioners. The amendments support current activities and will provide the appropriate authorities to drug manufacturers and reduce the administrative burden on practitioners.
Costs and benefits
The regulatory provisions will allow the Minister to request any other information to enable the Minister to determine whether to issue the letter of authorization. For example, this might include a request for information about the drug that was submitted to a foreign regulatory authority in regard to the monitoring of the safety, efficacy or quality of the drug in that jurisdiction. The Minister may request this information for the purpose of ensuring there are no new safety, efficacy or quality issues with the drug. These will add negligible costs to the manufacturer, as this information is part of the requirement for post-market surveillance monitoring of an authorized drug in the foreign jurisdiction and will already be in the possession of the manufacturer. To date, manufacturers have always complied voluntarily with any requests by Health Canada for additional safety-related information. In the event that a manufacturer does not wish to comply and the regulatory power is used, the only cost will be related to the transmission of the information, which can be done electronically. The incremental cost will therefore be zero.
As part of the Regulatory Impact Analysis Statement published in the Canada Gazette, Part II, on May 17, 2017, which accompanied the amendments to the FDR regarding Veterinary Drugs — Antimicrobial Resistance, costs were established for the reporting of sales of most veterinary antimicrobials. Based on the results of a 2015 stakeholder costing survey, it was estimated that the reporting activities will take approximately 10 hours and have a resource cost per hour of $112. The amendments relating to the sale of emergency drugs will expand antimicrobial reporting requirements to include veterinary drugs authorized by the EDR program.
These costs are expected to be limited. In the last two years, the EDR program has processed authorizations for two drugs containing an active pharmaceutical ingredient on the list of antimicrobial active pharmaceutical ingredients, which are supplied by two manufacturers. Based on an estimated one additional drug reported through the EDR program per year, this will result in a total annual cost of $1,120 to manufacturers, importers or practitioners collectively. This estimate is based on costing data collected in 2015 and at that time, manufacturers, importers and compounders had to enter data using an Excel spreadsheet. Health Canada has since launched a new web application for concerned parties to report sales data in an efficient user-friendly way. It is anticipated that the costs will thus be reduced when this web application is used. Since the web-based system was not costed by industry at the time, Health Canada is using the $1,120 figure as a conservative estimate of the cost impact for industry.
The pre-positioning provisions will be voluntary and will not result in any costs to manufacturers, as the amendments will clarify the requirements for drugs to be imported into Canada by the holder of an establishment licence. Allowing the manufacturer to pre-position a drug in Canada will reduce the time it takes to ship a drug to a practitioner and the costs for the manufacturer to ship small amounts of a drug each time there is an authorization by the SAP or the EDR program.
There are expected to be benefits associated with the amendments for practitioners who submit requests for access to drugs that have been previously authorized through the SAP or the EDR program. For drugs that meet the criteria set out in the amendments, the practitioner will no longer be required to submit use, safety and efficacy information in respect of drugs that have been previously authorized by the SAP or the EDR program, as is currently done under the existing regulations. Not submitting this information will reduce the administrative burden on practitioners for a drug that has been previously authorized by the SAP or the EDR program. It is estimated that 30–40% of the drugs submitted to the SAP could be subject to the reduced information requirements. However, these benefits are minimized by the need for the practitioner to contact Health Canada in order to find out if the drug has been previously authorized, until such a time as an electronic system for the SAP is created to help with the application process. For veterinary drugs, Health Canada is developing options for how the list of drugs will be made available in order to facilitate the application process and the completion of forms that can be downloaded from the EDR program web page.
The anticipated benefits, if using the current paper-based application process, will only be a couple of minutes; however, once the electronic system for the SAP is operationalized, practitioners will gain additional benefit from being able to quickly see if a drug has been previously authorized by Health Canada. Health Canada estimates this may save 15 minutes per application. Although the practitioner will no longer have to submit use, safety and efficacy information for a drug that has been previously authorized, he or she will still have to ensure the safety and efficacy information supports prescribing the drug to a patient for the medical emergency. While the regulatory changes will facilitate the less burdensome use of the electronic system, they do not require its use. As the savings are administrative in nature, the details of the savings are outlined below in the one-for-one rule section.
Removing the requirement for the practitioner to provide the names of the institutions where the drug is to be used will allow the shipping of the drug to other locations, such as community pharmacies or a commercial medicated feed mill, which will facilitate patient access to the drug, particularly in rural communities, and may ensure any delay in the treatment of patients is avoided.
The portion of the amendments that deals with pre-positioning will provide a more logistically efficient way to get a drug to a practitioner by allowing manufacturers to distribute the drug to a Canadian establishment licence holder, in advance of a request from a practitioner for the drug and subsequent authorization by the SAP or the EDR program. This may improve the time it takes for a drug to reach a practitioner once the practitioner receives a letter of authorization from Health Canada.
Small business lens
A small business is defined as a firm, including affiliates, that has fewer than 100 employees or less than $5 million in annual gross revenues.
Physician offices, pharmacies, and veterinary clinics are all considered to be small businesses for the purposes of the small business lens analysis. The only costs anticipated for small business will be for veterinary clinics, and these will be very small. Specifically, veterinarians importing certain antimicrobial products through the EDR program will have to report their sales of these drugs by using an electronic system established by Health Canada. On average, in the past, no more than one such product per year has been brought to Canada through the EDR program, with a maximum annual cost of $1,120.
This small potential cost increase will be more than offset by time savings and reduced costs provided under the SAP and the EDR program application and approval process. These benefits will be magnified by the flexibility the amendments provide when an electronic system for human drugs is operationalized for the SAP. These savings are discussed in more detail below.
The one-for-one rule measures the incremental changes to the amount of administrative burden imposed on businesses through regulations under the Red Tape Reduction Act. The amendments do not add or remove any regulatory titles for the purpose of the one-for-one rule. The amendments are expected to increase reporting costs under the EDR program for the purposes of antimicrobial resistance reporting; however, they will reduce administrative burden under the SAP overall and over time (i.e. when the electronic system mentioned above is in place). Under the one-for-one rule, the amendments will constitute a net “OUT” in the total annualized amount of $4,040 in administrative costs (2012 dollars, 7% discount rate, discounted to 2012) footnote 10 or an average saving of $1 per affected stakeholder.
Part of the SAP and the EDR program change is to remove the requirement to provide use, safety and efficacy data for repeat requests of drugs when certain conditions are met. No new requirements will be added. This represents a small reduction in administrative burden for applicants. The creation of an electronic system for SAP that will maximize the benefits of the provision is envisioned; however, the amendments do not specifically require its use. Therefore, any efficiencies the electronic system will realize are not captured under the one-for-one rule. Using the current process may save physicians only a couple of minutes per application. Health Canada anticipates an electronic system to be in place by spring 2020. The Department believes such a system should save on average 15 minutes of work per application that meets the criteria, but the Regulations do not require its use.
The new reduction in annual administrative burden for the amendments will be $6,942 ($7,905 + $157 − $1,120), as described below. Health Canada averages 16 000 requests from 5 000 physicians each year. For the purpose of the analysis, it is assumed that these requests are received from individual physicians and not from health care institutions. Of the 500 drugs that on average were approved in any given year through the SAP, 30–40% will meet the criteria allowing for the use of the abbreviated application process. Using the average of 35%, this represents 175 drugs. Assuming that the ratio between total requests and drugs is the same as the ratio between requests and drugs that meet the criteria set out in the amendments, there are 5 600 requests that could use the new SAP process (16 000 requests × 0.35 = 5 600 requests). The assumptions used have been validated by stakeholders.
On a per physician basis, this represents an average 1.12 requests per doctor who meet the criteria for using an abbreviated application process.
Using the standard hourly cost for health professionals from Statistics Canada footnote 11 in 2012 dollars, as required for the purposes of the one-for-one rule, and assuming a rate of $42.35 and multiplying by 2 minutes (or 1/30 hours), the savings will be $1.41 per request ($42.35 × 1/30 = $1.41). This represents a reduction in total annual administrative burden reduction of $7,905 ($1.41 × 5 600 requests = $7,905).
There are up to 1 000 requests per year under the EDR program from 400 veterinarians. Of the 45 drugs that on average were approved in any given year through the EDR program, approximately 5 drugs meet the criteria, representing 11%. Assuming that the ratio between total requests and drugs is the same as the ratio between requests and drugs that meet the criteria set out in the amendments, there are up to 111 requests that could use the new EDR program process. Using the wage rate for health professionals, this represents a reduction in total annual administrative burden reduction of $156.85 ($1.41 × 111 requests = $156.85).
On a per veterinarian basis, this represents 0.28 requests.
Additional amendments: The regulatory provisions will allow the Minister to request any other information to enable the Minister to determine whether to issue the letter of authorization. For example, this might include a request by the Minister for any other information from the manufacturer including information that was submitted to a foreign regulatory authority, for the purposes of monitoring safety, efficacy or quality. This provision will create a negligible administrative burden, as this is information that manufacturers already keep in their possession and they will only need to submit a copy of the information electronically. Further, when Health Canada has requested additional safety-related data in any form from manufacturers, they have provided all information voluntarily, and this requirement only formalizes already standard industry practices.
The amendments to expand antimicrobial reporting requirements to veterinary drugs authorized under the EDR program will simply treat these drugs like other antimicrobial drugs that are subject to the sales reporting requirement under the FDR. Based on the results of a 2015 stakeholder costing survey, it was estimated that the reporting activities by the importer will take approximately 10 hours and have a total resource cost per hour of $112 (in 2012 dollars). Based on one additional drug that will need to be reported through the EDR program per year, this will result in an annual increased administrative burden of $1,120.
Regulatory cooperation and alignment
The amendments for the sale of drugs for emergency treatment will continue to allow Canada to remain consistent with international regulatory approaches for human drugs, such as those found in the United States, the European Union, Australia, New Zealand and Ireland. In general, these jurisdictions have similar programs in place to provide for expanded access of drugs, which include reporting requirements.
The requirements will be voluntary for manufacturers, who will not be obligated to provide access to a drug requested through the SAP or the EDR program. Further, the amendments will not require manufacturers to change any aspect of their product to meet Canadian requirements with respect to providing access to a drug for use in a Canadian medical emergency.
The amendments will allow a practitioner to submit a request for access to an unauthorized drug without submitting information on the use, safety and efficacy of the drug in certain circumstances, including if the drug is authorized for sale without terms and conditions by the European Medicines Agency (EMA) or the United States Food and Drug Administration (U.S. FDA) for the same medical emergency for which the drug is requested. These foreign regulatory authorities were chosen as they represent international regulators of reference. Further, drugs requested through the SAP are primarily those that have been authorized in these two jurisdictions. The European Union and the United States have strong, internationally recognized regulatory regimes, and there is a long history of collaboration between Health Canada, the EMA and the U.S. FDA. Health Canada works regularly with these two trusted regulatory counterparts, both bilaterally and through multilateral international organizations, and there is substantial regulatory alignment between them.
Strategic environmental assessment
In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a preliminary scan concluded that this regulatory change will not result in positive or negative environmental effects; therefore, a strategic environmental assessment is not required.
Gender-based analysis plus
Consideration of gender and other social and cultural-related factors was taken into account during the development of this regulatory change. By arriving at less burdensome processes for drugs accessed through the SAP, these amendments may create improved access for people with a disease or health condition for which a drug is not otherwise available in Canada but its use as a treatment will improve a patient’s quality of life. This regulatory change may also positively impact patients in rural communities due to the changes in the emergency provisions governing the SAP that will allow for drugs to be shipped to community pharmacies. This will facilitate access to drugs for patients in rural communities. No other gender-based analysis plus (GBA+) impacts have been identified for these amendments, as these factors do not determine whether a drug is approved for use through the SAP; the SAP is also not tailored to serve any one particular socio-economic group (all Canadians may be eligible).
Implementation, compliance and enforcement, and service standards
The amendments come into force on the day on which they are registered. Guidance on implementation of the regulatory amendments will be outlined in Health Canada’s Guidance Document for Industry and Practitioners - Special Access Programme for Drugs. This document as well as the guidance on implementation of the regulatory amendments for the EDR program will be available on the Government of Canada website.
The timing of processing requests through the SAP and the EDR program is anticipated to remain unchanged (i.e. Health Canada works to process requests within 24 hours). The amendments do not result in any changes to existing compliance and enforcement activities conducted by Health Canada.
Office of Legislative and Regulatory Modernization
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