Vol. 151, No. 14 — July 12, 2017
SOR/2017-133 June 20, 2017
FOOD AND DRUGS ACT
Regulations Amending the Food and Drug Regulations (Importation of Drugs for an Urgent Public Health Need)
P.C. 2017-785 June 20, 2017
Whereas, pursuant to subsection 30(1.3) (see footnote a) of the Food and Drugs Act (see footnote b), the Minister of Health has taken into account existing information management systems, with a view to not recommending the making of regulations that would impose unnecessary administrative burdens;
Therefore, His Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsections 30(1) (see footnote c) and (1.2) (see footnote d) of the Food and Drugs Act (see footnote e), makes the annexed Regulations Amending the Food and Drug Regulations (Importation of Drugs for an Urgent Public Health Need).
Regulations Amending the Food and Drug Regulations (Importation of Drugs for an Urgent Public Health Need)
1 Section C.01.001 of the Food and Drug Regulations (see footnote 1) is amended by adding the following after subsection (1):
(1.1) For the purposes of the Act, serious adverse drug reaction has the same meaning as in subsection (1).
2 Part C of the Regulations is amended by adding the following after Division 9:
Access to Drugs in Exceptional Circumstances
C.10.001 (1) The following definitions apply in this section.
foreign regulatory authority means a government agency or other entity outside Canada that has a legal right to control the manufacturing, use or sale of drugs within its jurisdiction. (autorité réglementaire étrangère)
public health official means
- (a) the Chief Public Health Officer appointed under subsection 6(1) of the Public Health Agency of Canada Act;
- (b) the Chief Medical Officer of Health, or equivalent, of a province;
- (c) the Surgeon General of the Canadian Armed Forces; or
- (d) the Chief Medical Officer of Public Health for the First Nations and Inuit Health Branch of the Department of Health. (responsable de la santé publique)
(2) Despite sections A.01.040 and C.01.004.1, any person who holds an establishment licence that authorizes the importation of a drug may import a drug for which a notice of compliance has not been issued under section C.08.004 or C.08.004.01, or for which a drug identification number has not been assigned under subsection C.01.014.2(1), if the following conditions are met:
- (a) a public health official has, within the past year, notified the Minister in writing of
- (i) an urgent public health need for the immediate use of the drug within their jurisdiction, and
- (ii) the intended use or purpose of the drug;
- (b) the drug is authorized by a foreign regulatory authority in the United States, Switzerland or the European Union to be sold for the same use or purpose as that described under subparagraph (a)(ii);
- (c) the drug is in the same category as the category for which the licence was issued;
- (d) the drug is imported directly from the country in which it is authorized to be sold by the foreign regulatory authority; and
- (e) the drug is one for which the following information is set out in the List of Drugs for an Urgent Public Health Need that is published by the Government of Canada on its website, as amended from time to time:
- (i) brand name,
- (ii) medicinal ingredients,
- (iii) dosage form,
- (iv) strength,
- (v) route of administration, and
- (vi) identifying code or number, if any, assigned in the country in which the drug was authorized for sale.
(3) Sections C.01A.006 and C.01A.007 do not apply in respect of the importation of a drug under subsection (2).
(4) For greater certainty, a licensee may, despite subsection C.01A.004(1), import a drug under subsection (2) without having their licence amended under section C.01A.006.
(5) Divisions 2 to 4, other than the following provisions, do not apply to the importation of a drug under subsection (2):
- (a) sections C.02.003.1 and C.02.004 as they apply to the storage of the drug by the licensee;
- (b) section C.02.006;
- (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 drug by the licensee;
- (f) subsection C.02.021(1) as it applies to the storage of the drug by the licensee;
- (g) subsection C.02.022(1);
- (h) section C.02.023;
- (i) subsections C.02.024(1) and C.02.025(1);
- (j) section C.03.013; and
- (k) section C.04.001.1 as it applies to the storage of the drug by the licensee.
C.10.002 (1) A sale of a drug that is imported under subsection C.10.001(2) is exempt from the provisions of these Regulations only if the drug is sold, within the jurisdiction of a public health official who has notified the Minister as described in paragraph C.10.001(2)(a), for use in respect of the same urgent public health need for which it was imported.
(2) Any person who wholesales such a drug must hold an establishment licence to wholesale a drug in the same category and despite subsection (1), the following provisions apply in respect of the wholesale:
- (a) sections C.02.003.1 and C.02.004 as they apply to the storage of the drug by the licensee;
- (b) section C.02.006 as it applies to the storage of the drug by the licensee;
- (c) subsection C.02.012(1);
- (d) section C.02.013;
- (e) section C.02.015 as it applies to the storage and transportation of the drug by the licensee;
- (f) subsection C.02.022(1);
- (g) section C.02.023; and
- (h) subsection C.02.024(1).
C.10.003 Every licensee who imports a drug under subsection C.10.001(2) must notify the Minister within 15 days after the day on which it is imported by providing the following information:
- (a) the name, title and contact information of the person who imported the drug;
- (b) the brand name of the drug;
- (c) the medicinal ingredients, strength, dosage form, route of administration and the identifying code or number, if any assigned in the country in which the drug was authorized for sale;
- (d) the name of the country from which the drug was imported; and
- (e) the total quantity of the drug imported.
C.10.004 (1) For the purposes of section 21.8 of the Act, the prescribed health care institutions that must provide information to the Minister about a serious adverse drug reaction that involves a drug imported under subsection C.10.001(2) are the health care institutions authorized by the laws of a province to provide acute care services.
(2) The following prescribed information about a serious adverse drug reaction must be provided to the Minister in writing within 30 days after the day on which the reaction is first documented:
- (a) the name of the health care institution and the contact information of a representative of that institution;
- (b) the name and identifying number or code of the drug that is suspected of causing the reaction; and
- (c) a description of the serious adverse drug reaction.
Coming into Force
3 These Regulations come into force on the day on which section 5 of the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law), chapter 24 of the Statutes of Canada, 2014, comes into force, but if they are registered after that day, they come into force on the day on which they are registered.
REGULATORY IMPACT ANALYSIS STATEMENT
(This statement is not part of the Regulations.)
Urgent public health needs can occur, for example, during a flu pandemic or in a situation such as an opioid crisis. Addressing such an urgent need requires a mechanism that allows for a population-based response that is quick and efficient. There may be a situation where the immediate use of a drug is needed to respond to an exceptional public health crisis and the drug is not available for sale in Canada, but is authorized for sale in another country. A regulatory pathway that allows for the importation and sale of such drugs could assist in quickly addressing an urgent Canadian public health need, and could result in saving Canadian lives.
In Canada, there are currently regulatory pathways that provide access to drugs that are not authorized for sale in Canada. These include Health Canada’s Special Access Programme (SAP) and the filing of a Clinical Trial Application (CTA). However, there is no regulatory mechanism available in Canada to address an urgent public health need through a population-based approach. The SAP was designed to address individual patient needs and, therefore, requires an application to be made for the drug by the treating physician. The authorization that is issued is for a specific quantity of drug and must be issued once again if treatment for additional patients is sought. This system works well for the individual patient–practitioner situation, but was never intended for use in a population health treatment context to address an urgent public health need such as the current opioid crisis in Canada. Clinical trials are typically designed and conducted for the purpose of studying a drug’s effect and are not an ideal means for the ongoing treatment of patients.
Opioid use disorder is an urgent public health need in Canada at this time. This disorder is a medical condition associated with addiction to and dependence on opioids. Health Canada has authorized a number of drugs for use in treating opioid use disorder. These include methadone as well as buprenorphine/naloxone combinations and naltrexone. While most of the drugs used to treat opioid use disorder are available on the Canadian market, there are a number of drugs that have been authorized in foreign jurisdictions that have not been authorized for sale in Canada. Reasons for this may include a business decision by the manufacturer to not apply for an authorization in Canada because it is a smaller market, or a business decision to seek authorization in Canada at a later date.
The objective of the regulatory amendments is to enable access to drugs that would help address an urgent public health need (e.g. opioid use disorder) that have been authorized for sale in either the United States, the European Union, or Switzerland, but are not yet available in Canada.
Unlike the current schemes laid out in the Food and Drug Regulations (FDR) that authorize the importation and sale of a drug in Canada by means of an application, review and authorization process, the Regulations Amending the Food and Drug Regulations (Importation of Drugs for an Urgent Public Health Need) [the Regulations] allow for the importation of a drug included on the “List of Drugs for an Urgent Public Health Need” (the List) to address an identified urgent public health need. All drugs on the List must be authorized for sale in the United States, the European Union, or Switzerland.
The Minister of Health (the Minister) will, at his/her discretion, add drugs to the List based on a notification made by a provincial or territorial Chief Medical Officer of Health, the Chief Public Health Officer of the Public Health Agency of Canada or the First Nations and Inuit Health Branch (FNIHB) of the Department of Health (the Department), or the Surgeon General of the Canadian Armed Forces (collectively referred to as “public health officials”). This notification will need to be in writing and identify the urgent public health need for the use of the drug within their respective jurisdictions as well as the use or purpose of the drug.
A drug will be removed from the List if more than one year has elapsed since the last notification (regardless of jurisdiction) by the public health official, unless the Minister is once again notified of the continued need for the drug to address the same public health need, in the jurisdiction. Both the importation and sale of the drug will not be allowed if one year has elapsed, with no further notification. Further details on the notification process are set out in a publicly available document entitled Questions and Answers on the Importation of Drugs for an Urgent Public Health Need.
The List is incorporated by reference into the FDR, published on the Government of Canada website, and maintained by the Minister. The List contains, in accordance with the Regulations, the following details respecting a drug: the brand name, the medicinal ingredient(s), the strength, the dosage form, the route of administration, and the identifying code or number assigned by the foreign regulatory authority that authorized its sale. The List also contains other information obtained through the notification such as the country of origin, the requesting Canadian jurisdiction, the urgent public health need for the immediate use of the drug, the intended use or purpose of the drug, and the date of request by the public health official.
Existing establishment licence (EL) holders are allowed to import and wholesale a drug on the List where they are currently licenced for those specific activities; furthermore, drugs on the List can only be imported from the countries in which they are authorized. EL holders are required to notify Health Canada within 15 days after the importation and provide Health Canada with details such as the quantity of drug being imported. EL holders are also required to maintain records of the drug’s distribution in Canada, ensure that storage requirements under Part C, Division 2, of the FDR are maintained, and notify Health Canada if they undertake a recall of the drug. These requirements are similar to those that already exist for EL holders.
Drugs that are placed on the List are exempt from many requirements under the FDR respecting the sale and importation of a drug. Confidence that the drug meets a similar standard of safety, efficacy and quality to that of a Canadian authorized drug is provided by the fact that these drugs have, in being authorized for sale in either the United States, the European Union, or Switzerland, undergone a thorough examination by trusted regulatory partners and will be imported directly from those countries by EL holders. Similarly, Health Canada will rely on the oversight of the foreign manufacturer by the trusted regulatory partner. The countries are limited to the United States, the European Union, and Switzerland, as current experience shows that typically, drugs are first marketed in these countries. In addition, these regulatory partners adhere to similar standards and requirements as in Canada.
The sections of the FDR that apply to a drug on the List include, for example, inspector powers, requirements to keep records to enable a recall and report a recall, as well as certain requirements to control the quality of the drug, including those respecting its storage and transportation. As many drugs used to treat opioid use disorder are controlled substances, the List could include these drugs, which will also be subject to the requirements of the Controlled Drugs and Substances Act (CDSA), the Narcotic Control Regulations, and other regulations under the CDSA. This includes diacetylmorphine (heroin), which has been demonstrated to be effective in treating some patients who are unresponsive to first-line treatments such as methadone.
While the drugs on the List are exempt from most of the provisions of the FDR, it is important to note that the requirements in the Food and Drugs Act itself still apply to these drugs. This will allow the Department to recall the drug should a safety concern be discovered indicating that action is necessary to prevent a serious or imminent risk of injury to health.
Health care institutions that provide acute care services, including those that provide emergency services, are required to report information respecting a serious adverse drug reaction (serious ADR) associated with a drug on the List within 30 days of the event first being documented. The definition of a serious ADR under subsection C.01.001(1) of the FDR applies. The information that these institutions are required to report is limited to the name of the institution and a contact person for the name and identifying code of the drug on the List, and a description of the serious ADR. Institutions are required to provide this information in writing, either in a paper-based format or by electronic means according to the capabilities of their existing information management systems.
This reporting requirement is the first application of the Governor in Council’s ability, gained through the passing of the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law), to make regulations respecting the reporting of serious ADRs by health care institutions.
As the Regulations are meant to address a serious and existing public health crisis, they come into force immediately upon registration by the Clerk of the Privy Council. In addition, an Order in Council brought into force the sections of Vanessa’s Law necessary to implement requirements for serious ADR reporting by health care institutions.
These Regulations provide an alternate pathway for accessing drugs as a response to an urgent public health need. The use of this alternate pathway is not mandatory, as the existing pathways through the SAP and the filing of a CTA will remain.
The “One-for-One” Rule applies to this proposal, and it is considered an “IN” for the purpose of reporting administrative burden. The estimated cost will be offset by an equivalent reduction in the administrative credits available within the health portfolio.
This proposal creates an optional regulatory means to import drugs for use in responding to an urgent public health need such as a flu pandemic outbreak or the treatment of opioid use disorder.
The administrative requirements placed on EL holders that are importing and wholesaling drugs under the Regulations are less than the requirements regarding importation and distribution of drugs with Canadian market authorizations. However, the Regulations impose administrative requirements on EL holders, namely the requirement to notify Health Canada within 15 days of the importation of a drug on the List and the need to keep records to support a potential drug recall.
While the requirements of the Controlled Drugs and Substances Act will also apply when applicable, this will not impose a new burden on businesses, since meeting these existing requirements will not require the creation of new standard operating procedures or the need for staff to familiarize themselves with new reporting and record-keeping requirements.
It is estimated that there would be no more than 20 bulk shipments, per year, of drugs from the List and that an EL holder would spend 15 minutes preparing the notification of importation for Health Canada, and another 30 minutes generating the necessary records required under the recall provisions. Furthermore, there are approximately 970 businesses that could import drugs that are on the List, but this number declines if the product is a controlled substance.
The administrative costs are calculated using an average cost of $60 per hour, based on costs provided by industry for similar regulatory reporting tasks.
In accordance with the Red Tape Reduction Regulations, the administrative burden to EL holders was calculated over 10 years and discounted using a rate of 7%. The present value (2012) of the total annualized incremental administrative costs to EL holders has been estimated to be $589, or approximately $1 per business. These costs would only be borne by EL holders that choose to import drugs that are on the List.
Small business lens
Since the estimated annual costs of the Regulations are less than one million dollars, the small business lens does not apply.
In developing the Interim Order for naloxone hydrochloride nasal spray (see footnote 2) in the summer of 2016, Health Canada heard from provincial and territorial health authorities about their urgent need to have access to any available and effective drugs that might be useful in addressing the ongoing opioid crisis. As a result of this feedback and ongoing interactions with public health officials, Health Canada proposed a means to allow for the importation and sale of drugs to address an urgent public health need, including drugs that are currently unavailable to Canadian patients to treat opioid use disorder.
In March 2017, Health Canada discussed details of this proposal with representatives of the provincial, territorial and national health authorities, including Chief Medical Officers of Health. Health care institutions were also consulted on this proposal. At the time of consultation, it was proposed that public health officials would be the ones that would themselves import a drug on the List as well as the ones to whom the record-keeping and notification obligations would apply.
While there was some support for an initiative to improve access to drugs to treat opioid use disorder, it became apparent from these discussions that public health officials had neither the experience nor the capacity to take on the responsibility of managing the importation and distribution of these drugs and of fulfilling the proposed record-keeping and reporting obligations. In light of this, the proposal that was prepublished in the Canada Gazette, Part I, allowed for entities that have demonstrated experience with these activities, namely importers and wholesalers that already hold an establishment licence, to import and wholesale these drugs.
At least one provincial medical health officer inquired as to whether diacetylmorphine (heroin) could be added to the List and made available through the proposed scheme. At this time, a considerable number of patients who were subjects in a recent clinical trial to determine the efficacy of using diacetylmorphine to treat opioid use disorder are gaining access to the drug through the SAP.
As part of policy development around the broader requirement for mandatory reporting by health care institutions of serious ADRs set out in section 21.8 of Vanessa’s Law, Health Canada held consultation sessions with health care institutions. Concerns raised during this broader consultation included varying capabilities with respect to programs, systems, and the ability to accommodate a federal requirement for reporting. Several respondents expressed concerns with the ability to establish a causal relationship between a drug and an adverse event, and suggested that it should be sufficient to file a report based on just a suspicion of causality. Many suggested that acute care institutions would represent a reasonable starting point in capturing the majority of events.
In March 2017, over 90 people representing over 40 health care institutions were engaged to discuss reporting of serious ADRs under this particular proposal. Comments revolved around the administration of the List, uses for the approved drugs, reporting requirements, and sharing of serious ADRs (i.e. whether there would be sharing of information related to these events). Several participants expressed concerns similar to those raised by chief medical health officials regarding the procurement and distribution of these drugs.
In response to these observations, the proposal prepublished in the Canada Gazette, Part I, placed the reporting requirement at the level of acute health care institutions, given that it is likely that the majority of patients with serious ADRs would be treated in these types of institutions. Furthermore, the reporting requirement balanced the need to identify important safety concerns and the need to not impose unnecessary administrative burdens on health care institutions.
Prepublication in the Canada Gazette, Part I
The proposed Regulations Amending the Food and Drug Regulations (Importation of Drugs for an Urgent Public Health Need) were prepublished in the Canada Gazette, Part I, on April 22, 2017, followed by a 15-day comment period. Over the course of the consultation period, Health Canada received more than 200 comments from 30 different respondents. Respondents included drug industry associations and individual drug companies, associations representing health care institutions as well as health care provider organizations, other federal government agencies, provincial ministries of health and chief medical officers of health and a provincial substance abuse organization.
Overall, respondents were supportive of measures allowing the importation of foreign drugs under this scheme. A number of comments received were outside of the scope of the proposal and are not considered here.
A majority of respondents indicated that the term “urgent public health need” should be clarified or further defined. Health Canada has provided additional information and examples in the guidance document Questions and Answers on the Importation of Drugs for an Urgent Public Health Need document to address this. The regulatory text has also been revised to indicate that the urgent public health need must be for the “immediate” use of a drug. This means that the situation affecting public health must be occurring or imminent such that the drug could be used as soon as it becomes available to address that situation. The intent of Health Canada in developing the Regulations is not to provide a means for importing a drug that would remain pre-positioned for use to address future urgent public health needs.
A number of respondents indicated that the 15-day period to submit comments was too short and did not allow them to adequately assess the implications of the proposed Regulations. At least one industry respondent suggested that Health Canada limit the scope of the proposal at this time to drugs to address the opioid crisis and indicated that Health Canada should consider further development of the policy for other urgent public health needs in consultation with stakeholders. Health Canada has, given the need to act quickly to address the opioid crisis, developed the Regulations in a very short period of time but made every effort to consult with stakeholders prior to prepublication in the Canada Gazette, Part I. This was accomplished by teleconferences held with other government agencies and departments, with pharmaceutical industry associations, with health care providers and with representatives from the provinces and territories, including chief medical officers of health. Feedback from those meetings was used to finalize the prepublished proposal. As with any other new regulation, Health Canada will closely monitor the implementation and use of the Regulations to identify any unintended consequences so as to minimize any unanticipated risks to Canadians that may result from the importation of foreign approved drugs. Additionally, Health Canada recognizes that the mechanism that provides the best oversight of a drug is through the filing by the manufacturer of a new drug submission (NDS) and eventual issuance of a market authorization in the form of a notice of compliance (NOC). As such, it is actively considering means of encouraging manufacturers to file submissions.
A number of industry stakeholders and associations raised concerns about the possibility of infringement of Canadian patents. The Patent Act will continue to apply to products imported in accordance with the Regulations. Health Canada recognizes that there may be situations in which the foreign manufacturer would not hold the patent rights to the drug in Canada. However, as usual, Health Canada will not be confirming the status of Canadian patents and it will be the responsibility of anyone importing the drug to take the steps necessary to avoid patent infringement.
A number of industry stakeholders also enquired as to the impact of the Regulations on data protection. In applying the existing provisions under section C.08.004.1 of the FDR, Health Canada would consider that a drug could still meet the definition of “innovative drug” even if that drug had been sold in Canada under the Regulations. This means that regardless of having previously sold a foreign version of their drug in Canada, a manufacturer could still be eligible for the market exclusivity afforded under section C.08.004.1.
A number of industry and association stakeholders as well as provincial representatives questioned how a drug imported through this scheme would be distributed for sale in Canada. In identifying existing EL holders as the persons that could import and wholesale these drugs, Health Canada expects that the usual commercial pharmaceutical distribution channels through existing wholesalers and retailers would continue to operate.
Stakeholders also raised concerns that in not issuing a Drug Identification Number (DIN) for these products, the tracking of these products, serious ADRs reporting, and reimbursements associated with them will be problematic. Health Canada will not be issuing DINs for these products as the DIN has a legal character indicating that a drug has been authorized for sale in Canada following an application made under the FDR. Health Canada will not allow the over-labelling of these drugs so that they may remain readily identifiable as a foreign drug that has not been authorized for sale in Canada by the usual means. Health Canada believes that there is sufficient information associated with the drug, including the information on its label, such as its brand name and its foreign identifying code, to allow for its proper identification and tracking and that importers, wholesalers, payers and health care institutions could utilize their existing tracking and information management systems. Furthermore, many drugs sold in Canada are not assigned a DIN, such as radiopharmaceuticals and drugs sold under SAP.
One respondent representing a health care institution questioned whether Health Canada had accurately estimated the costs associated with reporting of serious ADRs by healthcare institutions. They indicated that the cost of determining the potential association between the adverse event and an unknown drug would be considerably higher than doing this for a drug that Canadian physicians would be familiar with, although actual numbers were not provided to substantiate this. However, new drugs are introduced to the Canadian market on a regular basis and, therefore, Health Canada feels that its costing analysis based on existing ADR reporting costs addresses the situation raised by this respondent.
Some stakeholders questioned whether there will be labelling requirements. The existing labelling requirements of the FDR do not apply to these drugs. It will be under the discretion of the public health official to determine whether supplementary information should be provided to patients or health care professionals when the drug is distributed in their jurisdiction.
One chief medical officer of health suggested that provincial ministers of Health would be in a better position to provide the notification of the urgent public health need as they would more likely involve all experts under their authority in the process. Health Canada believes that the chief medical officer of health is sufficiently qualified by virtue of their medical training and experience managing the public health needs in their jurisdictions to identify an urgent public health need and would consult with any persons, including other senior officials or experts, as necessary.
One industry respondent questioned why 30 days was required for serious ADR reporting when manufacturers are currently required to report ADRs in 15 days. Health Canada believes that 30 days provides a balance between timely reporting and the time needed to provide a quality report. Additionally, the reporting is from the time the ADR was first documented in the health care facility. In practice, many of the reports currently supplied to Health Canada from manufacturers were initially identified in health care institutions and reported to them. So, in many cases, the time from the initial documentation of an ADR to its reporting by the manufacturer is much longer than 15 days.
A considerable number of comments were received requesting clarification be added to various sections of the associated guidance document. These comments were all taken into consideration and are reflected in the final version of the guidance.
Summary of changes to the Regulations following prepublication
The Regulations differ from those prepublished in the Canada Gazette, Part I, in the following manner:
- A new provision C.01.001(1.1) was added to indicate that for the purposes of the Food and Drugs Act “serious adverse drug reaction” has the same meaning as in C.01.001(1).
- The definition of “public health official” under C.10.001(1) had incorrectly referred to the Canadian Forces and was corrected to refer to the Canadian Armed Forces (Forces armées canadiennes).
- C.10.001(2)(a) was revised to clarify that the urgent public health need is for the “immediate” use of the drug.
- C.10.001(2)(a) was further revised to indicate that the public health official in their notification to the Minister would include the use or purpose for the drug.
- C.10.001(2)(b) was revised to clarify that the use or purpose authorized in the foreign jurisdiction must be the same use or purpose as that notified by the public health official.
- C.10.002(1) was revised for clarification to indicate that the drug is exempt from the provisions of the Food and Drug Regulations if it is sold within the jurisdiction of a public health official who has notified the Minister under C.10.001(2)(a).
- C.10.002 was revised to indicate that C.02.006 of the Food and Drug Regulations continue to apply as it relates to the storage of a drug by the holder of an establishment licence for wholesaling (this existing provision requires that personnel responsible for the storage of a drug have the required training to do so).
The Regulations provide an alternative pathway to access unauthorized drugs to address an urgent public health need, such as a flu pandemic or the treatment of opioid use disorder. The risks associated with foregoing the normal means of market authorization of a drug through the filing and assessment of a new drug submission (NDS) is mitigated by the fact that only drugs that have been subject to similar scrutiny by trusted regulatory partners, and authorized for sale by them, would be allowed for sale in Canada. In managing the List, Health Canada would not consider adding a drug that is the equivalent of a drug already authorized for sale in Canada. In this way, manufacturers would not gain an unfair commercial advantage by this scheme.
In choosing this option, Health Canada considered a number of alternatives. As noted above, an earlier proposal that would have placed the burden on public health officials was rejected as being unworkable. The possibility of using the Minister’s ability under section 30.1 of the Food and Drugs Act to issue an interim order was examined and rejected. Interim orders are valid only for a maximum of one year, and as a public health need may be ongoing, a new order would need to be issued each year, which is not the intent of an interim order.
While Health Canada will explore measures to encourage manufacturers to obtain market authorization for a drug, obtaining an authorization under the existing regulatory pathways may not provide the timely access that would occur under the Regulations.
Benefits and costs
The Regulations allow for an optional regulatory means for the importation of drugs meant to address an urgent public health need. There is no requirement to utilize the Regulations, as access to drugs that do not currently have market authorization in Canada can still be obtained through the SAP or CTAs.
The benefits of the Regulations are dependent on how many health officials choose to notify the Department of an urgent public health need in order to trigger this optional means for the importation of drugs not already approved for the Canadian market, how many drugs are placed on the proposed List by the Minister of Health, and how many patients require drugs that are not already marketed in Canada. The benefits are therefore difficult to quantify, as it is impossible to estimate the number of lives that can be saved through timely access to drugs, or the economic benefit of fewer work hours lost due to illness during a public health emergency.
With regard to treating opioid use disorder, the Regulations would not reduce the number of people becoming addicted to both licit and illicit opioids. However, the proposal has the potential to increase access to treatment options. Nevertheless, the successful treatment of opioid use disorder is dependent on many other variables, and it is impossible to state how the access to the drugs made available by the Regulations will affect treatment success rates precisely. Furthermore, successful treatment could allow more illicit users to be brought into treatment and would reduce the social and economic costs to society. Several studies have shown the net positive socio-economic benefit of effective treatment programs. (see footnote 3)
The Regulations could also help address future health emergencies and mitigate associated costs. Using the 2003 SARS crisis in Toronto as an example, over the six-month outbreak in Toronto, there were 44 deaths, 400 hospitalizations and 25 000 people quarantined. (see footnote 4) The tourist industry reported an economic loss of $350 million and the retail sector reported seasonal adjusted losses of $380 million. (see footnote 5) If a drug that was not available in Canada was approved in another jurisdiction and could be rapidly deployed in Canada, there is the potential for substantial positive health outcomes and economic benefits in the event of a health crisis.
Finally, the Regulations also have positive benefits on drug importers, since they will be able to have access to a new revenue stream as they are contracted to import and distribute drugs placed on the List.
The total costs associated with this optional regulatory approach for importing drugs for use in a health emergency is also dependent on the number of drugs being imported, the number of health crisis that occurs and the number of serious ADRs that occur and are attributed to the drugs on the List.
By utilizing the powers under Vanessa’s Law to require adverse reaction reporting from health care institutions that provide acute care services, the Regulations place an administrative burden on these facilities, estimated at approximately $3,400 per year. This calculation is based on the assumption that each report would cost $100 (see footnote 6), and that there would be 34 (see footnote 7) reports per year. This suggests that the number of serious ADRs being reported would not overburden the acute care facilities.
The reporting requirement for those EL holders used for bulk importations are estimated at $900 annually. This is based on the assumption that, on an annual basis, there would be 20 (see footnote 8) bulk shipments of drugs from the List and that it would cost EL holders $45 (see footnote 9) bulk shipment to meet the additional regulatory requirements.
These requirements would not represent a higher burden compared to the existing requirements for the importation of a drug into Canada; in fact, the reporting requirements would be less burdensome, since the importer would not have access to, and therefore would not have to report, all the information that would be available during the importation of a drug already approved in Canada.
The cost to Government is considered to be insignificant as the review of adverse reaction reports from the SAP already occurs and the cost of maintaining the list of drugs for importation should not add any burden.
The total costs are therefore estimated to be $4,300 annually, or a present value cost of $28,797 over 10 years, discounted by 7%.
Implementation, enforcement and service standards
An Order in Council brought into force section 5, subsection 6(3) and section 4 of the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) that require the reporting by health care institutions of serious adverse drug reactions as well as the Governor in Council regulation-making authority respecting those requirements. The Regulations come into force on the same day or, if they are registered after that day, they come into force on the day they are registered.
Health Canada has developed a guidance document entitled Questions and Answers on the Importation of Drugs for an Urgent Public Health Need that details the process by which the Department will add a drug to or remove it from the List and the means by which a public health official can notify the Minister for the purposes of amending the List or keeping the drug on the List. It also provides further information to stakeholders regarding this new scheme. Both the guidance document and the List are available on Health Canada’s website.
As the Regulations will not impose substantial new obligations on existing stakeholders, it is expected that existing compliance and enforcement activities with respect to EL holders would suffice. At the border, the details provided on the List with respect to a drug will allow for the Canada Border Services Agency to determine, by examining the foreign labelling of the drug, whether it is eligible under this scheme for importation.
Any activities public health officials deem necessary to support the safe and effective use of the drug, including how the drug is provided to patients and whether the foreign labelling needs to be supplemented, would remain their responsibility.
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Department of Health
Holland Cross, Suite 14
11 Holland Avenue
Address Locator: 3000A
- Footnote a
S.C. 2014, c. 24, s. 6(4)
- Footnote b
R.S., c. F-27
- Footnote c
S.C. 2016, c. 9, s. 8
- Footnote d
S.C. 2014, c. 24, ss. 6(1) and (3)
- Footnote e
R.S., c. F-27
- Footnote 1
C.R.C., c. 870
- Footnote 2
Details of the Interim Order are available at http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/announce-annonce/notice-avis-nasal-eng.php.
- Footnote 3
Journal of Mental Health Policy and Economics, March 2000, Volume 3, Issue 1, pp. 1–58.
- Footnote 4
Varia, M., Wilson, S., Sarwal, S., McGeer, A., Gournis, E., Galanis, E., Henry, B.; Hospital Outbreak Investigation Team. Investigation of a nosocomial outbreak of severe acute respiratory syndrome (SARS) in Toronto, Canada. CMAJ 2003 Aug;169(4): pp. 285-292.
- Footnote 5
National Advisory Committee on SARS and Public Health, Naylor, D., Learning from SARS: renewal of public health in Canada: A report of the National Advisory Committee on SARS and Public Health. Ottawa: Health Canada; 2003.
- Footnote 6
This would cover the salaries of the staff creating the report, the physician verifying the report, and the administrator approving its release. Acute care facilities will have their own procedures in place. This breakdown is used only as an example.
- Footnote 7
This estimate is derived from the number of ADRs associated with Vivitrol in the United States, scaled to Canada’s population size.
- Footnote 8
This estimate is based on the assumption that there would be two products imported every year on average, and that products would be imported in bulk shipments no more than 10 times per year.
- Footnote 9
This estimate is based on the assumption that reporting each importation to Health Canada would cost $15 (assuming 15 minutes of work at an hourly rate of $60), and that record-keeping for the purposes of fulfilling the recall provisions would require a further 30 minutes of work at the same hourly rate.