Vol. 149, No. 12 — June 17, 2015

Registration

SOR/2015-132 June 5, 2015

CONTROLLED DRUGS AND SUBSTANCES ACT

Regulations Amending the Narcotic Control Regulations and the Marihuana for Medical Purposes Regulations (Communication of Information)

P.C. 2015-759 June 4, 2015

Whereas the annexed Regulations provide for the communication of information referred to in paragraph 55(1)(s) of the Controlled Drugs and Substances Act (see footnote a) to certain classes of persons and, in the opinion of the Governor in Council, it is necessary to communicate that information to those classes of persons for the proper administration or enforcement of the Act or the regulations;

Therefore, His Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 55(1) of the Controlled Drugs and Substances Act (see footnote b), makes the annexed Regulations Amending the Narcotic Control Regulations and the Marihuana for Medical Purposes Regulations (Communication of Information).

REGULATIONS AMENDING THE NARCOTIC CONTROL REGULATIONS AND THE MARIHUANA FOR MEDICAL PURPOSES REGULATIONS (COMMUNICATION OF INFORMATION)

NARCOTIC CONTROL REGULATIONS

1. Subsection 2(1) of the Narcotic Control Regulations (see footnote 1) is amended by adding the following in alphabetical order:

“former marihuana Regulations”
« ancien règlement concernant la marihuana »

“former marihuana Regulations” means the Marihuana Medical Access Regulations made by Order in Council P.C. 2001-1146 of June 14, 2001 and registered as SOR/2001-227.

2. Section 57 of the Regulations is replaced by the following:

57. (1) The Minister must provide in writing factual information about a practitioner that has been obtained under the Act, these Regulations, the Marihuana for Medical Purposes Regulations or the former marihuana Regulations to the provincial professional licensing authority that is responsible for the registration or authorization of persons to practise the profession

(2) The Minister is authorized to provide, in respect of a practitioner of medicine who made a medical declaration that formed the basis for the issuance of an authorization to possess under the former marihuana Regulations, the following information to the provincial professional licensing authority that is responsible for the registration or authorization of persons to practise medicine in the province identified in the declaration as the province in which the practitioner is authorized to practise:

3. The Regulations are amended by replacing “Marihuana Medical Access Regulations” with “former marihuana Regulations” in the following provisions:

MARIHUANA FOR MEDICAL PURPOSES REGULATIONS

4. (1) The definition “health care practitioner” in subsection 1(1) of the Marihuana for Medical Purposes Regulations (see footnote 2) is replaced by the following:

“health care practitioner”
« praticien de la santé »

“health care practitioner” means, except in sections 102 and 102.1, a medical practitioner or a nurse practitioner.

(2) Subsection 1(1) of the Regulations is amended by adding the following in alphabetical order:

“former Regulations”
« ancien règlement »

“former Regulations” means the Marihuana Medical Access Regulations made by Order in Council P.C. 2001-1146 of June 14, 2001 and registered as SOR/2001-227.

5. The Regulations are amended by adding the following after section 40:

Notice to licensing authorities

40.1 (1) Within 30 days after the issuance of its licence, a licensed producer must provide a written notice to each licensing authority that is responsible for the registration or authorization of persons to practise medicine or nursing in each province and provide a copy of the notice to the Minister.

Content of notice

(2) The notice must contain the following information:

6. Section 102 of the Regulations is replaced by the following:

Definition of “health care practitioner”

101.1 In sections 102 and 102.1, “health care practitioner” means

Information concerning health care practitioners

102. (1) A licensed producer must provide in writing, as soon as feasible, any factual information about a health care practitioner that has been obtained under the Act or these Regulations to the licensing authority that is responsible for the registration or authorization of persons to practise the profession

Factual information

(2) The factual information that may be requested includes information — notably patient information — contained in, or in respect of,

Secure transmission

(3) A licensed producer must ensure that information that is provided under this section is securely transmitted.

Quarterly reports to licensing authorities

102.1 (1) A licensing authority that is responsible for the registration or authorization of persons to practise medicine or nursing in a province may submit a written request to a licensed producer to receive information, on a quarterly basis, in respect of each client who is registered by the producer on the basis of a medical document that was signed by a health care practitioner. The health care practitioner must have been entitled, at the time of the verification performed in accordance with section 110, to practise the relevant profession in the province and must have been consulted in that province.

Information

(2) A licensed producer who receives a request must, after the end of each quarter and in accordance with subsection (3), provide the licensing authority with the following information in respect of each client referred to in subsection (1) who was validly registered at any time during the relevant quarter, together with details of any changes to the information that have occurred during the quarter:

Quarterly deadlines

(3) The information must be provided to the licensing authority by

Initial report

(4) For greater certainty, for the purpose of subsection (2), the first quarter in respect of which information must be provided is the quarter in which the request is received.

No information to provide

(5) If the licensed producer has no information to provide for a particular quarter, they must send a notice to that effect to the licensing authority by the relevant deadline referred to in subsection (3).

Deadline — ceasing activities

(6) If the licensed producer ceases to conduct activities, any information that they are required to provide to the licensing authority must, despite subsection (3), be provided no later than 30 days after the activities cease.

Revocation notice

(7) The licensing authority may, at any time, send the licensed producer a notice revoking the request referred to in subsection (1), in which case the final quarter in respect of which information must be provided to the authority is the one that precedes the quarter in which the notice is received.

Transmission of information

(8) A licensed producer, or former licensed producer, who provides information to a licensing authority under this section must

7. Section 147 of the Regulations is replaced by the following

Notices

147. A licensed producer must keep a copy of

8. The Regulations are amended by adding the following after section 147:

COMMUNICATIONS WITH LICENSING AUTHORITIES

Documents

147.1 A licensed producer must keep

9. (1) Paragraph 148(2)(a) of the Regulations is replaced by the following:

(2) Paragraph 148(2)(b) of the French version of the Regulations is replaced by the following:

(3) Subsection 148(2) of the Regulations is amended by striking out “and” at the end of paragraph (k) and by adding the following after paragraph (l):

10. The Regulations are amended by adding the following after section 259.3:

Licensing Authorities

Communication of historical information to licensing authorities

259.4 (1) A licensing authority that submits — on or before the day that is six months after the day on which this section comes into force — a request under subsection 102.1(1) may indicate in the request that it also wishes to receive information in respect of clients who were registered by the licensed producer on the basis of a medical document referred to in that subsection at any time during the period beginning on the day on which the producer was first issued a licence and ending on the day before the first day of the quarter in which the request is received, including clients whose registrations are no longer valid when the request is received.

Obligation to provide information

(2) If a licensed producer receives a request that has been submitted in accordance with subsection (1), they must, when they first provide information to the licensing authority under section 102.1, also provide the authority with the following information in respect of each client referred to in subsection (1):

Obligation to retain information

(3) A licensed producer must, in addition to any other retention period that may apply under these Regulations, retain any information that the licensed producer is, or may be, required to provide to a licensing authority under subsection (2) for as long as is necessary to be able to meet the obligations that the licensed producer has, or that may arise, under that subsection.

Additional obligations

(4) The licensed producer must comply with the requirements of the following provisions in respect of the information that is provided to the licensing authority:

No information to provide

(5) If the licensed producer has no information to provide, they must

Former licensed producers

(6) If the licensed producer’s licence expires without being renewed or is revoked, the former licensed producer must comply with the requirements of paragraphs 148(1)(a) and (2)(o) and section 149 in respect of any information that was provided under subsection (2).

11. The English version of the Regulations is amended by replacing “sent” with “provided” in the following provisions:

COMING INTO FORCE

12. 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.)

Executive summary

Issues: The Marihuana for Medical Purposes Regulations (MMPR) came into force on June 7, 2013. The MMPR aim to treat dried marihuana as much as possible like other narcotic drugs by creating the conditions for a commercial industry that produces and distributes quality controlled dried marihuana to individuals who receive support from their healthcare practitioners.

Despite the move to treat dried marihuana as much as possible like other narcotic drugs, to date, the scientific evidence supporting the safety and efficacy of dried marihuana for medical purposes has not reached the level required by the Food and Drugs Act and its regulations to which all other marketed narcotic drugs are subject. Therefore, healthcare practitioners have expressed concern with providing their patients with medical documents to support their access to dried marihuana.

Unlike other prescribed narcotics, there is very limited monitoring of professional practice of healthcare practitioners in respect to marihuana for medical purposes. The provincial and territorial healthcare licensing authorities, who regulate physicians and nurse practitioners, have identified the need to provide better education and guidance for and monitoring of their members who provide medical documents to their patients to support their access to marihuana for medical purposes. They have requested to be provided with access to information from licensed producers of marihuana for medical purposes on the medical documents signed by their members, to allow them to, amongst other things, provide better monitoring. Better monitoring of healthcare practitioners who provide their patients with a medical document to support their registration with a licensed producer of marihuana for medical purposes would help support the integrity of the MMPR.

Description: The Regulations Amending the Narcotic Control Regulations and Marihuana for Medical Purposes Regulations (Communication of Information) require licensed producers of marihuana for medical purposes, who receive a request from a healthcare licensing authority, to provide quarterly reports to the authority about their members who provided their patients with a medical document supporting the patients’ registration with a licensed producer. These reports would include healthcare practitioner information (name, address and professional licence number), daily quantity of dried marihuana supported, period of use, the date the document was signed by the practitioner, the quantity of dried marihuana provided to the client in each shipment and the date of the shipment, and basic client information (name, date of birth, postal code and province where the client ordinarily resides). In the course of an investigation, healthcare licensing authorities would also be able to seek factual information, including client personal information that was contained on the document used by the licensed producer to register the client (e.g. client name and date of birth).

The information that would be provided to the healthcare licensing authorities is consistent with the information collected by most provincial and territorial prescription monitoring programs. Patient information is provided to make follow-up with healthcare practitioners with respect to professional practice more meaningful and targeted. The Regulations would require licensed producers to provide quarterly reports in a compatible electronic format and to securely transmit the information to the healthcare licensing authorities.

The Narcotic Control Regulations (NCR) are amended to allow Health Canada to provide healthcare practitioner names, addresses and professional licence numbers (if available) — collected under the repealed Marihuana Medical Access Regulations (MMAR) — to their licensing authorities.

Cost-benefit statement: Based on an assumed total of 50 licensed producers, each submitting up to 25 data extracts to the healthcare licensing authorities per reporting cycle, the total annualized average cost to the industry is estimated to be about $676,279, assuming an annual discount rate of 7% for 10 years. Total present value, in 2012 dollars, over the impact period (2015–2025) is $4,749,899.

Health Canada will incur a one-time administrative cost of $5,047 to extract and share the information collected under the MMAR, as authorized by the Regulations.

The benefits of the proposal were not quantifiable.

“One-for-One” Rule and small business lens: This regulatory initiative will impose some burden on licensed producers of marihuana for medical purposes, as a result of requiring them to prepare, store and securely transmit reports to healthcare licensing authorities. The “One-for-One” Rule would not apply to the preparation and transmission of the reports, as the reports produced by the licensed producers would be provided directly to the provincial and territorial healthcare licensing authorities to enable them to more effectively monitor the practices of their members in respect to marihuana for medical purposes. The “One-for-One” Rule would, however, apply to the requirement for the licensed producers to maintain a copy of the report sent to the healthcare licensing authorities. During the 30-day comment period following prepublication in the Canada Gazette, Part I, on June 14, 2014, no issues were raised by licensed producers with the burden associated with the preparation and transmission of the reports to licensing authorities.

The small business lens does not apply as the estimated nationwide cost impacts do not meet the $1 million threshold for the small business lens, and there is no disproportionate impact on small business.

Domestic and international coordination and cooperation: The proposal takes into consideration the request from provincial and territorial healthcare licensing authorities for regulatory provisions to require licensed producers of marihuana for medical purposes to provide them with enhanced information on their members’ practices relating to marihuana.

Background

The Controlled Drugs and Substances Act (CDSA) and its regulations provide a framework for control of substances that can alter mental processes and that may harm an individual or society when misused or diverted to an illicit market. The purpose of the CDSA and its regulations is to protect public health and maintain public safety by balancing the need for access to these substances for medical, scientific and industrial purposes with the need to minimize the risk of their misuse or diversion.

Canadian courts have determined that individuals who have demonstrated a medical need for marihuana must have reasonable access to a legal source of marihuana for medical purposes.

The MMPR came into force on June 7, 2013. The MMPR aim to treat marihuana as much as possible like other narcotic drugs used for medical purposes, by creating the conditions for a commercial industry that produces and distributes quality controlled dried marihuana to individuals who have a medical document from their healthcare practitioner to support their registration with a licensed producer. The MMPR were developed as a comprehensive response to various concerns raised by stakeholders in relation to the MMAR, which were repealed on March 31, 2014.

Cannabis is also regulated by the Narcotic Control Regulations (NCR).

Medical use of marihuana

Controlled substances that meet the definition of a drug under the Food and Drugs Act (FDA) are generally subject to the requirements of the FDA and the Food and Drug Regulations (FDR) [e.g. to become an approved drug]. To date, the scientific evidence supporting the safety and efficacy of dried marihuana for medical purposes has not reached the level required by the FDA and the FDR, and therefore, dried marihuana is not an approved therapeutic product in Canada, does not have a Drug Identification Number, and is not otherwise endorsed by Health Canada. However, Canadian courts have found that individuals who need marihuana for medical purposes have a right to reasonable access to a legal source of marihuana. Therefore, dried marihuana produced by licensed producers, other than marihuana to be used for the purpose of a clinical trial, is exempted from the requirements of the FDR. Through the work of an expert advisory committee, Health Canada has made some scientific and medical information available about the use of marihuana for medical purposes. Notwithstanding these efforts, the information and other resources available to healthcare professionals is less than would typically be available for an approved prescription narcotic.

Narcotic and other prescription monitoring programs

In addition to these clinical information resources, the risks associated with the medical use of narcotics are also managed through monitoring. Systems vary across the provinces and territories, but in most jurisdictions, medical use of narcotics is monitored through a triplicate prescription program or prescription monitoring program. These monitoring programs are intended to promote the appropriate use of certain drugs which have the potential for abuse, misuse and diversion for non-medical purposes. Under these programs, each prescription is tracked. The information is captured from either the healthcare practitioner’s office or the pharmacy or both. Generally, one organization within the provincial health system plays a lead role in the monitoring program, but other organizations may have access to the data in line with their mandate. The information captured in these systems is used to look for prescription narcotic use outside clinical norms, to monitor healthcare practitioner’s prescribing patterns, to identify patients who may be exhibiting drug-seeking behaviour and to monitor and manage prescription drug costs. Marihuana is not captured by these programs.

Healthcare licensing authorities

Healthcare licensing authorities, which oversee the professional practice of medicine and nursing across all jurisdictions in Canada, determine who is licensed to practise and regulate the professional practices of their members to protect and serve the public interest. Among other things, healthcare licensing authorities determine professional practice standards and quality assurance relating to areas such as patient care and safety to which all its members must comply. Healthcare licensing authorities also play a critical role in monitoring and maintaining standards of practice and investigating complaints on behalf of the public. In carrying out their public interest mandates, these authorities typically undertake both specific investigations into healthcare practitioners’ professional conduct, as well as broader reviews and analyses of competence within the profession. The former may lead to corrective action, while the latter tend to lead to information products and training programs.

The role of licensing authorities in drug monitoring

Prescribing practices of healthcare practitioners, particularly with respect to controlled substances, is an area for which most licensing authorities have some form of active monitoring. Licensing authorities use information from monitoring programs to watch for potential harm, misuse or diversion. In some cases, they conduct system-wide analysis of drug use to look for unusual patterns of behaviour. They may also analyze the practices of individual healthcare practitioners. In both these instances, the licensing authorities may then initiate further investigations, identify training needs or simply flag out-of-norm patterns to practitioners. In some jurisdictions, they also monitor patient behaviours. If they find indications that a patient has multiple prescriptions for the same substance, they may flag it to practitioners involved in the patient’s care.

Under the current MMPR, provincial or territorial licensing authorities responsible for the practice of medicine or nursing may obtain factual information regarding a healthcare practitioner from licensed producers in the course of a professional investigation using section 102 of the MMPR. This is a limited authority that permits a healthcare licensing authority to obtain specific information from licensed producers about a specific healthcare practitioner. There were no requirement or authorization for licensed producers to share information about all healthcare practitioners who support access to dried marihuana for medical purposes and their patients with the practitioner’s licensing authority in order to support active monitoring.

Issues

The amended Regulations will enable the sharing of information with healthcare licensing authorities to enhance their capacity to monitor the professional practices of their members in regard to marihuana for medical purposes.

Marihuana is a controlled substance, similar to other narcotics used for medical purposes (e.g. like other narcotics it is listed in the schedule to the NCR). Like other narcotics used for medical purposes, dried marihuana is susceptible to misuse and abuse and oversight from government and healthcare licensing authorities is desirable. Since dried marihuana is not an approved therapeutic product in Canada, support by healthcare practitioners and use by patients are not currently monitored in most instances by the provinces or territories, healthcare licensing authorities, or other established narcotic monitoring systems that may be in place. Thus, healthcare licensing authorities did not have the tools to effectively monitor the practices of their members as they relate to marihuana for medical purposes. As a result, healthcare licensing authorities may not have the base of information to be able to provide education, support and feedback to healthcare practitioners as appropriate.

Healthcare licensing authorities have indicated that obtaining access to data on patterns of healthcare practitioners who provide medical declarations or medical documents in support of access to marihuana for medical purposes is an important step in improving their capacity to monitor the professional practices of their members with respect to marihuana for medical purposes. This information would enable healthcare licensing authorities to establish a baseline of information on overall patterns of access to marihuana for medical purposes, as well as individual healthcare practitioner behaviour. Access to basic patient information will enhance their ability to monitor for high dosages, multiple medical authorizations and multiple registrations with licensed producers. Improved oversight by healthcare licensing authorities may result in better education and support tools for healthcare practitioners, as well as enhanced patient safety.

The approach for sharing information is consistent with the mandate of the provincial and territorial healthcare licensing authorities and the level of access to information some of the licensing authorities have today under provincial and territorial monitoring programs for FDA approved narcotic drugs.

Objectives

In support of the overall goals of the MMPR, these regulations will achieve the objective of enhancing the role of healthcare practitioners under the MMPR by requiring licensed producers to share transactional information with their healthcare licensing authorities. The regulatory amendments will also enable Health Canada to proactively share healthcare practitioner information obtained under the MMAR.

Description

Consistent with the objective of providing information to healthcare licensing authorities to allow them to more effectively monitor the practice of their members, the Regulations will implement the following changes to the NCR:

Consistent with the objective of providing information to healthcare licensing authorities to allow them to more effectively monitor the practice of their members, the Regulations will implement the following changes to the MMPR:

Regulatory and non-regulatory options considered

To address the issue regarding the sharing of information with healthcare licensing authorities described above, the following options were considered.

Option 1: Status quo

Under this option, Health Canada would not make any changes to the MMPR or NCR.

Healthcare licensing authorities would be restricted to requesting that their members provide them with copies of medical documents provided to patients requiring access to marihuana for medical purposes. Healthcare licensing authorities would not be able to confirm if the medical document was used to register with a licensed producer. In this option, licensing authorities would essentially be limited to obtaining factual information about healthcare practitioners in the context of an investigation or compelling information from all healthcare practitioners under their jurisdiction.

The status quo option does not respond to the request made to Health Canada by healthcare licensing authorities to increase the information available to them in line with that which is available under some provincial and territorial monitoring programs on other narcotics used for medical purposes.

Option 2: Use existing authorities under the MMPR for Health Canada to compel information on healthcare practitioners from the licensed producers, and then share that information with the relevant medical and nursing licensing authorities

Section 149 of the MMPR requires that licensed producers provide the Minister with any information that the Minister may require in respect to records, documents and information referred to in the MMPR, in the form and time that the Minister specifies.

In this option, Health Canada would collect the information required by the healthcare licensing authorities on their members from the licensed producers, then use existing information sharing arrangements with the licensing authorities to proactively share the information. Where information-sharing arrangements do not exist, these arrangements would be established.

This option was rejected as it would require Health Canada to systematically collect personal information, which goes against one of the benefits of the MMPR. As well, this option would not provide the authority for Health Canada to proactively provide healthcare licensing authorities with the information they have identified they require to monitor the practices of their member in regard to marihuana for medical purposes.

Option 3: Recommended option

As described above, the recommended option requires licensed producers of marihuana for medical purposes to provide quarterly reports to healthcare licensing authorities about their members who provided their patients with a medical document supporting the patients’ registration with a licensed producer, including patient information. The information that would be provided to the healthcare licensing authorities is consistent with information collected under many provincial and territorial narcotic or other prescription monitoring programs.

These Regulations would provide healthcare licensing authorities with the information they have identified they require to better monitor the practices of their members with respect to marihuana for medical purposes. It would also give them the basis of information to develop education and guidance materials on marihuana for medical purposes in support of their members.

Cost assessment

The main cost associated with these regulatory amendments would arise from the need for licensed producers to prepare, store and provide quarterly reports to healthcare licensing authorities, when requested by the licensing authorities, about healthcare practitioners who provided their patients with medical documents required to register with a licensed producer and about their patient. Consumers would not be directly affected financially by the changes.

Licensed producers’ costs are summarized in Table 1. Based on an assumed total of 50 licensed producers, each submitting up to 25 data extracts to the healthcare licensing authorities per reporting cycle, the total annualized average cost to the industry is estimated to be about $676,279, assuming an annual discount rate of 7% over 10 years. The total present value, in 2012 dollars, over the policy impact period (2015–2025) is approximately $4,749,899.

Health Canada will incur a one-time administrative cost to extract and share the information collected under the MMAR, as required by the Regulations, at a total present value of $5,047.

The benefits of the proposal are explained elsewhere in this Regulatory Impact Analysis Statement and are not quantifiable.

Table 1 — Regulatory cost summary

Stakeholder Impact Activity Present Value (2012 CAD $) Annualized Average Cost Assumptions
1. Consumers        
No impact   None None The Regulations would not impose direct costs on patients who use marihuana for medical purposes or the general public.
2. Business        
Compliance Purchase secure USB keys for storing and transferring personal information to healthcare licensing authorities (see note 2) $2,295,795 $326,870 Assumes most or all licensed producers would use new, secure USB keys to transmit the data each cycle. No fixed capital costs, other equipment, software or infrastructure upgrade is required.
Ongoing purchases of materials required to store and transmit information in a secured manner Secured mailing/courier of USB keys to healthcare licensing authorities $304,468 $43,349 Each licensed producer would provide up to 25 reports by secure mail to the various healthcare licensing authorities across the country. This task would be undertaken by a clerk and would take up to 30 minutes of a clerk’s time to arrange for the courier or mail services.
  Learning about the new information sharing $1,064 $151 The Regulations would require licensed producers to share certain information collected under the MMPR. All businesses in the industry are new and may not be familiar with a requirement to share information with third parties (i.e. healthcare licensing authorities).
Ongoing cost of labour for time spent in preparing, reviewing and submitting data extracts Data retrieval, manipulation, checking and presentation $821,067 $116,901 Information retrieval and preparation for each licensing authorities would take about an hour to complete or a maximum of 25 hours, if a licensed producer prepares the maximum 25 reports each cycle.
  Review and approve data extracts/reports $658,027 $93,688 Management time allotted to review and approve data extract would take about 30 minutes per report or a maximum of 12.5 hours if a licensed producer prepares the maximum 25 reports per reporting cycle.
  Encryption, submission and follow-up $658,027 $93,688 Time allotted for follow-up and information/data clarification requests.
Notification of licence to licensing authorities Notify healthcare licensing authorities of licensed producers $1,164 $166 One-time cost to provide a notice to the colleges and Minister that the producer has been licensed.
Administrative Meet record-keeping requirements (of quarterly reports) $9,996 $1,423 This assumes that a clerk will spend about 15 minutes to copy and file a copy of each report submitted to a healthcare licensing authority.
  Providing the Minister with copy of notification to healthcare licensing authorities of becoming licensed $145 $21 This assumes a clerk will spend about 15 minutes making a copy of the notification provided to the healthcare licensing authorities and providing the copies to the Minister.
  Meet record-keeping requirements (of notification) $145 $21 This assumes that it would take about 15 minutes of a clerk’s time to save electronic copies/print and file copies of the notification provided to healthcare licensing authorities.
Business costs   $4,749,899 $676,279  
3. Government        
Salary One-time staff hours spent on MMAR data retrieval, compilation and sharing with licensing authorities for medicine $3,877 $552 45.5 hours of staff time to retrieve, manipulate and present 13 reports plus 13 hours of follow-up.
Operations and maintenance Materials and services cost to transmit information to colleges $1,170 $167 Health Canada would be preparing data extracts from the MMAR on secure USB keys and securely delivering them to medical licensing authorities in all 13 provinces and territories.
Government costs   $5,047 $719  

“One-for-One” Rule

The costs for licensed producers sharing information with healthcare licensing authorities are not expected to be significant as the MMPR require licensed producers to retain records related to their registered clients. Businesses would, however, incur costs in the retrieval, preparation, transmittal of and follow-up on the information to be communicated to healthcare licensing authorities. With the projection of the number of licensed producers in the near future and the fact that information would need to be communicated to a maximum of 25 provincial licensing authorities for medicine and nursing, the regulatory cost calculator model indicates that the total annualized average administrative cost as a result of the regulatory amendments for the industry is $1,465.

The “One-for-One” Rule would not apply to the preparation and transmission of the reports prepared by the licensed producers as they would not be made to the federal government, but to the provincial and territorial healthcare licensing authorities. The “One-for-One” Rule would, however, apply to the requirement for the licensed producers to maintain a copy of the report sent to the healthcare licensing authorities. The “One-for-One” Rule would also apply to the one-time requirement for licensed producers to provide the Minister with a copy of the notification they are required to provide to all healthcare licensing authorities informing them of their becoming licensed, and the requirement to retain a copy of that notification.

Small business lens

The small business lens applies to regulatory proposals that impact small business and that have nationwide cost impacts of over $1 million annually. The estimated nationwide cost impacts do not meet this threshold, and there is no disproportionate impact on small business, therefore the small business lens does not apply.

Consultation

Initial stakeholder engagement (winter to spring 2014)

The amendments to the MMPR to allow for the communication of information on a quarterly basis regarding healthcare practitioners who support marihuana for medical purposes and their patients, when requested by the healthcare licensing authorities, respond to feedback from licensing authorities.

Health Canada engaged healthcare licensing authorities through the Federation of Medical Regulatory Authorities of Canada (FMRAC). FMRAC is the national organization and voice of the provincial and territorial medical licensing authorities. It considers, develops and shares positions and policies on matters of common concern and interest. Healthcare licensing authorities, through the FMRAC, have indicated that information on their members who support marihuana for medical purposes would better enable them to understand the practices of their members respecting marihuana for medical purposes, to gain knowledge regarding the use of marihuana for medical purposes, and to take appropriate actions, as necessary. The information elements that these Regulations require licensed producers to provide to provincial and territorial licensing authorities reflect the data elements that the licensing authorities identified as being necessary for effective monitoring and meaningful, targeted follow-up. These data elements are also consistent with information provided through provincial and territorial prescription monitoring programs for other narcotics.

Health Canada also made preliminary efforts to engage with nurse licensing authorities through their federal coordinating body. Nurse practitioner involvement in supporting marihuana for medical purposes is new under the MMPR, and not all nurse practitioners across Canada have authority under their provincial/territorial legislation to support narcotics, such as marihuana for medical purposes.

In addition, Health Canada undertook focused engagement on the proposed information-sharing regulations with a targeted group of licensed producers. Their perspectives represented those of small, medium and large licensed producers. Licensed producers were asked if they would see a value in creating a mechanism for them to share information with healthcare licensing authorities. Overall, licensed producers indicated that they would regard this as a positive opportunity, as it would reinforce the integrity of the MMPR.

Licensed producers were also asked about their record-keeping systems and the level of effort required to prepare reports with targeted information for healthcare licensing authorities, noting that information to be shared would already be included in the medical document. Licensed producers indicated that they did not think that the compilation of information for the healthcare licensing authorities would be burdensome. They indicated that the greatest level of effort would be associated with producing the first report. After that, they expected that the production of the reports would be straightforward.

On March 31, 2014, the Government announced its intentions to work with licensed producers to enhance information sharing with healthcare licensing authorities on how doctors and nurse practitioners are supporting the use of marihuana. No comments were received in the 30 days following the announcement.

Comments received during the 30-day comment period following prepublication of the proposed Regulations in the Canada Gazette, Part I, on June 14, 2014 (prepublication)

Health Canada received a total of 24 comments during the 30-day comment period following prepublication. Of these, 8 were from medical or nursing licensing authorities and FMRAC; 5 were from provincial governments; 2 were from medical associations; 2 were from industry; 3 were from other organizations; 1 was from the Office of the Privacy Commissioner of Canada; and 3 were from the general public.

Below is a summary of the major issues raised by stakeholders in the comments received during the comment period.

Issue: Staying apprised of new licensed producers entering the marketplace

Licensing authorities and some provinces expressed concern about how licensing authorities would stay up to date regarding the licensed producers entering the marketplace. Licensing authorities were also concerned with the burden of having to send individual letters to each licensed producer in order to obtain access to the information specified in the Regulations to support their monitoring activities. Licensing authorities are of the view that it is not their responsibility to track the approval of licensed producers over time. Some licensing authorities have suggested that the reports from licensed producers should be provided to them automatically.

Further stakeholder engagement

Health Canada discussed the proposal to require licensed producers to notify healthcare licensing authorities when they are licensed with the marihuana for medical purposes industry association. They recognized the need to ensure that licensing authorities are aware of new licensed producers coming on line. Their preference was to have Health Canada inform the licensing authorities of new licensed producers, but indicated that they would not object to the requirement for them to provide notifications to the licensing authorities.

Health Canada’s response

Health Canada understands the concern of healthcare licensing authorities and some provinces. To alleviate the burden of licensing authorities having to track licensed producers coming on line, the Regulations now require that licensed producers provide a notice to each provincial and territorial healthcare licensing authority upon being licensed. Reporting on a quarterly basis would only be initiated once licensed producers receive a request from the healthcare licensing authorities that they would like to be in receipt of the reports. Health Canada will also undertake to provide provincial and territorial healthcare licensing authorities with regular updates of active licensed producers that are approved to register clients.

Issue: Frequency of reports

Licensing authorities and some provinces expressed concern with managing the volume of information that they would receive on a semi-annual basis from licensed producers. Licensing authorities were also concerned with ensuring that there would not be too long of a time lag between reports for effective monitoring. Licensing authorities were of the view that information should be provided to them more frequently if warranted by volumes (e.g. quarterly).

Further stakeholder engagement

Health Canada discussed the increase in reporting frequency with the marihuana for medical purposes industry association. While they expressed that less frequent reporting would be preferable, they agreed that more frequent reporting could be managed without any significant concerns.

Health Canada’s response

To address the concerns raised by licensing authorities and some provinces, the Regulations now require licensed producers to provide reports to licensing authorities on a quarterly basis, when licensing authorities request that licensed producers provide these reports on a quarterly basis.

Issue: Data elements required by healthcare licensing authorities to support monitoring

Licensing authorities and some provinces have indicated that additional data elements would support their monitoring of how marihuana for medical purposes is supported. In particular, licensing authorities have noted the need to be able to verify that there is a bona fide healthcare practitioner-patient relationship, and that this could be accomplished through being provided the licensed producer’s clients’ addresses in addition to their name and date of birth.

Licensing authorities have also suggested that the licensed producers should be required to transmit the quantity of dried marihuana shipped to the client. Licensing authorities have indicated that this information mirrors the information provided in provincial and territorial monitoring programs, and it would enable them to understand the correlation between what amount is identified in the medical document and what amount is accessed by the client.

Further stakeholder engagement

Health Canada discussed with the marihuana for medical purposes industry association the proposal for licensed producers to be required to provide healthcare licensing authorities with client addresses. Licensed producers confirmed that they could reasonably manage the inclusion of the additional information elements.

Health Canada also discussed the inclusion of the additional information elements with the Office of the Privacy Commissioner of Canada which identified potential concerns with requiring licensed producers to provide client addresses to healthcare licensing authorities.

Health Canada discussed with FMRAC the proposal to require licensed producers to provide healthcare licensing authorities with the client address, in particular concerns that stakeholders would not have had the opportunity to be consulted on that additional information element. FMRAC agreed that a reasonable compromise would be to have licensed producers provide healthcare licensing authorities with the postal code and the province where the client ordinarily resides.

Health Canada’s response

To address the concerns raised by licensing authorities and some provinces, the Regulations now require licensed producers to provide the quantity of dried marihuana provided to the client in each shipment and the date of each shipment, as well as the postal code and the province where the client ordinarily resides. This change is in recognition that the best available Canadian drug monitoring programs include information from both the prescriber and the dispenser, and that most prescription monitoring program models also include patient address.

Issue: Protection of privacy

The medical associations stressed the need to safeguard physician and patient privacy. It was suggested that Health Canada undertake a privacy assessment on the Regulations.

Health Canada’s response

Health Canada has assessed how the Regulations would interact with the relevant privacy legislation across Canada. Licensed producers are subject to the Personal Information Protection and Electronic Documents Act (PIPEDA) or to provincial privacy legislation that has been found to be substantially similar to PIPEDA (in British Columbia, Alberta, and Quebec). These statutes regulate the collection, use and disclosure of personal information by businesses and other organizations. Licensed producers would have to respect these statutes when disclosing the personal information required under the Regulations. In addition, the Regulations require that the quarterly reports be securely transmitted in accordance with specifications set out in the Electronic Transmission Directive.

Issue: What is being monitored and what is considered to be a high dose of marihuana for medical purposes

The lack of guidance on dosage was noted by the medical associations and one of the non-governmental organizations. In particular there was concern that pain doctors may be targeted as over prescribers. It was suggested that the consequences of exceeding what is determined to be a high dose be clarified. It was also recommended that healthcare licensing authorities be specific about their criteria for monitoring.

Health Canada’s response

Health Canada will share these concerns with licensing authorities. Healthcare practitioners wishing to better understand what their licensing authority will be monitoring should make that inquiry directly with their licensing authority. It should, however, be noted that healthcare practitioners are experienced at monitoring, as in most jurisdictions, the medical use of narcotics is already monitored.

With respect to guidance on dosage, marihuana is not an approved drug or medicine in Canada and has not gone through the necessary rigorous scientific trials to establish efficacy or safety. However, Health Canada has developed an information document and a daily amount fact sheet to provide healthcare professionals with scientific and medical information to guide them in discussions with patients.

Currently available information suggests most individuals use less than three grams daily of dried marihuana for medical purposes, whether it is taken orally, inhaled, or a combination of both. Improved oversight by healthcare licensing authorities may result in better education and support tools for healthcare practitioners, as well as enhanced patient safety.

Issue: Sharing historical information with licensing authorities

One of the provincial medical associations noted concern with the provision that would allow for healthcare licensing authorities to request, within the first six months of the coming into force of the Regulations, information as specified under section 102.1 that was collected by licensed producers, prior to the coming into force of the Regulations. Licensing authorities expressed support for this approach.

Health Canada’s response

The information that licensing authorities will have an opportunity to access under these Regulations provides an opportunity for them not only to monitor the professional practices of their members, but to build a better knowledge base of how marihuana is used for medical purposes. In consideration of this, Health Canada is of the view that it is reasonable that licensing authorities would be given a time-limited opportunity to access information on all healthcare practitioners and their patients that have registered with licensed producers to access marihuana for medical purposes.

Issue: Access

One of the medical associations and the marihuana for medical purposes industry expressed concern that monitoring by the healthcare licensing authorities might deter healthcare practitioners from providing patients with medical documents to support their access to marihuana for medical purposes. Industry expressed concern that prospective clients might choose to purchase marihuana from illegal sources rather than have licensed producers share their information with healthcare licensing authorities.

Health Canada’s response

Health Canada does not endorse the use of marihuana. The courts have required reasonable access to a legal source of marihuana for medical purposes. The Government of Canada believes that access must be provided in a controlled fashion to protect public health and safety. The Regulations would allow healthcare licensing authorities to more effectively monitor the practices of practitioners who sign medical documents in support of their patients registering with a licensed producer to access marihuana for medical purposes. The monitoring that these Regulations would support is consistent with the monitoring of the medical use of narcotics that occurs in most jurisdictions to which healthcare practitioners are accustomed. Monitoring will also support the development of guidance for medical practice regarding the use of marihuana for medical purposes, and may result in enhanced patient safety.

Issue: Informing clients of information being shared with healthcare licensing authorities

A licensed producer suggested that Health Canada notify registered clients of the Regulations. A non-governmental association supported this point and suggested that patients be informed of what information would be shared with healthcare licensing authorities, as well as how the information would be used.

Health Canada’s response

Health Canada does not have a list of licensed producers’ clients. Health Canada has, however, undertaken to inform Canadians about these Regulations through a news release about Health Canada’s work to support the medical community in respect to marihuana for medical purposes that was posted on Health Canada’s Web site, as well as the prepublication of the proposed Regulations in the Canada Gazette, Part I.

Issue: Limiting which healthcare licensing authorities could access information from licensed producers

The Office of the Privacy Commissioner suggested that only licensing authorities whose province/territory has in place a prescription monitoring program should be able to receive information about how doctors and nurse practitioners are authorizing patient access to marihuana for medical purposes. A non-governmental organization also suggested that there be clarity around who would have access to the information provided by the licensed producers to the healthcare licensing authorities.

Health Canada’s response

The mandate of healthcare licensing authorities is, amongst other things, to monitor the professional practices of their members. Healthcare licensing authorities undertake these activities in the absence of prescription monitoring programs, although these activities are conducted in a more effective manner where prescription monitoring programs exist. While prescription monitoring programs do not exist presently in all jurisdictions across Canada, where they do not exist, provinces and territories are working to establish such systems. In consideration of these things, Health Canada is of the view that it is appropriate that healthcare licensing authorities would have the option of requesting information from licensed producers to support their monitoring. Healthcare licensing authorities are competent regulatory authorities that are accustomed to handling sensitive personal information in carrying out their mandates under provincial legislation.

Issue: Disclosure of client information to healthcare licensing authorities

The Office of the Privacy Commissioner questioned whether the disclosure of client information collected by licensed producers was necessary to support healthcare licensing authorities’ monitoring.

Further engagement with the Office of the Privacy Commissioner

Health Canada met with the Office of the Privacy Commission to discuss the concerns raised in their comments and to discuss the changes Health Canada was planning to make to the regulatory proposal in consideration of the feedback received from stakeholders during the 30-day comment period.

The Office of the Privacy Commissioner reiterated their concerns with sharing client personal information with healthcare licensing authorities. As noted above, the Office of the Privacy Commissioner also expressed concern with the proposal from healthcare licensing authorities to require licensed producers to provide client addresses to healthcare licensing authorities. Health Canada was, however, able to confirm that the sharing of this personal information is consistent with the best available prescription monitoring program models in Canada. No other specific concerns with the revisions, resulting from the comments received during the 30-day comment period, were raised.

Health Canada’s response

In provincial and territorial prescription monitoring programs, each prescription is tracked, including patient personal information. The information that would be shared with healthcare licensing authorities through these Regulations is consistent with information that is accessible to licensing authorities through provincial and territorial monitoring programs.

There were other comments provided in the context of these Regulations that were beyond the scope of this regulatory initiative. These comments cannot be addressed at this time, but will be considered in the future.

Rationale

Marihuana is a narcotic and is susceptible to misuse and abuse. Provincial and territorial prescription monitoring systems — that have been put in place in most Canadian jurisdictions — do not provide oversight for physicians and nurse practitioners who authorize marihuana for medical purposes. This is because dried marihuana is not an approved therapeutic product in Canada. While efforts have been made to make information and other resources available to healthcare professionals about marihuana for medical purposes, it is less than would typically be available for an approved prescription narcotic.

Healthcare licensing authorities that are responsible for the regulation of the professional practices of physicians and nurse practitioners have identified the need to obtain information that would allow them to provide better education, guidance and monitoring for their members in respect to marihuana for medical purposes. Licensing authorities have identified that regular information from licensed producers about healthcare practitioners who provide their patients with medical documents in support of registering with a licensed producer of marihuana for medical purposes, including patient information, would enhance their ability to monitor their members’ professional practices.

The amendments to the MMPR to require licensed producers to share information on a quarterly basis on the request of the healthcare licensing authorities about the professional practices of healthcare practitioners in authorizing marihuana for medical purposes with their licensing authorities would help ensure that healthcare practitioners are better guided and supported by their licensing authority. Licensing authorities would also be better positioned to provide feedback, when necessary, when anomalies are observed. Better information regarding the professional practices of healthcare practitioners in relation to authorizing marihuana for medical purposes would also help support the integrity of the MMPR.

Implementation, enforcement and service standards

The Regulations will come into force on the day on which they are registered.

Compliance with these Regulations will be monitored through the regular compliance monitoring of licensed producers.

Health Canada will implement the sharing of information from the MMAR with healthcare licensing authorities after the Regulations come into force.

Contact

Office of Controlled Substances
Controlled Substances and Tobacco Directorate
Healthy Environments and Consumer Safety Branch
Health Canada
Address locator: 0302A
150 Tunney’s Pasture Driveway
Ottawa, Ontario
K1A 0B9
Email: OCS_regulatorypolicy-BSC_politiquereglementaire@hc-sc.gc.ca