ARCHIVED — Vol. 148, No. 24 — June 14, 2014

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

Statutory authority

Controlled Drugs and Substances Act

Sponsoring department

Department of Health

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. As a result, 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 practices of healthcare practitioners in respect of marihuana for medical purposes. The provincial and territorial healthcare licensing authorities, which 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, among 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 proposed Regulations Amending the Narcotic Control Regulations and the Marihuana for Medical Purposes Regulations (Communication of Information) [“proposed Regulations”] would require licensed producers of marihuana for medical purposes, who received a request from a healthcare licensing authority, to provide semi-annual 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, and basic patient information (name and date of birth). Healthcare licensing authorities would also be able to request this information in the course of an investigation.

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 proposed Regulations would require licensed producers to provide the required information in a compatible electronic format and to securely transmit the information to the healthcare licensing authorities.

The Narcotic Control Regulations (NCR) would be 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) — with 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 $423,461, assuming an annual discount rate of 7% for 10 years. The total present value, in 2012 dollars, over the impact period (2015–2025) is $2,974,211.

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

The benefits of the proposal were not quantifiable.

“One-for-One” Rule and small business lens: This regulatory proposal would 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 of 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. Licensed producers engaged to date have acknowledged the benefits of this proposal, and did not expect that the preparation of reports would result in significant burden.

The small business lens does not apply as the estimated nationwide cost impacts do not meet the $1 million threshold 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 the 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, 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, there is less information and fewer other resources available to healthcare professionals 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 that 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 practitioners’ 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 with 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 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 analyses 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 for patient behaviours. If they find indications that a patient has multiple prescriptions for the same substance, they may notify the 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 is no requirement or authorization for licensed producers to share with the practitioner’s licensing authority information about all healthcare practitioners who support access to dried marihuana for medical purposes and their patients in order to support active monitoring.

Issues

The proposed amendments would enable the sharing of information with healthcare licensing authorities to enhance the capacity of medical and nursing licensing authorities 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 do 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 information necessary 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 the patterns of healthcare practitioners who provide medical declarations or medical documents in support of access to marihuana for medical purposes would be an important step to improve 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 baseline information on overall patterns of access to marihuana for medical purposes, as well as individual healthcare practitioner behaviour. Access to basic patient information would 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 proposed approach for sharing information is consistent with the mandate of the provincial and territorial healthcare licensing authorities and the level of access that 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 regulatory amendments would achieve the objective of enhancing the role of healthcare practitioners under the MMPR by requiring licensed producers to share transactional information with healthcare licensing authorities. The regulatory amendments would 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 practices of their members, the proposed Regulations would implement the following changes to the NCR:

  • Section 57: The proposed amendment would ensure that healthcare licensing authorities would continue to be able to request factual information about a practitioner obtained under the MMAR to support an investigation given the repeal of the MMAR.
  • This section would also be amended to allow the Department of Health to proactively share healthcare practitioner information obtained under the MMAR with their licensing authorities.
  • The information Health Canada is proposing to provide to the licensing authorities would include authorized medical practitioner information (name, address, and professional licence number, if available) as of March 31, 2014.

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

  • Section 102: This section would be amended to require licensed producers to provide healthcare licensing authorities with patient information from the medical document when requested by a licensing authority to support a professional investigation.
  • A new section would be added after section 102 to include a requirement for licensed producers to provide, when requested by the relevant healthcare licensing authority, healthcare practitioner information (name, address and professional licence number), daily quantity of dried marihuana indicated on the medical document, period of use, date the medical document was signed by the practitioner and basic patient information (name and date of birth) to the healthcare licensing authority.
  • Licensed producers would communicate this information to the relevant healthcare licensing authority in writing on a semi-annual basis (i.e. on January 31 and July 31). The amendments also require this information to be provided no later than 30 days after a licensed producer ceases to conduct activities.
  • The MMPR would also incorporate by reference the Electronic Transmission Directive that would set out the specifications to be followed for ensuring the secure transmission of the information, as well as the electronic format in which the information must be provided.
  • This amendment would allow the healthcare licensing authority to opt out of receiving information from licensed producers (after having opted in) when a written notice is provided.
  • The amended Regulations would also include a transition provision that would allow healthcare licensing authorities to request that the initial report from licensed producers include healthcare practitioner and patient information covering all registrations made on the basis of a medical document from the point at which the licensed producers were licensed to the end of the initial reporting period. Licensed producers would not, however, be required to provide records older than two years. The transition provision would be in effect for six months after the Regulations come into force.
  • A new section after section 259.3 would be added to allow healthcare licensing authorities to request, in the first six months of the coming into force of the new section, that licensed producers provide them with information on earlier registrations than those specified under new subsection 102.1(2). The time period for requesting this information would correspond with the requirement for licensed producers to maintain records for two years.
  • Section 147: These amendments would add a new section after section 147 of the MMPR to require licensed producers to keep records with respect to the provision of information to healthcare licensing authorities.
  • Subsection 148(2): The French version of paragraphs (a) and (b) would be amended to harmonize with the English version.
  • This subsection would also be amended to add new paragraphs specifying the records that licensed producers would be required to maintain in regard to information that they would be providing to healthcare licensing authorities, as well as communications with those authorities. This would include the specification that records are to be maintained under the proposed new section 147.1 for a period of two years.
  • Section 254 would be amended to ensure that the rule, which is specified in section 256, on how the term “medical document” is to be read in the MMPR would continue to apply after March 31, 2015.
  • Section 256 would be amended to clarify that authorizations to possess can only be used to register with a licensed producer until March 31, 2015.
  • Paragraph 256(a) would be amended to include an exception to the interpretation that the reference to a medical document is to be read as a reference to an authorization to possess in relation to paragraph 102(2)(a) and subsection 102.1(1).
  • Sections 257 and 258 would be repealed because, as of March 31, 2014, a medical declaration can no longer be used to register with a licensed producer.
  • Paragraph 259(a) would be amended to clarify that the term “medical document” used in paragraph 102(2)(a) and subsection 102.1(1) does not include medical declarations.

Regulatory and non-regulatory options considered

In addition to the proposed approach to communicate information to healthcare licensing authorities described above, the following options were considered:

Option 1: Use existing authorities under the MMPR for Health Canada to compel licensed producers to provide information on healthcare practitioners, 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, they 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 give healthcare licensing authorities the information they have identified they require to monitor the practices of their members in regard to marihuana for medical purposes.

Option 2: 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 3: Recommended option

As described above, the recommended option would require licensed producers of marihuana for medical purposes to provide semi-annual 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.

This regulatory amendment 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.

Benefits and costs

The main cost associated with these proposed regulatory amendments would arise from the need for licensed producers to prepare, store and send semi-annual reports to healthcare licensing authorities when requested by the licensing authorities about healthcare practitioners who provided their patients 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 $423,461, 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 $2,974,211.

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

The benefits of the proposal are explained elsewhere in this RIAS and are not quantifiable.

Table 1 — Regulatory cost summary

Stakeholder Impact Activity Present Value (2012 Canadian Dollars) Annualized Average Cost Assumptions
1. Consumers        
  No impact None None The proposed 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 1) $1,437,921 $204,728 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 $187,648 $26,717 Each licensed producer would send 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 $2,313 $329 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 $515,514 $73,398 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 $413,148 $58,823 Management time allotted to review and approve data extract would be 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 $413,148 $58,823 Time allotted for follow-up and information/data clarification requests.
Administrative Meet record-keeping requirements $ 4,519 $643 This assumes that a clerk will spend about 15 minutes to copy and file a copy of each report submitted to a professional licensing authority.
Business costs   $2,974,211 $423,461  
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  

Note 1
While it is unknown what secure approach to the transmission of information will be used by licensed producers, Health Canada has used the example of the purchase of secure USB keys and ongoing mailing costs (e.g. registered mail) as the most expensive option that licensed producers might employ to securely transfer the required information to the healthcare licensing authorities.

“One-for-One” Rule

The costs for licensed producers to share information with healthcare licensing authorities are not expected to be significant as the MMPR already require licensed producers to retain records related to their registered patients. Businesses would, however, incur costs in retrieving, preparing, transmitting and following up on the information to be communicated to healthcare licensing authorities. Given 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 proposed regulatory amendments for the industry is $643.

The “One-for-One” Rule would not apply to the preparation and transmission of the reports prepared by licensed producers as they would be made not 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 licensed producers to maintain a copy of the report sent to healthcare licensing authorities.

Small business lens

The small business lens applies to regulatory proposals that impact small businesses 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 businesses. Therefore, the small business lens does not apply.

Consultation

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

Health Canada has 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 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, gain knowledge regarding the use of marihuana for medical purposes, and take appropriate actions, as necessary. The information that these Regulations would require licensed producers to provide to provincial and territorial licensing authorities reflects the data that licensing authorities identified as being necessary for effective monitoring and meaningful, targeted follow-up. These data are also consistent with information provided through provincial and territorial prescription monitoring programs of other narcotics.

Health Canada has 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 the 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 saw 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 the 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 of Canada 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.

Rationale

Marihuana is a narcotic and is susceptible to misuse and abuse. Provincial and territorial prescription monitoring systems — which 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. Despite the efforts that have been made, there is less information and fewer other resources about marihuana for medical purposes available to healthcare professionals 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 with respect to marihuana for medical purposes. Licensing authorities have identified that regular information, including patient 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 would enhance their ability to monitor their members’ professional practices.

The amendments to the MMPR to require licensed producers to share information 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 provisions requiring licensed producers to begin sharing information with healthcare licensing authorities in accordance with the Regulations would come into force on the day on which the Regulations are registered.

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

Health Canada would 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

PROPOSED REGULATORY TEXT

Notice is given that the Governor in Council, pursuant to subsection 55(1) of the Controlled Drugs and Substances Act (see footnote a), proposes to make the annexed Regulations Amending the Narcotic Control Regulations and the Marihuana for Medical Purposes Regulations (Communication of Information).

Interested persons may make representations concerning the proposed Regulations within 30 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to the Office of Controlled Substances, Controlled Substances and Tobacco Directorate, Health Canada, Address Locator 0302A, 150 Tunney’s Pasture Driveway, Ottawa, Ontario, K1A 0K9 (email: OCS_regulatorypolicy-BSC_politiquereglementaire@hc-sc.gc.ca).

Ottawa, June 5, 2014

JURICA ČAPKUN
Assistant Clerk of the Privy Council

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

NARCOTIC CONTROL REGULATIONS

1. Section 57 of the Narcotic Control Regulations (see footnote 1) 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 Marihuana Medical Access Regulations to the provincial professional licensing authority that is responsible for the registration or authorization of persons to practise the profession

  • (a) in a province in which the practitioner is, or was, registered or entitled to practise if
    • (i) the authority submits a written request that sets out the practitioner’s name and address, a description of the information being sought and a statement that the information is required for the purpose of assisting a lawful investigation by the authority, or
    • (ii) the Minister has reasonable grounds to believe that the practitioner
      • (A) has contravened a rule of conduct established by the authority,
      • (B) has been found guilty in a court of law of a designated drug offence or of a contravention of these Regulations or the Marihuana for Medical Purposes Regulations, or
      • (C) has contravened a provision of these Regulations or the Marihuana for Medical Purposes Regulations; or
  • (b) in a province in which the practitioner is not registered or entitled to practise, if the authority submits to the Minister
    • (i) a written request that sets out the practitioner’s name and address and a description of the information being sought, and
    • (ii) either
      • (A) documentation that shows that the practitioner has applied to that authority to practise in that province, or
      • (B) documentation that shows that the authority has reasonable grounds to believe that the practitioner is practising in that province without being authorized to do so.

(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 Marihuana Medical Access 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:

  • (a) the practitioner’s name and address; and
  • (b) the number assigned to their authorization to practise medicine.

MARIHUANA FOR MEDICAL PURPOSES REGULATIONS

2. 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.

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

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

  • (a) in a province in which the practitioner is, or was, authorized to practise if the authority submits to the licensed producer a written request that sets out the practitioner’s name and address, a description of the information being sought and a statement that the information is required for the purpose of assisting an official investigation by the authority; or
  • (b) in a province in which the practitioner is not authorized to practise, if the authority submits to the licensed producer
    • (i) a written request that sets out the practitioner’s name and address and a description of the information being sought, and
    • (ii) either
      • (A) documentation that shows that the practitioner has applied to that authority to practise in that province, or
      • (B) documentation that shows that the authority has reasonable grounds to believe that the practitioner is practising in that province without being authorized to do so.

Factual information

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

  • (a) any medical document that has been signed by the practitioner and that has formed the basis for registering a client;
  • (b) any authorization to possess that has formed the basis for registering a client and that was issued under the Marihuana Medical Access Regulations on the basis of a medical declaration that was made by the practitioner; and
  • (c) any medical declaration that was made by the practitioner under the Marihuana Medical Access Regulations and that has formed the basis for registering a client.

Secure transmission

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

Definition of “health care practitioner”

(4) In this section and in section 102.1, “health care practitioner” means

  • (a) a person who is, or was, registered and entitled under the laws of a province to practise medicine in that province; or
  • (b) a person who is, or was, a nurse practitioner as defined in section 1 of the New Classes of Practitioners Regulations and who is, or was, permitted to prescribe dried marihuana in the province in which they practise or practised.

Information from medical documents

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 obtain the following information from each medical document that forms the basis for registering a client and that is signed by a health care practitioner who was entitled — at the time of the verification performed under section 110 — to practise the relevant profession in the province and who was consulted in that province:

  • (a) the practitioner’s given name, surname and business address and the number assigned by the province to the practitioner’s authorization to practise;
  • (b) the given name, surname and date of birth of the person for whom the document was provided;
  • (c) the daily quantity of dried marihuana to be used by that person, expressed in grams;
  • (d) the period of use; and
  • (e) the date the document was signed by the practitioner.

Obligation to provide information

(2) If a licensed producer receives a request referred to in subsection (1), they must provide the information to the licensing authority in respect of registrations that are made on or after the first day of the relevant period referred to in subsection (3) in which the request is received.

Deadline

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

  • (a) January 31 of any given year if the registration was made in the six-month period beginning on July 1 and ending on December 31 of the previous year; and
  • (b) July 31 of any given year if the registration was made in the six-month period beginning on January 1 and ending on June 30 of that year.

No information to provide

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

Revocation notice

(5) 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 obligation to provide the information no longer applies in respect of registrations that are made on or after the first day of the relevant period in which the notice is received.

Exception — ceasing activities

(6) If a licensed producer ceases to conduct activities, any information that has yet to be provided to a licensing authority must be provided no later than 30 days after the activities cease.

Transmission of information

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

  • (a) ensure that the information is securely transmitted in accordance with the specifications set out in the Electronic Transmission Directive; and
  • (b) provide the information only in an electronic format that is set out in the Directive.

Definition of “Electronic Transmission Directive”

(8) In subsection (7), “Electronic Transmission Directive” means the Directive on the Electronic Transmission of Information under the Controlled Drugs and Substances Act published by the Department of Health, as amended from time to time.

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

LICENSING AUTHORITIES

Documents

147.1 A licensed producer must keep

  • (a) for each request received from a licensing authority under subsection 102(1),
    • (i) a copy of the request, together with any supporting documentation received,
    • (ii) a record of the date on which the request and documentation were received,
    • (iii) a copy of the information that was provided in response to the request,
    • (iv) a record of the date on which the information was provided, and
    • (v) a record of the steps that were taken to ensure that the information was securely transmitted to the authority;
  • (b) a copy of any request or notice received from a licensing authority under section 102.1 and a record of the date on which it was received;
  • (c) for each instance in which they provide information to a licensing authority under section 102.1,
    • (i) a copy of the information,
    • (ii) a record of the date on which the information was provided, and
    • (iii) a record of the steps that were taken to ensure that the information was securely transmitted to the authority; and
  • (d) in any case where there is no information to provide to a licensing authority for a period referred to in subsection 102.1(3), a copy of the notice sent under subsection 102.1(4).

5. (1) Paragraphs 148(2)(a) and (b) of the French version of the Regulations are replaced by the following:

  • a) s’agissant de tout avis écrit qu’il doit envoyer dans le cadre du présent règlement, pour une période de deux ans suivant son envoi;
  • b) s’agissant des renseignements qu’il doit consigner conformément aux articles 134 et 137, au paragraphe 138(1), à l’article 139, aux paragraphes 140(1) et 141(1) et aux articles 144 et 146, pour une période de deux ans suivant le jour de leur consignation;

(2) 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):

  • (m) in the case of a document or record referred to in paragraph 147.1(a), for a period of two years after the day on which the information was provided to the licensing authority;
  • (n) in the case of a request or notice referred to in paragraph 147.1(b), for a period of two years after the day on which it was received;
  • (o) in the case of a document or record referred to in paragraph 147.1(c), for a period of two years after the day by which the producer was required to provide the information; and
  • (p) in the case of a notice referred to in paragraph 147.1(d), for a period of two years after the end of the period to which the notice relates.

6. Section 253 of the Regulations is replaced by the following:

Definitions

253. (1) For the purpose of sections 256 to 266, “authorization to possess”, “designated-person production licence”, “medical practitioner” and “personal-use production licence” have the same meaning as in subsection 1(1) of the Marihuana Medical Access Regulations.

Medical declaration

(2) For the purpose of sections 256 and 259, “medical declaration” means a medical declaration that was made by a medical practitioner in accordance with sections 6 and 8 of the Marihuana Medical Access Regulations.

7. Section 254 of the Regulations is replaced by the following:

Applicable period

254. Section 255 applies until March 31, 2015.

8. Sections 254 and 255 of the Regulations are repealed.

9. (1) The portion of section 256 of the Regulations before paragraph (a) is replaced by the following:

Modified application of Regulations

256. If a registration application under section 108 was made in accordance with section 255 on or before March 31, 2015, the provisions of these Regulations, other than section 129, apply with the following modifications:

(2) Paragraph 256(a) of the Regulations is amended by adding the following after subparagraph (i):

  • (i.1) paragraph 102(2)(a),
  • (i.2) subsection 102.1(1),

10. Sections 257 to 259 of the Regulations are replaced by the following:

Modified application of Regulations

259. If a registration application under section 108 was made in accordance with section 258 on or before March 31, 2014, the provisions of these Regulations, other than paragraph 110(a) and section 129, apply with the following modifications:

  • (a) a reference in sections 1 to 150 to a “medical document” is to be read as a reference to a medical declaration, except in the case of
    • (i) the definition “medical document” in subsection 1(1),
    • (ii) paragraph 102(2)(a),
    • (iii) subsection 102.1(1),
    • (iv) paragraph 128(1)(b), and
    • (v) a provision referred to in paragraph (b); and
  • (b) a provision that is referred to in column 1 of the table to this section is to be read as set out in column 2.

TABLE

Item Column 1

Provision
Column 2

Modified text
1. paragraph 5(a)
  • (a) in the case of dried marihuana obtained from a licensed producer in accordance with a medical declaration, 30 times the daily amount specified in the medical declaration;
2. subparagraph 67(a)(ii)
  • (ii) the name of the medical practitioner who made the client’s medical declaration,
3. section 112 112. (1) A client’s registration expires at the earlier of
  • (a) the day that is one year after the day on which the medical declaration supporting the registration was signed by the medical practitioner, and
  • (b) if applicable, the day on which the period of usage specified in the medical declaration expires.
    (2) For the purpose of paragraph (1)(b), the period of usage begins on the day on which the medical declaration was signed by the medical practitioner.
4. paragraphs 113(d) to (f)
  • (d) more than one year has elapsed since the day on which the medical declaration submitted with the application was signed by the medical practitioner;
  • (d.1) if applicable, the period of usage specified in the medical declaration has expired, with that period being deemed to have commenced on the day on which the medical declaration was signed by the medical practitioner;
  • (e) the name or date of birth of the applicant is different from the name or date of birth that appears on the medical declaration;
  • (f) the medical practitioner who made the medical declaration informs the licensed producer in writing that the use of dried marihuana by the applicant is no longer supported for clinical reasons; or
5. subsection 124(1) (1) A licensed producer must not sell or provide to a client or an individual who is responsible for the client in any 30-day period a total quantity of dried marihuana that exceeds 30 times the daily amount specified in the medical declaration supporting the client’s registration.

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

Licensing Authorities

Additional information — earlier registrations

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 wishes to receive, in addition to the information referred to in subsection 102.1(2), the same information in respect of any earlier registrations.

Obligation to provide information

(2) If a licensed producer receives a request that has been submitted in accordance with subsection (1), they must provide the licensing authority with the additional information, if any, when they first provide information to the authority under section 102.1. The producer must also comply with the requirements of subsection 102.1(7) in respect of the information.

Recordkeeping requirements

(3) The licensed producer must comply with the requirements of the following provisions in respect of information provided under subsection (2):

  • (a) paragraph 147.1(c);
  • (b) subsection 148(1);
  • (c) paragraph 148(2)(o); and
  • (d) section 149.

Notice

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

  • (a) send a notice of that fact to the licensing authority;
  • (b) keep a copy of the notice for two years; and
  • (c) comply with the requirements of subsection 148(1) and section 149 in respect of the notice.

Former licensed producers

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

COMING INTO FORCE

12. (1) Subject to subsections (2) and (3), these Regulations come into force on the day on which they are registered.

(2) Section 8 comes into force on March 31, 2015.

(3) Section 6 and subsection 9(1) come into force on April 1, 2015.

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