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Excerpt the Health Canada site http://www.gazette.gc.ca/rp-pr/p1/2014/2014-06-14/html/reg1-eng.php from June 10, 2014 regarding --- Marihuana for Medical Purposes Regulations and Transitioning to the New System.
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 a 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 the 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 heathcare 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.
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