Vol. 149, No. 15 — July 29, 2015
SOR/2015-189 July 16, 2015
CONTROLLED DRUGS AND SUBSTANCES ACT
Regulations Amending the Narcotic Control Regulations (Tapentadol)
P.C. 2015-1079 July 16, 2015
His Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 55(1) (see footnote a) of the Controlled Drugs and Substances Act (see footnote b), makes the annexed Regulations Amending the Narcotic Control Regulations (Tapentadol).
REGULATIONS AMENDING THE NARCOTIC CONTROL REGULATIONS (TAPENTADOL)
1. The schedule to the Narcotic Control Regulations (see footnote 1) is amended by adding the following after item 17:
18. Tapentadol (3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]-phenol), its salts, derivatives and isomers and salts of derivatives and isomers
COMING INTO FORCE
2. These Regulations come into force 180 days after the day on which they are registered.
REGULATORY IMPACT ANALYSIS STATEMENT
(This statement is not part of the Regulations and the Order.)
Tapentadol is a synthetic opioid used for pain relief that has been marketed under the brand name NUCYNTA® since 2011 in immediate, controlled and extended-release formulations.
While opioids like tapentadol are generally safe and effective, they can lead to physical or psychological dependence, abuse and addiction. Tapentadol can be abused by crushing the tablet and then swallowing, snorting or injecting it, which could lead to an overdose that may have lethal consequences.
Canada is the world’s second largest consumer of prescription opioids per capita and there have been increasing concerns related to global access to prescription opioids due to their diversion and abuse potential, both within Canada and globally.
Scheduling tapentadol under the Controlled Drugs and Substances Act (CDSA) and the Narcotic Control Regulations (NCR) will help mitigate the risk of the diversion of tapentadol to an illicit market or use while allowing access for legitimate medical purposes. This scheduling amendment is supported by the sole manufacturer of tapentadol and is consistent with the Government of Canada’s continued commitment to addressing prescription drug abuse.
The CDSA and its regulations provide a framework for the control of substances that can alter mental processes and that may produce harm to an individual or to society when diverted to an illicit market or use. Their purpose 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 diversion to illicit markets and uses.
Opioids are generally listed in Schedule I to the CDSA and in the Schedule to the NCR, thereby making them subject to the most serious offences and corresponding maximum penalties.
The NCR set out the circumstances and requirements in which producers, distributors, importers, exporters, pharmacists, practitioners, and hospitals may conduct their respective authorized activities, including the possession, sale, provision, importation, exportation, and production of substances listed in the Schedule to these Regulations referred to as “narcotics.”
The purpose of this scheduling amendment is to help protect the health and safety of Canadians and decrease potential diversion and abuse by controlling tapentadol in a manner that is consistent with the scheduling of similar opioids, like morphine, hydromorphone and oxycodone.
Once tapentadol is listed in Schedule I to the CDSA, activities such as possession, trafficking, possession for the purposes of trafficking, importation, exportation, possession for the purpose of exportation, and production will be prohibited unless authorized under the NCR or exempted in accordance with section 56 of the CDSA.
This amendment will add tapentadol (3-[(1R,2R)-3-(dimethylamino)-1-ethyl-2-methylpropyl]-phenol), its salts, derivatives and isomers, and salts of derivatives and isomers to Schedule I to the CDSA and the Schedule to the NCR.
Upon scheduling tapentadol under the CDSA and the NCR, a licence issued under the NCR will be required to conduct activities such as production, distribution, importation, and exportation. The activities of importation and exportation will also require a permit. The Minister of Health has the authority under the NCR to issue, amend, renew, suspend or revoke dealers’ licences as well as issue import and export permits.
In addition, there are requirements under the NCR for the secure handling/storage, record keeping, and reporting of loss and theft. The requirements for secure storage at licensed dealer sites are outlined in Health Canada’s Directive on Physical Security Requirements for Controlled Substances (http://www.hc-sc.gc.ca/hc-ps/pubs/precurs/dealers-distrib/phys_securit_directive/index- eng.php).
This regulatory amendment will provide law enforcement agencies and the Canada Border Services Agency (CBSA) with the authority to take action against illegal activities involving tapentadol. Such actions could include the seizure of tapentadol-related products and the laying of charges against those conducting activities with these substances that are not in accordance with the CDSA.
In accordance with the Treasury Board Secretariat (TBS) requirements related to the Cabinet Directive on Regulatory Management, the “One-for-One” Rule was applied to calculate the estimated annualized average increase in administrative burden that would be imposed on stakeholders as a result of this amendment.
As this regulatory amendment will result in a net increase in administrative burden, the regulatory initiative is considered an “IN” under the “One-for-One” Rule. As a result, Health Canada will be required to offset an equal amount of administrative burden on business from its existing stock of regulations.
Products containing tapentadol have been marketed in Canada since 2011. Currently, there is one sole manufacturer and importer of tapentadol in Canada. In total, there are 37 licensed dealers. None of these companies meet the definition of a small business.
This regulatory amendment will lead to increased administrative burden for licensed dealers for two activities: (1) a one-time amendment to their licences to include tapentadol; and (2) the ongoing requirement to prepare import permits.
The total estimated annualized average increase in administrative cost burden for 37 licensed dealer sites will be $4,787 as a result of licence amendments and any applications for import permits. The majority of this burden ($4,516) will be borne by the sole manufacturer and importer of tapentadol in Canada due to the need to prepare import permits. The parameters applied in this calculation included a forecasted impact period of 10 years beginning in the year the regulatory amendment comes into force; a base year of 2012 in Canadian dollars, and a 7% discount rate.
The tapentadol supply chain also includes pharmacies; however, they will not incur additional administrative burden as a result of this amendment as they already handle narcotics. Hospital pharmacies do not meet the definition of a business under the “One-for-One” Rule.
Small business lens
The small business lens does not apply to this proposal, as there are no costs to small business.
On February 26, 2011, a Notice to Interested Parties outlining Health Canada’s proposal to add tapentadol to Schedule I to the CDSA and to the Schedule to the NCR was published in the Canada Gazette, Part I. Two comments were received and both were fully supportive of the scheduling of tapentadol under the CDSA and the NCR.
Health Canada consulted with the pharmacy distribution industry as well as the manufacturer of tapentadol.
Health Canada also examined how tapentadol is controlled in other countries. This proposal is consistent with scheduling in countries such as Australia, Chile, Germany, Ireland, Lithuania, the Netherlands, New Zealand, the United States and the United Kingdom.
On October 21, 2014, a World Trade Organization notification under the Technical Barriers to Trade Agreement was published for this regulatory amendment. Only one submission was received and it expressed support for the scheduling initiative and requested an extension of the proposed 90-day delayed coming-into-force period to 180 days. This request has been accommodated.
Studies have shown that tapentadol has abuse liability potential comparable to hydromorphone and is five times more potent for pain relief than intravenously injected morphine. Both hydromorphone and morphine are already listed in Schedule I to the CDSA and the schedule to the NCR due to their diversion and abuse potential.
No evidence of diversion or abuse in Canada has yet been reported. However, post-market surveillance of tapentadol in the United States has found low levels of diversion and abuse. To address public health and safety concerns, tapentadol was added to Schedule II of the United States Controlled Substances Act in 2009.
Given the elements articulated above (e.g. the need to protect the health and safety of Canadians from the risks of the diversion and abuse of tapentadol; the need to allow access for legitimate medical purposes; and trends in international controls), Health Canada has determined that tapentadol, its salts, derivatives and isomers, as well as the salts of derivatives and isomers, should be added to Schedule I to the CDSA and to the Schedule to the NCR.
This regulatory amendment will benefit Canadians, as the increased control of tapentadol will help mitigate the risks to health and safety associated with the potential diversion and/or abuse of products containing tapentadol, while allowing access to tapentadol for legitimate medical purposes.
The estimated regulatory cost calculator model total annualized average administrative costs for all stakeholders of $4,787 associated with this amendment is considered low relative to other CDSA-related regulatory proposals. The costs to Health Canada, to law enforcement and to the CBSA in implementing this regulatory amendment are expected to be minimal and will be absorbed within existing programs.
Implementation, enforcement and service standards
Health Canada will notify stakeholders (e.g. licensed dealers, law enforcement), provincial/territorial ministries of health, and provincial/territorial licensing authorities for medicine and pharmacy of this regulatory amendment and provide relevant links on the Department’s Web site.
Health Canada is responsible for assessing and responding to incoming requests regarding the use of substances scheduled to the CDSA for test kit applications and for monitoring compliance with the NCR.
Federal, provincial and local law enforcement agencies are responsible for taking enforcement action in response to contraventions of the CDSA or its regulations. The prosecution of contraventions under the CDSA is the responsibility of the justice system. The associated penalties of such contraventions may include the application of a fine and/or a term of imprisonment and vary according to which schedule the controlled substance is listed on under the CDSA.
The offences associated with Schedule I substances include production, possession, multiple doctoring, trafficking, possession for the purpose of trafficking, importation, exportation, and possession for the purpose of exportation.
The maximum penalties for a person convicted of possession and multiple doctoring, upon summary conviction of a first offence, are a fine of up to $1,000 or up to six months’ imprisonment, or both. Multiple doctoring occurs when a person seeks to obtain a prescription or a narcotic from a practitioner without informing the practitioner of every prescription or narcotic obtained in the previous 30 days. For a subsequent offence, the fine is increased up to $2,000 or up to one year of imprisonment, or both. If the case prosecuted as an indictable offence, the maximum penalty for possession and multiple doctoring is seven years’ imprisonment. For the indictable offences of trafficking, possession for the purpose of trafficking, importation, exportation, possession for the purpose of exportation and production, the maximum penalty is life imprisonment. In addition, mandatory minimum penalties of one, two or three years may apply if certain conditions are met.
This regulatory amendment has a coming-into-force date of 180 days after registration in order to provide sufficient time for licensed dealers to apply for an amendment to their licence to have tapentadol added.
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