SOR/2017-43: Regulations Amending the Food and Drug Regulations (Part G — Methylphenidate)
REGISTRATION OF FEDERAL REGULATION - VIA OIC DATABASE, PRIOR TO PART II OF THE GAZETTE
March 24, 2017
REGULATORY IMPACT ANALYSIS STATEMENT (This statement is not part of the Regulations or the Order.) Issues In recent years, there has been a significant increase in new psychoactive substances (NPS) created to mimic the effects of existing controlled substances and circumvent drug control legislation. Methylphenidate is currently controlled in Canada; however, several substances related to methylp... (Click for more)
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Published on March 30, 2017
SOR/2017-43: Regulations Amending the Food and Drug Regulations (Part G — Methylphenidate)
REGULATORY IMPACT ANALYSIS STATEMENT (This statement is not part of the Regulations or the Order.) Issues In recent years, there has been a significant increase in new psychoactive substances (NPS) created to mimic the effects of existing controlled substances and circumvent drug control legislation. Methylphenidate is currently controlled in Canada; however, several substances related to methylphenidate have been identified as NPS with similar stimulant effects, but with no known legitimate uses. Non-fatal and fatal effects from these substances have been reported internationally in the media and in scientific journals. With the emergence of NPS related to methylphenidate, there is a need for a broader approach to controlling these related substances. Background A trend in the illicit drug market is the growing number of NPS, commonly referred to as “designer” drugs, which are sold on the illicit drug market as allegedly “legal highs” or “safe” alternatives to controlled substances. NPS are substances with psychoactive effects in humans, either in a pure form or a preparation, which may pose a threat to public health. They can be natural materials or synthetic substances, often deliberately engineered from an ever-changing array of precursors. The continued growth of the global NPS market over the last few years has become a policy challenge and an international concern. (see footnote 2) Methylphenidate is a stimulant currently listed, along with its salts, in Schedule III to the Controlled Drugs and Substances Act (CDSA). While methylphenidate has some potential for misuse, it is also used in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and narcolepsy under several trade names. Legitimate activities, such as the production and sale of methylphenidate for therapeutic use, are currently authorized under Part G to the Food and Drug Regulations (FDR). Substances related to methylphenidate that have been identified as NPS include ethylphenidate, which was first identified in 2011 in the United Kingdom. In 2015, Health Canada conducted a review of the science literature and found these ethylphenidate-related incidents: three non-fatal intoxications in 2012 (Sweden); several hospitalizations in 2013 (Jersey, a British Crown dependency); a non-fatal adverse event report in 2014 (Canada); two non-fatal overdoses in 2014 (Canada); and a cardiovascular fatality in 2014 (United States). In April 2015, the United Kingdom issued a 12-month Temporary Class Drug Order (TCDO) for ethylphenidate, isopropylphenidate, 3,4-dichloromethylphenidate, methylnaphthidate, and propylphenidate due to concerns about their misuse. This TCDO allows placement of an NPS causing sufficient concern about its potential harms under temporary control. In June 2015, two additional related substances, ethylnaphthidate and 4-methylmethylphenidate, were placed under a similar temporary ban. Then in February 2016, the United Kingdom’s Advisory Council on the Misuse of Drugs (ACMD) provided a follow-up recommendation to extend the original TCDO for methylphenidate-based NPS. Ethylphenidate is also currently controlled in Austria, Sweden, Denmark, Germany and Jersey (a British Crown dependency). In the U.S. and Australia, ethylphenidate is captured under drug legislation as an analogue of methylphenidate. In November 2016, the World Health Organization’s 38th Expert Committee on Drug Dependence recommended that ethylphenidate be placed in Schedule II under the United Nations 1971 Convention on Psychotropic Substances. As of August 2016, there are no authorized therapeutic products in Canada containing the following: Ethylphenidate Isopropylphenidate Propylphenidate 3,4-Dichloromethylphenidate 4-Methylmethylphenidate 4-Fluoromethylphenidate Methylnaphthidate Ethylnaphthidate In addition, there are no ongoing clinical trials by researchers in Canada or the U.S. involving those substances, nor have any trials been registered. Finally, no industrial or commercial uses have been identified. While the derivatives and analogues of methylphenidate (as well as salts of derivatives and analogues) do not have approved therapeutic uses in Canada, certain analogues, like isopropylphenidate and ethylphenidate, offer potential as therapeutic agents for ADHD and other cognitive and fatigue-related disorders and should remain available for clinical research purposes. Objectives The objectives of the amendments are to protect the health and safety of Canadians and to mitigate the risk of misuse of NPS derived from methylphenidate, while allowing access for legitimate therapeutic, scientific and research purposes. The amendments also enable Health Canada and law enforcement agencies to administer and enforce provisions of the CDSA and its regulations with respect to these substances. It is expected that controlling these substances will limit their availability and create a strong deterrent against recreational use. It is also expected that these controls will lead to fewer cases of misuse and adverse events associated with these substances, including intoxication and death. Description Order amending Schedule III to the CDSA This Order expands the listing of methylphenidate and its salts in Schedule III to the CDSA to include its derivatives, isomers, and analogues (as well as the salts of the derivatives, isomers and analogues). In addition, the following eight related substances are explicitly included in this item of Schedule III: Ethylphenidate Isopropylphenidate Propylphenidate 3,4-Dichloromethylphenidate 4-Methylmethylphenidate 4-Fluoromethylphenidate Methylnaphthidate Ethylnaphthidate These substances have been identified as psychoactive, as having no legitimate purposes, and are known to be present in Canada. This expanded listing results in the control of these substances under the CDSA. With the addition of these substances to Schedule III to the CDSA, the possession, production, trafficking, possession for purpose of trafficking, importation and exportation and possession for the purpose of exporting of these substances are prohibited, unless authorized under the Regulations. As a result, law enforcement agencies can take action against activities that are not in accordance with the CDSA and its regulations. Regulations amending the schedule to Part G to the FDR Activities such as the production and sale of methylphenidate and its salts continue to be authorized under Part G to the FDR. These activities are not affected by this regulatory change. As noted above, certain analogues, like isopropylphenidate and ethylphenidate, offer potential as therapeutic agents for ADHD and other cognitive and fatigue-related disorders and should remain accessible for research purposes. Based on the potential therapeutic applications, the derivatives, isomers and analogues of methylphenidate as well as the salts of those derivatives, isomers and analogues have been included under Part I of the schedule to Part G to the FDR. For added specificity, the eight substances already identified above are also explicitly included in this item of Part I of this schedule. The chemical name of methylphenidate that was previously included under Schedule III to the CDSA and Part G to the FDR differs from the one used by the International Union of Pure and Applied Chemistry (IUPAC). For the purpose of harmonization, the listing of methylphenidate in both Schedule III to the CDSA and Part G to the FDR is changed to align with the standard IUPAC name (i.e. methyl 2-phenyl-2-(piperidin-2-yl) acetate). “One-for-One” Rule Companies supplying, importing or exporting the derivatives, isomers and analogues (as well as the salts of the derivatives, isomers and analogues) of methylphenidate will incur incremental administrative costs to meet the regulatory requirements, assuming they continue their activities with these substances. These administrative costs are associated with preparing and submitting applications for licence amendments, new licences (including licence renewals), as well as import or export permits. Currently, six companies (one large and five small) in Canada have been identified as having methylphenidate derivatives, isomers and analogues (or the salts of the derivatives, isomers and analogues) included on their product lists as research chemicals. The large company, already a licensed dealer, would incur costs to have its licence amended to include the derivatives, isomers and analogues (as well as the salts of the derivatives, isomers and analogues) of methylphenidate with which it wants to conduct activities. The one-time administrative burden cost to this company to prepare an amendment package is negligible and is estimated to take less than an hour to complete. The remaining five companies will have to apply for licences (up to four hours to prepare an application). All companies will have to renew their licences annually (one hour and a half to prepare a renewal package). There will be additional ongoing administrative burden to all six companies to prepare and submit import and/or export permit applications (0.75 hour) if they intend to import and/or export these substances. It is assumed that each company may apply for up to 20 permits per year. Assuming an employee in the natural or applied science field would be filling out these application forms at an average cost of $47.65 per hour, the present value (estimated over 10 years and discounted using a 7% discount rate) of the total administrative burden cost to these six companies is estimated at $28,640 (2012 dollars). The annualized incremental administrative cost to these businesses is estimated to be $4,080 or $680 per business (2012 dollars). Since the amendments will result in administrative burden, the “One-for-One” Rule applies and they are considered an “IN” under the Rule. The estimated cost will be offset by an equivalent reduction in the administrative credits available within the health portfolio. Small business lens The five small businesses will incur both compliance and administrative costs to obtain licences, as well as import or export permits, should they want to continue their activities with these substances. These costs will be associated with applying for and renewing licences, import and/or export permits, as well as meeting the CDSA’s security requirements under the Directive On Physical Security Requirements For Controlled Substances. However, the small business lens does not apply as the total compliance and administrative costs to these companies is less than $1 million both annually and over the 10-year period of analysis. Health Canada has investigated whether another option exists which would allow flexibility and reduce the overall burden on these companies; however, Health Canada determined that regulatory flexibility could not be provided as all the regulatory requirements faced by the interested companies are necessary for the effective administration of controls targeting these substances. Consultation On February 26, 2016, Health Canada published a Notice to Interested Parties (NTIP) in the Canada Gazette, Part I, to notify stakeholders and the general public of these proposed regulatory amendments. At that time, the proposed approach was to list the derivatives, isomers and analogues of methylphenidate under Part J to the FDR. Subsequent analysis identified potential therapeutic uses for isopropylphenidate and ethylphenidate. For this reason, all of the substances are scheduled under Part G to the FDR rather than Part J as per the NTIP. One substantive comment was received in response to the NTIP. It proposed that Health Canada temporarily schedule the substances under the CDSA in order to gather additional information on toxicity and risk of diversion which would inform a final scheduling decision. It should be noted that there are no provisions under the CDSA that allow temporary scheduling. It was clarified that controlling methylphenidate derivatives, isomers and analogues and salts of derivatives, isomers and analogues to the schedule to Part J to the FDR would allow access to these substances under certain conditions for scientific and research purposes and in the possible manufacture of test kits. (see footnote 3) Finally, a World Trade Organization Technical Barriers to Trade notification was also published on March 9, 2016. Health Canada did not receive any comments in response. Rationale The presence of NPS related to methylphenidate has been detected in many countries, including Canada, though there are no known industrial or therapeutic uses for these substances. With the rapid emergence of NPS in general, and NPS related to methylphenidate in particular, there is a need for a broader approach to scheduling of related substances. The CDSA and its regulations provide a framework for the control of substances that can alter mental processes and that may cause harm to health or to society when diverted to an illicit market or used inappropriately. Its purpose is to protect public health and maintain public safety by prohibiting certain activities associated with harmful substances, while allowing access to those substances for legitimate medical, scientific and industrial purposes. These amendments add the derivatives, isomers and analogues of methylphenidate and salts of those derivatives, isomers and analogues to Schedule III to the CDSA as well as to Part I of the schedule to Part G to the FDR. This expansion of the listing of methylphenidate and its salts under the CDSA captures the eight related substances identified to date as psychoactive, that have no legitimate purpose, and that are known to be present in Canada. It also captures other NPS derived from methylphenidate that could be developed in the future. Activities such as the production and sale of methylphenidate and its salts continue to be authorized under Part G to the FDR. These activities are unaffected by this regulatory change. The derivatives and analogues of methylphenidate (as well as salts of derivatives and analogues) currently have no approved therapeutic uses; however, certain analogues, like isopropylphenidate and ethylphenidate, offer potential as therapeutic agents for ADHD and other cognitive and fatigue-related disorders and should remain available as there may be future therapeutic applications. Companies or individuals intending to produce, make, assemble, import, export, sell, provide, transport, send or deliver need to obtain a licence under Part G of the FDR. Furthermore, companies or individuals intending to buy and possess these substances for research purposes need an exemption under Section 56 of the CDSA. These regulatory amendments will result in costs to stakeholders, such as licensed dealers, suppliers and researchers who wish to conduct activities with these substances. These stakeholders would need to become licensed dealers, amend their existing licence, apply for an exemption, as the case may be, and incur the associated incremental compliance and administrative costs. As indicated earlier, there are currently six companies (one large and five small) in Canada that have methylphenidate derivatives, isomers and analogues (or the salts of the derivatives, isomers and analogues) included on their product lists. The large company is already a licensed dealer and will not incur any incremental compliance costs. The five small companies will need to become licensed dealers and bear costs associated with: the payment of fees to obtain and renew a licence; acquisition and installation of physical security measures; for record-keeping; and the reporting of incidences of losses and thefts. The present value of these compliance costs (estimated over 10 years and using a 7% discount rate) amounts to $244,790. All six companies will bear incremental administrative costs related to preparing licence applications or amendment packages. The large company will only incur a negligible cost (i.e. less than $40) to have its licence amended to include the derivatives, isomers and analogues (as well as the salts of the derivatives, isomers and analogues) of methylphenidate with which it wants to conduct activities. The other five companies will incur $7,380 in administrative costs to prepare licence applications and licence renewal packages and to acquire additional information such as criminal record checks and education credentials. The administrative costs to the six companies over the period of analysis will amount to about $7,420. There would be additional ongoing administrative costs to all companies to prepare and submit an import and/or export permit application if they intend to import and/or export these substances, in addition to the cost to prepare and submit their licence applications. Assuming that each company would apply for an average of 20 permits per year, the total cost to these companies to apply for import/export permits over the period of analysis is estimated at $30,130 in present value. Researchers intending to use these substances for research purposes are required to be exempted under Section 56 of the CDSA. There are no fees associated with applying for an exemption; however, applicants will incur costs to prepare and submit applications. As indicated earlier, Health Canada is not aware of any research activities involving the derivatives and analogues (as well as their salts) of methylphenidate. The extent of research and the number of impacted researchers now or in the future is unknown. However, on an individual basis, a researcher wanting to use these substances will incur an administrative cost of $135 to submit an exemption application. Due to lack of available data and uncertainty around potential research using these substances, this cost is not included in the total cost estimates for these amendments but is provided for illustrative purposes. No incremental cost is expected to be incurred by the government. Compliance promotion and enforcement in relation to these amendments will be undertaken as part of current activities under the CDSA and no additional resources will be required. Overall, the present value of the total compliance and administrative cost of these scheduling amendments over a 10-year period will amount to $282,340, or an annualized cost of $40,200. It is expected that controlling these substances will limit their availability and create a strong deterrent for recreational use. It is assumed that this regulatory action will lead to fewer cases of misuse and negative health incidents associated with these substances, including intoxication and death. Law enforcement agencies will also be able to take action against unauthorized activities involving these substances. Implementation, enforcement and service standards These regulatory amendments come into force 30 days after the date of publication in Canada Gazette, Part II. As part of the implementation of these amendments, Health Canada will notify stakeholders of the changes and provide additional information on the Department’s website. Health Canada is responsible for issuing authorizations (e.g. licences, permits, and exemptions) for activities with substances scheduled under the CDSA and its regulations and for monitoring compliance with regulatory requirements. Federal, provincial and local law enforcement agencies are responsible for taking enforcement action in response to contraventions of the CDSA. Under the CDSA, a range of penalties apply to the offences associated with the substances covered by this initiative. These penalties may involve the application of a fine and/or a term of imprisonment. For certain offences (trafficking, possession for the purpose of trafficking, importing, exporting, possession for the purpose of exporting, production), there is a maximum penalty of up to 10 years of imprisonment if the offence is prosecuted by indictment or of up to 18 months of imprisonment if the offence is prosecuted by summary conviction. There are no additional service standards other than those that already exist for issuing licences and permits under the CDSA. Contact Anna Wheeler Healthy Environments and Consumer Safety Branch Health Canada Main Statistics Canada Building 150 Tunney’s Pasture Driveway Ottawa, Ontario K1A 0T6 Email: [email protected] Footnote a S.C. 2015, c. 22, s. 4(1) Footnote b S.C. 1996, c. 19 Footnote 1 C.R.C., c. 870 Footnote 2 United Nations Office on Drugs and Crime (UNODC) Global Smart Update: Special Segment — Legal responses to NPS: Multiple approaches to a multi-faceted problem, Volume 14, September 2015. Footnote 3 The response reflected the proposed change to Part J to the FDR as per the proposal in the NTIP.
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