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Review of Controlled Drugs and Substances Act: Canadian Medical Association submission to Health Canada in response to the consultation on the Controlled Drugs and Substances Act and its regulations

https://policybase.cma.ca/en/permalink/policy11114
Date
2014-03-17
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Response to consultation
Date
2014-03-17
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) is pleased to provide this brief in response to Health Canada's consultation on the Controlled Drugs and Substances Act (CDSA) "regarding any challenges, gaps or suggested improvements." The CMA welcomes the consultation and review of the CDSA and its associated regulations. This is an important legislative framework with direct implications for public health, quality care and patient safety. The CMA's recommendations outlined in this brief aim to establish new measures and mechanisms under the CDSA that would contribute to improved public health and patient safety. The CMA looks forward to the opportunity to discuss these issues in greater detail with Health Canada as this consultation proceeds. Part 1: Supporting a Regulatory Approach that Advances Public Health, Quality Care and Patient Safety As an overarching principle, it is the CMA's position that the modernization of the CDSA legislative and regulatory framework should be guided first and foremost by the objective of improving public health, promoting quality care and enhancing patient safety. In enacting the CDSA and promulgating its regulations, enforcement objectives have been emphasized, as demonstrated by the report on program spending in the National Anti-Drug Strategy Evaluation. The modernization of the CDSA legislative framework offers a significant opportunity to contribute to the greater advancement of public health and patient safety goals by establishing mechanisms that support prevention, treatment and harm reduction. This approach supports the Government of Canada's Throne Speech commitment to address prescription drug abuse as part of the National Anti-Drug Strategy. In 2013, the CMA's General Council, often referred to the Parliament of Canadian Medicine, recommended "that there be an increased emphasis on public health-oriented approaches by regulatory authorities responsible for psychoactive substances." Substance abuse is a complex behaviour influenced by many factors, and a therefore a public health approach to addressing it should incorporate a comprehensive multi-factorial strategy. A public health approach would place an increased focus on preventing drug abuse and misuse; on treatment of addiction and other consequences of misuse; on monitoring, surveillance and research; and on harm reduction. It would seek to ensure the harms associated with enforcement (e.g. crime, disease due to use of dirty needles) are not out of proportion to the direct harms caused by substance abuse. The CMA recommends that the modernization of the CDSA legislative framework focus on enabling and supporting such a public health approach. It should be noted that the substances governed by the CDSA include medications used by patients and prescribed by health care professionals for legitimate therapeutic purposes. We note that the schedules attached to the CDSA do not make a distinction between illicit substances of abuse and prescription medication. For example, Schedule I includes both illicit substances such as heroin, and opioid prescription medicines like oxycodone and hydrocodone. The potential of a drug or medication to cause harm has little if anything to do with its legal status. Therefore, the CMA recommends that as part of the review of the CDSA and its regulations, Health Canada undertake a review of the schedules, including the organization of the schedules, and the listing of substances within each schedule. The purpose of this review is to ensure that: (1) the schedules are up-to-date; (2) the CDSA allows for the incorporation of new illicit substances and prescription medication on the basis of available evidence and in a timely manner; and, (3) the schedules are organized based on risk status, legal status or other consideration. In the following sections, the CMA outlines recommendations that would facilitate the expansion of a public health approach. A) Establish Mechanisms to Address Prescription Drug Misuse and Abuse The misuse and abuse of controlled psychoactive prescription medicines, notably opioids such as oxycodone, fentanyl and hydrocodone, is a significant public health and patient safety issue. Canada has the second highest per capita consumption of prescription opioids in the world, after the United States. The abuse and misuse of prescription opioids among vulnerable populations, remains a significant concern. For instance, in 2013 opioids were reported as the third most common drug (after alcohol and marijuana) used by students in Ontario. While accurate data on the prevalence of the misuse of prescription medication among seniors is lacking, the CMA is concerned that as Canada's population ages, an increasing number of seniors will need treatment for harms related to prescription medication use, such as drug interactions, falls due to drowsiness or lack of coordination. Controlled prescription medications are legal products intended for legitimate therapeutic purposes, i.e. to control pain from cancer or terminal illness, or from chronic conditions such as nerve damage due to injury. However, they may also be misused or abused, and addiction may drive some users to illegal behaviour such as doctor-shopping, forging prescribers' signatures, or buying from street dealers. Canada's physicians are deeply concerned about the misuse and abuse of prescription opioid medication for a number of reasons. First, physicians need to assess the condition of the patient who requests the medication, and consider whether its use is clinically indicated and if the benefits outweigh the risks. Secondly, they may need to prescribe treatment for patients who have become addicted to the medication. Finally, they are vulnerable to patients who forge the physician's signature or use other illegal means to obtain prescriptions, or who present with fraudulent symptoms, or plead or threaten when denied the drugs they have requested. The 2014 federal budget promises $44.9 million over 5 years to the National Anti-Drug Strategy to address prescription drug abuse, and CMA believes that this is a positive step. Health Canada, in its role as drug regulator, could use the Controlled Drugs and Substances Act to help further this strategy in the following ways: i) Improving the approval, labelling and safety monitoring of controlled substances The CMA recommends that new sections be introduced to the CDSA to require higher levels of regulatory scrutiny for controlled prescription medication, during both the approval process and post-approval surveillance. Specifically, the CDSA should be amended to require: * More stringent pre-approval requirements for controlled prescription medication. Because of their high level of risk, Health Canada could require that they be subject to higher levels of scrutiny than other medications during the review of pre-approval clinical trial results, special post-approval conditions(e.g. formal post-market studies); * Stricter conditions on the marketing of controlled medication by the pharmaceutical industry to health professionals. * Tamper-resistant formulations of prescription opioid medication. New opioid medication or potentially addictive formulations should be tamper-resistant to reduce the potential for misuse or abuse. * Improved patient information and counseling to be offered to prescribers, dispensers, and patients receiving opioid prescriptions. ii) Establishing consistent requirements for prescription monitoring In our brief to the House of Commons Standing Committee on Health (see Appendix A), during its study on prescription drug abuse, the CMA encouraged all levels of government to work with one another and health professional regulatory agencies to develop a pan-Canadian system of real-time prescription monitoring and surveillance. Indeed, all stakeholders who testified before the Committee recognized the importance of prescription monitoring programs in addressing prescription drug abuse. While prescription monitoring programs (PMPs) exist in most provinces, they vary considerably in terms of quality, the nature of the information they require, whether health care practitioners have real-time access, and in the purpose for which the data is collected. Standardization of surveillance and monitoring systems can contribute to addressing the misuse and abuse of prescription medication by: * Allowing health care practitioners to identify fraudulent attempts to obtain a prescription, such as an attempt to fill prescriptions from a number of different providers, at the time the prescription is requested or filled. * Deter interprovincial or jurisdictional fraud, again, by allowing health care practitioners to identify fraudulent attempts at the time the prescription is requested or filled. * Improve professional regulatory bodies' capacity for oversight and intervention, by establishing a mechanism for real-time monitoring. * Finally, help Canada's researchers improve our knowledge of this serious public health concern, identify research priorities, and determine best practices to address crucial issues. Such a system should be compatible with existing electronic medical and pharmacy record systems and with provincial pharmaceutical databases such as that of British Columbia. Participation in prescription monitoring programs should not impose an onerous administrative burden on health care providers. Integration with electronic health records and the widespread use of electronic databases and transmission would go far to minimize the potential burden. The CMA recommends that a new reporting regulation be promulgated under the CDSA that addresses reporting requirements and disclosure requirements of practitioners, manufacturers and other stakeholders, in order to establish consistent standards for prescription monitoring. This regulation should: * Enable inter-jurisdictional accessibility and operability; * Ensure that practitioners have real-time access to the monitoring system; * Enable electronically-based prescription monitoring; and; * Conform to privacy laws, protecting patient confidentiality while enabling the sharing of necessary information. (Privacy concerns are addressed in greater detail in Part 2). B) Supporting harm reduction as a component of a drug strategy The CMA fully endorses harm reduction strategies and tools, including supervised injection sites, and believes that the CDSA should support and enable them. It is the CMA's position that addiction should be recognized and treated as a serious medical condition. Section 56 of the CDSA sets out conditions under which applicants may obtain exemptions from the provisions of the Act. Bill C-2, currently at Second Reading in the House of Commons, proposes new, far reaching, and stringent conditions that must be met by a proponent who is applying to establish a supervised injection site. The CMA maintains that safe injection sites are a legitimate form of treatment for the disease of addiction, that their benefit is supported by a body of research, and that the conditions proposed under Bill C-2 are overly restrictive. In addition, to support harm reduction, the CMA encourages Health Canada to amend section 2 (2) (b) (ii) (B) of the CDSA that states a controlled substance includes "any thing that contains or has on it a controlled substance and that is used or intended or designed for use... in introducing the substance into a human body" in order to enable the important role of safe injection sites. C) Developing clinical knowledge base about the medical use of marijuana The CMA has already made its position on the Marihuana for Medical Purposes Regulations known to Health Canada (see Appendix B). Despite repeated revisions since they were first established in 2001, the regulations do not address CMA's primary concern; that physicians are made gatekeepers for a product whose medical benefits have not been sufficiently researched, and which has not undergone the clinical trial process required for therapeutic products under the Food and Drugs Act. The absence of clinical evidence means that physicians lack scientific information and guidance on the uses, benefits and risks of marijuana when used for medicinal purposes. To address these issues, the CMA recommends that Health Canada invest in scientific research on the medical uses of marijuana. This could include establishing market incentives for Licensed Producers to undertake research, or requiring them to contribute to a research fund administered by the Canadian Institutes of Health Research. In addition, the CMA encourages the development and dissemination of evidence-based clinical support tools for physicians. Part 2: Ensuring protection of patient privacy In any legislative framework pertaining to patient care, physicians consider protecting the privacy of patient information to be paramount; indeed, privacy, confidentiality and trust are cornerstones of the patient-physician relationship (see Appendix C). For these reasons, the CMA strongly recommends that Health Canada undertake a privacy impact assessment of the existing CDSA and its regulations as well as of future proposed amendments. The CMA encourages Health Canada to make this assessment available to stakeholders as part of its consultation process on this legislative framework. As previously mentioned, the new regulation proposed under Part 1 (A) (ii) above must conform to privacy laws, and protect patient confidentiality while enabling the sharing of necessary information. The CMA is deeply concerned with the search provision under s.31 of the CDSA in which an exception to this broad authority for patient records is mentioned in subsection (1) (c). The CMA is concerned that this exception may not be sufficient to meet the existing privacy laws governing patient information and records, both federally and provincially. As such, the CMA recommends that the CDSA be amended to ensure that patient information and records are exempt from search authorities, consistent with the most stringent privacy laws at the federal and provincial jurisdictions. Part 3: Enabling e-prescribing As part of the review of the CDSA and its associated regulations, Health Canada should assess how this legislative framework may be used to facilitate and support the advancement of e-health, specifically e-prescribing. Electronic health records can support individual physicians or pharmacists to quickly identify potential diversion and double-doctoring, at the point where a prescription is written or filled. The electronic health record also facilitates the sharing of information among health professionals, as well as programs that allow physicians to compare their prescribing practices to those of their peers. For instance, sections of the Benzodiazepines and Other Targeted Substances Regulations, Narcotic Control Regulations, and Precursor Control Regulations, establish the conditions within which pharmacists may accept a prescription. The CMA recommends that these regulations be amended to specifically include electronic prescriptions in addition to verbal and written prescriptions among the forms that may be accepted by a pharmacist. This recommendation is consistent with the joint statement by the CMA and the Canadian Pharmacists Association on e-prescribing (see Appendix D). Health Canada should also ensure that regulatory amendments facilitate prescription monitoring, as discussed in a previous section. Part 4: Establishing a mechanism for changes to scope of practice The New Classes of Prescribers Regulations, promulgated in 2012, grants nurse practitioners, midwives and podiatrists the authority to prescribe controlled substances if their provincial scope of practice laws permit. The CMA's 2012 submission in response to this regulatory change is attached to this brief for information (Appendix E.) In it, the CMA recommended that "A regulatory framework governing prescribing authority, or any other aspect of scope of practice, should always put patient safety first. The primary purpose of scope of practice determination is to meet the health care needs and serve the health interests of patients and the public safely, efficiently, and competently." One of our main concerns at the time was that the more practitioners who could prescribe controlled substances, the greater the potential for the illegal diversion of products to street dealers. This remains a concern for us. Given the significance of scope-of-practice determinations to patient safety and patient care, the CMA strongly recommends that future changes to the scope of practice of a health care practitioner be undertaken only within a defined, transparent evaluation process based on clinical criteria and protection of patient safety. To this end, the CMA strongly recommends the introduction of new clauses to the CDSA and its associated regulations to establish a mechanism that governs future changes to scope of practice. These clauses should require, prior to the implementation of any change: * Demonstration that it will improve public health and patient safety; * Meaningful consultation with professional organizations and regulatory authorities; and, * Support of provincial and territorial ministers of health. Further, the CMA recommends that such a new regulation governing possible future changes to scope of practice require: * That new classes of prescribers have conflict of interest policies; * That new classes of prescribers be incorporated under the prescription monitoring regulation recommended under Part 1 (A) (ii) above; and * That a mandatory five-year review be established for new classes of prescribers. Part 5: Recognizing the authority of physician regulatory colleges As previously mentioned, many controlled substances governed under the CDSA and its associated regulations are prescribed by physicians and other health professionals, for therapeutic purposes. Medicine is a regulated profession, and the colleges of physicians have ultimate authority and responsibility for the oversight of physician practice, including monitoring prescribing activity, investigating practice and when required, taking disciplinary action. In its present form, section 59 of the Narcotic Control Regulations includes a duplicative and redundant provision for oversight and disciplinary action. The CMA strongly recommends that this section be amended to recognize the established authority of physician regulatory colleges for the oversight of the medical profession. Conclusion The CMA welcomes the consultation and review of the Controlled Drugs and Substances Act and its associated regulations. As mentioned before, this submission is not an exhaustive analysis of the Controlled Drugs and Substances Act¸ but an initial summary of CMA's position on issues of particular concern to patient safety and public health. This brief outlines numerous opportunities within the CDSA and its associated regulations to establish new measures and mechanisms that would contribute to improved public health and patient safety. In light of the breadth and importance of the issues raised in this review, CMA encourages further consultation and welcomes the opportunity to discuss these issues in greater detail. List of Appendices: * Appendix A: CMA Brief to the House of Commons Standing Committee on Health - The Need for a National Strategy to Address Abuse and Misuse of Prescription Drugs in Canada * Appendix B: CMA Policy Statement - Medical Marijuana * Appendix C: CMA Policy Statement - Principles for the Protection of Patient's Personal Health Information * Appendix D: CMA Policy Statement - Vision for e-Prescribing: a joint statement by the Canadian Medical Association and the Canadian Pharmacists Association * Appendix E: CMA submission - Response to the proposed New Classes of Practitioners regulations published in the Canada Gazette Part I (Vol. 146, No. 18 - May 5, 2012) Overview of recommendations The CMA recommends that the modernization of the CDSA legislative and regulatory framework should be guided first and foremost by the objective of improving public health, promoting quality care and enhancing patient safety. The CMA recommends that as part of the review of the CDSA and its regulations, Health Canada undertake a review of the schedules, including the organization of the schedules, and the listing of substances within each schedule. The CMA recommends that new sections be introduced to the CDSA to require higher levels of regulatory scrutiny as part of the approval and post-approval process for prescription opioid medication. The CMA recommends that a new reporting regulation be promulgated under the CDSA that addresses reporting requirements and disclosure requirements of practitioners, manufacturers and other stakeholders in order to establish consistent standards for prescription monitoring. To support harm reduction, the CMA recommends an amendment to section 2 (b) (ii) of the CDSA, which states a controlled substance includes "any thing that contains or has on it a controlled substance and that is used or intended or designed for use... in introducing the substance into a human body". The CMA recommends that Health Canada invest in scientific research on the medical uses of marijuana. This could include establishing market incentives that require Licensed Producers to undertake research, or requiring them to contribute to a research fund administered by the Canadian Institutes of Health Research. In addition, the CMA encourages the development and dissemination of evidence-based clinical support tools for physicians. The CMA recommends that Health Canada undertake a privacy impact assessment of the existing CDSA and its regulations as well as future proposed amendments, and provide this assessment to stakeholders as part of its consultation process on this legislative framework. The CMA recommends that the CDSA, specifically s.31 (1) (c), be amended to ensure that patient information and records are exempt from search authorities, consistent with the most stringent privacy laws at the federal and provincial jurisdictions. The CMA recommends that the CDSA and its regulations be amended to specifically include electronic prescriptions in addition to verbal and written prescriptions among the forms that may be accepted by a pharmacist, including sections within the Benzodiazepines and Other Targeted Substances Regulations, Narcotic Control Regulations, and Precursor Control Regulations. The CMA recommends the introduction of new clauses to the CDSA and its associated regulations to establish a mechanism that governs future changes to scope of practice, based on the introduction of a new regulation governing changes to scope of practice that will require, prior to the implementation of any change: * Demonstration of public health and patient safety improvement; * Meaningful consultation with professional organizations and regulatory authorities; and, * Support of provincial and territorial ministers of health. The CMA recommends that the new mechanism of the CDSA legislative framework governing possible future changes to scope of practice require: * That new classes of prescribers have conflict of interest policies; * That new classes of prescribers be incorporated under the prescription monitoring regulation recommended under Part 1 (A) (ii) above; and * That a mandatory five-year review be established for new classes of prescribers. The CMA strongly recommends that s.59 of the Narcotic Control Regulations be amended to recognize the established authority of physician regulatory colleges for the oversight of the medical profession.
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Response to the consultation paper Pension Innovation for Canadians: The Target benefit plan

https://policybase.cma.ca/en/permalink/policy11213
Date
2014-06-23
Topics
Physician practice/ compensation/ forms
  1 document  
Policy Type
Response to consultation
Date
2014-06-23
Topics
Physician practice/ compensation/ forms
Text
The Canadian Medical Association (CMA) is pleased to provide the comments below in response to Finance Canada's consultation document Pension Innovation for Canadians: The Target Benefit Plan. The CMA is the professional voluntary association representing over 80,000 physicians across Canada. Its mission is to serve and unite the physicians of Canada and to be the national advocate, in partnership with the people of Canada, for the highest standards of health and health care. The CMA has participated in, and made recommendations to, Finance Canada over the course of the government's multi-year consultation process on Canada's pension framework. Indeed, in light of the importance of the pension framework to our membership, the CMA has been an active participant in previous consultations regarding the pension framework. The CMA's participation in the current, multi-year initiative included responding to the 2010 consultative paper Ensuring the Ongoing Strength of Canada's Retirement Income System as well as participating in the legislative and regulatory consultation on the Pooled Registered Pension Plan (PRPP) framework. While the CMA recognizes that this consultation is focused narrowly on the federally regulated pension plans governed by the Pension Benefits Standards Act 1985, the CMA supports additional consultation on Canada's pension framework. The CMA recommends that Finance Canada expand its consultation to explore options to address weaknesses in Canada's pension framework, including a focus on the third pillar: tax-incentivized savings vehicles. As part of a consultation on the third pillar, the CMA recommends that Finance Canada explore three issues, as elaborated further below: * Increasing the combined contribution limit for registered retirement savings plans (RRSPs); * Enabling well-governed professional organizations that represent a particular membership as pension plan sponsors; and, * Possible impacts of registered retirement income funds (RRIF) mandatory drawdown rates. Like the Canadian population at large, physicians represent an aging demographic - 42% of Canada's physicians are 55 or older - for whom retirement planning is an important concern. In addition, the vast majority of CMA members are self-employed physicians and, as such, they are unable to participate in workplace registered pension plans (RPPs). This makes physicians more reliant on Registered Retirement Savings Plans (RRSPs) relative to other retirement savings vehicles. The Summary Report on Retirement Income Adequacy Research presented to the F/P/T Ministers of Finance in 2009, suggests that higher-earning Canadians may not be saving enough for retirement. This report highlighted that income replacement rates in retirement fall below 60 per cent of after-tax income for about 35 per cent of Canadians in the upper income quintile. This is related to the effect of maximum contribution limits on tax-incentivized retirement savings vehicles. Tax-incentivized private saving vehicles are a critical element of Canada's pension framework. As highlighted in the 2010 interim report of the Senate Banking Trade and Commerce Canadians Savings for Their Future: A Secure Retirement, the introduction of the RRSP framework in 1957 sought to address a tax inequity due to the ineligibility of private savings for tax-incentive in comparison with registered pension plans. From 1972 to 1991 the RRSP contribution limit was set at 20 percent of earned income and in 1991, the government reduced the contribution limit to 18 percent of earned income; further, over this time period the real value of the absolute dollar limit reduced significantly. Recent increases to the absolute dollar limits have been strongly welcomed. To ensure that contribution limits do not pose a barrier to saving for future retirement income needs, the CMA recommends that Finance Canada initiate a consultation on future increases to the RRSP contribution limit, both absolute and percent of earned income. As part of the 2010 Finance Canada consultation and as reiterated during the legislative and regulatory consultation period on the PRPP framework, the CMA highlighted its support for exploring measures to enable organizations to sponsor plans on behalf of the self-employed. During the PRPP consultation, the CMA recommended amending the legislation such that well-governed professional organizations representing a particular membership are able to sponsor and administer PRPPs for their own members, including self-employed members. Once again, the CMA supports an extension of this recommendation to the broader pension framework. Finally, the CMA has taken note of the concerns regarding the registered retirement income funds (RRIF) mandatory drawdown rates expressed in the C.D. Howe Institute's recent pension policy e-brief Outliving our savings: Registered retirement income funds rules need a big update. The CMA recommends that Finance Canada include RRIF mandatory drawdown rates as part of a consultation. The CMA appreciates the opportunity to provide comment as part of Finance Canada's consultation on enabling target benefit plans within the federally regulated pension framework. The CMA supports further consultation on Canada's pension plan with an aim to ensure optimization of the third pillar, tax-incentivized savings vehicles, to ensure it enables adequate savings levels by self-employed individuals for their future retirement income needs.
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Proposed amendments to the marihuana for medical purposes regulations

https://policybase.cma.ca/en/permalink/policy11293
Date
2014-07-11
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Response to consultation
Date
2014-07-11
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) is pleased to provide this brief in response to Health Canada's consultation on the proposed regulatory amendments to the Narcotic Control Regulations and the Marihuana for Medical Purposes Regulations of the Controlled Drugs and Substances Act, published in the Canada Gazette Part I, on June 14, 2014. The CMA has already made its position on the Marihuana for Medical Purposes Regulations known to Health Canada (see Appendix A). While recognizing the needs of those suffering from terminal illness or chronic disease, and for whom marijuana may provide relief, the CMA has raised significant concerns and objections to the regulatory framework since it was first proposed in 2001. Put simply, the CMA has significant and grave concerns with the regulatory framework governing medical marijuana. Of particular concern to physicians is the scarcity of evidence- based information about the use of marijuana as medical therapy, including on dosage, risks and benefits, and contraindications. While several amendments to the regulatory framework have been promulgated since its initial establishment, the CMA's primary concerns have yet to be addressed. In brief, as the CMA's position on the regulatory framework is detailed in Appendix A, the CMA opposes the approach placing physicians in the role of gatekeepers for a product whose medical benefits have not been sufficiently researched. The CMA continues to recommend that marijuana for medical purposes be held to the same standards as prescription pharmaceutics, including the clinical trial process required for therapeutic products under the Food and Drugs Act and be subject to the same safety and efficacy standards as pharmaceuticals if used for medical purposes. There remain fundamental concerns about quality, safety and efficacy of marijuana used for medical purposes, and the Canadian Medical Protective Association has advised physicians who are uncomfortable with the regulations to refrain from authorizing marijuana to their patients due to potential liability. The CMA advocates for education and licensing programs, clinical guidance and practice supports for health care practitioners who decide to authorize the use of marijuana for patients. The CMA recommends that Health Canada further revise the proposed amendments to the Marihuana for Medical Purposes Regulations to: 1) Enable consistent and best practice oversight In the CMA's submission to Health Canada as part of its review of the Controlled Drugs and Substances Act, as well as in parliamentary briefs on the prescription pharmaceutical regulatory framework, the CMA has recommended high regulatory standards for prescription medication; and even more stringent requirements for controlled substances, both during the approval and the post-approval phases. These recommendations are driven by the potential for harm to patients and the possibility for misuse or abuse of medications, particularly opioids and other such substances. For these reasons, the CMA advocates for an inter-operable, pan-Canadian system of real-time prescription monitoring and surveillance for controlled substances. Robust monitoring and surveillance programs facilitate professional regulatory bodies' oversight and intervention, by enabling the identification of prescribing outliers which include fraudulent attempts to access controlled medications. Prescription monitoring programs also gather information to improve the understanding of prescription drug abuse and to support the development and adoption of best practices. In order to be streamlined and optimized, such a system should be compatible with existing electronic medical and pharmacy record systems and with provincial pharmaceutical databases, and accessible as a point-of-care tool for health care practitioners. Currently, marijuana for medical purposes is exempt from the regulatory requirements of the Food and Drugs Regulations that apply to prescription pharmaceuticals in Canada. Under the Marihuana for Medical Purposes Regulations there is no system in place to monitor the authorization of marijuana for medical purposes. It is in this context that CMA supports the underlying principle of the proposed amendment to the Marihuana for Medical Purposes Regulations which requires licensed producers to provide information to the provincial professional licensing authorities for health practitioners regarding authorizations for marijuana for medical purposes in response to a request by the licensing authority. However, aligned with the CMA's support of a pan-Canadian prescription monitoring system, the CMA recommends that the provision of relevant information to licensing authorities should be part of required regular reporting procedures for the licensed producers, consistent with the prescription monitoring program requirements of the respective provincial and territorial jurisdictions. Finally, the CMA recommends that Health Canada support the integration marijuana for medical purposes within provincial/territorial prescription monitoring programs, including facilitating the availability of a point-of-care access tool for health care practitioners. 2) Safeguard protection of privacy As articulated in the CMA's Code of Ethics, physicians consider protecting the privacy of patient information to be paramount, and as such, the CMA has developed policy guidance concerning patient as well as physician information. The CMA's Principles for the Protection of Patients' Personal Health Information (see Appendix B) emphasizes that privacy, confidentiality and trust are cornerstones of the patient-physician relationship. Recognizing that health information is highly sensitive, this policy statement articulates foundational privacy principles that must be adhered to with respect to patient information. In addition to the provision of patient information, authorizations include physician information. The CMA's Principles Concerning Physician Information (see Appendix C) specify 11 conditions that must be met including with respect to the collection, use, access, storage and disclosure of physician information. The CMA recommends that the proposed amendments to the Marihuana for Medical Purposes Regulations be reviewed and revised as necessary to ensure it meets the standards of the CMA's Principles for the Protection of Patients' Personal Health Information and the CMA's Principles Concerning Physician Information. The CMA is concerned with the fact that licensed producers, not Health Canada, are the custodians of patient and licensed health practitioner information, in that they collect, use, have access to or disclose this information. For example, security safeguards, written privacy policies and designated accountable privacy officers, must be in place to protect personal health information and licensed practitioner identification in order to ensure that only authorized collection, use and disclosure or access occurs. The text of the proposed amendment addresses "secure transmission" of data, but it must also address secure storage. Safeguards must ensure that there is the same rigour as required for pharmacies as custodians of sensitive private information. The proposed period of record retention of two years should be reviewed in consultation with the professional licensing bodies, to ensure it is sufficient or if it should be extended. In recognition of the importance of health information privacy, including privacy of patient and physician information, the CMA strongly reiterates its recommendation that Health Canada undertake a privacy impact assessment of the proposed amendment. It is of the utmost importance that the proposed amendments to the Marihuana for Medical Purposes Regulations must conform to privacy laws, and protect patient confidentiality while enabling oversight by licensing authorities. The CMA recommends Health Canada to engage stakeholders as part of its consultation process as part of this privacy assessment. 3) Clarify and enforce consumer advertising requirements Regarding direct-to-consumer advertising, while marijuana for medical purposes is exempt from the Food and Drug Regulations, it is subject to requirements specified in the Narcotic Control Regulations and the Food and Drug Act. The CMA is concerned that licensed producers are circumventing existing direct-to-consumer advertising legislative and regulatory standards. Marijuana for medical purposes is subject to the following sections of the Food and Drugs Act: 3. (1) No person shall advertise any food, drug, cosmetic or device to the general public as a treatment, preventative or cure for any of the diseases, disorders or abnormal physical states referred to in Schedule A. 9. (1) No person shall label, package, treat, process, sell or advertise any drug in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety. (2) A drug that is not labelled or packaged as required by, or is labelled or packaged contrary to, the regulations shall be deemed to be labelled or packaged contrary to subsection (1). Marijuana for medical purposes is subject to the following section of the Narcotic Control Regulations: 70. No person shall (a) publish or cause to be published or furnish any advertisement respecting a narcotic unless the symbol "N" is clearly and conspicuously displayed in the upper left-hand quarter thereof or, if the advertisement consists of more than one page, on the first page thereof; (b) publish or cause to be published or furnish any advertisement to the general public respecting a narcotic; or (c) advertise in a pharmacy a preparation referred to in section 36. While the legislative and regulatory requirements appear consistent with the requirements governing the advertising of prescription and non-prescription medication, it appears that licensed producers are in gross contravention of these standards. The CMA recommends additional effort and action on the part of Health Canada to ensure compliance and enforcement of direct-to-consumer advertising provisions of the Food and Drugs Act and Narcotic Control Regulations. To this end, the CMA recommends that Health Canada issue guidance documentation outlining compliance with these standards and ensure enforcement of these regulations. The CMA welcomes the consultation and review of the amendments to the Marihuana for Medical Purposes Regulations with the view of promoting quality care to improve patient safety and public health. The CMA encourages further consultation and welcomes the opportunity to discuss these issues in greater detail. Overview of recommendations 1. The CMA recommends that the provision of relevant information to licensing authorities should be part of required regular reporting procedures for the licensed producers, consistent with the prescription monitoring program requirements of the respective provincial and territorial jurisdictions. 2. The CMA recommends that Health Canada support the integration of marijuana for medical purposes within provincial/territorial prescription monitoring programs, including facilitating the availability of a point-of-care access tool for health care practitioners. 3. The CMA recommends that the proposed amendments to the Marihuana for Medical Purposes Regulations be reviewed and revised as necessary to ensure it meets the standards of the CMA's Principles for the Protection of Patients' Personal Health Information and the CMA's Principles Concerning Physician Information. 4. The CMA recommends that Health Canada undertake a privacy impact assessment of the proposed amendments to the Marihuana for Medical Purposes Regulations. 5. The CMA recommends additional effort and action on the part of Health Canada to ensure compliance and enforcement of direct-to-consumer advertising provisions of the Food and Drugs Act and Narcotic Control Regulations. 6. The CMA recommends that Health Canada issue guidance documentation outlining compliance with these standards. List of Appendices: * Appendix A - CMA Policy Statement: Medical Marijuana * Appendix B - CMA Policy Statement: Principles for the Protection of Patient ' s Personal Health Information * Appendix C - CMA Policy Statement: Principles Concerning Physician Information
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Tamper Resistance under the Controlled Drugs and Substances Act

https://policybase.cma.ca/en/permalink/policy11295
Date
2014-08-26
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Response to consultation
Date
2014-08-26
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) is pleased to provide its response to the Tamper resistance under the Controlled Drugs and Substances Act consultation, published in the Canada Gazette on June 28, 2014. The CMA encourages Health Canada to accelerate the development of regulations to require products containing specified controlled substances, or classes thereof, to have tamper-resistant properties in order to be sold in Canada. The CMA reiterates its overarching recommendation to the House of Commons Standing Committee on Health during its 2014 study on addressing prescription drug abuse1; that the federal government work with provincial/territorial governments and other stakeholders to develop and implement a comprehensive national strategy to address the misuse and abuse of prescription medication in Canada. The CMA recommends that such a strategy must include prevention, treatment, surveillance and research, as well as consumer protection. One form of consumer protection is the requirement of modifications to the drugs themselves with the intent of minimizing their abuse potential. The CMA also reiterates its recommendation made to Health Canada during the consultation on the Controlled Drugs and Substances Act (CDSA) and its regulations in 20142, that Health Canada establish higher levels of regulatory scrutiny for controlled prescription medication, with more stringent pre-approval requirements. In that brief, the CMA recommends that prescription opioid medication or other potentially addictive medications have tamper- resistant formulations3 to reduce the potential for misuse or abuse. A similar position is taken by the National Advisory Council on Substance Misuse's strategy, First Do No Harm: Responding to Canada's Prescription Drug Crisis4, where one of the 58 recommendations made is that governments and other stakeholders "review existing evidence and/or conduct objective and independent research on the effectiveness of tamper-resistant and abuse-deterrent technology and packaging and make recommendations as needed to reduce the harms associated with prescription drugs and paediatric exposure." Tamper-resistant technology aims to reduce abuse readiness and reduce dependence potential of psychoactive medications, by reducing or impeding the achievement of a rapid euphoric effect ("high") from tampering of the formulation. This can be accomplished by altering physical or chemical properties or absorption rate, prolonging half-life, developing 1 Canadian Medical Association (2013) The need for a national strategy to address abuse and misuse of prescription drugs in Canada. CMA Submission to the House of Commons Standing Committee on Health. CMA. Retrieved from: https://www.cma.ca/Assets/assets- library/document/en/advocacy/Prescription-Drug- Abuse_en.pdf#search=The%20need%20for%20a%20national%20strategy%20to%20address%20abuse%20and%20misuse%20of%20prescription 2 Canadian Medical Association (2014) Review of Controlled Drugs and Substances Act. Submission to Health Canada in response to the consultation on the Controlled Drugs and Substances Act and its regulations. CMA. Retrieved from: https://www.cma.ca/Assets/assets- library/document/en/advocacy/CMA_SubmissiontoHealthCanada- CDSA_Modernization.pdf#search=Submission%20to%20Health%20Canada%20in%20response%20to%20the%20consultation%20on%20the%20 Controlled%20Drugs%20and%20Substances%20Act%20and%20its%20regulations%2E 3 There are different terms to characterize efforts to prevent the manipulation of psychoactive medications for abuse purposes: abuse or tamper resistant formulations, abuse or tamper deterrent formulations and others. In the literature, and for the purpose of this submission, terms are sometimes used interchangeably. 4 National Advisory Committee on Prescription Drug Misuse (2013) First do no harm: Responding to Canada's prescription drug crisis. Ottawa: Canadian Centre on Substance Abuse (p30). Retrieved from: http://www.ccsa.ca/resource%20library/canada-strategy-prescription-drug-misuse- report-en.pdf prodrugs (inactive forms that are converted to active forms in the human body), or adding ingredients that are unattractive to users when the drug is altered. The science around tamper resistance is relatively recent, and analytical, clinical and other methods for developing and evaluating such technologies is increasing. The regulations will have to account for this new and evolving area of expertise, in maintaining scientific rigour in the assessment and evaluation of new formulations both in the pre-approval stage as well as in the post-approval monitoring, while still ensuring efficacy for their target indication.5 Pre-marketing evaluations assess the potentially tamper-resistant properties of a product under controlled circumstances. They should include laboratory-based, pharmacokinetic and clinical abuse potential studies. Post-approval monitoring seeks to determine whether the marketing of the potentially tamper-resistant formulation results in changes in patterns of use, addiction, overdoses and deaths. It is important to understand whether there have been successful attempts to defeat or compromise such formulations. In the U.S., the Food and Drug Administration has not approved explicit label claims of abuse deterrence and will wait until there is sufficient post-marketing data.6 7 Generic manufacturers would have to be held to the same standards. The availability of good quality, systematic surveillance data from Canadian populations is essential to demonstrate epidemiological trends, and would inform these regulations. Regulations must take into consideration the drugs that are most frequently diverted for abuse, the most frequent forms of abuse of each drug, those causing most overdoses and deaths and the populations that are most affected. As stated previously, it is essential that such regulations be part of a comprehensive strategy to reduce abuse of prescription medications. Studies have shown that if no other measures are taken, people who are dealing with addiction and dependence will simply shift to another prescription drug that is not tamper-resistant, or even to illegal drugs. Deterrence is specific to the drug in question. Such has been the case with the introduction of oxycodone with the tamper-resistant formulation, OxyNEO(r), with a significant reduction of oxycodone as a drug of choice. However, at the same time, there was a rise in the use of heroin and other opioids which did not have abuse deterrent technology8, 9. Tamper-resistant technologies have not been proven to be 100% effective in preventing abuse. They are not successful in preventing the most common form of abuse, which is the ingestion of a large number of intact pills, although there have been some attempts at the addition of aversive agents. There is, however, the potential for a significant reduction in the 5 Center for Drug Evaluation and Research (2013) Guidance for Industry: abuse-deterrent opioids - evaluation and labeling. Draft Guidance. Food and Drug Administration. US Department of Health and Human Services. Retrieved from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM334743.pdf 6 Romach, MK, Schoedel, KA, & Sellers, EM (2013) Update on tamper-resistant drug formulations. Drug and Alcohol Dependence 130: 13-23. 7 Shaeffer, T (2012) Abuse-deterrent formulations, an evolving technology against the abuse and misuse of opioid analgesics. J.Med.Toxicol. 8:400-407. 8 Cicero, TJ, Ellis, MS, Surratt, HL (2012 Jul 12). Effect of abuse-deterrent formulation of OxyContin. N Engl J Med. 367(2): 187-9. 9 The Conference Board of Canada (2014) Innovations and policy solutions for addressing prescription drug abuse: summary report. Retrieved from: http://www.conferenceboard.ca/Libraries/CONF_PDFS_PUBLIC/14-0131_SummaryReport_June6.sflb progression from oral to other forms of use, such as chewing, snorting, smoking and injecting. There is an additional challenge, which is the fact that information about procedures and recipes for drug tampering is available among people who use drugs, and sometimes is found on the Internet. There is the possibility of negative unintended consequences in mandating tamper-resistant properties as a condition of sale for selected prescription drugs. There have been anecdotal reports that such forms might not be as effective in addressing the therapeutic needs of some patients. As well, some patients have had difficulties in swallowing tamper-resistant formulations of some drugs. It is essential that the regulations ensure that these medications have adequate clinical testing to ensure bioequivalence to the original formulations, without added adverse effects. The regulations must also take into account the affordability of the new formulations - that the development costs of the tamper-resistant technology not result in an excessive increase in the cost to patients. This must be closely monitored so that there are adequate options for pain management. Prescription drug abuse is a complex and very concerning health problem, and it will require more than a single policy solution. Safer drug formulations have the potential to be an important element of a comprehensive strategy, as medications are necessary tools for the treatment of pain. However, other components such as better surveillance and monitoring, clinical guidelines and tools, and enhanced access to withdrawal and addiction treatment services, as well as mental health and specialized pain services are also essential. The CMA is pleased to provide the recommendations listed below on the development and establishment of new regulations and encourages Health Canada to accelerate the advancement of the draft regulations. Recommendations The CMA recommends that: 1. Health Canada accelerate the establishment requirements for tamper-resistant formulations with the intent of minimizing their abuse potential, as part of a comprehensive national strategy to address the misuse and abuse of prescription medication in Canada, in collaboration with provincial/territorial governments and other stakeholders. 2. both brand name and generic manufacturers be held to the same standards regarding tamper-resistant formulations. 3. the regulations account for the new and evolving area of expertise in tamper-resistance formulations, in maintaining scientific rigour in the assessment and evaluation of new formulations in the pre-approval and post-marketing stages. 4. the regulations ensure that tamper-resistant formulations maintain the same levels of efficacy for their target therapeutic indication as the original formulations, without added adverse effects. 5. the regulations include requirements for post-approval monitoring to determine whether the marketing of the potentially tamper-resistant formulation results in changes in patterns of use, addiction, overdoses and deaths. 6. Health Canada strengthen surveillance systems to collect necessary data from Canadian populations to inform these regulations regarding epidemiological trends, including the drugs that are most frequently diverted for abuse, the most frequent forms of abuse of each drug, those causing most overdoses and deaths and the populations that are affected.
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Letter on cross-border pharmacy control

https://policybase.cma.ca/en/permalink/policy1947
Last Reviewed
2013-03-02
Date
2005-11-08
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Response to consultation
Last Reviewed
2013-03-02
Date
2005-11-08
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
On behalf of the Canadian Medical Association (CMA) I would like to respond to Health Canada’s papers, released on October 7, 2005, “Developing a Drug Supply Network and an Export Restriction Scheme” and “Requiring a Patient-Practitioner Relationship as a Condition of Sale of Prescription Drugs in Canada,” which invite discussion on the Minister of Health’s June 29, 2005 proposals to control cross-border pharmacy and ensure that Canadians have a continued supply of prescription drugs. The CMA agrees that Canadians must have a supply of drugs adequate to meet their needs. Currently the most serious threat to this supply appears to be the legislative proposals, currently before the United States Congress, that would allow Americans to purchase Canadian drugs in bulk. Proactive measures to protect our drug supplies are warranted to guard against this threat. In summary, our response to the Minister’s three proposals is as follows: * Supply monitoring network: We support supply monitoring as a necessary activity. * Export restrictions: We believe that all Canadian drugs should be subject to export restriction, and the Government of Canada should grant itself the power to enact bans on export as needed. * Requiring a patient-physician relationship: We do not believe this proposal can be enforced, or that it will contribute materially to securing an adequate drug supply for Canada. We recommend that Health Canada instead support the activities of medical and pharmacy regulatory authorities in ensuring that prescribing behaviour is appropriate. Our detailed comments on the proposals are below. 1) Drug supply monitoring system The CMA strongly supports the development of a comprehensive strategy and an adequately resourced system for monitoring domestic drug supply. Canada needs such a system to identify shortages and respond quickly to remedy them, and to ensure that policy and regulatory decisions are founded on accurate and reliable knowledge. We recommend that more careful consideration be given to the most effective design and functioning for a supply-monitoring network. It is our understanding that manufacturers and distributors currently monitor supply of their own products. Ideally, a mechanism should be found to unite these individual activities into a robust and effective network without creating a costly parallel effort. Specific comments follow: * 2.1 Gathering Drug Shortage Information: Voluntary reporting is a preferred approach. In designing a voluntary scheme, it should be taken into account that soliciting reports from a wide variety of players, including the public, may result in a flood of anecdotal, poorly documented reports that will require expert analysis to verify and put into context. Regardless of who is solicited for shortage reports, the reporting process should be made as clear, simple and user-friendly as possible, and all stakeholders who might be in a position to make reports should be made aware of its existence. * 2.2 Assessment and Verification: We agree that a baseline of drug inventory data is required, as are benchmarks for what constitutes an appropriate drug supply for Canada. These should be established as a first step, before the implementation of a voluntary reporting scheme. * 2.3 Communication of Information: While physicians may seldom be in a position to report drug shortages, it is essential that they be informed at once when a shortage exists, and how long it is expected to last. Guidance for physicians on measures they might take while the shortage lasts (for example, other drugs they might prescribe as substitutes) is highly desirable. Medical associations could help Health Canada communicate this information to their members. The paper makes reference to Health Canada’s preference for collaboration in this endeavour “without assuming responsibility for becoming the primary source of information for Canadians on drug shortages or for resolving all reported drug shortages.” This is not appropriate. Leadership responsibilities and public expectations preclude the Minister from shirking responsibility for these functions. Accountability for such a complex network must be vested in one authority, i.e. Health Canada. * 2.4 Response measures: Though the paper lists response capacity as an element of drug supply monitoring, it does not contain practical suggestions for responding in the event of a shortage. This is a crucial element and needs to be developed. There is no point in monitoring supply without a plan for managing shortages. 2) Export Restriction CMA supports this proposal. The power to restrict export of drugs offers Canada its best chance of protection should the U.S. legalize bulk purchasing. This power should be strong and far-reaching. Serious consideration should be given to the June 2005 motion from the House Standing Committee on Health motion to ban all bulk exports of prescription drugs. Specific comments follow: * 3.4.2 Drug products deemed necessary for human health: The discussion paper proposes to restrict export only under certain circumstances, e.g. if the drug is deemed necessary to human health, and to establish criteria to determine whether a drug meets this condition. All prescription drugs are necessary for human health; certainly those who are taking them consider them so. For equity’s sake - and also because establishing and abiding by criteria may prove impossible - we believe every prescription drug in Canada should be considered a candidate for export restriction. * 3.4.3 Implications for patient care: We acknowledge that in many cases, other effective therapies can be substituted for drugs in short supply. Many physicians will make these substitutions as needed; but they must first be made aware of the shortages. Physicians must be advised of available alternatives if an unavoidable shortage exists; however, we caution that the existence of alternatives should not be used as justification for not taking action if a drug is in shortage. The final decision as to the most appropriate available therapy should remain a matter to be determined by the patient and physician and consultation. 3) Requiring a Patient-Practitioner Relationship The Minister has expressed his desire to ensure that physicians maintain high ethical and professional prescribing standards. The CMA shares this desire. As discussed in the attached CMA Statement on Internet Prescribing (Appendix I), we hold that prescriptions should be written in the context of an appropriate patient-physician relationship. However, we do not accept that the proposed option of requiring an established patient-practitioner relationship for every prescription issued in Canada will have a meaningful effect on ensuring adequate drug supply, for the following reasons: * The proposal does not target the real problem. Most current drug shortages are caused by raw material shortages, inventory management disruptions, unexpected spikes in demand, and other conditions that have nothing to do with the clinical encounter. More important, targeting the patient-practitioner relationship will not protect Canadians from the impact of U.S. bulk purchasing should legislation pass Congress. * Prescribing outside the context of the patient-physician relationship is already subject to sanction by medical regulatory authorities. The vast majorities of Canada’s physicians conduct themselves ethically and only prescribe for patients in the context of a professional relationship. Those who do not, contravene both the CMA’s policy and the standards of practice for provincial/territorial regulatory Colleges of Physicians and Surgeons. These regulatory authorities, and the long and effective tradition of professional self-regulation they represent, should be respected and supported. * The proposal is burdensome and will be difficult to enforce. The proposal places the onus for evaluating the patient-practitioner relationship on pharmacists. While pharmacists are required, as part of their professional responsibility, to ensure that a prescription has been written by a physician licensed to practice in that jurisdiction, they are not customarily familiar with the details of the interaction leading up to the prescription. Requiring them to formally screen for this will impose a heavy administrative burden, and will compromise patient confidentiality. In addition, compliance monitoring by Health Canada will be complex, if feasible at all. For example, despite the Minister’s recent comment that prescriptions “can only be signed by a medical practitioner who actually sees and treats the patient in question”, it is generally accepted that perfectly legitimate prescribing can take place without a face-to-face encounter (e.g. through telemedicine) or an “ongoing” patient-physician relationship (e.g. in an emergency). While it is easy to detect flagrant infractions (such as a hundred prescriptions a day written for American patients by the same Canadian doctor) it will be much harder to precisely identify the boundary between what is legitimate prescribing behaviour and what is not. Many provincial regulatory authorities have already developed definitions of the patient-physician relationship, which Health Canada includes in the discussion document. It is unlikely that Health Canada will be able to improve on them. * Determining an appropriate relationship may be more appropriately a provincial or territorial responsibility. The patient-physician interaction, like other scope-of-practice issues, is regulated at the provincial level. We do not believe the cross-border prescribing problem justifies Health Canada’s overarching federal-level intervention. In conclusion, we support further exploration of the supply-monitoring and export-restriction options, and believe that existing medical and pharmaceutical regulatory authorities should be respected and supported in enforcing appropriate prescribing behaviour. We appreciate the opportunity to comment on your proposals. We look forward to further opportunities for input during the development of legislation. Yours truly, Briane Scharfstein, MD, CCFP, MBA Associate Secretary General, Professional Affairs cc: Ms. Meena Ballantyne, Director General, Health Care Strategies and Policy Directorate, Health Canada CMA Provincial/Territorial Divisional CEO’s
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Letter - CMA Submission to the Minister of Health

https://policybase.cma.ca/en/permalink/policy9286
Last Reviewed
2009-02-21
Date
2000-09-06
Topics
Health systems, system funding and performance
  1 document  
Policy Type
Response to consultation
Last Reviewed
2009-02-21
Date
2000-09-06
Topics
Health systems, system funding and performance
Text
The Canadian Medical Association (CMA) values the open, constructive and ongoing dialogue that has developed over the past year with you and your ministry in seeking solutions to the critical issues and challenges that face Canada's health system. As an open society, it is essential to the future of the health care system that every effort is made to work together to find lasting solutions to what is a series of complex and interdependent social policy issues. With many policy challenges placed squarely on the table, it is timely that we move beyond issue identification and strive to develop a comprehensive plan for health care that incorporates a set of solutions that are strategic, targeted, long-term, and sustainable. Given the evolving nature of the health care system, the plan must also be flexible, adaptive and innovative. To assist you as you enter into extensive policy discussions with your provincial and territorial colleagues, CMA believes it is crucial that there is a clear sense of where the medical profession stands on a number of issues. The purpose of the letter is to outline an action plan to revitalize Canada's health care system. The plan is a series of constructive proposals in which the sum is greater than the individual components. The proposals are grouped under the categories of sustainable and accountable federal funding, national health system innovation and physician resource strategy. This information will likely form the basis of the CMA's presentation to the House of Commons Standing Committee on Finance later this Fall. By their very nature, the proposals are strategically targeted and align policy solutions to a number of key policy challenges that face the health care system today, tomorrow and into the future. The proposals are designed to complement one another. They should be considered as a series of investments that address a spectrum of policy issues in the health care system. Our proposals are designed in such a manner that they are sufficiently flexible in meeting provincial and territorial health care priorities, while ensuring that the federal government is fully recognized for its essential investment. Furthermore, to promote a higher degree of accountability, transparency and legitimacy, each proposal sets out its own rationale and includes, where possible, an order-of-magnitude cost estimate. In specific terms, the total cost of the recommendations that the CMA is putting forward is a minimum of $10.15 billion. Each investment is accounted for as follows: * Health-specific Federal Cash Restoration $3.81 billion * National Health Technology Fund $1.74 billion * National Health Connectivity Investment $4.10 billion * National Physician Resource Strategy $0.50 billion Total $10.15 billion The attached documents summarize our recommendations and provide detailed information each proposal. The CMA has offered a powerful and strategic combination of policy initiatives designed to revitalize Canada's health care system. The proposals are realistic, practical and serve to focus on making the health care system one that is innovative, responsive and accessible by all Canadians. Finally, it must also be made clear that no one group can address all of the policy issues and challenges facing the health care system. Thus, the CMA's commitment to working with the federal government and others to ensure that our health care system will be there for all Canadians in need is once again offered. The CMA looks forward to discussing with you how these specific proposals can be implemented. Sincerely yours, Original signed by Peter Barrett Peter Barrett, MD, FRCSC President enclosures c.c. Prime Minister and Provincial and Territorial Premiers Provincial and Territorial Ministers of Health Federal Minister of Finance CMA Board of Directors CMA Provincial and Territorial Divisions and Affiliated Societies SUMMARY OF RECOMMENDATIONS September 6, 2000 In seeking to place the health care system on the road to long-term sustainability, the CMA is committed to working in close partnership with the federal government and others identifying, developing and implementing policy initiatives that serve to strengthen Canadians' access to quality health care. In the spirit of placing Canada's health care system on the road to recovery, the CMA offers the following recommendations: 1. That the federal government fund Canada's publicly financed health care system on a long-term, sustainable basis to ensure quality health care for all Canadians. 2. That the federal government, in consultation with the provinces and territories, and stakeholders, introduce a health-specific cash transfer mechanism to promote greater public accountability, transparency and linkage of sources to their respective uses. 3. That the federal government, at a minimum, increase federal cash for health care by an additional $3.8 billion, effective immediately. 4. That beginning April 1, 2001, the federal government introduce an escalator mechanism that will grow the real value of health-specific cash over time. 5. That the federal government must allocate new monies, over and above the $3.8 billion increase to the health-specific cash floor to facilitate the development of a comprehensive and seamless system of care. 6. That the federal government commit a minimum of $1.74 billion over three years to A National Health Technology Fund, to increase country-wide access to needed health technologies. 7. That the federal government make a minimum investment of $4.1 billion in National Health Connectivity 8. That the federal government immediately establish a Physician Education and Training Fund in the amount of $500 million to fund: (1) increased enrolment in undergraduate and postgraduate medical education; and (2) the expanded infrastructure (both human and physical resources) of Canada's 16 medical schools needed to accommodate the increased enrolment. 9. That the federal government increase funding targeted to institutes of postsecondary education to alleviate some of the pressures driving tuition fee increases. 10. That the federal government enhance financial support systems for medical students, provided that they are: (a) non-coercive; (b) developed concomitantly or in advance of any tuition increase; (c) in direct proportion to any tuition fee increase; and (d) provided at levels that meet the needs of the students. ON THE ROAD TO RECOVERY... AN ACTION PLAN FOR THE FEDERAL GOVERNMENT TO REVITALIZE CANADA'S HEALTH CARE SYSTEM September 2000 SUSTAINABLE AND ACCOUNTABLE FEDERAL FUNDING Since the introduction of the Canada Health and Social Transfer (CHST) on April 1, 1996, the CMA has taken the strong position that the federal government must restore the level of federal cash notionally allocated to health care that was in place in 1995. Since that time, the federal government has introduced a series of important first steps towards stabilizing Canada's health care system. Specifically, in 1999, the government announced a five-year fiscal framework that reinvested $11.5 billion, on a cumulative basis, in the health care system. In the budget papers, it was clear that this money was to be earmarked for the health care system only. In 2000, an additional one-time investment of $2.5 billion, unearmarked through the CHST over four years, was announced. While seen as a series of important first steps, the figures, however, must be placed in context. Specifically, it is important to note that the CHST monies that have been announced are a combination of increases to the CHST cash floor and "one-time" injections (i.e., "supplements"). Table 1 accounts for the increases via the CHST and its supplement. (NOTE Table content does not display correctly -- SEE PDF) TABLE 11 CANADA HEALTH AND SOCIAL TRANSFER BUDGET IMPACTS (1999 AND 2000) 1999/00 TO 2003/04 ($ BILLIONS) Year 1999/00 2000/01* 2001/02 2002/03 2003/04 5 Years Budget 2000 Increase CHST Supplement** -- 1.0 0.5 0.5 0.5 2.5 Budget 1999 Increase CHST Supplement*** CHST Cash Floor 2.0 -- 1.0 1.0 0.5 2.0 -- 2.5 -- 2.5 3.5 8.0 Budget 1998 Cash 12.5 12.5 12.5 12.5 12.5 62.5 Total CHST Cash 14.5 15.5 15.5 15.5 15.5 76.5 CHST Tax Transfers 14.9 15.3 15.8 16.5 17.2 79.7 Total CHST 29.4 30.8 31.3 32.0 32.7 156.2 * All figures for 2000/01 onward, with the exception of CHST cash, are projections. ** The $2.5 billion cash supplement will be paid to a third party trust and accounted for in 1999/00 by the federal government. Payments will be made in a manner that treats all jurisdictions equitably, regardless of when they draw down funds over four years. *** The $3.5 billion cash supplement was paid into a third party trust and accounted for by the federal government in 1998/99. In the latter case, these "CHST supplements," totaling $3.5 billion over three years in 1999 and $2.5 billion over four years in 2000 are specifically designed not to be included as part of the CHST cash floor. Nor is it intended to grow over time through an escalator. In fact the supplement, which is framed as a multi-year investment is charged to the preceding year's budget. Thus, once allocated and spent, the money is gone. While the CHST supplements were important first steps, the CMA views them as "tentative half-measures" and by no means a substitute for fostering short-, medium- and/or long-term planning of the health care system. A long-term commitment by the federal government is required to increase its health-specific cash allocation. Recognizing the limitations of the CHST supplement, on an annual basis, this means that CHST cash for health care increased by $2.0 billion in 1999/00; it will remain at the same level for 2000/01 and then increase by $500 million (to $2.5 billion) in 2001/02, and remain at that level for the 2002/03 and 2003/04. In other words, only in 2002/03 will the CHST cash floor return to its 1995 nominal spending levels, 7 years after the fact, with no adjustment for the increasing health care needs of Canadians, inflation or economic growth. The budget announcements by the federal government in 1998/99 and 1999/00 are presented in Table 2. Please note that the amounts applied to the CHST cash floor and the cash supplements have been separated. TABLE 2 TOTAL CHST CASH, HEALTH-SPECIFIC CHST CASH, CHST SUPPLEMENT 1995/96 TO 2003/04 ($ BILLION) Year Total CHST Cash CHST Cash for Health Care* CHST Supplement Total CHST Cash for Health Care 1995/96 18.5 7.59 N/A 7.59 1996/97 14.7 6.03 N/A 6.03 1997/98 12.5 5.13 N/A 5.13 1998/99 12.5 5.13 N/A 5.13 1999/00 12.5 + 2.0 = 14.5 5.13 3.5 8.63 2000/01 13.5 + 2.0 = 15.5 6.13 2.5 8.63** 2001/02 14.5 + 1.0 = 15.5 7.13 N/A 7.13 2002/03 15.0.+ 0.5 = 15.5 7.63 N/A 7.63 2003/04 15.0 + 0.5 = 15.5 7.63 N/A 7.63 * It is assumed that in 1995/96 the notional allocation to health care is 41% of CHST. Prior to the introduction of the CHST, Established Programs Financing (EPF) and the Canada Assistance Plan (CAP) were in place. In addition, federal cash that has been "earmarked" allocated for health care and added to the CHST base, as outlined in the past two federal budgets, are included ** Assumes that the $2.5 billion supplement was allocated to health care only. It is important to pay careful attention with regard to how the figures have been derived and on what basis. Close attention has been paid to the distinction between the increase to the CHST cash floor and the introduction of a "CHST supplement," which has been applied by the federal government over the last two years. In the latter case, the supplement has not been factored into the CHST cash floor analysis since it is a one time expenditure, charged to the previous fiscal year, that can never grow over time. Simply put, once allocated it is gone in perpetuity and does not have any further application in terms of facilitating future growth of the CHST cash floor. Based on Table 2, it is estimated that the CHST cash floor in support of health care currently stands at $6.13 billion in 2000/01. This is roughly $1.5 billion below the 1995/96 level without adjusting the cash floor in support of health care to reflect a number of factors including, a growing and aging population, the depreciation of the system's physical infrastructure, the cost of pharmaceuticals, or inflation, to name a few. At a minimum, the federal government must put back what it has taken out of the system. Specifically, the CMA believes that the federal government must re-establish the level of CHST cash allocated to health care at the 1995 level, adjusted to reflect the changing health care needs of Canadians in the coming year of 2001. The question then becomes on what basis can one arrive at a reasonable estimate? Based on a recent study prepared by the Provincial and Territorial Ministers of Health, the CMA believes that this is an important point of departure in considering orders of magnitude.2 Therefore, if one applies the growth factor that was recently calculated by the Provinces and Territories in its "cost driver" study (at 4.6% per annum), the health portion of CHST cash in 1995 at $7.59 billion is adjusted upwards to $9.94 billion in 2001 dollars (see Table 3). TABLE 3 ESTIMATED VALUE OF CHST HEALTH-SPECIFIC CASH FLOOR 1995/96 TO 2001/02 ($ BILLIONS) YEAR CURRENT CHST CASH FLOOR FOR HEALTH CARE ESCALATOR APPLIED TO BASE YEAR OF 1995/96 (% INCREASE) EXPECTED HEALTH-SPECIFIC CASH FLOOR 1995/96 7.59 4.6 1996/97 6.03 4.6 7.94 1997/98 5.13 4.6 8.30 1998/99 5.13 4.6 8.69 1999/00 5.13 4.6 9.09 2000/01 6.13 4.6 9.50 2001/02 7.13 4.6 9.94 Based on the recent combination of announcements by the federal government to increase the CHST cash floor and the supplements, it is estimated that the 2000/2001 health-specific cash floor stands at $6.13 billion. Therefore, to bring the health-specific cash that flows through the CHST in line with the changing health care needs of Canadians, it should, at a minimum, increase by $3.81 billion effective immediately. In reviewing the approach taken by the CMA, it is important to understand that the $3.81 billion figure is a health-specific cash calculation only. As the CHST is currently configured, it flows federal cash for health, post-secondary education and income support programs. Currently, the Provinces and Territories are adamant that the federal government return the CHST cash floor to its 1993-94 level of $18.7 billion by adding $4.2 billion immediately. However, the $4.2 billion that is being requested is in "1993/94 dollars"; it is not adjusted to account for the changing needs of Canadians between 1993/94 and 2000/2001 for health, post-secondary education or income support programs. While raising the health-specific cash floor will serve to stabilize the system, it is likely that there will be future debate about what is the appropriate share of federal cash. While there are those who factor in the value of the tax point transfer, it is only federal cash that can be used to sanction the provinces and territories that are in violation of the Canada Health Act.3 As the Minister of Health was recently quoted "For the Canadian government to continue to have the moral authority to influence reform, we have to be a more robust contributor."4 In this context, the adage "no cash, no clout applies" in its strictest sense. Therefore, while federal cash must be reinfused into the health care system, there must also be substantive policy discussion about what the federal government's contribution should be in the future, and through what mechanism. For example, should it be a fixed amount only; should it be tied to provincial/territorial public expenditures on health; and/or how should it grow over time? The Need for Financial Accountability In making a critical investment in the health care system, the CMA strongly supports the principle of financial accountability. This is consistent with the federal government's call for increased accountability in the health care system. After all, if the federal government is calling on provincial and territorial governments, and providers to be more accountable for what they do, then the federal government should be prepared to be measured by the very same principle when it comes to funding Canada's health care system. Therefore, every effort should be made to ensure that health-specific federal monies are visible and transparent. The CMA view is also consistent with the underpinnings of the recently negotiated Social Union Framework Agreement which calls for greater public accountability on all levels of government. These issues have been recently noted by the Auditor-General of Canada "Under the CHST, the federal government does not know its exact total contribution to provinces and territories for health care as distinct from social assistance and services and post-secondary education."5 The report goes on to recommend that the federal government explore options to improve information on its total contribution to health care, and work with the provinces and territories to develop requirements for information and reporting purposes with respect to CHST additional funds. The Canadian Institute for Health Information also observed that "following the introduction of the Canada Health and Social Transfer (CHST) in April 1996, total federal contributions to health care cannot be clearly defined."6 Furthermore a recent policy document released by Mr. Tom Kent, one of the policy architects of Medicare in the 1960s, refers to the CHST as "jelly...It can be varied as we choose, spent however each province chooses." 7 He also says "Ensure that the federal financial contribution to the medicare partnership is made continuingly clear. This transparency is required not only for the credit of the present government but, equally, to protect the provinces against any future federal government thinking that it could cut its funding with little political penalty...In short, the federal need for recognition of funding and the provincial need for security of funding are not in conflict."8 In many ways, the announcement of the $11.5 billion, cumulatively, in 1999 was a de facto recognition of the need for a health-specific allocation in support of health care. The recent calculations released by the Federal Department of Finance only serve to reinforce this point.9 At a time of increased societal awareness and demand for accountability, the CHST mechanism appears to be anachronistic by having one indivisible cash transfer that does not recognize explicitly the federal government's contribution to health in a post-Social Union Agreement world. Therefore, the CHST cash transfer mechanism should be restructured to ensure that there is a higher degree of transparency and explicit linkage between the sources of federal funding and their respective uses at the provincial and territorial level. This can be achieved such that the provinces and territories have the flexibility to allocate resources on the basis of agreed-upon priorities, while ensuring that the federal government is fully recognized for its investment. It would also underscore the relationship between financial "inputs" and health "outputs." A Mechanism to Grow the Real Value of Health-Specific Federal Cash Over Time In addition to increasing the federal cash floor in support of health care, there is also the need to ensure that the cash can grow over time to meet the future needs of Canadians. With this in mind, the CMA recommends the re-introduction of an escalator mechanism to grow the real value of health-specific federal cash. If left as is, federal cash will continue to erode over time with increasing demands from an ageing and growing population, epidemiological trends, new technologies, to name a few. In previous years, the CMA has proposed an escalator formula which recognizes that future health care costs are not always synchronized with economic growth. In fact, in times of economic hardship (e.g., unemployment, stress, and familial discord), a greater burden is placed on the health care system. The concept of an escalator is not new. In fact, at the time of Established Programs Financing, a three-year moving average of nominal Gross Domestic Product per capita was in place. This policy was regrettably tinkered with and then eliminated in the mid-1990s.10 Thus, the CMA believes that now is the time to reintroduce a policy measure that served federal-provincial/territorial fiscal relations well. Such a policy measure would be a clear signal to the provinces and territories that the federal government is prepared to be there over the long-term, and is prepared to move away from the annual finger-pointing that plagues federal/provincial/territorial collaboration when it comes to the future of the health care system. To illustrate the financial impact of an escalator, if the federal government's health-specific cash floor is $9.94 billion, assuming an escalator of 4.6% would yield an additional $457 million to the provinces and territories in year 1, and $547 million in year 5. This is not prohibitive when one considers the current revenues of the federal government, and its anticipated series of surpluses.11 It should also be noted that these recommendations are consistent with the direction set out by the National Liberal Caucus Task Force on Health Care Sustainability.12 Combined, the issues of the level of health-specific federal cash for health care and the need for an escalator mechanism speak not only to the fundamental principles of the necessity of stabilizing the health care system, but also in terms of the federal government taking the necessary concrete leadership steps to ensure that adequate and long-term funding is available to meet the health care needs of all Canadians. Their rationale is reasoned and strategic; they give the federal government full recognition for its investment and the provinces and territories flexibility in allocating monies to meet their respective priorities. It also serves to build on and strengthen the core foundation of Canada's health care system. If Canada's health care system is not only to survive, but thrive in the new millennium, we must give serious consideration to a range of possible solutions that place our system, and the federal role within that system, on a more secure and sustainable financial footing. The CMA therefore recommends: 1. That the federal government fund Canada's publicly financed health care system on a long-term, sustainable basis to ensure quality health care for all Canadians. 2. That the federal government, in consultation with the provinces and territories, and stakeholders, introduce a health-specific cash transfer mechanism to promote greater public accountability, transparency and linkage of sources to their respective uses. 3. That the federal government, at a minimum, increase federal cash for health care by an additional $3.8 billion, effective immediately. 4. That beginning April 1, 2001, the federal government introduce an escalator mechanism that will grow the real value of health-specific cash over time. Looking to the Future... While the federal government must make a series of investments to stabilize the health care system, it must also consider the broader spectrum of health care services needed to ensure that Canadians do not fall through the cracks. In the past, the CMA has proposed a Health System Renewal Fund. The purpose of the multi-year fund was to recognize the changing nature of our health care system and to facilitate the development of a more comprehensive and seamless system of care. The Fund proposed that as the system continues to evolve additional transitional funding is required to ensure that it remains accessible, and can do so with minimal interruption to Canadians. That being said, over the longer-term, the CMA recognizes that the federal government will have to move from transitional funding to investing significant new federal dollars that will not jeopardize access to quality acute care services. The CMA recommends: 5. That the federal government must allocate new monies, over and above the $3.8 billion increase to the health-specific cash floor to facilitate the development of a comprehensive and seamless system of care. HEALTH SYSTEM INNOVATION In reviewing the current state of Canada's health care system and the need to carefully consider its future, there are at least two fundamental issues that require our collective wisdom and action. First, there is the need for long-term sustainable funding. The second concerns the overall structure of the health care system, and the degree to which it must be revitalized. Often portrayed as a separate set of strategic policy issues, system funding and system structure are linked inextricably in a practical sense when it comes to ensuring timely access to quality health care. When it comes to structure, the CMA is of the view that renewal and innovation is essential if we, as a society, are to ensure that our health system remains sustainable and responsive over the short-, medium- and longer-term. While we must ensure that the health care system of tomorrow is structurally sound, it must also be sufficiently flexible, adaptive and focused on excellence. The CMA, therefore, proposes that the federal government invest in two areas that are strategically targeted, and serve to facilitate future innovation, adaptability and flexibility in the health care system. At the same time, they also give the provinces and territories full flexibility in determining their priorities within the mandate of the funds while giving the federal government full recognition for its investment. National Health Technology Fund As part of the CMA's submission to the 2000 House of Commons Standing Committee on Finance pre-budget consultations, it was recommended that the government establish a National Health Technology Fund. The purpose of the Fund is to address the significant concerns that have been raised about the lack of access to needed diagnostic and treatment technologies in Canada. Based on the most recent OECD information, Canada ranks poorly when it comes to the availability of technologies, ranking 12th (out of 15) for CT Scanners; 11th (out of 13) for MRIs; and 10th (out of 11) for Lithotripters. Canada ranks favorably only in the availability of radiation equipment 5th (out of 13) OECD countries. Given the very real concerns that have been raised with regard to waiting times across the country, Canadians deserve better when it comes to making available needed health technologies that can effectively diagnose and treat disease. Furthermore, it is clear that we must do more to facilitate the diffusion of new cost-effective health technologies that are properly evaluated and meet defined standards of quality. While physicians are trained to provide quality medical care to all Canadians, they must, at the same time, have "the tools" to do so. In the absence of ready access to current and emerging health technologies, Canadians face the prospect of continued and untreated progression of disease, increased anxiety over their health status, and possibly premature death, while the health care system and society bears the direct and indirect costs associated with delayed access. If Canada were to provide a level of access to these medical technologies that was comparable to other countries with similar standards of living, a minimum expenditure of $1.0 billion would be required for capital costs alone. Our proposal, however, recommends that targeted resources be provided to the provinces and territories to operate the equipment for a three-year period at an overall cost of $1.74 billion. This would give the provinces and territories the opportunity to factor in these additional resources into their respective health budgets. The CMA recommends: 6. That the federal government commit a minimum of $1.74 billion over three years to A National Health Technology Fund, to increase country-wide access to needed health technologies. For your information, a copy of the detailed proposal is enclosed. National Health Connectivity Investment In addition to a national health technologies fund there is a need for significant attention to be paid to ensure access to both hardware and software in order to develop a health information infrastructure that will create "connectivity" throughout the health care system. The health care system operates within an information intensive environment. However, to date, a substantial amount of the data being collected is gleaned as a derivative of administrative or billing/financial systems. Although this provides useful information for arriving at a "high level" view of the operation of the health care system, it is generally of limited value to health care providers at the interface with their patients. Much of the recent debate about the future of the health care system has focused on the need to improve its adaptability and overall integration. One critical ingredient in re-vitalizing the system has to with the necessary information technologies that physicians and other health care professionals must have at their disposal. Specifically, health care providers require access to a secure electronic health record (EHR) that provides details of all health services provided to the patient in front of them. An EHR that meets the clinical needs of health care providers when interacting with their patients will serve to benefit not only the health of Canadians, but the overall efficiency and effectiveness of the health care system. Introduction of new technology, such as an EHR, should be viewed as a "social investment" in the acquisition of knowledge. This benefits patients through the potential reduction in mortality/morbidity rates due to misdiagnosis and improper treatment as well as the reduction in medication errors through access to online drug reference databases and by largely eliminating handwritten prescriptions. Health promotion and disease prevention is enhanced through improved monitoring and patient education as well as improved decision-making by providers and patients. These benefits represent only a sub-set of the potential benefits to Canadians. There are many benefits to providers in having access to an EHR, ranging from administrative cost savings to decreased loss of medical records and improved privacy from physical intrusion of a medical record. The healthcare system as a whole benefits from increased efficiencies and effectiveness. In the United States, the Veterans Health Services and Research Administration (VHSRA) in a controlled prospective study found that a computerized patient record to support providers in outpatient geriatric clinics resulted in cost reductions and improvements in the quality and outcomes of patient care. With baby boomers some 10 - 15 years from retirement, cost reductions and improvements in the quality and outcomes of patient care are not an insignificant benefit of an EHR.13 With this as an introduction, the CMA recommends to the federal government that a national investment in health connectivity be established with the objective of improving the health of Canadians as well as improving the efficiency and effectiveness of the health care system by funding an information technology infrastructure for the health care system. The CMA has determined that a preliminary estimate of the total initial cost of such an investment in knowledge acquisition is a point order-of-magnitude estimate of $4.1 billion. This represents a capital of cost $1.6 billion with a five year implementation and operating costs of $2.5 billion, plus or minus 20%. The yearly operating costs after 5 years are estimated to be $830 million. Of course, substantial additional work is required to arrive at more precise cost estimates as well as the potential savings of such an endeavour. Such an investment would provide Canadians with a bold vision of the future of health care and the federal government's role in moving the health care system into the future. The CMA proposal for an investment in National Health Connectivity dovetails with the recent views of the First Ministers at their most recent meeting. The CMA concurs with the views of First Ministers that the broadened application of information and communications technologies to the health care sector will improve the quality, timeliness and integration of health care services. The CMA, as the representative of Canadian physicians, can play a pivotal partnership role in achieving the buy-in and cooperation of physicians and other health care providers, through a multi-stakeholder process that would encompass the health care team. Our involvement would be a critical success factor in helping the federal government in making a connected health care system a realizable goal in the years to come. The CMA therefore recommends: 7. That the federal government make a minimum investment of $4.1 billion in National Health Connectivity. NATIONAL PHYSICIAN RESOURCE STRATEGY As the federal government is aware, Canada is experiencing a physician shortage that will be significantly exacerbated in the next decade. In November 1999, when the Canadian Medical Forum (CMF) and Society of Rural Physicians of Canada met with the federal and provincial governments, a detailed report on physician supply, containing five specific recommendations, was submitted. The CMA and the other CMF organizations are encouraged to see that many of the jurisdictions across Canada agreed with the need to increase enrolment in undergraduate medical education programs, although we are still far from the 2,000 by 2000 proposed by the CMF. These increases in undergraduate enrolment in medicine require funding not only for the positions themselves, but also for the necessary infrastructure (human and physical resources) to ensure high quality training. The concomitant increases in postgraduate positions that will be required three to four years after entry into medical school must also be resourced appropriately. It is important to note that these positions are independent of the extra positions recommended in the November 1999 CMF report that are needed to increase: (a) flexibility in the postgraduate training system; (b) the capacity to provide training to international medical graduates; and (c) opportunities for reentry for physicians who have been in practice.) The federal government needs to demonstrate its commitment to the principle of self-sufficiency in the production of physicians to meet the medical needs of the Canadian population. The CMA recommends: 8. That the federal government immediately establish a Physician Education and Training Fund in the amount of $500 million to fund: (1) increased enrolment in undergraduate and postgraduate medical education; and (2) the expanded infrastructure (both human and physical resources) of Canada's 16 medical schools needed to accommodate the increased enrolment. Escalation and Deregulation of Tuition Fees The CMA remains very concerned about high, and rapidly escalating, medical school tuition fee increases across Canada. The CMA is particularly concerned about their subsequent impact on the physician workforce and the Canadian health care system. In addition to the significant impact of high tuition fees on current and potential medical students, the CMA believes that high tuition fees will have a number of consequences, including: (1) creating barriers to application to medical school and threaten the socioeconomic diversity of future health care providers serving the public; and (2) exacerbating the physician 'brain drain' to the United States so that new physicians can pay down their large and growing debts more quickly. The CMA decries tuition deregulation in Canadian medical schools and recommends: 9. That the federal government increase funding targeted to institutes of postsecondary education to alleviate some of the pressures driving tuition fee increases. 10. That the federal government enhance financial support systems for medical students, provided that they are: (a) non-coercive; (b) developed concomitantly or in advance of any tuition increase; (c) in direct proportion to any tuition fee increase; and (d) provided at levels that meet the needs of the students. Proposals for a National Health Technology Fund Currently, there is a crisis in confidence among Canadians that access to quality health care services will be there when they need it. In addition, there is a crisis of morale among health care providers who are concerned that they are not able to provide the quality care their patients need. One of the areas that your government could show strong and effective leadership is in the development of a national health technologies infrastructure program. In its 2000 pre-budget submission to the House of Commons Standing Committee on Finance the CMA made the following recommendation: "That the federal government establish a National Health Technology Fund to increase country-wide access to needed health technologies". The purpose of this recommendation recognizes that there are country-wide concerns with the availability of current health technologies in Canada and the speed with which the distribution of new technologies is taking place. In both instances, they have a direct impact on the ability of Canadians to access, within a reasonable time, needed health technologies. As a consequence, Canadians are facing ever-growing waiting lists for access to needed health technology services (including magnetic resonance imagers; computed tomography scanners; lithotripters; radiation therapy, dialysis) which are essential in the early detection of cancers (e.g., breast, prostate, lung), tumours, circulatory complications (e.g., stroke; hardening of the arteries) and treatment of disease. At the same time, physicians are either delayed or denied the ability to use proven state-of-the-art health technologies to assist them as clinicians. In the absence of ready access to current and emerging health technologies, Canadians face the prospect of continued and untreated progression of disease, increased anxiety over their health status, and possibly premature death, while the health care system and society bears the direct and indirect costs associated with delayed access. In considering this issue, the consensus view is that there is a lack of sustainable financial (i.e., capital) resources to purchase needed health technologies. As well, there also appears to be a lack of ongoing financial resources to ensure that the technology can be operated and maintained (i.e., operational) allowing for access on an ongoing basis. Notwithstanding the supply of health technologies, questions have also been raised about the adequate supply of health care professionals that are needed to operate the technology, and associated physical infrastructure to facilitate reasonable access to care. Currently Provincial and Territorial governments, and other groups have called on the federal government to continue its reinvestment in the health care system via the Canada Health and Social Transfer (CHST). However, one drawback of the transfer mechanism is that it is "blind" with no linkage or accountability between federal cash and its intended uses. Recognizing that there is an urgent need for additional funds to be invested and allocated for needed health technologies, the question from a policy perspective is how to design an accountable, targeted and visible program that will invest federal cash into a specific area of the health care system without intruding in the jurisdictional responsibilities of the Provinces and Territories. One approach is for the federal government to announce the creation of a National Health Technology Fund (NHTF). It is proposed that the NHTF would have the following features: 1) The NHTF would be a time-limited program with the singular focus of assisting the Provinces and Territories in the funding and acquisition of needed health technologies. 2) The NHTF would require that all Provinces and Territories apply to the federal government program for funding for needed health technologies. By so doing, it would give the Provinces and Territories full flexibility in determining their technological priorities, how many and what mix of technologies should be allocated in their jurisdiction. 3) The NHTF would provide full financing (i.e., capital) for the purchase of the technology, and defined resources to defray the operational costs associated with the health technologies across the country. Available monies to the Provinces and Territories could be allocated on a per capita basis and/or cost-sharing basis. 4) Once the program has been sun-setted, the Provinces and Territories would be responsible for the ongoing (operational) funding and maintenance for the technologies. The CMA believes that the form of the fund must be closely aligned with its function and would, therefore, make the following specific recommendations: 1. The NHTF would explicitly link the source of federal funding with its intended use at the Provincial and Territorial level - establishing a new level of federal accountability in financing strategic components of the health care system. 2. The federal government's investment in health care would be visible, with full recognition for the investment. 3. The federal government's investment would directly contribute to the increasing patient access to health technologies and reducing waiting lists across the country. 4. The NHTF would be targeted funding in an area of need. As designed, the NHTF would not be seen as intruding on the Provincial and Territorial decision-making process. The NHTF would give the Provinces and Territories full flexibility to apply for federal funding, as well as determining the number and mix of health technologies. Notwithstanding the immediacy and importance of the federal government making this critical investment in the health care system, there are a series of benefits to the federal government, Canadians and institutions/providers. The following are some of the benefits the CMA would ask you to consider: The Federal Government 1. The federal government begins the process of re-establishing its leadership role when it comes to preserving and enhancing Canadians' access to needed health technologies, and assisting in the stabilization of the acute care system. 2. The Fund avoids transferring non-earmarked money (such as via the CHST) to the Provinces and Territories, and ensures that it will be invested in a specific area of priority. 3. The NHTF is a visible and accountable Fund for which the federal government can take full credit. The Public 1. Canadians will benefit directly in terms of having increased access to needed health technologies. 2. Canadians will be fully aware of the federal government's investment into the acute care system. 3. Canadians will benefit in terms of quicker diagnosis and treatment of disease. 4. The public's confidence in its publicly financed health care system will improve. Improved access will reduce the direct (e.g., time off from work) and indirect costs (i.e., caring for family members) of illness, and accelerate Canadians' return to functional status. Health Care Institutions and Providers 1. The additional funding will give institutions increased flexibility in purchasing needed health technologies. 2. It will give institutions the ability to provide more readily accessible health care to Canadians. 3. Providers will have state-of-the-art diagnostic and treatment tools to provide quality health care to all Canadians. The CMA has assessed the cost implications of this national initiative and this information is attached. In addition to a national health technologies fund there is a need for significant attention to be paid to ensure access to both hardware and software in order to develop a health information infrastructure that will create "connectivity" throughout the health care system. The objective would be to foster the integration of the components of the system across the continuum of care supported by evidence-based decision-making by both clinicians and managers. The CMA would like to work with you and your colleague, the Minister of Industry, to explore opportunities to work in partnership with the profession and Canada's high technology industrial sector to develop this health information infrastructure. It is our hope that your government will give serious consideration to our recommendation for a national health technologies fund. The CMA believes that such a fund is clearly warranted. Cost Estimates: In support of the Canadian Medical Association's proposal for a National Health Technology Fund, the following cost estimates, based on the best available data, for the acquisition of medical technology has been compiled. The most recent data available on medical technology comparisons between countries is from the OECD (1997). Equipment costs, in terms of acquisition, siting and operating costs where provided by CMA Affiliates as noted in the cost estimates. If Canada were to provide a level of access to these medical technologies that was comparable to other countries with similar standards of living a minimum expenditure of $1 billion would be required for capital costs alone. Our program, however, in keeping with the spirit of the Canada Health Act, recommends that resources be provided to the provinces/territories to operate the equipment for a three year period at an overall cost (capital and three years of operating costs) of $1.74 billion. This would give the provinces/territories the opportunity to factor in these additional operating costs into their respective health budgets over the three year period. It should be noted that the CMA's estimates do not address the aging state of Canada's existing medical technologies. Unfortunately, information is not available to provide an estimate of the costs of updating such equipment. Medical Technology Acquisition Cost Estimates: Purpose: To estimate the costs of funding a National Health Technology Program. Data Sources: * OECD Health Data 99 - Number of units of technology equipment per million population for countries reporting data for 1997 (most recent year). * Costing information courtesy of: 1) Canadian Association of Radiologists; 2) Winnipeg Health Region Authority; and 3) Canadian Urology Association Data: * Capital cost includes, equipment acquisition cost and siting cost (building space, mechanical, technical, electrical, etc.). * Operating cost includes, yearly service contract and estimate for technical support staff. It does not include expenditures on medical services. Methodology: 1) Medical technologies included: - Computed Tomography scanners (CT scanners) - Magnetic Resonance Imaging units (MRI) - Radiation therapy equipment (linear accelerators, cobalt-60 units, caesium-137 telepathy units, low to orthovoltage x-ray units, high dose rate brachytherapy units, low dose rate brachytherapy units, conventional brachytherapy) - Lithotripters (extracorporeal shock wave lithotriptors) - Positron Emission Tomography (PET) 2) Technologies are expressed in units per million population and are compared only with countries included in the OECD database for 1997 that had a purchasing power parity PPP $ GDP per capita greater than $20,000. Canada's PPP GDP per capita in 1997 was $23,745 while the average for the comparator countries was $23,749. A GDP criteria for comparator inclusion was used to compare Canada with countries that have similar standards of living and potentially similar demands for access to their health care system and to medical technology. 3) The comparator countries are mainly from Europe which have a very high population density. The number of units per million population don't take into account the geographic diversity of Canada. 4) PET data were provided by the Canadian Association of Radiologists (CAR) who stated there were 200 PETs in the world in 1998. Europe and the USA each had a 40% share with Canada having a 3% share used mostly for research. CAR estimates that accounting for population size; and growth; and that PETs in Canada are mostly used for research, an additional 10 units are required. 5) The equipment highlighted are more readily identifiable given their high acquisition costs but other medical technologies in Canadian hospitals need replacement or upgrading as well. For example, gamma cameras are generally 10 to 15 years old and need to be replaced with gated imaging cameras at a cost of $650,000 each. Colour doppler ultrasound machines are also required at $200,000 each. As well brachytherapy equipment, which is used for cancer treatment, is becoming increasingly obsolete and has a replacement cost of $750,000 per unit. 6) An 85% factor has been used to estimate requirements for other medical technologies. That is, CAR estimates that radiological high technology medical equipment represents 85% of the overall cost of radiological medical technology. Therefore overall capital costs (equipment and siting) have been grossed up by a factor of (1/.85) or 17.65% to allow for the purchase of other medical technology equipment that cannot be accounted for with the information available. 7) Equipment acquisition cost estimates (excluding siting costs) are based on average estimated costs. Depending upon the sophistication of the equipment the ranges are: CT scanners: $0.50m - $1.50m Linear accelerators: MRIs: $1.25m - $2.50m Low energy: $1.50m Lithotripters: $1.25m - $1.50m High energy $1.80m 8) Operating costs have been calculated over a three-year period so that all provinces/territories would be able to make use of the program which is in keeping with the spirit if not the terms of the Canada Health Act. It would also give them the opportunity to factor these additional operating costs into their respective health budgets after the 3 years. Caveats: The cost estimates reflect the additional cost of bringing Canada up to a standard of access to medical technology of developed countries with similar $ PPP GDP per capita. The cost estimates do not take into account any replacement of existing medical technology equipment that may be required. The acquisition cost of medical technology equipment is only one factor. Associated with such equipment are the costs of a physical site, yearly service contracts and the yearly operating cost of materials and personnel. Findings The estimated overall capital cost is $1 billion. The overall cost of the program, which includes resources to operate the equipment for a three year period, is $1.74 billion. 1 Source: Backgrounder on Federal Support for Health in Canada. March 29, 2000. Department of Finance. 2 Understanding Canada's Health Care Costs - Interim Report. Provincial and Territorial Ministers of Health, June 2000. 3 One must keep in mind that once the tax point transfer occurred, they are part of the provinces own-source revenue structure. The tax points cannot be repatriated to the federal government. Furthermore, with the creation of the CHST cash floor, the relationship between the level of federal cash and tax points has been formally severed. 4 Iglehart J. Restoring the Status of An Icon: A Talk With Canada's Minister of Health. Health Affairs, Volume 19, Number 3, page 133. 5 Report of the Auditor-General of Canada. Chapter 29 Federal Support of Health Care Delivery, November, 1999. 6 Canadian Institute for Health Information. Health Care in Canada - A First Annual Report. 2000. 7 Kent T. What Should Be Done About Medicare. Caledon Institute of Social Policy, August 1, 2000. pp 3-4 8 Ibid, page 2. 9 Backgrounder on Federal Support for Health in Canada. Department of Finance, March 29, 2000. 10 Thomson A. Diminishing Expectations - Implications of the CHST. May, 1996. 11Beauchesne. Federal Surplus Soars. Ottawa Citizen, August 18, 2000. Through the first three months of the current fiscal year, the surplus stands at $8.2 billion - 42% higher than last year at the same time. Extrapolated over the full year, the surplus would be $32.8 billion. . McCarthy S. Ottawa May Have $74 Billion to Allocate. Globe and Mail, August 29, 2000. The article reports that the Ottawa should have a $44 billion surplus over the next five years even after allowing spending to rise by more than $3 billion a year to cover population growth and inflation and setting aside $3 billion annually for debt reduction. 12 Investing in New Approaches to Health Care. National Liberal Caucus Task Force on Health Care Sustainability. June 14, 2000. pp 3. 13Dammond KW, Prather RJ, Date VV, King CA. Computers in Biology and Medicine, Vol. 20, No. 4, pages 267-279, 1990, "A Provider-Interactive Medical Record Can Favorably Influence Costs and Quality of Medical Care."
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