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.
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.
The Canadian Medical Association (CMA) appreciates the opportunity to respond to the Health Canada consultations on the regulation of self-care products in Canada. The CMA is encouraged that Health Canada is proposing a framework for the regulation of self-care products that is reliant on scientific proof to support health claims.
The CMA has over 83,000 physician-members. Its mission is helping physicians care for patients and its vision is to be the leader in engaging and serving physicians, and the national voice for the highest standards for health and health care.
The CMA’s comments on the regulation of self-care products, particularly natural health products and non-prescription drugs is based on the CMA Policy on Complementary and Alternative Medicine attached as Appendix 1. Our position is based on the fundamental premise that decisions about health care interventions used in Canada should be based on sound scientific evidence as to their safety, efficacy and effectiveness - the same standard by which physicians and all other elements of the health care system should be assessed. Canadians deserve the highest standard of treatment available, and physicians, other health practitioners, manufacturers, regulators and researchers should all work toward this end.1 CMA supports a regulatory approach to self-care products such as natural health products that is based on risk assessment and the development of standards. 2
1 Canadian Medical Association. CMA Policy Complementary and Alternative Medicine (Update 2015). Ottawa: The Association: 2015. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD15-09.pdf
2 Canadian Medical Association. Brief BR1998-02 - Regulatory framework for natural health products. Ottawa (ON): The Association; 1998.
3Canadian Medical Association. CMA Policy Complementary and Alternative Medicine (Update 2015). Ottawa: The Association: 2015. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD15-09.pdf
4 Canadian Medical Association. Policy resolution GC08-86 - Natural health products. Ottawa (ON): The Association; 2008.
5 Canadian Medical Association. Policy resolution GC10-100 - Foods fortified with “natural health” ingredients. Ottawa (ON): The Association; 2010.
6 Canadian Medical Association. Brief BR2014-09 - Bill C-17 An Act to amend the Food and Drugs Act. Ottawa: The Association; 2014.
Risk Based Approach
As noted above CMA has recommended a regulatory approach that is based on risk assessment. We are troubled that the consultation document does not provide enough information on Health Canada’s risk assessment process. We are concerned that the proposal for a risk based approach could place many natural health and homeopathic products in a lower risk category based on whether or not the product makes a health claim which would require no Health Canada review or licensing of these products. As noted in the consultation document all health products have some level of risk and Health Canada’s role is to ensure that the benefits of a product outweigh any know risks. CMA does not believe that a determination of risk can be made based on historical use of a product or on the basis of a philosophical system not supported by science.
The CMA has a long standing position that the same regulatory standards should apply to both natural health products and pharmaceutical health products. These standards should be applied to natural health products regardless of whether a health claim is made for the product. This framework must facilitate the entry of products onto the market that are known to be safe and effective, and impede the entry of products that are not known to be safe and effective until they are better understood. 3
CMA would recommend that the initial risk assessment of a self-care product should be evidence informed and based on the same standards of proof and efficacy as those for conventional medicines and pharmaceuticals. As such, we are concerned that homeopathic and natural health products are given as examples of lower risk products that would not require Health Canada review or licensing.
The consultation document redefines a health claim to only those that pertain to diagnosis, treatment, prevention, cure or mitigation of disease or serious health condition. These claims will need to be supported by scientific evidence and only these health claims will be allowed and reviewed by Health Canada.
The CMA has recommended that safety and efficacy claims for natural health products, and claims for the therapeutic value of these products should be prohibited when the supportive evidence does not meet the evidentiary standard required of medications currently regulated by Health Canada. 4 Claims of medical benefit should only be permitted when compelling scientific evidence of their safety and efficacy exists.5 Therefore the CMA supports the proposal that two products making similar claims would have to provide the same level of scientific evidence and are held to the same standard. CMA would not be in support of the proposal that products can still make claims “based on traditional systems of medicine or alternate modalities” with only “adequate supporting information” to be maintained by the company without review or licensing by Health Canada.
CMA would also recommend that even those products that do not make health claims are held to the same standard as those established for pharmaceutical products. Since our position is that all self-care products from lower risk to higher risk should be reviewed for safety and quality, all products should undergo review by Health Canada.
It is certainly problematic that, as noted in the consultation document, fewer than 2 in 5 Canadians surveyed rated themselves knowledgeable about the effectiveness of self-care products. Canadians have the right to reliable, accurate information on self-care products to help ensure that choices they make are informed. It is very important that Canadians understand the level of scrutiny a product has undergone by Health Canada. CMA can support the proposal for an authorization number on those products that have been reviewed and approved by Health Canada. Equally, a disclaimer on the product label that indicates that the product has not been reviewed or approved by Health Canada for effectiveness is very important. We must guard against an assumption by the public that if Health Canada did not need to review a product there is no risk associated with the product.
The Information provided on self-care products should be user friendly and easy to access and include a list of ingredients, instructions for use, indications that the product has been proven to treat, contraindications, side effects and interactions with other medications.
In an era when product claims can be spread vie social media and the internet and cannot be easily monitored it is important to ensure consistent oversight of product marketing. Health claims can only be promoted if they have been established with sound scientific evidence. This restriction should apply not only to advertising, but also to all statements made in product or company Web sites and communications to distributors and the public. Advertisements should be pre-cleared to ensure that they contain no deceptive messages.
In its submission on Bill C -17 An Act to amend the Food and drugs Act – Protecting Canadians from Unsafe drugs the CMA recommended that the ministerial authorities and measures to address patient safety risks should extend to natural health products.6 We would therefore suggest that Health Canada explore the need for additional powers and tools to require a company to change labels, or order a recall of an unsafe product and institute new penalties to address patient safety issues.
Canada's physicians are prepared to work with governments, health professionals and the public in strengthening Canada's regulatory framework for self-care products to ensure that the health related products Canadians receive are safe and effective.
Jeff Blackmer, MD, MHSc, FRCPC
Vice-President, Medical Professionalism
Canadian Medical Association
COMPLEMENTARY AND ALTERNATIVE MEDICINE
This statement discusses the Canadian Medical Association’s (CMA) position on complementary and alternative medicine (CAM). CAM, widely used in Canada, is increasingly being subject to regulation. The CMA’s position is based on the fundamental premise that decisions about health care interventions used in Canada should be based on sound scientific evidence as to their safety, efficacy and effectiveness - the same standard by which physicians and all other elements of the health care system should be assessed. Patients deserve the highest standard of treatment available, and physicians, other health practitioners, manufacturers, regulators and researchers should all work toward this end. All elements of the health care system should “consider first the well-being of the patient.”1 The ethical principle of non-maleficence obliges physicians to reduce their patient’s risks of harm. Physicians must constantly strive to balance the potential benefits of an intervention against its potential side effects, harms or burdens. To help physicians meet this obligation, patients should inform their physician if the patient uses CAM.
1 Canadian Medical Association. CMA code of ethics (update 2004). Ottawa: The Association; 2004.
2 Canadian Medical Association. Policy resolution GC00-196 - Clinical care to incorporate evidence-based technological advances. Ottawa (ON): The Association; 2000. Available: http://policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm.
3 Canadian Medical Association. CMA code of ethics (update 2004). Ottawa: The Association; 2004. Available: http://policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm.
4 Canadian Medical Association. CMA statement on emerging therapies [media release]. Ottawa (ON): The Association; 2010. Available: www.facturation.net/advocacy/emerging-therapies.
CAM in Canada
CAM has been defined as “a group of diverse medical and health care systems, practices and products that are not presently considered to be part of conventional medicine.”i This definition comprises a great many different, otherwise unrelated products, therapies and devices, with varying origins and levels of supporting scientific evidence. For the purpose of this
i Working definition used by the National Center for Complementary and Alternative Medicine of the U.S. National Institutes of Health.
analysis, the CMA divides CAM into four general categories:
. Diagnostic Tests: Provided by CAM practitioners. Unknown are the toxicity levels or the source of test material, e.g., purity. Clinical sensitivity, specificity, and predictive value should be evidence-based.
. Products: Herbal and other remedies are widely available over-the-counter at pharmacies and health food stores. In Canada these are regulated at the federal level under the term Natural Health Products.
. Interventions: Treatments such as spinal manipulation and electromagnetic field therapy may be offered by a variety of providers, regulated or otherwise.
. Practitioners: There are a large variety of practitioners whose fields include chiropractic, naturopathy, traditional Chinese and Ayurvedic medicine, and many others. Many are unregulated or regulated only in some provinces/territories of Canada.
Many Canadians have used, or are currently using, at least one CAM modality. A variety of reasons has been cited for CAM use, including: tradition; curiosity; distrust of mainstream medicine; and belief in the “holistic” concept of health which CAM practitioners and users believe they provide. For most Canadians the use is complementary (in addition to conventional medicine) rather than alternative (as a replacement). Many patients do not tell their physicians that they are using CAM.
Toward Evidence-Informed Health Care
Use of CAM carries risks, of which its users may be unaware. Indiscriminate use and undiscriminating acceptance of CAM could lead to misinformation, false expectations, and diversion from more appropriate care, as well as adverse health effects, some of them serious.
The CMA recommends that federal, provincial and territorial governments respond to the health care needs of Canadians by ensuring the provision of clinical care that continually incorporates evidence-informed technological advances in information, prevention, and diagnostic and therapeutic services.2 Physicians take seriously their duty to advocate for quality health care and help their patients choose the most beneficial interventions. Physicians strongly support the right of patients to make informed decisions about their medical care. However, the CMA’s Code of Ethics requires physicians to recommend only those diagnostic and therapeutic procedures that they consider to be beneficial to the patient or to others.3 Until CAM interventions are supported by scientifically-valid evidence, physicians should not recommend them. Unless proven beneficial, CAM services should not be publicly funded. To help ensure that Canadians receive the highest-quality health care, the CMA recommends that CAM be subject to rigorous research on its effects, that it be strictly regulated, and that health professionals and the public have access to reliable, accurate, evidence-informed information on CAM products and therapies. Specific recommendations are provided below:
a) Research: Building an Evidence Base
To date, much of the public’s information on CAM has been anecdotal, or founded on exaggerated claims of benefit based on few or low-quality studies. The CMA is committed to the principle that, before any new treatment is adopted and applied by the medical profession, it must first be rigorously tested and recognized as evidence-informed.4 Increasingly, good-quality, well-controlled studies are being conducted on CAM products and therapies. The CMA supports this development. Research into promising therapies is always welcome and should be encouraged, provided that it is subject to the same standards for proof and efficacy as those for conventional medical and pharmaceutical treatments. The knowledge thus obtained
should be widely disseminated to health professionals and the public.
b) An Appropriate Regulatory Framework
Regulatory frameworks governing CAM, like those governing any health intervention, should enshrine the concept that therapies should have a proven benefit before being represented to Canadians as effective health treatments.
i) Natural Health Products. Natural health products are regulated at the federal level through the Natural Health Products Directorate of Health Canada.
The CMA believes that the principle of fairness must be applied to the regulatory process so that natural health products are treated fairly in comparison with other health products.5 The same regulatory standards should apply to both natural health products and pharmaceutical health products. These standards should be applied to natural health products regardless of whether a health claim is made for the product. This framework must facilitate the entry of products onto the market that are known to be safe and effective, and impede the entry of products that are not known to be safe and effective until they are better understood. It should also ensure high manufacturing standards to assure consumers of the products’ safety, quality and purity. The CMA also recommends that a series of standards be developed for each natural health product. These standards should include:
5 Canadian Medical Association. CMA statement on emerging therapies [media release]. Available: www.facturation.net/advocacy/emerging-therapies.
6 Canadian Medical Association. Brief BR1998-02 - Regulatory framework for natural health products. Ottawa (ON): The Association; 1998.
7 Canadian Medical Association. Policy resolution GC08-86 - Natural health products. Ottawa (ON): The Association; 2008.
8 Canadian Medical Association. Policy resolution GC10-100 - Foods fortified with “natural health” ingredients. Ottawa (ON): The Association; 2010. Available:
9 Canadian Medical Association. CMA code of ethics (update 2004). Ottawa: The Association; 2004. Paragraph 7. Available: http://policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm.
10 Canadian Medical Association. CMA code of ethics (update 2004). Ottawa: The Association; 2004. Paragraph 11. Available: http://policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm.
11 Canadian Medical Association. Brief BR1998-02 - Regulatory framework for natural health products. Ottawa: The Association; 1998.
12 Canadian Medical Association. Brief BR1998-02 - Regulatory framework for natural health products. Ottawa: The Association; 1998.
* manufacturing processes that ensure the purity, safety and quality of the product;
* labelling standards that include standards for consumer advice, cautions and claims, and explanations for the safe use of the product to the consumer.6
The CMA recommends that safety and efficacy claims for natural health products be evaluated by an arm’s length scientific panel, and claims for the therapeutic value of natural health products should be prohibited when the supportive evidence does not meet the evidentiary standard required of medications regulated by Health Canada.7 Claims of medical benefit should only be permitted when compelling scientific evidence of their safety and efficacy exists.8
The Canadian Medical Association advocates that foods fortified with “natural health” ingredients should be regulated as food products and not as natural health products
The CMA recommends that the regulatory system for natural health products be applied to post-marketing surveillance as well as pre-marketing regulatory review. Health Canada’s MedEffect adverse reaction reporting system now collects safety reports on Natural Health Products. Consumers, health professionals and manufacturers are encouraged to report adverse reactions to Health Canada.
ii) CAM Practitioners. Regulation of CAM practitioners is at different stages. The CMA believes that this regulation should: ensure that the services CAM practitioners offer are truly efficacious; establish quality control mechanisms and appropriate standards of practice; and work to develop an evidence-informed body of competence that develops with evolving knowledge.
Just as the CMA believes that natural health products should be treated fairly in comparison with other health products, it recommends that CAM practitioners be held to the same standards as other health professionals. All CAM practitioners should develop Codes of Ethics that insure practitioners consider first the best interests of their patients.
Among other things, associations representing CAM practitioners should develop and adhere to conflict of interest guidelines that require their members to:
. Resist any influence or interference that could undermine their professional integrity;9
. Recognize and disclose conflicts of interest that arise in the course of their professional duties and activities, and resolve them in the best interests of patients;10
. Refrain, for the most part, from dispensing the products they prescribe. Engaging in both prescribing and dispensing , whether for financial benefit or not, constitutes a conflict of interest where the provider's own interests conflict with their duty to act in the best interests of the patient.
c) Information and Promotion
Canadians have the right to reliable, accurate information on CAM products and therapies to help ensure that the treatment choices they make are informed. The CMA recommends that governments, manufacturers, health care providers and other stakeholders work together to ensure that Canadians have access to this information. The CMA believes that all natural health products should be labeled so as to include a qualitative list of all ingredients. 11 Information on CAM should be user-friendly and easy to access, and should include:
. Instructions for use;
. Indications that the product or therapy has been convincingly proven to treat;
. Contraindications, side effects and interactions with other medications;
. Should advise the consumer to inform their health care provider during any encounter that they are using this product.12
This information should be provided in such a way as to minimize the impact of vested commercial interests on its content.
In general, brand-specific advertising is a less than optimal way of providing information about any health product or therapy. In view of our limited knowledge of their effectiveness and the risks they may contain risks, the advertising of health claims for natural health products should be severely restricted. The CMA recommends that health claims be promoted only if they have been established with sound scientific evidence. This restriction should apply not only to advertising, but also to all statements made in product or company Web sites and communications to distributors and the public. Advertisements should be pre-cleared to ensure that they contain no deceptive messages. Sanctions against deceptive advertising must be rigidly enforced, with Health Canada devoting adequate resources to monitor and correct misleading claims.
The CMA recommends that product labels include approved health claims, cautions
and contraindications, instructions for the safe use of the product, and a recommendation that patients tell physicians that they are using the products. If no health claims are approved for a particular natural health product, the label should include a prominent notice that there is no evidence the product contributes to health or alleviates disease.
The Role of Health Professionals
Whether or not physicians and other health professionals support the use of CAM, it is important that they have access to reliable information on CAM products and therapies, so that they can discuss them with their patients.
Patients should be encouraged to report use of all health products, including natural health products, to health care providers during consultations. The CMA encourages Canadians to become educated about their own health and health care, and to appraise all health information critically.
The CMA will continue to advocate for evidence-informed assessment of all methods of health care in Canada, and for the provision of accurate, timely and reliable health information to Canadian health care providers and patients.
On behalf of 83,000 physician members, the Canadian Medical Association (CMA) welcomes this opportunity to provide input to the House of Commons Standing Committee on Health study on the Development of a National Pharmacare Program. Recognizing that the term “pharmacare” is used in different contexts, for the purposes of this brief, pharmacare is defined as a program whereby Canadians have comparable access to medically necessary prescription medications, irrespective of their ability to pay, wherever they live in Canada.
The Canadian Medical Association (CMA) is the national voice of Canadian physicians. Founded in 1867, the CMA’s mission is helping physicians care for patients.
On behalf of its more than 83,000 members and the Canadian public, the CMA performs a wide variety of functions. Key functions include advocating for health promotion and disease/injury prevention policies and strategies, advocating for access to quality health care, facilitating change within the medical profession, and providing leadership and guidance to physicians to help them influence, manage and adapt to changes in health care delivery.
According to the Canadian Institute for Health Information (CIHI), in 2014, of the estimated $28.8 billion spent in Canada on prescription medications (representing 13.4% of total health spending), governmentsi accounted for 42.0%, and private insurers and out-of-pocket (OOP) payment accounted for 35.8% and 22.2% respectively.1
The CMA is a voluntary professional organization representing the majority of Canada’s physicians and comprising 12 provincial and territorial divisions and over 60 national medical organizations.
i Includes federal. Social security fund and provincial/territorial spending
1 Canadian Institute for Health Information. Prescribed drug spending in Canada, 2013: a focus on public drug programs. https://secure.cihi.ca/free_products/Prescribed%20Drug%20Spending%20in%20Canada_2014_EN.pdf. Accessed 05/15/16.
2 Royal Commission on Health Services. Report Volume One. Ottawa: Queen’s Printer, 1964.
3 Canadian Institute for Health Information. National Health Expenditure Database 1975 to 2015. Table D 3.1.1-D3.13.1 https://www.cihi.ca/en/spending-and-health-workforce/spending/national-health-expenditure-trends. Accessed 05/08/16.
4 Statistics Canada. CANSIM Table 203-0022 Survey of household spending (SHS), household spending, Canada, regions and provinces, by household income quintile. Accessed 05/18/16.
5 Cancer Advocacy Coalition of Canada. 2014-15 Report Card on Cancer in Canada. http://www.canceradvocacy.ca/reportcard/2014/Report%20Card%20on%20Cancer%20in%20Canada%202014-2015.pdf. Accessed 05/08/16.
6 Canadian Cancer Society. Cancer drug access for Canadians. http://www.colorectal-cancer.ca/IMG/pdf/cancer_drug_access_report_en.pdf. Accessed 05/08/16.
7Schoen C, Osborn R, Squires D, Doty M. Access, affordability, and insurance complexity are often worse in the United States compared to ten other countries. Health Affairs 2013;32(12):2205-15.
8 Himmelstein D, Woolhandler S, Sarra J, Guyatt G. Health issues and health care expenses in Canadian bankruptices and insolvencies. International Journal of Health Services 2014;44(1):7-23.
9 Law M, Cheng L, Dhalla I, Heard D, Morgan S. The effect of cost on adherence to prescription medications in Canada. CMAJ 2012. 184)3):297-302.
10 Tamblyn R, Eguale T, Huang A, Winslade N, Doran P. The incidence and determinants of primary nonadherence with prescribed medication in primary care. Ann Inter Med 2014;160:441-50.
Pharmacare is clearly part of the unfinished business of Medicare. Numerous authors have pointed out that Canada is the only developed country that does not include prescription medications as part of its universal health program. Table 1 below shows how Canada compares with the 22 member countries of the Organization for Economic Cooperation and Development (OECD) on the proportion of public spending for major categories of health expenditure in 2012.
Table 1. Public spending as % of total spending: Major health spending categories, Canada and 22 OECD country average, 2012
% Public Spending
Prescription Drugs Hospitals Doctors’ Offices
Canada 42 91 99
OECD Average 70 88 72
Source: OECD.Stat, Doctors’ offices figure for Sweden is 2009
In the case of prescription medications, Canada was more than one-third (40%) below the OECD average.
The Patchwork Quilt of Public-Private Coverage
In 1964 the Hall Commission recommended 50/50 cost-sharing between the federal and provincial governments toward the establishment of a prescription drug program, with a $1.00 charge for each prescription. At the time, prescription medications represented 6.5% of spending on personal health services.2 This recommendation was not implemented. It might be further added that the Hall report contained 25 forward-looking recommendations on pharmaceuticals that remain current to this day, including bulk purchasing, generic substitution and a national formulary.2
As a result of the lack of inclusion of prescription medications in Medicare, there is wide variation today in public per capita spending on prescription drugs across the provinces. It may be seen in Table 2 that, for 2014, CIHI has estimated that public per capita expenditure ranged from $219 in British Columbia and $255 in Prince Edward
Island (PE) to $369 in Saskatchewan and $437 in Quebec.3 CIHI does not provide estimates of private per capita prescription drug spending (private insurance plus OOP) below the national level.
Table 2: Spending on prescription drugs: Selected indicators by province and territory, 2014
Public per capita spendinga
Average household out-of-pocketc $
a CIHI, National Health Expenditure Database 1975-2015, includes all public funding sources
b Canadian Life and Health Insurance Association
c Statistics Canada, Survey of Household Spending, 2014
d Provincial/territorial average
Table 2 also shows the significant role of private insurance in every region of Canada. Data provided by the Canadian Life and Health Insurance Association, shown in Column 3 of Table 2, show that private health insurance companies paid out $10.2 billion for prescription drug claims in 2014, representing 83% of the $12.3 billion paid for by governments. In three provinces — Newfoundland and Labrador, Nova Scotia and New Brunswick — the amount paid by private insurance exceeds that paid by governments. Table 2 also shows that there is wide variation in average household OOP spending on prescription drugs, according to Statistics Canada’s Survey of Household Spending (SHS). In 2014 this ranged from a low of $324 in Ontario to a high of $516 in PE and Manitoba.4
Even more striking variation is evident when looking at household out-of-pocket spending on prescription drugs by income quintile (detailed data not shown). According to the 2014 SHS the poorest one-fifth (lowest income quintile) of PE households spent more than twice as much ($645) OOP on prescription drugs than the poorest one-fifth in Ontario ($300).4 Aside from overall differences in public spending there are also differences in which medications are covered, particularly in the case of cancer drugs. The Cancer Advocacy Coalition of Canada reported in 2014 that four provinces have fully funded access to cancer medications taken at home. In Ontario and Atlantic Canada however, cancer drugs that must be taken in a hospital setting and are on the provincial formulary are fully funded by the provincial government; if the drug is taken outside of hospital (oral or injectable), the patient and family may have to pay significant costs out-of-pocket.5 More generally the Canadian Cancer Society has reported that persons moving from one province to another may find that a medication covered in their former province may not be covered in the new one. 6
Other sources confirm that prescription medication spending is an issue for many Canadians. On the Commonwealth Fund’s 2013 International Health Policy Survey, 8% of the Canadian respondents said that they had either not filled a prescription or skipped doses because of cost issues.7 Himmelstein et al. reported on a survey of Canadians who experienced bankruptcy between 2008 and 2010. They found that 74.5% of the respondents who had had a medical bill within the last two years reported that prescription drugs was their biggest medical expense.8
At least two Canadian studies have documented the impact that out-of-pocket costs, lack of insurance and low income have on non-adherenceii to prescription regimens. Law et al. examined cost-related non-adherence in the 2007 Canadian Community Health Survey and found that those without drug insurance were more than four times as likely to report non-adherence than those with insurance. The predicted rate of non-adherence among those with high household incomes and drug insurance was almost 10 times as high as that among those with low incomes and no insurance (35.6% vs. 3.6%).9 Based on a large-scale study of the incidence of primary non-adherence (defined as not filing a new prescription within nine months) in a group of some 70,000 Quebec patients, Tamblyn et al. reported that there was a 63% reduction in the odds of non-adherence among those with free medication over those with the maximum level of co-payment. They also reported that the odds of non-adherence increased with the cost of the medication prescribed.10
ii Non-adherence can be defined as doing something to make a medication last longer or failing to fill or renew a prescription.
Previous Pharmacare Proposals
In a recent monograph Katherine Boothe has contrasted the development of national prescription medication programs in Australia and the United Kingdom with the failure to do so in Canada.11
11 Boothe K. Ideas and the pace of change: national pharmaceutical insurance in Canada, Australia and the United Kingdom. Toronto: University of Toronto Press, 2015.
12 National Forum on Health. Directions for a pharmaceutical policy in Canada. http://www.hc-sc.gc.ca/hcs-sss/pubs/renewal-renouv/1997-nfoh-fnss-v2/index-eng.php. Accessed 05/18/16.
13 National Forum on Health. Canada health action: building on the legacy. Ottawa: Minister of Public Works and Government Services, 1997.
14 Bank of Canada. Inflation calculator. http://www.bankofcanada.ca/rates/related/inflation-calculator/?page_moved=1. Accessed 05/18/16.
15 Statistics Canada. Table 051-0001 Estimates of population, by age group and sex for July 1, Canada, provinces and territories. Accessed 05/15/16.
16 Canadian Institute for Health Information. National health expenditure database 1975 to 2015. Table C.3.1. Public health expenditure by use of funds, Canada, 1975 to 2015. https://www.cihi.ca/en/spending-and-health-workforce/spending/national-health-expenditure-trends. Accessed 05/25/16.
17 Berry C. Voluntary medical insurance and prepayment. Ottawa: Queen’s Printer, 1965.
18 Receiver General for Canada. Volume I Public Accounts of Canada for the fiscal year ended March 31, 1969. Ottawa: Queen’s Printer for Canada, 1969.
19 Receiver General for Canada. Volume I Public Accounts of Canada for the fiscal year ended March 31, 1972. Ottawa: Information Canada, 1972.
20 Privy Council Office. Speech from the Throne to open the first session thirty-sixth Parliament of Canada. http://www.pco-bcp.gc.ca/index.asp?lang=eng&page=information&sub=publications&doc=aarchives/sft-ddt/1997-eng.htm. Accessed 05/18/16.
21 Standing Senate Committee on Social Affairs, Science and Technology. The health of Canadians – the federal role. Volume six: recommendations for reform. Ottawa, 2002.
22 Commission on the Future of Health Care in Canada. Building on values: the future of health care in Canada. Ottawa, 2002.
23 Canadian Intergovernmental Conference Secretariat. 2003 First Ministers’ accord on health care renewal. http://www.scics.gc.ca/CMFiles/800039004_e1GTC-352011-6102.pdf. Accessed 05/18/16.
24 Council of the Federation. Premiers’ action plan for better health care: resolving issues in the spirit of true federalism. Communiqué July 30, 2004. http://canadaspremiers.ca/phocadownload/newsroom-2004/healtheng.pdf. Accessed 05/18/16.
25 Canadian Intergovernmental Conference Centre. A 10-year plan to strengthen health care. http://www.scics.gc.ca/CMFiles/800042005_e1JXB-342011-6611.pdf. Accessed 05/18/16.
26 National Pharmaceuticals Strategy. National Pharmaceuticals Strategy progress report. http://www.hc-sc.gc.ca/hcs-sss/alt_formats/hpb-dgps/pdf/pubs/2006-nps-snpp/2006-nps-snpp-eng.pdf. Accessed 05/18/16.
27 Canadian Intergovernmental Conference Secretariat. Backgrounder: national pharmaceutical strategy decision points. http://www.scics.gc.ca/english/conferences.asp?a=viewdocument&id=112. Accessed 05/18/16.
28 Canada’s Premiers. The pan-Canadian Pharmaceutical Alliance: April 2016 Update. http://www.pmprovincesterritoires.ca/en/initiatives/358-pan-canadian-pharmaceutical-alliance. Accessed 05/18/16.
29 Canadian Medical Association. General Council Resolution GC15-C16, August 26, 2015.
30 Gagnon M. The economic case for universal pharmacare. 2010. https://s3.amazonaws.com/policyalternatives.ca/sites/default/files/uploads/publications/National%20Office/2010/09/Universal_Pharmacare.pdf. Accessed 05/18/16.
31 Gagnon M. A roadmap to a rational pharmacare policy in Canada. Ottawa: Canadian Federation of Nurses Unions, 2014.
32 Morgan S, Law M, Daw J, Abraham L, Martin D. Estimated cost of universal public coverage of prescription drugs in Canada. CMAJ. 2015 Apr 21;187(7):491-7. doi: 10.1503/cmaj.141564.
33 Morgan S, Martin D, Gagnon M, Mintzes B, Daw, J, Lexchin, J. Pharmacare 2020. The future of drug coverage in Canada. http://pharmacare2020.ca/assets/pdf/The_Future_of_Drug_Coverage_in_Canada.pdf. Accessed 05/18/16.
34 Canadian Medical Association. Policy resolution GC15-C19, August 26, 2015.
35 Conference Board of Canada. Federal policy action to support the health care needs of Canada’s aging population. https://www.cma.ca/Assets/assets-library/document/en/advocacy/conference-board-rep-sept-2015-embargo-en.pdf. Accessed 05/18/16.
36 Government of the United Kingdom. Written statement to Parliament NHS charges from April 2016. https://www.gov.uk/government/speeches/nhs-charges-from-april-2016. Accessed 05/18/16.
37 Appleby J. Prescription charges: are they worth it? BMJ 2014;348:g3944 doi: 10.1136/bmj.g3944.
Among the several Canadian attempts that she describes, the most activity occurred in the decade following the National Forum on Health (NFH), which was struck in 1994 and reported in 1997. A NFH working group paper on pharmaceutical policy recommended first dollar coverage for prescription medications, but acknowledged that it could not occur overnight: “over time we propose to shift private funding on prescribed pharmaceuticals (estimated at $3.6 billion in 1994) to public funding”.12 The NFH included this recommendation in its final report, noting that “the absorption of currently operating plans by a public system may involve transfer of funding sources as well as administrative apparatus”.13
It is instructive to place the 1994 prescription drug expenditure cited by the NFH in today’s context. According to the Bank of Canada’s inflation calculator, the $6.5 billion in 1994 would have cost $9.5 billion in 2014.14 CIHI estimates that actual spending in 2014 was $28.7 billion1 – 203% above the level of 1994 spending, compared to population growth of 23% over the same time period.15 Annual prescription drug spending increases averaged 7.3% over the period, although they have averaged just over 1% since 2009. 16
A significant shift from private to public funding is not without precedent. A study prepared for the Hall Commission estimated that 9.6 million Canadians, representing 53% of the total population, had some form of not-for-profit or commercial insurance coverage for medical and/or surgical services in 1961.17 With the passage of the Medical Care Act in 1966 these plans were all displaced as the provinces joined Medicare. The funding shift did not occur overnight, although it did move quickly. In the first year, 1968/69, Ottawa paid out $33 million to the provinces pursuant to the Medical Care Act, which grew quickly to $181 million in 1969/70, and reaching $576.5 million in 1971/72.18,19
Since the 1997 NFH report the closest that the federal government has come to acting on pharmacare was a commitment in the 1997 Speech from the Throne to “develop a national plan, timetable and a fiscal framework for providing Canadians with better access to medically necessary drugs”, but nothing further was ever made public.20
Pharmacare was subsequently examined in two national studies, both of which recommended federal involvement in reimbursing “catastrophic” prescription drug expenditures above a threshold of household income. The Senate study on the State of the Health Care System in Canada, chaired by Michael Kirby, was authorized in March 2001 and the Commission on the Future of Health Care in Canada, headed by Roy Romanow, was approved in April 2001. Both issued their final reports in 2002.
The Kirby plan was designed so as to avoid the necessity of eliminating existing private plans or the provincial/territorial public plans, not unlike the approach taken by Quebec in 1997. In the Kirby plan, in the case of public plans, personal prescription medication expenses for any family would be capped at 3% of total family income. The federal government would then pay 90% of prescription drug expenses in excess of $5,000. In the case of private plans, sponsors would have to agree to limit out-of-pocket costs to $1,500 per year, or 3% of family incomes, whichever was less. The federal government would then agree to pay 90% of drug costs in excess of $5,000 per year. Both public and private plans would be responsible for the difference between out-of-pocket costs and $5,000, and private plans would be encouraged to pool their risk. Kirby estimated that this plan would cost approximately $500 million per year.21
The Romanow Commission recommended a $1 billion Catastrophic Drug Transfer through which the federal government would reimburse 50% of the costs of provincial and territorial drug insurance plans above a threshold of $1,500 per person per year.22
The advantage of these proposals is that they are fully scalable. The federal government could adjust either the out-of-pocket household income threshold, the ceiling above which it would assume costs, or the percentage of costs that it would pay above the ceiling.
Following the Kirby and Romanow reports there was a back and forth exchange between the federal and provincial-territorial (PT) governments on a plan for catastrophic coverage. In their February 2003 Accord, First Ministers agreed to ensure that Canadians would have reasonable access to catastrophic drug coverage by March 2006.23 At their annual summer meeting in 2004 the Premiers later called on the federal government to “assume full financial responsibility for a comprehensive drug program for all Canadians”, with compensation to Quebec for its drug program.24 In the September 2004 Health Accord, First Ministers directed health ministers to develop a nine-point National Pharmaceuticals Strategy (NPS), including costing options for catastrophic coverage.25
A federal-provincial-territorial Ministerial Task Force on the NPS was struck and a progress report was issued in June 2006. The estimates of catastrophic spending were markedly higher than those of the Kirby and Romanow reports. Using a variable percentage of income threshold it estimated that, based on public plan costs, only catastrophic spending represented 42% of total prescription drug spending. If private plan costs were also considered, catastrophic spending would represent 55% of total prescription drug spending. This report proposed four options for catastrophic coverage with estimates for new public funding ranging from $1.4 to $4.7 billion.26 Although no account of the methods was provided it is evident that a significant proportion of existing plan costs were included in the estimates of catastrophic expenditure. At their September 2008 meeting, the PT health ministers called for a national standard for drug coverage not to exceed 5% of net income and for the federal government to share 50/50 in the estimated $5.03 billion cost.27
The uncertainty about the projected cost of a pharmacare plan resulting from widely varying estimates has doubtless contributed to a reluctance of governments to engage on advancing this issue.
At the PT level, there has been a concerted effort on price negotiations during the past few years through the pan-Canadian Pharmaceutical Alliance (pCPA) that was established in 2010. As of March 31, 2015, the pCPA reported that price reductions in generic and brand-name prescription medications result in annual savings of an estimated $490 million.28 The federal drug plans are now participating in the pCPA and the CMA has recommended that the pCPA should also invite the participation of private health insurance companies.29
The prospect of savings through lower prices has been foundational to two recent studies that have made the case that a single public payer pharmacare program with little or no co-payment is affordable.
The first was by Marc-André Gagnon in 2010. The proposal was developed on the basis of a review of cross-provincial and international practices in pharmaceutical policy. The review formed the basis of a set of 11 assumptions that were used to develop four scenarios that resulted in estimates of prescription drug cost savings over the 2008 baseline expenditure of $25.1 billion that ranged to $2.7 billion to $10.7 billion.30 In a 2014 update Gagnon estimated that a first dollar coverage program would save 10% to 41% of prescription drug costs, representing savings of as much as $11.4 billion annually on a 2012-13 base of $27.7 billion.31
Steve Morgan and colleagues (2015) have estimated that a universal public plan with small co-payments could reduce prescription drug spending by $7.3 billion.32 Subsequently, in Pharmacare 2020 Morgan et al. set out five recommendations calling for the implementation of a single payer system with a publicly accountable management agency by 2020.33
Taking a First Step Forward
At its 2015 annual meeting, the CMA adopted a policy resolution that supports the development of an equitable and comprehensive national pharmacare program.34 Reflecting on the experience of the past 40 years since the enactment of the Established Programs Financing Act in 1977 that eliminated 50:50 cost-sharing, it seems highly unlikely that the federal government would take on a new open-ended program in the health and social arena, cost-shared or not. However, notwithstanding the progress of the pCPA, we are unlikely to address the significant access gaps in prescription medication coverage without the involvement of the federal government. These are fiscally challenging times for both levels of government, with budget deficits expected for several years to come. As noted previously, the Kirby and Romanow proposals for a federal funding role in pharmacare are scalable.
In 2015 the CMA commissioned the Conference Board of Canada to model the cost of covering prescription medication expenditure beyond a household spending threshold of $1,500 or 3% of gross household income, based on Statistics Canada’s 2013 Survey of Household Spending. The projected costs over the 2016 to 2020 are shown in Table 3 below.
The cost to the federal government of covering the entire amount above the ($1,500 – 3%) threshold would be $1.6 billion in 2016.35
Recommendation 1: The Canadian Medical Association recommends that the House of Commons Standing Committee on Health request the Parliamentary Budget Officer to conduct a detailed examination of the financial burden of prescription medication coverage across Canada and to develop costing options for a federal contribution to a national pharmacare program.
Recommendation 2: As a positive step toward comprehensive, universal coverage for prescription medications, the Canadian Medical Association recommends that the federal government establish a cost-shared program of coverage for prescription medications.
First dollar coverage?
The issue of co-payment arises in most discussions of pharmacare. Hall recommended a $1.00 prescription charge in 1964. In England, which does include prescription medications in the National Health Service (NHS), the current prescription charge is £8.40, although the government has previously noted that 90% of prescription items are provided free of charge.36 Appleby has noted however that the NHS’s in Wales, Northern Ireland and Scotland have eliminated prescription charges.37One observational study of dispensing rates in Wales found that the overall impact of removing prescription charges was minimal.38 Table 4 shows the total volume of prescriptions dispensed in Scotland over the period 2009-2015, which straddles the removal of prescription charges on April 1, 2011. It indicates that percentage increases in the annual dispensing volume diminished after 2012 and the increase observed in 2015 was just 1.4%. It should be added, however, that patient charges accounted for less than 4% of Scotland’s dispensing expenditures in 2010.39 It will be interesting to see the results of further studies in these jurisdictions.
38 Cohen D, Alam M, Dunstan F, Myles S, Hughes D, Routledge P. Abolition of prescription copayments in Wales: an observational study on dispensing rates. Value in Health 2010;13(5):675-80.
39 ISD Scotland. Prescribing and medicines. Data tables. http://www.isdscotland.scot.nhs.uk/Health-Topics/Prescribing-and-Medicines/Publications/data-tables.asp?Co=Y. Accessed 05/15/16.
40 Canadian Medical Association. A prescription for optimal prescribing. http://policybase.cma.ca/dbtw-wpd/Policypdf/PD11-01.pdf. Accessed 05/18/16.
41 Canadian Medical Association. Vision for e-prescribing; a joint statement by the Canadian Medical Associaiton and the Canadian Pharmacists Association. http://policybase.cma.ca/dbtw-wpd/Policypdf/PD13-02.pdf. Accessed 05/18/16.
42 Department of Finance Canada. Growing the middle class. http://www.budget.gc.ca/2016/docs/plan/budget2016-en.pdf. Accessed 05/18/16.
Table 4 Prescription Dispensing in Scotland, 2009 – 2015
Year Number of Prescriptions % increase from previous year
2009 88.4 3.8
2010 91.0 3.0
2011 93.8 3.1
2012 96.6 3.0
2013 98.4 1.9
2014 100.6 2.2
2015 102.0 1.4
Source: annual tabulations - Remuneration and reimbursement details for all prescribing made in Scotland.39
Other Elements of a National Pharmaceuticals Strategy
It was noted previously that the Hall Report contained 25 recommendations on pharmaceuticals, and the 2004 Health Accord called for a 9-point National Pharmaceuticals Strategy. Two of the NPS points that the CMA would emphasize are the need to influence prescribing behaviour and the need to advance electronic prescribing (e-prescribing).
The CMA refers to the first of these points as “optimal prescribing” and defines it as the prescription of a medication that is: the most clinically appropriate for the patient’s condition; safe and effective; part of a comprehensive treatment plan; and the most cost-effective available to best meet the patient’s needs. Toward this end the CMA has identified principles and recommendations to promote optimal prescribing, including the need for current information on cost and cost-effectiveness.40
The CMA believes that e-prescribing has the potential to improve patient safety, to support clinical decision-making and medication management, and to increase awareness of cost and cost-effectiveness considerations. In 2012 the CMA and the Canadian Pharmacists Association adopted a joint vision statement calling for e-prescribing to be the means by which prescriptions are generated for Canadians by 2015.41 Clearly that date has come and gone and we are not there yet. The current state primarily consists of demonstration projects and “workarounds”. The CMA was pleased to see an amount of $50 million allocated to Canada Health Infoway in the 2016 federal budget to support the advancement of e-prescribing and telehomecare.42
Finally the CMA remains very concerned about ongoing shortages of prescription drugs. We would caution that whatever measures governments might take to implement a pharmacare program these must not exacerbate drug shortages.
Recommendation 3: The Canadian Medical Association recommends that the Federal/Provincial/Territorial health Ministers direct their officials to convene a working group on a comprehensive National Pharmaceuticals Strategy that will consult widely with stakeholders representing patients, prescribers, and the health insurance and pharmaceutical industries to report with recommendations by spring 2017.
In conclusion, few would argue that prescription medications are less vital to the health and health care of Canadians than hospital and medical services. We would not have had the Medicare program that Canadians cherish today without the leadership and financial contribution of the federal government, and similarly without it now we will not have any form of a national pharmacare program.