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Policies that advocate for the medical profession and Canadians


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All-terrain vehicles

https://policybase.cma.ca/en/permalink/policy719
Last Reviewed
2014-03-01
Date
1989-08-23
Topics
Health care and patient safety
Population health/ health equity/ public health
Resolution
GC89-46
That the Canadian Medical Association recommend: a) that the federal departments of transport and consumer and corporate affairs enact legislation for the purpose of setting national safety standards for all-terrain vehicles, b) that provincial governments be urged to review and strengthen regulations related to the use of all-terrain vehicles, c) that provincial governments be urged to introduce a specific driver's licence category for all-terrain vehicle drivers; such licence would require demonstrating competence in handling the vehicle.
Policy Type
Policy resolution
Last Reviewed
2014-03-01
Date
1989-08-23
Topics
Health care and patient safety
Population health/ health equity/ public health
Resolution
GC89-46
That the Canadian Medical Association recommend: a) that the federal departments of transport and consumer and corporate affairs enact legislation for the purpose of setting national safety standards for all-terrain vehicles, b) that provincial governments be urged to review and strengthen regulations related to the use of all-terrain vehicles, c) that provincial governments be urged to introduce a specific driver's licence category for all-terrain vehicle drivers; such licence would require demonstrating competence in handling the vehicle.
Text
That the Canadian Medical Association recommend: a) that the federal departments of transport and consumer and corporate affairs enact legislation for the purpose of setting national safety standards for all-terrain vehicles, b) that provincial governments be urged to review and strengthen regulations related to the use of all-terrain vehicles, c) that provincial governments be urged to introduce a specific driver's licence category for all-terrain vehicle drivers; such licence would require demonstrating competence in handling the vehicle.
Less detail

CMA’s Recommendations for Bill S-5 An Act to amend the Tobacco Act and the Non-smokers’ Health Act and to make consequential amendments to other Acts

https://policybase.cma.ca/en/permalink/policy13918
Date
2018-02-15
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Health care and patient safety
  1 document  
Policy Type
Parliamentary submission
Date
2018-02-15
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Health care and patient safety
Text
The Canadian Medical Association (CMA) is pleased to provide this submission to the House of Commons Standing Committee on Health for its study of Bill S-5, An Act to amend the Tobacco Act and the Non-Smokers Health Act and to make consequential amendments to other Acts. We support the government’s effort to implement a new legislative and regulatory framework to address vaping products and related matters. Vaping products, such as electronic cigarettes (or e-cigarettes) replicate the act and taste of smoking but do not contain tobacco. We also recognize that the federal government is attempting to find a balance between regulating vaping devices and making them available to adults. Canada’s physicians, who see the devastating effects of tobacco use every day in their practices, have been working for decades toward the goal of a smoke-free Canada. The CMA issued its first public warning concerning the hazards of tobacco in 1954 and has continued to advocate for the strongest possible measures to control its use. The CMA has always supported strong, comprehensive tobacco control legislation, enacted and enforced by all levels of government, and we continue to do so. Our most recent efforts centred on our participation in the 2016 Endgame Summit, held late last year in Kingston, Ontario. This brief will focus on three areas: supporting population health; the importance of protecting youth; and, the promotion of vaping products. Overview Tobacco is an addictive and hazardous product, and a leading cause of preventable disease and death in Canada. Smoking has been on the decline in Canada the most recent Canadian Community Health Survey reports that 17.7% of the population aged 12 and older were current daily or occasional smokers in 2015 (5.3 million smokers); that is down from 18.1% in 2014.1 Many strong laws and regulations have already been enacted but some areas remain to be addressed and strengthened especially as the 1 Statistics Canada. Smoking, 2015. Health Fact Sheets. Statistics Canada Cat. 82-625-X. Ottawa: Statistics Canada; 2016. Available: http://www.statcan.gc.ca/pub/82-625-x/2017001/article/14770-eng.htm (accessed 2018 Feb 1). 2 Czoli CD, Hammond D, White CM. Electronic cigarettes in Canada: Prevalence of use and perceptions among youth and young adults. Can J Public Health. 2014;105(2):e97-e102. 3 Filippos FT, Laverty AA, Gerovasili V, et al. Two-year trends and predictors of e-cigarette use in 27 European Union member states. Tob Control. 2017;26:98-104. 4 Malas M, van der Tempel J, Schwartz R, Minichiello A, Lightfoot C, Noormohamed A, et al. Electronic cigarettes for smoking cessation: A systematic review. Nicotine Tob Res. 2016;18(10):1926–36. 5 O’Leary R, MacDonald M, Stockwell T, Reist D. Clearing the air: A systematic review on the harms and benefits of e-cigarettes and vapour devices. Victoria, BC: Centre for Addictions Research of BC; 2017. Available: http://ectaofcanada.com/clearing-the-air-a-systematic-review-on-the-harms-and-benefits-of-e-cigarettes-and-vapour-devices/ (accessed 2018 Feb 1). 6 El Dib R, Suzumura EA, Akl EA, Gomaa H, Agarwal A, Chang Y, et al. Electronic nicotine delivery systems and/or electronic non-nicotine delivery systems for tobacco smoking cessation or reduction: a systematic review and meta-analysis. BMJ Open. 2017 23;7:e012680. Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5337697/pdf/bmjopen-2016-012680.pdf (accessed 2018 Feb 1). 7 Shahab L, Goniewicz M, Blount B, et al. Nicotine, carcinogen, and toxin exposure in long-term e- cigarette and nicotine replacement therapy users: A cross sectional study. Annals of Internal Medicine. 2017;166(6):390-400. 8 Collier R. E-cigs have lower levels of harmful toxins. CMAJ. 2017 Feb 27;189:E331. 9 Sleiman M, Logue J, Montesinos VN, et al. Emissions from electronic cigarettes: Key parameters affecting the release of harmful chemicals. Environmental Science and Technology. 2016 Jul 27;50(17):9644-9651. 10 England LJ, Bunnell RE, Pechacek TF, Tong VT, McAfee TA. Nicotine and the developing human: A neglected element in the electronic cigarette debate. Am J Prev Med. 2015 Aug;49(2):286-93. 11 Foulds J. Use of Electronic Cigarettes by Adolescents. J Adolesc Health. 2015 Dec;57(6):569-70. 12 Khoury M, Manlhiot C, Fan CP, Gibson D, Stearne K, Chahal N, et al. Reported electronic cigarette use among adolescents in the Niagara region of Ontario. CMAJ. 2016 Aug 9;188(11):794-800. 13 U.S. National Cancer Institute and World Health Organization. The Economics of Tobacco and Tobacco Control. National Cancer Institute Tobacco Control Monograph 21. NIH Publication No. 16-CA- 8029A. Bethesda, MD: U.S. Department of Health and Human Services, National Institutes of Health, National Cancer Institute; and Geneva, CH: World Health Organization; 2016. 14 Miech R, Patrick ME, O’Malley PM, Johnston LD. E-cigarette use as a predictor of cigarette smoking: results from a 1-year follow-up of a national sample of 12th grade students. Tob Control. 2017 Dec;26(e2):e106–11. 15 Primack BA, Soneji S, Stoolmiller M, Fine MJ, Sargent JD. Progression to traditional cigarette smoking after electronic cigarette use among US adolescents and young adults. JAMA Pediatr. 2015 Nov;169(11):1018–23. Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4800740/pdf/nihms768746.pdf (accessed 2018 Feb 1). 16 Hoe J, Thrul J, Ling P. Qualitative analysis of young adult ENDS users’ expectations and experiences. BMJ Open. 2017;7:e014990. Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5353280/pdf/bmjopen-2016-014990.pdf (accessed 2018 Feb 1). 17 Fairchild AL, Bayer R, Colgrove J. The renormalization of smoking? E-cigarettes and the tobacco “endgame.” N Engl J Med. 2014 Jan 23;370:4 Available: http://www.nejm.org/doi/pdf/10.1056/NEJMp1313940 (accessed 2018 Feb 1). 18 Choi K, Grana R, Bernat D. Electronic nicotine delivery systems and acceptability of adult cigarette smoking among Florida youth: Renormalization of smoking? J Adolesc Health. 2017 May;60(5):592–8. tobacco industry continues to evolve. Electronic cigarettes and vaping represents the next step in that evolution. While Canada is to be congratulated on its success to date, it needs to maintain an environment that encourages Canadians to remain tobacco-free if smoking prevalence is to be reduced further in Canada. The CMA believes it is incumbent on all levels of government in Canada to keep working on comprehensive, coordinated and effective tobacco control strategies, including vaping products, to achieve that goal. Supporting Population Health The arrival of vaping products in Canada placed them in a “grey zone” with respect to legislation and regulation. Clarification of their status is crucial from a public health perspective because of their growing popularity, particularly among youth.2 E-cigarettes have both defenders and opponents. Proponents say they are safer than tobacco cigarettes since they do not contain the tar and other toxic ingredients that are the cause of tobacco related disease. Indeed, some believe they serve a useful purpose as a harm reduction tool or cessation aid (though it is forbidden to market them as such since that claim has never been approved by Health Canada). Opponents are concerned that the nicotine delivered via e-cigarettes is addictive and that the cigarettes may contain other toxic ingredients such as nitrosamines. Also, they worry that acceptance of e-cigarettes will undermine efforts to de-normalize smoking, and that they may be a gateway to the use of tobacco by people who might otherwise have remained smoke-free. This issue will be addressed later in this brief. This difference of opinion certainly highlights the need for more research into the harms and benefits of vaping products and the factors that cause people to use them.3 Encouraging smokers to move from combustible tobacco products to a less harmful form of nicotine may be a positive step. However the current available evidence is not yet sufficient to establish them as a reliable cessation method. A systematic review published by M. Malas et al. (2016) concluded that while “a majority of studies demonstrate a positive relationship between e-cigarette use and smoking cessation, the evidence remains inconclusive due to the low quality of the research published to date.”4 Indeed, some are helped by these devices to quit smoking but “more carefully designed and scientifically sound studies are urgently needed to establish unequivocally the long-term cessation effects of e-cigarettes and to better understand how and when e-cigarettes may be helpful.”4 The authors found that the evidence examining e-cigarettes as an aid to quitting smoking was determined to be “very low to low.”4 A similar result was found for their use in reducing smoking; the quality of the evidence was revealed as being “very low to moderate.”4 This conclusion is supported by another review conducted by the University of Victoria (2017). It too indicates that there are not enough studies available to fully determine the efficacy of vaping devices as a tobacco cessation device.5 This review also noted that there is “encouraging evidence that vapour devices can be at least as effective as other nicotine replacements.”5 Another review by R. El Dib et al. (2017) reinforces these findings. Limited evidence was also found with respect to the impact of electronic devices to aide cessation. They also noted that the data available from randomized control trials are of “low certainty” and the “observational studies are of very low certainty.”6 The wide range of devices available makes it very difficult to test which are the most effective in helping cessation efforts. Many of the studies are on older devices so it is possible that as second-generation technology becomes available they will prove to be more successful. In view of this uncertainty, the CMA calls for more scientific research into the potential effectiveness and value of these devices as cessation aids. Physicians need to be confident that if they recommend such therapy to their patients it will have the desired outcome. To that end, we are pleased that Health Canada will continue to require manufacturers to apply for authorization under the Food and Drugs Act to sell products containing nicotine and make therapeutic claims. Risk and Safety In addition to the discussion concerning the usefulness of vaping devices as cessation devices, concerns from a public health standpoint involve the aerosol or vapour produced by heating the liquids used in these devices, and the nicotine some may contain. The tube of an e-cigarette contains heat-producing batteries and a chamber holding liquid. When heated, the liquid is turned into vapour which is drawn into the lungs. Ingredients vary by brand but many contain nicotine and/or flavourings that are intended to boost their appeal to young people. The CMA is concerned that not enough is known about the safety of the ingredients in the liquids being used in vaping devices. While it is the case that because e-cigarettes heat rather than burn the key constituent, they produce less harmful toxins and are much safer than conventional cigarettes. Research in the UK suggested that “long-term Nicotine Replacement Therapy (NRT)-only and e-cigarette-only use, but not dual-use of NRTs or e-cigarettes with combustible cigarettes, is associated with substantially reduced levels of measured carcinogens and toxins relative to smoking only combustible cigarettes.”7 However, this study has been criticized because “it only looked at a few toxins and didn’t test for any toxins that could be produced by e- cigarettes.”8 The variety of flavourings and delivery systems available make it imperative that the risks associated with these products be fully understood. As one study noted “analysis of e-liquids and vapours emitted by e-cigarettes led to the identification of several compounds of concern due to their potentially harmful effects on users and passively exposed non-users.”9 The study found that the emissions were associated with both cancer and non-cancer health impacts and required further study.9 There is another aspect of the public health question surrounding vaping devices. There is data to support the idea that “nicotine exposure during periods of developmental vulnerability (e.g., fetal through adolescent stages) has multiple adverse health consequences, including impaired fetal brain and lung development.”10 Therefore it is imperative that pregnant women and youth be protected. There is not enough known about the effects of long-term exposure to the nicotine inhaled through vaping devices at this time.11 Recommendations: 1) Given the scarcity of research on e-cigarettes the Canadian Medical Association calls for ongoing research into the potential harms of electronic cigarette use, including the use of flavourings and nicotine. 2) The CMA calls for more scientific research into the potential effectiveness and value of these devices as cessation aids. 3) The Canadian Medical Association supports efforts to expand smoke-free policies to include a ban on the use of electronic cigarettes in areas where smoking is prohibited. Protecting Youth The CMA is encouraged by the government’s desire to protect youth from developing nicotine addiction and inducements to use tobacco products. Young people are particularly vulnerable to peer pressure, and to tobacco industry marketing tactics. The CMA supports continued health promotion and social marketing programs aimed at addressing the reasons why young people use tobacco and have been drawn to vaping devices, discouraging them from starting to use them and persuading them to quit, and raising their awareness of tobacco industry marketing tactics so that they can recognize and counteract them. These programs should be available continuously in schools and should begin in the earliest grades. The “cool/fun/new” factor that seems to have developed around vaping devices among youth make such programs all the more imperative.12 The CMA recommends a ban on the sale of all electronic cigarettes to Canadians younger than the minimum age for tobacco consumption in their province or territory. We are pleased to see that Bill S-5 aims to restrict access to youth, including prohibiting the sale of both tobacco and vaping products in vending machines as well as prohibiting sales of quantities that do not comply with the regulations. In fact, the CMA recommends tightening the licensing system to limit the number of outlets where tobacco products, including vaping devices, can be purchased. The more restricted is availability, the easier it is to regulate. The CMA considers prohibiting the promotion of flavours in vaping products that may appeal to youth, such as soft drinks and cannabis, to be a positive step. A recent report published by the World Health Organization and the US National Cancer Institute indicated that websites dedicated to retailing e-cigarettes “contain themes that may appeal to young people, including images or claims of modernity, enhanced social status or social activity, romance, and the use of e-cigarettes by celebrities.”13 We are therefore pleased that sales of vaping products via the internet will be restricted through prohibiting the sending and delivering of such products to someone under the age of 18. This will be critical to limiting the tobacco industry’s reach with respect to youth. There have also been arguments around whether vaping products will serve as gateways to the use of combusted tobacco products. The University of Victoria (2017) paper suggests this isn’t the case; it notes that “there is no evidence of any gateway effect whereby youth who experiment with vapour devices are, as a result, more likely to take up tobacco use.”5) They base this on the decline in youth smoking while rates of the use of vaping devices rise.Error! Bookmark not defined. Others contend that vaping is indeed a gateway, saying it acts as a “one-way bridge to cigarette smoking among youth. Vaping as a risk factor for future smoking is a strong, scientifically-based rationale for restricting access to e-cigarettes.”14 Further, in a “national sample of US adolescents and young adults, use of e-cigarettes at baseline was associated with progression to traditional cigarette smoking. These findings support regulations to limit sales and decrease the appeal of e- cigarettes to adolescents and young adults.”15 However, there may be a role for vaping products in relation to young users. A New Zealand study conducted among young adults that examined how electronic nicotine delivery systems (ENDS) were used to recreate or replace smoking habits. It found that study participants “used ENDS to construct rituals that recreated or replaced smoking attributes, and that varied in the emphasis given to device appearance.”16 Further, it was suggested that ascertaining how “ENDS users create new rituals and the components they privilege within these could help promote full transition from smoking to ENDS and identify those at greatest risk of dual use or relapse to cigarette smoking.”16 The CMA believes that further research is needed on the question of the use of vaping products as a gateway for youth into combustible tobacco products. Recommendations: 4) The Canadian Medical Association recommends a ban on the sale of all electronic cigarettes to Canadians younger than the minimum age for tobacco consumption in their province or territory. 5) The Canadian Medical Association calls for ongoing research into the potential harms and benefits of electronic cigarette use among youth. 6) The Canadian Medical Association recommends tightening the licensing system to limit the number of outlets where tobacco products, including vaping devices, can be purchased. Promotion of Vaping Products The CMA has been a leader in advocating for plain and standardized packaging for tobacco products for many years. We established our position in 1986 when we passed a resolution at our General Council in Vancouver recommending to the federal government “that all tobacco products be sold in plain packages of standard size with the words “this product is injurious to your health” printed in the same size lettering as the brand name, and that no extraneous information be printed on the package.” The CMA would like to see the proposed plain packing provisions for tobacco be extended to vaping products as well. The inclusion of the health warning messages on vaping products is a good first step but efforts should be made to ensure that they are of similar size and type as those on tobacco as soon as possible. The restrictions being applied to the promotion of vaping products is a positive step, especially those that could be aimed at youth, but they do not go far enough. The CMA believes the restrictions on promotion should be the same as those for tobacco products. As the WHO/U.S. National Cancer Institute has already demonstrated, e- cigarette retailers are very good at using social media to promote their products, relying on appeals to lifestyle changes to encourage the use of their products. The CMA is also concerned that e-cigarette advertising could appear in locations and on mediums popular with children and youth if they are not prohibited explicitly in the regulations. This would include television and radio advertisements during times and programs popular with children and youth, billboards near schools, hockey arenas, and on promotional products such as t-shirts and ball caps. As efforts continue to reduce the use of combustible tobacco products there is growing concern that the rising popularity of vaping products will lead to a “renormalization” of smoking. In fact, worry has been expressed that the manner they have been promoted “threaten(s) to reverse the successful, decades-long public health campaign to de- normalize smoking.”17 A recent US study indicated that students that use vaping products themselves, exposure to advertising of these devices, and living with other users of vaping products is “associated with acceptability of cigarette smoking, particularly among never smokers.”18 Further research is needed to explore these findings. Recommendations: 7) The Canadian Medical Association recommends similar plain packaging provisions proposed for tobacco be extended to vaping products. 8) Health warning messages on vaping products should be of similar size and type as those on tobacco as soon as possible 9) The Canadian Medical Association believes the restrictions on promotion of vaping products and devices should be the same as those for tobacco products. Conclusion Tobacco is an addictive and hazardous product, and a leading cause of preventable disease and death in Canada. Our members see the devastating effects of tobacco use every day in their practices and to that end the CMA has been working for decades toward the goal of a smoke-free Canada. The tobacco industry continues to evolve and vaping represents the next step in that evolution. The CMA believes it is incumbent on all levels of government in Canada to keep working on comprehensive, coordinated and effective tobacco control strategies, including vaping products, to achieve that goal. Bill S-5 is another step in that journey. Researchers have identified potential benefits as well as harms associated with these products that require much more scrutiny. The association of the tobacco industry with these products means that strong regulations, enforcement, and oversight are needed. Recommendations: 1) Given the scarcity of research on e-cigarettes the Canadian Medical Association calls for ongoing research into the potential harms of electronic cigarette use, including the use of flavourings and nicotine. 2) The CMA calls for more scientific research into the potential effectiveness and value of these devices as cessation aids.. 3) The Canadian Medical Association supports efforts to expand smoke-free policies to include a ban on the use of electronic cigarettes in areas where smoking is prohibited. 4) The Canadian Medical Association recommends a ban on the sale of all electronic cigarettes to Canadians younger than the minimum age for tobacco consumption in their province or territory. 5) The Canadian Medical Association calls for ongoing research into the potential harms and benefits of electronic cigarette use among youth. 6) The Canadian Medical Association recommends tightening the licensing system to limit the number of outlets where tobacco products, including vaping devices, can be purchased. 7) The Canadian Medical Association recommends similar plain packaging provisions proposed for tobacco be extended to vaping products. 8) Health warning messages on vaping products should be of similar size and type as those on tobacco as soon as possible 9) The Canadian Medical Association believes the restrictions on promotion of vaping products and devices should be the same as those for tobacco products.
Documents
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Consultation on proposed front-of-package labelling

https://policybase.cma.ca/en/permalink/policy13882
Date
2018-04-23
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Response to consultation
Date
2018-04-23
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
Dear Mr. Rodrigue: The Canadian Medical Association is pleased to have this opportunity to participate in the consultation on the proposed front-of-packaging labelling (FOP) as posted in the Canada Gazette Part One on February 9, 2018.1 This new requirement will “provide clear and consistent front-of-package information and updated nutrient content claims to help protect Canadians from the risks of chronic diseases” related to the intake of foods high in sugar, sodium, saturated fats and trans fat.2 1 Canada Gazette Part One. Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Nutrition Symbols, Other Labelling Provisions, Partially Hydrogenated Oils and Vitamin D) Department of Health Vol. 152, No. 6 — February 10, 2018 2 Ibid pg.1 3 Presentation to the House of Commons Standing Committee on Health, Nutrition Labelling, Canadian Medical Association, March 3, 2011 accessed at http://policybase.cma.ca The CMA believes that governments have a responsibility to provide guidance on healthy eating that can be easily incorporated into daily lives, and that the federal government has a continuous obligation to promulgate policies, standards, regulations and legislations that support healthy food and beverage choices; provide user-friendly consumer information including complete nutritional content and accurate advertising claims; and increase the amount of information provided on product labels. We also commend Health Canada for its current work on revising the Canada Food Guide. Front-of-Packaging Labelling The CMA has supported a standard “at a glance” approach to FOP food labelling that can reduce confusion and help consumers make informed dietary choices since 2011.3 FOP labelling on packaged foods will help Canadians make healthier food and beverage choices. It will draw attention to those ingredients to be avoided in higher levels and can reinforce public health messaging on healthy eating. An added benefit may be an incentive to the food industry to reformulate processed foods with lower amounts of those nutrients highlighted in FOP labelling. The CMA supports the placement of the proposed symbol on the upper and/or right hand side of the packaging, covering 25% of the principal display surface. The symbol must be clearly delineated from the product packaging so that it stands out and can be located with relative ease. It is important for the symbol to convey to the consumer that there is a certain degree of risk involved in consuming these foods, hence the colours used and the shape will be important. Of the four symbols proposed by Health Canada, our preference is for the one displayed here but with a more defined, thicker border, that includes a small outer buffer (in white). It will be essential for Health Canada to ensure that the symbol design has been tested thoroughly with consumers and is effective in conveying the intended “high in” message. As such, manufacturers will need clear guidance about the constraints on the use and placement of these symbols to ensure they cannot be misconstrued and to prevent the use of configurations that will diminish their effectiveness. Manufacturers must not be permitted to place voluntary nutrient content or health claims below or near the main symbol that would distort the message and create confusion. Foods to be exempted from front-of-package nutrition labelling There will be foods that are exempt from the labelling requirements and consumers will need clear explanations with respect to those that are exempt and why; some will be obvious, some will not. The CMA supports the proposed exemptions for eggs, fruits, vegetables and unsweetened, unsalted plain milk, and whole milk. However, we do not believe flavoured and/or seasoning salts and “sea salts” should be exempted from the requirement to have an FOP symbol on the package. Health Canada will need to undertake an education program to explain to consumers that these products are actually high in sodium. Nutrient thresholds for sodium, sugar & saturated fat CMA policy has encouraged governments to continue to work to reduce the salt, sugar, saturated fat, trans-fat and calorie content of processed foods and prepared meals.4 The nutrient levels chosen will therefore be critical in that regard. The CMA supports the proposed levels to identify foods high in sugar, salt or saturated fats. The CMA believes that it is important that there is consistency across all nutritional and healthy eating information and advice for Canadians. Ensuring consistency between the “high in” threshold and the 15% “a lot” daily value (DV) message delivers a clear message of concern. 4 Healthy Behaviours: Promoting Physical Activity and Healthy Eating, Canadian Medical Association Policy, 2014, accessed at http://policybase.cma.ca. While we understand the rationale behind increasing the nutrient threshold for prepackaged meals to 30% of the DV, we recommend that the threshold for “high in” sugar of 30 grams or more total sugars per serving of stated size may be too high and should be reconsidered. It should also be noted that the different thresholds on prepackaged foods and prepackaged meals may cause confusion for consumers and should be introduced with some consumer education. Nutrient content claims, in relation to Front-of-Packaging Labelling symbol Allowing a food that qualifies for a “high in” sugar FOP symbol to also display a “no added sugars” claim would be very confusing to consumers. The product label information would appear as quite contradictory; therefore the CMA does support not allowing “no added sugar” claims on these foods. The CMA would suggest that a food that is high in two or more of sugar, sodium or saturated fats not be allowed to display any content claims to avoid any consumer confusion. High-intensity sweetener labelling Canadians have come to rely on easy-to-recognize information that alerts them that food may contain artificial sweeteners. Therefore, we do not support the elimination of the labelling requirement for artificial sweeteners on the principal display panel. For products that have high intensity sweeteners added and which bear claims such as “unsweetened” or “no sugar added,” a declaration of “artificially sweetened” should be clearly visible on the FOP. The specific sweetener does not need to be identified so long as it is declared in the list of ingredients. As long as quantity is displayed on the nutrition facts table it doesn’t need to be on the principal display. Further, while we recognize that harmonizing with USA labelling regulations is desirable, we recommend strongly against the use of the term “phenylketonurics.” The proper approach would be to use the phrase “people with phenylketonuria” for any warnings on products containing aspartame, which contains phenylalanine. Consumer education For many Canadians, their diet can have a negative rather than positive impact on their overall health. There is a particular concern for children and youth who are growing up in increasingly obesogenic environments that reinforce practices that work against a healthy diet and healthy lifestyle. Determined action is required for children and youth to learn and acquire healthy behaviours that they will maintain throughout their life. The CMA supports the government’s Healthy Living Strategy and their efforts to create a healthier food environment. The addition of FOP nutrition labelling is an important tool to make the healthy choice the easy choice. Sincerely, Jeff Blackmer, MD, MHSc, FRCPC Vice-president, Medical Professionalism
Documents
Less detail

Health Canada consultation on tobacco products regulations (plain and standardized appearance)

https://policybase.cma.ca/en/permalink/policy13930
Date
2018-09-06
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Response to consultation
Date
2018-09-06
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) is pleased to provide this submission in response to Health Canada’s proposed regulations entitled Tobacco Products Regulations (Plain and Standardized Appearance) and an Order to amend Schedule 1 to the Tobacco and Vaping Products Act with respect to colouring agents, in Canada Gazette, Part 1. Canada's physicians have been working for decades toward the goal of a smoke-free Canada. The CMA issued its first public warning concerning the hazards of tobacco in 1954 and has continued to advocate for the strongest possible measures to control its use and for the past 30 years we have reiterated our long-standing support for the concept of tobacco products being sold in standardized packages in several briefs and policy statements. The CMA has been a leader in advocating for plain and standardized packaging for tobacco products for many years. We established our position in 1986 in a resolution recommending to the federal government “that all tobacco products be sold in plain packages of standard size with the words "this product is injurious to your health" printed in the same size lettering as the brand name, and that no extraneous information be printed on the package.” We are pleased to support the proposed regulations and that they will apply to the packaging of all tobacco products and that brand colours, graphics and logos will be prohibited on packages. No exceptions, including for cigars and pipe tobacco, should be considered. These measures will assist in promoting harm reduction efforts and further the goal of reducing and eliminating smoking. In 2017, 16.2% of Canadians aged 12 and older smoked either daily or occasionally; this is down from 17.7% in 2015. These proposed regulations will be a significant step in the goal of further reducing the smoking rate. However, there are three areas that the CMA would like to see strengthened and are described below. Slide and Shell Packaging – Minimum package dimensions and warning surface area The CMA supports strongly the concept of tobacco products being sold in standardized packages. We recommended that only the “slide-and-shell” style of package be authorized and that the “flip-top” package be removed. This would reduce the permitted style to one type and allow for the largest possible surface area to be used to convey health warnings and other health-related information. With respect to the draft regulation (s.39) concerning the dimensions of the new packages when closed, the CMA recommends that the measurements for the regular and king size cigarette packages be amended to allow for more surface area for warnings and to standardize packaging regulations across all Canadian jurisdictions.1 The Quebec requirement for a warning surface area of 46.5 sq. cm should be the minimum across Canada. To achieve that, we suggest that the new slide and shell package for regular size cigarettes have the following dimensions when it is closed: (a) its height must be no less than 74 mm and no more than 77 mm; (b) its width must be no less than 84 mm and no more than 87 mm for a package of 20 cigarettes, and no less 103mm and no more than 106 mm for a package of 25 cigarettes. A similar adjustment is recommended for the width of packages of king size cigarettes when closed: (a) its width must be no less than 83 mm and no more than 87 mm for a package of 20 cigarettes, and no less 103mm and no more than 106 mm for a package of 25 cigarettes. In both cases, this is over and above the dimensions in s.39 (1)(a) and (b) for regular size cigarettes and s.39(2)(b) for king size cigarettes. We also recommend that the number of cigarettes permitted in both package sizes be limited to 20 and 25 respectively, reflecting the quantities sold in the current market. This would also prohibit manufacturers from adding one or two additional cigarettes as a “bonus” or “premium.” Brand names The appearance of brand names on the packages should be in a manner that is standard for all brands. Tobacco manufacturers should not be able to include terms such as “organic” or “natural” as part of a brand name. These descriptions would convey the perception that these products are somehow better or are healthier for the consumer. As well, they may be used to evoke a lifestyle or are fashionable. Such terms and phrases should be banned in the regulations; the European Union’s Directive 2014/40/EU of the European Parliament and of the Council could serve as the guide is this instance. Leaflets Tobacco manufacturers make frequent use of subtle marketing messages to render smoking attractive and glamorous to their customers. The CMA has always supported educational and public health initiatives aimed at countering these messages. Permitting a leaflet inside packages “that warns consumers of the health hazards arising from the use of the tobacco product or that provides instructions for its use” (draft regulation s. 36.3) is a positive step but should not provide manufacturers with a potential loophole to exploit. The draft regulation should be amended to indicate that the only instance where any instructions are permitted on the leaflet are when the product has an electronic component. This would prevent manufacturers from using the leaflet as any sort of a promotional platform to minimize, for example, the impact of health warnings on the package exterior. Summary Canada's physicians have been working for decades toward the goal of a smoke-free Canada and we are pleased to support the proposed regulations. We recommend that the draft regulations be strengthened in the following manner: 1) The measurements for the regular and king size cigarette packages be amended to allow for more surface area for warnings and to standardize packaging regulations across all Canadian jurisdictions. 2) The number of cigarettes permitted in both package sizes be limited to 20 and 25 respectively, reflecting the quantities sold in the current market. 3) Use of terms and phrases such as “organic” and “natural” in brand names should be banned in the regulations. 4) The only instance where any instructions are permitted on the proposed leaflets are when the product has an electronic component. Tobacco and Vaping Products Act: Tobacco Products Regulations (Plain and Standardized Appearance) Canada Gazette, Part I, 2018 Jun 23 152(25). Available: http://gazette.gc.ca/rp-pr/p1/2018/2018-06-23/html/reg9-eng.html (accessed 2018 Aug 7). Statistics Canada. Smoking, 2017 Health Fact Sheets Cat. No. 82-625-X June 26, Ottawa, Ont.: Statistics Canada, 2018. Available: https://www150.statcan.gc.ca/n1/en/pub/82-625-x/2018001/article/54974-eng.pdf?st=7HkJdkUB (accessed 2018 Sep 5). Canadian Medical Association (CMA). Letter in response to Health Canada’s Consultation on “Plain and Standardized Packaging” for Tobacco Products. Potential Measures for Regulating the Appearance, Shape and Size of Tobacco Packages and of Tobacco Products. Document for Consultation. Ottawa: CMA; 2016. Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2016-09.pdf (accessed 2018 Aug 29). The European Parliament and The Council of the European Union. Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive. 2001/37/EC. Brussels: Official Journal of the European Union, 2014. Available: https://ec.europa.eu/health/sites/health/files/tobacco/docs/dir_201440_en.pdf (accessed 2018 Sep 4).
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Health Canada’s consultation on new health-related labelling for tobacco products

https://policybase.cma.ca/en/permalink/policy13939
Date
2018-12-14
Topics
Health care and patient safety
Population health/ health equity/ public health
  1 document  
Policy Type
Response to consultation
Date
2018-12-14
Topics
Health care and patient safety
Population health/ health equity/ public health
Text
The Canadian Medical Association (CMA) is pleased to provide this submission in response to Health Canada’s Consultation on “New Health-Related Labelling for Tobacco Products - Document for Consultation, October 2018”. Canada's physicians have been working for decades toward the goal of a smoke-free Canada. The CMA issued its first public warning concerning the hazards of tobacco in 1954 and has continued to advocate for the strongest possible measures to control its use and for the past 30 years we have reiterated our long-standing support for the concept of tobacco products being sold in standardized packages in several briefs and policy statements. Our response will follow the questions posed in the consultation document. Labelling on Individual Cigarettes Displaying a warning on individual cigarettes provides another means of conveying important health warnings about the hazards of smoking. The warnings should be like those that will be displayed on the leaflets included in the cigarette packages as well as the packages themselves. They should be of sufficient size, font and colour that will draw the attention of the smoker to the message. They should also be placed as close to the filter end of the cigarette as possible to remain visible for as long as possible. Health Information Messages The CMA has always supported educational and public health initiatives aimed at countering tobacco manufacturers messages that would render smoking attractive and glamorous to their customers. The health information messages and any leaflets included in the package must be of sufficient size, colour and font to prevent manufacturers from using the leaflet as any sort of a promotional platform to minimize, for example, the impact of health warnings on the package exterior. The CMA supports strongly the concept of tobacco products being sold in standardized packages and we have recommended that only the “slide-and-shell” style of package be authorized and that the “flip-top” package be removed. This would allow for the largest possible surface area to be used to convey health warnings and other health-related information. The CMA has recommended that the measurements for the regular and king size cigarette packages be amended to allow for more surface area for warnings and to standardize packaging regulations across all Canadian jurisdictions. Toxic Statements (Includes Toxic Emissions Statements and Toxic Constituents Statements) The size, colour and design of new Toxic Statements proposed in the consultation document should be sufficient to be read and easily understood. The Statements should be rotated periodically to include new and updated information related to emissions and toxic constituents. Connecting Labelling Elements/ Quitline Information Tobacco manufacturers make frequent use of subtle marketing messages to render smoking attractive and glamorous, especially to young people. The CMA supports packages displaying prominent, simple and powerful health warnings, such as the graphic pictorial warnings, as well as quit tips and information on product content and health risks.2 Connecting the themes should help to reinforce the messages being conveyed with these labels. The size, colour, and placement of the proposed quitline and website information should be sufficient to maximize the noticeability of the information on various types of tobacco product packaging. Percentage of Coverage/Minimum Size of Health Warnings on Tobacco Products Other than Cigarettes and Little Cigars The amount of space given to the warnings should be sufficient to convey the maximum amount of information while remaining clear, visible, and legible. The warnings should be in proportion to the packaging available, like that of a regular cigarette package. Labelling for All Tobacco Products that Do Not Currently Require Labels The CMA supports mandatory health warnings being applied equally to all tobacco products. If package size allows, Health Warnings, Health Information Messages, and Toxic Statements should all be included. The messages should be relevant to the types of tobacco products they are covering. Labelling Rotation The rotation timeframe suggested in the consultation document of 12 to 18 months is a reasonable period. Government of Canada. New Health-Related Labelling for Tobacco Products. Document for Consultation Ottawa: Health Canada; 2018. Available: https://www.canada.ca/en/health-canada/programs/consultation-tobacco-labelling.html (accessed 2018 Oct 29). Canadian Medical Association (CMA) Tobacco Control (Update 2008). Ottawa: The Association; 2008. Available: http:// policybase.cma.ca /dbtw-wpd/Policypdf/PD08-08.pdf (accessed 2018 Dec 5). Canadian Medical Association (CMA). Letter in response to Health Canada’s Consultation on “Plain and Standardized Packaging” for Tobacco Products. Potential Measures for Regulating the Appearance, Shape and Size of Tobacco Packages and of Tobacco Products. Document for Consultation. Ottawa: The Association; 2016. Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2016-09.pdf (accessed 2018 Nov 19). Canadian Medical Association (CMA). Health Canada Consultation on Tobacco Products Regulations (Plain and Standardized Appearance). Ottawa: The Association; 2018. Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2019-01.pdf (accessed 2018 Nov 19). Canadian Medical Association (CMA). Policy Resolution BD88-03-64 - Smokeless tobacco. Ottawa: The Association; 1987. Available: https://tinyurl.com/y7eynl5q (accessed 2018 Dec 5).
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Implementation of National Pharmacare

https://policybase.cma.ca/en/permalink/policy13933
Date
2018-10-02
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Response to consultation
Date
2018-10-02
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) welcomes this opportunity to provide input to the Advisory Council on the Implementation of National Pharmacare (Advisory Council) on the issues set out in its discussion paper.1 The striking of the Advisory Council by the federal government is long overdue. We will focus on the questions set out in the discussion paper and draw attention to more specific issues that the Advisory Council should consider as it develops its final report. At the outset, Canada’s physicians are very concerned about their patients’ access to prescription medicines. A June 2018 survey of the CMA member e-panel found the following:
71% reported that they always/often ask their patients if they have prescription drug coveragebefore writing a prescription;
60% reported that greater than 20% of their patients are either uncovered or inadequatelycovered for prescription drugs; and
79% reported that copayments pose affordability challenges among their patients with drugcoverage and that they resort to a variety of strategies to help them. Indeed, when asked to pick one of three options for a national prescription program, the results were as follows:
57% - a single, national, public pharmacare plan operated by the federal government and fundedby taxes collected by the federal government;
34% - a mix of private prescription drug plans operated by private insurance companies andpublic drug plans run by the provinces and territories, supplemented by a prescription drug planprovided by the federal government for persons with high out-of-pocket drug costs; and
9% - separate regional, public pharmacare plans in each province and territory, funded by taxescollected by both the federal government and the provincial governments. Who should be covered under national pharmacare? / How should national pharmacare be delivered? The CMA’s position is that all Canadians should have access to medically necessary drugs regardless of their ability to pay. The challenge is how to resolve the issue of the most expedient and affordable means of achieving this in a manner that is acceptable to the provincial/territorial governments. At the present time there are two main options that are being discussed. The first is the approach recommended by the Standing Committee on Health (HESA) that calls for the development of a common national prescription drug formulary and the amendment of the Canada Health Act to include out-of-hospital prescription drugs in the definition of insured health services; essentially a universal, single public payer program.2 The second is the “closing the gap” or “catastrophic coverage” approach recommended previously by the Kirby and Romanow commissions, and which was one of the unfulfilled commitments that First Ministers made in the 2003 Health Accord. There is a large difference in the cost of these two approaches. Regarding the first, the federal Parliamentary Budget Office (PBO) has estimated the net cost to the federal government of assuming the cost of a pharmacare program modelled on the Quebec drug formulary at $19.3 billion in 2015-16, increasing to $22.6 billion in 2020-21.3 Regarding the second approach, in 2002 the Kirby commission suggested that a catastrophic drug program with a cap of 3% of family income would cost $500 million per year.4 A 2015 study by the Conference Board estimated that a program with a cap of 3% of household income or $1,500 would cost the federal government $1.6 billion in 2016, increasing to $1.8 billion in 2020.5 There are parallels between the present situation with insurance coverage for prescription drugs and the insurance coverage for medical services that existed at the time of the Hall Commission (1961-1964). 4 In 1961 there were 9.6 million Canadians with some form of medical insurance or prepayment coverage, representing 53% of the population.6 Almost one-half of this number (4.5 million) were covered by the physician-sponsored not-for-profit Trans-Canada Medical Plans.7 In its 1962 brief to the Hall Commission the CMA projected that this percentage would increase to 67% by 1970 and it recommended a “closing the gap” approach for the uninsured and under-insured: That, for the 1,520,000 persons, or approximately 8% of Canada’s population who may adjudged to be medically indigent, tax funds be used to provide comprehensive medical insurance on services…for persons in economic circumstances just superior to the identifiable indigent we recommend the application of tax funds on proof of need to permit the partial assistance which they require.8 After Hall reported in 1964 with the recommendation of first dollar public Medicare, as they say, the rest is history. More than 50 years after the initial passage of the Medical Care Act in 1966, virtually nobody would suggest that Canada got it wrong. In the case of pharmacare today, the circumstances are somewhat different. First the prevalence of prescription drug insurance is much higher today than medical insurance was back in the early 1960s. A 2017 report from the Conference Board estimates that just 5.2% of Canadians are uninsured for prescription drugs.9 Other survey estimates indicate that roughly one in 10 Canadians report financial difficulty in filling prescriptions10, although some surveys have yielded higher results, such as a September, 2018 Abacus Data poll that found that 23% of Canadians reported that the medicines they need are unaffordable.11 Second, the role of the provincial/territorial (PT) governments paying for prescription drugs today is much greater than their role in paying for medical services prior to Medicare. In 1961 it was estimated that all public sources accounted for 12.4% of medical care expenditures.12 In 2017, PT governments accounted for an estimated 37% of prescription drug spending.13 It is also instructive to consider how Medicare ramped up from its initial spending under the Hospital Insurance and Diagnostic Services Act in 1958-59 through to the first payments under the Medical Care Act a decade later, shown in Table 1. The table shows clearly that Medicare payments increased gradually over the two stages. Medicare as a share of total federal program spending increased from 1% in 1958-59 to a high of 11% in 1971-72. Interestingly, federal spending on Medicare never reached the 50/50 cost-sharing that was offered, reaching 36% in 1976-77, the year prior to the Established Programs Financing Act coming into effect. As an aside, according to the 2017 Fall Economic statement the Canada Health Transfer, valued at $37.1 billion in 2017-18 represents 12.2% of program spending.14 This history highlights the need to consider how the federal government might phase in the program recommended by HESA given the cost estimated by the PBO at $19.3 billion. This appears a daunting challenge in light of the recent increases in federal health funding, which amount to annual increases in the Canada Health Transfer of just over $1 billion plus the $11 billion allocated in the 2017 federal budget over a 10-year period for home care and mental health.15 There is no disagreement that at the present time the fiscal prospects are better for the federal than the PT governments. In its 2018 Fiscal Sustainability Report, the PBO reported that over the 2018-92 projection period the federal government could either increase annual spending or reduce taxes by 1.4% of Gross Domestic Product ($29 billion) and maintain its net debt at the current (2017) level.16 However, the government has many other spending priorities. Conversely, sub-national governments would be required to either increase taxes or reduce spending by 0.8% of GDP or ($18 billion) to maintain net debt at the current level. The CMA has previously recommended that the federal government pursue a “close the gap” approach in partnership with the PT governments and the private insurance industry. This approach could be scaled up toward a full national public pharmacare by either or both of lowering the household income threshold or raising the level of federal contribution.17 However this has never developed any serious momentum. While the first Ministers committed in their 2003 Accord to take measures, by the end of 2005/06 to ensure that Canadians, wherever they live, have reasonable access to catastrophic coverage,18 this ran aground with the first and only progress report of the National Pharmaceuticals Strategy in 2006.19 It was 5 evident in the report that much of the current public funding had been shifted into the catastrophic category, ranging from $6.6 billion to $10.3 billion across the four scenarios presented. The only further public PT government pronouncement on a catastrophic drug plan was a three-point proposal set out in a backgrounder for the PT health Ministers meeting in 2008 calling for a funding formula that would: protect the autonomy of the PTs in program design; set a ceiling of 5% of income; and recognize the federal government’s role as an equal partner with 50/50 cost sharing of a total estimate cost of $5.03 billion (2006).20 The amount of $5.03 billion would have represented 62% of PT spending on prescription drugs in 2006. More recently, an “essential medicines” approach to universal pharmacare has been put forward by Morgan and colleagues, modelled on 2015 data. Essential medicines are defined by the World Health Organization (WHO) as those that satisfy the priority health care needs of the population.21 WHO maintains a model list of essential medicines, and the 2017 version contains some 430 medications.22 Using a multi-step review process, Taglione and colleagues adapted the 2013 version of the WHO list to produce a shorter list of 125 medications that they assessed against the prescription audits of two Toronto-based family health teams comprising 4,777 and 35,554 patients in 2014. They reported 90.8% and 92.6% coverage with the preliminary list of 125 medications in the two sites respectively.23 The list is now called the CLEAN Meds list (http://cleanmeds.ca/). Morgan and colleagues used 117 items from the CLEAN Meds list to model the impact of adding universal public coverage of an essential medicines list to the existing public drug plans in Canada, based on 2015 data. They reported the following base case results:
Total public expenditure would increase by $1.229 billion to $11.99 billion;
Total private expenditure would decrease by $4.272 billion to $11.172 billion; and
Public expenditure on essential medicines would be $6.14 billion, representing 51% of the total$12 billion in total public expenditure.24 In further research conducted for the Patented Medicine Prices Review Board (PMPRB), Morgan examined the listing of the CLEAN Meds list across the public formularies in Canada for 2015 and found that the public plans listed 93% on average of the 125 medicines, and that this increased to 98% when weighted by drug plan costs.25 The Institute of Fiscal Studies and Democracy at the University of Ottawa has done a similar analysis of 128 medications on the CLEAN Meds list and coverage ranged across provinces from Manitoba at the bottom (with 88 covered completely and 8 requiring special authorization) to Quebec at the top with coverage of 121 items.26 This would suggest that one approach would be for the federal government to offer to cover universal coverage for essential medicines, which would cost at least $6 billion. There would be coordination issues with both public and private plans, as was the case when Ontario introduced OHIP + in early 2018 to extend coverage to persons under 25.27 This could be subsequently scaled up by adding coverage for additional medications. In terms of how pharmacare should be delivered, that will depend on how far the federal government wants to go. Could the federal government administer a national pharmacare program? It already controls levers including drug approval by Health Canada and price-setting through the PMPRB, and it provides the majority (70%) of funding to the Canadian Agency for Drugs and Technologies and Health which oversees the Common Drug Review.28 In May, 2015 Canadian Blood Services (CBS) CEO Dr. Graham Sher proposed that CBS could be considered as a model for national pharmacare, given its history of running a national (except Quebec) formulary of plasma protein drugs at no cost to patients.29 In his subsequent testimony to the HESA pharmacare study Sher described CBS’ success in negotiating price reductions through public tendering and bulk purchasing’ although he did also note that their formulary includes 45 brands and classes of plasma protein products, far fewer than the thousands of items in PT formularies.30 More recently Flood et al. have suggested that one option for pharmacare could involve the PT governments delegating authority to an arm’s-length agency similar to CBS that would purchase drugs and administer drug benefits.31 6 However, in the comuniqué following their June 2018 meeting the PT health Ministers emphasized that provinces and territories must retain responsibility for the design and delivery of public drug coverage…Quebec will maintain its own program and will receive comparable compensation if the federal government puts a pan-Canadian program in place.32 This was repeated by the Premiers in their communiqué three weeks later, which would suggest that a national agency approach is a non-starter. Moreover, none of the PT drug plans testified to the HESA pharmacare study. One issue that has received scant attention in all of the discussions about pharmacare since 2015 is the future role of private supplementary health insurance. When Medicare came in in the late 1960s, while the expenditures increased steadily, enrolment in non-profit medical insurance plans disappeared virtually overnight, dropping from 8.3 million enrollees in 1968 to 1.1 million in 1970 and none thereafter.33 This appears unlikely to happen to private insurance in the foreseeable future. For example, in the essential medicines modeling done by Morgan et al. the essential medicines would represent just 27% of total prescription drug expenditures and all public drug expenditures would account for 52% of the total.24 If the federal and PT governments were able to collectively “wave a magic wand” and come up with the PBO’s $19.3 billion and a purchasing and distribution strategy it seems likely that this would raise questions about the continued viability of the health insurance benefits industry. In their testimony to HESA, the Canadian Life and Health Insurance Association did allude to an impact on the industry should prescription drugs become a public program but was not specific.34 We have been unable to locate any international comparative literature on the structure of the health benefits industry. In 2017 CLHIA’s members paid out $11.3 billion in drug benefits, representing 44% of the $25.5 billion total. Dental benefits accounted for $8.1 billion, or 32% of the total.35 Dental benefits paid by CLHIA members accounted for two-thirds (65%) of the estimated total expenditures on dental benefits in Canada in 2017; just 6% were publicly funded.13 Socio-economic inequalities in access to dental care are well-documented36, but this issue is nowhere on the public policy agenda. In addition, any transition from private to public coverage will require some administrative coordination. As noted above, Morgan et al. estimated that an essential medicines approach would reduce private spending by $4.2 billion, a large proportion of which would be currently paid for by private insurance.24 Which drugs should be covered/how much variability across jurisdictions should there be? In terms of which drugs should be covered, the CMA believes that optimal prescribing is the prescription of a drug 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 drug available to meet the patient’s needs.37 There is no dispute that private insurance companies offer wider formularies than the public drug programs. In their 2017 study the Conference Board compiled information on the number of drugs dispensed in 2015 through: both public and private plans, public plans only; and private plans only. This was presented for nine provinces, excluding PEI. Across the nine provinces, the following averages were observed:
4,878 drugs were dispensed from both public and private plans;
336 drugs were dispensed from public plans only;
1,938 drugs were dispensed from private plans only.9 On the 2018 CMA member e-panel survey, physicians were much more likely to report formulary coverage issues with their patients who with public coverage than they were for their patients with Private coverage. More than five in 10 (54%) physicians reported that they always/often have formulary coverage 7 issues with their publicly insured patients versus just over one in 10 (13%) for their privately insured patients. If the federal government plans to pursue national pharmacare Canadians should be well-informed about the range of prescription drugs that will be available to them. In terms of the variability of coverage, if pharmacare or some portion of it becomes a publicly insured service it should be offered to all Canadians under uniform terms and conditions, as specified in the CHA. In practical terms, Morgan and colleagues have previously demonstrated that there is a high degree of commonality in the formularies across the public drug programs. Based on a review of 2006 formulary listings of 796 drugs across all provincial formularies except PEI, they found that coverage ranged from 55% to 73%, but when weighted by national retail sales the measure of formulary coverage exceeded 86% in all 9 provinces.38 More recently, in the 2017 PMPRB study of formulary coverage Morgan studied 729 drugs across all provinces and the Non-Insured Health Benefits Plan for 2015. The public plans listed an average of 79% of the 729 drugs, and this increased to 95% when drug costs were factored in.25 These findings would lend further support to the case for an essential medicines approach to national pharmacare. Should patients pay a portion of the cost of drugs/should employers continue to play a role? If the federal government intends to define out-of-hospital prescription drugs as an insured service under the CHA it will be necessary to address the feasibility of first dollar coverage in light of the accessibility criterion that prohibits user charges. The CMA addressed this issue in our 2016 brief to the HESA pharmacare study with reference to Scotland, which eliminated prescription charges in April, 2011.39 There are now more recent data. In the four years leading up to the elimination of prescription charges the volume of prescriptions dispensed increased by 3.6% annually. In the seven years since the charges were eliminated, the annual increase has been 1.8%; indeed between 2016/17 and 2017/18 there was a decrease of 0.06%.40 It should be added however that dispensing charges only accounted for 3% of prescription costs in 2008/09. Wales and Northern Ireland have also eliminated prescription charges for their citizens. The experiences of these countries should be examined more closely. There has been very little research on how employers would react to the implementation of a full or partial public pharmacare plan. Ipsos conducted research among the employer community in 2012. Just under one in two (47) of respondents indicated that they would support a public program for supplementary benefits introduced by the federal government that was funded by increased taxes, but nearly nine in ten agreed that even if the government implemented a program I would recommend that our company/organization still offer a supplementary health benefits program (over and above the government offer) because it would give us an advantage in recruiting/retaining employees.41 If some form of a public pharmacare program is implemented, this will reduce the amount of drug benefits that private insurance companies are required to pay out, which should result in lower premiums for those employers who provide supplementary benefits. The implications of this in terms of how a pharmacare program might be funded have not received much scrutiny to date. However, regardless of the notionally ear-marked health taxes or premiums that are levied against businesses or individuals, Medicare has been paid for out of general tax revenues. Conclusion In conclusion, the initial modeling study published by Morgan et al. in 201542 has resulted in welcome attention to the longstanding issue of access to prescription drugs for Canadians who are either uninsured or under-insured. However the discussions have been light on how we could transition to a situation where Canadians can access prescription drugs on the same basis as they access medical and hospital services. This would require concerted discussion between the federal and PT governments and 8 the health insurance benefits industry and this has not yet occurred. The discussions since 2015 have mainly ignored the issue of highly expensive drugs for rare diseases and very expensive drugs for more common diseases, such as biologic drugs for rheumatoid arthritis. The CMA is pleased to see that HESA is launching a study on the barriers to access to treatment and drugs for Canadians with rare diseases and disorders.43 Recommendations The Canadian Medical Association recommends that the Advisory Committee on the Implementation of National Pharmacare: 1.Engage with the federal and provincial/territorial governments and the health insuranceindustry on the feasibility of a universal federally funded “essential medicines”prescription drug plan as a scalable approach to the implementation of a nationalpharmacare plan. 2.Engage the business community and the health insurance industry on the question of thecontinued viability of the provision of supplementary health benefits (e.g. dental care)should a national pharmacare plan be implemented. 3.Study the international experience of Scotland and other countries with respect to theprovision of first dollar coverage of prescription drugs. 9 Table 1. The Evolution of Medicare ($ million) Year HIDS Medical Care Act Total program spend Medicare as a % of total program Total hospital spend Total physician spend Medicare as a % of total H&P 1958-59 54.7 0 4716 1% 640.608 301.337 6% 1959-60 150.6 0 4919.4 3% 735.626 325.689 14% 1960-61 189.4 0 5160.5 4% 834.932 355.014 16% 1961-62 283.9 0 5681.6 5% 930.568 388.305 22% 1962-63 336.7 0 5652.5 6% 1031.749 406.075 23% 1963-64 392.2 0 5878.7 7% 1150.306 453.395 24% 1964-65 433.9 0 6167 7% 1273.38 495.657 25% 1965-66 319.6 0 6623.9 5% 1434.274 545.056 16% 1966-67 397.4 0 7589.2 5% 1637.647 605.2 18% 1967-68 468.6 0 8497 6% 1880.699 686.189 18% 1968-69 561.9 33 9258 6% 2179.906 788.089 20% 1969-70 635.9 181 10204 8% 2456.687 901.435 24% 1970-71 734.3 400.5 11262 10% 2775.391 1031.555 30% 1971-72 844.6 576.5 12831 11% 3095.367 1239.775 33% 1972-73 960.5 630.8 16324 10% 3384.801 1375.127 33% 1973-74 1065.7 677.9 20247 9% 3803.61 1471.971 33% 1974-75 1307.6 762.7 26037 8% 4579.041 1647.025 33% 1975-76 1709.2 795.8 30023 8% 5533.707 1900.483 34% 1976-77 2030.5 1003.6 34209 9% 6357.3 2071 36% Sources: Hospital Insurance and Diagnostic Services (HIDs) and Medical Care Act – Public Accounts of Canada Issues 1958-59 – 1976-77. Spending by National Health and Welfare. Total program spend – Public Accounts of Canada Issues 1958-59-1976-77. Budgetary Expenditures Classified by Function – Total spend less public debt charges. Total hospital and physician spend – calendar year data 1958 – 1975 in Statistics Canada, Historical Statistics of Canada. Series B504-513 Health expenditures, Canada, 1926 to 1975. 1976 – Canadian Institute for Health Information. National Health Expenditures Data Tables Table A.3.1.1. 1 Government of Canada. Towards implementation of national pharmacare. Discussion paper. https://www.canada.ca/content/dam/hc-sc/documents/corporate/publications/council_on_pharmacare_EN.PDF. Accessed 10/02/18. 2 House of Commons Standing Committee on Health. Pharmacare now: prescription medicine coverage for all Canadians. http://www.ourcommons.ca/Content/Committee/421/HESA/Reports/RP9762464/hesarp14/hesarp14-e.pdf. Accessed 10/02/18. 3 Office of the Parliamentary Budget Officer. Federal cost of a national pharmacare program. https://www.pbo-dpb.gc.ca/web/default/files/Documents/Reports/2017/Pharmacare/Pharmacare_EN_2017_11_07.pdf. Accessed10/02/18. 10 4 Standing Senate Committee on Social Affairs, Science and Technology. The health of Canadians – the federal role. Volume six: recommendations for reform. https://sencanada.ca/content/sen/committee/372/soci/rep/repoct02vol6-e.pdf. Accessed 10/-2/18.5 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 10/02/18.6 Berry C. Voluntary medical insurance and prepayment. Ottawa: Queen’s Printer, 1965.7 Clarkson G. The role of Trans-Canada Medical plans in Canadian medical insurance. News & Views on the Economics of Medicine 1966, Number 136.8 Canadian Medical Association. Submission of the Canadian Medical Association to the Royal Commission on Health Services. Toronto, 1962.9 Conference Board of Canada. Understanding the gap: a pan-Canadian analysis of prescription drug insurance coverage. https://www.conferenceboard.ca/temp/7bef4501-6ba6-4527-8b99-8b788c461d14/9326_Understanding-the-Gap__RPT.pdf. Accessed 10/02/18.10 Canadian Institute for Health Information. How Canada compares: Results from the Commonwealth Fund’s 2016 International Health Policy Survey of Adults in 11 Countries.https://www.cihi.ca/sites/default/files/document/commonwealth-fund-2016-chartbook-en-web-rev.pptx. Accessed10/02/18.11 Abacus Data. Canadian perspectives on pharmacare. http://abacusdata.ca/canadian-perspectives-on-pharmacare/. Accessed 10/02/18.12 Royal Commission on Health Services. 1964—Report Volume 1. Ottawa: Queen’s Printer, 1964.13 Canadian Institute for Health Information. National health expenditure trends 1975 to 2017: data tables.https://www.cihi.ca/sites/default/files/document/series_b-nhex2017-en.xlsx. Accessed 10/02/18.14 Department of Finance Canada. Progress for the middle class. Fall economic statement 2017.https://www.budget.gc.ca/fes-eea/2017/docs/statement-enonce/fes-eea-2017-eng.pdf. Accessed 10/02/18.15 Department of Finance Canada. Building a strong middle class. Budget plan 2017. https://www.budget.gc.ca/2017/docs/plan/budget-2017-en.pdf. Accessed 10/02/18. 16 Office of the Parliamentary Budget Officer. Fiscal sustainability report 2018. https://www.pbo-dpb.gc.ca/web/default/files/Documents/Reports/2018/FSR%20Sept%202018/FSR_2018_25SEP2018_EN_2.pdf. Accessed 10/02/18. 17 Canadian Medical Association. Funding the continuum of care. https://www.cma.ca/Assets/assets-library/document/en/advocacy/PD10-02-e.pdf. Accessed 1-/-2/18. 18 Canadian Intergovernmental Conference Secretariat. 2003 First Ministers’ Accord on Health Care Renewal. http://www.scics.ca/wp-content/uploads/CMFiles/800039004_e1GTC-352011-6102.pdf. Accessed 10/02/18. 19 National Pharmaceuticals Strategy. National Pharmaceuticals Strategy progress report. June 2006. https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/hcs-sss/alt_formats/hpb-dgps/pdf/pubs/2006-nps-snpp/2006-nps-snpp-eng.pdf. Accessed 10/02/18. 20 Canadian Intergovernmental Conference Secretariat. Annual conference of provincial-territorial Ministers of health. Backgrounder: National pharmaceutical strategy decision points. http://www.scics.ca/en/product-produit/backgrounder-national-pharmaceutical-strategy-decision-points/. Accessed 10/02/18. 21World Health Organization. Essential medicines and health products. http://www.who.int/medicines/services/essmedicines_def/en/. Accessed 10/02/18. 22World Health Organization. WHO model list of essential medicines. 20th list (Amended August 2017). http://www.who.int/medicines/publications/essentialmedicines/20th_EML2017.pdf?ua=1. Accessed 10/02/18. 23 Taglione M, Ahmad H, Slater M, Aliarzadeh B, Glazier R, Laupacis A, Persaud N. Development of a preliminary essential medicines list for Canada. CMAJ Open 2017, 5(1):E137-43. 24 Morgan S, Li W, Yau B, Persaud N. Estimated effects of adding universal public coverage of an essential medicines list to existing public drug plans in Canada. CMAJ 2017;189(8):E295-302. 25 Patented Medicine Prices Review Board. Alignment among public formularies in Canada. Part 1: General overview. http://www.pmprb-cepmb.gc.ca/CMFiles/NPDUIS/NPDUIS_formulary_report_part_1_en.pdf. Accessed 10/02/18. 26 Institute for Fiscal Studies and Democracy. National pharmacare in Canada: Choosing a path forward. http://www.ifsd.ca/web/default/files/Presentations/Reports/18006%20-%20National%20Pharmacare%20in%20Canada-%20Choosing%20a%20Path%20Forward%20-%2016%20July%202018%20-%20Final.pdf. Accessed 10/02/18. 27 CTV News. Ottawa dad raising red flag about OHIP+. https://ottawa.ctvnews.ca/ottawa-dad-raising-red-flag-about-ohip-1.3759115. Accessed 10/02/18. 28 Canadian Agency for Drugs and Technologies in Health. Financial statements March 31, 2018. https://www.cadth.ca/sites/default/files/corporate/planning_documents/CADTH-FS-FY17-18-e.pdf. Accessed 10/02/18. 29 Sher G. Canadian Blood Services as a model for national pharmacare. National Post, April 15, 2015. https://blood.ca/en/media/graham-sher-canadian-blood-services-as-a-model-for-national-pharmacare. Accessed 10/02/18. 11 30 House of Commons Standing Committee on Health. Evidence. Monday, May 2, 2016. https://www.ourcommons.ca/Content/Committee/421/HESA/Evidence/EV8226056/HESAEV09-E.PDF. Accessed 10/02/18. 31 Flood C, Thomas B, Moten A, Fafard P. Universal pharmacare and federalism: policy options for Canada. http://irpp.org/wp-content/uploads/2018/09/Universal-Pharmacare-and-Federalism-Policy-Options-for-Canada.pdf. Accessed 10/02/18. 32 Canadian Intergovernmental Conference Centre. Conference of provincial and territorial Ministers of health. Provincial/territorial health Ministers meeting communiqué. June 28, 2018. http://www.scics.ca/en/product-produit/news-release-provincial-territorial-health-ministers-meeting-communique/. Accessed 10/02/18. 33 Statistics Canada. Historical Statistics of Canada. Series 8514-516. Estimated enrolment in non-profit medical insurance plans, Canada, at 31 December, 1937 to 1975. https://www150.statcan.gc.ca/n1/en/pub/11-516-x/pdf/5500093-eng.pdf?st=W5ksoTqs. Accessed 10/02/18. 34 House of Commons Standing Committee on Health. Evidence. Monday, May 9, 2016. https://www.ourcommons.ca/Content/Committee/421/HESA/Evidence/EV8251913/HESAEV10-E.PDF. Accessed 10/02/18. 35 Canadian Life and Health Insurance Association. Canadian life and health insurance facts 2018 edition. https://www.clhia.ca/web/clhia_lp4w_lnd_webstation.nsf/resources/Factbook_2/$file/2018+FB+EN.pdf. Accessed 10/02/18. 36 Farmer J, Phillips R, Singhal S, Quinonez C. Inequalities in oral health: understanding the contributions of education and income. Canadian Journal of Public Health 2017;108(3):3240-5. 37 Canadian Medical Association. A prescription for optimal prescribing. http://policybase.cma.ca/dbtw-wpd/Policypdf/PD11-01.pdf. Accessed 10/02/18. 38 Morgan S, Hanley G, Raymond C, Blais R. Breadth, depth and agreement among provincial formularies in Canada. Healthcare Policy 2009;4(4):e162-84. 39 Canadian Medical Association. National pharmacare in Canada: getting there from here. https://www.cma.ca/Assets/assets-library/document/en/advocacy/submissions/national-pharmacare-canada-e.pdf. Accessed 10/02/18. 40 ISD Scotland. Data Tables Prescribing and Medicines. Volume and cost (NHSScotland) (Financial years 2008-09-2017/18). http://www.isdscotland.org/Health-Topics/Prescribing-and-Medicines/Publications/data-tables2017.asp?id=2204#2204. Accessed 10/02/18. 41 Ipsos Reid. Two in ten (18%) Canadians have no supplementary health coverage. https://www.ipsos.com/sites/default/files/publication/2012-08/5714.pdf. Accessed 10/02/18. 42 Morgan S, Law M, Daw J, Abraham L, Martin D. Estimated cost of universal public coverage of prescription drugs in Canada. CMAJ 2015;187(7):491-7. 43 House of Commons Standing Committee on Health Minutes of Proceedings, Meeting No. 100 April 18, 2018. http://www.ourcommons.ca/DocumentViewer/en/42-1/HESA/meeting-100/minutes. Accessed 10/02/18.
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Listening to our Patient's Concerns : Comments on Bill C 54 (Personal Information Protection and Electronic Document Act) : Submission to the House of Commons Standing Committee on Industry

https://policybase.cma.ca/en/permalink/policy1980
Last Reviewed
2019-03-03
Date
1999-03-18
Topics
Health care and patient safety
Health information and e-health
Ethics and medical professionalism
  2 documents  
Policy Type
Parliamentary submission
Last Reviewed
2019-03-03
Date
1999-03-18
Topics
Health care and patient safety
Health information and e-health
Ethics and medical professionalism
Text
Over the last year, CMA has become increasingly concerned that debate on the issues concerning health information have been framed in terms of access to information with an attendant erosion of privacy and confidentiality. This one-sided approach comes at a time of expansion in our capacity to collect, store, merge, transfer and access information, coupled with trends both in the health care sector and generally related to the use of information To address these concerns and to ensure that privacy and confidentiality in the medical context are valued, protected and preserved, CMA developed and adopted a Health Information Privacy Code. This Code should form the basis of all legislation governing the collection, use and disclosure of health information. Health information is special by its nature. Rules relating to health information must be developed in recognition of its special nature. Ensuring protection of privacy and confidentiality of the patient record must take precedence over other considerations. Bill C-54 fails to do this. Bill C-54 is written from the perspective of encouraging commerce. It appears to have access to information as its dominant value. CMA considers the world of health care to be very different from that of commerce and consequently requiring distinct rules. Health information use must, in all but exceptional and justifiable circumstances, occur only under the strict control of the patient. The patient must be able to exercise control through voluntary, informed consent. Bill C-54 permits the collection, use and disclosure of information without knowledge or consent on grounds such as expediency, practicality, public good, research, offence investigation, historic importance and artistic purpose. The evident lack of protection accorded health information based on such ground, is unacceptable. The absence of protection undermines the integrity of the patient-physician relationship and has the potential to erode the trust patients have in their physicians - a trust that is essential to patients’ willingness to provide the complete information needed to provide them with care. Moreover, distinctions must be made between a patient’s right to know what can or must happen to health information and the right to consent to such use. Not all purposes for the collection and use of health information are equal. Collection and use beyond the therapeutic context should be subjected to rigorous scrutiny before they are permitted to occur. Bill C-54 fails to make such a distinction and treats all purposes that could be identified for information collection or use as equal. Moreover, the Bill has no mechanism to distinguish legitimate purposes, which should be permitted from illegitimate purposes, which should not. In light of the clear deficits in Bill C-54 and the inadequate protection of patient privacy and health information confidentiality, CMA makes the following recommendations: That Bill C-54 be amended to incorporate specific provisions relating to health information and that the provisions of the CMA Code provide the basis of such provisions; and That the proposed rules for health legislation be subject to the legislative test found in CMA’s Code and formulated in light of this process; and That there be a clear definition of the information being accorded a right of privacy and that this definition, at least in the case of health information, include identifiable information, delinked information, anonymous information and any composite form produced when information is linked to any information about a person from any other source; and That, at least in connection with health information, the provisions of the Bill apply equally to the public and the private sectors. I. Introduction The Canadian Medical Association is the national voice of Canadian physicians. Our mission is to provide leadership for physicians and to promote the highest standard of health and health care for Canadians. The CMA is a voluntary professional organization representing the majority of Canada's physicians and comprising 12 provincial and territorial divisions and 43 affiliated medical organizations. On behalf of its 45,000 members and the Canadian public, CMA performs a wide variety of functions, including addressing the emerging issue of electronic health information and confidentiality and privacy. It is in this capacity that we present our position on Bill C 54, The Personal Information Protection and Electronic Documents Act. CMA commends the government for taking the first, important step of beginning the debate on the protection of personal information. The issues are complex and the interests at stake significant. CMA welcomes the opportunity to provide comments on Bill C-54. CMA hopes that its input will strengthen the Bill by ensuring that patient privacy and the confidentiality of medical records are adequately protected. In preparing this brief CMA has had the benefit of the final report of the federal Advisory Council on Health Infostructure, Canada Health Infoway: Paths to Better Health: Final Report. (“Advisory Council Report”) Where appropriate, CMA cites the findings contained in the report. CMA wishes to underscore the key themes of its brief: A. Health information is special by its nature. Rules relating to health information must be developed in recognition of its special nature. Ensuring protection of privacy and confidentiality of the patient record must take precedence over other considerations. Bill C-54 fails to do this. Bill C-54 is written from the perspective of encouraging commerce. It appears to have access to information as its dominant value. CMA considers the world of health care to be very different from that of commerce and consequently requiring distinct rules. B. Health information use must, in all but exceptional and justifiable circumstances, occur only under the strict control of the patient. The patient must be able to exercise control through voluntary, informed consent. Bill C-54 permits the collection, use and disclosure of information without knowledge or consent on grounds such as expediency, practicality, public good, research, offence investigation, historic importance and artistic purpose. The evident lack of protection accorded health information based on such ground, is unacceptable. The absence of protection undermines the integrity of the patient-physician relationship and has the potential to erode the trust patients have in their physicians - a trust that is essential to patients’ willingness to provide the complete information needed to provide them with care. Moreover, distinctions must be made between a patient’s right to know what can or must happen to health information and the right to consent to such use. C. Not all purposes for the collection and use of health information are equal. Collection and use beyond the therapeutic context should be subjected to rigorous scrutiny before they are permitted to occur. Bill C-54 fails to make such a distinction and treats all purposes that could be identified for information collection or use as equal. Moreover, the Bill has no mechanism to distinguish legitimate purposes, which should be permitted from illegitimate purposes, which should not. This brief will first look at the apparent rationale of Bill C-54 and its potential application to health information. The brief will next describe why CMA considers health information to be special in nature and worthy of special protection. Finally, the brief reviews the difference in approach between Bill C-54 and CMA’s Health Information Privacy Code to illustrate that Bill C-54 provides inadequate protection to patient privacy and health record confidentiality. II. Rationale and Scope of Bill C-54 A. Rational of Bill C-54 The driving force behind Bill C-54 is the support and promotion of electronic commerce. The second part of the Bill is devoted to permitting electronic versions of documents and signatures to be legitimate or ‘originals’ if the provisions of the Act are followed. Part two of the Bill is quite distinct from part one and both parts could stand alone as separate pieces of legislation. Part two simply allows electronic versions of documents and signatures to be recognized as legitimate. On its face, this has little to do with the protection of personal information except to the extent that storage of documents in electronic form provides greater ability to access, link and merge information. Certainly, the Bill appears to draw on this connection by including, in its statement of purpose, the provision of a right of privacy in an era in which technology increasingly facilitates the collection and free flow of information. Part one concerns all forms of information, electronic and otherwise. It gives some protection to personal information by requiring consent in some instances. In CMA’s view, a fundamental difficulty with part one and the Bill in general is that it’s goal is to promote commerce and thus all information is implicitly considered as falling within the ‘commercial’ realm. In the case of health information this is surely not the case or the only consideration. Moreover, this creates a clash of values when applied to a health care system that is a public system. The Advisory Council Report takes a hard line on this issue and states that legislation respecting the privacy protection of health information, “should also contain a clear prohibition against all secondary commercial use of personal health information.” Because all information is subjected to similar rules, there is no attempt within the Bill to distinguish some purposes for collecting information from other purposes. The Bill takes the approach that the purposes should be known and documented. While not stated explicitly, the assumption is that all purposes identified are legitimate and are permitted. CMA has quite a different view when it comes to health information and will expound its view throughout this brief. B. Scope - Application to Medical Records CMA is uncertain whether or to what extent Bill C-54 will apply to health records. The full name of the Act states, in part: An Act to support and promote electronic commerce by protecting personal information that is collected, used or disclosed in certain circumstances.... What are these circumstances? Section 4(1) states that Part 1 (the part protecting personal information) applies in respect of personal information that: (a) the organization collects, uses or discloses in the course of commercial activities; (b) the organization collects, uses or discloses interprovincially or internationally; or (c) is about an employee of the organization and that the organization collects, uses or discloses in connection with the operation of a federal work, undertaking or business. It should further be noted that three years after the Act is in force it will apply equally to activities that occur strictly within the province unless there is legislation in the province that is substantially similar to the Bill (see sections 27(2)(d) and section 30). The first issue is the provision of section 4(1)(a) - collection, use and disclosure in the course of commercial activities. There seems to be an assumption on the part of government that this automatically excludes health records, (although the Act fails to define what is meant by commercial activity). Is this accurate or does the assumption fail to recognize that there is not a clear, unambiguous distinction between what might constitute commercial activity or other activity? There are two points to be made here. The first concerns clarity around where commercial ends and health care begins. Which health care settings that operate for profit are excluded from the Act? This question speaks to the difficulty of delineating what activity is considered health care and what activity is considered commercial. Moreover it recognizes that the increased encouragement to public/private funding of endeavours within the health care sector may make it increasingly difficult to make this distinction; for example in the area of research. The second concerns the movement of health information from the health care setting (recognizing that this is not easily distinguished from the commercial setting) to the commercial setting; for example, health information provided to insurance companies. When health care information is collected in a health care setting and transferred to a commercial setting, which rules apply - Bill C-54 or no rules? In CMA’s view, there is no clear way of distinguishing commercial activity from health care activity in a way that ensures that the health care record is subject to different rules than those pertaining to other records. Moreover, the dilemma for government is that even if such distinction could occur, would it be desirable that health records be subject to no rules? Put in another way, will those organizations that currently collect health care information be entitled to claim that since the information forms part of the health record they are not subject to the provisions of C-54? Under such a regime health care records would be subject to an even lower standard than that provided for information collected in the commercial context. In terms of the provisions of 4(1)(b) - interprovincial and international transfer of information. This appears to apply to all information. In the existing environment and developments such as the “health information highway,” interprovincial transfers of information, the capacity for the central collection and storage of information, mechanisms such as telephone and cable to transfer information and general trends related to population health, it seems likely that interprovincial traffic will grow rather than diminish. The significance of this section, therefore, cannot be underestimated. Finally, the provisions of 4(1)(c) may well contain health information about the employee. In preparing this brief CMA has assumed that the Bill will provide a scheme that applies to some health information. No doubt the extent of the federal governments ability to legislate in this area generally will be the subject of extensive debate. However, CMA has no comment on this debate and provides its opinion in the interests of ensuring that the rules that relate to health information are compatible with preserving the integrity of the patient-physician relationship and the protection of patient privacy and health information confidentiality. CMA considers that the government has an opportunity to provide Canadians with strong privacy rights in health information. Indeed, CMA believes that it is incumbent upon the government to do so. C. Scope - Government Excluded Bill C-54 expressly excludes a large part of government activity from its ambit. While government activity is to some extent governed by the Privacy Act, R.S.C. 1985, P-21, the rules of this act provide less protection than those of Bill C-54. Government should subject itself to at least the same rules that it requires of the private sector in so far as it is a collector and user of information. Moreover, CMA is of the view that government’s practices relating to the collection, storage, merging, transfer and use of health information must be subject to more stringent rules than those found in either the Privacy Act or Bill C-54. The Advisory Council Report also calls for the same rules to apply to the public and private sectors, rules that are more stringent than those found in the Privacy Act or Bill C-54. Therefore, CMA recommends: That, at least in connection with health information, the provisions of the Bill apply equally to the public and the private sectors. III. Considerations Regarding Patient Privacy and Confidentiality: Medical Context Versus Commercial Context A. CMA’s Opinion Over the last year, CMA has become increasingly concerned that debate on the issues concerning health information have been framed in terms of access to information with an attendant erosion of privacy and confidentiality. This one-sided approach comes at a time of expansion in our capacity to collect, store, merge, transfer and access information, coupled with trends both in the health care sector and generally related to the use of information To address these concerns and to ensure that privacy and confidentiality in the medical context are valued, protected and preserved, CMA developed and adopted a Health Information Privacy Code, which is appended to and forms part of this brief. In commenting on this Code the Advisory Council Report notes: The code represents an important contribution to the deliberations of Canadians and legislators on how to safeguard privacy across the health domain. There are a number of principles underpinning the Health Information Privacy Code: 1. The provision of health care to all Canadians irrespective of social circumstances or health status is a highly regarded value in Canadian society. The system is publicly funded and universally accessible. 2. The right of privacy is fundamental to a free and democratic society. 3. Rules relating to health information must recognize its special nature. Health information has a high level of sensitivity, it is confided or collected in circumstances of vulnerability and trust for the primary purpose of benefiting the patient. 4. Physicians now and historically promise that they will keep their patients’ information secret; this is a hallmark of the profession. 5. The patient-physician relationship is one of trust and a central feature of this trust is the belief in patients that information confided in or collected by physicians and other health care providers will be kept secret. 6. Patients believe that the information they disclose or that is gathered as a result of their seeking health care will be used to provide them with health care; uses beyond the provision of health care without knowledge or consent go beyond what a patient’s reasonable expectations were when information was disclosed or gathered and is a breach of the trust patients place in their physicians. 7. Except in very limited circumstances, consent is required for health information collection, use, disclosure or access for any purpose. 8. Information required to provide patients with the health care sought should be readily available to those who require it to provide an aspect of care. 9. Uses of health information for purposes other than the provision of health care to the person seeking care should be subject to rules that: - protect and promote privacy and confidentiality; - generally require express consent; - can be justified according to specific criteria. 10. Patients should know the uses to which their health information is put prior to their disclosure of it. 11. Patients may be reluctant to disclose information if they are concerned about the uses to which the information is put or the persons entitled to access it. B. Public Opinion To determine the public’s view on these issues, CMA commissioned Angus Reid to conduct research in two forms, quantative (survey) and qualitative (focus groups), and has found the following: 1. Patients believe that their health information will be kept confidential and consider this to be important. 2. Patients believe it important to know and control how their health information is shared with others. 3. Patients do not want their health information released to third parties (including governments and researchers) without their knowledge and consent. 4. Patients may have concerns about the release of delinked or anonymous information to third parties without their consent. 5. Patients may be reluctant to confide information as a result of concerns related to its use or disclosure. These findings are consistent with general findings relating to the public’s concerns about privacy and confidentiality. C. The Advisory Council Report The Advisory Council Report relates to the electronic health record. However, given the direction towards the greater use of technology and the underlying principles informing the Advisory Council, CMA believes that the recommendations are generalizable to all health information. A key principle of the Advisory Council is that access by health care professionals should be based on a need-to-know basis under the strict control of the patient. The Council, like CMA calls for scrutiny and justification of secondary uses of health information. The Council is opposed to the use of multipurpose identifiers on the grounds that it becomes too easy for government officials from one department to gain access to a person’s health record or combine a number of records to assemble a comprehensive profile. (Anecdotal evidence suggests that this concern may be justified and that there are insufficient safeguards preventing the flow of health information among government departments) The Council recommends that all governments ensure that they have legislation to address privacy protection specifically aimed at protecting personal health information through explicit and transparent mechanisms. Included in these mechanisms are: * The provision of a precise definition of free and informed consent, as well as a statement of principle that informed consent should be the basis for sharing personal health information; * Any exemption to the requirement of informed consent should be clearly set out in law. More specifically, legislative guidance should be provided on how to balance the right of privacy with the public good for research purposes to implement a coherent and harmonized pan-Canadian system for independent, ethical review. * There should be provisions regulating secondary uses of non-identifiable health information. These provisions should address privacy concern surrounding the degree to which data might be linked back to an identifiable individual. * Legislation should set clear limits on access to and use of health information by third parties outside the health care system. To prevent the serious invasions of privacy that can result from the unrestricted linking of personal health information with other kinds of information on the same individual, the legislation should contain provisions prohibiting the use for any other purpose of unique personal identifiers in health information systems. D. The Approach in Bill C-54 Bill C-54 is inadequate in its protection of health information. The Bill makes a meagre attempt at distinguishing among varying types of personal information and gives no additional protection to information that is highly sensitive (such as health information). The Bill permits the collection, use and disclosure of information without knowledge or consent on grounds such as expediency, practicality, public good, research, offence investigation, historic importance and artistic purposes. In the context of health information, these grounds should be subject to intense scrutiny to determine their relevance and legitimacy. In CMA’s view and according to the tests established in the CMA’s Code, some of these grounds would not withstand such scrutiny. E. Conclusion CMA’s Code offers a template for the protection that should be accorded health information, a template that appears to have some public support and that strives to retain patient confidence in their physicians and the health care system. The Report of the Federal Advisory Council also recognizes that special rules are required for health information. The Council’s Report places strong emphasis on the protection of privacy, recognizes that as a general rule the flow of health information should be on a need-to-know basis and under the control of the patient through the exercise of free and informed consent and requires limits on the secondary use of health information. In CMA’s view, Bill C-54 should incorporate specific rules relating to health information and CMA’s Code should form the basis of these rules. CMA recommends: That Bill C-54 be amended to incorporate specific provisions relating to health information and that the provisions of the CMA Code provide the basis of such provisions. In addition, CMA’s Code provides a test that legislation addressing health information should be subjected to. This test (found in section 3.6 of the CMA Code) states: Any proposed or existing legislation or regulation made under legislative authority that permits or requires health information collection, use, disclosure or access shall be subjected to the following legislative test: (a) There must be demonstration that: (i) a patient privacy impact assessment has been conducted, the analysis has been made public and has been duly considered prior to the introduction of legislation [section 3.5 of the Code provides guidance with respect to the patient privacy impact assessment]; (ii) collection, use, disclosure and access will be limited to the greatest degree possible to ensure that * the collection of health information by persons external to the therapeutic context will neither trade on nor compromise the trust of the patient-physician relationship; * patients are not likely to be inhibited from confiding information for primary purposes; * the ability of physicians to discharge their fiduciary duties to patients will not be compromised; and, * patient vulnerability will not be exploited; (iii) collection, use, disclosure and access will be restricted to what is necessary for the identified purpose(s) and will not impede the confiding or collection of information for primary purposes; (iv) provisions exist for ensuring that patients are provided with knowledge about the purpose(s) and that, subject to 3.6(b), patient consent is clearly voluntary; (v) the means used are proportionate and the collection will be limited to purposes consented to or made known to the patient; (vi) the patient’s privacy will be intruded upon to the most limited degree possible in light of the purpose(s) consented to or made known to the patient; (vii) linkage of the health information will be limited; and (viii) unless clear and compelling reasons exist: * all reasonable steps will be taken to make health information anonymous; and * if it has been demonstrated that making health information anonymous would render it inadequate for legitimate uses, the information will be collected and stored in a deidentified-relinkable format. (b) When nonconsensual collection, use, disclosure or access is permitted or required by legislation or regulation that meets the requirements of the Code, the following conditions must also be met: (i) the right of privacy has to be violated because the purpose(s) could not be met adequately if patient consent is required; and (ii) the importance of the purpose(s) must be demonstrated to justify the infringement of the patient’s right of privacy in a free and democratic society. (c) Any legislative provision or regulation that permits or requires health information collection, use, disclosure or access nonconsensually shall not, without compelling reasons, be applied retroactively to existing health information. In its current form, Bill C-54 would not pass the scrutiny of the test. Consequently, CMA recommends: That the proposed rules for health legislation be subject to the legislative test found in CMA’s Code and formulated in light of this process. IV. Specific Comments on Bill C-54 From the Perspective of CMA’s Health Information Privacy Code This section highlights some key distinctions between the approach taken by Bill C-54 and CMA’s Health Information Privacy Code. The purpose of this section is to illustrate through examples the divergence of approaches taken with the ultimate aim of demonstrating that Bill C-54 is inadequate in the protection it accords health information. A. General Bill C-54 and CMA’s Health Information Privacy Code are based on the Canadian Standards Association’s Model Code for the Protection of Personal Information (CSA Code). Bill C-54 and the CMA Code also augment the CSA Code’s provisions where considered necessary. The need to extend the provisions of the CSA Code demonstrates that the CSA Code, being general in nature, provides inadequate protection to information in many instances. Although Bill C-54 and the CMA Code are based on the CSA Code, each takes a different approach to the ultimate protection accorded information. This divergence demonstrates that there are many ways to resolve issues left unresolved by the CSA Code. In other words, it is not a foregone conclusion that basing provisions on the CSA Code will result in appropriate or adequate protection of information. Rather, resolution of issues requires thought and deliberation and will depend in some measure on the primacy given to certain values. Bill C-54 appears to have given access primacy in the pursuit of commerce, whereas CMA gives privacy protection primacy in the pursuit of the provision of health care in accordance with physicians fiduciary obligations to patients and the integrity of the patient-physical relationship. CMA did not develop its approach in a vacuum. It reviewed and was inspired by the report of the House of Commons Standing Committee on Human Rights and the Status of Persons with Disabilities, entitled Privacy: Where Do We Draw the Line? This report articulates and makes explicit many of the issues that should be informing the current debate on Bill C-54. In addition, the Report of the Advisory Council takes a very different approach to Bill C-54. The Report recognizes the need to pay more than lip service to protecting privacy and confidentiality and recommends specific measures aimed at doing this. B. Information Protected Bill C-54 The Bill covers “personal information” which is defined to mean “information about an identifiable individual that is recorded in any form.” This definition raises a host of questions: 1. Does the Bill cover or not information that has been delinked to an identifiable individual but that could be relinked to identify them? 2. Does the Bill only exclude anonymous information - that is, information that could never be relinked to an indentifiable individual? And if so, is there an unjustified assumption that information can, in all cases, be rendered truly anonymous? 3. In the case of delinked and anonymous information, who decides that information about an identifiable individual can be rendered delinked or anonymous? The holder of the information or the person to whom the information pertains? 4. Is it accurate or reasonable to assume that people have no interest in information emanating from them once it has been rendered delinked or anonymous? CMA Health Information Privacy Code The CMA Code provides a broad definition of health information: Health information means any information about a patient that is confided or collected in the therapeutic context, including information created or generated from this information and information that is not directly or indirectly linked to the provision of health care. It includes all information formats. In addition, the CMA Code covers identifiable information, delinked information, anonymous information and any composite form that is produced when health information is linked to other information about the patient. CMA’s research indicates that patients may have an interest in their information when it is in delinked and anonymous formats. Advisory Council Report The Advisory Council Report addresses this issue in a number of ways. In making recommendations concerning the definition of health information the Report calls for legislation that embodies: a clear definition of health information, broad enough to incorporate health information collected in public and private systems and to ensure that equal obligations and penalties apply to both public and private sectors. The report recognizes a spectrum of data formats: completely anonymous, linked to pseudo-identities, code linked and reidentifiable, completely identifiable. In terms of sensitivity, the Report notes that information that can be re-identified is somewhat more sensitive that completely anonymous data or anonymous data linked to pseudo-identities and that completely identifiable health information is the most sensitive type of health information. The Report also notes that there can be some degree of risk of re-identification of what was believed to be anonymous data through such processes as data matching and the results of analysis using small cells. In this light, the Report recommends: A definition of personal health information, which takes into account the spectrum of potential identifiability in the case of health information. Furthermore, in the case of secondary uses of health information, the Report notes that provisions regulating secondary uses of non-identifiable health information must form part of the legislation. Such provisions should address privacy concerns surrounding the degree to which data might be linked back to an identifiable individual. The Report raises further issues relating to the use of delinked and anonymous data. The Report notes that there may be group interests and concerns regarding data collected and states: Privacy can also be a concern for groups such as Aboriginal and immigrant communities. These communities worry that research on their members could be released to the media without notice and used in a negative way. This emerging issue is growing in importance and, in the Council’s view, should be a serious consideration in the context of ethical reviews of proposed research projects. It is important to note that in these instances it is not the fact that data is linked to an identifiable individual that is of concern. Rather, it is the ability to accumulate, process and dissect information that has ramifications for an individual because they are part of a group segregated and identified by the research. Finally, the Report considers the use of person-based data but not people’s names, for statistical purposes and notes that this too raises concerns about privacy. The Report notes that: “These concerns have traditionally been seen as a tradeoff against data access for research and analysis in the public interest.” The Report restates this to provide a more positive view of privacy and states: “the best way for analysts to maintain the public’s consent to use sensitive (but anonymous) health data is to show the public that privacy, confidentiality and security are being taken seriously.” Recommendation That there be a clear definition of the information being accorded a right of privacy and that this definition, at least in the case of health information, include identifiable information, delinked information, anonymous information and any composite form produced when information is linked to any information about a person from any other source. C. Knowledge of Purpose Prior to Collection Bill C-54 Bill C-54 is ambiguous in its provisions relating to whether or not a person should know the purposes for which information will be used prior to disclosure. This is due in part to the use of the term “knowledge and consent” as one concept rather than distinguishing the knowledge requirement from the consent requirement. What a person should know in relation to the purposes information might be used or disclosed for, prior to its being given is distinct conceptually from whether the person must consent before information can be used or disclosed for a particular purpose. Schedule 1 of the Bill contains a number of principles. For the purposes of this brief the schedule will be referred to in terms of the principles (and their subparagraphs). Principle 2 addresses the identification of purposes that information will be used or disclosed for. Provided a purpose is identified it becomes a legitimate purpose under the Bill. Subparagraph 3 states that the identified purposes should be specified at or before the time of collection. Section 5(2) of the Bill states that the use of ‘should’ in schedule 1 indicates a recommendation and does not impose an obligation. Therefore, according to subparagraph 3, it is recommended but is not obligatory that disclosure occur. On the other hand, principle 3 addresses consent and appears to impose an obligation by stating that the knowledge and consent of the individual are required for the collection, use, or disclosure of personal information, except where inappropriate. Similarly subparagraph 2 appears to create something of an obligation by stating, “organizations shall make a reasonable effort to ensure that the individual is advised of the purposes for which the information will be used.” The relationship between these sections should be clarified and made consistent. CMA is pleased to note that principle 3 has been modified to define when, and only when, organizations may collect information without knowledge or consent. Section 7(1)(a) permits the collection of information without knowledge and consent when collection is clearly in the interests of the individual and consent cannot be obtained. The intent of this section could be made clearer, particularly in terms of who determines the “interests of the individual.” Otherwise this exception could give undesirable license to collect without knowledge or consent. The provision in section 7(1)(b) is more problematic. This section appears to favour withholding knowledge from an individual if such knowledge would compromise accuracy, defeat the purpose for collection or prejudice the use. In some instances it may well be that if an individual is provided with knowledge of the purposes for which information is collected and the uses to which it will be put, they may choose to withhold information rather than disclose it, and in doing so would clearly compromise accuracy, defeat the purpose for collection or prejudice the use the information will be put to. This is contrary to the principle found in principle 4.1 which recognizes that information should not be collected by misleading or deceiving individuals. The intent of this section should be far clearer and circumscribed in such a way as to make it clear that it is not permissible to withhold knowledge or not seek consent simply on the basis that if a person had knowledge they would not wish to disclose information. Section 7(1)(c) allows collection without knowledge or consent for journalistic, artistic or literary purposes. This provision is totally inappropriate in the case of health information. CMA Health Information Privacy Code The CMA Code is considerably more restrictive that Bill C-54. It recognizes that in the therapeutic context, health information is confided by or collected from patients under the patient presumption that it is necessary to meet his or her therapeutic needs. CMA also believes that the potential that health information may be subsequently collected, used, disclosed or accessed for other purposes without patient consent should be made known to patients before information is confided or collected for the primary therapeutic purpose. CMA further notes that it is not acceptable to withhold knowledge from patients deliberately out of concern that knowledge could inhibit them from confiding important information fully and truthfully. CMA limits the circumstances the nonconsensual collection of health information to those: 1. Permitted or required by legislation; 2. When ordered or decided by a court of law. Moreover, the CMA gives explicit direction to legislators with respect to the conditions under which legislation should permit or require health information collection (see section 3.6 of CMA Code). In the case of nonconsensual collection, the following conditions are stipulated: 1. The right of privacy has to be violated because the purposes could not be met adequately if patient consent is required; and 2. The importance of the purposes must be demonstrated to justify the infringement of the patient’s right of privacy in a free and democratic society. While Bill C-54 is clearly enabling the collection of information, it does not, in CMA’s opinion put sufficient emphasis on or provide protections that preserve privacy and confidentiality, especially in the medical context. D. Use Without Knowledge Or Consent Bill C-54 Once information has been collected and despite the, albeit inadequate, limits placed on collection without knowledge or consent, it can be put to even greater use than the purposes it has been collected for with or without knowledge or consent. Section 7(2) opens up dramatically the uses to which collected information may be put without either knowledge or consent. At a minimum and without little additional administrative effort, the enumerated grounds of section 7(2) (and 7(3))should be made known to an individual prior to their disclosure of information, which would be in keeping with the principle of openness and explicitness. Section 7(2)(a) allows use in connection with the investigation of an offence. In the medical context this might be problematic particularly if it is interpreted to impose an obligation. Generally, there is no obligation to assist in the investigation of an offence and indeed the fiduciary duty between patient and physician and the duty of confidentiality owed to the patient by the physician would suggest that physicians not offer information despite its usefulness. Section 7(2)(b) recognizes emergency situations. However, as worded, section 7(2)(b) would allow access to anyone’s information if it is for the purpose of acting in respect of an emergency threatening the life, health or security of an individual. The implications of this section should be carefully thought through. Do we really intend to give such a broad licence to access anyone’s information on the basis of an emergency. In CMA’s view there should be some limiting principle that takes into account the prevailing view that people generally are not required to go to the assistance of others (emergency or otherwise) and that information about oneself is considered worthy of protection against use or disclosure despite its potential benefit to others for example, genetic information or HIV, Hepatitis C status. Section 7(2)(c) is very problematic as it permits the use of “identifiable” information for a host of purposes, including statistical and research, when it is impractical to seek consent. Even though the Commissioner must be informed of the use before the information is used the Commissioner has no power to approve or reject the use, and since the use is legitimate under the Bill provided the Commissioner has been notified there would be no grounds open to the Commissioner to cause an audit to occur. This section gives significant scope to use information that has been collected without knowledge or consent and certainly in the case of health information is problematic. CMA Health Information Privacy Code The CMA Code makes a clear distinction between the primary purpose for the collection and use of health information and secondary purposes for its use. The key distinction between these two categories is that primary purposes relates to the provision of the health care benefit sought whereas secondary purposes are ends or aims that are not directly related to the provision of care. The CMA Code divides secondary purposes into two categories: 1. Secondary legislated purposes, those purposes that have been subjected to the legislative test specified in the Code and have subsequently been written into law; 2. Secondary nonlegislated purposes are any other purposes, such as education or research not governed by legislation, that meet the provisions of the CMA Code and the secondary nonlegislative test provided by the Code. The tests that CMA requires both to go through relate to: 1. Impact on privacy. 2. Impact on the patient-physician relationship, especially confidentiality and trust. 3. Impact on the willingness of patients to disclose information. 4. Impact on patients’ ability to receive care. 5. Evidence of broad public support for the measure. 6. The use will not exploit or compromise the trust of the patient-physician relationship. 7. Patient vulnerability will not be exploited. 8. Under most circumstances patients will be fully informed of the purpose and patient consent will be clearly voluntary. 9. Patient privacy will be intruded upon to the most limited degree possible. 10. Linkage of health information will be restricted and consented to by patients. In other words, CMA is not satisfied that any and all secondary purposes for the use of health information should be permitted. Rather, CMA seeks justification for the secondary use and assurance that the secondary use will neither impede nor undermine the patient-physician relationship and the provision of health care to the patient. Moreover, the CMA Code only permits use without consent if it is permitted or required by legislation or when ordered or decided by a court of law. The Advisory Council Report Like CMA, the Advisory Council Report makes distinctions among various types of uses. The report calls for legislation to clearly prohibit all secondary commercial use of personal health information. In addition, the Report recommends that there be provisions regulating secondary uses of non-identifiable health information and that such provisions should address privacy concerns surrounding the degree to which such data might be linked back to an identifiable individual. In this context, the Report recommends that legislation set clear limits on access to and use of health information by third parties outside the health care system. In addition the Report reviews the uses of health information for statistical and research purposes. The Report’s findings with respect to statistical use have already been discussed. In connection with research, the Report calls for a number of safeguards and restrictions: 1. Where the data sets used have a higher level of potential identifiability, “the general rule should be informed consent and stringent assurances about privacy protection and security arrangements are necessary before a researcher can have access to personally identifiable information.” 2. The Report recognizes that in some instances it may be impractical to obtain consent from patients. Whether in anonymous or identifiable form the Report requires that notice be given about the use of the information in either form. In the case of the use of identifiable information, the Report states that the research should be subject to independent ethics review with the onus on the person seeking to use the information without consent to demonstrate that: (a) a tangible public good of significant benefit will result; (b) consent is impossible to secure at a reasonable cost; (c) less identifiable data will not serve the same purpose; and (d) no harm can occur to any person directly or indirectly [note the above discussion on group privacy] as a result of this use of his or her personal information. E. Disclosure Without Knowledge Or Consent Bill C-54 The comments found under C. and D. above apply equally here. Section 7(3) adds further instances when collected information can be disclosed to others without knowledge or consent. CMA Code In the case of health information CMA takes a far more restrictive approach. In the case of use, disclosure or access the CMA Code states: The potential that health information, in whole or in part, may be subsequently collected, used, disclosed or accessed for other purposes without their consent, and what those purposes might be, must be made know to the patient by reasonable means before it is confided or collected for primary purposes. Moreover, the CMA Code recognizes that information disclosed by one organization is collected by another. The Code defines collection to mean: the act of accessing, receiving, compiling, gathering, acquiring or obtaining health information from any source, including third parties, and by any means. It includes information collected from the patient, as well as secondary collection of this information in whole or in part by another provider or user. The collecting organization should be bound by the provisions of the CMA Code, which generally requires consent for use for any purpose and always requires knowledge of the potential purposes that information will or must be put to prior to the information being disclosed. CMA’s Code states: Health information custodians must ensure that third parties privy to health information have adopted this Code or are bound by equivalent provisions. Finally, the CMA Code explicitly recognizes that information can be retrieved from a variety of sources to formulate records. Any and all such practices and the composite form developed are given the same degree of protection as that accorded the original data collected by or through the patient. F. Information Flow Within Organizations Bill C-54 Bill C-54 defines use to include, “the transfer of personal information within an organization.” Therefore, to the extent that Bill C-54 restricts the free flow of information it restricts in within an organization. In the health care context this is not a reasonable or desirable outcome. CMA Code The CMA Code recognizes that the free flow of health information is desirable to the extent that it furthers the provision of the health care benefit sought and that it occurs with patient consent. The CMA Code defines the primary purpose to mean: (i) Primary therapeutic purpose is the initial reason for a patient seeking or receiving care in the therapeutic context, and pertains to the delivery of health care to a particular patient with respect to the presenting health need or problem. It encompasses consultation with and referral to other providers on a need-to-know basis. (ii) Primary longitudinal purpose concerns developing composite health information about a particular patient, such as a detailed medical history, beyond direct application to the presenting health need or problem, in order to enhance ongoing care to that person. The Code goes on to state that: Health information collection, use, disclosure or access for the primary therapeutic and longitudinal purposes may be as extensive as necessary to fulfil these purposes and reflect the high level of trustworthiness and accountability of health professionals in the therapeutic context. And further states that: Security safeguards shall impede as little as possible health information collection, use, access and disclosure for primary purposes. Finally, in addressing consent the Code states: Consent to health information collection, use, disclosure and access for the primary therapeutic purpose may be inferred. Consent to subsequent collection, use, disclosure and access on a need-to-know basis by or to other physicians or health providers for this purpose, and for this purpose alone, may be inferred, as long as there is no evidence that the patient would not give express consent to share the information. G. Individual Access Bill C-54 Bill C-54 restricts the right of individual access to personal information. The grounds for denying access to information are inappropriate in the health care context. CMA Code The CMA Code follows the prevailing case law as it relates to medical records. Primarily this gives the patients a right of access to their record in all but very limited circumstances. These circumstances are, if there is a significant likelihood of a substantial adverse effect on the physical, mental or emotional health of the patient or substantial harm to a third party. The onus lies on the provider to justify denial of access. H. Accuracy and Amendment Bill C-54 Bill C-54 requires that information be as accurate, complete and up-to-date as possible and that it shall not be routinely updated unless this is necessary to fulfil the purpose for its collection. In so far as amendment is concerned, Bill C-54 permits amendment to the record in specified circumstances. CMA Code The CMA Code takes a different approach in light of the nature and purpose of health information. The Code recognizes that the “recording of statements of fact, clinical judgements and determinations or assessments should reflect as nearly as possible what has been confided by the patient and what has been ascertained, hypothesized or determined to be true using professional judgement.” In terms of amending the record in light of a patient’s request, the CMA Code seeks to preserve the original record but also note the patient’s concerns. To accommodate both requirements the CMA Code states: Patients who have reviewed their information and believe it to be inaccurately recorded or false have the right to suggest amendments and to have their amendments appended to the health information. I. Sensitivity Bill C-54 In a number of instances Bill C-54 and in particular schedule 1 recognize that medical records have a high level of sensitivity attached. Which in turns warrants special attention concerning consent, reasonable expectations, individual access and implicity, the degree of security that is appropriate. CMA Code The CMA Code seeks to recognize that while all health information is sensitive (when considered against other forms of information about individuals) there are also variations in the level of sensitivity in various aspects of the health record. The CMA Code defines the “sensitivity of health information” to refer to: the patient’s interest in keeping the information secret. It varies according to the nature of the information, its form, and the potential negative repercussions of its collection, use or disclosure on the patient’s interests. Under the Code’s consent provisions it is stated that: Although all health information is sensitive and should be treated as such, the more sensitive the health information is likely to be, given what is known about the circumstances or preferences of the patient, the more important it is to ensure that consent is voluntary and informed. With respect to security the Code states: The development of security safeguards with respect to levels of access for various users shall recognize the differences in the sensitivity of health information and permit access accordingly. V. Conclusions The increased capacity to collect, store, transfer, merge and access information coupled with trends that support increased use of and access to information have the potential to erode our traditional understanding and protection of privacy and confidentiality. The issues are complex and the choices we must make are difficult. Nevertheless, these issues should be squarely on the table and the choices that we make must be clear, transparent and defensible. Of paramount importance is that the public is not mislead into believing that their information is being protected or kept confidential when in fact it is not. Therefore, even to refer to Bill C-54 as the “Personal Information Protection and Electronic Documents Act” should be the subject of debate. Is the Bill truly about information protection or is it actually about permitting access to information? Bill C-54 presents one approach, an approach that values commerce and access. In CMA’s view the approach is totally inadequate when applied to health information. CMA also believes that the public would also find Bill C-54 inadequate. CMA presents a different approach, an approach that values privacy and the preservation of the trust and integrity of the patient-physician relationship. CMA believes that its approach would receive broad public support. Moreover, CMA believes that to the extent the CMA Code presents tests rather than conclusions, these tests should be administered in good faith prior to legislative initiatives related to health information or in the case of secondary usage of health information in general. CMA believes that its approach draws support from the Federal Advisory Council Report, which also recognizes the importance of preserving patient privacy and the confidentiality of the health record in an era of increased use of technology. Implicitly, the Report recognizes that the benefits of such technology cannot be realized if public support, based on assurance of privacy protection, cannot be secured. CMA urges this committee to implement CMA’s recommendations and in doing so provide the type of protection that health information deserves and that Canadians desire. VI. Summary of Recommendations That Bill C-54 be amended to incorporate specific provisions relating to health information and that the provisions of the CMA Code provide the basis of such provisions; and That the proposed rules for health legislation be subject to the legislative test found in CMA’s Code and formulated in light of this process; and That there be a clear definition of the information being accorded a right of privacy and that this definition, at least in the case of health information, include identifiable information, delinked information, anonymous information and any composite form produced when information is linked to any information about a person from any other source; and That, at least in connection with health information, the provisions of the Bill apply equally to the public and the private sectors.
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Proposed Amendments to the Criminal Code of Canada (Impaired Driving) : Response to Issue Paper of the Standing Committee on Justice and Human Rights

https://policybase.cma.ca/en/permalink/policy1983
Last Reviewed
2018-03-03
Date
1999-03-05
Topics
Health care and patient safety
Population health/ health equity/ public health
  2 documents  
Policy Type
Parliamentary submission
Last Reviewed
2018-03-03
Date
1999-03-05
Topics
Health care and patient safety
Population health/ health equity/ public health
Text
The CMA believes that comprehensive long-term efforts that incorporate both deterrent legislation and public awareness and education constitute the most effective policy in attempting to reduce the number of lives lost and injuries suffered in crashes involving impaired drivers. The CMA supports a multidimensional approach to the issue. The CMA therefore recommends the following: * developing awareness campaigns and education programs, particularly at the high school level where the pattern of alcohol misuse is often established; * retaining the curative treatment provision found in Section 255(5) of the Criminal Code; * providing comprehensive treatment suited to the needs of the individual person. Those repeatedly convicted of impaired driving should be considered for mandatory assessment; * seizing or impounding the driver’s vehicle for the length of the license suspension if an individual is charged with impaired driving while his or her licence is suspended because of a previous impaired driving conviction; * lowering the legal BAC limit to 50 mg%; and * creating probationary licence systems for new drivers that would make it an offence to drive a motor vehicle during this probationary period with any measurable alcohol in the body. I. Introduction The Canadian Medical Association is the national voice of Canadian physicians. Our mission is to provide leadership for physicians and to promote the highest standard of health and health care for Canadians. The CMA is a voluntary professional organization representing the majority of Canada's physicians and comprising 12 provincial and territorial divisions and 43 affiliated medical organizations. On behalf of its 45,000 members and the Canadian public, CMA performs a wide variety of functions, including advocating health promotion and disease and accident prevention policies and strategies. It is in this capacity that we present our position on proposed amendments to the Criminal Code sections on impaired driving. The CMA welcomes this opportunity to comment on the issue of drinking and driving and the safety of our public roadways. The injuries and deaths resulting from impaired driving present a major public health concern. Physicians see the consequences of impaired driving in their practices. In 1996, 3,420 persons were killed in motor vehicle crashes. Alcohol was involved in 39.7% of those fatalitiesi. In CMA policy documents and publications like the Physicians’ Guide to Driver Examination, the CMA has advocated for measures to reduce injury and death resulting from drinking and driving. The CMA has previously endorsed legislation aimed at reducing the incidence of drinking and driving, including the use of the breathalyser test, more severe penalties for those convicted and the taking of a mandatory blood sample if the individual is unable to provide a breath sampleii. Several of CMA’s provincial and territorial divisions have also issued policy statements on impaired driving (Appendix 1). II. Multidimensional Approach From 1987 to 96, there was a general decline in the percentage of fatally injured drivers who had been drinkingiii. In 1996, of tested drivers fatally injured in motor vehicle crashes, 41.6% had been drinking (with a Blood Alcohol Content (BAC) over 1 mg%>) while 34.9% were legally impaired (BAC >80 mg%)iv. CMA believes that to reduce the number of fatalities and injuries even further, a comprehensive, multidimensional approach encompassing the expertise, resources and experience of health professionals and all levels of government is required. This approach encompasses: (1) public education, (2) medical assessment and treatment interventions and (3) legislation. 1. Public Education Drinking and driving must be viewed as socially unacceptable behaviour and until this change in attitude occurs, the judicial system cannot be completely effective in controlling the drinking and driving patterns of individuals. Education and information programs which increase society’s awareness of the consequences of using alcohol in combination with driving are integral parts of any attempt to reduce injuries and fatalities. The CMA supports and recommends the development of awareness campaigns and education programs, particularly at the high school level where the pattern of alcohol misuse is often established. 2. Medical Assessment and Treatment Interventions CMA shares the belief of specialists in the field of addiction medicine that punishment in the form of incarceration will not solve the problem of impaired drivingv. Rather, in addition to public education campaigns and criminal law sanctions, government must create and fund appropriate assessment and treatment interventions. Impaired drivers may be occasional users of alcohol. They may also suffer from the disease of Substance Dependence. In the case of alcohol, this disease is commonly known as alcoholism. There are several assessment tools and screening tests to diagnose chronic alcoholismvi. The term “Hard Core” drinking driver has also been coined to describe impaired drivers who repeatedly drive after drinking, often with a high BAC of 150 mg% or more. They are also resistant to change despite previous actions, treatment or education effortsvii. Although roadside surveys have revealed a general decrease in the overall level of drinking-driving in Canada, drivers with very high levels of BAC (over 150 mg%) seemed immune to this trendviii. “Hard Core” drinking drivers are most likely suffering from substance dependence or alcoholism, a condition requiring significant treatment interventionix. Physicians, in their educational capacity, can assist in establishing programs in the community aimed at the recognition of the early signs of alcohol abuse or dependency. These programs should recognize the chronic, relapsing nature of alcohol addiction as a disease. There is also good evidence that physician interactions like the Alcohol Risk Assessment and Intervention program developed by the College of Family Physicians of Canada can have a positive impact on the behaviours of moderate drinkersx. Another tool to aid physicians in the assessment of patients who drive impaired is the CMA publication, The Physicians’ Guide to Driver Examination. The Physicians’ Guide to Driver Examination is a collection of guidelines and expert opinions designed to help physicians assess their patients’ medical fitness to drive. The Physicians’ Guide discusses the impact of a variety of medical conditions on driving, including alcohol use, abuse and dependency. The Physicians’ Guide underlines the fact that alcohol-induced impairment is the single greatest contributor to fatal motor vehicle accidents in Canadaxi. The Physicians Guide to Driver Examination takes a strong stance on the status of drivers with chronic alcohol problems. It recommends that a chronic alcohol abuser should not be allowed to drive any type of motor vehicle until the patient has been assessed and received treatment. The Physicians' Guide to Driver Examination is currently under revision with an anticipated distribution date in the fall of 1999 for the sixth edition. (a) Discharge for Curative Treatment The Standing Committee on Justice and Human Rights has asked whether it is appropriate under Section 255(5) of the Criminal Code to allow the courts to discharge an impaired driver who is in need of “curative treatment” by placing that person on probation with a condition that he or she attends such treatment. Section 255(5) of the Criminal Code reads: Notwithstanding subsection 736(1), a court may, instead of convicting a person of an offence committed under section 253, after hearing medical or other evidence, if it considers that the person is in need of curative treatment in relation to his consumption of alcohol or drugs and that it would not be contrary to the public interest, by order direct that the person be discharged under section 730 on the conditions prescribed in a probation order, including a condition respecting the person’s attendance for curative treatment in relation to his consumption of alcohol or drugs. The CMA believes that Section 255(5) should remain within the Criminal Code. Section 255(5) is an important recognition within the punitive framework of the Criminal Code of the necessary medical and rehabilitative elements at stake in the issue of impaired driving. CMA believes that there are sufficient safeguards within the wording of Section 255(5) to conclude that it does not invite misuse. There are several hurdles to meet in Section 255(5) before the court may award curative treatment. First, the court hears “medical or other evidence”. In essence, the granting of the curative treatment order is not merely dependent on the pleas of the impaired driver. Second, the court must be satisfied that the discharge is not contrary to the public interest. In determining what is in the public interest, the courts look to the accused’s motivation and good faith, whether he or she was already subject to a driving prohibition, the risk of recidivism, previous convictions for impaired driving, prior curative discharges and the circumstances of the offence, including consideration of whether the accused was involved in an accident which caused death, bodily harm or significant property damagexii. Finally, it is highly unlikely that the “curative treatment” at issue in Section 255(5) would be involuntary or enforced against the wishes of the accused because his or her motivation or good will in pursuing treatment as an alternative to conviction is a key factor in the court’s decisionxiii. The CMA recommends retaining the curative treatment provision found in Section 255(5) of the Criminal Code. (b) Assessment and Rehabilitation Rehabilitation can occur through education and treatment programs designed for impaired drivers. The CMA believes it is important to provide comprehensive treatment suited to the needs of the individual person. The CMA recognizes that as an exception to the general rule that medical interventions should be voluntary, individuals repeatedly convicted of the offence of impaired driving should be considered for mandatory assessment. This mandatory assessment, followed by medical recommendations for appropriate treatment, would not only benefit those with a chronic alcohol problem but could also help to reduce the incidence of drunk driving incidents attributable to repeat offenders. Physicians have the training, knowledge and expertise to assist in developing alcohol assessment, treatment and rehabilitation programs. Currently, nine jurisdictions have some form of mandatory assessment and rehabilitation programsxiv. The CMA recommends providing comprehensive treatment suited to the needs of the individual person. Those repeatedly convicted of impaired driving should be considered for mandatory assessment. 3. Legislation (a) Impoundment On the issue of whether the current penalties provide sufficient deterrence, the CMA is in general agreement with the impoundment measures currently found in eight provincial and territorial jurisdictionsxv. CMA would encourage jurisdictions that do not have these impoundment programs to consider enacting them. Since 1989, the CMA has recommended that if an individual is charged with impaired driving while his or her licence is suspended because of a previous impaired driving conviction, the suspended driver’s vehicle should be seized or impounded for the length of the license suspension. (b) Blood Alcohol Content (BAC) In response to the question of whether the legal BAC limit should be lowered from 80 mg%, since 1988 the CMA has supported 50 mg% as the general legal limit. Studies suggest that a BAC limit of 50 mg% could translate into a 6% to 18% reduction in total motor vehicle fatalities or 185 to 555 fewer fatalities per year in Canadaxvi. A lower limit would recognize the significant detrimental effects on driving-related skills that occur below the current legal BACxvii. Finally, the CMA notes that many jurisdictions have 50 mg% as the limit for impairmentxviii. The CMA recommends lowering the legal BAC limit to 50 mg%. The CMA has also supported the 1987 recommendation of the former Standing Committee of National Health and Welfare on Alcohol and Drug Abuse in Canada that the provinces establish a probationary or graduated licence system for new drivers that would make it an offence to drive a motor vehicle during this probationary period with any measurable alcohol in the body. Several studies have remarked on the significant reduction in casualty collisions when there is a 0 BAC limit for novice drivers xix. The CMA notes that several provinces have instituted such a graduated licensing systemxx. The CMA supports probationary licence systems for new drivers that would make it an offence to drive a motor vehicle during this probationary period with any measurable alcohol in the body. (c) Police Powers On the issue of police powers to demand breath, blood or saliva samples for alcohol and/or blood testing, the CMA reiterates its earlier support for mandatory blood alcohol testing as outlined in the Criminal Code. At the request of CMA, physicians and other health care workers who take blood samples under this law are specifically protected from criminal and/or civil litigation, but it is not an offense for these health care workers to refuse to take a blood samplexxi. III. Conclusion The CMA believes that comprehensive long-term efforts that incorporate both deterrent legislation and public awareness and education campaigns constitute the most effective policy in attempting to reduce the number of lives lost and injuries suffered in crashes involving impaired drivers. It is prefererable to use countermeasures that prevent the occurrence of motor vehicle crashes involving impaired drivers rather than those that deal with the offender after the fact. The multifaceted nature of the issue of impaired driving requires multidimensional countermeasures as part of a comprehensive policy involving all levels of government, private organizations, communities and individuals. The CMA urges all Canadians to support such efforts to reduce the prevalence of drinking and driving. IV. Appendix 1 A List of Some Policy Statements and Resolutions on Impaired Driving from CMA Provincial and Territorial Divisions: * Alberta Medical Association, 1983: That the AMA recommend to the Government of Alberta that it take whatever steps are necessary to ensure that there are adequate penalties for impaired driving and that such penalties are well enforced. * New Brunswick Medical Society: February, 1988.“Statement on Driving Impairment” October, 1992. “NBMS Position Statement on Alcohol” * Northwest Territories Medical Association: Endorsed June, 1998. “Strategy to Reduce Impaired Driving in the Northwest Territories: Interagency Working Group on Impaired Driving. June, 1996.” * Ontario Medical Association: November, 1994. “An OMA Position Paper on Drinking and Driving”. V. Endnotes i.Traffic Injury Research Foundation (TIRF) (1998).Strategy to Reduce Impaired Driving 2001: STRID 2001 Monitoring Report: Progress in 1996 and 1997. Ottawa: Traffic Injury Research Foundation at 25, 28. ii.Canadian Medical Association (1989). Substance Abuse and Driving: A CMA Review. Ottawa: Canadian Medical Association at 3. 3. Mayhew, D.R., S.W. Brown and H.M. Simpson. (1998) Alcohol Use Among Drivers and Pedestrians Fatally Injured in Motor Vehicle Accidents: Canada, 1996. Ottawa: Traffic Injury Research Foundation at 19. iv.Ibid at 13-14. v. Hajela, Raju CD, MD, MPH, CCFP, CASAM, FASAM, President of the Canadian Society of Addiction Medicine. Letter to CMA dated January 13, 1999. vi.American Psychiatric Association (1994). Diagnostic and Statistical Manual of Mental Disorders, DSM-IV. Washington, D.C.: American Psychiatric Press. vii. Beirness, D.J., H.M. Simpson, and D.R. Mayhew (1998). Programs and policies for reducing alcohol-related motor vehicle deaths and injuries. Contemporary Drug Problems 25/Fall 1998. See also the Century Council (1998) National Hardcore Drunk Driver Project. http://www.dwidata.org. viii. Beirness, D.J., Mayhew, D.R., Simpson, H.M. and Stewart, D.E. (1995) Roadside surveys in Canada: 1974-1993. In Kloeden, C.N. and McLean, A.J. (eds). Alcohol, Drugs and Traffic Safety-T’95.Adelaide, Australia:NHMRC Road Accident Research Unit, University of Adelaide, pp. 179-184 as cited in Mann, Robert E., Scott Macdonald, Gina Stoduto, Abdul Shaikh and Susan Bondy (1998) Assessing the Potential Impact of Lowering the Blood Alcohol Limit to 50 MG % in Canada. Ottawa: Transport Canada, TP 13321 E at 14-15. ix. Hajela, note 5 at 2. x. Brison, Robert J., MD (1997). The Accidental Patient. Canadian Medical Association Journal, 157 (12) 1661-1662. xi. Canadian Medical Association (1991).Physicians' Guide to Driver Examination. Ottawa: Canadian Medical Association at 51. xii. R v. Storr (1995), 14 M.V.R. (3d) 34 (Alta. C.A.). xiii. Ibid. xiv.Traffic Injury Research Foundation (TIRF), note 1 at 12. xv.Ibid. xvi. Mann et al., note 8 at 54. xvii. Moskowitz, H. and Robinson, C.D. (1988). Effects of Low Doses of Alcohol on Driving Skills: A Review of the Evidence. Washington, DC: National Highway Traffic Safety Administration, DOT-HS-800-599 as cited in Mann, et al., note 8 at page 12-13. xviii.Mann et al., note 8 at 24. xix.Hingson, R., Heeren, T. and Winter, M. (1994) Lower legal blood alcohol limits for young drivers. Public Health Reports, 109, 738-744 as cited in Mann et al., note 8 at 36. xx.Mann et al., note 8 at 29. xxi.Canadian Medical Association, note 2 at 3.
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Putting Patients First : Comments on Bill C 6 (Personal Information Protection and Electronic Documents Act) : Submission to the Senate Standing Committee on Social Affairs, Science and Technology

https://policybase.cma.ca/en/permalink/policy1979
Last Reviewed
2019-03-03
Date
1999-11-25
Topics
Ethics and medical professionalism
Health care and patient safety
Health information and e-health
  2 documents  
Policy Type
Parliamentary submission
Last Reviewed
2019-03-03
Date
1999-11-25
Topics
Ethics and medical professionalism
Health care and patient safety
Health information and e-health
Text
CMA commends the federal government for taking this important first step that begins the debate on privacy and the protection of personal information. The issues are complex and the interests at stake significant. CMA welcomes the opportunity to provide comments on Bill C-6 and hopes that its input will strengthen the Bill by ensuring that patient privacy and the confidentiality of medical records are adequately protected. CMA’s chief concern with Bill C-6 is the inadequacy of its provisions to protect the right of privacy of patients and the confidentiality of their health information. The right of privacy encompasses both the right to keep information about ourselves to ourselves if we so choose and to exercise control over what subsequently happens to information we confide in trust for the purpose of receiving health care. In recent years, this right, and the ability of physicians to guarantee meaningful confidentiality, have becoming increasingly threatened. Computerization of health information facilitates easy transfer, duplication, linkage and centralization of health information. Captured in electronic form, patient information is potentially more useful for the purpose of providing care. However, thus captured, it also becomes much more valuable and technically accessible to various third parties -- private and public, governmental and commercial -- wishing to use this information for other purposes unrelated to providing direct care. An additional concern is that the demand for health information, referred to by some commentators as ‘data lust’, is growing, partly as a consequence of ‘information hungry’ policy trends such as population health. There is also a disturbing tendency toward ‘function creep’, whereby information collected for one purpose is used for another, often without consent or even knowledge of the individual concerned and without public knowledge or scrutiny. Furthermore, initiatives concerning health information technology tend to be dominated by those who seek access to this information for secondary purposes. From this perspective, privacy may appear less as a fundamental right than as a hindrance or even roadblock. As we move further into the information age there is some danger that we will become so spell-bound by the promise of information centralization and database linkages that we lose sight of the patients who confided this information or reduce them to impersonal ‘data subjects’. To avoid this danger and the allure of the technology we need to ground the application of information technology and practices in well-tested, enduring principles. We need to put privacy first rather than treat it as a nuisance or impediment. Rules and regulatory regimes concerning health information should be based on the principle of patient privacy because ultimately health information technology is not about ‘bits and bytes’ or ‘data’ or even ‘data subjects’ but about patients, and patients deserve to be treated with respect and dignity and to have their wishes and choices valued and respected. If we are to put patients first the right of privacy must be given primacy in rules concerning health information. This does not mean that this right is absolute. What it does mean is that the burden of proof must rest with those whose purposes, however compelling they may be, encroach upon the right of privacy. It means that we value patient privacy at least enough to demand explicit justification of any proposal that would diminish privacy. Bill C-6 begins with the right premise: that “rules to govern information collection, use and disclosure” should recognize the “right of privacy”. However, it fails to recognize the special nature of health information and to tailor its provisions accordingly. In consequence there is confusion and uncertainty about Bill C-6's application to health care. Even more seriously, however, Bill C-6 fails to recognize that health information requires stronger or greater privacy protection than other types of information. The inadequacy of Bill C-6 for health care is not surprising because clearly it was not drafted with health information in mind. Rather, it is written from the perspective of encouraging commerce. It appears to have access to information as its dominant value. The world of health care is very different from that of commerce and consequently requires distinct rules that are more protective of privacy. Confiding information to your physician under the trust of the patient-physician relationship is not on par with giving your address to a salesclerk when you purchase a toaster or rent a movie. Health information is special by nature. Canadians know this. In a recent Angus Reid poll commissioned by CMA Canadians told us loudly and clearly that they regard their health information as especially sensitive. However, the obvious sensitivity of health information is not the only thing that makes it special and in virtue of which it warrants distinct rules to strengthen privacy protection. It is important to recognize that this information is typically collected under the trust patients vest in their physicians. Patients confide their information for the purpose of receiving care and in the expectation that it will be held in the strictest confidence. This purpose, and the preservation of this trust, should be given primacy in rules concerning health information. It is also important to recognize that the trust under which patients confide in their physicians is fundamental to the patient-physician relationship. If patients can not trust their physicians to protect their information and keep it secret they will not confide it as freely as they do. In consequence, the ability of physicians to provide the care needed would be severely diminished. Rules relating to health information must be developed in recognition of its special nature and the circumstances of trust and vulnerability in which it is initially collected or confided. Patients confide in their physicians for the purpose of receiving care. The potential that the information thus confided may subsequently be used for other purposes must not impede the therapeutic purpose or diminish the trust and integrity of the patient-physician relationship. In recent years the secondary use of information for purposes other than those for which it was collected has been increasing without adequate oversight or public knowledge. This ‘function creep’ undermines the trust of patient-physician relationship. Collection and use beyond the therapeutic context and for purposes unrelated to the provision of direct care should be subjected to rigorous scrutiny before they are permitted to occur. To the extent that they are permitted to occur without patient consent they should be explicitly authorized in legislation to ensure transparency and adequate oversight. Putting patients first means ensuring that health information, in all but exceptional and justifiable circumstances, is used only under the strict control of the patient. The patient must be able to exercise control through voluntary, informed consent. Moreover, a distinction must be made between a patient’s right to know what can or must happen to health information and the right to consent to such use. Bill C-6 permits the collection, use and disclosure of information without knowledge or consent on grounds such as expediency, practicality, public good, research, offence investigation, historic importance and artistic purpose. The laxness and breadth of these exemptions as applied to health information is unacceptable. These uses, without the patient’s consent (or even knowledge), reduce the patient to a means to someone else’s end, however worthwhile that end may be. Moreover, the absence of consent (or even knowledge) undermines the integrity of the patient-physician relationship and has the potential to erode the trust patients have in their physicians - a trust that is essential to patients’ willingness to provide the complete information needed to provide them with care. CMA has developed and adopted a Health Information Privacy Code (Appendix A) in recognition of the special nature of health information and to give primacy to patients and to the right of privacy. This Code begins from the same starting point as Bill C-6, the Canadian Standards Association (CSA) Code which the Bill includes as Schedule 1. However, unlike Bill C-6, the CMA Code tailors the CSA Code to the specific circumstances of health information. The CMA Health Information Privacy Code, therefore, is able to address issues specific to health information that Bill C-6 either fails to address or, even worse, exacerbates. In light of the clear deficits in Bill C-6 and the inadequate protection of patient privacy and health information confidentiality, CMA urges this committee to accept the recommendations put forward in this brief to strengthen the Bill’s provisions for protecting privacy and to accept the amendment (Appendix B) CMA has prepared to give effect to these recommendations. CMA believes that Canadians desire and deserve no less than this as concerns the right of privacy with respect to health information. I. Introduction The Canadian Medical Association is the national voice of Canadian physicians. Our mission is to provide leadership for physicians and to promote the highest standard of health and health care for Canadians. The CMA is a voluntary professional organization representing the majority of Canada's physicians and comprising 12 provincial and territorial divisions and 43 affiliated medical organizations. On behalf of its 46,000 members and the Canadian public, CMA performs a wide variety of functions, including addressing the emerging issue of electronic health information and confidentiality and privacy. It is in this capacity that we present our position on Bill C 6, The Personal Information Protection and Electronic Documents Act. CMA commends the federal government for taking this important first step of beginning the debate on privacy and the protection of personal information. The issues are complex and the interests at stake significant. CMA welcomes the opportunity to provide comments on Bill C-6 and hopes that its input will strengthen the Bill by ensuring that patient privacy and the confidentiality of medical records are adequately protected. In preparing this brief CMA has had the benefit of the final report of the federal Advisory Council on Health Infostructure, Canada Health Infoway: Paths to Better Health: Final Report. (“Advisory Council Report”) Where appropriate, CMA cites the findings contained in the Report. CMA wishes to underscore the key themes of its brief: A. Health information is special by its nature. Rules relating to health information must be developed in recognition of its special nature. Ensuring protection of privacy and confidentiality of the patient record must take precedence over other considerations. Bill C-6 fails to do this. Bill C-6 is written from the perspective of encouraging commerce. It appears to have access to information as its dominant value. The world of health care is very different from that of commerce and consequently requires distinct rules. B. Typically, health information is confided in the context of the therapeutic relationship and under the trust upon which this relationship is built. Rules concerning health information -- and in particular its collection, disclosure and use for purposes unrelated to the provision of direct care -- must be consistent with the expectations of patients about confidentiality and must not exploit the trust patients have in their physicians or compromise the ability of physicians to earn and maintain this trust. C. Health information must, in all but exceptional and justifiable circumstances, be used only under the strict control of the patient. The patient must be able to exercise control through voluntary, informed consent. Moreover, a distinction must be made between a patient’s right to know what can or must happen to health information and the right to consent to such use. Bill C-6 permits the collection, use and disclosure of information without knowledge or consent on grounds such as expediency, practicality, public good, research, offence investigation, historic importance and artistic purpose. The laxness and breadth of these exemptions as applied to health information is unacceptable. These uses, without the patient’s consent (or even knowledge), reduce the patient to a means to someone else’s end, however worthwhile that end may be. Moreover, the absence of consent (or even knowledge) undermines the integrity of the patient-physician relationship and has the potential to erode the trust patients have in their physicians - a trust that is essential to patients’ willingness to provide the complete information needed to provide them with care. D. The root of most of the problems in applying Bill C-6 to health care information is its failure to distinguish among purposes for the collection, use and disclosure of health information. In particular, the Bill fails to distinguish between the primary purpose, which is to deliver care to and for the benefit of an individual patient, and secondary purposes, which are not for the direct benefit of the patient (and indeed may even use the patient’s information to his or her detriment). Provisions to protect privacy should give recognition to the difference between these purposes and should not hinder the ability of physicians and others to provide care consistent with the patient’s wishes. Moreover, the Bill has no effective mechanism to distinguish legitimate purposes, which should be permitted, from illegitimate purposes, which should not, notwithstanding the limitation to “purposes that a reasonable person would consider are appropriate in the circumstances” in Section 5(3). E. In recent years the secondary use of information for purposes other than the purpose for which it was collected has been increasing without adequate oversight or public knowledge. This ‘function creep’ undermines the trust of patient-physician relationship. Collection and use beyond the therapeutic context and for purposes unrelated to the provision of direct care should be subjected to rigorous scrutiny before they are permitted to occur. To the extent that they are permitted to occur without patient consent they should be explicitly authorized in legislation to ensure transparency and adequate oversight. This Brief will first look at the apparent rationale of Bill C-6 and its potential application to health information. The brief will then describe why CMA considers health information to be special in nature and worthy of special protection. Finally, the brief reviews the difference in approach between Bill C-6 and CMA’s Health Information Privacy Code to illustrate that Bill C-6 provides inadequate protection to patient privacy and medical confidentiality. II. Rationale and Scope of Bill C-6 A. Rationale of Bill C-6 The driving force behind Bill C-6 is the support and promotion of electronic commerce. The second part of the Bill is devoted to permitting electronic versions of documents and signatures to be legitimate or ‘originals’ if the provisions of the Act are followed. Part 2 of the Bill is quite distinct from Part 2 and both parts could stand alone as separate pieces of legislation. Part 2 simply allows electronic versions of documents and signatures to be recognized as legitimate. On its face, this has little to do with the protection of personal information except to the extent that storage of documents in electronic form provides greater ability to access, link and merge information. Certainly, the Bill appears to draw on this connection by including, in its statement of purpose, the provision of a right of privacy in an era in which technology increasingly facilitates the collection and free flow of information. Part 1 concerns all forms of personal information, electronic and otherwise. It gives some protection to personal information by requiring consent in some instances. In CMA’s view, a fundamental difficulty with Part 1 and with the Bill in general is that its goal is to promote commerce and thus all information is implicitly considered as falling within the ‘commercial’ realm. In the case of health information this is surely not the case or the only consideration. Moreover, this creates a clash of values when applied to a health care system that is a public system. The Advisory Council Report takes a firm stand on this issue and states that legislation respecting the privacy protection of health information, “should also contain a clear prohibition against all secondary commercial use of personal health information.”Moreover, Bill C-6 fails to distinguish and priorize different purposes for collecting, using and disclosing information and in doing so treats all purposes as more or less equal and subject to the same rules. CMA takes a quite a different view when it comes to health information and will expound its view throughout this brief. B. Scope - Application to Health Records CMA has argued from the outset that C 6 (and its predecessor C 54) will apply to some health information. This view now appears to be widely accepted. Nevertheless, it is unclear as to what extent Bill C 6 will apply to health records. The full name of the Act states, in part: An Act to support and promote electronic commerce by protecting personal information that is collected, used or disclosed in certain circumstances . . . . What are these circumstances? Section 4(1) states that Part 1 (the part protecting personal information) applies in respect of personal information that: (a) the organization collects, uses or discloses in the course of commercial activities; or (b) is about an employee of the organization and that the organization collects, uses or discloses in connection with the operation of a federal work, undertaking or business. The definition of commercial activity given in 2(1) that commercial activity Ameans any particular transaction, act or conduct or any regular course of conduct that is of a commercial character@ is circular and does nothing to clarify uncertainties concerning the Bill’s scope. There are two points to be made here as concerns the application of this Bill to health information. The first concerns clarity around where commercial ends and health care begins. Which health care settings that operate for profit are excluded from the Act? This question speaks to the difficulty of delineating what activity is considered health care and what activity is considered commercial. Moreover the increase in public/private partnerships and joint funding of endeavours within the health care sector, which the government appears to be promoting, may make it increasingly difficult to make this distinction; for example in the area of research. The second concerns the specification of different regimes for information protection and privacy rights, depending on whether the information is deemed to come under commercial activity. This is clearly not desirable. However, the solution to this problem is not to reduce the privacy rules for all health information to the lowest common denominator but to raise them to a higher level of protection than is afforded commercially acquired information. Subjecting all health information to the regime laid out in the CMA Health Information Privacy Code would achieve this objective. In preparing this brief CMA has assumed that the Bill will provide a scheme that applies to at least some health information. Three years after it is in force it will apply equally to activities that occur strictly within the provinces, unless there is legislation in the province that is substantially similar to the Bill (see sections 27(2)(b) and 30). No doubt the extent of the federal government’s ability to legislate in this area generally will be the subject of extensive debate. However, CMA has no comment on this debate and provides its opinion in the interests of ensuring that the rules that relate to health information are compatible with preserving the integrity of the patient physician relationship and the protection of patient privacy and health information confidentiality. The federal government has an opportunity to provide Canadians with strong privacy rights in health information. It is incumbent upon the government to do so. C. Scope - Government Excluded Bill C-6 expressly excludes a large part of government activity from its ambit. Although government activity is to some extent governed by the Privacy Act, R.S.C. 1985, P-21, the rules of this Act provide less protection than those of Bill C-6. Government should subject itself to at least the same rules that it requires of the private sector in so far as it is a collector and user of information. Indeed, government’s practices relating to the collection, storage, merging, transfer and use of health information should be subject to more stringent rules than those found in either the Privacy Act or Bill C-6. The Advisory Council Report also calls for the same rules to apply to the public and private sectors, rules that are more stringent than those found in the Privacy Act or Bill C-6. Therefore, CMA recommends: That, at least in connection with health information, the provisions of the Bill apply equally to the public and the private sectors. III. Considerations Regarding Patient Privacy and Confidentiality: Medical Context Versus Commercial Context A. CMA’s Position The world of health care is very different from that of commerce and consequently requires distinct rules that are more protective of privacy. Confiding information to your physician under the trust of the patient-physician relationship is not on par with giving your address to a salesclerk when you purchase a toaster or rent a movie. Health information is special by nature. Canadians know this. In a recent Angus Reid poll commissioned by CMA Canadians told us loudly and clearly that they regard their health information as especially sensitive. However, the obvious sensitivity of health information is not the only thing that makes it special and in virtue of which it warrants distinct rules to strengthen privacy protection. It is important to recognize that this information is typically collected under the trust patients vest in their physicians. Patients confide their information for the purpose of receiving care and in the expectation that it will be held in the strictest confidence. This purpose, and the preservation of this trust, should be given primacy in rules concerning health information It is also important to recognize that the trust under which patients confide in their physicians is fundamental to the patient-physician relationship. If patients could not trust their physicians to protect their information and keep it secret they would not confide it as freely as they do. In consequence, the ability of physicians to provide the care needed would be severely diminished. Rules relating to health information must be developed in recognition of its special nature and the circumstances of trust and vulnerability in which it is initially collected or confided. Patients confide in their physicians for the purpose of receiving care. The potential that the information thus confided may subsequently be used for other purposes must not impede the therapeutic purpose or diminish the trust and integrity of the patient-physician relationship. In recent years the secondary use of information for purposes other than those for which it was collected has been increasing without adequate oversight or public knowledge. This ‘function creep’ undermines the trust of patient-physician relationship. Collection and use beyond the therapeutic context and for purposes unrelated to the provision of direct care should be subjected to rigorous scrutiny before they are permitted to occur. To the extent that they are permitted to occur without patient consent they should be explicitly authorized in legislation to ensure transparency and adequate oversight. Putting patients first means ensuring that health information, in all but exceptional and justifiable circumstances, is used only under the strict control of the patient. The patient must be able to exercise control through voluntary, informed consent. Moreover, a distinction must be made between a patient’s right to know what can or must happen to health information and the right to consent to such use. Bill C-6 permits the collection, use and disclosure of information without knowledge or consent on grounds such as expediency, practicality, public good, research, offence investigation, historic importance and artistic purpose. The laxness and breadth of these exemptions as applied to health information is unacceptable. These uses, without the patient’s consent (or even knowledge), reduce the patient to a means to someone else’s end, however worthwhile that end may be. Moreover, the absence of consent (or even knowledge) undermines the integrity of the patient-physician relationship and has the potential to erode the trust patients have in their physicians - a trust that is essential to patients’ willingness to provide the complete information needed to provide them with care. CMA has developed and adopted a Health Information Privacy Code (Appendix A) in recognition of the special nature of health information and to give primacy to patients and to the right of privacy. In commenting on this Code the Advisory Council Report notes: The Code represents an important contribution to the deliberations of Canadians and legislators on how to safeguard privacy across the health domain. In his 1998-99 Annual Report, the Federal Privacy Commissioner writes in support of the Health Information Privacy Code: Legislators looking for guidance on health information privacy law need not re-invent the wheel; the Canadian Medical Association’s Health Information Privacy Code is a comprehensive benchmark for achieving a high national level of protection for personal information. The Code could be the basis for drafting legislation. Given the grumblings that the Code sets the bar too high, perhaps some Health Infoway funds should be used to study the impact of its implementation. The patients at the heart of this system deserve no less. There are several key principles that guided the development of the Health Information Privacy Code and upon which it is based: 1. The provision of health care to all Canadians irrespective of social circumstances or health status is a highly regarded value in Canadian society. The system is publicly funded and universally accessible. 2. The right of privacy is fundamental to a free and democratic society. 3. Rules relating to health information must recognize its special nature. Health information has a high level of sensitivity and is confided or collected in circumstances of vulnerability and trust for the primary purpose of benefiting the patient. 4. The hallmark of the medical profession since the time of Hippocrates has been the willingness and ability to hold information confided secret. 5. The patient-physician relationship is one of trust. A central feature of this trust is the belief of patients that information confided in or collected by physicians and other health care providers will be kept secret. 6. Patients believe that the information they disclose or that is gathered as a result of their seeking health care will be used to provide them with health care. Use beyond the provision of health care without knowledge or consent goes beyond what a patient’s reasonable expectations were when information was confided or collected and therefore is a breach of the trust patients place in their physicians. 7. Except in very limited circumstances, consent is required for health information collection, use, disclosure or access for any purpose. 8. Information required to provide patients with the health care sought should be readily available to those who require it to provide an aspect of care as consistent with the wishes of the patient. 9. Uses of health information for purposes other than the provision of health care to the person seeking care should be subject to rules that: - protect and promote privacy and confidentiality; - generally require express consent; - can be justified according to specific criteria. 10. Patients should know the uses to which their health information may be put prior to disclosing it. 11. Patients may be reluctant to disclose information if they are concerned about the uses to which the information is put or the persons entitled to access it. B. Public Opinion To determine the public’s views on issues concerning privacy and health information, CMA commissioned Angus Reid to conduct research in two forms, quantitative (survey) and qualitative (focus groups), and has found the following: 1. Canadians believe that health information is the most sensitive type of information, and indeed more sensitive than their financial information. 1. 2. Canadians believe that their health information will be kept confidential and consider this to be important. 3. Canadians believe it important to know and control how their health information is shared with others. 4. Canadians do not want their health information released to third parties (including governments and researchers) without their knowledge and consent. 5. Canadians have concerns about the release of delinked or anonymous information to third parties without their consent. 6. Some Canadians are reluctant to confide information to their physicians due to concerns about it subsequently being disclosed to others without their consent. 7. Patients believe that privacy rules should apply equally to the public and the private sector. These findings are consistent with the published literature and other findings relating to the public’s concerns about privacy and confidentiality. The CMA Health Information Privacy Code was developed in consideration of these views. Once developed, its principles were subsequently tested with the public in a series of cross-country focus groups and it was found that the Code appears to enjoy considerable public support. C. The Advisory Council Report The Advisory Council Report relates to the electronic health record. However, given the direction towards the greater use of technology and the underlying principles informing the Advisory Council, its recommendations are generalizable to all health information. A key principle of the Advisory Council Report is that access by health care professionals should be based on a need-to-know basis under the strict control of the patient. The Council, like CMA, calls for scrutiny and justification of secondary uses of health information. The Council is opposed to the use of multipurpose identifiers on the grounds that it becomes too easy for government officials from one department to gain access to a person’s health record or to combine a number of records to assemble a comprehensive profile. (Anecdotal evidence suggests that this concern may be justified and that there are insufficient safeguards preventing the flow of health information among government departments.) The Council recommends that all governments ensure that they have legislation to address privacy protection specifically aimed at protecting personal health information through explicit and transparent mechanisms. Included in these mechanisms are: * The provision of a precise definition of free and informed consent, as well as a statement of principle that informed consent should be the basis for sharing personal health information; * Any exemption to the requirement of informed consent should be clearly set out in law. More specifically, legislative guidance should be provided on how to balance the right of privacy with the public good for research purposes to implement a coherent and harmonized pan-Canadian system for independent, ethical review. * There should be provisions regulating secondary uses of non-identifiable health information. These provisions should address privacy concerns surrounding the degree to which data might be linked back to an identifiable individual. * Legislation should set clear limits on access to and use of health information by third parties outside the health care system. To prevent the serious invasions of privacy that can result from the unrestricted linking of personal health information with other kinds of information on the same individual, the legislation should contain provisions prohibiting the use for any other purpose of unique personal identifiers in health information systems. D. The Approach in Bill C-6 Bill C-6 begins with the right premise: that “rules to govern information collection, use and disclosure” should recognize the “right of privacy”. However, it fails to recognize the special nature of health information and to tailor its provisions accordingly. In consequence, there is confusion and uncertainty about Bill C-6's application to health care. Even more seriously, however, Bill C-6 fails to recognize that health information requires stronger or greater privacy protection than other types of information. The Bill makes a cursory attempt at distinguishing among varying types of personal information and gives inadequate additional protection to information that is highly sensitive (such as health information), notwithstanding the provisions in Paragraph 4.3.4 of Schedule 1 concerning consent which do provide some latitude for more stringent requirements in the case of sensitive information. The Bill permits the collection, use and disclosure of information without knowledge or consent on grounds such as expediency, practicality, public good, research, offence investigation, historic importance and artistic purposes. In the context of health information, these grounds should be subject to intense scrutiny to determine their relevance and legitimacy. Some of these grounds would not withstand scrutiny if subjected to the tests established in the CMA’s Health Information Privacy Code. E. Conclusion CMA believes that health information is special and deserves a higher level of privacy protection than other types of information. The Advisory Council Report also recognizes that distinct rules, more protective of privacy, are required for health information. The Council’s Report places strong emphasis on the protection of privacy, recognizes that, as a general rule, the flow of health information should be on a need-to-know basis and under the control of the patient through the exercise of free and informed consent, and requires limits on the secondary use of health information. The inadequacy of Bill C-6 for health care is not surprising because clearly it was not drafted with health information in mind. Rather, it is written from the perspective of encouraging commerce. It appears to have access to information as its dominant value. However, the world of health care is very different from that of commerce and distinct rules that are more protective of privacy. The CMA Health Information Privacy Code begins from the same starting point as Bill C-6, the Canadian Standards Association (CSA) Code which the Bill includes as Schedule 1. However, unlike Bill C-6, the CMA Code tailors the CSA Code to the specific circumstances of health information. The CMA Health Information Privacy Code, therefore, is able to address issues specific to health information that Bill C-6 either fails to address or, even worse, creates. It offers a template for the protection that should be specifically accorded to the right of privacy in health information, a template that appears to have considerable public support and is designed to uphold patient confidence in their physicians and the health care system. Amending Bill C-6 to incorporate the principles in the CMA Code would ensure adequate privacy protection. CMA recommends: That Bill C-6 be amended to incorporate specific provisions relating to health information and that the provisions of the CMA Health Information Privacy Code provide the basis of such provisions. CMA developed the Health Information Privacy Code in recognition of trends and developments that pose new threats to patient privacy and the trust of the therapeutic relationship. In recent years the secondary use of information for purposes other than the purposes for which it was collected has been increasing without adequate oversight or public knowledge. This ‘function creep’ undermines the trust of patient-physician relationship. Collection and use beyond the therapeutic context and for purposes unrelated to the provision of direct care should be subjected to rigorous scrutiny before they are permitted to occur. To the extent that they are permitted to occur without patient consent they should be explicitly authorized in legislation to ensure transparency and adequate oversight. CMA’s Health Information Privacy Code provides a test to which legislation addressing health information should be subjected. This test (found in section 3.6 of the CMA Code) states: Any proposed or existing legislation or regulation made under legislative authority that permits or requires health information collection, use, disclosure or access shall be subjected to the following legislative test: (a) There must be demonstration that: (i) a patient privacy impact assessment has been conducted, the analysis has been made public and has been duly considered prior to the introduction of legislation [section 3.5 of the Code provides guidance with respect to the patient privacy impact assessment]; (ii) collection, use, disclosure and access will be limited to the greatest degree possible to ensure that * the collection of health information by persons external to the therapeutic context will neither trade on nor compromise the trust of the patient-physician relationship; * patients are not likely to be inhibited from confiding information for primary purposes; * the ability of physicians to discharge their fiduciary duties to patients will not be compromised; and, * patient vulnerability will not be exploited; (iii) collection, use, disclosure and access will be restricted to what is necessary for the identified purpose(s) and will not impede the confiding or collection of information for primary purposes; (iv) provisions exist for ensuring that patients are provided with knowledge about the purpose(s) and that, subject to 3.6(b), patient consent is clearly voluntary; (v) the means used are proportionate and the collection will be limited to purposes consented to or made known to the patient; (vi) the patient’s privacy will be intruded upon to the most limited degree possible in light of the purpose(s) consented to or made known to the patient; (vii) linkage of the health information will be limited; and (viii) unless clear and compelling reasons exist: * all reasonable steps will be taken to make health information anonymous; and * if it has been demonstrated that making health information anonymous would render it inadequate for legitimate uses, the information will be collected and stored in a deidentified-relinkable format. (b) When nonconsensual collection, use, disclosure or access is permitted or required by legislation or regulation that meets the requirements of the Code, the following conditions must also be met: (i) the right of privacy has to be violated because the purpose(s) could not be met adequately if patient consent is required; and (ii) the importance of the purpose(s) must be demonstrated to justify the infringement of the patient’s right of privacy in a free and democratic society. (c) Any legislative provision or regulation that permits or requires health information collection, use, disclosure or access nonconsensually shall not, without compelling reasons, be applied retroactively to existing health information. In its current form, Bill C-6 would not pass the scrutiny of the test. Consequently, CMA recommends: That the proposed rules for health legislation be subject to the legislative test found in CMA’s Health Information Privacy Code and formulated in light of this process. IV. Specific Comments on Bill C-6 From the Perspective of CMA’s Health Information Privacy Code This section highlights some key distinctions between the approach taken by Bill C-6 and CMA’s Health Information Privacy Code. It uses examples to illustrate divergent approaches taken for the purpose of demonstrating that Bill C-6 is inadequate in the protection it accords health information and to show how the CMA Health Information Privacy Code would address the issues adequately. A. General Bill C-6 and CMA’s Health Information Privacy Code are based on the Canadian Standards Association’s Model Code for the Protection of Personal Information (CSA Code). Bill C-6 and the CMA Code also augment the CSA Code’s provisions where considered necessary. The need to extend the provisions of the CSA Code demonstrates that the CSA Code, being general in nature, provides inadequate protection to information in many instances. The CSA recognized this at the time it developed its Code and specifically issued additional, specific guidance for health information in the form of an appendix to the Workbook for applying the Code. The Workbook begins: Information regarding one’s health and health records may be among the most sensitive of all personal data. Individuals are concerned that inappropriate disclosure of such information could unduly affect their employment status or their lives in general. . . Some health information is obtained directly from health care providers who have been given a patient’s private information with the expectation that this information will remain as a private communication. Health care providers . . . in turn, feel that such concerns could influence individuals to withhold vital information or avoid treatment to ensure their private information remains as such. Implementation of privacy procedures that adhere to the principles in the CSA Code and rigid applications of such procedures are essential steps for organizations that require access to health information, to maintain an individual’s trust that sensitive personal information remains confidential. In designing and implementing such procedures, organizations should recognize the sensitive nature of such information and also the fact that the primary reason that health care providers maintain records is to ensure that safe and efficacious care is provided. The Workbook goes on to list 7 interpretative points to augment the CSA Code, providing additional privacy protection as it applies to health information, including the following: requirements for the individual’s knowledge and consent be rigidly followed. Consent to acquire and disclose health information should be undertaken with the individual’s full knowledge of the scope of information to be requested. Bill C-6 does not include these additional interpretive points. It does not give due recognition that health information, because of its high sensitivity, deserves even stronger protection than is provided in the CSA Code as appended in Schedule 1 of the Bill (which even the Committee that drafted the CSA Code recognized). Although Bill C-6 and the CMA Code are based on the CSA Code, each takes a different approach to the ultimate protection accorded information and to the right of privacy. This divergence demonstrates that there are many ways to resolve issues left unresolved by the CSA Code. In other words, it is not a foregone conclusion that basing provisions on the CSA Code will result in appropriate or adequate protection of information. Rather, resolution of issues requires thought and deliberation and will depend in some measure on the primacy given to certain values. Bill C-6 appears to have given access primacy in the pursuit of commerce, whereas CMA gives privacy protection primacy in the pursuit of the provision of health care in accordance with physicians’ fiduciary obligations to patients and the integrity of the patient-physician relationship. CMA did not develop its approach in a vacuum. It reviewed, and was inspired by, the report of the House of Commons Standing Committee on Human Rights and the Status of Persons with Disabilities, entitled Privacy: Where Do We Draw the Line? This report articulates and makes explicit many of the issues that should be informing the current debate on Bill C-6. In addition, the Report of the Advisory Council takes a very different approach than Bill C-6. The Report recognizes the need to pay more than lip service to protecting privacy and confidentiality and recommends specific measures aimed at doing this. B. Primacy of the Therapeutic Purpose The root of most of the problems in applying Bill C-6 to health care is its failure to distinguish among purposes for the collection, use and disclosure of health information. In particular, the Bill fails to distinguish between the primary purpose, which is to deliver care to and for the benefit of an individual patient, and secondary purposes, which are not for the direct benefit of the patient and indeed may even involve using the patient’s information to his or her detriment. Under Bill C-6, the same rules apply equally to both the primary and to secondary purposes. In other sectors this failure to distinguish different purposes and to fashion rules in light of salient differences may not pose problems. In the health care sector, however, the consequences could be quite serious. As applied to secondary purposes, the provisions in Bill C-6 fail to limit access appropriately. Access to information may occur in ways that are inappropriate and violate the privacy of patients. As applied to the primary purpose -- the use of a person`s information to provide that person with care -- the rules in the Bill, if rigidly construed, may inhibit access that would otherwise be appropriate and consistent with the patient`s right of privacy. For example, the consent provisions in the Bill could create impediments to information flow where various members of a ‘health care team’ require information about the patient in order to be effective for the patient’s benefit; the provisions in the Bill that seek to limit the extent of information collection could inhibit physicians from being as extensive as they sometimes are and should be in collecting information from patients for the purpose of providing care; the provisions in the Bill requiring that the patient`s request to review his or her record be in writing could in fact be a barrier to patient access which might otherwise be facilitated informally and consistently with the patient`s wishes by a simple verbal request. Such consequences no doubt would be unintended by the drafters of the Bill; the drafters might even argue that for someone to interpret the provisions mentioned above as potentially leading to these consequences would be to misinterpret them. Regardless, the fact is that the Bill, on these matters and others, is somewhat strained when its provisions are applied to health care. The CMA Health Information Privacy Code, however, is not. It begins from the same starting point as Bill C-6, which is the CSA Code. However, the CMA, recognizing (as the drafters of the CSA Code apparently also did) that the CSA Code would need to be tailored to deal adequately with health information, did so in drafting its Health Information Privacy Code. This document was written from the ground up not just with privacy first and foremost as a value but also with specific reference to the health sector. And it is based on the fundamental premise that not all purposes for the use of health care are equal and that the therapeutic purpose must be given primacy. Thus the CMA Health Information Privacy Code avoids the kind of problems identified above that might arise as Bill C-6 is applied to health information. For example, it specifies that the collection of health information for the primary purpose of providing care “may be as extensive as necessary to fulfil these purposes and reflect the high level of trustworthiness and accountability of health professionals in the therapeutic context” (3.2) but that for any secondary purposes it should be “as minimal as necessary in recognition of the need to protect the patient’s right of privacy in the therapeutic context” (3.3.). As concerns consent, which CMA recognizes to be core to the protection of privacy, the CMA Code articulates rules for consent in recognition of the importance of timely information flow in the team context and as appropriate to meet the purpose for which the patient has confided the information in the first place, which is to receive care. It stipulates that consent for the primary purpose may therefore be implied, albeit with certain qualifications. Moreover, where consent is required, the provisions of the Code allow that “the conveyance of generic information is a reasonable means of providing knowledge” in most circumstances, which means that this requirement is unlikely to create unreasonable burdens that would diminish rather than strengthen the therapeutic relationship. Finally, the CMA Code limits itself to issues of principle concerning patient access to their records; Bill C-6, by specifying that requests must be in writing, could in fact be creating a barrier to patient access or an undue burden upon the patient-physician relationship as there may be instances when an informal request would be quite appropriate. C. Knowledge of Purpose Prior to Collection Bill C-6 Bill C-6 is ambiguous in its provisions relating to whether or not a person should know the purposes for which information will be used prior to disclosure. This is due in part to the use of the term “knowledge and consent” as one concept rather than distinguishing the knowledge requirement from the consent requirement. What a person should know in relation to the purposes for which information might be used or disclosed, prior to its being given, is distinct conceptually from whether the person must consent before information can be used or disclosed for a particular purpose. Schedule 1 of the Bill contains a number of principles. For the purposes of this Brief the schedule will be referred to in terms of the principles (and their subparagraphs). Principle 2 addresses the identification of purposes for which information will be used or disclosed. Provided a purpose is identified it becomes a legitimate purpose (this Brief recognizes that the addition of the “reasonable person” clause in 5(3) takes precedence and provides some grounds for distinguishing legitimate and illegitimate purposes). Subparagraph 3 states that the identified purposes should be specified at or before the time of collection. Section 5(2) of the Bill states that the use of ‘should’ in schedule 1 indicates a recommendation and does not impose an obligation. Therefore, according to subparagraph 3, it is recommended but is not obligatory that disclosure occur. On the other hand, principle 3 addresses consent and appears to impose an obligation by stating that the knowledge and consent of the individual are required for the collection, use, or disclosure of personal information, except where inappropriate. Similarly subparagraph 2 appears to create something of an obligation by stating, “organizations shall make a reasonable effort to ensure that the individual is advised of the purposes for which the information will be used.” Section 7(1)(a) permits the collection of information without knowledge and consent when collection is clearly in the interests of the individual and consent cannot be obtained. The intent of this section could be made clearer, particularly in terms of who determines the “interests of the individual.” Otherwise this exception could give undesirable licence to collect without knowledge or consent. The provision in section 7(1)(b) is more problematic. This section appears to favour withholding knowledge from an individual if such knowledge would compromise accuracy, defeat the purpose for collection or prejudice the use. In some instances it may well be that, if an individual is provided with knowledge of the purposes for which information is collected and the uses to which it will be put, he or she may choose to withhold information rather than disclose it, and in doing so would clearly compromise accuracy, defeat the purpose for collection or prejudice the use to which the information will be put. This is contrary to principle 4.4.2, which recognizes that information should not be collected by misleading or deceiving individuals. The intent of this section should be far clearer and circumscribed in such a way as to make it clear that it is not permissible to withhold knowledge or not seek consent simply on the basis that if a person had knowledge they would not wish to disclose information. Section 7(1)(c) allows collection without knowledge or consent for journalistic, artistic or literary purposes. This provision is totally inappropriate in the case of health information. CMA Health Information Privacy Code The CMA Health Information Privacy Code is considerably more restrictive that Bill C-6. It recognizes that, in the therapeutic context, health information is confided or collected under the patient’s presumption that it is necessary to meet his or her therapeutic needs. The potential that health information may be subsequently collected, used, disclosed or accessed for other purposes without patient consent should be made known to patients before information is confided or collected for the primary therapeutic purpose. Moreover, it is not acceptable to withhold knowledge from patients deliberately out of concern that knowledge could inhibit them from confiding important information fully and truthfully. The CMA Health Information Privacy Code limits the nonconsensual collection of health information to circumstances where it is either permitted or required by legislation or ordered or decided by a court of law. In addition, the CMA Code gives explicit direction to legislators with respect to the conditions under which legislation should permit or require health information collection (see section 3.6 of CMA Code). In the case of nonconsensual collection, the following conditions are stipulated: 1. The right of privacy has to be violated because the purposes could not be met adequately if patient consent is required; and 2. The importance of the purposes must be demonstrated to justify the infringement of the patient’s right of privacy in a free and democratic society. D. Use Without Knowledge Or Consent Bill C-6 Once information has been collected and despite the limits, inadequate though they be, placed on collection without knowledge or consent, it can be put to even greater use than for the purposes for which it has been collected (with or without knowledge or consent). Section 7(2) opens up dramatically the uses to which collected information may be put without either knowledge or consent. At a minimum, and with little additional administrative effort, the enumerated grounds of section 7(2) (and 7(3) should be made known to an individual prior to their disclosure of information, which would be in keeping with the principle of openness and explicitness. Section 7(2)(a) allows use in connection with the investigation of an offence. In the medical context this could be problematic, particularly if it is interpreted to impose an obligation. Generally, there is no obligation to assist in the investigation of an offence, and indeed the fiduciary duty between patient and physician and the duty of confidentiality owed to the patient by the physician would suggest that physicians not offer information, despite its usefulness. Section 7(2)(b) recognizes emergency situations. However, as worded, section 7(2)(b) would allow access to anyone’s information if it is for the purpose of acting in an emergency threatening the life, health or security of an individual. The implications of this section should be carefully thought through. It is not desirable to give such a broad licence to access anyone’s information on the basis of an emergency. There should be some limiting principle that takes into account the prevailing view that people generally are not required to go to the assistance of others (emergency or otherwise) and that information about oneself is considered worthy of protection against use or disclosure, despite its potential benefit to others (for example, genetic information or HIV or Hepatitis C status). Section 7(2)(c) is very problematic as it permits the use of “identifiable” information for a host of purposes, including statistical and research, when it is impractical to seek consent. Even though the Commissioner must be informed of the use before the information is used the Commissioner has no power to approve or reject the use. If the use is legitimate under the Bill there would be no grounds open to the Commissioner to cause an audit to occur. This section gives significant scope for the secondary use of information that has been collected without knowledge or consent; in the case of health information it is very problematic. CMA Health Information Privacy Code The CMA Code makes a clear distinction between the primary purpose for the collection and use of health information and secondary purposes for its use. The key distinction between these two categories is that primary purposes relates to the provision of the health care benefit sought whereas secondary purposes are ends or aims that are not directly related to the provision of care. The CMA Code divides secondary purposes into two categories: 1. Secondary legislated purposes are those purposes that have been subjected to the legislative test specified in the Code and have subsequently been written into law; 2. Secondary nonlegislated purposes are any other purposes, such as education or research not governed by legislation, that meet the provisions of the CMA Code and the secondary nonlegislative test provided by the Code. The tests that the CMA Code requires of both relate to: 1. Impact on privacy. 2. Impact on the patient-physician relationship, especially confidentiality and trust. 3. Impact on the willingness of patients to disclose information. 4. Impact on patients’ ability to receive care. 5. Evidence of broad public support for the measure. 6. The use will not exploit or compromise the trust of the patient-physician relationship. 7. Patient vulnerability will not be exploited. 8. Under most circumstances patients will be fully informed of the purpose and patient consent will be clearly voluntary. 9. Patient privacy will be intruded upon to the most limited degree possible. 10. Linkage of health information will be restricted and consented to by patients. In other words, the CMA Code does not permit any and all secondary purposes for the use of health information. Rather, it requires justification for the secondary use and assurance that the secondary use will neither impede nor undermine the patient-physician relationship and the provision of health care to the patient. This test is much more privacy protective than the “reasonable person” test the Bill contains in Section 5(3). Moreover, the CMA Code only permits use without consent if it is permitted or required by legislation or when ordered or decided by a court of law. The Advisory Council Report Like the CMA, the Advisory Council Report makes distinctions among various types of uses. The Report calls for legislation to clearly prohibit all secondary commercial use of personal health information (in which respect the Advisory Council takes an even stronger position than the CMA). In addition, the Report recommends that there be provisions regulating secondary uses of non-identifiable health information and that such provisions should address privacy concerns surrounding the degree to which such data might be linked back to an identifiable individual. In this context, the Report recommends that legislation set clear limits on access to and use of health information by third parties outside the health care system. In addition the Report reviews the uses of health information for statistical and research purposes. In connection with research, the Report calls for a number of safeguards and restrictions: 1. Where the data sets used have a higher level of potential identifiability, “the general rule should be informed consent and stringent assurances about privacy protection and security arrangements are necessary before a researcher can have access to personally identifiable information.” 2. The Report recognizes that in some instances it may be impractical to obtain consent from patients. Whether in anonymous or identifiable form, the Report requires that notice be given about the use of the information. In the case of the use of identifiable information, the Report states that the research should be subject to independent ethics review with the onus on the person seeking to use the information without consent to demonstrate that: (a) a tangible public good of significant benefit will result; (b) consent is impossible to secure at a reasonable cost; (c) less identifiable data will not serve the same purpose; and (d) no harm can occur to any person directly or indirectly as a result of this use of his or her personal information. E. Disclosure Without Knowledge Or Consent Bill C-6 The comments found under C. and D. above apply equally here. Section 7(3) adds further instances when collected information can be disclosed to others without knowledge or consent. CMA Health Information Privacy Code In the case of secondary use of health information, the CMA Code takes a far more restrictive approach. As concerns use, disclosure or access, it states: The potential that health information, in whole or in part, may be subsequently collected, used, disclosed or accessed for other purposes without their consent, and what those purposes might be, must be made known to the patient by reasonable means before it is confided or collected for primary purposes. Moreover, the CMA Code recognizes that information disclosed by one organization is collected by another. The Code defines collection to mean: the act of accessing, receiving, compiling, gathering, acquiring or obtaining health information from any source, including third parties, and by any means. It includes information collected from the patient, as well as secondary collection of this information in whole or in part by another provider or user. The collecting organization should be bound by the provisions of the CMA Code, which generally requires consent for use for any purpose and always requires knowledge of the potential purposes that information will or must be put to prior to the information being disclosed. CMA’s Code states: Health information custodians must ensure that third parties privy to health information have adopted this Code or are bound by equivalent provisions. Finally, the CMA Code explicitly recognizes that information can be retrieved from a variety of sources to formulate records. Any and all such practices and the composite form developed are given the same degree of protection as that accorded information collected directly from the patient. F. Consent Bill C-6 In those cases where consent for collection, use or disclosure are required, the provisions in Bill C-6 are inadequate as applied to health care. Schedule 1 distinguishes between express and implied consent. Express consent is not adequately defined and it appears that this is not equivalent to what in health care is called ‘informed consent’. For example, Principle 4.3.2. says that “organizations shall make a reasonable effort to ensure that the individual is advised of the purposes for which the information will be used”. In the health care context, the notion of ‘reasonableness’ with respect to the doctrine of informed consent applies not to the effort to advise or inform (that much is assumed or given) but rather to determinations regarding what information should be provided to the patient. In addition, the application of some of the means described in Principle 4.3.7 by which individuals can give consent, and in particular the ‘negative option’ checkoff box in (b), may be quite problematic in the health care context. The broad scope allowed to implied consent in the Bill is also worrisome as applied to the health care setting. Principle 4.3.6 says “implied consent would generally be appropriate when the information is less sensitive”. However, with implied consent the issue is not the sensitivity of the information but rather the wishes of the patient. It is appropriate to infer consent even when the information is very sensitive provided one has reason to believe this is grounded in the patients wishes; conversely, it is not appropriate to infer consent, even in the case of information deemed not to be sensitive, if there is reason to believe the patient would object if asked explicitly. CMA Health Information Privacy Code The CMA Code furnishes clear definitions for consent: “Consent” means a patient’s informed and voluntary agreement to confide or permit access to or the collection, use or disclosure of his or her health information for specific purposes. For purposes other than the provision of direct care, which is the purpose for which the patient presents in the first place, the consent must always be explicit or express since there is no logical connection between secondary purposes and the desire to achieve care. Therefore inferences cannot be made with any confidence. The Code defines express consent as follows: “Express consent” is given explicitly, either orally or in writing. Express consent is unequivocal and does not require any inference on the part of the provider seeking consent. The CMA Code defines implied consent to disallow the loose use of the term, which is increasing today, to justify access for purposes (secondary purposes in particular) that the patient may not wish to occur: Implied consent arises where agreement may reasonably be inferred from the action or inaction of the individual and there is good reason to believe that the patient has knowledge relevant to this agreement and would give express consent were it sought. The CMA Code also lays out clear rules for the use of the concept of consent and makes clear that consent can be inferred for primary purposes (i.e., the provision of health care to the patient) but not for secondary ones, which require express consent. The Code grounds the notion of implied consent not in the desire to subvert express consent and thereby gain access to information that might otherwise be denied but rather in the wishes of the patient and the importance of providing health care for therapeutic purposes as consistent with those wishes. Advisory Council Report In addition to being more stringent than Bill C-6 about exemptions to consent, the Advisory Council Report also gives greater importance to defining the term clearly and strictly. It says that any legislation concerning health information should: contain a precise definition of free and informed consent, as well as a statement of principle that informed consent should be the basis for sharing personal health information. Although not as precise and emphatic on the subject of consent as is the CMA Health Information Privacy Code, the Report is certainly more so than is Bill C-6. G. Information Flow Within Organizations Bill C-6 Bill C-54 defined use to include “the transfer of personal information within an organization.” Bill C-6 no longer defines use, which leaves it uncertain whether the definition of use quoted above from Bill C-54 would be a reasonable interpretation of Bill C-6. If so, this would create a problem. Interpreting use in this way could have the effect of inappropriately restricting the free flow of information within an organization. In the health care context this is not a reasonable or desirable outcome and would hinder, rather than promotes, the patient’s right of privacy. CMA Code The CMA Code recognizes that the free flow of health information is desirable to the extent that it furthers the provision of the health care benefit sought and that it occurs with patient consent. The Code defines the primary purpose to mean: (i) Primary therapeutic purpose is the initial reason for a patient seeking or receiving care in the therapeutic context, and pertains to the delivery of health care to a particular patient with respect to the presenting health need or problem. It encompasses consultation with and referral to other providers on a need-to-know basis. (ii) Primary longitudinal purpose concerns developing composite health information about a particular patient, such as a detailed medical history, beyond direct application to the presenting health need or problem, in order to enhance ongoing care to that person. The Code goes on to state that: Health information collection, use, disclosure or access for the primary therapeutic and longitudinal purposes may be as extensive as necessary to fulfil these purposes and reflect the high level of trustworthiness and accountability of health professionals in the therapeutic context. And further states that: Security safeguards shall impede as little as possible health information collection, use, access and disclosure for primary purposes. Finally, in addressing consent the Code states: Consent to health information collection, use, disclosure and access for the primary therapeutic purpose may be inferred. Consent to subsequent collection, use, disclosure and access on a need-to-know basis by or to other physicians or health providers for this purpose, and for this purpose alone, may be inferred, as long as there is no evidence that the patient would not give express consent to share the information. The principles in the CMA Code that give effect to the patient’s right to control what happens to his or her information are not incompatible with the free flow of information among members of a health team for the purpose of providing care to the patient. Indeed, they facilitate and enable this flow to the extent this is in keeping with the patient’s wishes. H. Information Protected Bill C-6 The Bill covers “personal information” which is defined to mean “information about an identifiable individual, but does not include the name, title or business address or telephone number of an employee of an oganization.” This definition raises a host of questions: 1. Does the Bill cover information that has been delinked to an identifiable individual but that could be relinked to identify them? 2. Does the Bill only exclude anonymous information - that is, information that could never be relinked to an identifiable individual? And if so, is there an unjustified assumption that information can, in all cases, be rendered truly anonymous? 3. In the case of delinked and anonymous information, who decides that information about an identifiable individual can be rendered delinked or anonymous? The holder of the information or the person to whom the information pertains? 4. Is it accurate or reasonable to assume that people have no interest in information emanating from them once it has been rendered delinked or anonymous? 5. Given that anonymous information is generated from personal information, is the act or process rendering personal information into anonymous form considered a use under the terms of the Bill, and if so does this use require consent? In considering these questions, it is important to keep in mind that the concept of “anonymity” means different things to different people. Moreover, there are no generally used or accepted standards that address what is required to render identifiable information truly anonymous. As a consequence, different people use different standards (of varying degrees of rigour), if they use a standard at all. It is also important to note that, in virtue of sophisticated techniques for identifying individuals from supposedly anonymous information, there is debate about the extent to which true anonymity can ever be achieved or guaranteed. CMA Health Information Privacy Code In light of issues concerning the definition of ‘personal information’ and in the interest of ensuring a thorough scrutiny of information practices, the CMA Code provides a broad definition of health information: Health information means any information about a patient that is confided or collected in the therapeutic context, including information created or generated from this information and information that is not directly or indirectly linked to the provision of health care. It includes all information formats. The CMA Code covers identifiable information, delinked information, anonymous information and any composite form that is produced when health information is linked to other information about the patient. CMA’s research indicates that patients have an interest in their information even when it is in delinked and in anonymous formats. This view has recently received support from a decision of the High Court of Justice in England that is particularly relevant in the context of the commercial use of health information (Source Informatics Ltd. v. Department of Health). The issue arose because a prescription database company sought judicial review of a Department of Health policy document that advised National Health Service GPs and pharmacists not to sell “anonymous” prescribing or dispensing information. The document contained the following analysis: Anonymisation (with or without aggregation) does not, in our view, remove the duty of confidence towards the patients who are the subject of the data. Apart from the risk of identification of a patient despite anonymisation, the patient would not have entrusted the information to the GP or the pharmacist for it to be provided to the data company. The patient would not be aware of or have consented to the information being given to the data company, but would have given it to be used in connection with his care and treatment and wider NHS purposes. Anonymisation of the data (with or without aggregation) would not obviate a breach of confidence. . . .The duty of confidence may in some circumstances be outweighed by the public interest in disclosure. However we have severe reservations that disclosure by GPs or NHS pharmacists of dispensing information to X or other data companies would be argued to be in the public interest. Indeed it might well be contrary to the public interest if the data company is further selling the information on doctors prescribing habits to the pharmaceutical industry. High Court Justice Latham upheld the policy document, arguing that the information in question, though anonymous, was nonetheless confidential. He also argued that consent to its release was necessary and could not be implied, and that the breach of confidentiality involved in selling this information could not be justified as being in the public interest: In my view, it is impossible to escape the logic . . . that the proposal involves the unauthorised use by the pharmacist of confidential information. . . . In my judgement what is proposed will result in a clear breach of confidence unless the patient gives consent, which is not part of the proposal at present. Nor is it suggested that the patient can be said to have given implied consent. . . . I recognize that, for some, the sensitivity, as they see would see it, of the information may be such that they would feel that any use of the information without their consent, would be unconscionable. In other words it would be a breach of trust which they were reposing in the pharmacist. . . I have come to the conclusion that . . . this [is] a type of situation . . . in which there is a public interest in ensuring that confidences are kept. It is important that those who require medical assistance should not be inhibited in any way from seeking or obtaining. As I have indicated, I believe that there may be some patients who will feel very strongly that the pharmacist should not give any information obtained from the prescription without their consent. In view of the fact that there is a growing industry in so-called anonymous health information, it is important to ensure that this information is protected as consistent with the duties of health care providers and the expectation patients have that their providers will keep their information confidential. Advisory Council Report The Advisory Council Report addresses this issue in a number of ways. In making recommendations concerning the definition of health information, the Report calls for legislation that embodies: a clear definition of health information, broad enough to incorporate health information collected in public and private systems and to ensure that equal obligations and penalties apply to both public and private sectors. The Report recognizes a spectrum of data formats: completely anonymous, linked to pseudo-identities, code linked and reidentifiable, completely identifiable. In terms of sensitivity, the Report notes that information that can be re-identified is somewhat more sensitive than completely anonymous data or anonymous data linked to pseudo-identities and that completely identifiable health information is the most sensitive type of health information. The Report also notes that there can be some degree of risk of re-identification of what was believed to be anonymous data through such processes as data matching and the results of analysis using small cells. In this light, the Report recommends that legislation should recognize: A definition of personal health information, which takes into account the spectrum of potential identifiability in the case of health information. Furthermore, in the case of secondary uses of health information, the Report notes that provisions regulating secondary uses of non-identifiable health information must form part of any comprehensive legislation. Such provisions should address privacy concerns surrounding the degree to which data might be linked back to an identifiable individual. The Report raises further issues relating to the use of delinked and anonymous data. The Report notes that there may be group interests and concerns regarding data collected and states: Privacy can also be a concern for groups such as Aboriginal and immigrant communities. These communities worry that research on their members could be released to the media without notice and used in a negative way. This emerging issue is growing in importance and, in the Council’s view, should be a serious consideration in the context of ethical reviews of proposed research projects. It is important to note that, in these instances, it is not the fact that data is linked to an identifiable individual that is of concern. Rather, it is the ability to accumulate, process and dissect information that has ramifications for an individual because they are part of a group segregated and identified by the research. Finally, the Report considers the use of person-oriented data (data linked to individuals in a form where personal identifiers have been replaced by a code) for statistical purposes and notes that this too raises concerns about privacy. The Report notes that: “These concerns have traditionally been seen as a tradeoff against data access for research and analysis in the public interest.” The Report restates this to provide a more positive view of privacy and states: the best way for analysts to maintain the public’s consent to use sensitive (but anonymous) health data is to show the public that privacy, confidentiality and security are being taken seriously. In view of the issues concerning the definition of personal information and in the interest of ensuring maximum scrutiny of practices concerning health information and maximum protection of the right of privacy with respect to health information, CMA recommends: That there be a clear definition of the information being accorded a right of privacy and that this definition, at least in the case of health information, include identifiable information, delinked information, anonymous information and any composite information produced when health information is linked to any information about a person from any other source. I. Individual Access Bill C-6 Bill C-6 restricts the right of individual access to personal information. The grounds for denying access to information are inappropriate in the health care context. CMA Code The CMA Code follows the prevailing case law as it relates to medical records. Primarily this gives patients a right of access to their record in all but very limited circumstances. These circumstances are when there is a significant likelihood of a substantial adverse effect on the physical, mental or emotional health of the patient or substantial harm to a third party. The onus lies on the provider to justify denial of access on these grounds. J. Accuracy and Amendment Bill C-6 Bill C-6 requires that information be as accurate, complete and up-to-date as possible and that it shall not be routinely updated unless this is necessary to fulfil the purpose for its collection. In so far as amendment is concerned, Bill C-6 permits amendment to the record in specified circumstances. CMA Code The CMA Code takes a different approach in light of the nature and purpose of health information. The Code recognizes that the recording of statements of fact, clinical judgements and determinations or assessments should reflect as nearly as possible what has been confided by the patient and what has been ascertained, hypothesized or determined to be true using professional judgement. In terms of amending the record in light of a patient’s request, the CMA Code seeks to preserve the original record but also provide for noting the patient’s concerns. To accommodate both requirements the CMA Code states: Patients who have reviewed their information and believe it to be inaccurately recorded or false have the right to suggest amendments and to have their amendments appended to the health information. K. Sensitivity Bill C-6 Schedule 1 recognizes that medical records have a high level of sensitivity attached. For this reason this information may warrant special attention concerning consent, reasonable expectations, individual access and the degree of security that is appropriate. CMA Code The CMA Code recognizes that, even as all health information is sensitive (when considered against other forms of information about individuals), there are also variations in the level of sensitivity in various aspects of the health record. The CMA Code defines the “sensitivity of health information” to refer to: the patient’s interest in keeping the information secret. It varies according to the nature of the information, its form, and the potential negative repercussions of its collection, use or disclosure on the patient’s interests. Under the Code’s consent provisions it is stated that: Although all health information is sensitive and should be treated as such, the more sensitive the health information is likely to be, given what is known about the circumstances or preferences of the patient, the more important it is to ensure that consent is voluntary and informed. With respect to security the Code states: The development of security safeguards with respect to levels of access for various users shall recognize the differences in the sensitivity of health information and permit access accordingly. Moreover, the Code recognizes that health information is special and therefore requires distinct rules that afford stronger privacy protection not just due to its sensitivity but also to the circumstances of vulnerability and trust under which it is initially confided or collected. These special circumstnaces, which include much more than sensitivity, are outlined in Principle 2 of the Code. Bill C-6, by contrast, fails to consider these other features that make health information a special case. In consequence its provisions are not adquately tailored to the special nature of health information and do not accord it the strong privacy protection it warrants. V. Conclusions The increased capacity to collect, store, transfer, merge and access information, coupled with trends that support increased use of and access to information, have the potential to erode our traditional understanding and protection of privacy and confidentiality. The issues are complex and the choices we must make are difficult. Nevertheless, these issues should be squarely on the table and the choices that we make must be clear, transparent and defensible. Of paramount importance is that the public is not mislead into believing that their information is being protected or kept confidential when in fact it is not. Therefore, even to refer to Bill C-6 as the “Personal Information Protection and Electronic Documents Act” should be the subject of debate. Is the Bill truly about information protection or is it actually about permitting access to information? The approach to rules for information in Bill C-6 is directed toward commerce and appears to have access, and not privacy, as its dominant value, notwithstanding the Bill’s reference to a “right of privacy”. In CMA’s view, the Bill’s approach is inadequate when applied to health information. Based on the evidence, it seems highly likely that the public would also find Bill C-6 inadequate. Bill C-6 was not developed with health information in mind. In consequence there is confusion and uncertainty about its application to the health care context. Even more seriously, however, Bill C-6 fails to recognize that privacy with respect to health information requires stronger or greater protection than other types of information. CMA presents a different approach, an approach that recognizes the special nature of health information; an approach that puts patients first and values privacy and the preservation of the trust and integrity of the patient-physician relationship. This approach appears to be well-grounded in the values that Canadians hold about privacy and would likely enjoy broad public support. In addition, the CMA approach draws support from the Federal Advisory Council Report, which like CMA recognizes the importance of preserving patient privacy and the confidentiality of the health record in an era of increased use of technology. Implicitly, the Report recognizes that the benefits of such technology cannot be realized if public support, based on respect for privacy, cannot be secured. The CMA’s Health Information Privacy Code does what Bill C-6 fails to do. Amending Bill C-6 to incorporate the principles in the CMA Code would ensure adequate privacy protection. In light of the clear deficits in Bill C-6 and the inadequate protection of patient privacy and health information confidentiality, CMA urges this Committee to accept its recommendations and the amendment that incorporates them. Nothing less would give Canadians the high level of privacy protection they desire and deserve when it comes to their health information. VI. Summary of Recommendations That Bill C-6 be amended to incorporate specific provisions relating to health information and that the provisions of the CMA Health Information Privacy Code provide the basis of such provisions; and That any proposed rules for health legislation be subject to the legislative test found in CMA’s Health Information Privacy Code and formulated in light of this process; and That there be a clear definition of the information being accorded a right of privacy and that this definition, at least in the case of health information, include identifiable information, delinked information, anonymous information and any composite information produced when health information is linked to any other information about a person from any other source; and That, at least in connection with health information, the provisions of the Bill apply equally to the public and the private sectors. CMA has drafted an amendment to Bill C-6 (Appendix B) which, if accepted, would achieve all of these recommendations and adequately give Canadians the kind of privacy protection with respect to their health information that they deserve and desire.
Documents
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Regulations for genetically modified organisms

https://policybase.cma.ca/en/permalink/policy380
Last Reviewed
2020-02-29
Date
1999-08-25
Topics
Health care and patient safety
Resolution
GC99-82
That the Canadian Medical Association urge the federal government to act quickly to adopt regulations controlling the development, testing and commercialization of genetically modified organisms.
Policy Type
Policy resolution
Last Reviewed
2020-02-29
Date
1999-08-25
Topics
Health care and patient safety
Resolution
GC99-82
That the Canadian Medical Association urge the federal government to act quickly to adopt regulations controlling the development, testing and commercialization of genetically modified organisms.
Text
That the Canadian Medical Association urge the federal government to act quickly to adopt regulations controlling the development, testing and commercialization of genetically modified organisms.
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