The Canadian Medical Association (CMA) welcomes the opportunity to provide comments to the Standing Committee on Justice and Human Rights of the House of Commons concerning the study of Bill C-32 (An Act to amend the Criminal Code (impaired driving) and to make consequential amendments to other Acts).
The CMA supports measures aimed at reducing the incidence of drug-impaired driving. We believe impaired driving, whether by alcohol or another drug, to be an important public health issue for Canadians that requires action by all governments and other concerned groups.
The CMA has, on several occasions, provided detailed recommendations on legislative changes concerning impaired driving. In 1999, the CMA presented a brief to the House of Commons Standing Committee on Justice and Human Rights during its review of the impaired driving provisions of the Criminal Code (attached). While our 1999 brief focuses primarily on driving under the influence of alcohol, many of the recommendations are also relevant to the issue of driving under the influence of drugs.
Recently, the CMA has published the 7th edition of its guide, Determining Medical Fitness to Operate Motor Vehicles (attached). It includes chapters on the importance of screening for alcohol or drug dependency and states that the abuse of such substances is incompatible with the safe operation of a vehicle. This publication is widely viewed by clinical and medical-legal practitioners as the authoritative Canadian source on the topic of driver competence.
While changing the Criminal Code is an important step, the CMA believes further actions are also warranted. In our 2002 presentation to the Special Senate Committee on Illegal Drugs (attached), the CMA put forth our long standing position regarding the need for a comprehensive long-term effort that incorporates both deterrent legislation and public awareness and education campaigns. We believe such an approach, together with comprehensive treatment and cessation programs, constitutes the most effective policy in attempting to reduce the number of lives lost and injuries suffered in crashes involving impaired drivers.
Drug-impaired drivers may be occasional users of drugs or they may also suffer from substance dependence, a well-recognized form of disease. Physicians should be assisted to screen for drug dependency, when indicated, using validated instruments. Government must create and fund appropriate assessment and treatment interventions. Physicians can assist in establishing programs in the community aimed at the recognition of the early signs of dependency. These programs should recognize the chronic, relapsing nature of drug addiction as a disease, as opposed to simply viewing it as criminal behaviour.
While supporting the intent of the proposed legislation, the CMA urges caution on several significant issues. With regard to Clause 4 that amends the act as follows:
254.1 (1) The Governor in Council may make regulations
(a) respecting the qualifications and training of evaluating officers;
(b) prescribing the physical coordination tests to be conducted under paragraph 254(2)(a); and
(c) prescribing the tests to be conducted and procedures to be followed during an evaluation under subsection 254(3.1).
CMA contends that it is important that medical professionals and addiction medicine specialists in particular, should be consulted regarding the training offered to officers to conduct roadside assessment and sample collection.
Provisions in the Act conferring upon police the power to compel roadside examination raises the important issue of security of the person and health information privacy. As well, information obtained at the roadside is personal medical information and regulations must ensure that it be treated with the same degree of confidentiality as any other element of an individual's medical record. Thus, the CMA would respectfully submit that Clause 9 of Bill-32 on the issue of unauthorized use or disclosure of the results needs to be strengthened because the wording is too broad, unduly infringes privacy and shows insufficient respect for the health information privacy interests at stake.
For instance, clause 9(2) would permit the use, or allow the disclosure of the results "for the purpose of the administration or enforcement of the law of a province". This latter phrase needs to be narrowed in its scope so that it would not, on its face, encompass such a broad category of laws.
Moreover, clause 9(4) would allow the disclosure of the results "to any other person, if the results are made anonymous and the disclosure is made for statistical or other research purposes" CMA would expect the federal government to exercise great caution in this instance, particularly since the results could be of individuals who are not actually convicted of an offence.
One should query whether the Clause 9(4) should even exist in a Criminal Code as it would not appear to be a matter required to be addressed. If it is, then CMA would ask the government to conduct a rigorous privacy impact assessment on these components of the Bill, studying in particular, such matters as sample size, degree of anonymity, and other issues, especially given the highly sensitive nature of the material.
CMA would ask whether clause 9(5) should specify that the offence for improper use or disclosure should be more serious than a summary conviction. Finally, it is important to base any roadside testing methods and threshold decisions on robust biological and clinical research.
CMA also notes with interest Clause 5, specifically the creation of a new offence of being "over 80" (referring to 80mg of alcohol in 100ml of blood, or a .08 blood alcohol concentration level or BAC) and causing an accident that results in bodily harm which will carry a maximum sentence of 10 years and life imprisonment for causing an accident resulting in death. (Clause 5)
We would also urge the Committee to take the opportunity that the review of this proposed legislation provides to recommend to Parliament a lower BAC level. 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 Canada.1 A lower limit would recognize the significant detrimental effects on driving-related skills that occur below the current legal BAC.2
In our 1999 response to this Committee's issue paper on impaired driving3 and again in 2002 when we joined forces with Mothers Against Drunk Driving (MADD), CMA has consistently called for the federal government to reduce Canada's legal BAC to .05. Canada continues to lag behind countries such as Austria, Australia, Belgium, Denmark, France and Germany, which have set a lower legal limit. 4
CMA expressed the opinion that injuries and deaths resulting from impaired driving must be recognized as a major public health concern. Therefore we once again recommend lowering the legal BAC limit to 50 mg%. or .05%.
Finally, CMA believes that comprehensive long-term efforts that incorporate deterrent legislation, such as Bill C-32, must be accompanied by public awareness and education strategy. This constitutes the most effective approach to reducing the number of lives lost and injuries suffered in crashes involving impaired drivers. The CMA supports this multidimensional approach to the issue of the operation of a motor vehicle regardless of whether impairment is cause by alcohol or drugs.
Again, the CMA appreciates the opportunity to provide input into the legislative proposal on drug-impaired driving. We stress that these legislative changes alone would not adequately address the issue of reducing injuries and fatalities due to drug-impaired driving, but support their intent as a partial, but important measure.
Colin J. McMillan, MD, CM, FRCPC, FACP
1 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.
2 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
3 Proposed Amendments to the Criminal Code of Canada (Impaired Driving): Response to Issue Paper of the Standing Committee on Justice and Human Rights. March 5, 1999
4 Mann et al
The Canadian Medical Association represents more than 65,000 physicians in Canada; its mission is to serve and unite the physicians of Canada and to be the national advocate, in partnership with the people of Canada, for the highest standards of health and health care. In pursuit of this mission we are developing a growing body of policy on pharmaceutical issues. In November 2003, we presented to the House of Commons Standing Committee on Health during its study of prescription drug issues. In July 2006 CMA, along with four other national organizations representing patients, health professionals, health system managers and trustees, formed the Coalition for a Canadian Pharmaceutical Strategy and released a framework and principles that we believed should govern the development of pharmaceutical strategy in this country.
We understand that the current study of the Common Drug Review (CDR) is part of a larger, more comprehensive study of prescription drugs being contemplated by the House of Commons Standing Committee on Health. We look forward to assisting you with this study. In the meantime, we will note that the CDR is intimately linked to related issues such as catastrophic coverage and a national formulary, and will also briefly discuss these in our presentation.
Pharmaceuticals are important to the health of Canadians. For many patients prescription drugs have prevented serious disease, reduced hospital stays, replaced surgical treatment and improved their capacity to function productively in the community. Pharmaceuticals also offer health-care system benefits by reducing other costs such as hospital expenses and disability payments.
While prescription drugs offer significant benefits, expenditures on them are also growing faster than any other component of health care. It is realistic to expect that the role of prescription drugs in health care will continue to increase and that as a result government expenditures on them will rise accordingly. As patients become increasingly knowledgeable and politically aware, they will continue to expect and demand access to an expanded range of prescription drugs.
CMA believes that any pharmaceutical strategy should be predicated on two pre-eminent principles, which are in keeping with longstanding Canadian values:
* All Canadians should have access to safe and effective prescription drugs; and
* No Canadian should be deprived of medically necessary drugs because of inability to pay.
Whether the CDR serves to further these goals has been a matter of vigorous debate. Federal and provincial representatives have told the House of Commons Committee that the CDR is meeting their needs and has in some cases provided them with a higher-quality review than they could have achieved on their own. On the other hand, patient groups have charged that the CDR is an unnecessary layer of bureaucracy and a barrier between them and potentially life-saving new therapies. It is possible, if not probable, that reforms to the CDR may never completely eliminate the tension between these two viewpoints.
We understand the frustration of patients and their advocates when the CDR recommends against public reimbursement or even more, when the CDR approves a drug but individual provinces refuse to include that drug on their formularies. In both these cases, sustainability of the health care system is an important and valid consideration. It would be unfortunate if our limited health care dollars, which might otherwise have been spent on disease treatment or prevention strategies of proven effectiveness, went instead to funding expensive drugs which ultimately proved no more beneficial to patients than others which cost much less.
2) General principles regarding drug review
The process of reviewing drugs for inclusion in public formularies did not begin with the CDR. Before it was created, each federal and provincial formulary conducted its own review. Without the CDR, separate reviews would still be taking place. To dismantle the review process entirely would be unacceptable, both economically and politically.
Within the context of an overarching goal to enhance access to medically required pharmaceuticals to the extent that they are needed, the primary purpose of a drug review process should be to help ensure access to prescription drugs for which evidence indicates safety and effectiveness in the treatment, management and prevention of disease, and/or significant benefits in quality of life. To help ensure that it achieves this purpose, we believe the following principles should apply to drug review in Canada:
* The review process should be impartial and founded on the best available scientific evidence.
* The primary criteria for inclusion in a formulary should be whether the drug improves health outcomes, and offers an improvement over products currently on the market.
* The review process should also incorporate evaluation of the drug's cost-effectiveness.
* Drugs should be evaluated not in isolation but as an integral part of the health care continuum. The review should consider:
* A drug's impact on overall health care utilization. If a drug reduces a patient's hospital stay, helps an otherwise disabled patient return to work, or replaces other costlier or more invasive therapies, this should be considered in evaluating its overall cost-effectiveness.
* Alternatives to the drug under review. The review should compare a drug's performance to other drugs in the same class, and to available non-drug therapies.
* The review process should be flexible, taking into account the unique needs and therapeutic outcomes of individual patients, and the expertise of physicians in determining which drugs are best for their patients.
* The review process should be open and transparent. We support the CDR's intent to publish the rationales for its decisions, including lay-language versions.
* CDR findings are a valuable source of information on the safety and effectiveness of the drugs physicians prescribe. As such, they should be communicated to caregivers and patients as part of an ongoing strategy to encourage best practices in prescribing.
* Meaningful participation by patients and health professionals should be part of the review process; we note with approval the expansion of the Canadian Expert Drug Advisory Committee to include members of the public. We also suggest that the CDR experiment with open fora and other means of obtaining public input.
* A process for appealing the review's decisions should be established.
* Ongoing evaluation of the review process should be required. We note that the CDR has already undergone an evaluation, and is planning to implement some of the key recommendations. Impartial evaluations should continue to take place, to assess whether the CDR is having a positive impact on the health of Canadians and of their health care system.
3) The Larger Picture
The Common Drug Review does not exist in isolation. As the Coalition for a Canadian Pharmaceutical Strategy - of which CMA is a member - stressed in its 2006 statement, the elements of a comprehensive Canadian pharmaceutical strategy are interdependent and should be developed concurrently to ensure that the strategy is coherent and holistic. The CDR is interlinked with other issues concerning access to health care generally and to prescription drugs more specifically, and we suggest that the Committee also consider the following issues:
a) Drugs for Rare Disorders. One controversy surrounding the CDR is that its approval rates are low for drugs for very rare disorders, many of which are first-in-class. One reason may be the cost of these drugs, which is often extremely high. It is also alleged that the Canadian Expert Drug Advisory Committee's (CEDAC) current review standards, which place a high value on large-sample clinical trials, are unable to adequately capture the value of these drugs.
It has been recommended that more drugs for rare disorders be approved based on interim targets or surrogate endpoints. The ultimate measure of a drug's effectiveness is its clinical endpoint; this should not be forgotten in any process of drug approval. This issue merits closer consideration, as do all issues related to drugs for rare disorders. CMA recommends that Canada develop a policy on drugs for rare disorders, which:
* Encourages their development;
* Evaluates their effectiveness; and
* Ensures that all patients who might benefit have reasonable access to them.
b) Common Formulary. CMA recommends that Canada's governments consider the possibility of establishing a pan-Canadian formulary. Canadian patients need a national standard; 18 different levels of coverage is not acceptable. Should the CDR form the basis of this formulary? That would depend on whether evaluation proves that the CDR is the most effective vehicle.
We do believe that cost control, though not the primary function of a pan-Canadian formulary, is a valid system concern. If two drugs in the same class are equally effective, it is reasonable to expect that the less expensive drug should be preferentially covered and/or prescribed. On the other hand, a pan-Canadian formulary should be flexible. It should include a process to allow patients access to off-formulary drugs if in the opinion of the attending physician the recommended product is not the right choice for them. This process should be designed so as to minimize the administrative burden on health professionals.
c) Catastrophic Drug Coverage. It is now generally accepted that a pan-Canadian catastrophic drug program is needed. The point of discussion now is what type of program should be put in place. To ensure that Canadians can access the drugs they need, regardless of where they live or how much they earn, CMA recommends that federal, provincial and territorial governments, in collaboration with private insurers, assess the drug needs of Canadians, particularly those who are uninsured or under-insured, and agree on an option for providing equitable and comprehensive prescription drug coverage. As a starting point, CMA has recommended that governments give priority to a national pharmacare program to provide necessary drugs for all Canadian children and youth.
In principle, CMA believes that a process for reviewing prescription drugs for their clinical effectiveness and cost-effectiveness can contribute to improving the health of Canada's patients and our health care system. The value of the CDR will be determined by how well it performs this function.
Canadian Medical Association May 14, 2007