Thank you, Mr. Chair.
The Canadian Medical Association represents more than 65,000 physicians in Canada, and pharmaceutical issues play a critical part in the everyday practices of these physicians. To help Canada's doctors better serve and treat patients, the CMA is developing a growing body of policy on pharmaceutical issues. In November 2003, we presented its study of prescription drug issues to the House of Commons Standing Committee on Health. Last July, the CMA partnered with four other national organizations representing patients, health professionals, health system managers, and trustees to form the Coalition for a Canadian Pharmaceutical Strategy. That coalition released a framework and principles that we believed should govern the development of pharmaceutical strategy in this country.
The CMA believes that any pharmaceutical strategy must be built on the foundation of two critical principles: all Canadians should have access to safe and effective prescription drugs, and secondly, no Canadian should be deprived of medically necessary drugs because of inability to pay.
Whether the common drug review, or CDR, furthers these goals has been a matter of vigorous debate. Federal and provincial representatives told the committee that the CDR is meeting their needs, and they even said that in some cases it 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.
We understand the frustration of patients and their advocates when the CDR recommends against public reimbursement, and it can be even more frustrating when the CDR approves a drug but provinces refuse to include that drug on their formularies. In each of these cases, sustainability of the health care system is an important and valid consideration. It would be unfortunate if our limited health care dollars that could have been spent on treating patients and preventing illness were wasted funding expensive drugs, ultimately found to be no more beneficial to patients than other cheaper versions.
There must always be a drug review process. To dismantle it entirely would be unacceptable, both economically and politically.
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, drug review in Canada should follow these principles.
The review process should be impartial and founded on the best available scientific evidence.
The primary criterion for inclusion in a formulary should be whether the drug improves health outcomes and is an improvement over products currently on the market.
Evaluation of cost-effectiveness should be part of the review process.
Drugs cannot be and should not be evaluated in isolation, but as an integral part of the health care continuum. For example, the review should consider a drug's impact on overall health care use. If a drug reduces a patient's hospital stay or replaces other costlier or more invasive therapies, this should be considered in evaluating its overall cost-effectiveness. It should also consider 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, such as surgery, for instance.
The review process should be flexible, taking into account the unique needs of individual patients and the expertise of physicians in determining which drugs are best for which 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.
The CDR results 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. Here we would recognize and applaud the expansion of the Canadian Expert Drug Advisory Committee to include members of the public. We also suggest that the CDR experiment with other means of obtaining public input, open forums, for example.
A process for appealing the review's decisions should also be established.
Ongoing evaluation of the review process should be required. 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 their health care system.
The common drug review does not and cannot exist in isolation. It is linked to other issues in prescription drug policy, and there are three specific issues that merit the committee's consideration.
The first is drugs for rare disorders. It has been alleged that the Canadian Expert Drug Advisory Committee's current review standards, which place a high value on large-sample clinical trials, cannot capture the value of these drugs. This issue merits much closer consideration.
The CMA recommends that Canada develop a policy on drugs for rare disorders, that it encourage their development, evaluate their effectiveness, and that these policies ensure that all patients who might benefit have reasonable access to them.
Second is a common formulary.
The CMA recommends that Canada's governments consider the possibility of a establishing a pan-Canadian formulary. Canadian patients need a national standard; having 18 different levels of coverage is simply not acceptable.
Should the CDR form the basis of this formulary? Well, the answer to that question would depend on whether evaluation proves that the CDR is the most effective vehicle.
Third is catastrophic drug coverage. It's now generally accepted that Canada must institute a pan-Canadian catastrophic drug program.
The CMA recommends that governments and private insurers work together to assess the drug needs of Canadians, particularly those who are uninsured or under-insured, and agree on an option for meeting these needs. The underlying principles of this effort must be to ensure that Canadians can get the drugs they need, regardless of where they live or how much they earn.
As a starting point, the CMA recommends that governments give priority to a national pharmacare program to provide necessary drugs for all Canadian children and all Canadian youth.
In conclusion, the CMA believes that a process for reviewing the clinical and the cost-effectiveness of prescription drugs can contribute to improving the health of Canada's patients and our health care system. The value of the CDR in this process will be determined by how well it performs its function on evaluation.
We understand that the CDR study is part of a larger and more comprehensive study of prescription drugs being contemplated by the committee, and we look forward to assisting you with this study.
Thank you.