Thank you, Madam Chair.
We at the Consumers' Association are very pleased to have this opportunity to appear here today.
By way of background, for over 60 years the Consumers' Association of Canada has represented the interests of ordinary Canadians in their role as consumers of goods and services as provided by both the public and private sectors. We are not a professional medical advocacy association, nor do we represent persons with specific medical interests or illnesses. Our mandate is to inform and educate consumers on marketplace issues, advocate for consumers with government and industry, and work to solve marketplace problems in beneficial ways.
I am one of those 33 million Joes and Janes—to be politically correct—on the sidewalk mentioned by a committee member. And in fact, I am a volunteer. Since I am a layman, I will speak in those terms and not in medical jargon, in which I am not well versed.
Canadian consumers expect that the goods and services of which they avail themselves will be safe. This particularly applies in the medical arena. We at CAC recognize that the term “safe” is an absolute that can rarely, if ever, be guaranteed, and that a more appropriate term would be “to do no harm”. Consumers instinctively recognize this distinction, since they are aware that overdosing on even relatively benign products can have harmful effects and that many medications have potential side effects or contraindications, to use the technical term, I believe, even though they may not be familiar with the specific details.
We are extremely concerned that apparently an increasing number of pharmaceutical products that have been deemed safe, in that they were available for purchase, have subsequently been found to be anything but. Additionally, consumers are confused by the frequent media reports purportedly based on sound information that tell us that pharmaceuticals that had been promoted yesterday as life-saving are now seen as likely to harm or kill us. All of this raises the question: who, if anybody, is minding the store?
It is our understanding that the current system for approving pharmaceuticals is analogous to the way drivers used to be licensed. After a specified test or tests, the privilege to drive, or in this case to sell, is bestowed and is not revoked except for egregious circumstances. There is no attempt to determine if the capability to perform as required or expected still exists. Unfortunately, the analogy breaks down because there is no capability to revoke the right to sell pharmaceuticals.
Health Canada is proposing the introduction of a progressive licensing regime. To continue the driver analogy, this is similar to the graded drivers' licences that have been introduced over the years, whereby a young driver, after passing a test, is allowed to drive under limited circumstances. As time passes and additional tests indicate enhanced performance, the limitations are reduced until they are completely removed. But again, there does not appear to be a mechanism for following up over time or for revoking the privilege to sell.
Instead of a progressive licensing system—and part of the problem, I think, is interpretation of what that system is—we would prefer to see a continuous one. This would be one in which it is clearly recognized that an authorization to sell pharmaceuticals to Canadians is not an absolute, but that Health Canada can revoke that privilege if at any time it has cause to believe that the health and welfare of Canadians would be better served by removing that product. This means that there has to be an ongoing surveillance of the products. This would include the regulatory authority to require new or additional studies if clinical trials or data gathered either domestically or internationally suggest that there are safety risks for Canadian patients.
We do feel there is merit in allowing some products, as alluded to by Durhane, to be used in limited circumstances during the early stages of evaluation, and maybe evolution. These are cases in which the need for a drug is critical and the risks can be well documented by the manufacturer sufficient for the patient and doctor to make an individual risk assessment and decision.
We have noted during the course of these hearings numerous objections to the establishing of a post-authorization or post-market surveillance system, with reasons ranging from the idea that it would impose too great a burden on the reporters to the idea that the mechanism doesn't exist, how would Health Canada cope with and be able to sort through a multitude of reports, and how is it to be funded. There seems to be surprisingly little thought given to going beyond the excuses to how this can actually be made to work. The starting point has to be a positive one.
We think the Canadian Medical Association has got the right approach, which I think is worth repeating:
...to effectively monitor the safety and effectiveness of the country's drug supply, ...a strong post-market surveillance system should include an effective process for gathering drug safety data coupled with a simple, comprehensive, and user-friendly reporting system; a rigorous process for analyzing this data to identify significant threats to drug safety; and a communications system that produces useful information distributed to health care providers and the public in a timely and easily understood manner.
We need to look at the establishment of a simple, cost-effective reporting system for reactions to pharmaceuticals that may be indicative of potential harm. We are not medically qualified to suggest what the cutoff point for reporting should be; however, much of the discussion seems to have been revolving around whether reporting only severe adverse drug reactions should take place. We understand that a working definition of an adverse drug reaction is “a noxious or unintended response to a drug occurring at doses normally used or tested for the diagnosis, treatment, or prevention of a disease or modification of an organic function”. In some cases we understand that this is qualified by some practitioners who add “significant morbidity or injury to patient, but did not directly cause death”.
We feel that in the interest of patient safety, the lower threshold should apply. We would even express some concerns about the limitation of doses normally used. There will be instances in which patients frequently exceed the specified dose either because they feel that an increase will help them get better faster and/or they were not made sufficiently aware of the dangers of doing so.
The system has to be able to track patterns of behaviour as well as low levels of unintended responses, which may be indicators of a widespread or imminent problem. In some cases, solutions may be as simple as including more, better, or more understandable information with the drug. Of course, if there are indications of a pending serious problem, appropriate stronger action would have to be taken.
We also note that there have been many comments about international harmonization of testing requirements and suggestions that Canada should not proceed on its own but should work only within that environment. It is our fear that this approach would most likely result in extreme delays in moving forward. The work of international bodies' attempts to achieve common ground or consensus usually moves at a glacial pace and with a great deal of politics involved—usually.
One last comment that doesn't appear to directly relate to the topic at hand is that we are adamantly opposed to consumer advertising of pharmaceuticals. In fact, in the context of this current discussion, we think that such advertising has an extremely detrimental effect on the efficacy of the medical system. It can lead to increases in misuse and inappropriate use, leading to overloading any reporting system that may be devised and diverting attention from more substantial concerns.
Thank you very much. I'd be pleased to try to answer any questions you might have for me.