Thank you, Mr. Chair, and good morning to the committee. Thank you to the Standing Committee on Health for the invitation to appear this morning. My name is Jeff Morrison. I'm director of government relations and public affairs with the Canadian Pharmacists Association. With me—I'm very happy—is Barry Power, a pharmacy consultant with CPhA, an adjunct assistant professor at the school of pharmacy with the University of Waterloo, and a pharmacist himself.
As you know, CPhA is the national association representing the pharmacist profession in Canada.
Drug safety is a priority for the Canadian Pharmacists Association and for all pharmacists in Canada. Although it is not possible to completely eliminate all risks associated with the use of prescription drugs, pharmacists spend a lot of time counselling patients on the appropriate and safe use of the drugs they are taking. That is why the CPhA supported the general spirit and thrust of Bill C-17, Vanessa's Law, when it was introduced by the minister in December 2013.
In particular, the CPhA supports the bill's intent to increase penalties for unsafe products and to provide Health Canada with new powers to recall unsafe products and to compel companies to do further testing on a product when issues are identified with certain at-risk populations, as well as the requirement for drug companies to revise labels to clearly reflect health risk information, including potential updates for health warnings for children.
However, there are some concerns and outstanding questions we have with regard to the bill. Although these questions and concerns may be addressed during the regulatory development process, we still wish to raise them with the committee this morning.
First, the bill provides a blanket exemption for natural health products. As NHPs are medicinal products and have the ability to cause harm, and given that Health Canada and several provinces state that between 60% to 70% of therapeutic products consumed by Canadians are in fact NHPs, the CPhA feels that NHPs should be included within the scope of the bill.
Second, the bill mandates the need for adverse drug reporting by stating the following, which I'm sure you know:
A prescribed health care institution shall provide the Minister, within the prescribed time and in the prescribed manner, with prescribed information that is in its control about a serious adverse drug reaction that involves a therapeutic product or a medical device incident that involves a therapeutic product.
However, this clause raises several questions that frankly the bill doesn't clarify.
For example, what is a prescribed health care institution? Is a pharmacy a health care institution? Will the downtown community health centre, of which I was the president, be considered a health care institution?
It would be helpful to specify the definition of a prescribed health care institution that is required to provide information.
Also, what is a serious adverse drug reaction? How is that to be defined? For example, is it necessary to report a well-known but serious reaction? All health care professionals know of many of the serious adverse reactions caused by chemotherapy, for example, during cancer treatment. Would they be expected to report these? Where do we draw the line between what is to be reported and what is considered well-established fact? Again, clarification within the bill would be useful.
Also, what will happen with this information? Will it be analyzed? Will all the information that is reported be made publicly available? If so, how so? As pharmacists we believe that Health Canada should be transparent in the provision and aggregation of the information it receives from this mandatory reporting, but at present, the legislation as written is unclear on whether this information will be properly analyzed and shared with health practitioners and with Canadians.
The same issue regarding transparency can also be applied to the bill's requirement that the minister may order the manufacturer to conduct additional assessments and tests of a questionable product or drug in regard to health and safety. The legislation states that the results of these tests will be provided to the minister. However, there is no allowance currently in the bill for providing that information more publicly, including to pharmacists, other practitioners, and Canadians. As you can probably guess, we feel it should.
Last, the bill also states that this reporting requirement “shall take into account existing information management systems, with a view to not recommending the making of regulations that would impose unnecessary administrative burdens”. However, this clause would appear to be at odds with the reality of the situation on the ground.
By its inclusion in the bill, the requirement for prescribed health care institutions to report adverse drug reactions will impose additional administrative burdens. Although technological solutions can and should help, the fact remains that additional human resources will be required to collect and provide this data. If the definition of prescribed health care institution is broad in scope—as I mentioned earlier, we don't have that—then the administrative requirements will likely increase. As a result, we're uncertain about how the bill can reconcile what would appear to be two contradictory goals of, on the one hand, increasing reporting, but on the other hand, without imposing administrative burdens.
In short, Mr. Chair, the Canadian Pharmacists Association is very supportive of Bill C-17. Given pharmacists' preoccupation with safe and effective use of medications, the CPhA believes the legislation is a step in the right direction. However, as I've outlined, we feel that there are clauses within the bill that could benefit from greater clarity and certainty in terms of how they will be applied.
Thank you, Mr. Chair.
We are ready to answer the committee's questions.