Mr. Speaker, I congratulate the member for Winnipeg North Centre on her initiative in bringing forward this motion. All Canadians want to know that the prescribed medications they take are safe. They place tremendous confidence in the ability of Health Canada to provide health care professionals with up to date drug safety information. Health Canada is open to suggestions or new activities that could increase its capacity to detect drug safety problems and thereby avoid serious adverse reactions to drugs taken by Canadians.
The government welcomes the motion by the NDP health critic that it should immediately, in consultation with provincial and territorial governments, establish a system for mandatory reporting of adverse drug reactions. Such a system should address not only the quantity but the quality of reports received.
This follows up on one of the 59 recommendations that came out of the coroner's inquest into the death of Vanessa Young who died at the age of 15 while taking the prescribed drug prepulsid. Her death was a sad event in my home riding of Oakville. I was fortunate enough to have known Vanessa Young and her parents. I saw the community grieving at her death. It was a tragedy.
Evidence presented at the inquest showed that the current system for reporting adverse drug reaction in Canada is not organized to its full potential. The inquest identified the need to implement improvements that would enable Health Canada to compile information on drug safety more quickly and thereby act faster on potentially dangerous situations once they are identified.
The jury recommended that it be mandatory for health care professionals to forward information to Health Canada on all serious adverse drug reactions within 48 hours. The inquest used the same definition of serious adverse reaction that is currently found in our food and drug regulations.
Before discussing the many issues pertaining to mandatory reporting I will give a bit of background on the approval and post-market surveillance programs of Health Canada.
First, no drug is authorized for sale in our country before it has gone through a rigorous review process. Once a drug is on the market Health Canada continues to monitor it for adverse reactions, investigate complaints or reported problems and update conditions of its use via changes to the product monograph. If necessary it can remove a drug from the market.
As well, the product licensing framework that will soon be implemented has defined mandatory reporting requirements regarding emerging safety issues in other countries.
Another current initiative is the collaboration between Canada and the U.S. in a shared adverse events reporting system. Once implemented such a database would enable earlier detection of drug safety problems than is currently possible.
A mandatory system for adverse drug reaction reporting has great potential as an improvement to the current system. However all aspects of such reporting must be carefully weighed.
For example, if mandatory reporting generated a higher number of quality reports of drug safety problems it would increase the ability of Health Canada to determine such problems. However at present Health Canada has no clear evidence that mandatory reporting would result in the submission of quality information and thereby substantially increase its capacity to detect drug safety issues.
Other countries have reported success with mandatory reporting. France has mandatory reporting yet does not seem to have a significantly higher number of reports than countries without it. Nor does it detect drug safety signals at a higher rate than countries that do not have mandatory reporting. France has also found it problematic to enforce mandatory reporting. Because of issues of patient confidentiality it is difficult to gain access to physicians' offices where much of the reporting is done.
I support the motion as a means of strengthening Health Canada's ability to generate drug safety signals. However there are aspects of it that require further clarification and discussion.
First, who is expected to report? Should it only be doctors or should pharmacists, nurses or other health care professionals report? What about the time frame for reporting? In addition, what about issues of patient confidentiality? The implications of mandatory reporting need to be thought out and its scope and expectations clearly defined so that informed decisions can be made in moving this motion forward into action.
Some of the other initiatives aimed at strengthening the post-market surveillance capacity of Health Canada are the adverse event reporting system currently used by the United States and the plans of Health Canada to partner with the U.S. in this system. It is among one the largest databases of its kind in the world and is specifically designated to assess the risks associated with drugs that are approved for sale. The U.S. has several years of experience using it. It contains close to three million adverse drug reaction reports. Each year about 300,000 new adverse reactions are entered. We think that partnering with the FDA and the use of this database will provide a powerful tool to enable Health Canada to detect potential drug safety issues in a more timely manner than is currently possible.
Another initiative is the creation of a joint committee between Health Canada and provincial and territorial health professional groups to examine the effectiveness of the risk information delivery system among all concerned parties.
In addition to their input to the issue of mandatory adverse drug reaction reporting, this joint committee will be asked to evaluate risk communication tools and techniques used to inform health care professionals and the general public with a view to improving their effectiveness. Ultimately this committee will report its findings, including any recommendations for improvement, to the coroner within one year of the date of the Vanessa Young verdict, which will be April 24, 2002.
Health Canada has also had discussions with the Royal College of Physicians and Surgeons and the Canadian College of Family Medicine as to their interest in incorporating new drug risk information into their maintenance of competency programs for physicians. This initiative will help ensure that physicians keep current on drug risk information disseminated by Health Canada or other reputable information sources.
I wish to assure members of the House and all Canadians that Health Canada is actively seeking more effective ways to identify drug safety problems and to manage them in a timely manner. Health Canada values the health and well-being of Canadians above everything else. Our country has a good safety record with respect to drugs.
The motion to establish a mandatory reporting system is one potential step toward improving the availability of drug safety information and in identifying risks that could pose life threatening situations.
Identifying risks posed by drugs and communicating such risks in a timely manner is what Canadians want. I know I can call on the members of the House to support our future initiatives to improve the post-market surveillance activities of Health Canada among which mandatory reporting is one.