Madam Speaker, the motion placed before the House by the member for Yukon is certainly worth considering. Any proposal that would contribute to maintaining and improving the health and safety of Canadians deserves thoughtful discussion.
There is some ambiguity in the member's motion. Does the hon. member want a national registry of drugs and devices or a national registry of patient profiles and adverse reactions to those drugs and devices or both?
The fundamental question regardless of what the member means is would setting up a national registry of drugs, medical devices and various forms of biotechnology protect the health of Canadians better than the system we have in place? Before we review that system we should consider the context of the motion.
In 1992 a resolution by the subcommittee on the status of women called for such a registry. In its report, "Breast Cancer: Unanswered Questions", the subcommittee said one of the problems with breast implants in particular and medical devices in general is adequate mechanisms are not in place to monitor the complications and long term effects of implanted devices. The resolution called for a national patient adverse reaction registry through which patients would be able to register any problems, complications or ill effects.
No one disputes this but the resolution on which the motion is based was conceived in response to a specific problem, the need for women to have accurate information regarding the use of breast implants.
The subcommittee had heard wrenching testimony by women who said they had been scarred and made ill as a result of breast implant surgery. In its report the subcommittee concluded a crucial factor for women facing these decisions was the need for accurate information regarding the risks and possible complications associated with the use of implants, hence the idea of a national registry.
The report says: "We see the lack of such a registry as a major inadequacy in our current system. Without such a mechanism physicians and surgeons can easily lose track of patients who have breast or other implants. This complicates their ability to pass the new or emerging information on possible problems with implants".
This specific resolution and the motion go well beyond implants to take in drugs and various forms of biotechnology. Whatever the merits of a registry for breast implants, Canadian women and Canadians in general are at present well served when it comes to the safety and efficacy of medical drugs and devices.
Many Canadians and the hon. member may be unfamiliar with the co-operative system administered by federal, provincial and territorial governments which ensures medical drugs available in Canada are safe, effective and of high quality. I will limit my remarks to mostly drugs, and my hon. colleague will discuss devices.
The department's health protection branch through its drugs directorate not only approves all drugs offered for sale in Canada before they go on the market but monitors their use after they are on the market so that any drugs sold in Canada must meet the requirements of the food and drugs regulations.
Once a drug has met these requirements the department issues a notice of compliance, an NOC, and assigns a drug identification number, a DIN, to the drug. The drug directorate maintains a database that includes information on all the drug products assigned and the identification number. This database now contains information on approximately 22,000 drug products sold in Canada.
In addition, Health Canada makes information on drug products sold in Canada available to the public in a variety of ways, including the drug directorate's electronic bulletin board system which we can access through modem. The building blocks of a national drug registry are already in place through the co-operation of all three levels of government.
In addition to registering drugs and giving public information, the drugs directorate through its bureau of drug surveillance promotes and supports the safe and rational use of drugs after they enter the market and are in the public domain. This bureau ensures drugs are manufactured according to regulations and internationally recognized good manufacturing practices and standards, ensuring the safety of market drugs.
An important part of the bureau of drug surveillance is the adverse drug reaction monitoring program. Canada has had a system to gather information on adverse drug reactions since 1965. Under this program health professionals report adverse drug reactions voluntarily. Reporting by pharmaceutical manufacturers is subject to control by the Food and Drugs Act and regulations.
To enhance the value of spontaneous reporting in Canada the adverse drug reaction program has established a series of regional reporting centres across the country, serving as a front line for this reporting program.
There are four centres fully operational right now: the B.C. adverse reporting centre located at the drug and poison information centre at St. Paul's hospital in Vancouver; the Saskatchewan adverse drug reporting centre located at the drug information centre at the University of Saskatchewan's college of pharmacy; the regional drug information service for the Atlantic region at Camp Hill hospital in Halifax; the Quebec regional adverse drug reaction centre located at the Centre d'information pharmaceutique at Hôpital du Sacré Coeur de Montréal.
However, in my experience as a physician I believe voluntary reporting may not be as accurate as it should be. There should be mandatory reporting by physicians of adverse drug reactions.
What I am really trying to say is this building block will provide the basis for future evolution of national drug programs.
The initiatives involve the federal, provincial and territorial governments as well as industry and a number of professional health organizations, including the Canadian Co-Ordinating Office for Health Technology Assessment, CCOHTA, the Canadian Institute for Health Information and the Patented Medicines Review Board. CCOHTA is an excellent example of the way the federal, provincial and territorial ministries of health work together and jointly fund it. CCOHTA collects, analyses, creates and disseminates information concerning the effectiveness and cost of technology and its impact on health.
Currently CCOHTA is conducting pharmaceutical evaluations to provide information on the relative therapeutic and economic value of medicines and alternatives.
Referring back to the original resolution on which the motion is based, we can safely say that when it comes to medical drugs we do have national mechanisms in place to ensure our medical drugs are safe and effective. Patients and physicians are educated about the side effects and use, and adverse effects are reported, albeit voluntarily, which is the weak link in a very strong national chain.
Would mandatory reporting by physicians of adverse drug reactions instead of the current voluntary system be the only step needed to put in place a complete system of drug and medical device safety? If so, the question to be asked of the hon. member is whether this motion is redundant.