November 2, 2011
Honourable senators, legislators are obliged to weigh and consider both the costs and benefits to society of any piece of legislation before them. Bill S-202 reminds us, once again, how critical and often challenging a task this really is.
Bill S-202 is designed to establish a national and voluntary registry of medical devices that would contain the names and addresses of people who use implantable or prescribed home-use medical devices.
Honourable senators, this bill has been considered, reviewed and debated in this chamber, as well as in the other place, since its first introduction in 2003. It has had six different titles over these years and was referred to the Standing Senate Committee on Social Affairs, Science and Technology on two separate occasions. Each time this bill has come before the Senate, the very same concerns have been raised: Does this bill exceed federal jurisdiction? How will it function without the support of provincial and territorial governments? What impact will it have on the privacy of Canadians?
Over the years, there have been many requests to establish patient registries for medical devices. In every case, Health Canada has carefully reviewed the issues of establishing and maintaining such national registries, looking in particular at the potential benefits and associated costs.
Honourable senators, we can all agree that issues of health and safety are of the utmost importance for Canadians. Let us begin by examining the Canadian medical devices regime currently in place. Since coming into force in 1998, the goal of the Medical Devices Regulations, administered by Health Canada, has been to provide Canadians access to medical devices that are safe, effective and of high quality. The fundamental principle of the regulations is that safety and effectiveness of a device can best be assured through a balance of quality management system requirements, pre-market scrutiny, and post-market surveillance.
In fact, today, the Medical Devices Regulations under the Food and Drugs Act provides Health Canada with the authority to regulate both the safety of medical devices, as well as the manufacturers. The mechanisms currently in place do not compromise the privacy of the patient, the role of the physician, nor the jurisdiction of provinces and territories to regulate the practice of medicine. This is in stark contrast to the proposed bill.
Perhaps it is best noted here that the term “medical device” covers a wide range of products used in the treatment, mitigation, diagnosis and prevention of diseases. Health Canada organizes these products into risk classes. Class I medical devices include such simple household items as toothbrushes and bandages, while Class IV, the highest risk category, includes such high-tech devices as pacemakers and implantable drug pumps. Health Canada maintains electronic databases of all licensed Class II through IV medical devices.
In addition to overseeing quality assurance in the pre-market, the current provisions and mechanisms comprise both necessary aspects of post-market surveillance, and those most relevant to this bill: implant registration for specific implantable medical devices and requirements for mandatory problem reporting. Together, these support the timely communication of risks to all Canadian hospitals, physicians and the general public. Moreover, manufacturers, importers and distributors are required to keep distribution records, to have written procedures in place to handle complaints, to investigate these complaints and to recall defective devices from the market. Manufacturers and importers must also report serious problems post-sale to Health Canada.
The Health Products and Food Branch Inspectorate is responsible for compliance and enforcement activities related to medical devices. Its risk-based classification system permits the monitoring of company recalls in real time. Although the manufacturer issuing the recall is legally responsible to report the details, Health Canada will often provide an additional press release.
Honourable senators, let us focus on these two necessary aspects of post-market surveillance: registration and reporting.
As for registration, the current regulations set out requirements to help track high-risk implantable devices. Devices subject to the requirements are listed in Schedule 2 of the regulations. The information collected includes a unique hospital identifier number. The hospital can link this unique identifier to personal information provided for a patient at the time of surgery. The patient also receives an implant registration card clearly identifying the manufacturer and device that he or she received during surgery. Patients also provide consent to participate in a process that provides their personal information to the manufacturer. The current system ensures that individual privacy is protected.
When a medical device is reported to be a problem, the manufacturer must provide a very detailed account including the name of the recalled device, the reason for the recall, the number of affected devices in Canada, and the device distribution lists. This regulated record-keeping facilitates the retracement of devices to the original purchasers — generally the hospitals. The hospitals are responsible for informing the patients and surgeons involved. This reporting system works well for a number of reasons. The patient generally will receive information from a familiar health professional who can begin to remedy the situation with all the critical knowledge of the patient’s medical history and current condition. Also, the patient will receive the information about the recall within the confidentiality of the patient-physician relationship.
As for more general warnings and communications with the public, Health Canada has made enormous strides towards entering the digital age. The Health Canada website offers Canadians a wealth of information. The “MedEffect” section provides consumers and health professionals with complete lists of advisories, warnings and recalls. The “Summary Basis of Decision” documents that contain the original scientific reasoning and risk-benefit analysis performed by Health Canada in the device authorization phase are also available.
Canadians can also subscribe to public health and safety updates via RSS feeds, Twitter and email. These alerts provide instant information about drug advisories and device recalls. This system is an efficient tool for risk communication. It provides fast and timely alerts without violating the privacy of the individual. These measures demonstrate how Health Canada is adapting their services to meet the needs of Canadians in an increasingly technological society.
Health Canada also invites individuals to report adverse health events associated with their medical devices. Consumers can access this service through the Canada Vigilance program or through a hotline maintained by the department. In addition to the Canada Vigilance program, the Canadian Adverse Reaction Newsletter is a valuable source of information for consumers and health practitioners. It is clear that Health Canada continues to take the necessary steps to gather the appropriate information and communicate that information to the public.
Honourable senators, establishing a national implant registry raises a number of issues that must be considered. These include federal, provincial and territorial jurisdictions and funding, the benefits of a registry versus its costs, the need to ensure privacy and informed consent, and the potential legal liability issues for the federal government as the registrar of such a system.
Under the current act and regulations respecting federal constitutional jurisdiction, the federal government is responsible for regulating the sale and importation for sale of medical devices. As laid out in the Food and Drugs Act and the Medical Devices Regulations, responsibility for the safety, effectiveness and quality of medical devices sold in Canada falls on the medical devices’ manufacturers. The proposed bill has the potential to weaken the existing “duty of care” responsibilities on the part of manufacturers.
The provinces and territories are responsible for the delivery of health care services, including the regulation of the practice of medicine through provincial and territorial licensing bodies. Requirements for physicians and other health care professionals to provide information to a registry must be supported by the provinces and territories.
Registries have been consistently problematic from the vantage of personal privacy rights under the Privacy Act. Neither Health Canada nor the manufacturers have direct access to the patient’s identity under the current Medical Devices Regulations. To build a national database, a registry that would have real value, demands the collection of linked pieces of personally identifiable information, rarely permitted under any circumstances within our constitutional framework.
The implementation of a patient registry system at the national level would come with significant financial costs. Such a system would have to meet the needs of physicians, patients and researchers. It would require staffing and resources sufficient to monitor, detect and respond to safety flags immediately. Today, there are registries established by organizations intended to gather information in a post-market setting or to provide a service to an individual for a fee, such as MedicAlert and the Canadian Joint Replacement Registry, operated by the Canadian Institute for Health Information.
I would be remiss if I did not make some reference here to a certain degree of confusion that exists over the research value of registries, especially voluntary ones. They may provide a mechanism for contacting patients who have chosen to enrol and maintain their personal data on file. However, such registries are certainly not a replacement for randomized clinical trials or other carefully designed studies. They cannot lead to accurate estimates of incidence or adverse outcome rates, nor can they be used to compare different treatment options. A voluntary registry, such as the one proposed in this bill, will never provide an unbiased set of data as it will not contain the information for any whole or complete population of device users; nor will it contain an entire subset of patients with particular problem devices or failed devices.
Honourable senators, the high costs and serious challenges associated with the implementation of a voluntary national registry are not justified by the projected benefits. The current mandatory provisions for the reporting of device-related problems to Health Canada under the Medical Devices Regulations promote an appropriate balance between individual privacy rights and the mitigation of risks to health. Our government does not support Bill S-202.