Thank you very much, Mr. Chair and members of the committee. I'd like to thank you for the invitation to appear before you to provide an update on Health Canada's regulatory review of the six pending medical device licence applications for silicone gel-filled breast implants.
As you know, medical devices are regulated under the medical devices regulations and the Food and Drugs Act, which fall under the responsibility of the health products and food branch, for which I am the assistant deputy minister.
My colleague Dr. Supriya Sharma, the associate director general of the therapeutic products directorate, is joining me today.
We welcome this opportunity to come before the committee to discuss the issues raised over the last few weeks and to answer any questions that you may have.
I would like to begin by addressing the two fundamental issues raised recently, first by outlining briefly how medical devices are regulated and reviewed by Health Canada, and second, by outlining the role of external advisory bodies in this regulatory review process, and I will then conclude by providing you with an update on the status of the review of the six pending applications for breast implants.
As you are aware, breast implants—including saline and silicone gel-filled breast implants intended for reconstruction following mastectomy, primary augmentation, or for replacement—are regulated as medical devices in Canada. The importation, sale, and advertisement of medical devices in Canada are governed by the Food and Drugs Act and the medical devices regulations. Through the act, Parliament has created a legislative regime to govern the approval of medical devices for sale in Canada. This regime is given full effect through the medical devices regulations, created pursuant to the act.
Under this regime, the minister has the legal responsibility for approval of licences to permit the sale of these medical devices in Canada. In turn, the minister relies on Health Canada's scientific and regulatory expertise and its processes to execute this responsibility. Decisions are made following an independent, impartial, and objective analysis of the scientific evidence related to the safety, quality, and effectiveness of a medical device included in a licence application. Such decisions are taken in consideration of sound scientific expertise, in an environment that encourages collaboration among a team of experts skilled in a variety of fields and disciplines.
This process reflects the key principles that underpin both the integrity and quality of Health Canada's regulatory decision-making framework and the public's confidence in Health Canada's ability to fulfill its mandate and to make objective, evidence-based regulatory decisions. Health Canada's decision-making framework outlines the key principles that guide such evidence-based decision-making. These include a recognition of the need for comprehensive information; the value of team work and expert opinions, given that sound evidence-based decisions can only come from a collaborative process where varying opinions are encouraged and considered in all phases of an evaluation; and the value of the multiple disciplines of the experts whom we consult and of the Health Canada employees who contribute to our decision-making teams. Such disciplines include microbiology, material sciences, medicine, chemistry, physiology, toxicology, engineering, and ethics.
The medical devices regulations are based on a current, internationally consistent, risk-based approach. I note this point in addition to our recognition of the need for comprehensive information to support decision-making, as they are, together, the core determinants of Health Canada's regulatory approach with respect to higher-risk—or class IV—medical devices such as breast implants. The medical devices regulations and Health Canada's publicly available guidance documents outline that manufacturers of class IV medical devices must submit certain specific information in support of each medical device licence application. This information alone, in addition to any information obtained from external experts and the public, represents a very significant amount of scientific, manufacturing, and quality data, which Health Canada reviews in order to reach a regulatory decision.
I'll also note that the panel was requested to provide its advice in response to very specific questions posed by Health Canada, related to the safety and effectiveness of the silicone gel-filled breast implants described in the device licence applications—advice to inform Health Canada's assessment of those specific medical device licence applications.
The panel was not asked to make a decision on behalf of the minister or Health Canada, nor was it asked to recommend whether any of the specific products should or should not be licensed for sale in Canada. That decision is the responsibility of Health Canada alone, to make on behalf of the minister. As this committee is aware, the advice resulting from the expert advisory panel's deliberations was presented in the panel's final report to Health Canada on December 2, 2005, and, following a review for confidential information and translation, was made publicly available by the previous Minister of Health on January 12, 2006.
The panel's work is now concluded, and its report speaks for itself with regard to the various viewpoints represented on the panel. It is now being taken into consideration by Health Canada as one important piece of information, among others, in the regulatory review of the six pending medical device licence applications for silicone gel-filled breast implants.
Health Canada's decision will be based on a solid, evidence-based, scientific assessment of all the information before it. It is public knowledge that Mentor Corporation and Inamed Corporation each have separate medical device licence applications currently under review by Health Canada. The first of six licence applications was received almost five years ago. The Health Canada review team is led by two scientists, one with a degree in chemistry and the other with a degree in material sciences, and input is received from medical officers and biomedical engineers as required. Together, these individuals have more than 20 years of experience in the regulatory review of medical device issues.
Health Canada has examined more than 65,000 pages of evidence submitted by the manufacturers. Health Canada has reviewed the scientific literature, the report of the expert advisory panel on breast implants, documentation from the American Food and Drug Administration, and submissions from interest groups and interested persons. The scientific literature alone consists of over 2,500 articles, including over 300 review articles dating from the 1960s. In the interest of obtaining comprehensive information to inform the review of each of these applications, Health Canada has most recently in January 2006, during the course of these separate reviews and consistent with the advice received from the expert advisory panel on breast implants, requested that each manufacturer clarify existing information, or provide additional information. Health Canada is continuing with its reviews of these applications, and once these assessments are completed, regulatory decisions will be made in accordance with the responsibilities conferred upon it via the minister's role under the Food and Drugs Act and the medical devices regulations.
The potential decision for each application is one of the following: a licence for general sale in Canada, a licence with post-approval conditions, or a refusal to licence. Once the regulatory decisions have been made, Health Canada commits to reporting publicly to Canadians, through the publication of a summary basis-of-decision document for each application, outlining the nature of the evidence considered and the conclusions reached.
In conclusion, I would like to reiterate that the legislative regime created by Parliament and given full effect through the medical devices regulations to govern the approval of medical devices for sale in Canada and the execution of the responsibilities Parliament conferred upon the Minister of Health through Health Canada's scientific and regulatory expertise and processes is strong. It's built upon the independent, impartial, and objective analysis of evidence that is supportable and is driven by the key principles. These principles support the use of a collaborative process in which comprehensive information and varying opinions from multiple disciplines and consideration of all of the best scientific evidence are integral to regulatory decision-making.
Thank you very much, Mr. Chair. Those are our opening remarks. I do need to advise the committee that, regrettably, I have to leave after the first portion of this hearing, but my colleague Dr. Sharma is available throughout.