REPORT OF THE COMMITTEE
Tuesday, April 30, 2013
The Standing Senate Committee on Social Affairs, Science and Technology
has the honour to present its
Your committee, to which was referred Bill S-202, An Act to establish and maintain a national registry of medical devices, has, in obedience to the order of reference of Wednesday, November 2, 2011, examined the said bill and now reports as follows:
Your committee recommends that this bill not be proceeded with further in the Senate for the reasons that follow.
Your committee has heard that Health Canada currently has the necessary authorities in place to adequately regulate medical devices through the Medical Devices Regulations under the Food and Drugs Act. Also, your Committee heard that Canada’s pre-market evaluation requirements are rigorous and comprehensive in comparison to regulators in other jurisdictions.
Your committee heard that the safety of medical devices in Canada is a shared responsibility. Any requirement for physicians or health care providers to maintain or provide patient information to a national registry goes beyond the federal role.
Your committee also heard that a national medical devices registry containing names and addresses of patients, as proposed in Bill S-202, would pose significant privacy concerns. While the voluntary nature of the disclosure addresses some of the privacy concerns, it would at the same time greatly limit the impact and effectiveness of the proposed registry.
Your committee believes that the implementation of Bill S-202 would represent a significant cost to the Canadian taxpayer and that those costs would outweigh the benefits of the proposed registry.
As an alternative, your committee believes that a comprehensive national integrated electronic health records system would be a more useful vehicle for capturing, maintaining and monitoring patient data, including that related to medical devices, to achieve the goals set out in Bill S-202.
KELVIN K. OGILVIE