Thank you, Mr. Chair and members of the INDU committee.
On behalf of Medtech Canada, we're grateful to have the opportunity to participate in the committee’s review of Bill C-244. My name is Raj Malik. I am the vice-president of federal affairs for Medtech Canada. Joining me today is Mia Spiegelman, Medtech Canada’s vice-president of regulatory affairs.
Medtech Canada is the national association representing Canada's innovative medical technology industry. We represent approximately 120 member companies that range from small emerging med-tech companies to large multinationals serving the Canadian market, collectively employing over 35,000 Canadians. Medical devices range from the smallest technologies, such as pacemakers, to the largest of diagnostic imaging technologies, such as MRIs, and everything in between.
With our time at the committee today, I would like to share some insights on the current regulations under which the med-tech industry operates and how this relates to our recommendations for Bill C-244 to ensure protections for patients and health care providers are upheld.
Our primary concern with the proposed amendments to the Copyright Act in Bill C-244 is that this would allow for the access to highly sensitive medical technology software by unregulated and untrained service providers. In addition, the amendments would allow for the creation of uncontrolled and unregulated service parts for medical devices, leading to potential patient or health care provider harm.
To be clear, our industry continues to support the availability of federally regulated third party entities to service and repair medical devices. We know this is critical to the functioning of the Canadian health care system.
Medical devices in Canada are heavily regulated by our federal government. Most medical devices undergo a rigorous licensing process that ensures the medical devices sold in Canada are safe for use, and this includes any related software and accessories. In addition, most facilities or organizations that handle medical devices throughout the supply chain are also regulated, such as hospitals, manufacturers, importers, distributors and regulated third party service providers that fall under their umbrella. Through this network, we ensure that throughout the life cycle of a medical device, which can range anywhere from seven to 15 years, the device remains as effective and safe as the day it was approved for sale into Canada.
At this time, third party service providers who provide only a service of repair are not covered under any government quality assurance regulations, which leaves very little protection for our patient and health care provider populations.
As an example of federal safeguards, the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) was passed in 2014. This legislation was brought forward by the Oakville MP at the time, Terence Young, following the death of his 15-year-old daughter Vanessa in 2000 when she used a prescribed therapeutic product as intended but suffered an adverse reaction.
Vanessa’s Law was enacted to further tighten the post-market surveillance and oversight of therapeutic products. As of 2019, manufacturers, importers and other companies across the supply chain are now required to further analyze and/or gather reports on risks and issues identified after the medical device is sold into the Canadian market. Unregulated third party service providers, on the other hand, are not currently captured under these requirements.
Additionally, unregulated service providers today are not required by Health Canada to adhere to any standard procedures such as proper training of personnel, evaluating parts suppliers, calibrating tools, maintaining records of device service and preventive maintenance or maintaining device design.
The current Copyright Act prevents unregulated third party servicers both from circumventing technical protection measures—TPMs—in our medical devices and from replacement of untested or unapproved repair parts. These protection measures ensure that only highly trained and authorized service providers can access this highly sensitive technology to perform the necessary repairs. These protections are in place to lower the risk of impacting device effectiveness and the risk of causing serious medical harm to patients.
When it comes to medical devices, TPMs are vital to the safety of patients and health care providers, as they are an integral part of what Health Canada reviews during the licensing process. TPMs ensure the device functions properly and alarms appropriately and that malicious actors cannot access patient data. If TPMs are bypassed and software modified improperly, serviced medical equipment can malfunction, causing risk to patients and technicians.
In conclusion, as medical devices are heavily regulated products requiring licences and adherence to robust safety standards, including aftermarket surveillance and reporting requirements, allowing access to unregulated third party servicers undermines existing safety measures that protect patients and our health care providers today. On behalf of Canada’s medical technology industry, we strongly recommend that medical devices and technologies regulated for sale by Health Canada be provided a specific exemption in any proposed amendments to the Copyright Act.
Thank you. We will be pleased to take any questions.