Bill C-17 (Historical)

Protecting Canadians from Unsafe Drugs Act (Vanessa's Law)

An Act to amend the Food and Drugs Act

This enactment amends the Food and Drugs Act regarding therapeutic products in order to improve safety by introducing measures to, among other things,
(a) strengthen safety oversight of therapeutic products throughout their life cycle;
(b) improve reporting by certain health care institutions of serious adverse drug reactions and medical device incidents that involve therapeutic products; and
(c) promote greater confidence in the oversight of therapeutic products by increasing transparency.

[Dr. Lorraine Greaves]

Okay, I will.

By and large, this is a non-medically necessary procedure.

I'll just wrap up by saying a few words about postmarket vigilance on all devices. Vanessa's Law came into effect in 2019, mandating hospitals to report adverse reactions. There have been promises to extend this to long-term care and private clinics. We need that. We need that to support a robust registry.

Second, Canada does not yet have mandatory sex- and gender-related reporting of data in submissions by industry for devices or drugs, despite a federal SGBA+ policy. Therefore, we don't have adequate warning labels and consumer and clinician monographs.

Promises have been made to improve this. Some promises have been fulfilled, but there's a long way to go. It is extremely important that, even though the pace of these commitments has been slower than we thought, these goals should not be eliminated or reduced by departmental budget cuts.

I will conclude by saying that it's past time to have a registry. It's past time to compel parties to take these important steps on medical devices.

Thank you very much.

[Raj Malik, Vice-President, Federal Affairs and National Strategic Partnerships, Medtech Canada]

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.

[Pamela Aung-Thin]

Thank you for the question. I can start off and perhaps my colleague Linsey can add in anything she wishes.

As we outlined earlier, there are a number of recommendations in the report and we have agreed with all five of them. I'll also add that leading up to the report there already had been work started, and that was clearly under way to tackle some of the gaps that came out later in the report.

I think the deputy minister covered fairly extensively earlier that we continue to pursue legislation through Vanessa's Law to provide additional protections for consumers, and that follow-up continues fairly vigorously as we work with our colleagues not only internally but with central agencies to move that forward.

Linsey.

[Dr. Stephen Lucas]

Mr. Chair, I'm not aware of a mandatory review time for Vanessa's Law specifically, but as I indicated, we are committed to having that legislative change made as quickly as possible. The decision was made at the time to not include natural health products, and we want to see that change made at the earliest possible opportunity.

[Jeremy Patzer, Conservative, Cypress Hills—Grasslands, SK]

Okay. For lots of regulations, there's a mandatory review time frame. Is there one in place for Vanessa's Law, or is this something that is basically just left up to your department to do whenever it sees fit?

[Dr. Stephen Lucas]

I think the department's commitment, as outlined in the response to the audit report and our management response in our testimony today, clearly commits us to seek the legislative change needed to add natural health products to Vanessa's Law and we will seek the earliest possible opportunity to do that in consultation with central agencies and others to enable that legislation to move forward as quickly as possible.

[Dr. Stephen Lucas]

As I indicated, and as is outlined in the report, Health Canada does believe and will seek the opportunity to include in Vanessa's Law natural health products, such that those increased fines and other powers, such as product recall, can be granted.

In regard to information on when products are brought to market and requirements for site license information for quality review, we are taking steps now and have been taking steps to strengthen that, as my colleagues have noted. We'll be making modifications to the regulations to build in those requirements. On the side of notification and the site licence information, those would be regulatory changes, but we are taking steps in advance of that at this time.

[Dr. Stephen Lucas]

I think it was initially advice provided in Bill C‑51 in 2008. It was not included in Vanessa's Law, which received royal assent in 2014. The department has been working and continues to work to see that these authorities—

[Philip Lawrence, Conservative, Northumberland—Peterborough South, ON]

With respect, I'd like to ask specific questions and I'd like some very specific answers. When was the first time your department asked for the strengthening of Vanessa's Law to include natural health products?

[Philip Lawrence, Conservative, Northumberland—Peterborough South, ON]

Just on that, since Vanessa's Law was passed in 2014, Deputy Minister, how many times have you asked the government to change the laws? Has the government responded in the, I guess, eight years now since then? How many times have you asked, when did you first ask, and what has been the government's response and when will they give you these powers?

[Dr. Stephen Lucas]

Okay. I will make one further point before passing this to Linsey Hollett on that point.

One of the recommendations in the audit and an area that Health Canada has been working to address is to strengthen our powers for mandatory recall, mandatory labelling changes and increased fines, for example. These were not included in Vanessa's Law, which was passed in 2014, as I noted, and we are working to have those included.

Linsey, can you speak specifically to the recall issue?

[Dr. Stephen Lucas, Deputy Minister, Department of Health]

Thank you, Mr. Chair and committee members, for the opportunity to appear before you today.

Joining me today are Pam Aung-Thin, associate assistant deputy minister of the health products and food branch, which is responsible for product and site licensing, as well as monitoring of advertising; and Linsey Hollett, director general of health product compliance for the regulatory, operations and enforcement branch, which supports the compliance and enforcement of natural health products.

Natural health products are used by Canadians daily to care for themselves and their families. They include vitamin supplements, minerals, probiotics, herbal remedies, homeopathic products and traditional products, such as traditional Chinese medicines. Natural health products also include frequently used products such as toothpaste, mouthwash and sunscreen. Particularly relevant in the context of COVID-19, they also include alcohol-based hand sanitizers.

In Canada, these products are regulated under the Food and Drugs Act and the Natural Health Products Regulations. Through the natural health products program, Health Canada provides oversight to ensure that the natural health products available for sale in Canada are safe and effective.

Overall, the audit found both strengths and areas for improvement.

The audit found that Health Canada licensed products appropriately, based on evidence of safety and efficacy. The audit also found that, when an issue was brought to Health Canada’s attention, immediate action was taken.

It also identified areas for improvement, such as the need for increased oversight on the quality of natural health products, greater monitoring of labels and advertising and improving labelling compliance and enforcement activities. The recommendations validated key gaps that the department had already identified and started working on to address prior to the audit.

The audit supports the direction Health Canada is taking to strengthen the oversight of these products.

To address the recommendation to improve quality oversight, Health Canada has taken steps to require site licence applicants to demonstrate compliance with good manufacturing practices, such as by requiring test results instead of relying on an attestation-based approach.

In March 2021, Health Canada launched the natural health products good manufacturing practices inspection pilot to promote and verify industry compliance with the regulatory requirements through inspections of licence-holders across Canada. Results of the pilot to date are demonstrating a high rate of non-compliance and a need to further industry education as well as ongoing, proactive, risk-based oversight. In this regard, Health Canada is on track to implement a permanent good manufacturing practices inspection program to increase oversight of NHPs and better protect Canadians.

The department is building on work that began during the pandemic to expand its oversight of online advertising of natural health products to ensure that advertisements are consistent with the product license.

Additionally, the department recently consulted on a regulatory proposal to improve product labelling with the objective of ensuring that labels are clear, consistent and legible for consumers to support the safe use of these products.

In response to the audit, Health Canada indicated its intent to propose new tools to strengthen the department’s ability to deter and address non-compliance, notably the extension of powers under the Protecting Canadians from Unsafe Drugs Act to natural health products. Known as Vanessa's Law, which received royal assent in 2014, this law strengthened Health Canada’s ability to collect information and take quick and appropriate action when a serious health risk is identified for therapeutic products and medical devices. However, these authorities do not exist for natural health products, and as a result, we lack the authority to force a recall or a label change of a product, even in the case of a serious health risk such as contamination.

In our departmental response to the audit findings, Health Canada reaffirmed the need for sustainable and predictable funding through fees charged to industry to support increased oversight of these products. Natural health products are the only line of health products for which all regulatory activities are funded by the public. Revenues from fees would support pre- and post-market regulatory activities, including inspections of the facilities that make them.

In closing, Health Canada’s priority is the health and safety of Canadians. For many Canadians, natural health products are an important part of maintaining a healthy lifestyle. Health Canada welcomes the commissioner’s recommendations and is committed to the continuous improvement of the NHP program to ensure that the products sold in Canada are safe and effective.

Again, I would like to thank the committee for inviting me.

I will be pleased to answer any questions you may have.

[Dr. Durhane Wong-Rieger]

First of all, we want to make sure we do not have the barriers that the proposed reforms to the PMPRB would have, and that is to discourage countries from coming in.

I think we want to talk about having a national program that would allow us to bring in all of those patients. The numbers are small, so we're not going to be able to....

Most of these drugs have to come into specialty clinics, so we have a proposal for a rare disease strategy that would also include centres of excellence. They would include the ability to do what we call a life-cycle approach. We can bring in the drugs. We can identify early on, as we're bringing them in, which patients are going to be immediately eligible—like those with ALS—and which ones are not at all going to be eligible, set up a monitoring program for them to have access to it, and then over time, as we are learning from those patients who are on it....

In the old days, we would call it post-market monitoring. As Cathy talked about, under the new bill, Bill C-17, we can enforce those kinds of post-market monitoring programs that we can learn from.

We have a lot of tools at our disposal and, quite frankly, we do not necessarily need to invent them. We can look at some of the model programs we've put together. Canada knows how to do this. We already have these kinds of monitoring programs with very specific drugs, but we want to be able to make that the standard, make it so we can do it nationally, which we don't necessarily do well, and then not wait until we've gone through two more years of negotiations before we implement it.

We know how to do it. We just need to make sure we put that template in place and have the specialty clinics that are there also able to support the use of them, and, as she talked about, the administration of them, and the ongoing data collection to make sure they're used appropriately and, at the end of the day, price readjustment.

[Catherine Parker]

You are correct that in 2012 the Minister of Health announced that Canada was going to proceed with the development of an orphan drug framework for Canada. We advanced a significant amount of work under that project. Most notable was the enactment of Bill C-17, Vanessa's law, which gave the regulator under the Food and Drugs Act many more powers that would be useful, especially in the rare disease space.

At that time we also considered going forward with a specific set of regulations. We decided on a change of course in this respect. We had conversations and dialogue with our international regulatory partners on some of the challenges they face because they had specific legislation for orphan drugs. We ultimately decided not to proceed with specific regulations, but through a regulatory review of drugs and devices initiative, we incorporated new processes and new pathways that could be very valuable for the approval of orphan drugs and also for some other products.

[Colin Carrie, Conservative, Oshawa, ON]

Dr. Tamblyn, I think that's a great idea on the adverse drug events. I mentioned Vanessa's Law and the safety component. What kind of doctor uptake and buy-in are you getting with this adverse drug reaction reporting? Do you have an update on how things are going with Vanessa's Law?

Professor Herder, do you?