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.

[Blaine Calkins, Conservative, Red Deer—Lacombe, AB]

That's a good question. Thank you, Mr. Julian, for your question. You're exactly right.

Here's how it played out: Bill C-51 was brought forward. I don't think the industry responded well to Bill C-51 back when that happened. The right thing to do when Parliament or a government in the House of Commons makes a mistake is to step back, ask “What have we done?”, and then consult with the industry, consult with stakeholders, and consult with people who are going to be affected by this.

Mr. Julian, if the claim that 80% of Canadians.... You asked me during the debate on Bill C-368 whether I take these products. You and I are part of the 80% of Canadians who take them. As a matter of fact, you and I both take magnesium, which is very understandable, considering the lifestyles and the work demands that we have.

That's how you do it. You do it by engaging. What's missing in this particular case is that the government did make a misstep with Bill C-47. The misstep is that it didn't consult with the industry and that it was tucked into a budget implementation act. It passed basically with no discussion. I don't recall anybody in the debate on Bill C-47 even raising the issue, because it was just four little lines in this great big omnibus piece of legislation, until people figured out what was actually going on with the implementation of the self-care framework. Then the industry came forward and asked the government, similar to what it did with Bill C-51 and Bill C-17, to take a step back and to consult the industry before moving forward. That's how you do things in a constructive way.

What I've seen happen here is that the government has not only dug in on Bill C-47 but has also doubled down on it in Bill C-69, the next budget implementation act, giving the power to Health Canada and to the minister to make immense changes to the industry.

To my knowledge, to this day the industry has not been consulted by the minister, who's been responsible for making those last two changes.

How can you build goodwill and get to a place where everybody is happy, where Canadian consumers are happy, where the industry is happy and where the government can provide adequate oversight? Nobody's arguing that there should be no oversight. We're simply saying, the industry is saying and Canadians are saying that there was not a really big problem with the way things were, and if there are a few small flies, we don't need to swat them with a sledgehammer. That seems to be what's happening.

My recommendations would be to pass Bill C-368 and take it back, and then, if the government does have some legitimate problems, start all over again. Start working with the industry on a broader level. Do consultations before making this kind of a misstep again, because we've riled up thousands—millions—of Canadians with this, as has been evidenced by the cards we've received, and rightly so, Mr. Julian.

Our job, as members of Parliament, is to work on behalf of Canadians, not to work on behalf of the government.

[Peter Julian, NDP, New Westminster—Burnaby, BC]

Thank you very much, Mr. Chair.

I congratulate you, Mr. Calkins. You have a long experience in the House; it's almost 20 years, I believe. The fact that you've brought the bill this far is an exception in terms of private members' bills. You're obviously responding to a very clear need. There is no doubt that the issue of natural health products bears much closer examination. That is why I and the NDP voted for the bill to get to committee so that we can do this more extensive examination.

You didn't mention in your introduction—but I think it's fair enough to reference—that this is the third time since we've been in the House of Commons that we've had bills that have an impact, or a potential impact, on natural health products. I'm referencing, of course, Bill C-51. That was brought forward by the Harper government. It was, in the end, not adopted. Then there was Bill C-17, Vanessa's Law. Those were both under the Harper government. We now have the most recent legislation that's been brought forward.

In your preface to your initial statement, I think your very eloquent reference to the importance of the industry and the importance of natural health products was absolutely valid. We've been going around in circles on this issue. The industry obviously needs some assurance that what will be put into place will benefit the industry and will benefit consumers. I count myself as one of the consumers of natural health products. In fact, I take magnesium because my doctor prescribed it; it makes a difference on the long hauls that we take, which I will be taking shortly to go back to B.C. This is important.

We've had a number of different iterations of the bills. How do we get the balance right to ensure that we are actually benefiting the industry and making sure that consumers have access to important natural health products, while also making sure that there is some oversight?

Food and Drugs Act

[Alistair MacGregor, NDP, Cowichan—Malahat—Langford, BC]

Madam Speaker, I am very pleased to speak to Bill C-368. I would like to thank the member for Red Deer—Lacombe for bringing it forward for the House's consideration.

The reason I am very pleased is that the issue of natural health products has garnered a lot of attention in my riding of Cowichan—Malahat—Langford. I have had a lot of constituents and local businesses approach me concerning this issue in particular. I am pleased to be able to stand here, as their elected representative, and let my constituents know that I will be supporting the bill at second reading.

I was also very pleased to be able to add my name as a joint seconder to the bill. To fulfill the wishes of my constituents, I will be voting to send it to committee for further study.

What are we talking about when we say “natural health products”? I have always thought it a weird thing that they are regulated under a statute such as the Food and Drugs Act. They are not really a food, nor are they a drug. They occupy a special place for many people. We must face that humans have had relationships with natural health products dating back thousands of years. Many of these products have a very special place in human history, and a lot of cultures have very long relationships with them.

Today, in the modern world, natural health products often come in a variety of forms, such as tablets, capsules, tinctures, solutions, creams, ointments and drops. There is quite a large variety for people to pick and choose from. They are often made from plants, but they can also come from animals, from micro-organisms and from marine sources. They include vitamins and minerals, herbal remedies, homeopathic medicines, traditional medicines, probiotics and other products, such as amino acids and essential fatty acids. They are found in many everyday consumer products.

Let us come to the bill in question, Bill C-368. As shown in the summary, it would amend the Food and Drugs Act to provide that natural health products are not therapeutic products within the meaning of that act and, therefore, are not subject to the same monitoring regime as other drugs.

Before we get into the substance, we need to take a little history lesson on how we arrived here. I want to say that both Conservatives and Liberals have run into trouble when trying to regulate natural health products. In fact, the previous government, under Harper, learned this lesson very quickly back in 2008 when it introduced Bill C-51. That was also an act to amend the Food and Drugs Act. Under Bill C-51, the term “therapeutic products” encompassed a range of products sold for therapeutic purposes, including drugs, medical devices, biologics and natural health products. In the end, because of an election, that bill was never adopted. However, I believe the Harper government at that time learned its lesson because of the uproar that came in response to Bill C-51, and it did not attempt to change Canada's regulations for natural health products again while in government.

What the Harper government did do, in 2014, was introduce Bill C-17 to amend the Food and Drugs Act. It was also known as Vanessa's Law. This introduced a definition for the term “therapeutic product”, but what was different this time was that the definition was worded in such a way that it did not include natural health products, within the meaning of the natural health products regulations.

We then fast-forward to the present Liberal government and Bill C-47. That bill, in a clause buried deep within a budget implementation act, again amended the term “therapeutic product” to make sure that the exemption from the natural health products regulations was actually removed. This has caused much of the uproar we see today.

I want to point out, as I said in my intro, that natural health products have a long history of use in Canada as low-risk, affordable methods of promoting well-being. It is very important that I stand here today and say unequivocally that they must remain accessible to all Canadians. I am proud to be a member of a caucus, the NDP caucus, that has long supported an appropriate regulatory category for natural health products to certify their safety and efficacy based on sound evidence, as well as to ensure that they are widely available for those who use and value them.

It is unacceptable that the changes to the regulatory regime under the Food and Drugs Act was snuck into a budget omnibus bill, because it did not allow for proper study. I am glad to see that, because Bill C-368 is a stand-alone, quite simple and easy-to-read piece of legislation, from reading the room, it should have enough votes to send it to committee. We can then have the proper study; hear from Canadians and businesses that sell natural health products, the practitioners involved in this every day; and, finally, get the proper scrutiny that this issue so richly deserves.

I do not want to spend too much longer speaking to the bill, but I want to talk a bit about the people in my riding of Cowichan—Malahat—Langford who took the time to write to my office, phone me personally and come into my office. In particular, I want to recognize a few of the local businesses. Essential Remedies, Benoit and Associates Health Education, some holistic health practitioners, the Community Farm Store, Botanical Bliss, a certified homeopathic practitioner, a naturopathic physician and Lynn's Vitamin Gallery all took the time in the summer of 2023 to come into my office. We had a great round table discussion. It lasted well over an hour. It was really enlightening for me, as their member of Parliament, to hear their views on this subject and learn a little more about why it is so important.

Yes, my immediate family definitely uses natural health products, and I know that many friends and relatives in my immediate vicinity also use them. However, to hear from professionals who work with clients every day about why this issue is so important was particularly enlightening for me. It is also important to note that 71% of Canadians, which is a very big number, have used natural health products, such as vitamins and minerals, herbal products and homeopathic medicines. Therefore, it is important that, when the NHP community speaks to their elected representatives, it represents a very clear majority of Canadians. Based on a proper cross-sampling of the correspondence that I, like many other members, have received, I know that they want their elected representatives to treat this issue with the seriousness that it deserves and give the bill full scrutiny.

Finally, I want to congratulate the NHP community and industry, which have been very actively engaged on this issue through their work. I really want to single out the local businesses in my riding of Cowichan—Malahat—Langford and the constituents who live on Vancouver Island. I congratulate them for their advocacy, for stepping up to the plate and for engaging me as their elected representative, because it has worked. I am proud to say that, in this place, as their elected representative, I will be pleased to vote to send Bill C-368 to committee.

[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.