THE STANDING SENATE COMMITTEE ON SOCIAL AFFAIRS, SCIENCE AND TECHNOLOGY
EVIDENCE
OTTAWA, Wednesday, May 29, 2024
The Standing Senate Committee on Social Affairs, Science and Technology met with videoconference this day at 4:15 p.m. [ET] to examine the subject matter of those elements contained in Divisions 3, 4, 5, 14, 21, 22, 23, 31, 32 and 38 of Part 4 of Bill C-69, An Act to implement certain provisions of the budget tabled in Parliament on April 16, 2024.
Senator Ratna Omidvar (Chair) in the chair.
[English]
The Chair: I’m Ratna Omidvar from Ontario, Chair of the Standing Committee on Social Affairs, Science and Technology.
Before we begin, I ask all senators and other in-person participants to consult the cards on the table for guidelines to prevent audio feedback issues. Please take note of the following preventative measures in place to protect the health and safety of all participants, including the interpreters:
If possible, ensure that you are seated in a manner that increases the distance between microphones. Please only use an approved black earpiece; the former grey earpieces may no longer be used. Please keep your earpiece away from all microphones at all times. When you’re not using your earpiece, please put it face down on the sticker placed on the table in front of you for this purpose. Thank you all for your cooperation.
Today we’re studying the subject matter of certain elements contained in Part 4 of Bill C-69, An Act to implement certain provisions of the budget tabled in Parliament on April 16, 2024. We will focus today on Divisions 23, 31 and 32, which bring amendments to the Employment Insurance Act, the Food and Drugs Act and the Tobacco and Vaping Products Act, or TVPA. As our study examines the subject matter of these elements, the report of this committee will be made to the Standing Senate Committee on National Finance, and the final report on Bill C-69 will be made by the Standing Senate Committee on National Finance to the Senate of Canada.
Before we begin, I would like to ask my colleagues to introduce themselves to the audience, starting with the deputy chair of this committee, Senator Cordy.
Senator Cordy: Welcome to our committee. I am Jane Cordy, senator from Nova Scotia.
Senator Osler: Gigi Osler, senator from Manitoba.
[Translation]
Senator Cormier: Welcome. I’m Senator Cormier from New Brunswick.
[English]
Senator Burey: Sharon Burey, senator from Ontario.
Senator Moodie: Rosemary Moodie, senator from Ontario.
Senator Bernard: Wanda Thomas Bernard, senator from Nova Scotia, Mi’kmaq territory.
[Translation]
Senator Petitclerc: Chantal Petitclerc from Quebec.
Senator Seidman: Judith Seidman from Montreal, Quebec.
Senator Mégie: Marie-Françoise Mégie from Quebec.
[English]
Senator Dasko: Donna Dasko, senator from Ontario.
The Chair: Thank you, colleagues.
Today, we welcome officials from Health Canada: Celia Lourenco, Associate Assistant Deputy Minister, Health Products and Food Branch; David K. Lee, Chief Regulatory Officer, Health Products and Food Branch; and Sonia Johnson, Director General, Tobacco Control Directorate, Controlled Substances and Cannabis Branch. Thank you for joining us today.
We also welcome, for the second part of our meeting, officials from Employment and Social Development Canada, or ESDC: Benoit Cadieux, Director, Policy Analysis and Initiatives, Employment Insurance Policy Directorate, Skills and Employment Branch; and Russell Sharpe, Manager, Policy Analysis and Initiatives, Employment Insurance Policy Directorate, Skills and Employment Branch. Your cards must be very big to hold all of that information.
We will begin with opening remarks from Health Canada, followed by remarks from ESDC. I understand that Ms. Lourenco and Ms. Johnson will be making the remarks today from Health Canada.
Celia Lourenco, Associate Assistant Deputy Minister, Health Products and Food Branch, Health Canada: Good afternoon. Thank you for the opportunity to speak with you today. I’m joined by David Lee, Chief Regulatory Officer for our branch.
[Translation]
We’re here to speak with you about Division 31 of Part 4, which proposes a number of amendments to the Food and Drugs Act. Health Canada regulates the safety, efficacy and quality of therapeutic products, such as drugs and medical devices, as well as food. While Canada’s regulations governing the sale of therapeutic products and food work well in most situations, situations can arise where it is in the public interest to tailor our regulatory approach to ensure that people in Canada have access to the products they need.
[English]
The Budget Implementation Act proposes three key amendments that will provide the Minister of Health with new authorities to, first, put in placing targeted exemptions from specific regulatory requirements for therapeutic products or food adding conditions as appropriate to ensure that health and safety standards are met; second, rely on information or decisions from select regulatory authorities to satisfy specific regulatory requirements for therapeutic products or food; and third, put in place supplementary rules for certain therapeutic products to protect against potential health risks or adverse effects.
The budget implementation act also proposes three other more technical amendments. For example, Division 31 expands existing regulation-making authorities for shortages, to include foods for a special dietary purpose like infant formula. It also streamlines the process of updating performance standards documents incorporated by reference and addresses inconsistencies between the English and French definition of “drug.” The new authorities will improve regulatory flexibility and adaptability while maintaining Health Canada’s rigorous scientific standards for therapeutic products and foods.
You may have read in the budget document about some of the real ways that this legislation will make a difference for Canadians and their families. This includes being able to respond effectively during shortages of important products, such as infant formula. It would also allow us to take action to protect Canadians from potential harms associated with the unintended use of therapeutic products, such as keeping nicotine products intended to help adults quit smoking out of the hands of children and youths.
On the other hand, I assure senators that this legislation is not intended to ban, block or reduce the availability of the products that Canadians rely on, bypass Health Canada’s stringent scientific approval processes or regulate in any way the ability of health professionals to direct the treatments they believe are best for their patients.
[Translation]
This legislation would ensure that Health Canada has the necessary regulatory tools to facilitate access to safe, effective high-quality therapeutic products and food.
We are happy to take any questions.
[English]
Sonia Johnson, Director General, Tobacco Control Directorate, Controlled Substances and Cannabis Branch, Health Canada: Good afternoon, everyone. I’m pleased to be here to speak to you today about Division 32 of Part 4 of Bill C-69, which proposes a number of amendments to the Tobacco and Vaping Products Act. These amendments would support the tobacco and vaping cost recovery frameworks that are currently being proposed in Bill C-59. The implementation of these cost recovery frameworks would help minimize the cost burden on taxpayers of funding federal tobacco and vaping activities.
The proposed amendments under Bill C-69 would enhance the sharing of information related to tobacco and vaping products across the federal government. These amendments would support the administration and enforcement of the Tobacco and Vaping Products Act. Specifically, if the cost recovery provisions in Bill C-59 are adopted, we would be able to validate the information received from tobacco and vaping manufacturers. This information would be used to calculate the fees or charges to be paid.
The amendments would, first, authorize the Canada Border Services Agency to provide Health Canada certain customs information collected under the Customs Act; and second, enable Health Canada to disclose information collected under the Tobacco and Vaping Products Act with other federal departments and agencies. This would make it possible to verify compliance with other federal legislation, such as the Customs Act and the Excise Act, 2001.
The budget implementation act also proposes a technical amendment regarding documents such as forms developed by Health Canada in relation to future cost-recovery-related regulations. This would allow us to reference the documents in those regulations so the documents can be periodically amended without amending the regulations.
If Bill C-59 is adopted, this provision would provide flexibility and increased efficiency for the implementation of the proposed tobacco cost recovery framework. We’re happy to take any questions. Thank you.
The Chair: Thank you, Ms. Johnson.
[Translation]
Benoit Cadieux, Director, Policy Analysis and Initiatives, Employment Insurance Policy Directorate, Skills and Employment Branch, Employment and Social Development Canada: Good morning, honourable senators. My name is Benoit Cadieux. I’m the director responsible for the employment insurance policy on regular and fishing benefits at ESDC. With me today is Russell Sharpe, the manager responsible for the EI policy on regular and fishing benefits at ESDC.
[English]
Today, I will be speaking to Division 23 of Part 4 of the bill, which can be found on page 549.
Division 23 would amend the Employment Insurance Act to extend by two years — from October 26, 2024, to October 24, 2026 — the end date of the current temporary Employment Insurance legislated measure that provides additional weeks of EI regular benefits to workers in seasonal employment in specific EI economic regions. This extension would enable eligible workers and seasonal employment in those 13 targeted EI regions to continue to have access to up to five additional weeks of EI regular benefits, to a maximum entitlement of 45 weeks in their off-season.
Thank you. With that, I’m happy to respond to questions.
The Chair: Thank you very much, Mr. Cadieux. We have a line-up of senators wanting to ask questions. We will provide four minutes each.
Let me kick it off with the first question to Ms. Lourenco. When this committee hears about exceptions from regulatory environments, there’s always a concern about safety, efficacy and quality standards. Would you comment on this concern?
Ms. Lourenco: Thank you for the question, senator. The intent of the exemption authorities is to deal with extraordinary circumstances when we must support Canadians in having access to products in Canada. As an example, over the past two years, we have been grappling with a shortage of infant formula, and to address that shortage, we put in place an enforcement discretion approach, a policy approach that’s not grounded in the law.
Having an exemption authority will allow us to better manage these types of situations in the future. We could quickly issue a ministerial order that would provide rules for bringing new infant formulas or new products into the country that would deal with the situation we’re faced with. That’s a unique example of how the ability to exempt products from certain aspects of the act and regulations will allow us to bring products in quickly to address an unmet need in Canada.
To do so, we would ensure we’re bringing in products from reputable countries with very similar rules to ours; that is what we did for infant formula, through the enforcement discretion policy we put in place.
The Chair: I’ll have a follow-up question.
Senator Cordy: Thank you for being here with us. My question is related to Division 23 and the Employment Insurance Act.
These are temporary measures that would be extended by Division 23. They were introduced in 2018 as a pilot project and then extended in 2021, 2022 and 2023 in the budgets. Last year, we studied at this committee the extension for 2023.
Our committee said that the “. . . committee looks forward to the development of a more permanent solution that will support seasonal workers across the country.”
But here we are again, for the fourth year, having an extension with no permanent position or legislation in place. Could you explain why it’s a temporary rather than permanent solution?
Mr. Cadieux: Thank you for your question.
Extending the measure by an additional two years will continue to provide much-needed support for these seasonal workers who are depending on the Employment Insurance program during their off-season, and fill the gap until the next season starts.
I remember that last year there was a lot of criticism for repeated one-year extensions of the measure. This is in part why this year it is being extended for two years. This provides additional stability and predictability for those workers who are depending on the measure and those extra weeks of benefits. Nothing would prevent the government from later introducing a permanent measure to support seasonal workers on a permanent basis following this two-year extension. What the extension does is provide more flexibility for the government to develop a permanent solution for these workers.
Senator Cordy: I remember being on the Social Affairs Committee many years ago, and one of the senators asked a witness why we have seasonal workers and rules for seasonal workers. She responded with, “When we stop having seasons —” This is Canada. We’re going to have seasons, and yet this is the fourth time that we’re adding to this.
Is there work being done to either make it permanent or not make it permanent? I think it should be made permanent, but that would not be for me to tell the government. Is there work being done, rather than adding to it every year?
I look at this because our committee has just finished doing a report on temporary foreign workers. That policy has been in place for over 50 years. There has been a lot of tweaking of it but no larger changes made to it. Everything seems to be temporary. It seems to be the same thing is happening here.
Could you reassure me that, after these two years, a solution will be found? Maybe you can’t do that, but could you at least tell me if they’re working toward a permanent solution, whether it’s to give the extra five weeks or not? Hopefully, it is to give the extra weeks.
Mr. Cadieux: I assure you that the government has mentioned many times that it remains committed to improving the EI program, including for seasonal workers. As I said, the two-year extension will provide more time to find an appropriate permanent solution for these workers.
I can add that since the pilot was first introduced in 2018, the labour market has gone through many changes. It’s important to take the appropriate amount of time to ensure that a permanent measure would continue to respond to the changing needs of those seasonal workers.
Senator Cordy: Thank you.
The Chair: Thank you, Senator Cordy. I think you’re working yourself up into an observation.
Senator Seidman: Thank you for being with us. My question is about section 31 for anyone prepared to answer. Please jump in.
On page 191 of the overview prepared by department officials with questions and answers, it’s noted that:
. . . nicotine replacement therapies are products developed to help adults stop smoking. However, nicotine is a highly addictive substance and if these products are marketed and made available to youth, they have the potential to result in exposure and potentially addiction to nicotine. This is an existing challenge, as companies have developed forms of nicotine delivery that do not contain tobacco, and therefore do not fall under the controls of the Tobacco and Vaping Products Act.
This is a serious problem. My first question is this: Why don’t nicotine products, given they’re so dangerous and addictive, fall under the Tobacco and Vaping Products Act? Why wouldn’t the government make that kind of change instead of what is proposed in this bill?
You talk about nicotine replacement therapy for adults. My second question is this: Why couldn’t that be in pharmacies and by prescription only, instead of behind counters in convenience stores? After all, it’s called a nicotine replacement “therapy.”
Ms. Lourenco: I’ll start before my colleagues, if they have anything to add after. Regarding your first question about why it is not under the Tobacco and Vaping Products Act, these nicotine replacement therapy products are therapies. They are products that have been reviewed for safety, efficacy and quality to help smokers quit smoking. They’re regulated under the Food and Drugs Act because they have a health and safety rationale and intended use as opposed to a recreational use, which is what the TVPA does in terms of regulating vaping products or regulating tobacco. Because they’re intended for health use, they’re regulated under the Food and Drugs Act and the food and drug regulations.
In the past, many of these products were prescription. Going back many years to the 1970s and 1980s, some of these products were prescription. Then, at a certain point, the decision was made to make them non-prescription, first, because we had a lot of experience with the use of these nicotine replacement therapy products; and second, to provide better access to these products for adults who are looking to quit smoking and help them in that journey.
Senator Seidman: We’re talking about things like pouches, for example, which are beautifully designed to attract young people. So you would classify pouches as nicotine replacement therapy; however, others might classify it as some kind of pleasurable activity, shall we say. That, for example, would be sold in a convenience store. You’re hoping that they’re used as replacement therapy, as a treatment for health with health benefits, but that is not always the case, and we know that for a fact.
Have you done research? Do you have data to show anything around the successful use of these products for smoking cessation? Do you have data on their abuse?
Ms. Lourenco: Thank you for the questions. These products are regulated as nicotine replacement therapy products, because that’s the claim being made by the manufacturer wanting to market those products in Canada.
What we’re trying to do with one of the authorities under the budget implementation act is introduce the ability to better manage these types of products, to ensure that we can control the place of sale, as well as aspects around appeal to youth, such as elements used in packaging, labelling and advertising, ensuring they’re only advertised for use as nicotine replacement therapy products. We would like the authority to introduce restrictions so that the products don’t fall into the wrong hands but are used, when needed, by adults who intend to quit smoking.
It is just another type of product that can be made available to adults who want to quit smoking, in addition to those already available, like patches, gums and lozenges.
Senator Osler: Thank you to the witnesses for being here today. I have two questions, and I suspect they’ll be for Health Canada.
The first question is a follow-up to Senator Omidvar’s question about the exempted food or products. For the exempted food or therapeutic products, are there post-market assessments to establish their safety and efficacy once those products are in Canada?
The second question is this: What types of rules would the Minister of Health be able to establish under Division 31 of Part 4? It talks about new rules. Can you give us some examples of what those rules could be?
Ms. Lourenco: Specifically with regard to exemption?
Senator Osler: Exempted products come into Canada and have not gone through the typical safety and efficacy processes. The first question on exemption is this: Once they are in Canada, how will their safety and efficacy be established?
The second question is this: What would be some examples of new rules that the Minister of Health could establish?
Ms. Lourenco: Thank you for the questions.
In terms of the exemption rule and what we are trying to achieve with that, it is really to address situations when we have shortages in the Canadian market. It could be shortages of health products, medical devices, infant formula or food for special dietary purposes. We would like to address those shortages and bring products in from countries that have very similar regulatory rules around safety, efficacy and quality that we do.
The ministerial order would have criteria around how those products can come in and what types of labelling we would like to see, because these products could come from countries that may not have bilingual labelling, for example. That is the objective of that particular new authority that we are trying to introduce.
We would have post-market oversight of these products, just like we do with other types of products. How we want to manage these products can be written into the ministerial order as well.
Senator Osler: Before you go on to the second question, are exemptions time limited or permanent? Is there a time limit that becomes attached to the exemption?
Ms. Lourenco: It depends on the situation; it would be written into the ministerial order to address the specific scenario.
Senator Osler: And can you speak to the types of new rules the minister could establish under Division 31?
Ms. Lourenco: Yes. There are three key authorities that we are trying to introduce. There is the exemption that I have just spoken about. The department could develop a ministerial order to address, for example, shortages. That would be an exemption order that would allow products to come in, exempted from certain regulation requirements so that we can access to those products.
The second set of rules relates to relying on a foreign decision or review by a competent regulatory authority in order to facilitate the review of health products in Canada. We have an important news case there with regard to pediatric medicines, for which we have a great need and which are not coming to Canada because of the smaller size of the Canadian market. So, the second authority would be around incentivizing companies to bring those products in by creating a pathway that allows us to rely on a review done by another competent regulator.
The third is around what we call “supplementary measures,” which deal with issues where there is intentional misuse of products, such as the nicotine pouches. We want to be able to put in place a ministerial order allowing us to manage situations where there is intentional misuse or diversion of products to other uses, such as a toxic drug supply.
Senator Osler: Thank you.
[Translation]
Senator Cormier: My question concerns Division 23 and is addressed to Mr. Cadieux and Mr. Sharpe. I heard your answers to Senator Cordy. Could you remind us what criteria were initially used to set up this pilot project?
Mr. Cadieux: Thank you very much for the question, Senator Cormier. This pilot project isn’t the first one set up to provide additional support to seasonal workers. Several pilot projects preceded it. There was a pilot project in place from 2018 to 2021, and the current pilot project was subject to mandatory criteria. The same criteria were used for the previous measure and for the current one, i.e., the pilot project granted up to five additional weeks of regular benefits for claimants who lived in one of the 13 targeted regions. I imagine you want to know how those 13 regions were identified.
Senator Cormier: Yes.
Mr. Cadieux: Originally, two criteria were used to identify the regions. The first was that the unemployment rate had to be higher than the national average — at the time, it was 6.3%. The second was that there had to be a high percentage of seasonal workers. At the time, a rate above 4% was the criterion used. If regions met those criteria, they were identified.
Consequently, 13 regions have been identified and claimants must qualify for regular EI benefits to be eligible. They must live in one of the 13 regions. They must have made at least three previous EI claims in the last five years, and two of these claims must have been made around the same time as the current claim.
Senator Cormier: Thank you. I’m from the Acadian Peninsula in New Brunswick, where the lobster fishery was recently shut down. The famous spring gap for seasonal workers has been a recurring problem for years. Climate change and the presence of whales in the region, for example, are existing and recurring factors.
You say that the project is being extended for two years to allow the government to find a solution to make the program sustainable. Can you tell us more specifically how the government intends to do that, given that there will always be problems related to climate change? How will the government be able, in a more than reasonable timeframe, to strike the balance between environmental issues and the survival of the fishing industry and plant workers, in this case processors? I know you’re not elected officials, but since you work in government, you must surely have more specific information to give us.
Mr. Cadieux: Thank you very much for the question. As I mentioned in my previous answer, the labour market changed a lot over the last year and since the introduction of the pilot project in 2018. That’s one reason why the government wants to take the time to take a good look at this issue, especially after the pandemic.
Senator Cormier: The work back home hasn’t changed. Factory workers still work a certain number of weeks. I don’t know exactly what you mean by that.
Mr. Cadieux: What I mean to say is that unemployment rates have dropped significantly in the last five years in the EI program in terms of the number of weeks a person can receive benefits. It depends on the unemployment rate in the region where the person lives.
Since unemployment rates have fallen sharply, the number of weeks that seasonal workers receive off-season benefits has generally declined. They receive benefits for fewer weeks and are increasingly dependent on this temporary measure. The question is: Are five weeks still enough? Are the 13 targeted regions still the right regions? Are there other regions that could be targeted? There are seasonal workers across Canada. The government wants to thoroughly review this issue and have one or two years of data collected from the labour market after the pandemic. We need good data to determine how to use the measure. Is it sufficient for these workers? Is usage increasing?
Senator Petitclerc: My question is on Division 31 of Part 4. I’m not surprised to share my colleague Senator Seidman’s concerns, and I myself have questions about the fact that these nicotine replacement therapies are there rather than in the Tobacco Act, but I don’t want to go into that again.
Compared to Health Canada’s standard regulatory process, will this proposal to give the minister the power to impose requirements allowing for a quicker response and greater flexibility as soon as data on a possible hazard or undesirable use of these products becomes available? Is that the intention?
Ms. Lourenco: Thanks for the question. Of course, the idea is to have more flexibility and to be able to react more quickly to issues like nicotine replacement products, where there are concerns about young people’s access to such products. We want to be able to put in place ministerial orders that can address issues like these quickly. That said, we will also be consulting all stakeholders involved in the issue.
Senator Petitclerc: Thank you. I’m trying to see how we can be proactive here. I have in mind the experience with vaping, where there were early indications that the flavours were appealing to young people and that there was a potential danger. It seems to me that it takes a long time before we react.
Alongside these provisions, how proactive are we in seeking out information and applying precautionary principles to ensure that the experience isn’t repeated? Once a dependency is created, there can be gateway effects. How proactive are we in seeking out information before it’s too late?
Ms. Lourenco: We already have evidence to support initiatives. We’re working on a ministerial order for nicotine replacement products. That said, it’s not necessary to have all the data. Having authority means that we can move forward to prevent access to those products. It’s not necessary to have all the data; it’s important to have some data and professional opinions from physicians and other professionals with experience in the field. The regulatory framework we’re putting in place allows us to move forward without having all the data, even if there is a degree of uncertainty.
Senator Petitclerc: Thank you.
[English]
Senator Moodie: Thank you to our witnesses today.
I want to zero in on your comments around the changes being made in Division 31. You specifically referenced pediatric medications.
Are you referring to the Pediatric Rule here, wherein we are now able to accept the research of trusted countries on pediatric medications that are currently being used off-label?
Ms. Lourenco: Thank you for the question.
What this will do is allow us to rely on thorough and in-depth reviews conducted by other competent regulatory authorities, such as the United States Food and Drug Administration or the European Medicines Agency, of submissions that companies have provided to those regulatory authorities but that have not come to Canada for different reasons — business reasons and so on.
We would like to create a pathway that incentivizes the industry to bring pediatric medicines to Canada by facilitating the regulatory process for those medicines without sacrificing safety, efficacy or quality, by ensuring that we work with trusted partners with whom we have years of experience and are confident about the approaches they take in reviewing products.
Senator Moodie: This is a huge breakthrough for the pediatric community in Canada. We are very pleased about that; I consider myself among its members.
How will you integrate this information into current labelling practices to allow each and every physician who will work on and use these drugs to know exactly what this research information is?
The second part of the question is this: What mechanisms will be in place to ensure transparency and accountability once these amendments are made in an open forum for Canadians to follow?
Ms. Lourenco: Those are great questions.
First, we are working closely with the Canadian Paediatric Society, Canadian pediatricians, pharmacists and others involved in pediatric medicine to develop a national list of priority medicines for children. We are very close to arriving at that list.
Then, once we have the list, the idea is to publish it for all Canadians and companies to be aware of in order to, again, incentivize companies to bring those products to Canada. It will be transparent in terms of the unmet needs for children in Canada.
Then, once we have those products in Canada, have reviewed them and used the science and reviews done by our international colleagues, we will be transparent about the process used to review those products. The labelling will be transparent in terms of the process used to approve those products as well.
Senator Moodie: Congratulations on this work.
Senator Burey: Thank you. I am also a pediatrician and was happy to hear the information that was relayed. I am sure a lot of hard work went into that.
My question is on Division 31. You talked about the new authorities. I am going to refer to the supplementary measure authority. We talked about vaping and the “for unintended purposes” aspect.
Among the proposed amendments to the Food and Drugs Act are new ministerial authorities that would allow the Minister of Health to regulate these therapeutic products and veterinary drugs so they are not used for unintended purposes. In your remarks, you specifically said this is not intended to block or ban products that Canadians rely on or health professionals use to provide necessary therapies.
My question is this: Could there be any unintended consequences? Would these ministerial powers, for example, be used for off-label pediatric use of psychotropic medication? I’m not talking about that in particular; I am saying that when you change laws, you have to look for unintended consequences down the road. There are other instances. Could you comment on that?
Ms. Lourenco: That is an excellent question.
The authority around putting in place those supplementary measures regarding unintended uses would only be enacted through a ministerial order. We have these authorities at the level of the act but need a ministerial order to enact them.
In developing the ministerial order, we will be prudent and cautious in terms of the situations in which we would use the order. We are anticipating it will be in rare instances when there is intentional misuse — such as the nicotine pouches, for example — or when products could be diverted to other uses. I will provide a very specific example: There is a decongestant medication called ephedrine that is currently held behind the counter, because it’s a precursor for and could be used in the manufacture of methamphetamine for the toxic drug supply.
We want to ensure that this drug is accessible by Canadians but that it is kept behind the counter so it doesn’t fall into the wrong hands. Giving the minister the ability to put an order in place to ensure that’s the case would be very helpful.
Senator Burey: You alluded to making a specific rubric and specific circumstances. As a follow-up question, is a framework being developed to ensure that we do not leave the door open for a carte blanche change of medications that we’re used to prescribing?
Ms. Lourenco: Indeed. The supplementary measures are not at all meant to impact off-label prescribing by health care professionals.
They are really to address safety concerns and risks to health that could emerge from intentional misuse or inappropriate use that does not fall within the framework of the health care system of physicians and pharmacists in the practice of medicine and pharmacy.
Senator Burey: Thank you.
[Translation]
Senator Mégie: Thank you for being with us. I have two questions for Ms. Lourenco.
My first question follows on from your reply to Senator Burey. I don’t know whether they have a drug identification number (DIN), but are so-called therapeutic products, which aren’t drugs, also subject to control and research, especially if they come from abroad?
Ms. Lourenco: If I understand your question correctly, you’re talking about therapeutic products that aren’t drugs.
Senator Mégie: Yes, therapeutic products. You said that therapeutic products and drugs were two different things.
Ms. Lourenco: Yes, we’re talking about drugs. Therapeutic products include drugs as well as medical devices and natural health products.
Senator Mégie: Thank you. So it’s to ensure the safety of the consumers who are going to use them. I know that health care professionals receive all the documents they need to ensure the safety of their patients. However, when ordinary people go to the pharmacy to get some medication labelled in English, French or a foreign language, who ensures that these labels are uniformly bilingual or translated, so that users can understand what is written on them?
Ms. Lourenco: All products approved by Health Canada must be labelled in both official languages. For products that enter the market through ministerial orders, such as the exemption order, we work with pharmaceutical companies to find solutions. These solutions may include point-of-sale training when the patient buys the product, providing information in both languages, or providing online information to the patient in both official languages.
We work out these details with pharmaceutical companies to ensure that patients have access to the right information.
Senator Mégie: Thank you.
I’m looking at Division 31. Are there costs associated with that? I see decrees in particular, but are there costs for a budget? I was thinking it might be in a different bill than the budget bill.
Ms. Lourenco: There is no cost involved in these new authorities. The cost could, however, manifest itself in the ministerial orders, depending on the type of order in question. For example, the order on nicotine pouches could result in a cost to pharmaceutical companies, who may have to change their labelling or advertising approach. However, at present, there is no cost to the proposals we have here.
Senator Mégie: Thank you very much.
[English]
Senator Dasko: Thank you, witnesses, for being here today. First, I want to offer congratulations, especially on Bill C-59 and the cost recovery initiative. It’s absolutely great that this has finally happened, and I can only hope that the provinces will have success in their efforts to achieve cost recovery as well when it comes to tobacco and the costs of your tobacco control program. This is great. You mentioned that in your comments earlier, so I wanted to reiterate that. That works together with what is in Bill C-69 regarding the taxes.
There has always been a relationship between increasing taxes and lowering consumption of tobacco products. I wanted to ask you about whether that same relationship exists with respect to vaping products.
I have two questions: Does increased taxation — which is what is in this bill — lower vaping rates? Is there strong evidence of that? If so, is it among youth or any particular subsets of the vaping population? Tell me anything you can about the relationship between higher taxes and lower vaping.
Ms. Johnson: Thank you very much for that question.
The amendments proposed under Bill C-69, the increases in vaping taxes, are with colleagues from the Canada Revenue Agency. In terms of general evidence that is out there regarding taxes and consumption, we do know that in the tobacco space — as you mentioned — an increase in tobacco taxes will lead to lower consumption, particularly among youth, as they are more price sensitive than the rest of the population. We suspect that same evidence would apply to vaping products as well.
A vaping product excise tax has been in place for a year and a half. We’re conducting an evaluation to see what impact the federal excise tax may have, as well as provincial excise taxes, now that some provinces are coming on board.
Senator Dasko: So you don’t have the evidence yet, to say whether this has the same effect when it comes to vaping, because it’s so new.
Ms. Johnson: It is still relatively new, yes.
Senator Dasko: Okay. That will be very important to follow.
I have a question about your plans, which are in section 31, to prevent nicotine replacement therapies from being marketed to youth. This is part of what you’re doing.
What plans do you have to do that? I would assume you would have had the space to do that without this legislation, right? Anyway, that’s just a subquestion. I’d like to know what plans you have to deal with the marketing to youth, because I think this is a really important part of this bill.
Ms. Lourenco: Thank you very much. That’s a great question.
Unfortunately, under the Food and Drugs Act and regulations, we currently don’t have the ability to restrict advertising appealing to youth. We don’t have that authority right now.
Senator Dasko: I thought you might have it, but you don’t.
Ms. Lourenco: No, we don’t, so this will take care of that.
Senator Dasko: What are your plans, then? What are you going to do?
Ms. Lourenco: We’re working on the policy and what that should look like in terms of advertising to youth — what exactly the criteria and restrictions should be. Very soon — starting next week — we will be consulting with health care professionals, provinces and territories, industry and other interested parties around the plans to move forward.
Senator Dasko: You have identified marketing as an issue.
Ms. Lourenco: Yes.
Senator Dasko: You know it is out there. You’ve studied the landscape.
Ms. Lourenco: Yes. Marketing will be one of the areas of consultation, in terms of what we want the restrictions to look like, as well as packaging and labelling, place of sale and flavours.
Senator Dasko: Thank you.
Senator Bernard: Thank you all for being here today. Some of my questions have already been asked and answered, but I have a couple of follow-ups that I’d like to ask.
Ms. Lourenco, in response to an earlier question from one of my colleagues, you gave the example of baby formula as one of the food products. I’m wondering if there are other food products that are being targeted by this amendment.
Ms. Lourenco: It’s a category of foods we call “foods for special dietary purposes,” of which infant formula is one, but there are other foods that are complete meal replacements or foods for individuals who have inborn errors of metabolism that don’t allow them to metabolize certain foods and who need special foods to help them. Those are the ones that would be captured.
Senator Bernard: Thank you. You also mentioned that you consulted with all stakeholders. I’d be interested in knowing whom these stakeholders are.
Ms. Lourenco: Indeed. With regard to the food?
Senator Bernard: Yes.
Ms. Lourenco: First, we launched the notice of intent to inform stakeholders that we were planning to update our regulatory framework to really change the current rules, which are very prescriptive and outdated, to make them more flexible to allow different foods to come into the country without sacrificing on the nutritional quality and safety of these products. So, we launched both a notice of intent and a consultation that will lead to eventual revisions to our regulatory framework; however, in the meantime, we are working on this ministerial order to allow us to continue to have that flexibility to bring those foods for special dietary purposes into the country in order to meet ongoing needs until we can make permanent changes to our framework.
Senator Bernard: Who are the stakeholders that you would be reaching out to?
Ms. Lourenco: We consulted with health care professionals, stakeholders in the food industry space and provinces and territories —
Senator Bernard: Health departments?
Ms. Lourenco: Yes, health departments. In general, those would be the stakeholders.
Senator Bernard: Thank you.
The Chair: Thank you, colleagues. With this, we finish our first round. The officials have been invited to stay until 5:15 p.m. If you can indulge us for 10 more minutes, we have four senators on round two. I’m seeing you say yes, that you can stay for another 10 minutes. We will go to two and a half minutes each, colleagues — so short questions, short answers.
Senator Osler: Thank you for staying. I have a short question, again, on Division 31 of Part 4 and the exemptions. It talks about the Minister of Health being able to “. . . exempt any food, therapeutic product, person or activity. . .” What type of person or activity would be exempt?
Ms. Lourenco: Maybe I’ll turn this one over to David so he can explain in a bit more detail what the thinking was around that.
David K. Lee, Chief Regulatory Officer, Health Products and Food Branch, Health Canada: Thank you for the question, senator. The language mirrors our Governor-in-Council exemption making. We wanted ensure we cover all the bases. With exemptions, it’s important that on some occasions we’ll give one to an individual company. It won’t be a rule for a number of companies, but it may go to an individual, which is a person that can include a company, for example.
Senator Osler: And would that person or company have the food or product?
Mr. Lee: Yes. If they brought in a food or therapeutic product, we issue it to that person, and that person would be subject to the exemption order.
Senator Osler: Thank you.
[Translation]
Senator Cormier: My question is for Ms. Lourenco, but I’m afraid it could be a long answer. Could you briefly enlighten me on the minister’s new powers?
There is a Health Canada approval process for all therapeutic products. I’d like to understand the connection. In other words, are the minister’s new powers being put in place because there are shortcomings in Health Canada’s approval process? I’d like to understand the connection. I don’t know if my question is clear, but you have about a minute to answer.
Ms. Lourenco: I believe I understand what you’re asking.
We already have a very good regulatory framework for products. In Canada, there are over 250,000 health products; that’s a lot. However, we need more flexibility in certain circumstances to manage shortages of important products, such as infant formula or certain drugs.
To achieve this, we need greater flexibility in implementing regulations that allow products to enter Canada, without reducing their efficacy, security, drug safety, or quality.
Senator Cormier: Thank you.
[English]
Senator Moodie: Just so I can understand a bit more, who would be exempt in terms of a therapeutic product? Am I correct in thinking this could apply to devices? If so, would you be looking at your trusted jurisdictions to understand whether this device can be imported? What process would you use?
Ms. Lourenco: Yes, the exemption can apply to health products, therapeutic products — which includes devices — natural products, drugs or foods. Indeed, in terms of products that we would allow to be exempted from the regulations in order to enter the country, we would look at certain criteria. For example, is it coming from a country that follows very strict rules like we do?
Senator Moodie: Do you have an example of such a device that has come under this need before?
Ms. Lourenco: During the COVID-19 pandemic, we were able to rely on foreign approvals to bring in devices. I don’t remember the exact kinds of devices, but that is an example. There were many types of devices, not just the rapid tests — ventilators and so on.
Senator Burey: Thank you for staying. The Government of Canada has cost recovery frameworks in place for other regulated products, such as cannabis products, drugs, medical devices, et cetera. Would this federal cost recovery framework for tobacco and vaping products include the cost of health promotion and awareness?
Ms. Johnson: Thank you for the question. The amendments put forward in Bill C-69 and Bill C-59 for the tobacco and vaping cost recovery framework would give us the authorities to move forward with the next step. This is the first step of a few that would need to be undertaken. The next step, if these amendments are adopted, would be public consultations, where we would come up with a fee proposal, for example, that would list eligible activities that could be cost recovered.
Senator Burey: I understand that, but in your vision of what it would look like, are you looking at health promotion and awareness as part of what the government has to do and the funds they have to expend?
Ms. Johnson: Yes. Under Canada’s Tobacco Strategy, we have a number of themes, including prevention, which itself includes health promotion and public education. That falls under the strategy, yes.
The Chair: This brings us to the end of our panel. I want to thank, on behalf of all of us, your generosity with respect to the extra time and your willingness to take all the questions. We could have gone on for a longer time, but unfortunately, we have to adjourn.
Colleagues, tomorrow is an in camera meeting with observations. You know the routine — observations that have been circulated in both official languages are always more welcome than those that are crafted on the fly. Please cooperate as best as you can. Thank you so much.
(The committee adjourned.)