Evidence of meeting #208 for Finance in the 42nd Parliament, 1st Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was payment.
A video is available from Parliament.
NDP
Pierre-Luc Dusseault NDP Sherbrooke, QC
I see.
What I'm afraid of is that we're creating a regime involving many powers and that some individuals, subject to a variety of influences, will manage to convince the minister to add other products to schedule G in short order, while the regulatory process for the approval of medication or medical devices drags on for others.
Chief Regulatory Officer, Issues Management, Health Products and Food Branch, Department of Health
It's important to state that we do not want to create less of a safety or evidentiary standard. It may be that you do the same amount of work. It's just that we don't have old regulations from the 1960s governing, for example, a drug that's very advanced. We're seeing right now, for example, in artificial intelligence there is a rule in the medical device regulations that says every time you make a significant change you have to revalidate the software. For artificial intelligence, you would be constantly doing this.
It would be tailoring the requirements. It wouldn't be lifting away any safety requirements. It would be saying, for artificial intelligence, which hospitals are using now very beneficially, “This is something that's an advanced technology product. We're not going to make you revalidate. Here's the thing that we will do: We will look at your quality control system.”
It's doing that without having to make a regulation for a whole number of years. It's not lowering the bar or making it easier or harder. It's actually tailoring the requirement.
We do share those concerns. That's why we regimented the schedule and we're making sure that we would have the safety requirements well in order.
Liberal
Francesco Sorbara Liberal Vaughan—Woodbridge, ON
I have a quick question. I'm not sure this applies to it but I think so.
In the case of biologics, how would this apply?
Chief Regulatory Officer, Issues Management, Health Products and Food Branch, Department of Health
Biologics right now are scheduled. They're regulated well in our regulations for the drugs. For the most part, companies will keep going through that pathway.
For example, some of the stem cell research and advanced cell work that we're seeing done in hospitals may not, with the manufacturing model, fit well within the biologics regulations. In that case, we would take a species of biologics and move them into that schedule so that we could tailor some of the requirements.
Many of the requirements will remain the same. You always need to show that it works the way we think it should, that it's safe within the disease it's treating and that there's a high-quality manufacturer. All those ground rules will still apply, but this is where again we need to be flexible with the biologics.
Biologics may thus straddle both their home, which they're in right now, but also this new pathway.
Liberal
Francesco Sorbara Liberal Vaughan—Woodbridge, ON
As biologics or personalized medicines become more and more available, developing any sort of national pharmacare plan and looking at developing a formulary is difficult, in the sense that as time advances, medicines become so personalized that you may have Jane Doe needing a certain medicine for breast cancer that you can't just list on a formulary because it's for Jane Doe. The system has to be flexible enough to incorporate that, or else the formulary, for all intents and purposes, is not very useful.
Chief Regulatory Officer, Issues Management, Health Products and Food Branch, Department of Health
Certainly from the Health Canada side, part of the reason we rationalize this pathway is, very much to your point, that in hospitals we're seeing more and more abilities to fabricate products right at bedside; you'll genetically inform a cell and put it in a patient. You're right. This is something that is creating a more personalized lens.
Certainly from the safety regulations standpoint we want to make sure we're getting it right. We may not see the big clinical trials that we used to see. It may be a one-time therapy. That's pretty disruptive for us. Usually we see drugs given over time and can see how patients are doing.
Some of these new models are thus going to take some thinking, but that's why we have it so that we can tailor the requirements. We are making sure that we're keeping in touch with health technology assessors and others who are currently dealing with these types of therapies.
Liberal
The Chair Liberal Wayne Easter
Are there any more questions on that division?
Ms. Ritchot, I'll let you introduce the next crew, on subdivision D.
Executive Director, Regulatory Policy and Cooperation Directorate, Regulatory Affairs Sector, Treasury Board Secretariat
I think we're still at the table here, Mr. Chair.
It's Tim Krawchuk, from the Canada Revenue Agency. I'm sorry; I don't have my notes here.
Go ahead, Tim.
Tim Krawchuk Manager, Excise Duty Operations – Alcohol, Canada Revenue Agency
Thank you very much.
This will be an amendment to the Importation of Intoxicating Liquors Act. It would remove the federal requirement that alcohol moving interprovincially be sold or consigned to a provincial liquor authority. Provinces and territories would still have the authority to control the sale and distribution of alcohol within their jurisdictions. The Importation of Intoxicating Liquors Act would only apply to alcohol imported into Canada. Finally, the amendment fulfills the commitment made during the first ministers meeting in December 2018.
NDP
Pierre-Luc Dusseault NDP Sherbrooke, QC
You're confirming that this is indeed a symbolic change but that, in actual fact, it will have no real effect on Canadian citizens.
Manager, Excise Duty Operations – Alcohol, Canada Revenue Agency
You are correct. The provinces derive their power through the Constitution. We learned that in the Comeau case last year, and there was a prior Supreme Court case as well.
NDP
Pierre-Luc Dusseault NDP Sherbrooke, QC
So is every statement the government makes to the effect that it's now making it easier to transport alcohol in Canada incorrect?
Manager, Excise Duty Operations – Alcohol, Canada Revenue Agency
It's not incorrect; it's up to the provinces. Currently, there are three provinces that allow it to some degree. It's really the provinces that control it.
NDP
Pierre-Luc Dusseault NDP Sherbrooke, QC
I see.
So there will be no major changes after the bill's passed, unless the provinces decide to do something.
Manager, Excise Duty Operations – Alcohol, Canada Revenue Agency
That's correct. What it does, though, is send the message that the federal government is encouraging interprovincial trade, certainly in the area of alcohol.
Liberal
The Chair Liberal Wayne Easter
Pierre, you never know; you might be able to get some of that good P.E.I. moonshine yet if things go right.
Is that it for that subdivision?
Then on subdivision E, the Precious Metals Marking Act, we'll go to Mr. Schaan.
Director General, Marketplace Framework Policy Branch, Innovation, Science and Economic Development Canada
I'm going to cover at the same time subdivision E, the Precious Metals Marking Act, and subdivision F, the Textile Labelling Act, because they're related measures.
The proposed legislative amendment would expand the current regulatory authority in the act that allows for exemptions from labelling rules to be made by regulation. It's to allow for exemptions that are conditional on the performance of a certain action or actions. These proposed legislative amendments will not require subsequent regulatory amendments.
In 2000, the Standing Joint Committee for the Scrutiny of Regulations concluded that the Textile Labelling Act's regulatory authority is not broad enough to allow for certain of the textile labelling and advertising regulations that grant exemptions from labelling rules conditionally upon the performance of specific actions. In the absence of legislative amendments, such ultra vires regulations would have to be repealed and the Standing Joint Committee for the Scrutiny of Regulations could recommend disallowance by the Governor in Council, which would lead to undesirable consequences.
We've taken the opportunity at the same time as making this change to the Textile Labelling Act to do so as well for the Precious Metals Marking Act, which has exactly the same regulatory issue at play.
That means when a precious metal or a textile arrives that does not meet our current regulatory standards for labelling, instead of rejecting it outright, it can be brought in on a non-commercial basis, subject to the meeting of the conditions that are required. Essentially it gets relabelled before it actually enters the marketplace. It's a well-utilized function and we heard loudly from industry and others that, should this provision be struck down, there would be great risk of the possibility of deferred shipments and other things. This just cleans up two very long-standing statutes, both the Precious Metals Marking Act and the Textile Labelling Act.
Liberal
The Chair Liberal Wayne Easter
Does anyone have any questions?
Then on subdivision G, the Weights and Measures Act, we have Mr. Spicer or Mr. Cotton.
Vice-President, Regulatory Modernization, Innovation, Science and Economic Development Canada
Mr. Chair, there are five amendments to the Weights and Measures Act. Most are proposed to remove prescriptivity in the current legislation.
For example, in clause 192, the definition of “measuring machine” is amended to remove the reference to “moving or movable part”. This amendment is proposed to address the increasing number of measuring devices that no longer have moving parts, including those devices based on software for measurement or measurement-related apps.
In addition to that change, there is a similar ministerial regulation-making authority to that proposed for the Electricity and Gas Inspection Act, which I described earlier, that would add new units of measure with a similar rationale. These changes would allow the act to keep pace with international standards and the flexibility to allow new measurement approaches that may arise with new and unforeseen technology developments.
The other proposed amendments to the Weights and Measures Act would provide greater flexibility in the act, while others would align the act with international definitions.
Liberal
The Chair Liberal Wayne Easter
Are there any questions?
All right. That sounds pretty straightforward to me.
We'll turn to subdivision H, the Hazardous Materials Information Review Act.
Ms. Ritchot, do you have the names before you?
Executive Director, Regulatory Policy and Cooperation Directorate, Regulatory Affairs Sector, Treasury Board Secretariat
Yes, Mr. Chair. Tolga Yalkin from Health Canada will speak to this subdivision.
Tolga Yalkin Director General, Consumer Product Safety Directorate, Department of Health
Good afternoon, ladies and gentlemen.
To give you some context, Canadian law requires businesses to disclose on their labels the ingredients used in chemical products sold for use in the workplace.
That said, some companies consider their formulas trade secrets, and accordingly, they can file a claim to exempt a chemical product from the requirement to disclose its ingredients on the label.
When a company makes such an application to Health Canada, we review the other information that a company plans on providing a worker on the chemical product in question, including the hazard symbols, the precautionary statements and the first aid treatment in the case of exposure. We review that information obviously to make sure that it is sufficient and accurate to keep workers safe.
The proposed measures, although not radical, would make minor improvements to our process for considering the claims businesses make that their chemical formulas not be disclosed.
The first is removing the requirement that Health Canada be the guarantor of the information they do plan on providing workers on their chemical products as required by the law.
The second is replacing the Canada Gazette process for publishing individual product notifications with an online system. I want to stress that this is not about eliminating the gazetting process for new regulations. That would remain. Rather, it's about individual product notifications. That we are still gazetting these, I think, is really a reflection of the fact that the act in question was conceived of over 40 years ago, a time in which gazetting was really the only way to communicate to companies such notifications.
Other similar notifications you might be interested to know about, as well, for which Health Canada is responsible, such as relating to natural health product licences, drug sale authorizations and novel food safety assessments, for example, are not gazetted but are presented online.
The third is eliminating a heavy and cumbersome appeal process and leaving any disputes to be dealt with by way of judicial review.
The fourth is providing for more graduated sanctions for non-compliance.
The fifth is providing the Minister of Health with the authority under a very narrow set of circumstances to disclose chemical formulas where there is a serious or imminent danger to human health or safety.
That concludes my remarks, Chair, and I'm happy to take any questions.