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Proceedings of the Standing Joint Committee for the 
Scrutiny of Regulations

Issue 35 - Evidence - May 3, 2018

OTTAWA, Thursday, May 3, 2018

The Standing Joint Committee for the Scrutiny of Regulations met this day at 8:32 a.m., in public and in camera, to review Statutory Instruments.

Senator Joseph A. Day and Mr. Harold Albrecht (Joint Chairs) in the chair.


The Joint Chair (Mr. Albrecht): I know there was some question whether we should proceed today following the sudden death of our colleague Gord Brown. In consideration of what happened and in consideration of Gord’s work ethic, I know that he would want us to carry on, but I think before we do begin, I would like us all to pause for a moment of silence in honour of Gord Brown.

Honourable senators and Members of Parliament then stood in silent tribute.

The Joint Chair (Mr. Albrecht): Thank you.

We have a number of items to care for in camera today, so I would ask if one would move that the committee proceed to sit in camera, and that notwithstanding usual practice, committee assistants be allowed to remain, that the committee allow the transcription of today’s in camera meeting and that one copy be kept in the office of general counsel for consultation by committee members.

Mr. Badawey: So moved.

The Joint Chair (Mr. Albrecht): All those in favour?

Hon. Members: Agreed.

(The committee continued in camera.)

(The committee resumed in public.)


(For full text of documents, see Appendix B, p. 35B:1.)

The Joint Chair (Senator Day): I think we should be able to move through the remainder of our agenda fairly expeditiously, with your cooperation.

Item No. 3. This is under the heading “Part Action Taken” by the department. Counsel, can you help us with that?

Evelyne Borkowski-Parent, General Counsel to the Committee: This is the first time the file is being presented to the committee, so I’ll just go briefly over the six points raised in the letter. Points 2, 3 and 4 dealt with what we call matters of internal coherence in regulations.

Point 2 dealt with the absence of authority for listing certain non-medicinal ingredients in combinations.

Under point 3, it was noted that the wording of subsection C.01.004(4) did not make it clear that the provision applied only to non-medicinal ingredients.

Lastly, under point 4, the comments made in the initial letter were aimed at clarifying the operation of that same section with regard to non-prescription drugs that are to be administered under the supervision of a practitioner.

Points 5 and 6 dealt with inconsistent terminology used in the French version of certain provisions.

So four of these points — that is, points 3 to 6 — have been resolved by instruments made in the last year or so.

According to the department’s latest estimate, point 2 on the listing of “combinations” of non-medicinal ingredients should be addressed in miscellaneous amendment regulations to be made in 2020.

Under point 1, it was raised that some provisions used the term “adequate” as opposed to the term “suitable” used elsewhere in the regulations. The distinction has not been explained by the department, and the committee could reiterate its request in that regard.

That brings us to the other part of point 1, which deals with section A.01.017, which requires that information on drug labels be prominently displayed, readily discernible and expressed in plain language. The broad and vague character of this provision was raised with the department. The definition of a regulation is that it establishes a rule of conduct of general application that has the force of law. In its current form, section A.01.017 resembles more of a guidance statement than an enforceable legal rule.

The department’s response states that while the language of the section is broad, it is appropriate and necessary given the subject matter. Mention is made of the large number of drugs covered by the regulations, the various drug classifications, packaging sizes, safety risks and how it would be impossible to make rules that apply to all.

The department also cited author Salembier’s work, which is often cited by the committee, which states that vagueness is permissible in legislative drafting “where the circumstances in which a rule is to operate are considered to be so variable that it is not possible to adequately address them all with any degree of precision.”

Let’s dissect that for a second. In dealing with vague and subjective language, the committee has never requested that regulations enumerate all the possible circumstances known and unknown. The committee insists on having objective criteria that accompanies the vague language so the user of the regulations can go about his business with a degree of certainty.

In this particular instance, the vague section is supplemented by at least three detailed and lengthy guidance documents. I have one here. Guidance documents are administrative in nature and are therefore not legally binding. It bears asking the question, however, how that criteria were developed in guidance documents when it was supposedly impossible to do so in the regulations. The end result is the regulations have little effect and decisions are made on a case-by-case basis. It’s not a regulation; it’s an open-ended subdelegation.

The note provided for members today enumerates some examples of jurisdictions where an effort was made to include such criteria in the regulations, and that includes the U.S. Code of Federal Regulations.

At the point I’m in the committee’s hands on whether it considers the explanation provided by the department on point 1 satisfactory or whether it wants to pursue that point with the department.

The Joint Chair (Senator Day): And point 2, they say that by 2020 they should have it?

Ms. Borkowski-Parent: Yes.

The Joint Chair (Senator Day): Are we content to wait until 2020? Is there any likelihood that this could adversely affect the public if we wait for two years?

Mr. Badawey: To that point, there’s a reason for the regulation and to clean it up, I would agree, but my question through you, Mr. Chairman, to the legal counsel is this: Is it the intent to align and/or to compare with the U.S. regulation in order to tighten it up?

Ms. Borkowski-Parent: As a matter of policy, I don’t know if the intent is to line it up. They are similar in content.

Mr. Badawey: I don’t mean align it “because of”; what I mean is using that as an example to strengthen the instrument to be then used in the regulation.

Ms. Borkowski-Parent: Yes.

Mr. Badawey: So I guess it goes back to your question. Are we willing to wait two years?

The Joint Chair (Senator Day): Those are the two issues, I think. In point 2, on the second issue we raised, they say they’ll deal with this in 2020. The second question is do we go back to them with respect to the proposal in relation to how to deal with point 1?

The Joint Chair (Mr. Albrecht): Is 2020 the first opportunity for a MARs package? I would assume there is an earlier opportunity. So is there a good reason for them not to take advantage of an earlier opportunity for the miscellaneous amendments process?

Ms. Borkowski-Parent: That’s the only information we were provided. We could ask.

The Joint Chair (Senator Day): So you’re proposing we go back to them with a letter from counsel pointing out these two items and asking for more expeditious action on it?

Ms. Borkowski-Parent: On point 2, we could ask if there is a way to make it before 2020.

On point 1, I need guidance from the committee as to whether it accepts the current language and the explanation provided by the department, or if it wants to pursue the matter of vagueness some more.

Mr. Di Iorio: Where is the legislation that authorizes this regulation? I can’t find it.

Ms. Borkowski-Parent: Subsection 30(1) of the Food and Drugs Act.

The Joint Chair (Senator Day): Counsel is looking for some direction in relation to what they proposed.

Mr. Di Iorio: Do we have the legislation? I don’t have it. Could you read it briefly to us? What does the legislation say? Do you remember vaguely what it says?

Ms. Borkowski-Parent: I could not repeat it with any level of preciseness at this point.

Mr. Di Iorio: Is it like a general one or just where it goes specific as to what could be?

Ms. Borkowski-Parent: Give us a minute. We’ll find it.

Mr. Di Iorio: Mr. Albrecht, would you mind briefing us as to what you were told, because you said you were approached by —

The Joint Chair (Mr. Albrecht): It was related to this section of the Food and Drugs Act. I don’t remember the details of their request, but I remember them expressing concern about the vagueness.

Mr. Di Iorio: The reason I ask you is they approached me too and I don’t remember either.

The Joint Chair (Mr. Albrecht): It was relating to the issue of vagueness and lack of definition. There were a number of other issues as well, which are beyond the scope of our committee, dealing with policy. We don’t deal with policy on this committee, so I explained that. But it did deal partially with the issue of vagueness.

I suggest we move ahead and try to have them — if they can put it in a guideline, they can put it in a regulation.

Mr. Di Iorio: I agree entirely.

Ms. Borkowski-Parent: I have the subsection. Subsection 30(1) states:

The Governor in Council may make regulations for carrying the purposes and provisions of this Act into effect, and, in particular, but without restricting the generality of the foregoing, may make regulations . . .

(b) respecting

(i) the labelling and packaging and the offering, exposing and advertising for sale of food, drugs, cosmetics and devices,

(ii) the size, dimensions, fill and other specifications of packages of food, drugs, cosmetics and devices,

(iii) the sale or the conditions of sale of any food, drug, cosmetic or device, and

(iv) the use of any substance as an ingredient in any food, drug, cosmetic or device . . . .

Mr. Di Iorio: We can’t let it pass.


How do you say “disposition habilitante” in English?


Ms. Borkowski-Parent: Enabling provision.

Mr. Di Iorio: The enabling provision, we can’t let this pass like this. We have to carry out our duty. This is unacceptable. As you pointed out correctly, they were able to do it in a separate document but not the appropriate document.


Mr. Dusseault: I’m having a bit of trouble with this. I would rather not pack everything in an explanatory document into the regulations, details like font type and size. I would be more in favour of allowing for the development of some sort of clear guide afterwards. To my mind, the regulations are quite clear. The information has to be visible, discernible and written in easy-to-understand language. I think that’s good enough; in any case, the parameters are fairly clear. The details can be set out afterwards, but I don’t think they always need to appear in the regulations, since that would result in even longer and more complex regulations. I don’t think the committee really needs to press the matter too much further.


The Joint Chair (Senator Day): That would be somewhat contrary to the comments made earlier that we should try to put guidance in the regulation as much as possible. Mr. Dusseault feels maybe it’s okay to have a guidance document.

Mr. Di Iorio: Our country is governed by laws, not by individuals. The individuals will enact laws, but then we have to obey the law, not the individuals.

What we have here is a clear situation where a citizen is not being asked to obey the law. He’s being asked to obey the individual, group of individuals or whoever they might be — we might never know their names — who decide to draft that directive, sub-directive, generality, administrative booklet, guidance whatever they want to call it — a tulip, a rose, whatever — and that is not how our country functions.

Our country is one where we set out the laws. We think we have very able people to write them, whether it be in a statute or regulation. And then we ask people to comply with them, not to comply to the will, whim or whatever the humour of any individual could be at any moment when they decide to write a book.

Senator Woo: I’m a bit torn. With the explanation from the department, I’m quite prepared to accept the necessity for somewhat vague language around the terms “prominently displayed,” “readily discernable,” “expressed in plain language,” and so on. And even “suitable” and “adequate,” I’m willing to live with.

If the question for our committee is whether we might want to ask them why the vague and subjective requirements cannot be replaced with detailed and objective requirements, I’m okay to ask that question, but I wouldn’t want to push this too far. Some level of discretion is necessary in the language they have used, and the explanation they provided to me is a certain sign of good faith, if you will, on the part of the department.

The Joint Chair (Senator Day): Can we accept that as a compromise? We will ask the department to see if some of the guidance could not be incorporated into the regulation itself.

Senator Woo: The way our analyst has phrased the ask is to put it in a slightly more neutral way. Why would these vague and subjective regulatory requirements not be replaced? Is there a good reason for it as opposed to more of a directive approach? It’s a very subtle distinction.

The Joint Chair (Mr. Albrecht): I agree with you, but that question has already been asked by our previous general counsel, Peter Bernhardt, in the letter in the documents here. I think we’re simply prolonging again. Either we deal with it or we don’t and close the file, but I think we need to move ahead and not ask another question.

The Joint Chair (Senator Day): We are going back to them with respect to point 2 for 2020.

The Joint Chair (Mr. Albrecht): We’re telling them what to do.

The Joint Chair (Senator Day): We’re asking if they couldn’t do it a little more expeditiously.


Mr. Dusseault: My question is for counsel. Is the language used in the regulations, in other words, the terms “prominently displayed,” “readily discernible” and “expressed in plain language” precise? When you read the regulations, you don’t know what those expressions mean. That’s where guidance documents come in to help the user or company understand. They will try to find more detailed information. Is the language relatively precise as compared with other regulations?

Ms. Borkowski-Parent: I would say no. Consider, for instance, what the expressions “prominently displayed” and “readily discernible” mean in the case of a medication for individuals with a visual impairment.

Mr. Dusseault: But that’s where the information or guidance document comes into play. Do we really want those details to appear in the regulations?

Ms. Borkowski-Parent: If the intent of the regulations was to say that the requirement must be interpreted from the user’s standpoint and not that of the person making the label, then the details need to appear somewhere other than an information document. I’m not saying everything in the information document has to appear in the regulations. I agree; that would be rather long. However, legislative drafting also makes use of something called abstraction, where a number of specific circumstances are distilled to arrive at a common meaning.

It may be possible to find a happy medium, in terms of a provision that basically expresses a wish and would be difficult to apply. Actually, the administrative regulations are what would be applied. With the help of an administrative document that is completely incorporated, it may be possible to find a happy medium with objective criteria so that the person reading the provision knows what is expected.


Mr. Oliver: Thank you for those comments.

Like Senator Woo, I’m a bit uncertain on this one. We’re not the drafters of the regulation. It’s not our authority to write the regulations. It’s not our authority to find the balance in them. It’s either consistent or not consistent with the act.

Of the 13 criteria we have to review legislation, what does this fall under? I don’t remember one on vagueness.

Ms. Borkowski-Parent: There is point 10: “makes the rights and liberties of the person unduly dependent on administrative discretion or is not consistent with the rules of natural justice.”

Mr. Oliver: I don’t find that applies because there are both the regulations and the further descriptive documents that are black and white. It’s not left to the whim of an individual at the Department of Health to decide whether the packaging is adequate.

Ms. Borkowski-Parent: It is. It could be changed at any time, but right now —

Mr. Oliver: I just know the diversity of medications and size and packaging. I’m a bit uncertain on this one as to the vagueness. Again, it seems like we’re suggesting the balance isn’t right. I don’t know if we’re in the business of determining the balance of or the clarity of regulations.

Ms. Borkowski-Parent: There’s also point 13: “is defective in its drafting or for any other reason requires elucidation as to its form or purport.” Those are the two criteria I would see as being applicable in this case.

The Joint Chair (Senator Day): Counsel has brought this to us because they’re concerned this guideline document, which does not have the effect of law, has an important role to play here that impacts the public.

The question is this: Do we go back to them with respect to their reply to point 1 and ask why they couldn’t incorporate, as Senator Woo said, some of the guideline into the regulation itself so it had the force of law?

Mr. Di Iorio: They’re not limited by the use of characters or the number of pages. They can make distinctions different types of drugs, different types of products. They’re the body drafting the regulation, so they’re able to do it.

I feel strongly that what I read here is simply that they abdicated their role. The problem when they put it in an administrative document is, first of all, the availability. There are no constraints, no parameters to availability. It can be modified at any time without any prior notice, any prior consultation, and it is not subject to any supervision by law.

The regulation is subject to the entire process that we have here in Parliament. If I’m a producer or retailer and I want to commercialize some products, I look at this and then I go and read the booklet. When they change the booklet, if I’m later prosecuted, they will go back to this and to the last version of the booklet. What kind of country governs its citizens in that way? I find it’s really a lack of respect for citizens.

The Joint Chair (Senator Day): For consensus here can we agree that we will try to pick up the spirit of what has been said by various members? You don’t want to go all the way and put all of the guidance document into the regulation? That just wouldn’t work?

Mr. Di Iorio: I think this, though, is at the core of our mandate. If we shy away from this, we shy away from the heavy part of our mandate. We’re just going to be at agenda items: “Please write another letter.”

The Joint Chair (Mr. Albrecht): If we look at Peter Bernhardt’s letter of April 2016 at page 3, right near the top, a new paragraph starts out:

In other words, the existence of policy manuals or guidelines intended to assist the exercise of a discretion undermines any claim that the subject-matter is so complex that it cannot be reduced to rules.

That’s the heart of what we’re getting at. If they have the guidelines printed but they’re not in the actual regulations, there is a disconnect there. I think we need to insist that many of the guidelines — I agree that we need to get them into the regulations so that the person who needs to use those regulations, the use, we want to make it accessible for them to be able to discern what their obligations are. That’s at the heart of what we’re trying to get at.

I would say we need to request that they clarify in regulation many of these guidelines and that we also ask if there is any possibility of having the miscellaneous amendment system implemented before 2020.

The Joint Chair (Senator Day): I think we have consensus on the latter point .

Can counsel pick up the spirit of what has been discussed here in relation to the role between guidelines and regulations, and the vagueness and the impact on the public?

Ms. Borkowski-Parent: Yes.

Senator Woo: I’m not trying to be vague about my instructions.

The Joint Chair (Senator Day): Can we leave it vague like that? This is the first time we’ve wrestled with this. We will proceed in that regard.


(For full text of documents, see Appendix C, p. 35C:1.)



(For full text of documents, see Appendix D, p. 35D:1.)


(For full text of documents, see Appendix E, p. 35D:1.)



(For full text of documents, see Appendix F, p. 35F:1.)


(For full text of documents, see Appendix G, p. 35G:1.)


(For full text of documents, see Appendix H, p. 35H:1.)


(For full text of documents, see Appendix J, p. 35J:1.)


(For full text of documents, see Appendix K, p. 35K:1.)


(For full text of documents, see Appendix L, p. 35L:1.)


(For full text of documents, see Appendix M, p. 35M:1.)

Mr. Badawey: I will move the rest of the agenda as it pertains to the items under “Reply Satisfactory,” “Progress,” as well as “Action Taken.”

The Joint Chair (Senator Day): Okay. I move a vote of thanks and acceptance of counsel’s recommendation. We can close it.

Which one of these items have been included, then, in your motion?

Mr. Badawey: That would be Item 4 right through to 14.

The Joint Chair (Senator Day): Is there anything, counsel, in any of those items? We all want to thank you for the work you have done and congratulate you on achieving success.

Is there anything outstanding in any of these items?

Ms. Borkowski-Parent: There would be just one under Item No. 10.

The Joint Chair (Senator Day): Can we deal with all the other items other than Item 10, first of all?

Ms. Borkowski-Parent: Yes.

The Joint Chair (Senator Day): All those in favour of that motion? Contrary? Carried.


(For text of documents, see Appendix I, p. 35:I1.)

Ms. Borkowski-Parent: The problem in this file is the retroactive application of the regulations to offences that were committed before the regulations came into force. It’s a serious matter, as regulations cannot apply retroactively, especially when it comes to offences.

It was brought to the attention of the Department of Justice, and they committed to taking a miscellaneous amendment regulation to fix the date issue in four months. The lesson is that when there’s a will, there’s a way.

The Joint Chair (Senator Day): It’s nice that you told us about that. Thank you.

So item No. 10 is satisfactorily concluded as well. There is consensus on that. I think we can go by consensus; we have had the motion on the others.

That concludes our agenda for today. Was there anything circulated that we haven’t seen?

Cynthia Kirkby, Counsel to the Committee: I was going to suggest that we can seek clarification on whether the regulations will be repealed at the same time, or whether they were intending to do it afterward. So we could just seek clarification on when that’s expected.

The Joint Chair (Senator Day): That’s a modification to the motion earlier, subject to clarification with respect to Item No. 5 that counsel has pointed out.

The Joint Chair (Mr. Albrecht): I’m in agreement with the motion, but the number of times we’ve had it pointed out that there’s been no communication followup with Item No. 6. That’s clearly unacceptable. We haven’t even heard back at all from the department. So I think we should authorize our counsel to communicate that we’re expecting a reply.

But I agree with the motion.

The Joint Chair (Senator Day): Everybody okay with that? Consensus on that item?

Anything further, counsel? We circulated one document.

We do have a list that has been circulated of the meetings between now and the end of the spring session. The next meeting is next week.

(The committee adjourned.)

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