Proceedings of the Standing Senate Committee on
Social Affairs, Science and Technology
Issue 21 - Evidence - October 9, 2014
OTTAWA, Thursday, October 9, 2014
The Standing Senate Committee on Social Affairs, Science and Technology met this day, at 10:29 a.m., to give clause-by-clause consideration to Bill C-17, An Act to amend the Food and Drugs Act.
Senator Kelvin Kenneth Ogilvie (Chair) in the chair.
[Translation]
The Chair: Welcome to the Standing Senate Committee on Social Affairs, Science and Technology.
[English]
I am Kelvin Ogilvie from Nova Scotia, chair of the committee. I'm going to ask my colleagues to introduce themselves, starting on my right.
Senator Seidman: Judith Seidman from Montreal, Quebec.
Senator Stewart Olsen: Carolyn Stewart Olsen, New Brunswick.
Senator Seth: Asha Seth, Ontario.
Senator Wells: David Wells, Newfoundland and Labrador.
Senator Oh: Victor Oh, Ontario.
Senator Ngo: Thanh Hai Ngo, Ontario.
Senator Nancy Ruth: Nancy Ruth, Ontario.
[Translation]
Senator Chaput: Maria Chaput from Manitoba.
[English]
Senator D. Smith: David Smith, Toronto.
Senator Cordy: Jane Cordy, Nova Scotia.
Senator Eggleton: Art Eggleton, Toronto, and deputy chair of the committee.
The Chair: Colleagues, I want to remind you that we are here today to deal with clause-by-clause consideration of Bill C-17, An Act to amend the Food and Drugs Act, otherwise known as the proposed Protecting Canadians from Unsafe Drugs Bill or Vanessa's Law.
The sole item in our agenda today is clause-by-clause consideration of the bill, and I will inform the committee that the experts are in the audience in the event that there are questions that require their input and they would then be invited to the table by the committee to help clarify any issues that might arise.
With that, is it agreed by the committee that we proceed to clause-by-clause consideration of Bill C-17, An Act to amend the Food and Drugs Act?
Hon. Senators: Agreed.
The Chair: That is agreed. Thank you.
Shall the title stand postponed, agreed or not?
Hon. Senators: Agreed.
The Chair: Agreed. Thank you. Shall the preamble stand postponed?
Hon. Senators: Agreed.
The Chair: That's agreed.
Shall the short title in clause 1 stand postponed?
Hon. Senators: Agreed.
The Chair: That's agreed. Thank you.
Shall clause 2 carry?
Hon. Senators: Agreed.
The Chair: That's carried. Shall clause 3 carry? Senator Eggleton?
Senator Eggleton: Mr. Chair, colleagues, this bill is a good start, as I said at second reading in the Senate. It is the biggest change that has been made to the Food and Drugs Act in some 50 years and we all know that it's long overdue. How do we know that? Because we've been studying pharmaceuticals in this committee for the last two, two and a half years, and we've been trying hard to get these kinds of changes and finally these changes are coming.
But we have heard from a number of witnesses, and the witnesses all told us this bill can be improved. One of the things they said that needed improvement was to make it a greater sense of certainty that this is in fact going to be implemented. They were concerned, as they expressed it, by the usage of the word ''may'' — may do this, may do that, which also means may not do this or may not do that — as opposed to ''shall,'' which makes it far more instructed by the people in Parliament to the department that they must carry this out. That's the kind of message I think we clearly need to send to the department.
The minister has all the good intent in the word; we heard from her yesterday. But you all know that we have had difficulties with the department in terms of delivering on many of the things that we felt that they needed to deliver on. Remember, at the end of the day, this gets implemented by the department.
I think we need a cultural change in that department and I think we need to start by being more prescriptive in terms of the kind of changes that should be made.
That's what this is. This is a motion. It's an amendment to clause 3. It starts on page 3. It replaces some lines, the word ''may'' with the word ''shall.'' It goes on to page 4 and on to page 6 as well, and provides for:
All clinical trials and investigational tests involving human subjects shall be registered with the Minister.
This is something we have advocated for and it's time that we had it delivered, and made it ''shall'' as opposed to ''may,'' and so on and so forth down this page and into the next page in terms of a more prescriptive direction to the ministry on this matter.
So that's the first motion I would move, Mr. Chair.
The Chair: Thank you, senator. All senators have copies of this. I want to make sure you understand it. I recognize Senator Seidman.
Senator Seidman: Thank you, chair. If I recall correctly, we did discuss the use of the word ''shall'' and the use of the word ''may'' with the minister yesterday. She said that all the legal advice was to use the word ''may,'' that it allows the minister a step-by-step approach, stepped up, including voluntary measures, as opposed to the heavy hand, ''thou should immediately do this,'' so that it provides an opportunity, and if you use the word ''shall'' it removes the option for that, those escalating options that the minister has at her disposal.
There are other issues around the use of the word ''may,'' which in the legal sense is an authoritative term and it grants the minister the authority to use discretion, which is important when discerning potential risks and deciding how to proceed.
I would be against this amendment.
The Chair: I think I should inform all members of the committee to make certain they know that Senator Seidman is the sponsor of the bill in the Senate and Senator Eggleton is not only deputy chair but is also the critic of the bill.
Senator Cordy: In light of the study that we've been doing over the past few years related to pharmaceuticals, and before I say that I want to say that I agree wholeheartedly, as I said at every hearing regarding this bill, that I want to thank Terence Young for the work that he has done in bringing forward this legislation because, as Senator Eggleton said, it is a great start and it is long overdue.
I think it needs a little bit more oomph to it. I was concerned when I first read it by the number of times I saw the word ''may.'' In our study of pharmaceuticals with Health Canada particularly we heard over and over again about the lack of action by Health Canada, and to use the word ''may'' causes me some concern. I look at the amendment on page 4, for example:
The Minister may, if he or she believes that doing so is necessary to prevent injury to health, order the holder of a therapeutic product authorization that authorizes the import or sale of a therapeutic product to modify the product's label . . .
Why wouldn't that be ''shall''? I would think that if it's going to prevent injury to somebody's health that it should be ''shall,'' that they should have to do it. It should not just be, well, maybe we will, maybe we won't. I think if we're looking at somebody's health that that is something that the department and the minister have to take full charge of.
I know yesterday that the minister was fully supportive and said that the department would do all these things, but we've been around this table for quite a while. Ministers come and go. While I do trust the word of the minister, she may not be the minister in six months or six years, so I think when it's legislation we have to ensure that the legislation actually gives the minister the power to deal with these matters accordingly.
Senator Chaput: There is no doubt this is a good bill, and it's going in the right direction, and that's what we heard from all witnesses. There is no doubt of the minister's will to make it happen; we heard from her yesterday. But I believe that because we are dealing with the safety of Canadians, that by changing this word, we will make the legislation stronger. Thank you.
The Chair: Seeing no other interventions — Senator Seidman?
Senator Seidman: I understand what you're saying, totally, in the common sense use of the words ''may'' and ''shall.'' In daily common usage, you make sense, but in legal usage, for purposes of legislation, it's very clearly different. The word ''may'' has a very clear legal usage, and this is the proper usage of the word ''may.''
I would also suggest that this bill doesn't depend or hinge on a particular minister. This current minister, of course, made an excellent case yesterday, but a piece of legislation is a piece of legislation. It's not legislation for a particular minister; it's legislation for every minister.
So, clearly, in this legislation, the incremental steps are absolutely necessary. The use of the word ''may'' is an authoritative usage, perfectly in accord with every piece of legislation that has been put forward, and it allows the minister the option of incremental steps, but it doesn't in any way lessen her powers to take the necessary steps to protect the health of Canadians.
Senator Eggleton: I was not going to speak a second time, but since Senator Seidman did, I wanted to make a couple of points. I know she used the phrase ''heavy hand.'' We're here, in fact, as legislators, to provide for a legal framework, so I don't consider it to be a heavy hand, and it's not something that should be left on a volunteer basis of maybe yes or maybe no. That's the point of all of this.
It's not that ''shall'' isn't used in legislation. It is used in legislation, not in every piece, but in fact, even in this one, there were some prescriptive requirements put in by the House of Commons committee on the initiative of Terence Young. They were put in here.
So what I'm suggesting here is going to bring that all in line in terms of the prescriptive nature of it and our desire to have a system that is open and transparent and that, in fact, does provide for the necessary safety and protection of Canadians.
The Chair: Thank you, senator. Are you ready for the question?
Some Hon. Senators: Question.
The Chair: A question has been called and we will have a recorded vote. Is that agreed?
Hon. Senators: Agreed.
The Chair: Thank you. We shall have a recorded vote. I will ask the clerk to poll the committee.
Ms. Richardson: The Honourable Senator Chaput?
Senator Chaput: For.
Ms. Richardson: The Honourable Senator Cordy?
Senator Cordy: Yes.
Ms. Richardson: The Honourable Senator Eggleton?
Senator Eggleton: Yes.
Ms. Richardson: The Honourable Senator Nancy Ruth?
Senator Nancy Ruth: No.
Ms. Richardson: The Honourable Senator Ngo?
Senator Ngo: No.
Ms. Richardson: The Honourable Senator Oh?
Senator Oh: No.
Ms. Richardson: The Honourable Senator Seidman?
Senator Seidman: No.
Ms. Richardson: The Honourable Senator Seth?
Senator Seth: No.
Ms. Richardson: The Honourable Senator Smith?
Senator D. Smith: I shall vote — ''shall'' vote yes.
Ms. Richardson: The Honourable Senator Stewart Olsen?
Senator Stewart Olsen: No.
Ms. Richardson: The Honourable Senator Wells?
Senator Wells: No.
Ms. Richardson: Yeas, 4; nays, 7.
The Chair: The amendment is defeated by a vote of 7 to 4. So I shall return and ask you again, shall clause 3 carry?
Hon. Senators: Agreed.
The Chair: That's agreed. Carried.
Shall clause 4 carry?
Hon. Senators: Agreed.
The Chair: Clause 4 is carried. Shall clause 5 carry?
Senator Eggleton: This is my second amendment, and beyond that I get into some observations that don't affect the bill at all.
On page 7, this would be a new clause, 5.1, by adding the following after section 29.2. This is to protect the minister and to protect Health Canada from taking actions that it does. It says here that we add in an immunity clause:
29.3 Despite any other Act of Parliament, no civil or criminal proceedings lie against the Minister or any persons acting on behalf of, or under the direction of, the Minister for anything done or omitted to be done in good faith in the exercise or performance of any powers, duties or functions that under this Act are intended or authorized to be exercised or performed.
This is not, I take it, frequently done in the federal context — this kind of immunity provision — but it is done by other governments. The point here, we're dealing with an industry that's very litigious. There are numerous lawsuits at the drop of the hat that are put out there against one party or another, relevant to pharmaceutical products. In fact, one was recently launched by Eli Lilly. It's a $500 million lawsuit against Canada because of a court decision that invalidated patents. The proceeding is being taken under Chapter 11 of the North American Free Trade Agreement.
I only use that to illustrate that, in fact, the minister and the department, by nature, are going to be very cautious before they issue a recall notice or some other provision for the safety of Canadians to make sure they're not going to be vulnerable to a lawsuit. It creates a chilling effect.
We're dealing with a big enterprise. In the pharmaceutical industry, the revenue of their top 10 is higher than the total revenue of the Government of Canada, so you're dealing with a pretty powerful, very heavily financed group of organizations. I think this immunity provision is necessary.
I've talked with Mr. Lee about it. Obviously, he does not agree with that. He thinks the provision is okay, but I don't agree with him. So I am offering this immunity provision to protect the minister, to make sure that she does not fetter her discretion when she finds that there is a need to protect the safety of Canadians.
Senator Seidman: Clearly, you're showing generosity and goodwill in proposing this. It's not that there is anything offensive about it in any way.
However, it's also very clear, as we heard yesterday, that all the lawyers had been consulted on this piece of legislation, and one of the questions asked was whether it was necessary to have such a clause in this bill, liability insurance or something against the federal minister, and they all said it was not a problem or it would have been put in the bill. The lawyers consulted said, ''No, not necessary, not done in federal legislation at the federal level.'' In fact, it parallels the Safe Food for Canadians Act. The Safe Food for Canadians Act uses ''may'' and not ''shall,'' so this is really not necessary.
The Chair: Thank you. Any further interventions?
Senator Cordy: I think that the amendment proposed by Senator Eggleton is certainly one that we should consider. I think human nature being what it is, somebody in the department, before making a recommendation against a pharmaceutical company — which are inclined to sue, as we all know — might think twice about it. I think by having this particular aspect added to the bill, that the minister and officials in the department would know that they are protected.
The Chair: Thank you. Is there any further intervention? Are you ready for the question?
Some Hon. Senators: Question.
The Chair: The question has been called on the proposed amendment to clause 5. A recorded vote has been requested. I'm going to ask the clerk to poll the committee.
Ms. Richardson: The Honourable Senator Chaput?
Senator Chaput: Yes.
Ms. Richardson: The Honourable Senator Cordy?
Senator Cordy: Yes.
Ms. Richardson: The Honourable Senator Eggleton?
Senator Eggleton: Yes.
Ms. Richardson: The Honourable Senator Nancy Ruth?
Senator Nancy Ruth: Yes.
Ms. Richardson: The Honourable Senator Ngo?
Senator Ngo: No.
Ms. Richardson: The Honourable Senator Oh?
Senator Oh: No.
Ms. Richardson: The Honourable Senator Seidman?
Senator Seidman: No.
Ms. Richardson: The Honourable Senator Seth?
Senator Seth: No.
Ms. Richardson: The Honourable Senator Smith, P.C. (Cobourg)?
Senator D. Smith: Yes.
Ms. Richardson: The Honourable Senator Stewart Olsen?
Senator Stewart Olsen: No.
Ms. Richardson: The Honourable Senator Wells?
Senator Wells: No.
Ms. Richardson: Yeas, five; nays, six.
The Chair: From the results of the clerk, the amendment is defeated by a vote of 6 to 5. I declare the amendment defeated.
I shall now put to you, shall clause 5 carry?
Hon. Senators: Agreed.
The Chair: Carried. Thank you.
Shall clause 6 carry?
Hon. Senators: Agreed.
The Chair: Carried. Thank you.
Shall clause 7 carry?
Hon. Senators: Agreed.
The Chair: Carried. Thank you.
Shall clause 8 carry?
Hon. Senators: Agreed.
The Chair: Carried. Thank you.
Shall clause 9 carry?
Hon. Senators: Agreed.
The Chair: Carried.
Shall clause 10 carry?
Hon. Senators: Agreed.
The Chair: Carried. Thank you.
Shall clause 11 carry?
Hon. Senators: Agreed.
The Chair: Carried. Thank you.
Shall clause 12 carry?
Hon. Senators: Agreed.
The Chair: Carried.
Shall clause 13 carry?
Hon. Senators: Agreed.
The Chair: Carried.
Shall clause 14 carry?
Hon. Senators: Agreed.
The Chair: Carried.
Shall clause 15 carry?
Hon. Senators: Agreed.
The Chair: Carried.
Shall clause 1 carry?
Hon. Senators: Agreed.
The Chair: Carried.
Shall the preamble carry?
Hon. Senators: Agreed.
The Chair: Carried.
Shall the title carry?
Hon. Senators: Agreed.
The Chair: Carried.
Shall the bill carry?
Hon. Senators: Agreed.
The Chair: Carried. Thank you.
Does the committee wish to consider appending observations to the report? I hear mixed views, and I hear a comment from Senator Eggleton.
Senator Eggleton: I understand the decision on the two amendments. I can count the numbers, but I would hope that those on the government side would be more favourably disposed to observations. Remember, observations don't amend the bill. They are simply statements that we make. Sometimes they are looked at favourably by a minister and sometimes they're ignored, but I think these are worth making.
I've got four of them. We'll do them one at a time then. They're different subjects.
The first observation is:
That the regulations of Bill C-17 be expedited and presented to the Standing Senate Committee on Social Affairs, Science and Technology for a brief review and comment before they are proclaimed and implemented.
I remember Mr. Lee saying yesterday that there were a number of minor or technical kinds of amendments. I'm not talking about those kinds of things. Those kinds of things should proceed apace.
I also heard him say that there would be some consultation in this process. Well, I'm saying this committee is a good place to start a consultation process. We've spent two and a half years on pharmaceuticals, and I think we have something of value to add.
On the major issues that come before the department in terms of the regulations, I think we should have that involvement. He mentioned one of them yesterday, for example, this matter of defining what a serious or imminent risk is. Particularly the word ''imminent'' is not going to be easy to define, yet this whole bill is going to stand or fall on the regulations that are put into effect, the regulations that have yet to be written. They're in process but they have yet to be adopted or finalized. It's going to stand or fall on those regulations and the implementation of them by the department. This is the same department that we've had some concerns about in terms of implementation of the laws and regulations as they stand in this area of pharmaceuticals.
I go back to that old phrase, the devil is in the details. Regulations are the details, and they're very important to making this bill work.
That's the first observation. It's not an amendment to the bill, it's an observation.
The Chair: Thank you, senator. Just for clarity for the committee, I would like to note the following. First, in order for the Senate standing committee to actually carry this out it would need to get an order of reference from the Senate itself. Second, because of the terms of the bill there would be no requirement on the minister or anyone else to pay attention to the report, should we make one. Finally, the consultation on regulations is a public consultation and any member of this committee, or even a group of members of this committee, would have every opportunity to give input to that process.
As we heard yesterday, regulations occur in a variety of steps from almost immediate to taking a considerable period of time. That's simply for the information of the committee.
Senator Seidman, did you wish to comment?
Senator Seidman: Sure. Actually, just for the information of the committee, and we all know this, there is already, in addition to the points that you made, chair, the Joint Committee for the Scrutiny of Regulations, House of Commons and Senate, that looks over these matters. It seems rather superfluous to me.
Senator Eggleton: This committee has the expertise. It has been dealing with these issues for two and a half years.
Senator Seidman: I think all the other aspects that the chair already put out there speak to that point.
Senator Eggleton: If you're trying to block it, yes, I guess so. If you want to facilitate it, then this resolution can be put in a form or can in fact be developed in such a way that it meets whatever requirement of the Senate rules and regulations. I think it's appropriate that this committee continue to deal with this issue. We're the ones that have developed the expertise. Do you deny that?
Senator Seidman: I don't deny we've had a two-year study on these matters and our reports are out there. As the minister said yesterday, she has enormous respect for the work that this committee has done and she consults and has consulted the recommendations in those reports and has in fact put forward changes based on those recommendations, so I have no doubt that those reports are taken extremely seriously.
Senator Cordy: Scrutiny of Regulations, to my recollection, and I only sat on it a couple of times, deals specifically with the legality of the regulations that are brought in.
I think what Senator Eggleton is saying is, because of the expertise that our committee has developed over the past few years relating to pharmaceuticals, that our committee would be in an excellent position to look at things like definitions and how the regulations would in fact make the bill proceed in a successful manner. The idea that the regulations, as much as possible, be expedited is an excellent comment, an excellent observation to put on the bill.
I certainly want the bill to be dealt with quickly. I certainly want the regulations to be brought forward as quickly as possible. We've waited 50 years for a bill similar to this. I would like the regulations put in place quickly.
The minister, as you said, has tremendous — the word she used was ''enormous'' — respect for this committee, and I can't see why the minister or the department would take any offence to having the regulations come before our committee for discussion and consultation.
Senator D. Smith: And enlightenment.
Senator Cordy: And enlightenment.
The Chair: I want to get a sense of the committee, unless Senator Eggleton wishes to make a motion? Senator Eggleton is formally moving that his first proposed observation be appended to the bill. Does everyone understand that? Are you ready for the question on it?
Hon. Senators: Question.
The Chair: The question has been called. Senator Eggleton requests a recorded vote. Is that correct?
Senator Eggleton: Yes.
[Translation]
Ms. Richardson: The Honourable Senator Chaput?
Senator Chaput: Yes.
[English]
Ms. Richardson: The Honourable Senator Cordy?
Senator Cordy: Yes.
Ms. Richardson: The Honourable Senator Eggleton?
Senator Eggleton: Yes.
Ms. Richardson: The Honourable Senator Nancy Ruth?
Senator Nancy Ruth: Yes.
Ms. Richardson: The Honourable Senator Ngo?
Senator Ngo: No.
Ms. Richardson: The Honourable Senator Oh?
Senator Oh: No.
Ms. Richardson: The Honourable Senator Seidman?
Senator Seidman: No.
Ms. Richardson: The Honourable Senator Seth?
Senator Seth: No.
Ms. Richardson: The Honourable Senator Smith, P.C. (Cobourg)?
Senator D. Smith: Yes.
Ms. Richardson: The Honourable Senator Stewart Olsen?
Senator Stewart Olsen: No.
Ms. Richardson: The Honourable Senator Wells?
Senator Wells: No.
Ms. Richardson: Yeas, 5; nays, 6.
The Chair: The results from the clerk are that the motion to append the first observation on the list from Senator Eggleton has been defeated by a vote of 6 to 5. I declare the motion defeated. Senator Eggleton?
Senator Eggleton: The second one deals with openness and transparency — two words that have been used so much in the last couple of years and two words that indicate a concern that we have had about the department.
The department, we have heard from many witnesses, has just been too secretive and has not provided a lot of information that people in medical practice and researchers need. This is an effort to emphasize it. I know the minister wants to do this, but I think we should emphasize it in the terms of the regulations by saying:
That in the preparation of the regulations, openness and transparency of information to the public, health-care professionals and researchers be maximized for both pre- and post-approval studies and reviews. This is an issue that can be found throughout the Standing Senate Committee on Social Affairs, Science and Technology's four reports on our review of prescription pharmaceuticals in Canada, tabled between 2012 and 2014.
There is one more to come this year. The observation continues:
The extent of openness and transparency should be no less than what is publicly available from the Federal Drug Administration in the United States and the European Medical Agency in the European Union.
Sometimes we hear that in some cases we may have a little more information than they do — I think we heard a bit of that yesterday. However, the preponderance of the expert witnesses before this committee, time and time again, is that no, we don't have the same degree of openness and transparency as the FDA does in the United States or the EMA does in the European Union.
This observation is to emphasize this point and to draw the attention to the drafters of the regulations what we have already said in our reports. How can we argue with a resolution that deals with what we have already said in our reports?
Senator Seidman: First, the committee has already made this recommendation. It has already been taken seriously. In fact, as you can see in the amendment in this bill, the amendments proposed enhance transparency concerning Health Canada's regulatory decisions, information regarding clinical trials and the scope of confidential business information and disclosure. This transparency is built into the bill. In fact, requiring further studies, as we heard yesterday — for example, clinical trials and then publishing the results, whether they be positive or negative — is an authority now mandated to the minister. This is in the bill. I don't think there is any need for going beyond since it is already there in the bill. It seems redundant.
Senator Cordy: Senator Seidman, you said earlier, in relation to the first observation brought forward by Senator Eggleton, that if we wanted to do so, we could all go before the department and listen and engage in the development of the regulations.
The problem is that we have heard, over and over again — everybody on this committee — continuously from witnesses who appeared before this committee, about the lack of transparency at Health Canada. We have heard that Canadians are going to websites — in the United States the FDA and the European Medical Association — to get their information. That is wrong.
Senator Eggleton is asking that these procedures and preparations for the regulations be done in an open and transparent way so that the average Canadian, or a Canadian senator, will know when this is taking place, where it is taking place and that they are able to go and be a part of those discussions. I think that is a pretty straightforward observation to make. I can't see the harm in allowing the process to be open and transparent. Certainly from what I have heard in the past three years studying pharmaceuticals, that has not been Health Canada's nature to be open and transparent. This is simply an observation that in the process, in the preparation, it be open and transparent.
Senator Chaput: This issue is of utmost importance. It can be found throughout at least four reports of this committee. I understand that it has already been said, been made and been taken seriously, but Canadians need to know and need to be part of the process. We need to communicate the information to Canadians. We need to work harder, so I don't see any problem in repeating this even if it has already been said because more work needs to be done.
The Chair: Given some of the comments made here today, which I know are all constructive in light of the things that we have all heard in the past, I think it is important that we bring it up to the bill itself.
What this bill actually does is it provides the access that we have requested all along. Not only that, it goes further than some of the other jurisdictions because we had an amendment proposed by industry, when they appeared before us, to put in language that would restrict the minister's ability to move on this by imposing words that would be subject to considerable legal challenge such as ''imminent,'' and so on. We have heard that this bill makes access to information more accessible as a result of that.
With regard to the department — and, we have certainly had a great deal of interaction with them along the lines that have been indicated — the fact that they have anticipated, with this bill moving forward, an openness and transparency program into which this bill will fit indicates, hopefully, that there is a significant change in their attitude and that they are now being given a tool to do something which they did not have before. That is simply a comment that I would like to put on the record.
Senator Eggleton: Thank you for that. However, I would point out that we have had the department, many times in the past — before this bill — come and tell us how open and transparent they were. They are a couple of words.
In the bill, since you didn't take my amendment, there is still a lot of ''may'' in there — may do it; may not do it. I am talking about the regulations here, too, where the devil is in the details, remember? I want to make sure this is still front and centre with them.
You say, Senator Seidman, that the point has already been made. Well, we have made the point many times about electronic health records. Remember that? We felt that we had to keep repeating things until they were actually implemented. That is why I think we need to keep repeating this until it actually gets implemented. Openness and transparency will help the health care professionals and the public to be able to steer away from serious drug problems as they will understand the impact. People die in this country every year from abuse or misuse of drugs. We all know that. It is a big safety issue. That is my case.
Senator Cordy: I guess I see this particular observation as being a red flag. That is, take note. We have mentioned it before in our reports. We have heard from the witnesses who appeared before our committee that there has been a lack of openness and transparency on the part of Health Canada. What we are saying, again, is put a little red flag on it, as we have talked about should be put on pharmaceuticals when people get them, as a notification. Let us put it in here.
I don't see the problem. These are observations. This isn't changing the bill or stopping the bill from going forward. Can't we have a bit of collegiality in saying yes, it is an observation? Let us have a red flag to say that openness, accountability and transparency have to be recognized as being extremely important.
Senator Stewart Olsen: I hear what you are saying about observations but I did sit here yesterday and listened to the minister, who repeated time after time that her focus is on openness and transparency and moving this forward within the department. Therefore, I'm not certain, and because it is within the bill itself, and because she herself stated they want to move this legislation forward expeditiously and I take her at her word, I trust that and I think the Senate has put it in reports and we're very much there. However, I would like to say that I take you at your word that you're moving forward on this.
I'm also not comfortable with the Senate comparing our health department with the United States and with the European Union in a public document. I will leave that with you.
[Translation]
Senator Chaput: Here is what I am wondering. Has this committee not already issued the same recommendations in its report to place further emphasis on this issue and ensure that actions are taken? So I see no problem with repeating this if it has already been said. I also do not see how this could not be considered as something positive for the minister and for the bill. Thank you.
[English]
Senator D. Smith: I'll be brief. I'm not a member of this committee and this is the first time I've sat on it.
Speaking as a lawyer — and not all lawyers would agree with me — I like clarity and I think this enhances clarity. I see no downside to it whatsoever. I have known the minister for many years and I accept everything she says, but if this enhances clarity I think it is a good idea so I shall vote yes.
Senator Eggleton: Senator Stewart Olsen, I heard your objection to the comparison with the FDA in the United States and the European Medical Association. If that part were removed would you be supportive of the balance of the observation?
Senator Stewart Olsen: No, I would not.
Senator Eggleton: Thank you.
Senator Stewart Olsen: That is good enough? Okay.
The Chair: I believe that Senator Eggleton would like this put to a vote.
Senator Eggleton: Everything.
The Chair: Each one. It is understood that Senator Eggleton has moved the proposed observation listed as No. 2 on the sheet before you; is that understood by the committee?
Hon. Senators: Agreed.
The Chair: Are you ready for the question?
Hon. Senators: Agreed.
The Chair: The question has been called. Senator Eggleton would like a recorded vote. I approach the clerk.
[Translation]
Ms. Richardson: The Honourable Senator Chaput?
Senator Chaput: Yes.
[English]
Ms. Richardson: The Honourable Senator Cordy?
Senator Cordy: Yes.
Ms. Richardson: The Honourable Senator Eggleton, P.C.?
Senator Eggleton: Yes.
Ms. Richardson: The Honourable Senator Nancy Ruth?
Senator Nancy Ruth: Yes.
Ms. Richardson: The Honourable Senator Ngo?
Senator Ngo: No.
Ms. Richardson: The Honourable Senator Oh?
Senator Oh: No.
Ms. Richardson: The Honourable Senator Seidman?
Senator Seidman: No.
Ms. Richardson: The Honourable Senator Seth?
Senator Seth: No.
Ms. Richardson: The Honourable Senator Smith, P.C. (Cobourg)?
Senator D. Smith: Yes.
Ms. Richardson: The Honourable Senator Stewart Olsen?
Senator Stewart Olsen: No.
Ms. Richardson: The Honourable Senator Wells?
Senator Wells: No.
Ms. Richardson: Yeas 5; nays 6.
The Chair: According to the clerk the motion has been defeated by a vote of 6 to 5. I declare the motion defeated.
Senator Eggleton: The third one is:
That the Government of Canada ensure that necessary funding be provided to Health Canada to fully implement Bill C-17 as soon as the regulations are proclaimed in effect. We draw attention to recommendation 4 found in the Senate Standing Committee's report ''Prescription Pharmaceuticals in Canada: Post-Approval Monitoring of Safety and Effectiveness''. It states:
And the Senate agreed.
The committee therefore recommends that the Minister of Health work to achieve equal funding for both pre- and post-approval drug regulatory activities and ensure that post-approval resources are adequate for implementation of a comprehensive life-cycle approach to drug management.
We used the ''life cycle'' before Health Canada did.
This observation was discussed yesterday. I presented the case where the Auditor General had said that the inspections quota had not been reached in terms of clinical trials. The target at 2 per cent had not been reached. The Auditor General was also critical of how long it took Health Canada to notify parties of a problem in a non-compliance issue. It took between 56 and 142 days to notify the parties about a problem. We're talking about drug safety for the public.
We all know about the poor record of the inspection of foreign drug manufacturing sites. It got a lot of attention in The Toronto Star not too long ago and the minister responded to it. I give her credit for that. She responded and took some action on that. However, we knew that months ago because that was here at the committee. We were hearing months ago about substandard pharmaceuticals and the fact that there wasn't sufficient inspection.
What does all that indicate? I will give them the benefit of the doubt that they're trying their best but what it indicates is maybe they don't have the resources that they need to be able to do their job now. If they don't have the resources to do their job now do they have the resources to implement this bill, which takes everything a few steps further?
In finishing that comment yesterday and that question to the minister I said:
On top of all that, the federal budget in 2012 cut 275 positions, I understand, from the health products division of Health Canada.
To which the minister said:
First of all, Anne just told me that there was nothing cut, so that's some misinformation. She can always elaborate on it off-line with you, if you'd like.
She is referring to the Assistant Deputy Minister who was sitting beside her and who I think is here, so I talked with her this morning about it.
Where does this 275 come from? Well, it comes from a departmental document. It comes from their departmental performance report or DPR. Going specifically to the Health Products Division, it says that Human Resources FTAs plan 2,174, actual 1,899. That's a difference of 275. That is where the 275 comes from, so it's 275 fewer positions were actually used.
When I did talk to the assistant deputy minister I was told that this is all relevant to revenues — I might get this wrong — roughly relevant to revenues, and it says that, in fact, on the document ''mainly due to lower projected revenues based on actual demand for regulatory reviews.'' Actual demand for regulatory reviews when the Auditor General says they're not doing what they're supposed to be doing? There's a disconnect here somewhere.
That is what the 275 figure comes from. Interestingly enough, there was a presentation made, this document here, ''Health Products and Food Branch'' on May 8 of 2012, in which the director, Bureau of Pharmaceutical Sciences put on a slide presentation and said in one of the slides that savings were realized primarily through consolidation of activities. He was talking about the impact of the budget, which is what I was talking about, the impact of Budget 2012. He says that approximately 190 people across the branch were affected. It says right here, 190 people. Now, they do go on to say that there were no reductions to operational areas, the drug medical device review.
Well, maybe they aren't making changes to the frontline workers but the support staff can be just as important. Consider all of us at this table to be front line and somebody comes along and says we're cutting all your support services. How effectively do you think you could do your job? The support services are all part of it as well. There is other documentation that came out of Budget 2012 that indicated in the health department as many as 1,416 number of FTA reductions were to be made as part of the budget cuts and now we see a report this week whereby the number of cuts in the public service are going up to even higher numbers than they were in 2012 — 35,000 public service jobs, according to a report in the Ottawa Citizen.
I think there is justification for concern about the ability of the department to do the job and having the necessary resources to do it. It comes from their material and government documents.
I move the third amendment to say to the government as a whole — not just the minister — that they need to pay attention to this, to make sure the department has the resources, and to not scrimp on it. Don't do what we found in the Food Inspection Agency, where we had all sorts of problems crop up with tainted meats and things like that after there had been cutbacks. We don't want that kind of thing to happen here because, again, we are dealing with the health and safety of Canadians.
It is a simple observation to say, please ensure the necessary funding. That's all.
The Chair: I just need to correct the language. Senator Eggleton meant that he was moving that the observation be appended; he was not moving an amendment.
Senator Eggleton: Yes, the observation.
The Chair: That is for clarity of the record.
Senator Seidman: I am sure that almost every single person around this table yesterday asked the minister this very question when she was here. It is quite remarkable. Maybe four or five of us asked the question about resources because it was a concern. The minister answered that question over and over again, very clearly, and said:
Health Canada currently spends a significant amount of their time and resources negotiating with companies to resolve and address safety issues related to drugs and medical devices. I have been a part of that. I have seen how long it has taken at times for us to see movement from a company. Vanessa's Law will free up all the resources as it will give to officials the tools they need to act quickly, decisively and to move on. The key to it is that they will have the authority to take that kind of swift action.
The problem now is they spend hours and hours negotiating these things. She is saying very clearly that this will help to ensure that companies comply with this new law. It sends a strong message about what they should expect from the department, and she knows that Health Canada will not hesitate to use these new powers. Therefore, this will ensure that officials spend far less time trying to enforce things.
She says that Vanessa's Law will have a huge impact and will free up a lot of resources and time for departmental officials to spend on the safety issue as opposed to on time negotiating with companies. Again, Vanessa's Law has anticipated these issues and has built into the bill the opportunity to spend far less time negotiating and far more time enforcing proper safety for Canadians.
I also suggest that the minister said clearly yesterday that she would continually reassess to ensure that the resources were adequate. She stated that to all of us who asked that question of her, namely that this was a work in progress, that she wouldn't be afraid at any point in the process to ensure that resources were adequate, and that this would be an ongoing process for her.
Senator D. Smith: I wasn't here yesterday to hear what she said, but I have known her for many years. She is a longtime friend and I believe what she says. But this isn't in here. This observation says the ''Government of Canada as a whole.'' In fact, it might reinforce her muscle a bit if she's running into problems down the road. What vibe would this send off? A good vibe. You can't talk the talk unless you walk the walk, so you better walk the walk. I think this message reinforces her in the event she needs a little muscle from time to time. It is a good observation, so I am for it.
Senator Cordy: Senator Eggleton has brought in observations to help make the implementation of this bill better. Everyone around this table is in favour of Vanessa's Law. We have said this from the very beginning. We congratulated Terence Young on his initiative and his tenacity in sticking with it since becoming a member of Parliament in 2008. These are observations. The suggestion that someone made earlier that it might slow the bill down is totally incorrect. It is an observation. It is sort of like a ''take note.'' these are things that we heard during our discussions. These are things that we heard from our witnesses. These are things that we heard even before we had the bill in our study of pharmaceuticals.
Senator Eggleton has brought forward an observation related to openness and transparency. We have heard that over and over. It was voted down. He brought forward an observation that the regulations be brought forward to this committee. That was voted down. He brought forward an observation that the regulations be expedited — that we have the regulations in a hurry. It is pretty self-evident to me that that should be accepted. That was voted down. Now he brings forward an observation or a ''take note'' that the necessary funding be provided to Health Canada to implement this bill. The bill that we are all in favour of, he wants to ensure that the Government of Canada ensures that the necessary funding is there so this bill that we all want is implemented in a timely way. Yet, we are being told, ''Don't worry about openness and transparency. Don't worry about the resources. Everything will be there. Life will be wonderful. Be happy.'' Why are we afraid to put observations to make the implementation of this bill better? I just can't understand that.
Senator Chaput: I agree with this observation. Many of our witnesses talked about the resources. Many of them talked about ''additional resources.'' I had a problem with that because I wasn't sure if additional resources were needed.
Yesterday, we heard from the minister. Today, we have this observation which says ''necessary funding.'' the minister will ensure that the necessary funding is there. I am really at ease with this and I vote for that.
Senator Eggleton: I appreciate the comments of my colleagues.
I want to tackle a couple of things here that Senator Seidman said. First, on this question of negotiating, we have never been presented with any evidence as to how much time is spent on negotiating. When you get into dialogues with pharmaceutical companies, there is a lot of back and forth just to get information that takes up a fair bit of staff time before you even get into what you might formally call a negotiation. Maybe less time will be spent on that. I am not sure it will be completely eliminated, given that we are not giving protection to the minister for the immunity of law suits, and there could be some hesitancy to jump on the recall provision before there is some discussion about it. I don't know how much time, really, they will save on that so they can focus on investigations. We haven't been given any evidence to that effect.
You also said that the department would have no hesitation to use the new powers. The powers already there they haven't used very well. Look at Ranbaxy and the fact that they were still allowing medications in pharmacies in Canada when the United States had banned them. The FDA had taken them off the shelves. In fact, they were convicted — criminal conviction in the United States — on substandard drugs.
So they won't hesitate to use the new power? Well, I hope you're right; I hope that's the way it works out. But it's going to require some cultural change.
Finally, there is this question that she would ensure that resources are adequate. As Senator Smith points out, this isn't directed specifically at her; it's directed at the Government of Canada. Both Senator Smith and I have been ministers of the government at a previous time, and we know that you've got to go — it's the Finance Minister who has the biggest control when it comes to resources, or the Prime Minister, and you need every support you can get when you go to cabinet to try to get your money.
So let's give some support to her by saying that the Government of Canada should provide the necessary funding. This is supportive of Minister Ambrose.
The Chair: I'm going to put the question to you in a moment, but I think there are a couple of pieces of information for clarification. First, there is a substantial difference between the authority of the minister under this bill with regard to recall and dealing with anything that is problematic, versus the old legislation that simply allowed for suspension on an ongoing basis.
Second, I take great pride in the fact that our report has been referred to as being a significant contributor to the language of this bill and the life-cycle approach — our term — in terms of a report that this committee took to the Senate and had this very recommendation in it. The report was passed by the Senate and requires the minister to respond, which I believe is a far more powerful contribution than just the observation here today, which I think would be redundant.
With that, I'm going to have the clerk call for the vote on the motion to add the observation identified as observation 3 on the sheet provided by Senator Eggleton.
Senator Cordy: Just for clarification —
The Chair: I have no further comment. I'm calling the vote. Clerk, would you call the vote?
Ms. Richardson: The Honourable Senator Chaput?
Senator Chaput: Yes.
Ms. Richardson: The Honourable Senator Cordy?
Senator Cordy: Yes.
Ms. Richardson: The Honourable Senator Eggleton, P.C.?
Senator Eggleton: Yes.
Ms. Richardson: The Honourable Senator Nancy Ruth?
Senator Nancy Ruth: Yes.
Ms. Richardson: The Honourable Senator Ngo?
Senator Ngo: No.
Ms. Richardson: The Honourable Senator Oh?
Senator Oh: No.
Ms. Richardson: The Honourable Senator Seidman?
Senator Seidman: No.
Ms. Richardson: The Honourable Senator Seth?
Senator Seth: No.
Ms. Richardson: The Honourable Senator Smith, P.C. (Cobourg)?
Senator D. Smith: Yes.
Ms. Richardson: The Honourable Senator Stewart Olsen?
Senator Stewart Olsen: No.
Ms. Richardson: The Honourable Senator Wells?
Senator Wells: No.
Ms. Richardson: Yeas 5, nays 6.
The Chair: According to the information of the clerk, the motion was defeated in a vote of 6 to 5. I therefore declare that the motion to add observation No. 3, proposed by Senator Eggleton, has been defeated.
Senator Eggleton: This is the last one. Maybe this one will be more successful.
I understand the desire of senators on the government side to support the minister and support the bill. It is a good bill, and I've said that. It's a good start.
But we've had witness after witness here — not all of you were here for those witnesses — who have said it needs improvement. Every witness said ''improvement.'' Maybe some of the improvements suggested we might not like, and I certainly haven't exhausted the list of improvements.
The Chair: Which ones?
Senator Eggleton: I haven't exhausted the list of improvements here. Even though Senator Smith has had to leave, maybe this is the one that somebody else will support and maybe we will get this one through. Let me tell you what this one is about.
It reads:
That where the Minister, pursuant to new section 21.31 and 21.32 of the Act, instructs the holder of a therapeutic product to: (1) conduct an assessment of the therapeutic product to which the authorization relates, and provide the Minister with the results of the assessment; and (2) compile information, conduct tests or studies or monitor experience in respect of the therapeutic product; that the Drug Safety and Effectiveness Network, or an alternative arms-length entity, provide oversight to ensure the proper conduct and accuracy of results of the investigation.
I mentioned this to the minister yesterday and she said, ''Well, there are openness and transparency provisions.'' Yes, except that you need to have somebody who understands what the studies are going to say to be able to evaluate whether they have been done properly. Remember, the pharmaceutical industry has a conflict of interest in this. They're not going to come out with a report that says, ''This is all bad, and we shouldn't have done it'' or whatever. They want to see a report that helps keep that product on the market or reinstates it through the market, as the case may be.
All I'm saying here is that there needs to be an oversight mechanism, and if it's going to be the Drug Safety and Effectiveness Network, that's fine by me. That's why I spelled it out specifically there.
That's my final observation.
The Chair: Senator Seidman?
Senator Seidman: It's my understanding from what we heard yesterday, and from everything we know about requests to do further testing — so the request is made to the company — there is some issue here, and you need to do further testing. That's what you're referring to. The fact is that the company has to submit a study plan to Health Canada. So if it's a trial or whatever mechanism they use, they have to submit the study plan with a clear design. And that must be approved by Health Canada. Health Canada has to then say whether this will answer their question or resolve their problem about this particular drug.
So it's already built in; the oversight that you're asking for is already built in by Health Canada, because they use experts. They have to approve the study design and specifically say to the company, ''Yes, this will answer the question,'' or ''No, it won't answer the question.''
Therefore, I don't think we need an observation when it's built into the process as it stands.
Senator Eggleton: I don't think so. What I'm saying is that we need an arm's-length third-party observation of this. Health Canada could well have approved this product in the first place, so they obviously have an interest in all of this, as well. I'm looking for an arm's-length third party, and I think the Drug Safety and Effectiveness Network would be a good one. It could be another one if the minister so suggests, but I think we need to make this a little more arm's length, is what I'm saying.
Senator Seidman: We are talking about a Phase 4 approach here, because you have an adverse reaction or you have some problem. So Health Canada goes to the company and says, ''You need to do further testing, whether it be on a subpopulation group'' or whatever it is. The company then has to submit the study design — the plan — and Health Canada's experts — and they may indeed consult DSEN or whomever it is they consult — to say find out whether that study design will answer the problem observed.
So there is that oversight that this observation asks for already built in to a process.
Senator Eggleton: I don't think so.
The Chair: Okay. Are you finished?
Senator Eggleton: I'm finished.
[Translation]
Senator Chaput: Mr. Chair, I do not understand why this observation cannot be included in the committee's report. I do not see anything negative about including that observation. I see it as something that will strengthen the bill. I do not understand why we cannot include it.
[English]
The Chair: I think Senator Seidman gave her response to that. The committee is ready for the question? I'm calling the question on the observation listed as No. 4, proposed by Senator Eggleton, who has made a motion to include that observation in our report. I am going to put the question to you through a recorded vote. I will ask the clerk to poll the committee.
[Translation]
Ms. Richardson: The Honourable Senator Chaput?
Senator Chaput: Yes.
[English]
Ms. Richardson: The Honourable Senator Cordy?
Senator Cordy: Yes.
Ms. Richardson: The Honourable Senator Eggleton, P.C.?
Senator Eggleton: Yes.
Ms. Richardson: The Honourable Senator Nancy Ruth?
Senator Nancy Ruth: Yes.
Ms. Richardson: The Honourable Senator Ngo?
Senator Ngo: No.
Ms. Richardson: The Honourable Senator Oh?
Senator Oh: No.
Ms. Richardson: The Honourable Senator Seidman?
Senator Seidman: No.
Ms. Richardson: The Honourable Senator Seth?
Senator Seth: No.
Ms. Richardson: The Honourable Senator Stewart Olsen?
Senator Stewart Olsen: No.
Ms. Richardson: The Honourable Senator Wells?
Senator Wells: No.
Ms. Richardson: Yeas, 4; nays, 6.
The Chair: Okay. According to the information provided by the clerk, the motion to append Item No. 4 as an observation to our report was defeated. I declare that motion defeated.
I will now return to the script and ask you, is it agreed that I report this bill to the Senate?
Hon. Senators: Agreed.
The Chair: That's agreed. I believe that completes the formal requirement.
I would like to say to the committee that I believe this bill is a very substantial improvement and benefit to Canadians. I think this committee can take considerable pride in the fact that it has contributed to the understanding of the issues. It has made recommendations formally to the government, through the minister, largely, and Health Canada, a number of which are reflected in this bill. Whether or not we influenced it directly, they reflect the issues we raised, and I think it will move things forward substantially.
I didn't disagree with the issues that Senator Eggleton was raising. I personally felt that we had covered them one way or another, absolutely, including, as I indicated in the last one, a specific recommendation and a specific report that has been approved by the Senate. It's a formal contribution to, or request forward, with regard to a very critical issue, the life cycle approach.
I do understand the issue of the process in the last one, and that's why I questioned Mr. Lee yesterday, and he confirmed my detailed understanding, which Senator Seidman has summarized very well today. It is a major step forward with regard to the life cycle approach to monitoring prescription pharmaceuticals for Canadians.
In spite of the differences with regard to observations, I would like to acknowledge the contribution of the entire committee over its studies in terms of contributing, we hope, to what all of us consider a major advance in this area.
With that, I declare the meeting adjourned.
(The committee adjourned.)