I call this meeting to order.
Welcome, everyone, to meeting number nine of the House of Commons Standing Committee on Health. The committee is meeting today to study the emergency situation facing Canadians in light of the second wave of the COVID-19 pandemic, for the first hour, and the Patented Medicine Prices Review Board's guidelines for the second hour.
I want to thank the witnesses for appearing today. For the first hour, from the House of Commons, we have Philippe Dufresne, Law Clerk and Parliamentary Counsel; and Michel Bédard, deputy law clerk and parliamentary counsel.
For the second hour, from the Patented Medicine Prices Review Board, we will have Dr. Mitchell Levine, chairperson; and Douglas Clark, executive director.
I would like to start the meeting by providing you with some information following the motion that was adopted in the House on Wednesday, September 23, 2020.
The committee is now sitting in a hybrid format, meaning that members can participate either in person or by video conference. All members, regardless of their method of participation, will be counted for the purpose of quorum. The committee's power to sit is, however, limited by the priority use of House resources, which is determined by the whips.
All questions must be decided by recorded vote, unless the committee disposes of them with unanimous consent or on division. Finally, the committee may deliberate in camera, provided that it takes into account the potential risks to confidentiality inherent to such deliberations with remote participants.
The proceedings will be made available via the House of Commons website. So you are aware, the webcast will always show the person speaking rather than the entirety of the committee.
To ensure an orderly meeting, I would like to outline a few rules to follow.
For those participating virtually, members and witnesses may speak in the official language of their choice. Interpretation services are available for this meeting. You have the choice, at the bottom of your screen, of floor, English or French. Before speaking, click on your microphone icon to activate your own mike. When you are done speaking, please put your mike on mute to minimize any interference.
As a reminder, all comments by members and witnesses should be addressed through the chair. Should members need to request the floor outside of their designated time for questions, they should activate their mike and state that they have a point of order. If a member wishes to engage in debate, they should use the “raise hand” function. This will signal to the chair their interest to speak and create a speakers list. In order to do so, they should click on “participants” at the bottom of the screen. I should note that people who want to respond to points of order or raise their own points of order consequent to a given point of order should not use the “raise hand” function. Just use a hand gesture or speak up with a point of order statement.
When speaking, please speak slowly and clearly. Unless there are exceptional circumstances, the use of headsets with a boom microphone is mandatory for everyone participating remotely. Should any technical challenges arise, please advise the chair. Please note that we may need to suspend for a few minutes as we need to ensure that all members are able to participate fully.
For those participating in person, proceed as you usually would when the whole committee is meeting in person in a committee room. Keep in mind the directives from the Board of Internal Economy regarding masking and health protocols. Should you wish to get my attention, signal me with a hand gesture or, at an appropriate time, call my name. Should you wish to raise a point of order, wait for an appropriate time and indicate to me clearly that you wish to raise a point of order.
With regard to a speakers list, the clerk and I will do the best we can to maintain a consolidated order of speaking for all members, whether they are participating virtually or in person.
With that, we'll invite the law clerk, Mr. Dufresne, to make a statement.
You have 10 minutes, please.
As the Law Clerk and Parliamentary Counsel for the House of Commons, I am pleased to be here today to address any questions that the committee may have with respect to the House's motion and the role it prescribes for my office. I hope that my answers will assist the committee.
As you know, the House's motion includes an order for certain documents from the Government of Canada to be provided to my office no later than November 30. This includes documents from the Office of the ; the Privy Council Office; the Office of the ; the Office of the , Health Canada and the Public Health Agency of Canada. This also includes all documents relating to the COVID-19 vaccine task force and its subcommittees; the Government of Canada's COVID-19 vaccine distribution and monitoring strategy; and the government's communications with the World Health Organization concerning the Global Public Health Intelligence Network.
The motion states that the Clerk of the Privy Council Office may request an extension of up to seven additional days by writing a letter to the committee.
The House's motion expressly excludes from its order the minutes of meetings of the cabinet and its committees. It also requires that all documents provided in response to the order be vetted by my office for matters of personal privacy information and national security, and that the category of documents relating to the COVID-19 vaccine task force and its subcommittees also be vetted for information the disclosure of which could reasonably be expected to interfere with contractual or other negotiations between the government and a third party.
The motion provides that my office is to complete this work within seven days of receipt of the documents from the government, and to provide them to the Speaker for tabling in the House of Commons at the next earliest opportunity. Upon being tabled, the documents are to be permanently referred to this committee. I confirm that my office has not yet received documents in response to the order.
The order allows the government to exclude any minutes of meetings of cabinet and its committees.
For all the other categories of redactions—personal privacy, national security and information that, if disclosed, could reasonably be expected to interfere with contractual or other negotiations between the Government of Canada and a third party—the order is clear that my office must vet those redactions.
In our view, the House's order does not preclude the government from proposing what it feels the redactions on those grounds should be, but my office needs to see the documents and make the final determination about what is provided to the House and to this committee in accordance with the order.
It is up to this committee, and ultimately the House, to determine whether it is satisfied with documents provided in response to the order, with the government's approach and with any redactions made. This is consistent with the House's role as the grand inquest of the nation.
In terms of the process and resources, my office has 15 counsel, along with two paralegals and other employees, including jurilinguists, the publications team, translators, administrative assistants and an articling student, for a total of 35 employees.
My office provides comprehensive legal and legislative services to Parliament, the Board of Internal Economy, the House and its committees, members of Parliament and the House Administration. It's also responsible for drafting private member’s bills and motions to amend government bills, and for the printing the bills as they progress through the legislative process. In some sense, it provides similar types of legal and legislative services to the House that the Department of Justice provides to the government.
In response to the House's order, we've taken steps to acquire additional resources in anticipation of receiving a very large volume of documents for review and redaction.
My office has reviewed the House's order and made the necessary preparations so that we can respond and begin our work as soon as we receive the documents. We have established a project team to prepare for the receipt of documents, led by the deputy law clerk and parliamentary counsel, legal services, Monsieur Michel Bédard, who is with me today.
The project team has carefully reviewed the text of the House's order and developed an internal process for uploading, organizing, reviewing and redacting documents. As mentioned, we've taken steps to acquire additional resources in anticipation of receiving what we expect will be a very large volume of documents for review and redaction. This includes hiring two additional legal counsels to assist with this work as required.
We have taken steps to mobilize and leverage our existing resources in anticipation of this work.
The House's order states that we are to complete our work within seven days of receipt of the documents. We understand this to mean calendar days. We are then to provide the redacted documents to the Speaker, who will table them, and they will then be referred to the committee.
At this stage, while I do not know how many documents we will receive from the government in response to the House's order, I understand it is expected to be a very large number of documents.
Indeed, in his testimony before the finance committee on Tuesday this week, the Clerk of the Privy Council, Mr. Ian Shugart, suggested that it could be millions of pages. Given the unprecedented volume of documents, we are expecting that this will represent a significant amount of work and full-time, dedicated resources.
I'm prepared to devote close to 100% of my office’s resources to the review and redaction of documents for the seven-day period set out in the motion.
This means that all our other activities—including the provision of legal advice and drafting of private member's bills—will be severely curtailed or delayed, except those services that are essential.
Since the House is sitting, those essential services include the preparation of government bills; the publication of bills tabled in the House; the reprint of bills at the request of a committee; the printing of parchment copies; the drafting of amendments to legislation at all stages; and responses to requests for urgent legal advice.
Now let's see how many pages we could process in seven days.
Basically, if all counsel each review between 300 and 500 pages a day, we estimate that we could process up to 50,000 pages in the first seven days following the receipt of the documents.
This estimate is based on the 6,000 pages that the government recently sent us in response to a production order by the Standing Committee on Finance.
In this case, the volume of documents could be exponentially more than that, and the scope of redactions my office has to vet is also larger. Of course, these estimates may change depending on the volume and type of documents we receive in response to the House's order. The approach the government takes may also impact our estimated timelines.
Should the volume of the documents provided go beyond what my office can complete in seven days, I will immediately inform and seek guidance from the committee with respect to the way forward.
With that, my colleague and I would be pleased to answer any questions.
Thank you. Those were my thoughts exactly.
With that, Mr. Chair, I move:
That the Chair be instructed to present the following report to the House forthwith, provided that dissenting or supplementary opinions, pursuant to Standing Order 108(1)(b), shall be filed with the clerk of the committee within 24 hours of adoption of this motion:
The Standing Committee on Health has met pursuant to its Order of Reference of Monday, October 26, 2020, and recommends the following:
That the Law Clerk and Parliamentary Counsel, when vetting documents under subparagraph (aa)(ii) of the Order adopted by the House on Monday, October 26, 2020, be instructed to prioritize the vetting in the following order: (a) documents, produced by the Public Health Agency of Canada in response to paragraphs (y) and (z) of the Order, concerning vaccines; (b) all other documents, produced in response to paragraphs (y) and (z) of the Order, concerning vaccines; (c) documents, produced in response to paragraph (w) of the Order, concerning rapid testing; (d) other categories of documents which may be specified, from time to time, by the Standing Committee on Health; and (e) all other documents; that all documents be circulated to the committee in both official languages; and
That the Standing Committee on Health may, on the request of the Law Clerk and Parliamentary Counsel, grant one or more extensions of the deadline, prescribed by subparagraph (aa)(ii) of the Order adopted by the House on Monday, October 26, 2020, for his vetting of documents, provided that he shall provide the Committee with a weekly status report on the vetting process.
Chair, while the clerk is here, I think we've heard a lot of interest in the Canadian media, putting it mildly, on the vaccine production process and distribution, etc. The documents that are going to be relevant to the committee could be prioritized, as the clerk just said. What this would do is, per the clerk's suggestion, give him some directions on what to prioritize first and foremost, and produce first and foremost. It would also give him the ability to come back to our committee at future points.
What I'm thinking here is that we prioritize the topics that are first and foremost in the minds of Canadians and that I think have been in front of Parliament the most frequently over the last few months and are probably the most material to our response to COVID, so that we can look at those in an expeditious manner, and then allow the clerk to come back to committee and essentially tell us how it's going. I think this is an elegant solution to perhaps some challenges that have been outlined. It would allow us to move forward as parliamentarians and to be able to scrutinize the government's response—the adequacy of it—while providing some direction and clarity.
I will note this. I do find it odd that the clerk has not received any documents yet. For the PCO, in a letter today, which is now public—and I can speak to this—to say that there is a substantive quantity, to quantify that volume and not to have passed anything to the clerk to date, is odd.
Again, I would like to commend the clerk and his team for helping parliamentarians do their job. It is my hope that the committee will support this motion so that we can give him some direction on what to prioritize, and then what we can be scrutinizing in the first order.
First of all, I think it's an excellent motion. From the beginning, one of the main concerns of the government side—in fact, I think of all of us—has been how we can efficiently get important information to us, given that there could be a large volume. I think this is an excellent way to prioritize, given the realities of the letter I just saw this morning from the Clerk of the Privy Council, Mr. Shugart. He is essentially saying that the government can't provide all the documents in time. I'm hearing from the law clerk that, given the Herculean efforts and extra resources of his office, he can't meet the requirements of the motion in the time period given.
As parliamentarians, the only responsible thing to do is see how we can shape our motion to respond to that reality. I can speak for the New Democrats in that I think we should be focusing on vaccines and rapid testing, which are two issues Canadians are probably most interested in hearing about. I think this is nothing more than an attempt to shape the motion into a more reasonable path forward, so that we can actually get started on getting the documents coming to the committee, as the House wanted.
In light of Ms. Rempel Garner's last comment, I was a little unclear about the way forward, too. I think she and the chair are right that this has to go back to the House. However, at the end of the clerk's speaking notes, after taking us through the practical difficulties of processing the information in time, he says:
Should the volume of the documents provided go beyond what my Office can complete in 7 days, I will immediately inform and seek guidance from the Committee with respect to the way forward.
If I may, it might help all committee members to put that question to the clerk and ask him to explain that. I read that to mean that, given that the motion has passed to refer these documents to the committee, perhaps this committee can work with the law clerk on getting an efficient path forward, so that we can get documents coming to the committee in an orderly fashion, given the practical and pragmatic realities of the volume of documents.
Can I ask the law clerk that? Can this committee simply work with you, or does this have to go back to the House?
Thank you very much, Mr. Chair.
Although I don't support this motion, we have the law clerk in front of us for an hour, as requested by the Conservatives—which we supported. We're happy to have you here today.
It's now 2:32 here in Nova Scotia, so it's 1:32 there. We're not going to get all the questions in that we'd hoped to get in, so this seems like just another one of those things thrown in the way—a monkey wrench in the middle of this.
I guess, with the 45 seconds or so since I've printed this motion and looked at, we won't support this motion. We also won't speak to it, because I think it's important—and out of respect for the law clerk—that we get rolling on this so that we can ask these questions. Probably a couple of members now will lose their opportunity to speak to this.
I will say that we debated this all day in the House of Commons and we passed it. I think we should respect the motion the House sent to us. However, like I said, I think the important thing right now is getting to Mr. Dufresne.
Just quickly, I would like to respond to Mr. Fisher's comments. We do have the law clerk here, and after giving his statement, the nub of his testimony or statement so far is that he does not have the resources necessary to actually implement the motion that was passed by the House.
I think the motion by Ms. Rempel Garner is directly on point, because we're dealing with the substance of the matter before us.
The other thing that I must say is troubling, and is in the back of my mind, is that essentially what we're hearing from the government, from the Clerk of the Privy Council and now from the law clerk, is that the government cannot respect the order of the House. That's what we're hearing.
Mr. Fisher referred to respecting the motion of the House. Well, the motion of the House is clear. We've asked for all these documents. We've given a timeline, and the House passed it. What we're really hearing the government say is that they are not going to do it. The question is, can't they, or won't they?
I think it's a question of resources. The law clerk has clearly indicated that they've put in additional resources and hired additional staff to do it. Even with that, it's not sufficient. There is a reference to millions of documents. I have no idea where that comes from. I have no means of assessing whether that's accurate or not. I don't know if that's rhetorical spin or if that's based on data.
The other way to go is to say that the House of Commons passed a motion ordering the government to produce those documents, and it's up to the government to produce whatever resources are required in order to comply. I don't know that it lies in the mouth of the government to say that it can't do it or it won't do it.
I'm speaking directly to the motion, because the motion is predicated on the witness's statement that, given the resources he has, he cannot provide all the documents that have been ordered by the House to come to this committee. Ms. Rempel Garner's motion is an attempt to respond to that in a very responsible way by saying, let's prioritize them.
I support the motion, because I think we should prioritize them. That's a rational, reasonable and sensible way to deal with the matter, but I'm also raising the underlying question, which is, why isn't the government able to send all the documents, even if it is a million documents? That's a question of resources. It's a tough job to do, but it's not an impossible job to do.
I raise that for my colleagues to consider, in lieu of simply expecting the government to comply with the order. I suppose we can take appropriate procedures after that, if they don't. I think this motion is very rational and reasonable.
I'll conclude by saying that I listened to Liberals in the House oppose the motion in the House to produce documents, and one of their prime arguments was that there were too many documents and it would be too difficult for the government to comply. Here we have a motion in front of us that seeks to prioritize them and focus on vaccines and testing. Let's at least get those documents going, and we can give the government more time for the rest of the documents. Now I hear the Liberals saying they don't agree with that, so that's pretty tough to understand.
I'll be supporting this motion, and I thank my colleague for bringing it forward.
Mr. Dufresne, thank you for giving a clear presentation and clear answers.
I don't have many questions. I found Mr. Van Bynen's questions very useful. However, I'm not sure whether you addressed all my concerns.
First, when I read the letter from the Clerk of the Privy Council, I was a little stunned to see that there could be millions of pages. According to the calculation that you provided today, it would take at least 20 days of diligent and ongoing work to produce the documents for the House and the committee. This is on top of the fact that, in his letter, he says that the documents would be sent as they are. In other words, we don't know how much of the documents are in English or French, so we can't estimate how long it may take to translate them. The documents must be provided in both official languages. This unknown variable seems quite important. It may also apply, but in a much more limited way, to the motion undertaken today with respect to the sequential processing of information.
I'm also wondering about the Clerk of the Privy Council's decision to exclude confidential business information. Perhaps you can shed some light on this. I thought that he was sending you all the relevant documents.
The motion that we passed states that information may be redacted in cases where full disclosure could reasonably be expected to interfere with contractual or other negotiations between the government and a third party. This relates to your judgment and the analyses of your legal proceedings, not to the Clerk of the Privy Council.
Didn't the House order basically instruct the Clerk of the Privy Council to send us all the documents?
I believe that all the measures that you just described will be part of our plan, once the new regime comes into effect in January 2021.
We'll proceed in stages, starting with the implementation of the new price ceilings, which are the result of the new comparator countries.
We'll be able to conduct audits only much later, probably in two or three years. It will depend on the Federal Court of Appeal's decision. The Federal Court of Appeal must determine whether we can obtain the information that we need to check whether patent holders are complying with the new confidential price ceilings.
Right now, that's exactly what we're doing. We're moving forward, one step at a time. First, the new country-specific price ceilings will begin to apply in January 2022. At this time, the confidential price ceiling, or the maximum rebated price, isn't being applied.
In the meantime, we'll mainly be consulting with the patent companies. However, we'll also be working on this issue with other stakeholders, as we move forward.
It is. I think that's your challenge. I don't know if it's really my place to advise you in that regard.
It's important to understand a little bit of history here. Maybe that would help you at least contextualize it. It used to be that the federal government contributed to charitable organizations like patient advocacy groups, but in the mid-1990s, they decided to no longer fund organizations of that kind if they had a policy-lobbying arm, because the government didn't want to have to engage with an organization that's ultimately giving it grief for a policy that it didn't like. That created a vacuum, and in defence of these organizations, they had to fill that gap somewhere, so industry was only too happy to step in and provide that funding.
It varies across the developed world, but in some countries they continue to fund their patient groups only on the condition that they prove that they're independent from industry. In many of those countries, it's much easier to have a rational, evidence-based discussion about policy changes, in particular policy changes of this kind.
I'm not saying that every patient group that accepts money is biased, and I'm sure they certainly don't feel that way, but there's a lot of research out there to show that, when you take money from someone, it—even implicitly, without your knowledge, subconsciously—impacts your views. There's definitely a correlation, and a pretty strong one, between where patient groups stand on these reforms and the extent to which they accept funding from industry. Whether it's positive, I don't know, but there's definitely a correlation. It's hard to deny if you go through those briefs.
Hello, colleagues, and hello, witnesses.
I just want to say how insightful I find this conversation, and I know Canadians do as well, with the great questions from all of my colleagues and the answers that follow.
I have three questions. We'll see if we can get through all of them.
The first one is around investments. Several other countries benefit from significant pharmaceutical industry investments while having considerably lower prices than Canada. For example, Belgium receives four times more investment dollars than Canada, despite prices being 20% less.
For both witnesses, can you identify any lessons from the evolvement of the drug regulation processes of our international partners, particularly those within the PMPRB11, that Canada could apply to our own drug regulation processes?
We have a number of sort of motherhood, seminal policy documents out there that I think I would refer you to. It's a big question with a long answer, so I think I would refer you, first and foremost, to our 2015-18 strategic plan. It really sets out exactly what you're talking about in writing, and in a way that I hope is accessible to most people.
Going back to Dr. Levine's opening remarks, it's the dramatic shift that we've seen in the nature of the products that are dominating the market. These go from small-molecule drugs that treat common ailments and that arguably are within the means of ordinary people, to complex biologic drugs to treat more rare diseases that clearly are not within the means of anybody and even institutional payers struggle with. That's one big change. It has necessitated a corresponding change to our regime.
There's another big change. Canada pioneered this practice of international reference pricing as a way to ensure we were getting a reasonable and fair price, but since doing that in the late eighties, through the creation of the PMPRB, most other countries have copied that. One of the ways industry has responded, to try to make that a less effective policy, is by negotiating confidential rebates and discounts off the public list price. That has driven pricing underground, which has proven to be another big challenge for us.
The changes that have been made to the regulations and the guidelines go directly to the heart of those changes. The new regulatory tools, the economic tools, the pharmacoeconomic value and market size will enable us to ensure that Canadians are getting value for their money for these products that have nosebleed price tags.
One of the other changes, which is currently before the Federal Court of Appeal, requires patentees to provide us with the information on those confidential discounts and rebates so that we can regulate the true price in the market.
I know that's a long-winded answer, but if you want more information, I'd really encourage you to go to our website. We've been very transparent over the last five years about what the problem is, what our proposed solution is, and the path for getting there.
That's a really good question. As I said, that's what patient groups were threatening to do in the U.K. and Switzerland, and that's kind of what brought Vertex back to the table. That's my understanding.
There are a number of provisions in our Patent Act that allow for compulsory licensing. One—section 65 and section 66—refers to the kind of situation you just described, when the patentee refuses to provide the product on reasonable terms, but there's a much more open-ended provision, section 19 in the act, that allows the government to override a patent for public, non-commercial use or in emergent circumstances.
All of these provisions.... As you probably know, Mr. Davies, Canada used to have a compulsory licensing system in effect that allowed generics to produce patented drugs at any point in the lifetime of the patent, but in the early 1990s and mid-1990s we entered NAFTA and we entered the WTO TRIPS agreement, and those agreements have a lot of standards and restrictions on the degree to which countries can avail themselves of those provisions, so our provisions reflect the language, track the language in NAFTA and TRIPS.
However, it's not an impossibility. When I go abroad and meet with my counterparts, a lot of countries are saying they lack the tools to deal adequately with the types of prices they're seeing and they need to explore this option of compulsory licensing more and see whether they need to make changes to their legal regimes and whether they need to amend the multilateral agreements they've entered into. They're saying, “Have we gotten to a point where we're in the same position that developing countries were 20 years ago with drugs for tuberculosis, AIDS and malaria, where we just can't afford the market price?”
I think developed countries increasingly find themselves in that same situation, so now there's an openness to talking about compulsory licensing more broadly.