Health Committee on Oct. 18th, 2018

[Christine Moore, NDP, Abitibi—Témiscamingue, QC]

I'd like to know what you think about this model: government corporations making generic drugs, mainly essential or basic medicines, that are widely used in their country?

[Rachel Kiddell-Monroe]

One such example is Brazil, with Farmanguinhos, a nationally owned maker of generic drugs. The impact in Brazil has been unbelievable. Thanks to generic drugs developed in the country, Brazil has avoided the scourge of HIV-AIDS.

That's the case in India as well. India has always been considered a global pharmacy for generic drugs, and it's had a tremendous impact on the country's population.

I think it's a very promising approach.

[Christine Moore, NDP, Abitibi—Témiscamingue, QC]

Under such a model, what criteria should be used in deciding which generic drugs to make or setting priorities?

[Rachel Kiddell-Monroe]

I think that ties in with what Mr. McKinnon was asking about determining which drugs to prioritize.

A nationally owned company would likely support priorities that reflect the population in that country. In the world we live in, however, it's not a question that can be answered without looking at the broader issue, as we talked about earlier.

[Christine Moore, NDP, Abitibi—Témiscamingue, QC]

I have one last question.

The scourge of fake drugs is a fairly widespread phenomenon. We know that people are fighting for access to affordable drugs. When you visit certain countries in Africa, for instance, you find street vendors who seem to have absolutely no qualifications to dispense drugs but sell just about anything. People try to find a way to buy medicines, online or otherwise.

Has the problem of fake drugs levelled off, or is it still growing?

[Rachel Kiddell-Monroe]

As long as drugs aren't accessible, fake drugs will always be a problem. If people can't buy a drug, they will look for an alternative. That's always the way.

I think the problem of fake drugs is the result of medicines being too expensive for people to afford. If people could access a drug to combat malaria or HIV-AIDS, they wouldn't need to turn to the guy on the corner selling God knows what. I really think it has to do with drug prices.

[The Chair, Liberal, Bill Casey]

I think there's a lot of interest in our witnesses today. Our official time for questioning is up, but I'm going to propose that we do another first round at four minutes each. If everybody keeps their time to four minutes, we'll be able to get them all in. It's an incredible group of witnesses. You've provided us with an awful lot of information already—very succinctly, too, I would say.

We're going to start with, I believe, Dr. Eyolfson.

[Doug Eyolfson, Liberal, Charleswood—St. James—Assiniboia—Headingley, MB]

Yes. Thank you.

We were talking before about the cost of research. They are different costs from when I was a grad student. My research was basic medical science. I was basically a lab rat for three years—test tubes, centrifuges, years of plodding work to generate some numbers that may or may not mean something.

If I had come out with a molecule and said, “Hey, this could be really useful,” I would have done the cheapest part of the research. To take an interesting effect in an animal or a cell membrane model and turn it into a workable medication that's actually going to improve or save lives is of course the real big-ticket item. The gold standard is a randomized clinical trial of 10,000-plus patients. Those are very expensive.

We had a witness last meeting who said that we needed to be doing more population-based research. Although that's a little different from what I'm getting at, this is what we are leaving for private industry to do because it's so expensive. They have the resources to invest in this, and of course, again, they're a business. They're not a charity. They want to make up their investment, so they charge a lot of money, and they want extended patents for this.

Now, if we were investing more public money in universities and the universities were performing these large, 10,000-plus randomized clinical trials, would this lower prices and improve access to medications?

[Dr. Jason Nickerson]

This is, effectively, the experience that we've had with the drugs for neglected diseases initiative. DNDi is, effectively, a virtual not-for-profit pharmaceutical company. It coordinates. It runs randomized controlled trials under very difficult field circumstances. If you think it's difficult to do an RCT, a randomized controlled trial, in a well-functioning Canadian hospital, try doing it in the Democratic Republic of the Congo. It's complicated.

The difference there is that the DNDi model is transparent. We know what it costs. I have the figures in front of me. I've told you what they are. It's transparent. It relies on a partnership model that brings people together within a framework that says we are going to do this, and this is the way we're going to do it; and the end product is going to be accessible and affordable. It has brought the costs down through collaboration. Second, frankly, it's a transparent number.

The $1-billion figure was mentioned previously, but I think it's important to note that there's no transparency in that estimate. Nobody is actively quantifying the public investment that goes into individual drugs that are developed or the private investment, so we're left with this kind of black box figure that, frankly, doesn't align with the estimates that we're getting from our partners.

There's certainly at least a cheaper way of doing it, but I think that there's also a need for more transparency in this entire process. That is one of the things that public funders could be demanding. In the situation that you described, where a molecule is discovered in a public lab, at the point that it moves out of that lab, simply attach safeguards to it, and make that a requirement. Require that there be public reporting on the public and private R and D that goes into this in the subsequent stages, and require that at the point of licensing, there be safeguards attached that say, we're going to negotiate for this specific product what a reasonable final price, pricing strategy, or registration strategy going to be.

You described an exact moment at which there is actually quite a bit of leverage that could be exercised through basic policy changes. These are not legislative changes; these are policies that could be implemented to change that dynamic at a critical moment.

[The Chair, Liberal, Bill Casey]

Thank you very much.

We'll go to Mr. Van Kesteren.

[Dave Van Kesteren, Chatham-Kent—Leamington, CPC]

Thank you, Chair. Thank you all for being here.

I'm normally not a committee member here. I have sat on the heath committee for a short duration, so I'm coming in a little bit cold.

I want to go to you, Dr. Nickerson. I want to continue on with what Doug was talking about. I think that's essential as well.

What is the plan, then? Given that research is primarily being done at universities, are you suggesting that all that research would be offered to pharmaceuticals to produce the drugs, or would they contract for it? The fine details really make this thing difficult, as I see it. Maybe you could just elaborate on that.

[Dr. Jason Nickerson]

Yes, you're absolutely right. Right now, the pathway is effectively a licensing agreement. Someone discovers something, and then it's handed over through an exclusive licence. I'm simplifying things significantly here, but let's just work with that. From that point on, things are developed and bought up. There's a whole spectrum of things that happen, and as Dr. Eyolfson mentioned, it's complicated and expensive.

What our experience shows is that at that point, as opposed to issuing an exclusive licence that effectively grants a monopoly to develop and deliver something, partnerships that bring many of the same actors together within a program—if you want to call it that—still have the ability to develop and deliver these products. We have many of these capabilities that exist within publicly funded institutions anyhow, or industry brings certain things to the table. At a very early stage, we'll say that the universities or the health charities are able to coordinate the clinical trials and that industry is necessary for manufacturing capabilities and marketing capabilities, or whatever it may be. We define those things very early on, at the point of issuing that licence.

It is entirely possible to start setting these parameters. Canada can create that mechanism and create that framework to develop and deliver these things as opposed to stopping at the point of funding discoveries that are then commercialized, and saying, “Hope it works out.”

[Dave Van Kesteren]

How are you going to control the pricing?

[Dr. Jason Nickerson]

Well, that really depends on the kind of product we're talking about. On Tuesday we heard from a witness who said that as we move toward more precision medicine, everything will become a rare disease, right? Every version of diabetes, all the different genetic variations, and so on will require different products, so I think we need to be careful about assigning blanket strategies.

One thing UBC has done in their access licensing provisions is establish basic principles that make sense. These are publicly funded discoveries, and their principles essentially state that they should be accessible and affordable to people who need them. Individual products will still require specific strategies, and for some products there will be a competitive market, but perhaps for others there won't be. What we need to get right is that there should be, at the very least at the institutional level, a set of principles that says we are paying for this discovery, and it's incumbent on us, as an institution, to ensure that there is affordable access to it and it's available to the patients who need it.

[Dave Van Kesteren]

Do I have a few more seconds?

[The Chair, Liberal, Bill Casey]

You have 15 seconds.

[Dave Van Kesteren]

Once a pharmaceutical buys a licence, how are you going to stop them from what you might call “exploitation”, although they would just call “profitability”?

[Dr. Jason Nickerson]

I'm not a contract lawyer—I'm a clinician—but I think you insert some sort of clause that says these are the conditions under which the licence is being issued.

My colleagues from UAEM have put more thought into the particularities of this than I have.

[Dr. Rachel Kiddell-Monroe]

Basically, the difference would be that you wouldn't give an exclusive licence to that pharmaceutical company. You'd have a non-exclusive licence.

[Dave Van Kesteren]

But do you think they'd be interested?

[Dr. Rachel Kiddell-Monroe]

Yes, they'd still be interested. This was one of the things we were talking about.

To go back to Mr. Ayoub's question right at the beginning, one of the concerns was around why universities were not doing this, since it seemed so obvious. Well, one of the concerns they had was that they would lose income from royalties. In fact, though, the experience of Yale and Harvard, which their technology transfer offices have told me directly, is actually the opposite. It hasn't affected any bottom line.

As well, universities are not going to suddenly get this massive cash cow of hundreds of millions of dollars pouring in through the door because of the result of a discovery. That's just an urban myth. We can go into the story of how that happened, but it is an urban myth. This idea of technology transfer offices being this big, huge source of revenue for universities has absolutely not panned out. Now that we know that's not the case, there is no reason not to do it, but that is the key concern they have.

[The Chair, Liberal, Bill Casey]

Okay.

Now we will go to Ms. Moore.

[Christine Moore, NDP, Abitibi—Témiscamingue, QC]

Thank you.

Do you think we are paying enough attention to other disease-related factors that aren't directly tied to medicines?

Think about the tuberculosis problem. Other factors can play a role, including overcrowded housing, substandard accommodations up north and a lack of access to quality food, which is often unaffordable. These things can affect a person's immune system.

For instance, diabetes can be treated with insulin, but people with diabetes also have to maintain a healthy lifestyle, which has a huge impact on their health.

Do you think we are paying enough attention to all that? Are we giving people the tools to address other factors so that they derive the maximum benefit from their treatment?

[Rachel Kiddell-Monroe]

A disease like tuberculosis is considered a social disease. Tuberculosis still exists in Canada because indigenous populations live in appalling conditions. Up north, several families live together in the same house. Of course, the situation is ripe for the spread of tuberculosis. I live in Montreal, and that isn't an issue.

It is indeed a social disease. We need to focus more on that and address all of the factors involved. We can't overlook those who will become ill regardless, though. We can't focus exclusively on the recommendations of public health authorities. We need to pay more attention to the medical dimension and access to drugs because, even with ideal housing and the best living conditions, people will always get sick.

For example, I don't think Ms. Kyle takes insulin because of poor eating habits.

[Louise Kyle]

I think it's a really good point. It's important to know that when we look at social determinants, that's one of the biggest predictors of the health status of Canadians. You're absolutely right that there are other factors that influence a condition that someone is living with.

I have type 1, so I'm not taking insulin because of a poor diet. Type 2 diabetes has a lot of stigma around it, and it's not just a lifestyle disease; it is a condition that people are genetically predisposed to. When they're put in poor situations in which perhaps they don't have access to good-quality food or they don't have access to places to move and be outside and be active, those are contributing factors, but they are not the underlying causes of that disease. That's a really important distinction to make. There are a lot of factors.

Outside of this space, I talk a lot about preventive health care strategies for everyone in terms of ensuring that those other factors are met, but if someone doesn't have access to their diabetes treatment or their insulin, you end up with a lot of problems down the road that are more expensive for a health system than a bottle of insulin.