Industry Committee on April 16th, 2007

[Christopher Armstrong]

I understand your question. At the moment we have not undertaken to use that model. It's one we'd have to look at in terms of issues of aid effectiveness and putting ownership and decisions in the hands of developing countries to enable them to access the medicines most relevant, affordable, and efficacious to them. So we'd need to look at it from that perspective.

We'd also need to look at the overall objective of the WTO decision, which was to provide greater flexibility for developing countries to access affordable medicines. So I absolutely understand your question. The model is worth looking at, but CIDA would have to give it consideration within the context of those issues.

[Gerry Byrne, Liberal, Humber—St. Barbe—Baie Verte, NL]

To the panel, have any companies approached you to say, “Listen, we are not in the business of international development; we are in the business of profit. We'll help out where we can, but this is a really low-profit margin business for us, and the risks related to this environment are huge. We're not interested. We'd like to present the fact that we're interested, but until something changes in terms of.... If we're actually supposed to be the delivery mechanism for international assistance, we're not onboard.”

It seems to me that is the attitude or position of the private sector in this country. I don't necessarily like it, but I can understand why. I thought it would be the role of government to actually facilitate, as we have done, because I don't think international development assistance is normally a really high-profit area for most companies.

[The Chair, Conservative, James Rajotte]

Thank you.

Mr. Armstrong, would you like to comment?

[Christopher Armstrong]

I have not been approached specifically about those issues from generic companies, so you'd have to ask them directly. I don't have any evidence of that perspective from them.

On their engagement in it and whether or not it's viewed as a humanitarian or profit-making issue, certainly the overall intention of the WTO decision was humanitarian. There's no doubt about that. But as Mr. Clark has mentioned, it's facilitating legislation to enable the engagement of our private sector, so it does rely on private sector engagement, and I don't have the answer on how that happens.

[The Chair, Conservative, James Rajotte]

Thank you.

We'll go to Monsieur Arthur.

[André Arthur, Independent, Portneuf—Jacques-Cartier, QC]

Thank you, sir.

As you were making your presentations, I tried not draw up a list of the successes that have been achieved with this system. It was a struggle.

Thirty or so countries have worked with the WTO to draw up agreements to waive obligations under certain important laws. Canada has entered into negotiations with two firms, namely Apotek and one another, whose name remains confidential, in an attempt to reach some kind of arrangement. As of 3:30 p.m. this afternoon, when our meeting convened, not one single pill had been shipped to a developing country by one of the thirty countries, including European Union nations. Not one! At 5:06 p.m., thousands of words later, I would bet that still not a single pill has been shipped.

I see here representatives of a prestigious body like Health Canada, which tells me that care is being taken to ensure that the pills that one day will be shipped will be distinct from those sold in Canada. Foreign Affairs, a serious-minded department, maintains that it has contacted international agencies as required to ensure a certain measure of efficiency, but it is still not able to issue passports on time to Canadians who need them. I see the HIV/AIDS team leader who has become somewhat of a Santa Claus with a maple leaf in the eyes of the entire world. Yet, he still doesn't think it would have been a good idea to ship drugs that companies could have made available.

If I had purchased a bottle of Advil before coming to this meeting and had shipped it to a hospital administrator in Ouagadougou, I would have done more than what all of you have managed to accomplished with 30 countries in two years.

Since Industry Canada has a mandate to review this agreement with a view to improving its terms and conditions, I'm trying to understand what more you need to admit that your initiative has failed miserably. What more do you need to stop gadding about in an attempt to convince people? What more do you need to make this system even a tiny bit efficient? What are you waiting for to give up on this system and weigh another alternative?

[The Chair, Conservative, James Rajotte]

Who wants to start with that one?

[Douglas Clark]

I'm not sure how to answer that question, sir.

[André Arthur, Independent, Portneuf—Jacques-Cartier, QC]

I'm realizing that you don't quite know how to answer. You are loyal public servants. You were asked to do a job because we had a prime minister who was nearing the end of his term and wanted some praise from Africa. The House of Commons ended up voting unanimously to adopt legislation that couldn't and doesn't work, either for us or for anyone else.

I understand why you cannot answer the question.

[Douglas Clark]

I do believe the legislation can work. It's premature to conclude otherwise. We're making a sincere effort here to explore possible changes and improvements to the regime. Judging from all of the discussions that we've had to date, not much will happen because of a lack of money. Basically, it boils down to a question of funding.

Mention is often made of the regime's regulatory impediments. All of the obstacles that we've talked about are far more serious than those faced by generic drug companies when they wish to market a generic version of a patented drug. Companies manage to overcome these obstacles daily.

It really comes down to a question of incentives and it's not up to Industry Canada to...I don't know what to tell you. The regime was set up, but it is not being funded.

[The Chair, Conservative, James Rajotte]

Mr. Arthur.

[André Arthur, Independent, Portneuf—Jacques-Cartier, QC]

Before we adjourn, could someone phone my office to ask if a single pill has been shipped in the last 10 minutes?

[The Chair, Conservative, James Rajotte]

Mr. Arthur, your time is up. I'm sorry.

[André Arthur, Independent, Portneuf—Jacques-Cartier, QC]

Thank you, sir.

[The Chair, Conservative, James Rajotte]

We'll go now to Mr. Boshcoff.

[Ken Boshcoff, Liberal, Thunder Bay—Rainy River, ON]

Thank you very much.

We seem to be onto something that perhaps has taken us off on a tangent, but maybe only a bit. We're talking about pills as opposed to other forms of medicines--pharmaceuticals, vaccines--and we're also talking about this one particular component of our service delivery. Do we not deliver anything whatsoever through the whole umbrella of the family of Canadian public servants or NGOs in terms of these products, whether it's Advil, vaccines, these kinds of things, not necessarily through this particular protocol but through the agencies that you represent? At this stage, I'm almost feeling that we're not sending anything to anybody in any country that's been asking us for materials or support. So can we clarify that? You've been answering the questions within the box, but you haven't mentioned that there are other people who care or do deliver services. Or are there not?

[Christopher Armstrong]

I have been trying to present that, and I apologize that I haven't presented it as clearly as possible. There are numerous things to delineate. But it's a very long list of organizations that we provide support to that are helping to provide medicines in developing countries through multilateral institutions. As I mentioned, we were the largest donor to the World Health Organization initiative to provide treatment for HIV and AIDS, which has resulted in huge increases in access to HIV treatment. We're providing support for bed nets for malaria. We're providing huge amounts of support to provide drugs for tuberculosis, and vitamin A to deal with micro-nutrient issues with respect to children and child survival. There's a long list of things we're doing. I'm sorry that hasn't come out clearly. So, absolutely, Canada can be proud of a number of things we're doing.

[Ken Boshcoff, Liberal, Thunder Bay—Rainy River, ON]

Is that the qualification between “patent” and “generic”? Also, while you have the ice time, to address things like Rotary International's PolioPlus, is the federal government involved in the delivery mechanism? If I left this meeting and I thought one MP who could deliver a bottle of Advil had done more than the entire weight of the Canadian government, I'd feel that the Canadian people would be rather shortchanged.

[Christopher Armstrong]

You're right. It's putting this piece of legislation, which is facilitating legislation to enable compulsory licensing, as one possible mechanism for providing generic versions of otherwise patented medicines in the developing world. Not every drug that's delivered in the developing world requires compulsory licensing, whether it is off-patent or whether or not they're accessing those medicines from Indian generics, Chinese generics, or Brazilian generics. All of those issues are happening, and Canada is providing the support. Not all the medicines, as I said, that are needed in the developing world are under patent. So we are providing support to all of those things. Rotary is another example that I didn't name. Absolutely, Canada has been a leading supporter of polio vaccines.

[Ken Boshcoff, Liberal, Thunder Bay—Rainy River, ON]

When we look at the list of countries then that are going through this exact same process that we are doing now, is someone somewhere out there closer--whether they feel it's their particular system, such as the United States versus another nation--to being able to come up with the formula outside of the United Nations protocol, or the WTO, that they think will do that job better in terms of generics?

[Douglas Clark]

As I said, I think we're all in the same boat. Just for your own information, the United States does have a government program, in contrast to what this is, which is a private sector program, in place to facilitate access to meds in the developing world. But insofar as the actual countries that have implemented the waiver are concerned, I think, again, we all have the same sort of fundamental legislation or regulations in place. But we're all in the same boat. And nobody is any closer, I don't think, to having a pill exported tomorrow than Canada is. I think if we get a test case at some point and it does work its way through the system somewhere, then we'll have something to compare it to and figure out, how did they manage to overcome the barriers that we're facing here?

[The Chair, Conservative, James Rajotte]

Thank you.

As the chair, I'm going to ask a few questions, since we've gone through everyone at least once.

Mr. Clark, you mentioned some information on outreach activities that you've done in developing countries. You don't have to go through them all now, but if you have them there, can we get all the initiatives that you've taken, perhaps in written form? The CD you mentioned would be very helpful.

The second issue that I want to raise is the issue of the schedules. On page 11 of your presentation, you have “Stakeholder Positions on CAMR”, under which you say the NGOs “want immediate liberalization of the regime (eg eliminate restrictions on eligible importers and drugs...)”.

You also mentioned earlier on, on page 9, that of the other countries that have developed legislation similar to ours, “None rely on pre-approved lists of eligible importers or drugs.” I think today you said that having these schedules actually facilitates or would facilitate quicker delivery of the drugs. Can you explain why Canada has chosen to go this route, and whether it would in fact be quicker, as some have suggested, to eliminate these schedules?

[Douglas Clark]

The reason is a simple one. In the absence of a pre-approved list, some government body, some decision-maker, is going to have to look at the law, interpret the law, have an application before them—obviously, the patent authorities in all the countries that I'm aware of, in any event—and decide if this is a pharmaceutical product within the definition set out by the WTO, which we've adopted word for word; if it is needed by a country suffering from a public health problem; if it's a developing country, not a least developed one; if that country has established that it has insufficient or no manufacturing capacity; if it is a country that qualifies in the first place; and if it meets the WTO definition.

All of these things require an exercise of some discretion. As soon as you have that, you have the legal basis for challenging them. This is aside from the fact that patent authorities are not the best-placed decision-makers to make calls of that kind. They're not experts on the development status of countries or the public health problems that afflict them. By having a pre-approved list, you avoid those problems and you insulate the decision from litigation to the extent that it is possible to do so.

[The Chair, Conservative, James Rajotte]

My second question deals with the issue of my understanding that the number of companies and NGOs....

There are two cases. One is a public case and one is confidential, in terms of take-up of the system. On page 10, you have a statement:

• The Minister of Health announced an early review of CAMR....

• On November 24, 2006, the Government released a consultation paper....

• During the subsequent 60-day consultation period, Industry Canada and Health Canada received approximately 30 submissions from interested parties....

Clearly there's interest in the legislation, in the issue. There's a system in place. I'm not sure whether the system is what's wrong or whether it's the take-up in the system. Mr. Byrne certainly raised some valid questions in terms of whether you need CIDA to take some leadership.

In terms of the system, we don't have a lot of cases to go on in terms of analyzing whether it's working or not. The one case that is public and that we can talk about is the case with respect to Apotex and a drug that I believe is called APO-TriAvir. According to Apotex's submissions to the government's statutory review of this legislation, this has not happened because of the complexity of the process, so nothing has moved since.

Just using this one case, because it's the one case we can talk about, can you explain to the committee the development of that process and why it has not moved forward from a regulatory point of view?

[Douglas Clark]

We've all heard that criticism of the regime: that it's unduly complicated and difficult to navigate. But anybody who is familiar with patent litigation in the pharmaceutical industry, particularly under the patented medicines notice of compliance regulations, with which some of you are familiar, will find that criticism hard to accept.

We're talking about some of the savviest, most sophisticated, smartest legal entities out there. As I mentioned earlier in French, the regulatory burden that generic drug companies face in trying to get into the domestic market is far in excess of the regulatory steps they have to go through here. It's really a question of will and it's a question of enticement. If you told a generic company that they had to get a man on Mars to be the first with a generic version of a blockbuster drug, they'd have a guy there in six months, not including travel time. So I don't find that objection credible, from my own perspective.

In terms of the actual Apotex example, my understanding is that it got bogged in the voluntary licensing phase. But David knows the facts of that case better than I do, so I'll turn it over to him.