Proceedings of the Standing Senate Committee on
Banking, Trade and Commerce
Issue 10 - Evidence, October 8, 2009
OTTAWA, Thursday, October 8, 2009
The Standing Senate Committee on Banking, Trade and Commerce, to which was referred Bill S-232, An Act to amend the Patent Act (drugs for international humanitarian purposes) and to make a consequential amendment to another Act, met this day at 10:30 a.m. to give consideration to the bill.
Senator Michael A. Meighen (Chair) in the chair.
[English]
The Chair: Good morning. Thank you for being here. Today the Standing Senate Committee on Banking, Trade and Commerce is examining Bill S-232, An Act to amend the Patent Act (drugs for international humanitarian purposes) and to make a consequential amendment to another Act. The Honourable Senator Goldstein, a former colleague and deputy chair of this committee, introduced this bill in the Senate on March 31, 2009.
According to the bill's summary, Bill S-232 would:
[Translation]
Bill S-232 amends the Patent Act and the Food and Drugs Act to make it easier to manufacture and export pharmaceutical products to address public health problems afflicting many developing and least-developed countries, especially those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics.
[English]
I am sure we will all be very interested in today's discussion, since this bill addresses an important issue that could affect the volume of essential, low-cost patented pharmaceutical products delivered to developing countries with health crises.
We have a full slate of witnesses and a limited time period, so I would ask questioners and responders to be crisp and to try to accomplish the greatest possible amount in the shortest possible time.
As one of our first witnesses, I am delighted to welcome back Senator Yoine Goldstein, who was our deputy chair, a colleague to us all and the former sponsor of this bill. He is accompanied by our colleague Senator Sharon Carstairs, who is the current sponsor of this bill.
Hon. Yoine Goldstein, former senator, as an individual: Thank you very much, Mr. Chair, and former colleagues. I am delighted and honoured to be here. I am not accustomed to being on this side of the table, but that is one of the prices one pays for becoming a person of a certain age.
In 2004, a bit more than five years ago, Canada amended its legislation to create exceptions to intellectual property rules, enabling generic drug manufacturers to produce low-cost medication for export to developing countries. The medication was intended at the time to deal with the epidemics, predominantly in Africa, of HIV/AIDS, tuberculosis and malaria. It became known as Canada's Access to Medicines Regime, CAMR, and was also and still is known as the fulfillment of the Chrétien promise to Africa.
It was heralded internationally as an opportunity for Canada to be a major player in the fight against disease in poor and underdeveloped countries. It was unanimously supported by all parties.
Unfortunately, the regime has failed. There has been only a single shipment consisting of two parts to Rwanda, and that was of an HIV/AIDS drug. The supplier, Apotex, who I understand will be a witness two weeks hence, has indicated that it will never do it again under the current regime because of the obstacles, the delays and the bureaucracy that accompanied the manufacture and shipment.
I will tell you what the problems are with the current regime. First, it is country specific, that is, you have to undertake to ship to a particular country. There is an inadequate and limitative definition of products that can be licensed. There is a terribly cumbersome bureaucracy that accompanies any request for a licence. There are extensive delays and notice periods built into the legislation and the regulations. The recipient countries tender mechanisms are undeveloped, undeveloped or simply do not exist. There is a two-year time limitation on the compulsory licence. Everyone knows that you cannot treat AIDS for two years and then suddenly stop; you have to continue. There are inhibitions by proposed recipient countries to request licences for fear of adverse effects on foreign aid and on trade. Many recipient countries are unable to cope with the complicated statutory mechanisms, and the process envisaged by the legislation as it currently exists is on an order-by-order basis, one order at a time, which makes it virtually impossible to deal with a multiplicity of countries.
CAMR has not worked, which is why Bill S-232 was introduced. No manufacturer other than Apotex has stepped forward to say that it is willing to work within the present structure, and Apotex has indicated that it will not do it anymore under the current structure. The result is that after five and a half years, only one dual shipment from Canada to Rwanda has taken place and there are no shipments pending.
What will Bill S-232 do? It is not easy to see from the bill itself what changes will be made because the bill was drafted solely as amendments to the current Patent Act. I apologize for that, but it is the only way to do it. Reading the bill does not allow you to understand what it is all about.
I will tell you specifically what the bill does by implication, by amendment or, in some cases, by deletion. First, the range of products is extended. The products, rather than being limited, as they were, are now extended to any drug that is defined as a drug in section 2 of the Food and Drugs Act. It provides for a one-licence solution, which is fundamental. You get one licence for a multiplicity of shipments to a particular country or to a general list of countries, all of which are listed in the legislation, and they are so listed because these are the only countries that can benefit from shipments of drugs under a compulsory licence.
Under the current legislation, countries used to have to request compulsory licences. That is not the case under the proposed legislation. NGOs such as Médecins sans frontières, Save the Children Fund, UNICEF, UNAIDS and any others may make the request.
It is no longer limited to two years, but the licence would be indefinite. Bureaucracy is essentially eliminated. Delays and notices are essentially eliminated, and you no longer require an order-by-order process. In other words, the process is streamlined but, as we will see in a few moments, the protections required for equality for patent holders remain in the proposed legislation.
Because there would no longer be either a quantity or a time limitation, countries and NGOs would no longer be faced with the rather insurmountable task of predicting the quantity of a drug needed in the future at the time the purchase is made, and purchases could be made to meet fluctuating needs without having to undertake the entire process anew each time a process is made.
A licence would allow exports to any of the developing countries without restriction. Royalties would still be paid to the pharmaceutical company in accordance with the current regime. All reporting, tracing and protective mechanisms would remain intact, without built-in delays. The proposed regime complies entirely with Canada's obligations under the World Trade Organization and under TRIPS. TRIPS is the agreement on trade-related aspects of intellectual property rights. There would continue to be total safeguards against diversion; they would remain intact. The TRIPS Article 30, which I cite on page 10, provides for an opportunity to do exactly this. There is no provision that inhibits or prohibits doing this in the current legislation.
All protections that are now envisaged for pharmaceutical companies would remain intact. Royalties would be paid, the anti-diversion mechanisms would be remain in force, quality controls would be assured, and compulsorily licensed products would not be distributed in Western countries currently served by these pharmaceutical companies, so there would be no competitive issues at all.
All patent rights would continue to be protected and would not be adversely affected. Whatever inspection rights may be available now under applicable legislation or international agreements would continue to be available.
The streamlined, straightforward process would give generic manufacturers in developing countries an incentive to produce their own products. The generic manufacturer-producer would continue to be required to disclose basic details about the value of contracts entered into; with whom they are entered into; and various other relevant details of the contracts, all of which is destined and intended to protect current patent holders.
The royalty payment on any given contract would be based on the UN Human Development Index ranking of the country to which the product is being exported, exactly as it is under the current legislation. What would be the problem and what is the opposition?
Pharmaceutical companies may be concerned about trans-shipments or diversions, but the protective mechanisms of the current legislation would remain intact and some companies have been supplying pharmaceutical products to these countries with anti-diversion mechanisms built in and they do not seem to have had any problems.
Some pharmaceutical companies may see this as the thin edge of the wedge, allowing competition by generic producers for other products, but the countries envisaged by this legislation are not countries that have any competitive impact of any nature whatsoever on Canadian or, for that matter, American pharmaceutical companies. These companies have absolutely no market in the countries that are envisaged by this legislation.
Pharmaceutical companies may say that they fear loss of income, but the compulsory licence concept is a well- defined and well-accepted manner of proceeding and the usual royalties envisaged by the current legislation would continue to be payable.
There is an assertion by the pharmaceutical companies of a fear of diversion, but exactly the same anti-diversion mechanisms that exist in the current legislation would continue to exist in the forthcoming legislation.
I heard it said this would inhibit or diminish research and development, but there is absolutely no instance in Canada or in the United States where a compulsory licence has inhibited or diminished or otherwise adversely affected research and development of the licensed drug or, for that matter, any other drug. This legislation will have no effect, none at all, on high-profit markets.
In 2007, there was a review of the House of Commons committee of this legislation as it then existed and the committee concluded that there was no evidence at that time — and I emphasize the words "at that time" — that would justify changes in the legislation. However, the Standing Senate Committee on Foreign Affairs and International Trade, in February 2007, before this report, recommended that the legislation be amended. The fact that the legislation is not working and that there has been only one delivery, and only to Rwanda, indicates that it is not working.
I should tell you that the medication that was shipped to Rwanda was shipped at a landed cost of 19 cents per pill. You cannot buy an aspirin for 19 cents nowadays. African countries can afford these complex pills, can afford these complex formulations and can afford to treat their populations if they are given the opportunity to do so.
The important principle is twofold. In the first instance, legislation has to be changed in order to accomplish the objectives of the legislation; and second, no one will suffer because of this legislation. Royalties will continue to be paid, anti-diversion mechanisms will remain in place, reporting mechanisms will remain in place, and the changes will cost the taxpayer nothing. Patent holders will in no way whatsoever be adversely affected.
This proposed legislation is supported by virtually every NGO, including UNICEF, Canadian HIV/AIDS Legal Network, Grandmothers to Grandmothers, Oxfam. I gave a list of 30 of these NGOs to the clerk, and some of you have it. There is no NGO that is not supporting this legislation. The Canadian Federation of Medical Students, representing approximately 7,000 medical students in 14 faculties across the country, supports the bill.
I have reached 10 minutes, and I do not propose to continue because I am sure you have questions. I just want to say that if Canada does not do this, who will? If we do not do it now, when will we do it and how many children, how many others will die in the interim for lack of these drugs?
Hon. Sharon Carstairs, P.C., sponsor of the bill: I am here before the Standing Senate Committee on Banking, Trade and Commerce because this is a bill with respect to a patent. To treat this bill as a piece of technical legislation would truly miss the mark. This bill is about people — people living primarily in sub-Saharan Africa, people who live in abject poverty, people whose opportunities to get treatment from malaria, tuberculosis and HIV/AIDS is virtually impossible. It is a bill about giving the chance of life to children, their moms and dads and their grandparents. It is about ensuring that a child receives treatment as soon as diagnosed, at a cost that is affordable.
It is a bill that would allow Médecins sans frontières, UNICEF, Oxfam Canada, Save the Children Fund, and many others, to be able to purchase these low-cost, generic drugs for the population groups that they serve.
We always hope that countries will ensure that drugs reach the most disadvantaged, but we know that this is not always the case. We do know that when NGOs purchase drugs, they do reach those most in need because that is their care group, but the present legislation prohibits their purchase of these drugs.
Honourable senators, every 15 minutes, 75 people die from HIV/AIDS. That is about the time that we have presently spent in this committee. Even more die from malaria and tuberculosis. I believe Canada can and should take a leadership role in this area. Canada can do better and, in my view, we must do better.
This legislation, originally supported by members of all political parties, is not working. You have the opportunity to ensure that it will work. You have the opportunity to save the lives of innocent children and adults, and I urge you to accept the challenge that we have laid before you.
The Chair: Thank you, Senator Carstairs. Thank you both for excellent presentations and for the relative brevity of both. That will allow more time for questioning.
[Translation]
Senator Massicotte: It is easy for us to agree with the objective through the amendments proposed. But will it satisfy the need? Will it work? The situation is clear: to date, it has not worked. Our country, perhaps the whole world, needs us to find a solution.
I understand that all this is a consequence of a ruling that recommended openness in allowing the purchase of patents to fill a need. I understand that it has not worked in Canada or anywhere else. It is not working anywhere in the world. Other countries are facing the same problems and it has failed almost everywhere. I am trying to understand why.
Each country has its own legislation. I assume that every country has its own legislation. Why is this not working anywhere? Is it really because of Canadian legislation? This is a problem all over the world. I would like to gain a better understanding of what is not working.
Senator Goldstein: Thank you for the question, Senator Massicotte. You are absolutely right. The WTO amendments and the TRIPS agreement set the stage for every developed country to initiate legislation to allow compulsory licenses or permits to be issued so that these medications could be exported to underdeveloped countries. Some other countries began the process of adopting legislation of that kind, but they did not pursue it. One country, I believe it was Belgium, as I recall, began the process, but never finished putting it into effect.
Canada remains practically the only country to have adopted legislation whose intent, when passed, was to encourage and allow the export of these medications.
Other countries are now watching what will happen with the proposed legislation that you are now considering, to see if they are going to pass similar legislation.
They had apparently decided that the initial legislation, the legislation currently in force, was not appropriate and could not work as intended, and they were right because the plan is not working.
Will other countries follow suit? I hope so. But, whatever happens, Canada cannot avoid its moral obligation to help those it can as long as it does not negatively affect pharmaceutical companies, Canadians, or anyone else, and as long as it works for the good of all.
You are legislators and you know that law-making is a constant effort to find a balance between legitimate competing interests. This legislation does not seek that balance between competing interests because no interests are affected by this legislation. On the contrary, all the legislation does is to allow a program that harms no one.
Senator Massicotte: All the attention is on amending or fixing Canadian legislation. Since we know that this has not worked elsewhere, is the Canadian legislation really the problem? I accept all my moral obligations as a citizen of the world, but is the problem really the Canadian legislation or is there something more fundamental, a global need, that we need to address, in Africa, for example?
Senator Goldstein: I cannot speak for other countries. I understand NGOs. I spoke with several NGOs and their belief is that the amendments to our legislation would allow the system to function more easily and completely. I also understand that other countries, a number of other countries, including Belgium, France and others, are watching to see how successful we will be in amending it so that they can join us in this effort to save lives.
[English]
Senator Carstairs: I think it is fair to say that Canada took the lead on this legislation. No country had it before Canada. Other countries sat back and watched. In reality, our legislation did not work, and that was the signal to see what would happen in Canada in the future.
[Translation]
Senator Massicotte: The House of Commons and the department were aware that it was not working.
In 2007, they did a fairly major review of the participants and published a report reviewing the legislation. The department came to its own conclusions.
May I ask Senator Goldstein to add one comment and tell us that he read the report, that he does not agree with the minister's conclusions and that, despite the minister's recommendations, he is requesting an amendment to the legislation? The minister came to the conclusion that there are deficiencies, but he did not provide any suggestions for correcting the legislation. If it is not too much to ask, it would be greatly appreciated if he could state that he does not agree with those conclusions. I would appreciate receiving a document like that.
Senator Goldstein: I will do what you ask, Senator Massicotte, if you can give me a few days.
I must say that there are two things about this report that I need to point out to you. First of all, the House of Commons inquiry and the department's conclusions came barely two years after the act went into effect.
So there was no reasonable experience at that time for passing any judgments. That is why the minister said that he did not need to make any changes "at this time." Those three words are very important. After five years of experience, we obviously have to make changes or throw the legislation out. Continuing with the legislation in its present form is ridiculous.
Senator Massicotte: What bothers me most in the minister's report is that he almost makes the case, when talking about a generic manufacturer, that even if he is allowed to go into production, he cannot be competitive with a manufacturer in India, that 17 cents is not very much, but that other manufacturers are even less. Maybe Canada does not hold the solution.
This is important. Are we going to find a solution or are we going to throw up our hands and think that someone else will take care of it? We should talk about that some more.
Senator Goldstein: I would like nothing better than to see competition around the world from other countries that want to do the same thing. No one wants to do it because everyone realizes that the current legislation in Canada is doomed to failure. Why do it if they are doomed to failure?
On the other hand, if we adopt the proposed amendments for improving the structure of the system, hopefully other countries will follow suit and will supply generic products for the same price as here. That is all I could ask.
[English]
Senator Greene: It is good to see you. Contrary to what you are saying, it seems to me that the program is not a failure. We have had a delivery, and the cost per pill, as you indicated, was a reasonable one.
One of the reasons you believe it is not working is "cumbersome bureaucracy" — a phrase you used. When I look at the timeline, it looks like there were just two weeks between the request for a compulsory licence and the granting of the licence. Two weeks for a government to grant a licence is quite quick.
I do not understand your point about cumbersome bureaucracy. Could you elaborate?
Senator Goldstein: Thank you for the question. You are right about that single time period. I do not remember if it was two weeks, but it was a short period of time between the request to the Commissioner of Patents to grant the licence and the granting of the licence. What is not apparent is what preceded the request for the licence. This particular drug, there was not one licence but three licences because the nature of the drug for the treatment in Rwanda required, for a variety of complex medical and sociological reasons, that there be three drugs incorporated into this one single 19 cent pill.
The procedure required under the present act to ask the pharmaceutical companies for a voluntary licence. Apotex will be here in two weeks to tell you exactly what happened, but I understand from discussions with Apotex that it took months upon months for the three pharmaceutical companies to respond to the voluntary request, and under the present legislation, you have to ask for voluntary licence before you can ask for a compulsory licence. Therefore, behind the scenes, it took months, perhaps years, of delays until it happened. After it happens, you have to jump through a variety of hoops.
Again, I do not want to impinge on the presentation by Apotex, but they lived the experience and it took years, so much so, and it was so complicated, that they said publicly that they would never do it again.
That legislation was not working. It was only one company in five years, but if one company does not want to do it because there are too many hoops to jump through, is that legislation that works? I do not think so.
Senator Greene: I will be interested to ask Apotex those questions because the timeline I have does not fit what you are telling me. The timeline I have is that on July 19, Rwanda ordered the product, and on September 4, 2007, about six weeks later, Apotex filed for the licence. Then it was granted within two weeks and about eight or nine months later the product was delivered, but the delay after that was more on the Rwanda end than our end.
Senator Carstairs: First, I think you need to hear from Apotex, as you will, and they will take you through an account of what they went through. More importantly, this bill addresses the fact that it does not have to be a country that accesses this particular drug. It could be an NGO, and that was not permitted in the previous legislation. From my perspective, that is one of the principal failures of the previous legislation. While we do not know what is going on within an individual country in sub-Saharan Africa, we do know what is going on with the NGOs who can make the request and get the adoption of the drugs.
Senator Greene: Given the fact that we are cutting out countries and it will just be NGOs, do you have a legal opinion from the WTO or an international trade lawyer that says that your legislation does not contradict our WTO obligations?
Senator Goldstein: That is not exactly the relevant issue to the WTO and TRIPS. The issue that is relevant is blanket authorization, which is not permitted under section 31, not directly but by implication. I do not have an opinion because I am not active in that field of law and would not presume to offer one.
I do know that the current legislation is TRIPS-compliant and WTO-compliant and that the changes that are proposed would cause the legislation to remain compliant because it does not have a blanket authorization. The Commissioner of Patents is still the person, the institution if you will, that permits and authorizes compulsory legislation, and that would make it TRIPS-compliant. I hope you will be hearing from an expert by the name of Edwards. He is from Texas, I believe. I understand you will be hearing from him.
The Chair: I am not sure whether we managed to conclude arrangements with him, but we do have his name. Thank you.
Senator Goldstein: Thank you. I hope you will. If not, I can arrange for someone to come and tell you that it is TRIPS-compliant.
Senator Ringuette: Thank you for being here and thank you for your well-intentioned bill to provide for the needy.
One reoccurring concern in your presentation is the anti-diversion mechanism. I can understand the situation of black markets and that drug companies could be skeptical about where it would end up, and I certainly support the fact that NGOs would now be in the picture to eliminate some of these concerns.
Could you give us examples of what kind of anti-diversion mechanisms there are and who is responsible for enforcing those mechanisms?
Senator Goldstein: The same anti-diversion mechanisms that exist in the current legislation would continue to exist in exactly the same form in the proposed legislation. The pharmaceutical companies and all members of the House of Commons were satisfied five years ago, with respect to the anti-diversion mechanisms.
One mechanism is contractual; one is an ongoing supervisory mechanism that would exist in all the countries where these drugs are imported.
Generally speaking, the formulations of these drugs, because of unique requirements in sub-Saharan Africa, are formulations that would not be useful to Western countries or to countries with which Canadian or American pharmaceutical companies deal. The labelling both on the bottles and on the packaging would make it clear, as the legislation requires that they cannot be diverted.
By the way, pharmaceutical companies have shipped their own pharmaceutical products to these African countries, perhaps to most of them, with the same anti-diversion mechanisms. They seem to have had no problem, so I cannot imagine that there should be a diversion problem when Doctors Without Borders or UNICEF causes the importations of drugs to treat children. I do not think there will be a problem.
Senator Carstairs: The reality is that we have not had enough shipments to know whether the original anti-diversion policies envisaged in the first bill work or not. If you only had one shipment — the second aspect of it went out two weeks ago — you hardly have a body of proof to indicate whether it is working. They have not changed the previous anti-diversion mechanisms and only the future will tell us whether we will have to tighten them.
As Senator Goldstein has indicated, the pharmaceutical industry, which has indicated that this might be a potential problem, and did at the introduction of the bill five years ago, has been shipping its own drugs without any problem and without any concern about the diversion of these drugs.
Senator Ringuette: Were the drugs that you mentioned from the pharmaceutical companies destined for HIV/AIDS, tuberculosis, and malaria specifically? Is there a duplication of process?
Senator Goldstein: I cannot address exactly which drugs were shipped because I simply do not know. However, the pharmaceutical companies that have been shipping all kinds of drugs, including HIV drugs in some cases, have not had diversion problems.
Senator Ringuette: We might encounter negative comments. If they are shipping drugs for the same purpose, to the same countries for the diseases we are looking at, we may be facing a competition situation.
Senator Carstairs: The reality is that the countries listed in this bill are countries that are not receiving drugs. There are other African countries that can afford to pay the price of non-generic drugs that are receiving the shipments of pharmaceutical drugs. The generic drugs are that much cheaper and therefore that much more accessible by the sub- Saharan countries that the bill addresses. By the way, the countries listed in this bill are exactly the countries that were listed in the bill five years ago.
Senator Goldstein: To the credit of Canadian pharmaceutical companies, of which there are about 50, over the years they have shipped millions of dollars worth of drugs without being paid for them, and that is perfectly noble. Statistics show that the average over the years has been $200,000 worth of drugs per company per year. Although I am glad that they shipped at least that much, that is a drop in the bucket in terms of what is needed in these countries.
[Translation]
Senator Fox: Did opening this to NGOs create opposition from the pharmaceutical companies or does everyone now agree on that?
[English]
Senator Goldstein: You will have to ask the pharmaceutical companies that question. When I was still in your august chamber, I was lobbied by the pharmaceutical companies, as I think most of us were. I do not say that negatively, because lobbying is a fundamental aspect of legislation. We get to know our legislation better because of the explanations we get from lobbyists.
[Translation]
Senator Fox: On page 11 of your brief, you say that this new process will hopefully give generic drug companies in developing countries incentives to produce their own products. Is this something new, or did it already exist in the former legislation?
Senator Goldstein: It is neither in the current legislation, nor in the proposed bill. By saying that, I meant that I was suggesting that, to the extent that compulsory licenses seem to be available, some countries that already have even a basic generic industry could encourage that industry to apply for a compulsory license.
Senator Fox: First, would this allow, for example, generic pharmaceutical companies in other countries — after all, other countries have companies like that; I am thinking of China, India and maybe one more — to make a request for a compulsory licence through an NGO? Second — I think everyone is in favour of this bill, but we are trying to see how it can work — when you mention anti-diversion measures, I can understand the interests of pharmaceutical companies in Canada. If a generic company in China or India or anywhere else can go into huge production, diversion could happen. We just have to think about the tobacco industry in Canada. We exported tobacco to the United States only to see it come back to Canada. Now, talk to me a little more about people being able to get compulsory licences and sending them off to generic manufacturers in the countries I mentioned. Those are sophisticated countries.
[English]
Senator Goldstein: The current legalisation would also permit China to manufacture generically. India has obtained a compulsory licence in Canada and has been manufacturing and shipping to Africa; that will not change under the proposed legislation. The fact that NGOs are permitted to request a compulsory licence does not prohibit countries or manufacturers in any country to request a licence. In that respect, nothing has changed. I want to emphasize that in almost all respects nothing has changed except that the legislation will be streamlined and effective, which it currently is not.
Although I appreciate the question and although it is a concern, because it may be that some countries that want to manufacture are less concerned about diversion than some other countries may be, the reality is that WTO supervises diversion rather stringently. Any country whose generic manufacturer does not impose appropriate anti-diversion techniques would be the subject of an immediate complaint to the WTO, and I hardly need tell you how seriously countries regard complaints against them at the WTO.
Senator Massicotte: I have the same question for both witnesses. I thought this bill was to amend the current act under which shipments must be made directly from the manufacturer to the country requesting the product. I thought you were giving more leniency to allow shipments from that destination to other destinations. Am I correct?
Senator Goldstein: Yes and no. The country into which shipments are being made may, under this proposed legislation, ship to other countries that are within that country's trade group provided that those other countries are listed in the list attached to the legislation.
I will give an example. If Benin, which has no ability to arrange for its own licensing and its own drugs, asks Rwanda, which is next door, to transship, the legislation will permit that provided the NGO that has requested and obtained the licence so advises the Commissioner of Patents. This is not an open and shut automatic thing that will cause HIV medication to rain all through Africa and the sub-Sahara. It is a highly controlled procedure that will permit some transshipment under rigid, predetermined public conditions.
Senator Harb: It is very telling the fact that only Canada has attempted to ship to least-developed countries and it is telling that they were only able to do it once or twice and stopped.
My question focuses on a couple of fronts. First, was the agreement that WTO did back in 2003 open-ended?
Senator Goldstein: It does not end. Section 31 is an elaboration of the section 30 prohibition, which makes the exception to permit this kind of legislation.
Senator Harb: The scheduled countries that you provided, are these the eligible countries?
Senator Goldstein: Yes.
Senator Harb: At that time, WTO said those countries were the least-developed countries. I draw to the attention of my colleagues, and it has nothing to do with our witnesses, countries like Korea, noted on page 10, Liechtenstein, on page 11, and Singapore, on page 13. Each of these countries has a per capita income that is similar to that of Canada.
When you look at that list, you presume that they do not have the capacity to produce unlicensed drugs, yet, places like India, Brazil, and others, like Korea, have the capacity to do so.
Is it your view that possibly, because the offer-and-demand issue is not there, we are not creating enough awareness of the fact that this mechanism exists for developing and least-developed countries? Could that be a reason why we do not have many takers and not many providers?
Senator Goldstein: I really cannot give you an answer. I did not create that list. It is a WTO list, as you know. It is appended to the current legislation; I just reproduced it for this legislation because for whatever reasons the WTO may have at the time it listed those particular countries.
I do not think that Doctors Without Borders will make a great number of demands for compulsory licences for Korea, for instance. Korea does not need that, and certainly not Liechtenstein or Singapore.
Senator Harb: If the WTO has listed countries and said countries will have to make that request, then I think you are suggesting that the NGOs will have to go to the country in order to get the permission. Is that true or they can do it on their own?
Senator Goldstein: No, that list is for recipient countries, not requesting countries. The NGOs would not have to go to the country itself initially, although from a practical perspective, if an NGO wants to operate in Rwanda, it would have to do so with the cooperation of the country, obviously, but it would not require formal permission.
One of the problems is that some of these countries have structures that make it difficult to get cooperative reactions from countries, without providing special considerations to some of the leadership of those countries. They cannot make a constructive deal with those countries.
Senator Harb: When the WTO agreed on a list of products or medicines, your bill, in fact, went beyond that and you decided that if there is a need, there is a need. You want to open it up.
There are some steps that would need to be taken in order to continue to be WTO compliant in your view, or this will save the day anyway?
Senator Goldstein: The WTO does not deal with particular products; it deals with patenting products, whatever the product maybe. The current legislation has a limiting definition of what products can be the subject of compulsory licence. The proposed legislation broadens that list to anything that is listed in our Food and Drugs Act as being medicines, as being pharmaceutical.
Senator Carstairs: In reality, far more people in sub-Saharan Africa die of tuberculosis and malaria than they do of HIV/AIDS. It certainly is a scourge and needs to have our help, but there are other diseases which have far greater impact on those populations.
Senator Gerstein: I am interested to know the extent to which you looked at other factors that may have implications as to why CAMR has not been used to date, and I am thinking particularly with regard to the cost of the product?
As I understand, when the presentations were made at the 2007 review, it was stated that despite the fact that Apotex is said to be offering its product at cost, five major Indian generic pharmaceutical companies are listed on the Clinton Foundation website as having lower-priced versions of the same product for sale to African countries. The lowest price is roughly one-half the price specified by Apotex in its application to the commissioner.
Perhaps it is not the fault of the legislation. Why would Rwanda buy from Apotex if they can buy it at one-half of the price from an Indian supplier?
Senator Goldstein: The answer is apparently that they could not buy it at one-half of the price from the Indian supplier. The Apotex price was reduced. It was 19.5 cents per pill: I do not the Indian price but the product was not the same product, and for a similar product, it was not competitive.
If NGOs and countries can get these drugs from India, or from Russia or from wherever they get them, so much the better. I am delighted. If they cannot, then Canada should be there.
The Chair: There has been a lack of application under the CAMR process. There has only been one we know of. One of the elements of the last question was could that be because, with the exception of the Apotex example, most of the needs are being filled, or many of the needs, by generic manufacturers in countries such as India and China. Do you have any information as to the extent to which that is so?
Senator Goldstein: I have no specific information but subsequent witnesses will be able to give you statistics that I do not have in hand at the moment. I do know that the needs are not being fulfilled. Many countries, and at the moment it is country-specific, are very reluctant to try to seek compulsory licences. Many countries are unable to mobilize themselves to seek them and certain countries have distribution problems. Because of the limitations of their distribution networks, they cannot distribute many drugs to outlying regions. Those that can distribute and want to distribute cannot get the drugs to distribute. That is a reality and subsequent witnesses will give you facts and statistics concerning those problems.
The answer is that it is not correct that supplies from China or India would fill the need; they would not.
Senator Greene: Have any countries tried and failed to access our system?
Senator Goldstein: I am not aware of any. I do know that, in order to access the system, a country has to have an available generic manufacturer that will fill the need, and there are no generics in Canada prepared to enter into the mechanics of this current legislation; they simply will not do it.
Senator Greene: Yes, but that is a different issue than a country trying to access the system. They might or might not know if a generic is able to provide what they need. However, I am talking about a simple inquiry on behalf of eligible countries that were not able. Have there been any of those?
Senator Goldstein: Senator, the system does not work that way. The way the current system works is a country has to find a manufacturer willing to supply and only then can it make the request. The company has to make a request from the drug manufacturers for voluntary licences, and only then can an application be made if they refuse.
Senator Greene: Have any countries that have contacted our generic suppliers about specific drugs been turned down?
Senator Goldstein: I do not know the answer, senator.
The Chair: Thank you very much. We are about on time. It remains for me to thank Senator Carstairs and our former colleague Senator Goldstein for their attendance and their presentations. I think we have all learned a great deal this morning. This is not an easy subject. There are many ramifications. We will pursue our study with another panel of witnesses after a two-minute break.
[Translation]
Order, please. We are now ready to hear views on Bill S-232 from the Canadian Intellectual Property Office, from the Department of Foreign Affairs and International Trade, from Health Canada and from the Canadian International Development Agency.
[English]
The bill, if implemented, could affect Canada's patent regime, WTO obligations, pharmaceutical safety and assistance to developing countries. I am the committee is anxious to hear the thoughts of these government organizations on this bill and their assessment of Canada's Access to Medicines Regime.
From the Canadian International Development Agency, we are pleased to welcome Chris MacLennan of the Strategic Policy and Performance Branch; from DFAIT, Edith St-Hilaire of the Information and Technology Trade Policy Division; from Health Canada, Brigitte Zirger of Science and International Programs; and from Industry Canada, Colette Downie, Director General, Marketplace Framework Policy Branch, Strategic Policy Sector.
Colette Downie, Director General, Marketplace Framework Policy Branch, Strategic Policy Sector, Industry Canada: Thank you for the invitation to appear before the committee this morning.
I have a presentation that will quickly cover the key features of CAMR, the Access to Medicines Regime, particularly focusing on those provisions that Bill S-232 proposes to change. I will pause for a minute to mention the different roles of the departments represented here today.
First, Mr. MacLennan, on my right, is here from the Canadian International Development Agency to answer questions about Canada's broader strategy to deal with access to medicines in the developing world. Ms. Zirger from Health Canada is here to speak to Health Canada's reviews under the existing Access to Medicines Regime; and Edith St-Hilaire, from the Department of Foreign Affairs and International Trade, will speak to the WTO and international framework within which the Access to Medicines Regime is designed and constrained.
I propose that we begin the presentation with Ms. St-Hilaire giving you that initial context about the WTO, decisions you have heard about, and then I will proceed through my deck and will try to do that as quickly as I can.
[Translation]
Édith St-Hilaire, Director, Intellectual Property, Information and Technology Trade Policy Division, Acting Director General, Multilateral Trade Policy, Foreign Affairs and International Trade Canada: First, I am going to take a little step back and talk about the Agreement on Trade-Related Aspects of Intellectual Property Rights, or TRIPS. This agreement was adopted in 1995; it attempts to strike a balance between the long-term social objective of providing incentives for future inventions and research and development and the short-term objective of allowing people to use existing inventions and creations. It sets out the minimum standards that WTO members must adhere to in protecting intellectual property rights.
It covers a wide range of subjects such as copyright, trademarks and patents. Like other WTO agreements, it is subject to dispute settlement, which means that, if a member does not respect its obligations, another member can bring a dispute settlement claim against it. It is therefore a very significant agreement.
Article 31 of the TRIPS agreement allows for the compulsory licensing or governmental use of patents without the authorization of the patent holder under certain conditions. One such condition, article 31(f), is that the compulsory licence or government use of the patented invention be predominantly for the supply of the domestic market.
The declaration on the TRIPS agreement and public health was adopted in 2001 and confirmed that TRIPS includes flexibilities allowing WTO members to take measures to address grave public health concerns.
It further recognized that developing and least-developed countries with insufficient or no pharmaceutical manufacturing capacity could face difficulties in making use of the compulsory licensing provisions in TRIPS. The declaration instructed the TRIPS Council to find expeditious solutions to this problem and to report to the General Council before the end of 2002.
After two years of negotiations, where Canada played an active role, the Decision on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health was adopted in August 2003. This decision is the result of an intensive negotiation process between all WTO member states whose positions were informed by a wide breadth of actors such as NGOs, industry and academia. It was adopted unanimously by all member states and represents a careful balance of interests.
The decision waives subsections (f) and (h) of article 31, subject to certain terms and conditions, so as to give members with pharmaceutical manufacturing capacity the right to issue compulsory licences authorizing the manufacture and export of pharmaceutical products to countries with insufficient or no pharmaceutical manufacturing capacity. The remaining obligations under article 31 of the TRIPS agreement were not waived and therefore remain in effect.
The purpose of the waiver is to facilitate developing and least-developed countries' access to less expensive medicines needed to treat HIV/AIDS, tuberculosis, malaria and other epidemics.
In December 2005, WTO members agreed to transform the decision into a permanent amendment. Canada strongly welcomed the amendment decision, as it demonstrated positively how WTO members can work together to respond to the needs of developing and least-developed countries. The amendment will take effect after two thirds of the members have accepted it.
They had until December 1, 2007 to do so. The deadline was extended to December 31, 2009 and may be further extended by the General Council.
As of now, 53 WTO members have accepted the amendment. Canada accepted the amendment on June 16, 2009 by depositing its instrument of ratification at the WTO.
In conclusion, to return to the terms and conditions of the WTO waiver, the waiver was agreed upon after intensive negotiations. The key provisions of the terms and conditions are that only WTO members with little or no pharmaceutical manufacturing capacity and suffering from public health problems such as HIV/AIDS, tuberculosis, malaria or other such epidemics are eligible to import drugs. The importing country must notify the WTO of its intent to use the waiver and must identify the name, the amount of the drug needed and its patent status in the importing country.
The generic company must request a voluntary licence from the patentee or patentees prior to applying for a compulsory licence. The quantity of the drug produced under a compulsory licence cannot exceed the amount requested by importing countries and the entirety of the drug produced must be exported. The licencee must pay adequate compensation to the patentees.
Finally, the decision was accompanied by a statement from the chairman of the General Council reiterating, amongst other things, that the decision must be used in good faith for public health purposes and not for industrial or commercial objectives.
Thank you for the opportunity to present to the committee.
[English]
The Chair: Thank you for your presentation. I, for one, would be interested to hear whether you had concluded Bill S-232 would open the door to a challenge. I thought you would end by telling us whether it would, but you did not, so maybe someone will ask you a question in that regard.
Ms. Downie: I should mention that I am here representing Industry Canada, and my department is responsible for the Patent Act in which this Access to Medicines Regime is housed.
Slide 3 is entitled Canada's Access to Medicines Regime.
[Translation]
As Ms. St-Hilaire has just mentioned, Canada played an active role in the international negotiations that led to the WTO decision. We were then one of the first countries to announce that we would implement it.
[English]
In 2003 this led to the introduction in Parliament of one of the first legislative frameworks of its kind.
The Access to Medicines Regime legislation was grounded in certain core principles. These initiatives are listed on slide 4 and aim to ensure consistency with the WTO decision that you have just heard about. You will see that it really tries to balance divergent and often competing stakeholder interests.
The two key principles are the first two on the slide deck: First, to facilitate access for affordable medicines to the developing world while also complying with Canada's international trade obligations. Second, to provide generic manufacturers with incentives to participate in the regime while also ensuring that Canada's patent system for drugs continues to provide stable and consistent and predictable protection for rights' holders as new drugs come onto the market in Canada.
On slide 5, the committee will see what Bill S-232 proposes to do with respect to the key features of CAMR. First, CAMR includes a pre-approved list of eligible drugs for export and three lists of eligible countries differentiated by level of development and WTO status.
[Translation]
These schedules reduce the discretionary elements of the program by focusing and speeding up the decision-making process. This seems to be supported by the fact that it took less than three weeks from the date of the application for the commissioner to grant Apotex an authorization to export to Rwanda.
[English]
Bill S-232 would eliminate the list of eligible drugs and replace it with a much broader scope that would allow any drug under the Food and Drugs Act to be exported under CAMR.
[Translation]
The initial objective of the WTO decision was to make it easier for developing countries to gain access to the pharmaceutical products they need to deal with public health problems such as HIV/AIDS, tuberculosis, malaria and other epidemics.
It was never the purpose of the decision to create a mechanism for manufacturers to break legitimate patents on a drug for any reason at all.
[English]
On slide 6 we see that CAMR outlines the steps that a generic company must take before it seeks a mandatory export authorization. It offers some basic informational requirements that need to be included in an application to the Commissioner of Patents; I have those forms with me if you are interested in them. The requirements include the name of the eligible importing country and eligible drug and the quantity requested for export.
In our view, these requirements ensure that an authorization under CAMR responds directly to a country's identified need for a particular drug and that access occurs in the timeliest way possible.
It should be noted that once a country notifies the WTO of its intent to use CAMR, it is full steam ahead under our regime. Nothing in the current regime would enable a rights holder to delay a generic company from applying for export authorization 30 days after it has requested that voluntary licence. I underline "requested" — not 30 days after it has received it, but 30 days after it has requested it.
Bill S-232 proposes to overhaul completely the application process in CAMR, eliminating the voluntary licensing requirement and many of the other informational requirements, and it would replace it with a one-licence approach that allows a generic company to get a single broad licence to export any drug in Canada to any country at any time.
This could have an impact on Canada's compliance with international patent obligations and could create a perception that CAMR would allow users to infringe patents, which would have implications for the stability of our business environment for the provision of pharmaceutical products. It might also reduce incentives to sell pharmaceutical products here in Canada
Third, CAMR includes a number of measures that prevent exported drugs from being diverted back to Canada, and other rich country markets that, unlike developing, or least-developed countries, do not need facilitated access to cheaper medicines. The private member's bill, Bill S-232, proposes to remove a number of these measures, including the requirement that generic products exported under CAMR can be distinguished from patented versions sold in Canada by markings and the lettering XCL on the products. Aside from raising potential issues about our compliance with international obligations, removing these requirements could also limit CAMR's effectiveness in ensuring that drugs actually get to people and countries that need them and are not sent to countries where that is not the case.
Slide 8 discusses the statutory review of CAMR. In 2007, that review was completed. It concluded that no changes to CAMR were needed. As a result, the framework has worked successfully and, in fact, it is the only Access to Medicines Regime in the world that has actually successfully allowed for export under its provisions.
CAMR may not be perfect; no piece of legislation is, and always need fine-tuning. It may differ in some respects from other countries' implementation of the WTO waiver. However, it is the only regime in the world to have actually had a successful export under its provisions.
The Chair: Thank you very much, Ms. Downie. How do you account for the fact that there has been very little take- up on CAMR?
Ms. Downie: I fall back to the results of the review and the testimony that was heard before the industry committee. I have also heard that it is difficult for Canadian generic manufacturers to compete with the rest of the world, particularly in India. That has been the main difficulty.
[Translation]
Senator Massicotte: I would like to follow up on the question. The initial hypothesis is that there is a global problem. They have not reacted to these countries' requests. But, based on what you have observed, you suggest that there is no problem with the legislation and that nothing needs to be done. Let us go back a little. We are led to believe that there is a problem. The WTO was open to dealing with the serious global problems but it is our impression that there has been no global solution.
There is a problem. Is it a legislation problem? Why do we have this problem? Why has nothing been resolved? There has been very little global trade. There have been only two shipments from Canada. As soon as we determine what the problem is, we can begin to find a solution. But where is the problem?
Chris MacLennan, Director General, Thematic and Sectoral Policy Directorate, Strategic Policy and Performance Branch, Canadian International Development Agency: First of all, we need to examine the entire system that controls medical drug supply and identify the challenges in developing countries. Difficulty in accessing medical drugs is only one of the problems that developing countries face.
Let us talk about prevention, first of all. There are several ways to approach the problems and we know very well that, in developing countries, there is an underlying problem. We can start by talking about malaria. We are well aware that having nets treated with insecticides is a first step towards preventing the disease.
[English]
We also know that we have to address a whole series of other problems that go to the actual problems of the spread of the types of diseases that drugs are treating.
[Translation]
Senator Massicotte: May I interrupt you, since we do not have a lot of time? We can spend a lot of time finding solutions for other problems, but the problem I am talking about is the high cost of importing generic products.
Why is this not being done worldwide? What is the problem? The WTO's goal initially was to find a way to export generic products at little cost. This approach was not very successful at all. We might say that it was a failure. Can you tell me why?
[English]
Mr. MacLennan: One thing to take into consideration is that since the waiver was granted in 2004, a number of things have taken place. There is a supply side issue and a demand side issue with respect to the procurement of medicines. These issues have to do with where the price point ends up. On the one hand, since 2002, with the creation of The Global Fund to Fight HIV/AIDS, Tuberculosis and Malaria, a tremendous amount of money has been put in for the purposes of the procurement and treatment of disease, particularly those three big diseases. We are talking about almost U. S. $16 billion into the system, which has allowed developing countries the actual purchasing power to go out and purchase drugs. The other side, we have come to understand that this huge supply side push we have seen over the same number of years, there has been a decline in some of the prices, particularly for anti-retroviral drugs associated with HIV/AIDS.
The basic answer to the question is there are other mechanisms that are available to developing countries to deal with the problems of these diseases. That is why I started with prevention.
Senator Massicotte: These countries do not have a need for low-cost, generic drugs for malaria? You are saying the solution has been found elsewhere?
Mr. MacLennan: No, not that the solution has been found elsewhere but there are other solutions, a number of other ways of procuring these drugs.
[Translation]
Senator Massicotte: That is no longer a problem? You think that there is no longer a need out there in the world?
Mr. MacLennan: No, I did not say that. I said clearly that there are other ways because developing countries are currently using them.
Senator Massicotte: How many people have died from malaria since? Is there not still a major health problem?
Mr. MacLennan: There certainly is.
Senator Massicotte: You say that those countries have the means to buy these products. So why are they not buying them? Why is this not working?
Mr. MacLennan: I do not know why they are not buying.
Senator Massicotte: I am trying to understand why these countries are not applying. Perhaps the problem is not in Canada. Why are other countries not applying to register for this program? Are the pharmaceutical companies using leverage or blackmail that discourages countries from applying, from registering for our program? Is that what is happening? I was told that there was a case with Abbott where Abbott said: "if you apply, we will stop exporting our products to your country". If that is true, it would explain to some extent why countries are not very interested in the program. Can you tell us what happened with Abbott?
[English]
Ms. Downie: Could you repeat the question please?
Senator Massicotte: Why are countries not making application to allow the importation of low-cost generic drugs? Some people say that the reason is that pharmaceutical companies are saying to some countries if you do that you would discourage trade in the rest of our products. I heard of an instance in Thailand with Abbott. Is that why countries are showing less interest? It amazes me why they are not showing interest saying they are interested, and yet we must ask NGOs to do the same.
Ms. Downie: I have not heard about that particular instance and I do not know exactly why. I have only heard anecdotally why, and it is administration issues. I have also heard there is sometimes a lack of awareness, although a growing awareness about access to medicines regimes. I do not think it is unique to Canada's regime particularly and that is particularly so because we have successfully shipped under our program. Eight other such regimes in the world have not had a result like we have had.
Senator Massicotte: My problem is you say the legislation is good, no problem. From a technical point of view — I read your summary — it is all very good. However, there seems to be a problem worldwide; it is not working. We can argue that this status quo is good enough, but you have a responsibility to say if it is good enough what is the problem and here is my proposed solution. There is a problem and it is not getting resolved. We can argue if the status quo is good enough and defend ourselves, but I think we owe it to the world to say this is the problem and here is the solution. Is it the legislation, the WTO? First you have to identify the problem as opposed to saying there is no problem. It is not happening.
Ms. Downie: I am sorry if I was not clear because obviously, there is a problem and that is undeniable. My main point is this legislation is one part of solution to that problem. It is not the main or only solution.
Senator Massicotte: What is the main solution?
Ms. Downie: The main solution is the other work that CIDA is doing with respect to access to medicines and dealing with some other issues in the developing world.
Senator Massicotte: I appreciate the other stuff. We will deal with it in the next legislation. As to the generic drug problem, how do we get this portion working? It is part of a multi-package solution, but how do we get this part working if it is not legislation?
Ms. Downie: My main message is that it has worked.
Senator Massicotte: Two shipments.
Ms. Downie: At least that is something.
Senator Massicotte: They always say life is relative. It seems to me that is a failure, not a success, only two shipments.
Ms. Downie: It has done better than either of the —
Senator Massicotte: It is better than zero.
Ms. Downie: Exactly.
Senator Massicotte: Not as good as 20, 40, or 60.
Ms. Downie: It is difficult to say that it is a problem with the legislation when all kinds of other things are going on in those markets. We have to look at what is going on in those markets and at the other competitors and what quantities of drugs the brand name companies are shipping directly or through some of the foundations.
Senator Massicotte: I agree with you that it could be other stuff, but I think you have a responsibility to us and to Canadians. There have only been two shipments. In my definition that would be a failure, but maybe the solution is not amending legislation but is this or that as opposed to simply saying: I am not sure what the problem is and I think it is good enough. I do not think it is good enough.
Ms. Downie: We are here to comment on this Bill S-232 and what it does rather than to talk about the broad issue of access to medicines and other things going on in the developing world.
The Chair: Let us get this right out on the table. You have listed some of the things that Bill S-232 does, but is it your position — and maybe I should address this to Ms. St-Hilaire — that if Parliament passed the bill we would be exposed almost certainly to a challenge from one of our WTO partners. Is that your concern? Is that one of your concerns?
Ms. St-Hilaire: Actually, we judge that some elements in the bill are not in conformity with the WTO decision, so yes, it would be a risk.
The Chair: Do you have a legal opinion to that effect?
Ms. St-Hilaire: We consulted our legal bureau, our trade law bureau. We do not have a formal legal opinion. We looked at the bill with them and have some of their comments. They are doing more work as well. They are doing more work, so it is not a formal legal opinion. We have had informal discussions.
The Chair: It will not become an opinion eventually.
Ms. St-Hilaire: It depends if we ask for more.
The Chair: It seems to me that it would be not only interesting but also determining if you and we had access to a legal opinion on that issue.
Senator Moore: The other witnesses told us that this bill is TRIPS- and WTO-compliant. If you have information to the contrary, I would suggest you get it in here.
Ms. St-Hilaire: There are a few elements; I can give you some of them. For example, the bill would remove the requirement that includes that the application needs to indicate which country would import the drugs and the quantities that are manufactured, and that was very important in terms of diversion. Anti-diversion was a main concern during the negotiations, so there are some elements in the decisions to prevent diversion of drugs.
The new definition of "pharmaceutical products" possibly would not be compliant with the WTO waiver. If someone exports a drug, they have to put information on the Internet, and it is not in the bill, and it is clear in the decision that you have to have a website and indicate where the drugs go, how many drugs are going there and the length of the licence. A few elements are not in the current bill.
Senator Ringuette: This bill was introduced in the Senate and must have been highlighted to you by your parliamentary liaison people. You must have been informed that this bill was introduced in the Senate in March. That is seven months ago. You come before us having known for a while that this bill would come to this committee and the only arguments you bring are assumptions.
Ms. St-Hilaire, if in your department in the last seven months you have looked at the bill and its implications with WTO and have not yet received any kind of written opinion, then I ask you the question: What has been done in the last seven months? When can this committee expect to have the legal opinion of this bill in regards to WTO?
Ms. St-Hilaire: I should have been clearer. We worked with our legal services and we have information from legal services.
When someone asked earlier if there was a case already or if our legislation was challenged in front of the WTO, there has been no challenge so far, so it is difficult to determine for sure what would or would not be compliant. As long as you do not have a challenge, a panel decides if it conforms or not. However, the elements I mentioned were raised by our legal services, and we looked at it as well. We did the work before.
Senator Ringuette: Could you provide a copy of the work that was done to this committee so that we can see if your assumptions have some legal implications for this bill?
I am sorry; were you asking Ms. Downie if you could provide that opinion?
Ms. St-Hilaire: I was asking her if she was aware of a formal legal opinion.
Senator Fox: Point of order: We might want to debate this in camera. I am not sure it is in the interests of the country to have legal opinions that say all sorts of things in public. I would like to think about that before asking anyone to produce a legal opinion.
The Chair: If it is not, I am sure it will not be produced, but I do not have an answer in that respect.
I think you know Senator Ringuette's position, and perhaps — same as other members of the committee — if there is a legal opinion and it can be made available, we will appreciate receiving it. If it cannot be made available, we would like to be so told.
Senator Oliver: Her evidence has been repeatedly that there is no legal opinion. Her evidence has been that, in the course of preparing a review of this bill before us, they talked with their legal department and other departments, and, because there is no case and there has been no panel, they have no case to judge this on. However, to the best of their legal advice, there are two or three points that might indicate it might not be legally compliant. There is no legal opinion, as I understand it.
Ms. St-Hilaire: Yes.
Senator Ringuette: If there is no legal opinion, there is no basis for us to accept your assumptions because the reality is that this committee has to deal with facts.
Mr. MacLennan, in 2005, when the initial CAMR legislation was passed, what was CIDA's budget in regard to dealing with Africa?
Mr. MacLennan: Perhaps I do not understand the question. Is the question what were our total disbursements in 2005 in Africa?
Senator Ringuette: What was your budget for Africa in 2005-06?
Mr. MacLennan: I do not have that specific information in front of me. I can tell you that the Government of Canada made a commitment to double its overall international assistance to Africa, and Canada met that commitment in March at the end of the fiscal year, that is, last year of the past year, and it is to the order of $2.1 billion. That is in 2008-09. Do not quote me exactly on the number. You caught me off guard.
For the year 2005-06, I am sorry, but I do not have that data in front of me.
Senator Ringuette: Can you provide us with that?
Mr. MacLennan: Certainly.
The Chair: Any other questions that colleagues wish to raise? Are there any further comments, Ms. Downie, that you would like to make?
Ms. Downie: No, I have no further comments. I do have a timeline, if that would be helpful to the committee, in terms of the timing around the Apotex shipment. I also have copies of the forms that show the actual information that is required to apply under CAMR, and I am happy to provide those as well.
The Chair: Thank you very much. We would be very grateful if you would do so.
Senator Oliver: I can give the answer to Senator Ringuette about Canada's commitment to Africa. Canada has met its commitment to double aid to Africa going from $1.5 billion in 2003-04 to 2.1 billion in 2008-09. Those are the official figures.
The Chair: Thank you, Senator Oliver.
Thank you to the witnesses for their attendance, and thank you, colleagues, for yours. We will adjourn the meeting and reconvene on October 21 to pursue our study of this bill.
(The committee adjourned.)