Thank you, Mr. Chair, and thank you to the members of the committee for the opportunity to appear before you today. Thank you as well to the committee for actually studying this bill, because I know that was something that has been in some question.
I want to draw your attention to the material that we have provided. You will find a copy of our brief. I think it's been provided to you already. I will come back to it in the course of my remarks, and I hope it will address many of the questions that you have. I hope to answer those questions over the course of the next two hours.
By way of introduction, I'm a lawyer who has been working on HIV-related legal issues for 18 years. For the last nine years I've been working intensively on questions of international law, including WTO law, and access to medicines, including doing graduate work on the subject.
This is also a personal issue for me, not just an intellectual one. I was born in Africa and raised there for a significant portion of my life. I have worked for many years in Africa with various partner organizations responding to the global AIDS crisis.
The organization for which I work, the Canadian HIV/AIDS Legal Network, has been working on this particular issue for nine years now, from back when the World Trade Organization members were adopting a declaration recognizing that they needed to do something about the barriers that patents pose for developing countries in getting access to affordable medicines, to the discussions that led to the drafting of Canada's access to medicines regime--enacted unanimously by Parliament in 2004--to organizing international consultations with experts from around the world on pharmaceutical procurement and intellectual property law, to a consultation that we held earlier this year with the UN Development Programme. This consultation generated some analysis that will be coming to you as an additional submission on the question of whether the proposed reforms in Bill C-393 are compliant with Canada's obligations as a member of the World Trade Organization.
This is an issue on which we have a fair depth of knowledge. It is perhaps not a surprise, therefore, that the brief we've submitted to you is some 50 pages in length. However, I hope it will be of use to you, and I want to draw to your attention the appendix in particular, because I think it will be a particularly useful reference for you.
As you know from reading Bill C-393, the bill makes a number of amendments to two pieces of existing legislation, the Patent Act and the Food and Drugs Act. Of course, it's hard to get the real sense of what the bill does unless you track all of the changes that the bill would make to the existing statutory provisions. To make it simpler, we've done that for you; in the appendix to our brief you'll find the relevant sections from the Patent Act that constitute Canada's access to medicines regime and the relevant provisions in the Food and Drugs Act. We have tracked onto the existing text of the law the additions and deletions that Bill C-393 proposes to make so that you can actually read it through in its entirety and see what the final text of the law would look like with these proposed amendments. I find it's much easier to have the discussion when you can see what we're actually talking about, and not in isolation.
I'd like to cover four areas in my remarks today, if I could: I'd like to tell you what CAMR is supposed to do, but I won't belabour that too much, because you know that; I'd like to say what CAMR has actually done, but that won't take very long, because the answer is “not much”; I'd like to tell you what Bill C-393 would do; and I'd like to tell you what Bill C-393 would not do, because there is a fair bit of misinformation circulating, including some of what you heard from government representatives last Thursday at your meeting, claiming all sorts of things about what Bill C-393 supposedly would do, and that information is not in fact correct. Let me speak to each of those four, if I could.
Briefly, what is CAMR, the access to medicines regime, supposed to do? The fundamental purpose of CAMR, as reflected in the discussions that preceded it at the World Trade Organization, is to help developing countries make effective use of compulsory licensing. That is the terminology negotiated by World Trade Organization members, including Canada. They are to make effective use of compulsory licensing in order to address public health problems by getting more affordable medicines.
The goal, stated by WTO members themselves, is to promote access to medicines for all. This arises out of discussions at the WTO in 2001, nine years ago, in which WTO members, including Canada, explicitly recognized that patent restrictions on medicines are a barrier--not the only barrier, but a barrier, and an important barrier--to affordable medicines getting to patients in developing countries.
Very specifically, one of the things WTO members recognized was that when you have patent restrictions in a place like Canada, where there is the capacity to make generic medicines and to supply them to developing countries that don't, you need to have some mechanism to get around that; otherwise it's patent infringement for a generic manufacturer here to be producing and exporting these generics. So WTO members set themselves the task of coming up with a mechanism that would get around that barrier, and that was a decision adopted in 2003, about which you've heard a great deal and which is really the central piece of WTO law relevant to any discussion of the existing CAMR and the reforms proposed in Bill C-393.
The purpose of CAMR—to implement a mechanism so that developing countries can make effective use of compulsory licensing to get generic drugs from Canada—is aimed at harnessing the power of competition. We're operating within a market paradigm here and we're harnessing the power of competition in the market to drive the prices of medicines down for developing countries. That is the purpose, and that in fact is what we've seen globally, that when countries have had the ability to get generic AIDS drugs, the prices of those drugs have dropped from over $10,000 U.S. per patient per year to $100 per patient per year now for some regimens. That's an order of magnitude of difference, and of course it makes feasible the task of putting people on life-saving treatment.
Because of this we have now seen four million people with AIDS in the developing world getting life-saving medicines in just a matter of a few years. This has only been made possible because there was competition in the pharmaceutical marketplace for those countries, and generic medicines were available at much lower prices. None of that would have been possible if the limited moneys made available for donor aid to buy medicines had to be spent to buy $10,000 courses of a treatment per patient per year, as opposed to $100 per patient per year.
That's what CAMR is supposed to do. Second, what has CAMR actually done?
As you know, it's been more than six years since CAMR was enacted by Parliament, and in that time, after a lot of work by a number of NGOs, after the commitment from one generic manufacturer, we have seen one drug leave this country to go to one country. That's tremendously significant for us, because it shows that we can do things, that we can make a difference. But I think it would be wrong to conclude that it somehow proves that the current access to medicines regime works. That result came about, as I said, because of years of hard work by various NGOs. It came about partly by chance. It came about because of conditions that are not easily replicable in future, and the one generic manufacturer that had made a commitment to NGOs, that is, to Doctors Without Borders, to try to make this regime work has said it will not attempt to do it again because its experience so far has not been encouraging.
However, that same company has also publicly committed that if the legislation is streamlined the way Bill C-393 proposes to do, the first next step for them would be to make a pediatric version of this drug. Access to AIDS treatment for children living with HIV falls way behind access to treatment for adults with HIV—who already are less than half of the people who need treatment now, and who will die without it. That's why it's so important that we have pediatric formulations of antiretroviral drugs, because 80% of children who are born with HIV will die by the age of two if they do not get medicines.
There are some medicines out there now that are being used to treat children. In many cases, they are not particularly user-friendly. If you can imagine that you're a grandmother caring for several orphans, some of whom are HIV-positive, it's not a particularly helpful way to make AIDS treatment available to children if you have to periodically get to a clinic—if they have the medicine at an affordable price—to get a syrup that you have to carry back to your home, where you may or may not have refrigeration.
If you could instead get something in simple tablet form, that is, something much more portable and not requiring refrigeration for storage, or in the form perhaps of something dispersible so it could be administered more easily to infants, then you would really be trying to get into the real world of getting medicines to people in a form that is easily usable. That's something that we can do if we fix this legislation. It would be a first next step, and then we would move beyond that with more medicines from generics at lower prices.
So what CAMR has actually done so far is relatively little. I don't think we can say that one drug to one country in six years is a success, given the need out there and given what was promised.
What would Bill C-393 do then?
You will have heard and seen in our material that we have described the core of Bill C-393 as putting in place what we call a one-licence solution.
Under the current legislation, every single drug order for each individual country requires a separate process of trying to get a licence to supply that country with a fixed quantity of medicines. It also requires that you know ahead of time the country and the specific quantity of medicines that you want to supply. In CAMR's experience to date, that has proven to be one of the most significant stumbling blocks, and it explains in part why it took two and half years to get to the point of having the first licence issued. I can explain to you why that is.
Our proposal in Bill C-393, which we fully support, is to change that process of licensing so that a generic manufacturer will get one licence, once, that will authorize that generic manufacturer to supply any of the eligible developing countries that are already recognized in the WTO law and in the Canadian legislation with the quantities of those medicines that developing countries will notify from time to time.
That will reduce the transaction costs of using the system. It would put generic manufacturers in a better position, because they can bid to supply multiple countries simultaneously, knowing that they already have the legal authorization in hand to do that. In the current process, they have to go into a bidding process individually with the different countries, without even knowing whether they'll be able to get the licence in the end to supply the drug, should their bid be chosen, because they will need to go through the current cumbersome CAMR process. Bill C-393 would simplify that and cut through that.
