I was at a reading given by Stephanie Nolen back in April at the Art Gallery of Hamilton when a very earnest young woman stood up duing the question and answer session and asked her what she thought of the 'tragedy' that was 'Canada's AIDS drug law and the fact not one drug has been delivered so far?'. "I don't how much of a tragedy it is", answered Ms. Nolen (to the best of my recollection), "things have kind of moved on. They get the drugs from India and South Africa now. The drugs aren't really the issue anymore. The issue is now more infrastructure, and people, and money.". And with that the discussion of 'Canada's AIDS drug law', on this particular occasion, came to an end.
Which brings us to proverbial gadfly Dr. Amir Attaran and his article in the April 20, 2007 edition of the Canadian Medical Association Journal concerning the brief history and fate of The Jean Chretien Pledge to Africa Act, formerly called Bill C-56. I certainly think it t bears a second look for all that it addresses concerning Canadian law and government, humanitarian aspiration, the pharmaceutical industry, essential medicines and global health. And so if I may, I think I shall quote it extensively.
From the article:
In May 2004 Canada's Parliament was the the first in the world to subscribe to reforms enacted by the World Trade Organization, which promised to bring cheaper medicines to poor, epidemic-ridden developing countries. Parliament passed a new law, setting out an 'access to medicines regime' that Canada's manufacturers of generic drugs could use to override the patents of brand name drugs in order to manufacture and export generic medicines according to the needs of governments and charities in poor countries. Canada's new law - The Jean Chretien Pledge to Africa Act - was meant as a grand humanitarian project, and it got a fillip from numerous churches, labour unions, university groups, and especially nongovernment organizations such as the Canadian HIV/AIDS Legal Network and Medicins Sans Frontieres, which lobbied vigorously for its passage.
Parliment is now reviewing the law 2 years after it came into force, but it faces this difficult reality: The law has never been used, and it has caused zero treatments to be manufactured for zero patients. (boldness mine) Even the law's advocates concede that it "is failing to meet its goals.".
"There are basically 2 competing theories for why the law has failed, and for what Parliament should do about it.", Attaran writes, "The first theory lays the blame at the law's complexity. Although it welcomed the law just 2 years ago, the Canadian HIV/AIDS Legal Network now believes that the law is cumbersome ... to the point that it effectively deters those who might [use it].".
(To get a sense of this, heres an indication from the Department of Foreign Affairs and International Trade as well as the application process itself from Canada's Intellectual Property Office. In addition - here's the announcement of the Act from Industry Canada. Here is the Prime Minister's Official Statement: Prime Minister's Statement at the time. And here is some some legal analysis from Andrew Bernstein and Grant Worden, two lawyers of the firm Torys LLP (gotta love that name) at Managing Intellectual Property)
In some ways, this criticism is correct. The law stipulates that charities and governments in poor countries, working with Canadian manufacturers of generic drugs, may apply to Canada;s Commissioner of Patents for a 'compulsory license' - a type of patent override. But Applications must be filed and processed singly; they cannot be shared by countries or charities who want to band together to submit joint applications to minimize the work of the application process. Even successful applications are hobbled by the fact that a compulsory license cannot last more than four years, after which the entire applications process must begin again. These national and temporal limitations make no sense alongside the global, chronic nature of epidemics such as HIV/AIDS, and they portend a churning bureaucracy of application-handlers if the law ever comes into common use. There is no reason why Canada has to have such an inefficient, user-unfriendly law.
Unless of course, (an forgive me for being cynical since, yes, I don't have any real world sense of how such things work) Canadian pharmaceutical companies and lawyers and lobbyists for Canadian pharmaceutical companies never had any intention of the law actually working, for anybody. I do believe that one of the things that caused the bill to be bogged down in the first place was the insistence by the pharmaceutical industry for the insertion of a 'Right of First Refusal Clause' . This 'clause give/gave the patent drug companies the right to steal any deal from a generic drug company at the last minute'. If this was the case then what incentive would there be for generic drug manufacturers to develop any 'deal' with any 'nation'? Not sure what became of this.
But, as Attaran continues, "there is a second theory for why the law is not used: it is barely relevant, and it will remain so no matter how Parliament struggles to streamline it.
Contrary to popular belief, drug patents are extraordinarily rare in the developing world. In a study of 65 low and middle-income countries, patenting was rare for 319 products termed "essential medicines" by the World Health Organization; only 17 of the essential medcines were patentable, although usually not actually patented, so that overall patent incidence was low (1.4%). Critics argue correctly that, within this 1.4%, there are certain instances in which patents cause exploitive pricing in poor countries; however, that reasoning focuses on rare exceptions and dresses them up as to prove a rule. The better-supported rule is that, where pharmaceuticals are covered by patents in poor countries, the manufacturers usually offer a donation or deep discount (as for 15 of the 17 medicines studied), so the patent's economic effect on price-setting is unlike raw monopoly power.
Thus, there are few patents, and most are voluntarily attenuated already. Accordingly, it stands to reason that opportunities to improve public health by overriding patent rights will be very rare.
Even in the isolated cases in which the overriding of patents might benefit public health in poor countries. Canada's manufacturers of generic drugs are unlikely sources of help. Lack of competitiveness is the reason. Simple economics argues that generic drugs made in Canada would tend to be pricier than those made in newly industrializing countries such as China and India, where the cost of wages, regulatory compliance and other noncapital inputs is traditionally less. Further, Canada's manufacturers of generic drugs are accustomed to charging such uncommonly high prices that selling to poor countries , at little profit, is out of character. According to the federal Patented Medicine Prices Review Board, prices of generic drugs in Canada exceed those in Australia, Finland, France, Germany, Italy, the Netherlands, New Zealand, Spain, Switzerland, the United Kingdom, and the United States. Even in tiny, remote New Zealand, generic drugs cost 77% less than those in Canada. All things considered, cash-strapped developing countries can get better value buying generic drugs from almost anywhere but Canada.
And finally, Attaran closes with perhaps his most salient point in all of this, and thus the one that produces the greatest opportunity to learn.
(P)ossibly the strangest fact is this: the poor countries that might ask to import generic medicines made under compulsory license are, to date, simply not asking. (italics mine) Both the World Trade Organization and Canadian law require that, as a first step to issue a compulsory license, the country wanting the generic medicines has to notify the World Trade Organization of the type and the quanity of medicines it needs. That notification need not be complex: a brief letter will do, and Canada even helps with easy step-by-step instructions for lawyers to follow. However, as of March 2007, the World Trade Organization reported that 'no notifications have been made so far'.
If poor countries are interested in compulsory licensing, curiously they have not taken advantage of it. The complexity of Canada's law is not to blame, since the European Union, Norway, Switzerland, China and South Korea (31 countries in all) also have laws permitting compulsory licensing and exporting of medicines - and none of those laws have been used either.
Taken together, these facts suggest that any amendment Parliament might contemplate to Canada's law is bound to be fruitless. There is probably no amendment that, while remaining consistent with the World Trade Organization's rules, could differentiate Canada's law from those in the 31 other countries. Even if one imagined that Canada's law could undergo a magic amendment to make compulsory licensing easy where 31 other countries have failed, the princely pricing of Canadian-made generic drugs would make that success nugatory.
None of this is to say that overriding patents is never justified. The appalling failure of manufacturers of brand name drugs to pool efforts and patents - for manufacturing co-packaged or co-formulated antiretroviral treatments that are convenient for first-line AIDS treatment in poor countries - was remedied only once manufacturers of generic drugs in India ignored patents and acted (although the fact that these same manufacturers in India patented their new formulations in Africa is a helpful reminder that even they are not impelled by altruism). some allowance in law must exist to prevent patents standing in the way of desperately needed inventions such as this.
But it is doubtful that Canada's law can ever fill that role. One can plausibly argue that the law is not only a dead letter, but that groups such as the Canadian HIV/AIDS Legal Network and Medicins Sans Frontieres did more harm that good in expending political capital to pass a law that resulted in zero treatments for zero patients. Patients would have been far better if those groups had instead spent the political capital to increase Canada's foreign aid funding, or to reverse the brain-drain of African doctors. Setting a naiive and ill-informed goal (me) led to poor results. With the evident failure of Canada's law, Parliament would be wise to cut its losses and concentrate on the more concrete things it can do to help the world's poor.
Now, I will admit that I am just beginning to learn about all of this, but I think Attaran's article is important and instructive. The people involved with this law should have perhaps coordinated more with the countries involved and sought some input from them with regards to all this; at least to check and see if anyone was at least considering buying generic drugs from Canada, whatever the price. But I do think it is important to remember that at the time (2003ish?) of the advent of these laws, and this law in particular, according to UNAIDS, about 2% of the people who needed access to antiretroviral drugs in sub-Saharan Africa were receiving them - so this law was, I suppose, an attempt to respond to a humanitarian emergency - which of course still is a humanitarian emergency. So in that regard I guess you could say that they were looking to do something, anything. But as Attaran asserts - has a good deal of 'political capital' been spent here (i.e. wasted) that could have been 'spent' elsewhere, and will this have an effect on further Canadian policy decision making in this area? I don't know.
I think its important to remember that all of this didn't happen in a vacuum. As everybody knows in 1998 a group of 39 pharmaceutical companies did try and sue The South African government to try and prevent them from producing generic drugs for which they held the patents. And though the ensuing international outrage forced them to back down, I think this case and others like it - (including one of those 39 companies - Novartis - which is presently similarly attempting to sue the Indian government. And another the Chicago-based company - Abbott - which has decided to 'withdraw all applications to register drugs in Thailand' after the government there issued compulsory licences for three AIDS medications that it manufactures. The very excellent MSF Campaign for Access to Essential Medicines website is currently covering both stories. And I certainly think its telling that if you visit the websites of both those above mentioned multinational pharmaceutical companies - they certainly want to impress you with their 'social responsibility', in a very post-1998 kind of way) -certainly went along way towards establishing the climate where something like the 'Jean Chretien Pledge to Africa Act' would subsequently manifest itself. As I said, its important history that should be remembered; as the absolutely crucial activism that came out of it all.
And, reading this Attaran article has certainly cause me to go back and look at the AIDS numbers, which I will admit that I do forget - i.e. the number of people suffering and dying, and the growing percentage of those covered by ARV treatment. And I think one can get some sense of this through this this Stephen Lewis Foundation AIDS in Sub-Saharan Africa fact sheet.
And some recently released progress reports from UNAIDS:
"Access to antiretroviral therapy for advanced HIV infection in low and middle-income countries continued to grow throughout 2006, with more than 2 million people living with HIV/AIDS receiving treatment in December 2006, a 54% increase over the 1.3 million people on treatment one year earlier in these countries.
"The (UNAIDS Progress) report shows that countries in every region of the world are making substantial progress in increasing access to HIV treatment. More than 1,3 million people in sub-Saharan Africa were receiving treatment in December 2006, representing coverage of approximately 28% of those in need compared to just 2% in 2003. Coverage in other regions varied, from 6% in North Africa and the Middle East, to 15% in Eastern Europe and Central Asia and 72% in Latine America and the Caribbean. Overall, while encouraging trends continue, just 28% of the estimated 7.1. million in need of treatment in all low-and-middle-income countries were receiving it in December 2006.".
We here at Global Health Nexus will certainly be examining these reports further, and will report back in the future.
Happy Canada Day everybody!