Keldeagh Lindsay is a first year law student at Osgoode Hall and is taking the Legal Values: Challenges in Intellectual Property course.
Canada’s Access to Medicines Regime (CAMR) is an amendment of the Patent Act following the 2003 WTO Decision to waive certain intellectual property rights, with the aim of providing low-cost generic pharmaceutical medicines to developing countries. Although it was enacted in May 2005, nearly four years later the legislation can count only one successful export of Canadian generics to a developing country: in 2008 a deal was struck to export two-years’ worth of generic anti-retroviral medicines to Rwanda to help combat HIV/AIDS.
If Canada is committed to increasing developing nations’ access to medicines, CAMR needs to be overhauled to facilitate procurement of much needed pharmaceuticals. The trick is in balancing the aim of the legislation with the rights of the patent holder. At present, the legislation appears to inadvertently favour the patent holder in the number of hoops that a developing country and generic pharmaceutical manufacturer must jump through in order to export two years supply of patented medicine.
In his recent article Delivery past due: global precedent set under Canada’s Access to Medicines Regime published in HIV/AID Policy & Law Review, Executive Director of the Canadian HIV/AIDS Legal Network Richard Elliot summarizes the suggestions of various civil society groups for reforming CAMR. These recommendations attempt to address certain inefficiencies of the Regime by removing barriers to procurement, or the re-use of the legislation, by developing countries.
One recommendation summarized by Elliot that is particularly ambitious in scope and far-reaching in terms of the ramifications for intellectual property rights is the ‘one-license solution’. Under this recommendation, only one compulsory license would be required per generic manufacturer, and would authorize the manufacture and export of any pharmaceutical patented in Canada. A manufacturer could obtain this license without first specifying quantity of product to be produced and without having a prior arrangement with an importing country.
An amendment of such potency raises the question of whether there would be any purpose at all for retaining voluntary licensing under the revised Regime. Generic manufacturers would have little incentive for negotiating in good faith with the patent holder, as this more muscular compulsory license is likely to be far more profitable than any concession squeezed out of the patent holder. In fact, in this scenario Elliot states that “a [one-license solution] would also eliminate the need for any period of attempting to negotiate voluntary licences with patent-holders”.
Whether we should bother to protect intellectual property rights under CAMR when millions of people die each year to tuberculosis, malaria, AIDS and other diseases afflicting developing countries is certainly a valid question. But a long-term view of the question could show that weak intellectual property rights will inhibit research and development of medicines most applicable to the needs of developing countries, as patent holders will have a compulsory license foisted on any relevant pharmaceutical patent the moment it is granted. With such a diminished return on their inventions, pharmaceutical development could likely shift to developing medicines targeted solely at diseases afflicting the developed world, such as obesity—inventions unlikely to be poached by generic manufacturers out to make an easy buck.
In fact, it may be that an intellectual property regime that is stronger, at least in some respects, could actually spur the development of medicines most needed by developing countries. This is the logic behind the additional six-months of exclusivity granted to pharmaceutical patents for paediatric medicines: that pharmaceutical companies may be enticed into the noble work of developing medicines for children in exchange for an extension on their monopoly. Perhaps, then, corollary of the apparent incentives of a stronger intellectual property regime, is that a weaker regime would act as a disincentive for the development of those medicines most needed by developing countries.
Taken in their entirety, the proposed changes summarized by Elliot would radically alter CAMR at the expense of intellectual property rights while diminishing the role of the pharmaceutical patent holder and substantially loosening regulations that ostensibly protect the end-user and country of import. While CAMR’s lack of success undoubtedly reflects inherent flaws in the legislation which require changes should Canada decide to stand by it’s commitment of increasing developing nation’s access to medicines, a balance must be struck between increasing access and maintaining intellectual property rights, lest we kill the goose that lays the golden eggs.
I agree with you regarding the fact that CAMR needs to be overhauled, even if only to streamline the process, cut through the bureaucratic red tape and to actually get some functionality out of it. What’s the point in having this noble, optimistic regime if it’s impossible to use? I was surprised to learn that there’s only been one successful export. Perhaps once Rwanda’s deal expires and we see how the two countries and the pharmaceutical companies deal with the renewal process, it’ll give us a sense of how feasible the whole regime is.
Your argument about protecting intellectual property rights when millions of people are dying each year is an interesting one. At face value, it seems deceptively simple to say, “Of course it’s more important to save lives!” but I also think the issue is not as simple as providing the drugs to cure it –there has to be preventative and educational efforts as well. In addition, could not these arguments also be made for folks who just can’t afford medicines in developed countries? There are probably millions of people in Canada and the U.S. who would benefit from cheaper drugs, who can’t afford the brand-name ones and who may not even have the option to purchase generic drugs because they aren’t available. It may even be a life or death situation for them. Could the arguments not be broadened to get generic drugs to all those who can’t afford them as a whole?
I don’t think overriding IP to get cheap drugs will be a solution. The truth is, developing drugs do cost money and unless we can provide incentives for these companies to keep their R&D going, why should they continue? At the end of the day, employees still need to get paid, overhead costs are still there and you still have to pay for supplies. Perhaps most people have a problem with this issue because they see the reported earnings of major pharmaceutical companies being in the billions and so by not helping developing countries may just seem like plain old fashion greed; maybe some kind of formula can be devised where a certain percentage of earnings goes towards charitable issues like getting drugs to developing countries? I know that’s sidestepping the IP issue but it might be a solution at least in the interim while CAMR gets sorted out.
It seems that striking an acceptable balance between the opposing forces of innovation, competition, and access to affordable drug products is impossible – granting any weight to one side will necessarily result in a detriment to the other.
At base, it comes down to what we feel the priorities of the medicine industry should be. Should pharmaceutical companies be working with the altruistic prioritization of healing the sick before pocketing their pay-cheque? Canada’s nationalized health-care system might suggest that we, as a nation, support such a prioritization.
However, we must not forget that our economic system is structured in a fundamentally capitalistic way. Making money is the central moving force for most commercial activity, especially when we are discussing a practice as costly and prolonged as drug manufacture. Indeed, it is no wonder that American drug companies churn out the most innovative developments, but also turn the greatest profit. Therefore, I agree with your conclusion – it would seem to be in the best long-term interest of research and development to maintain the patent protection and secure the incentives of future innovation.
In restructuring CAMR to increase access to those without the deep pockets, we need to locate some commercial or monetary incentive for the production of drugs. These incentives might take the form of tax breaks, or possibly government subsidies to the manufacturer (although locating the appropriate funds may be a major obstacle). However, taking profits away from the brand does not seem to be the appropriate solution.
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