After years of waiting, Canadian legislation designed to encourage shipments of low-cost HIV/AIDS drugs to developing countries has finally been put to use. Unfortunately, the delay has only served to highlight some of the problems with the initiative.
The shipment of 7 million tablets was sent to Rwanda on September 24 using Canada’s Access to Medicines Regime (CAMR). This legislation, the first of its kind in the world, was designed to allow developing countries to import drugs at a lower cost by working in conjunction with Canadian drug manufacturers. By allowing manufacturers to circumvent patent rights under specific circumstances, the Government had hoped that CAMR would assist developing nations in their struggle against HIV/AIDS and other diseases. However, the initiative has been met with criticism for its disappointing output.
The big criticism is the time-consuming and complicated process required under CAMR. The procedure requires eligible countries to coordinate with a Canadian pharmaceutical company, which then has to gain Health Canada approval and make submissions to the World Health Organization. Once those requirements are satisfied, the pharmaceutical company must attempt to achieve a voluntary license from the relevant patent holder(s) or, if that attempt fails, request a compulsory license from the Commissioner of Patents. The importing country has obligations as well under CAMR.
The fact that it took more than three years for CAMR to produce anything fruitful has been a sore spot for many health advocates. Special interest groups have proposed specific changes to the legislation which include enlarging the list of drugs that can be manufactured under the program, eliminating the requirement for permission of the importing country (so that humanitarian organizations can make use of CAMR), and removing the arbitrary two-year time limit on compulsory licenses.
Those on the opposite side of the debate have been quick to point out that due to lower overhead and labour costs, countries such as China and India may be able to offer drugs at lower costs than Canadian manufacturers. Accordingly, it may be that there is just not enough motivation for a developing country to look to Canada for HIV/AIDS medications in the first place. The pharmaceutical industry response (generic and innovative alike) can also hardly be criticized – according to reports, the generic pharmaceutical company is selling the September 2008 product at cost, and the innovator will not be seeking payment of the prescribed royalty fee.
The law that created CAMR required a review and report to Parliament by the Minister of Industry within two years of the legislation coming into force. In spite of changes advocated by special interest groups, the report finally tabled in Parliament in December 2007 opined that it would be premature to initiate amendments to the legislation. Rather, the report recommended continuing to publicize the regime to developing countries.
It is laudable that Canada is attempting to become a world leader in this area through its government and pharmaceutical industry. But there is much that remains to be done if the objectives of CAMR are to be achieved.
One Response
I agree with Jonathan that Canada’s efforts are laudable. However, I find that the ‘situation’ created by these very same efforts places the Patent Act and legislation in need of some analysis.
Although patents represent a bargain between the inventor and the state in which the former gets a complete monopoly for a pretty generous period of time in exchange for full disclosure, there are exceptions. Canada’s access to medicines regime as discussed by Jonathan is one such example. Such efforts represent government trying to breathe holes into the Patent Act, to lessen the effect of such a monopoly on society, for reasons that are in the public interest. Granted, it seems like a very positive measure, but what is surprising in this case is that despite the fact that the intervention is minimal and for a specific purpose, i.e. saving human lives, there is much restraining its effective operation. Simply put, it is not user friendly. As Jonathan pointed out, a major criticism is “that it is a time-consuming and complicated process” under the CAMR.
In a case such as this, where there are already a host of safeguards put in place (only specific drugs are to be used, to specific countries, with products having special markings, etc) to protect the inventor’s economic interest, I am left wondering why there is still a lag time and much difficulty making CAMR’s goals a reality. Are the problems discussed by Jonathan issues relating to CAMR itself or rather the Patent Act? More specifically, could it be that the ‘holes’ we breathe into the Act are too small?
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