In 1999, between 1.3 and 2.1 billion people did not have access to essential medicines (around 30% of the world’s population), with most of these people being concentrated in Africa and India.[1] In May 2004, after pressure from Canadian civil society groups and Stephen Lewis (the UN Special Envoy on HIV/AIDS in Africa), and in an effort to “facilitate access to 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”[2], the Canadian government enacted Bill C-9 the Jean Chrétien Pledge to Africa Act (JCPA), which implemented the WTO August 30th Decision to waive the Article 31(f) requirement of the TRIPS Agreement. However, since Canada passed the legislation in 2004, not a single drug has been manufactured for export under a compulsory license.[3] In a 2005 Globe and Mail article, Dennis Bueckert reported: “Government officials say the Jean Chrétien Pledge to Africa Act has been stalled by technicalities. Critics say it is fatally flawed and will never have any real impact”.[4] Médecins Sans Frontières Canada also expressed concerns regarding several flaws that undermine effectiveness of the legislation. First, the JCPA includes a limited list of drugs (Schedule 1) that can be manufactured under a compulsory licence for export (even though the August 30th Decision does not impose any limits), which has especially negative consequences in the case of fixed-dose combination formulations of antiretrovirals which are critical in HIV/AIDS treatment and which are currently not in Schedule 1. Second, the JCPA also appears to employ a double standard between WTO members and non-members, in that it only allows for export to non-members when they have declared a “national emergency”. This is too restrictive and since this condition that does apply to WTO countries, there is little justification for this double-standard. Moreover, a compulsory licence granted under Canadian legislation is limited to two years, even though such a restriction on the term is not required under the August 30th WTO Decision. As a consequence, the financial costs associated with obtaining the regulatory approvals for the use compulsory license by generic manufacturers may be greater than the revenues that could be made, and only serves as a disincentive for using the legislation. Furthermore, before a compulsory license can be issued under the JCPA, the generic manufacturer must notify the patent holder of the name of the prospective importing country. This can expose the importing country to outside pressure from the patent holder and other countries, such as the U.S., to refrain from importing generic drugs. Nevertheless, the legislation has some positive aspects. The JCPA JCPA provides a clear formula for calculating the royalty rate payable to the patent holder, which sets the maximum royalty at 4 percent of the total value of the product to be exported under a licence (whereas the WTO 2003 Decision refers to “adequate remuneration”). The Act also provides a clear negotiation period of 30 days for a voluntary license (whereas WTO Decision states that a voluntary license was to be negotiated “within a reasonable period of time”).
The effectiveness of the JCPA is yet to be determined. However, Stephen Lewis had this to say: “If in fact there’s been no significant initiative for drug production and export thus far under the bill, then I think the bill is in danger of becoming a non-entity because it will be lost in the politics of Canada.”[5] As submitted in a joint statement made by over 30 non-governmental organizations and civil society groups[6], the government of Canada needs to immediately amend the JCPA in order to create an approach that is simpler and more direct than the current cumbersome process, while still complying with the World Trade Organization rules.
[1] World Health Organization, “The World Medicines Situation. Chapter 7: Access to Essential Medicines” (2004), online: http://www.who.int/medicinedocs/en/d/Js6160e.9#Js6160e.9.
[2]An Act to Amend the Patent Act and the Food and Drugs Act (The Jean Chrétien Pledge to Africa), S.C. 2004, c. 23 (Bill C-9), S.C. 2004, c. 23.
[3] Canadian HIV/AIDS Legal Network Submission to the Government of Canada, “Delivering on the Pledge: Reforming Canada’s Access to Medicines Regime” (January 2007) at page 1, online: http://www.aidslaw.ca/publications/interfaces/downloadFile.php?ref=970. [Canadian Legal Network].
[4]Dennis Bueckert, “Drug Aid for Africa Political Illusion” (Globe and Mail: May 1, 2005).
[5]Ibid.
[6]Canadian HIV/AIDS Legal Network Submission to the Government of Canada, “Delivering on the Pledge: Reforming Canada’s Access to Medicines Regime” (January 2007) at page 1, online: http://www.aidslaw.ca/publications/interfaces/downloadFile.php?ref=970.