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.
3 Responses
Is patent reform the best method for Canada to fight AIDS in Africa? The above post outlines the following issues limiting the effectiveness the Jean Chrétien Pledge to Africa Act (JCPA): patent holder pressure, national emergency requirement, and limited license term of two years.
Reforms to s. 21 of the Patent Act which make it easier for developing nations to access needed drugs would be welcomed. However, the general aim of the patent system is to rewarded inventors with a limited monopoly on their invention. It is therefore difficult to balance the needs of the inventors (pharmaceutical companies) with beneficiaries (countries ravaged by disease) under the existing patent framework.
Instead Canada should focus disease reduction efforts in developing countries. This could include the following three options: (1) Increasing our contributions to the Global Fund to Fight AIDS, Tuberculosis, and Malaria; (2) Funding programs targeted at basic education and health needs; (3) Implementing a patent rewards system for low cost AIDS, Tuberculosis, and Malaria drugs for developing countries.
Children of mothers with at least a primary education are significantly less likely to be infected with AIDS. Funding the Global Fund is the most targeted way to fight disease and does not necessarily tie benefits back to Canadian drug companies. Finally a patent rewards system would compensate for the social benefit of low cost drugs that fight disease.
Poverty and disease are major challenges facing the developing world. Consequently, they deserve a focused response from the developed world.
I agree with Joanna that the JCPA is a seriously flawed piece of legislation. However, I would go farther and say that in practical terms the Act is a complete failure. Simply reforming the legislation would not facilitate innovative solutions. Instead, the JCPA must be completely replaced with an Act and accompanying program that allows countries in need to *anonymously* solicit bids from generic (or original) manufacturers to supply drugs at as close to cost as possible. Drugs could even be sold below cost if the winning bid was then subsidized by the Canadian government (this seems to be an effective and efficient way to target foreign aid).
Regulatory requirements must be significantly reduced, and the process simplified as much as possible (while still being in compliance with WTO requirements). In particular, the 2 year time limit must be eliminated. One requirement that may be necessary is that shipments be sent in specified quantities and carefully tracked to avoid drugs being illegally resold at higher prices. Emerging technologies such as markers printed on pill might be helpful here.
It was a striking statistic in HP CTO Victor Garcia’s presentation that the market for counterfeit pharmaceuticals is roughly 10 times (!) larger than other forms of counterfeiting. A new approach and attitude seems necessary. Drug developers should abandon their protectionist attitudes and work with governments and generic manufacturers to provide drugs at close to marginal cost to people who otherwise can’t afford them anyway
United Nations-Millennium Development Goals. This might interest you…
Malaria, together with HIV/AIDS and TB, is one of the major public health challenges undermining development in the poorest countries in the world. Many children who survive an episode of severe malaria may suffer from learning impairments or brain damage.
I think its high time we all individually or collectively Stand Up and Speak Out for our rights
This will help all you people on this blog to do something along with the United Nations in your locality.
Check this
http://www.orkut.com/Community.aspx?cmm=47234928
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