[DEBATE] : First compulsory license under Canadian legislation on exporting generics
Riaz K. Tayob
riazt at iafrica.com
Mon Sep 24 11:33:26 BST 2007
From: Richard Elliott <relliott at aidslaw.ca> To: IP-health
<ip-health at lists.essential.org>, Health GAP list
<HEALTHGAP at LISTSERV.CRITPATH.ORG>
As noted below (and at the link provided), yesterday the Canadian
Commissioner of Patents issued the first compulsory licence under the
country's legislation on compulsory licensing for export. This is the
first compulsory licence issued under any national legislation
implementing the WTO General Council Decision of 30 August 2003. This
follows Rwanda's notification in July of this year to the WTO of its
intent to use the August
3th, 2003 decision to import a generic product, potentially from Apotex,
the largest generic manufacturer in Canad.
It now remains to be seen whether, following requisite government
procurement practices, Rwanda will conclude an agreement with Apotex for
this generic fixed-dose combination product (AZT+3TC+NVP).
While welcoming this latest development, the Canadian HIV/AIDS Legal
Network recalls that it has been over 4 years since the adoption of the
WTO's decision in August 2003, and over 3 years since the adoption of
Canada's law implementing that decision. This is not the "rapid"
response that is needed to address the lack of access to affordable
medicines in developing countries.
Nor is the Canadian legislation, or the underlying WTO decision, the
"flexible" solution that is needed to ensure countries lacking
sufficient pharmaceutical manufacturing capacity can "make effective use
of compulsory licensing", which is what was called for and was promised
in the 2001 Doha Declaration on TRIPS and Public Health. The Legal
Network has consistently called, and continues to call, for amendments
to Canada's legislation that would streamline the process for compulsory
licensing and remove unnecessary restrictions, thereby increasing the
likelihood that other developing countries and other generic
manufacturers can and will use the legislative regime in future.
For a detailed analysis of Canada's legislative regime, and concrete
amendments that have been proposed, see: "Getting the Regime Right", our
brief to a Parliamentary committee that recently reviewed the
Richard Elliott Executive Director Canadian HIV/AIDS Legal Network
-----Original Message----- Sent: Thursday, September 20, 2007 10:55 AM
Subject: CIPO announces authorization
September 19, 2007
Commissioner of Patents authorizes the manufacture of an anti-viral drug to
On September 19, 2007, the Commissioner of Patents granted to the generic
drug company Apotex, Inc. an authorization to manufacture a pharmaceutical
product used in the treatment of HIV/AIDS for export to Rwanda.
This first authorization falls under Canada's Access to Medicines Regime
(CAMR), which was established as a result of amendments to the Patent Act
and the Food and Drugs Act, and the adoption of the Use of Patented
Products for International Humanitarian Purposes Regulations.
These amendments resulted from an August 2003 World Trade Organization
(WTO) Decision on Access to Medicines that waived certain international
trade obligations relating to patented drugs and medical devices. These
obligations were thought to be barriers to developing and least-developed
countries' access to affordable treatments.
CAMR allows the Commissioner of Patents to authorize, under section 21.04
of the Patent Act, the use of inventions pertaining to Canadian patents in
order to facilitate the provision of pharmaceutical products to developing
nations facing public health crises such as AIDS, malaria and tuberculosis.
Drugs exported under CAMR must meet the same safety, efficacy and quality
standards as those approved for sale in Canada.
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