[Ip-health] first compulsory license under Canadian legislation on exporting generics

[Richard Elliott]

Dear colleagues:

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 legislation,
at http://www.aidslaw.ca/publications/publicationsdocEN.php?ref=705.


Richard Elliott
Executive Director
Canadian HIV/AIDS Legal Network
www.aidslaw.ca


-----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

 Rwanda





 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.




http://strategis.gc.ca/sc_mrksv/cipo/new/new-e.html#sep19b