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The Doha Declaration reaffirmed countries’ right to use TRIPS safeguards such as compulsory licences. But the TRIPS Agreement limits the use of compulsory licences, saying they must be “predominantly for the domestic market”. This poses huge problems for countries that have little or no drug manufacturing capacity. Countries may be able to issue a compulsory licence to make their own generic versions of patented drugs – but how can a country with no drug industry do that?
In 2003, the World Trade Organization attempted to solve the problem by establishing, in what is known as the August 30th Decision, the rules that govern the exportation of a drug under compulsory licence. It is a complex and cumbersome mechanism: it took five years for the first pill to reach a patient under the Decision.
Testing the law in Canada
Canada was one of the first places to amend its national laws to implement the Decision. Médecins Sans Frontières decided it would attempt to use the Canadian law, and put considerable energy and resources into getting an essential AIDS treatment – patented in Canada - exported to a country that had no drug industry of its own.
It proved impossible. Our experience shows that the problem of exporting generic versions of patented drugs under a compulsory licence is far from solved.
Read the 2006 report detailing MSF's experience: 
The WTO August 30th Decision Is Unworkable
Five years from Decision to action
Billed as an 'expeditious solution' that would open up access to medicines to millions of patients in need, the Decision has proved more of a 'straightjacket for access.'
Until September 2008, not a single drug had been exported under this process. Finally, five years after the agreement was concluded, the first shipment of a triple combination AIDS drug (AZT/3TC/NVP) was due to arrive in Rwanda where thousands are in need of these medicines. The second shipment is due to arrive in September 2009.
While the fact that the drugs may finally arrive is obviously good news, it’s quite clear that a process that takes so long, for just one drug, for just one country is deeply flawed. Given the global situation where 70% of patients needing ART still do not have access to treatment, this procedure is simply not up to the task.
In September 2008, MSF brought together key actors with experience in working with processing compulsory licences to ask them the question: Five years from the Decision to the action - is the 2003 August 30th Decision the "expeditious solution" for access to medicines we need?
For more information about the meeting, including agenda, presentations, audio and coverage, please click here.
Last updated: January 2009
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