Yes, the South African government fought Big Pharma and held their ground even when the US weighed in with threats of trade sanctions. Gotta admire their guts. Well, they had dead bodies stacking up in the streets so what else to do?
They eventually won the right to import and use cheaper generic HIV medicines which were still within the 20 year patent protection term. So there is no need for us nowadays to re-invent the wheel. It has been done successfully already and the legislation which allowed it is still in place.
Which brings me right back to the question that just won’t go away:
Why is no other country (with the possible exception of Australia) stepping up to the plate to end the price rationing of HCV drugs by importing generics?
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I have lifted more or less verbatim what I think are the key passages of the Patents Law saga between South Africa and Big Pharma.
“In February 2001, the Bush Administration reaffirmed that the United
States would not raise any objection if WTO (World Trade Organization) Members taking steps to address major health crises “availed themselves of the flexibility” afforded by TRIPS (Trade-Related Aspects of Intellectual Property Rights).”
From the standpoint of international patent law, the key legal issue underlying the South African controversy was whether the explicit authorization of generic imports of patented pharmaceuticals complied with TRIPS. The South African experience brought the potential tension between patent protection for pharmaceuticals and public health concerns to the forefront of public awareness. It triggered a global debate about what should be allowed and what should be prohibited under TRIPS in order to preserve the incentives for investments in research and development of pharmaceuticals, while still allowing countries the flexibility to respond to public health crises as they deem fit.
The Doha Declaration strives to reconcile the TRIPS agreement with efforts of WTO Member States to protect public health by reaffirming their right to use “the provisions in the TRIPS Agreement, which provide flexibility for this purpose” (Article 4).
In Article 5, the Doha Declaration addresses the issues mentioned above and clarifies that each WTO Member (i) has the right to grant compulsory licenses and the freedom to determine the grounds upon which such licenses are granted, (ii) has the right to determine what constitutes a national emergency or other circumstances of extreme urgency (the HIV/AIDS crisis is explicitly recognized as a case of emergency or urgency), and (iii) is free to establish its own patent exhaustion regime without challenge (and thus free to allow generic imports).
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