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Compulsory licensing for pharma sector — WTO meet fails to reach consensus

Our Bureau

Solving the compulsory licensing hurdle would have a significant impact on the fortunes and market access of the pharma big-guns, particularly in the US.

NEW DELHI, Feb 18

CONSENSUS continued to elude WTO members on the modalities for granting compulsory licensing by countries having "insufficient or no manufacturing capacities in the pharma sector".

Compulsory licences broadly authorise generic companies to produce a drug, after payment of royalty to its inventor, for meeting the public health requirements arising from a crisis. Solving the compulsory licensing hurdle - i.e. how it would be granted and under what conditions for countries without production facilities - would have a significant impact on the fortunes and market access of the pharma big-guns, particularly in the US.

Commerce Ministry sources, who attended the just concluded three-day mini-ministerial WTO meeting at Tokyo, said that India stood its ground in ensuring that there was no dilution to the "width" of the Doha Declaration on Trade-related aspects of Intellectual Property Rights (TRIPs).

The Doha Declaration empowered Governments to take actions and make medicines accessible, in the event of public health crises — the over-arching commitments under the TRIPs agreement notwithstanding.

"Taking a position that did not find favour with the US, India made it clear that in the garb of agreeing to the modalities on compulsory licensing, the original width of the Doha Declaration should not be diluted," the source said.

Elaborating on the dynamics of the positions taken by the different Governments that participated in the meeting, the source said: "India's position found a new supporter in the European Union, which was broadly behind us. Japan was reluctantly behind us."

Trade experts contend that there has been little progress on TRIPs, since the December meeting in Geneva, where widespread resentment came to the fore as the US tried to limit the scope of diseases under which the Government could act in the interest of public health.

Even on the four Singapore issues — trade facilitation; transparency in Government procurement; competition policy and investment; and labour standards - India maintained its position that negotiations on these issues can commence only after "explicit consensus" to negotiate was achieved.

India's stand on the Singapore issues echoed the US sentiments, much to the dismay of the EU, sources said. "The EU-US disagreement on agriculture had a fall-out in the manner in which the two countries stood behind India — with the former two indulging in shadow-boxing against each other, by selectively endorsing Indian positions on TRIPs and Singapore issues."

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