New Indian IPR regime to bug global generics industry

EPP News Bureau - New Delhi

“Every time a new drugs enters the market, it is a wait of long 20 years before you could get access to it,” said William Haddad, father of US generics & generic biotech industries. “I am damn angry,” he said while talking at a press conference on the impact of Patent Amendment Ordinance 2004 in Delhi organised by Indian Drug Manufacturers Association.

The Ordinance 2004 will impact the growth of global generic drug industry adversely. The generic drug industry in the US that is depended on off-shoring its API requirements to countries like India would feel the pinch, Haddad pointed out. Of the 7000 odd mail box applications at least 400 are patent filings for APIs and this will deny access to cheap raw material to developed world.

Haddad said that he would strongly advise Indian government against any commitment that go beyond TRIPs. “The Ordinance should be placed in the Parliament for discussion and should not be passed in its current form,” asserted Haddad.

India should join hands with Brazil and other countries to get exemption from implementation of TRIPs till 2016. “It should not be economic indicators that decide but we need to redefine the eligibility criteria for participation in the 2016 exemptions”. According to Haddad, those nations which have traditionally supplied essential medicines to poor countries of the world should be exempted. By 2016 many of the smaller nations will be able to develop their own pharmaceutical industry, but in the interim the manufacturing nations should be put back into the equation, he said.

In his testimony in the European Parliament hearing on TRIPs and Access to Medicines, last month, Haddad called for reconvening a mini-Doha to explore the failures for the past attempts leading towards a WTO meeting this summer to correct these flaws.

He also urged to clarify and simplify the methodology for poor nations to use compulsory licensing. Right now the generic industry and the NGOs believe the process is too cumbersome for most nations. “I believe that CL should be part of the WHO process so that each nation does not have to reinvent the wheel,” he said.

Unveiling certain truths about the research based pharmaceutical industry he said, “the R&D cost of a drug put at $800 million is a big lie and studies show that the actual cost is only $250 per drug. Moreover, since most of the approved medicines entering the market are not truly new or novel or are acquired from other sources, according to Dr Marcia Angell, who was the editor of the New England Journal of Medicine, the real time cost is a mere $100 million. Angell wrote that were the figure been anywhere near the claimed $802 million, the industry would not have been so secretive about its data.