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[e-drug] India's choice

E-DRUG: India's choice
[Editorial in NY Times about the new TRIPS/patents arrangements in India. 
Copied as fair use. WB]

January 18, 2005
India's Choice

For an AIDS patient in a poor   
country lucky enough to get antiretroviral treatment, chances are that the 
pills that stave off death come from India. Generic knockoffs of AIDS      
drugs made by Indian manufacturers - now treating patients in 200          
countries - have brought the price of antiretroviral therapy down to $140  
a year from $12,000.                                                       

That luck may soon run out. India has become the world's supplier of cheap 
AIDS drugs because it has the necessary raw materials and a thriving and   
sophisticated copycat drug industry made possible by laws that grant       
patents to the process of making medicines, rather than to the drugs       
themselves. But when India signed the World Trade Organization's agreement 
on intellectual property in 1994, it was required to institute patents on  
products by Jan. 1, 2005. These rules have little to do with free trade    
and more to do with the lobbying power of the American and European        
pharmaceutical industries.                                                 

India's government has issued rules that will effectively end the copycat  
industry for newer drugs. For the world's poor, this will be a double hit  
- cutting off the supply of affordable medicines and removing the generic  
competition that drives down the cost of brand-name drugs.                 

But there is still a chance to fix the flaws in these rules, because they  
are contained in a decree that must be approved by Parliament. Heavily     
influenced by multinational and Indian drug makers eager to sell patented  
medicines to India's huge middle class, the decree is so tilted toward the 
pharmaceutical industry that it does not even take advantage of rights     
countries enjoy under the W.T.O. to protect public health.                 

In November 2001, members of the World Trade Organization agreed that      
countries can issue compulsory licenses to permit generic production of    
patented drugs without the patent holder's agreement in order to protect   
public health, at home or abroad. But under the Indian decree, getting a   
compulsory license would be slow and difficult; each application would     
face a fight from multinational drug firms and the governments that do     
their bidding. India should adopt laws that expedite compulsory licenses,  
including allowing challenges to proceed after production begins instead   
of holding it up. In addition, India must close an important loophole      
affecting the sick overseas: under the current rules, Malawi, for example, 
could not import from India an inexpensive version of a medicine that is   
not under patent in Malawi. This needs to be changed.                      

Industry lobbyists managed to insert two noxious provisions in the decree  
that go well beyond the W.T.O. rules. The decree would limit efforts to    
challenge patents before they take effect. Also, it is uncomfortably vague 
about whether companies could engage in "evergreening" - extending their   
patents by switching from a capsule to tablet, for example, or finding a   
new use for the product. This practice, a problem in America and           
elsewhere, extends monopolies and discourages innovation.                  

While some drugs - those that existed before 1995 - will always be off     
patent in India, some widely used drugs are at risk. So are new            
generations of much more expensive AIDS drugs that will soon be needed     
worldwide as resistance builds to current medicines. If the decree is not  
changed before Parliament approves it, it will be very difficult for India 
to supply them. India's parliamentarians must keep in mind that this       
arcane dispute is actually a crucial battleground for the health of        
hundreds of millions of people in India and worldwide.                     

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