William Haddad initiated the Hatch-Waxman Act in 1984, which opened the floodgates to cheaper, off-patent drugs in the US. Dubbed the 'father of generics', Haddad has passionately sided with Cipla's attempt to make cheap copies of patented AIDS drugs for poor nations. He speaks equally passionately against multinationals who charge high prices for their patented drugs. In Mumbai recently to address the annual meeting of the Indian Drug Manufacturers' Association, Haddad who is also CEO of US generics manufacturer, Biogenerics Inc, spoke to BW's Gauri Kamath. Excerpts:

• What is the next big thing that will shake up the US pharma market?
  
  Generic biotech. We can't get regulatory approval for generics because the US FDA hasn't created a pathway for approval. We need a legislative measure for that. The Hatch-Waxman Act, partly due to my failure, never thought of biotech. If we had put in a clause, that would've covered it.
  
  
• What will you do first to influence biogenerics legislation?
  
  We (Generic Biotechnology Association of about 10 generics manufacturers) will list steps to reach our goal and make decisions. Whether we are going to fight first in Europe, or the US depends on where politicians are the weakest. I think we'll push for the US since we have strong support there. Don't expect major change for another 18 months. Europe is accepting biogenerics applications but there's no approval process. They are sitting on it. They were ahead of the US but have now slowed down.
  
  
• Your company is looking at India's capabilities for making biogenerics?
  
  I'd like to do raw materials in India, because of price and talent. We will invest, but with a partner.
  
  
• Will that be Cipla or Wockhardt?
  
  I am not sure. Several companies have talked to us. I would say I like Cipla but am not sure whether they want to do biotech. I talked to Wockhardt officials in New York during an investor's meet. I want to see what their plants look like, but I haven't done that yet. On paper it has all the five products I am looking for.
  
  
• What happened to the initiative with Cipla to make AIDS drugs cheaper?
  
  We were very successful through every kind of intimidation. The UN had set up a programme called Accelerated Access to Medicines with MNCs, which gave them a monopoly in many countries at 10 times the price that generic companies were offering. We destroyed that. Indian companies won when nine Andean nations and Mexico had open bidding. At the WTO meet in Geneva, the US told the poor nations that you can name your epidemics and treat them. In exchange you let us set up a pathway of approval. So, we are back to square one .
  
  
• Are drug prices high in the US as no one else wants to pay for research?
  
  That's the argument used by MNCs to advance their agenda. They need an alibi for high prices in the US. They tell everybody to change their social delivery system to accommodate the US. Any nation that does that is foolish. They have the opportunity to delay us through legal techniques.