As India considers granting more compulsory licences on patented drugs to improve reach and affordability some experts have predicted more voluntary licensing deals – where the innovator voluntarily gives a licence to a generic company to sell its product and hopes to avoid a compulsory licence. Cipla, a leading patent challenger in India, has yet to get one though a a smaller company, Pune-based Emcure, has. Last year, Emcure secured a licence from Swiss drug maker Roche to package and sell its breast cancer cancer drug trastuzumab (branded Herceptin by Roche) under a different brand.
Y K Hamied, chairman, Cipla explains why he’d rather launch his own generic than one under licence. What’s more, he urges the US to grant compulsory licences on HIV drugs so he can supply generics to Americans who cannot afford treatment, at African prices.
On Emcure’s deal with Roche
In anticipation of (biosimilar) Herceptin coming into the market 2 years down the line, Roche said (it would) continue to sell Herceptin to the upper strata of society and let Emcure do it at half the price (for everyone else). But the pricing is so high that it does not matter. We are thinking of coming out at 10 per cent (of the innovator price).
On why Cipla has yet to win a voluntary licence
First you have to apply to the patent owner for a voluntary licence. He replies to you after six months. Then he says, “before we consider you for a voluntary licence can you answer the following questions?”Now you can’t answer those questions. All sorts of legal documents that will take you months and months to fill up. We applied but the terms and conditions are so deadly that it is impossible. Here is a licence for this drug for 5 years, we will supply you raw material, we will do this we will do that, this is only valid for India, it is not valid here, it’s not valid there. Then they say you have to sell it under our brand name and that belongs to us. I want to market the product under my name. Otherwise, I am a distributor network. That’s what they want. I am not a distributor, I’m a manufacturer.
On why the US should start issuing compulsory licences
A customer in America pays $24000 per year for the worlds’ top-selling (HIV) drug Atripla. The wholesale price is about $18,000 per patient per year. Cipla, Mylan and Aspen quoted in the South African tender for the same, which is PEPFAR-approved (the US President’s Emergency Plan for AIDS Relief) and there is bioequivalence to Atripla. Cipla’s quotation is $8 a month, $96 a year (per patient).
Now the question is where is $96 and where is $24000? Nobody raises that. Then two months ago, another product was approved in America called Truvada as prophylaxis. If you are a high-risk candidate, you take a tablet a day. In America, Truvada sells at $13,000 per patient per year. And the wholesale price is about $11,000. We’ve been selling this with US FDA approval under PEPFAR at about $6 (per patient) per month ie $70 to 80 a year. There are 5 to 10,000 HIV patients in America who cannot today afford treatment. They are left high and dry. So what I suggest is that if the American government brings out a compulsory licence I will guarantee to supply at African prices to those Americans who cannot afford it. For that, (the US government) have to bring out a compulsory licence. No chance (of that happening).
On January 29, Yusuf Khwaja Hamied, 75, chairman of India’s third-largest drug maker Cipla, and the Grand Old Man of the Indian pharmaceuticals industry, sat down with Gauri Kamath at Cipla’s Mumbai headquarters for a wide-rangeing interview. Apothecurry presents the Y K Hamied interview in three parts. This is part two. For part one click here.
Pic courtesy Cipla Ltd.