Govt speaking in two voices on generic medicines
By Priyanka Golikeri
30 August 2010
The government’s doublespeak on generic (off-patent and low-cost) medicines has the stakeholders in a tizzy.
On the one hand, the Department of Industrial Policy and Promotion is keen to explore the scope of a provision which, if enforced, can allow a generic drug maker to produce a patented medicine after giving the patent holder some royalty.
On the other hand, the government appears keen to seal free trade agreements (FTAs) with the European Union and Japan, which have provisions that can delay early market entry of generics.
Industry experts see the doublespeak pulling and pushing availability and affordability of medicines in two different ways at a time when there is growing concern over the dominance of MNCs in the local market.
Worries over access to affordable medicines are rising after large-scale takeovers of Indian companies by MNCs in the recent past, with pharmaceutical industry data suggesting that by 2015, when the medicine market in India is touted to be over $20 billion, about 15% of total medicines would be patented medicines, giving full liberty and monopoly to the patent holder to charge any amount.
Healthcare experts say there will then be a stronger push towards expensive brands, which would keep medicines beyond the reach of many people.
According to an official from the ministry of commerce and industry, the government is considering a provision like compulsory license, which is a flexibility allowed by the World Trade Organisation and would imply allowing generic companies to produce generics of patented medicines by paying patent holders royalty.
“FTA is a separate issue. Government is very keen on concluding it with EU this year and interests of our people will be protected,” the official said.
However, the FTAs include what is called data exclusivity —- a provision which can delay early entry of generics of even non-patented medicines for a certain period of time —- as well as a call for patent-term extensions.
“Data exclusivity is something which can retard utilisation of generics, while compulsory licence is for promoting generics. Government seems to be considering both through different routes.
“What will ultimately be done is not clear. Saying that public interest will be safeguarded is doing diplomatic talk,” said Amit Sengupta, secretary general of All India People Science Network.
BK Keayla, convenor, National Working Group on Patent Laws said that unless provisions in FTA like patent extensions and data exclusivity are resisted firmly, measures like compulsory license would mean little.
“There are chances that in its hurry to sign the FTAs with Japan and EU, the government will accede provisions that can prolong entry of generics, rendering any future measures to promote generics useless,” a New Delhi-based intellectual property expert said.