No more cheap drugs?

India is the world's fourth largest producer of drugs by volume and this is largely due to the fact that almost any drug available in the western world is also produced in India for a fraction of the cost. Till now, this was aided by the liberal patent regime in India where you could legally recreate a patented drug as long as you did not copy the original method i.e. the patent was for the process, not the final product. (The process-patent regime existed from 1970-1994. India signed the TRIPS in 1995 which gave it a 10-year grace period to usher in the new patent regime. Since 1995 drug companies have been allowed to apply for product patents.)

One might argue that the high cost of drugs in the US is due to the high cost of R&D and the costs of getting FDA approval, but we are talking about life saving drugs such as AIDS drug cocktails, not botox. If these drugs were to be sold at the same price in India and other countries, very few people would actually be able to afford them (there is no widespread system of insurance to pay for overpriced drugs - most people pay for medicines using cash), so we are not really talking about lost sales, but lost lives here.

In order to comply with the WTO, the Indian parliament has now approved a bill that changes the patent regime to outlaw such generic copies of drugs. There are some redeeming features, such as the ability to override patents during national emergencies, the ability to challenge patents before they are granted and disallowing new patents for minor molecular changes to existing drugs, but this is probably a backward move for people in India (and many other countries who depend on drugs manufactured in India) who will not have access to new drug inventions. Yes, as a signatory to the WTO India has obligations, but how severe could the repercussions of not amending the patent system be? More severe than reducing the life-expectancy of millions?

On the bright side, this may lead to more R&D in the Indian pharma labs so that drugs do not have to be copied in the first place.

[elsewhere: Indian Patent Laws / Ranbaxy takes on 'Goliath' Pfizer / Africa rallies against Indian patent law changes / Pharma industry denies price hikes in the future ]

Tags: patents, wto, trips, pharma, drugs, ip, india