Major healthcare NGOs namely Affordable Medicines and Treatment Campaign, Medicins Sans Frontieres, Lawyers Collective HIV/AIDS Unit, Alternative Law Forum have pointed out that the Patent Bill was passed in the Lok Sabha without necessary provisions to safeguard against wholesale hiking of medicine prices.

The NGOs alleged that under the new Bill, the country will start granting product patents for medicines - something they have not done since 1970 - without the necessary procedures to prevent wholesale hiking of medicine prices. India amended its 1970 Patent Act in order to be compliant with the requirements of the World Trade Organisation.

"A key safeguard to assure availability of affordable medicines is the procedure of compulsory licenses with which the government grant patents but allows generic companies to make their versions of the patented medicines against a payment of a royalty to the patent holder. However, in the Bill that was passed in the Lok Sabha on Tuesday, the procedures are still extremely complex and there is no clarity on levels of royalties to be paid, which will lead to endless litigation and delays," they cautioned.

Though the new Bill permits products that are already on the market by allowing for automatic right to produce, the generic companies in such cases will pay royalties to be set by the government to the patent holder. International norms for royalties are in the range of 3-4 per cent. This new law however does not set a fixed royalty rate. In South Africa, GlaxoSmithKline attempted to charge 40 per cent royalty until activists and the courts intervened, the NGOs pointed out.

"The worst-case scenario for people living with life-threatening diseases has been averted, but only in the short-term. People who rely on low-cost medicines will have to wait three years before a generic company can even make an application for a right to produce the drug. People in wealthy countries will have access to new medicines immediately when they are proved safe and effective, whereas people in poor countries will have to wait years," say the NGOs.

In addition, with this Bill the government has crippled the critical right of the members of the public to oppose patent applications on medicines, the so-called ¦pre-grant opposition. It is has been rendered ineffective because the essential information on which to base the opposition will be withheld from the public. The NGOs expressed grave concern that the Bill will go before the Rajya Sabha for a final vote in its current form.