Change for the better

Amid high political drama and an opposition walk-out the controversial Patent Amendment Bill was passed in the Parliament marking India’s shift to the WTO product patent regime. The air is filled with apprehensions on one side and hopes on the other side. The fears of sudden rise in drug prices, de-growth of domestic industry and an impending economic slowdown, are unfounded. There is not need to panic, be it domestic industry or the common man. With over 95 per cent of the medicines available in the generic form and off patent products ruling the therapeutic scene for many of the ailments, the immediate impact will be neutral. However, a larger section of the society will have to wait till the product patent expires for any post 1995 patented high technology novel therapy coming to market.

Under the generics favouring regime also it was only a 30 plus per cent of the population in the country that had access to modern therapies. This indicates the need for better structures to make medicine affordable and accessible to the common man, like public paying mechanisms, insurance and other schemes. Obstructing strong IPR regime was never a solution. Genuine innovative R&D and a strategic patent portfolio management policy are the key to long term growth of the drug industry in India. The strong IPR regime is unleashing a new era that will help domestic industry establish themselves as equal and competent competitors in the global arena. The new regime opens up avenues for growth and economic prosperity given the scientific strength and biodiversity of the country. The basic safeguards have been built in. But the question here is, “Is that enough?” If one goes by patent experts’ opinion, the country should have more effectively utilised all available flexibility in the TRIPs agreement. Of all the key controversial issues, the definition of patentability and patenting of micro-organisms were to be put before an expert committee. Good decision. The Compulsory Licensing provisions and pre-grant opposition provisions are amended too, but it could have been made better.

Providing for parallel imports and allowing export of patented products to least developed countries on request by these nations without linking it to Compulsory Licensing is a commendable step. Allowing generics manufacturers to continue production of mailbox application products is another welcome move for the Indian manufacturers. However, it is crucial that the Act should have a section on `what is patentable’ and it could have ideally be achieved by modifying Section 5 rather than omitting it. The country should have adopted the model of Western and Latin American countries in providing for license of rights to generics manufacturer if patent holder denies CL when approached with commercial terms.

The recommendations of the expert committee that will deliberate on definition of patentability and on patenting of micro-organism are yet to be known. And at this point it cannot be guessed as to what action the government will take based on the suggestions. Ideally, the country should limit product patents to novel inventions of new chemical/medical entity and should wait till the WTO assembly takes its decision on micro-organisms. In view of public health concerns of the developing nations Indian government should ward off any measure that will block basic research. At a time when affluent nations like the USA are reworking systems to derive ways and means to make medicines affordable to their citizens, it would be suicidal of India if it ignores the appeal by global NGOs. India could be a model and strong force in having ideal IPR mechanisms that will ensure economic growth at the same time assuring access to medicine to all.