Preparing for the flu

With the influx of migratory birds picking up with the onset of winter, the risk of the dreaded avian influenza (bird flu) hitting India is rising by the day. So also are the chances of an outbreak of an influenza pandemic, caused by mutation of the H5N1 bird flu virus in human beings. Unfortunately, the government's strategy to cope with this potential menace is limited largely to surveillance and testing of birds for early detection of the malady, and does not include looking further ahead and simultaneously getting ready for the worst, should the virus actually get established unnoticed and spark an endemic. Proven cases of bird flu as well as human deaths have already been recorded in other countries that lie on the route of the migratory birds that land in India in hordes at this time of year. Under the circumstances, stockpiling of the anti-viral drug has to be an essential part of any strategy to ward off human deaths. While most countries facing a similar, or even lesser, degree of threat have already begun building up their drug inventories, India has not gone much beyond expressing its intention to arrange for about one million doses of the medicine. How even this is to be done remains unclear.

The task of building up a stock of the anti-bird flu drug is not so easy that it can be done once the problem has set in. For all practical purposes, there is only one known medicine for this and its supplies are under pressure because of the sudden spurt in global demand. At present, eseltamivir (commercially known as tamiflu) is the most favoured drug as it has shown, in laboratory studies, the ability to reduce the severity and duration of illness caused by seasonal influenza. It belongs to a class of medicines useful for both prevention and treatment of the disease. In cases of human infection of H5N1, this drug is believed to be capable of curtailing the intensity of the disease and improving the prospects of survival, but only if administered early.

The real problem at hand is that tamiflu is a patented medicine of the Swiss drugmaker Roche, which does not have a patent to produce it in India. Besides, the major source of shikimic acid, the starting point in the 10-step process to make tamiflu, is the star-shaped anise, a herb grown at present only in China. Though India has requested China to supply this herb at reasonable rates, that alone will not serve the purpose unless the trade-related intellectual property rights (TRIPs) issues concerning the manufacture of tamiflu are taken care of. For this, India will either have to expedite the issue of a patent to Roche (whose application for this is reported to be pending in the Indian patents office) or issue compulsory licences to local generic companies to produce copies of tamiflu under the public health-related concessions available in the TRIPs agreement. But legal opinion differs on whether or not compulsory licences can be issued to Indian companies without first granting the patent to Roche. A possible way out could be to issue the patent and the compulsory licence simultaneously, in order to stay clear of any controversy. The important point is that action has to be taken early, as the new manufacturers will take time to start churning out consignments, and there should be no delay in making the drug available should a national emergency occur.