Two stories currently in the news both raise the vexed issues of pharmaceutical patents, and the clout of large pharmaceutical companies, colloquially ‘big pharma’. In Australia, in response to a number of factors the price of a number of PBS subsidised medications drops today. Meanwhile, in India, Swiss drug giant Novartis is suing the government over its refusal to grant a patent for cancer drug Glivec. India has in the past been a haven for production of generic medications, bioequivalent (the same in terms of active ingredient content) copies of brand name drugs, and has only recently introduced tougher patent laws. Novartis current fight with India is however symptomatic of the ‘have your cake and eat it too’ approach of pharmaceutical companies. Part of this is the practice of evergreening.
Put simply, the practice of evergreening is making minor molecular changes to a drug so as to gain the continuing benefits of patent protection. Patent protection in itself is a good and necessary thing, given that companies need the incentive to invest in research and development of new drugs. But drug companies abuse this by evergreening so they can continue to benefit from patent protection. For example, in response to its popular antidepressants Cipramil (citalopram) going off patent, Danish drug company Lundbeck created a modified version of the molecule, escitalopram, which is basically the first thing the body metabolises citalopram into. It has then marketed it, at a higher price, as Lexapro, even though there is very little difference in efficacy between the two. Linking back to the case in India, the reason for the conflict between Novartis and the government is that the new law includes the provision that for a patent to be granted to a slightly altered drug, it must be proven to have additional efficacy, which is generally not the case. Put simply, Novartis is crying foul about India calling it to account for this practice, which is solely intended to protect profits.
Such exploitative practices are bad enough, given they lead to higher prices for governments and consumers. But where they prove to be particularly heinous is when the impact of such practices are felt in the third world. Lobbying by drug companies of governments to protect their bottom lines can and does limit the access of impoverished HIV patients. If you go to the websites of any of the major drug companies today, you will find sections dedicated to a facade of corporate social responsibility. But as the current Novartis case demonstrates, it is just that, a facade.
Update: In a win for third world disease sufferers, the Supreme Court of India today ruled against Novartis.