The cost of cheaper medicines

Healthcare around the world has evolved—revolutionized so to speak. But availability of quality medicine still remains a distant dream for much of the third world. Right to healthcare is regarded as one of fundamental rights in a progressive society. However, the escalating costs of the latest drugs developed by pharmaceutical companies render them out of bounds for the poor. For them, generic drugs are in many cases the only medicines.

Generic drugs are non-branded drugs, out of patent protection, which can be manufactured and sold by any company provided they ensure that the efficacy and the administration routine for the drug would not change. Naturally, generic drugs are much cheaper than their branded counterparts.

Apparently, it would seem that generic medicines provide the answer to the problem. But sadly, that is not the case. Reality always reserves a little bit of irony for the uninitiated. It is imperative to understand that generic drugs do not appear out of nowhere. They are mimicked on a tried and tested drug, basically a known drug which has been in circulation for some time and has gone out of patent protection. And that parent drug comes into being only through immense expenditure of labor, time and money into research.

There’s a decent estimate which says that under regulations of the US FDA, it takes 12-15 years and over $1 billion on an average to transform a molecule into a commercial medicine available in the market. As a ‘reward’ for their efforts, the makers are awarded the patent for the drug. They then brand the medicine and sell it in the market at a price which allows them to make healthy profits. Once the patent expires, generic versions of the drug come into picture. But that would be 20 years on.

So, what if generics for a particular drug were allowed in the market right away? Would that lead to cheaper medicines? No. That would simply take away from the makers the incentive to invest in research and development that led to the discovery and validation of the drug in the first place. It essentially would lead to a situation where you have no new drugs coming in the market. In this irony lay the crux of the problem.

As of now, it seems an insurmountable predicament. Whatever the solution, it has to be in striking a delicate balance—there has to be a place for both forms of medicines, branded and generic. On the government side, more work needs to be done to make available the approved generic drugs as easily as their branded counterparts. And then, once that is done, it also comes down to doctors to prescribe generic medicines to patients wherever possible.

On a very superficial level, one would think that for the current situation to change, somehow the cost of bringing a medicine from the laboratory to the market has to reduce. In this regard I can’t help but be influenced by Juan Enriquez, one of the leading visionaries in biology and medicine, who holds the view that the regulatory guidelines of the FDA are just too stringent. In his opinion, even the innocuous table salt would not make it to the market under the current FDA regulations! If indeed the regulations are relaxed in future remains to be seen, but it would certainly be a gigantic step towards cheaper medicines.