Drug Regulation Innovation Patent

Barriers in Access to Medicine: Yet another Culprit – an Apathetic Government


Patents impede access to affordable medications. This is now a well-established proposition, though the rate and extent of such impediment will vary from case to case. However, what of non-patent barriers? Unfortunately, this is a topic that has not received as much attention as patents in the mainstream debates. Below is a sorry story reflecting one of the biggest non patent barriers: namely, government apathy!

(Image Source: https://flic.kr/p/qiCHRc)

(Image Source: https://flic.kr/p/qiCHRc)

This story begins with a detailed analysis by Vidya Krishnan in an article on LiveMint, of the acute drug shortage being faced by the National Aids Control Program (IV). Not only are the treatment centres running out of drugs, they are even running out of Viral Load Assessment kits themselves. As the article details, the shortage is only getting worse. One of the key supplier of the antiretroviral drug, Cipla, stopped participating in government tenders from July 2013 to May 2014 as it had not received payments for previous supplies. The government only reacted to this in September 2014, more than a year after the situation first emerged – and that too when the supply of the medicines for children was about to run out by the end of the same month!

The article also mentions that the tender for the supply of drugs for that period had actually been awarded in June 2014, but the same had not been notified for a three months! And in fact, this discovery was made after activists wrote to multiple agencies to raise the issue with the then Health Minister.

The article goes on to note that the major cause of this shortage is governmental red tape. To quote, “AIDS is not sexy any more. The government is short of cash. Most importantly, AIDS is not a priority for the (Narendra) Modi government”.

And this is not a one-off situation. The same story of shortages and inefficiencies came up in the context of Tuberculosis drugs in 2013. Even then, the National Tuberculosis Control program was functioning efficiently as long as the British government was providing the drugs through its Stop TB Partnership program, but as soon as that ended in 2011, issues started cropping up. The government did not solicit bids for companies to replace the British supply in time, a lengthy process, and was unable to procure the relevant drugs since 2012. Again, multiple letters were sent to the Central government, in 2012 and in 2013, appraising it of the situation. But despite being one of the largest producers of anti-TB drugs in the world, despite multiple clear notices about the shortage, the country ended up facing a stock-out. And despite the steps that were taken to fix this situation, the shortage of supply still continues, as of January 2015.

The same situation is being repeated, right now, with Swine Flu, which has recently seen an upsurge in infections across the country, the death toll being 624 at last count. Some chemists are reporting a shortage of the Swine Flu treatment, The government currently insists that there is no drug shortage, stating that the endemic states have produced the drug in bulk, and some are even supplying it to other states which need it.

Crucially, swine flu medication is regulated by the government, mostly in government-run hospitals with some private hospitals, in order to prevent self-medication. Therefore, the above can mean one of two things. The first is that there is a drug shortage though the government denies it. The second is that there isn’t a drug shortage, and despite actually having the drugs, the state governments are unable to get them to the patients who need them! The situation, then, seems akin to a choice between boiling water in a pan or a fire!

Moreover, as Shamnad Sir discusses in his article here, the Indian pharmaceutical industry seems to be undergoing a fundamental change, and partnerships and deals between Indian generic companies and global innovators are on the rise. Relying on the free market and private companies, which work on the basis of demand and supply, to provide affordable drugs is no longer a viable option. It is thus becoming more and more crucial that the government itself take up slack, once again participating in bulk production and cutting edge R&D in the pharmaceutical sector, as it did in the heyday of CDRI and IDPL. And yet, if the above instances are anything to go by, the government seems to be intent on doing the exact opposite – perhaps even knowingly. The stark truth of this is evident in the fact that the Indian healthcare budget for 2014/2015, already the lowest in the world, has been further slashed by 20%. (For more on this and related issues, refer to Chaitanya Kalbag’s excellent article here.)

When questions of access come up in a legal environment, the focus tends to be more on policies. This is especially true in India, with all the upheavals that we have seen in the past few months. These developments are stark reminders that implementation is one of the most crucial aspect of ensuring access to the necessary resources, especially with regards to pharmaceuticals. And here, it would seem that the government, its inefficiencies, and its negligence are the biggest culprits.

My thanks to Shamnad Sir for his inputs on this post.

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