Humanizing Pharmacy

Supreme Court verdict on Novartis has established the sanctity of Indian Patent Laws and also sent a message across Big Pharma that its laws cannot be exploited. 

As the court struck down ‘evergreening’ of drugs and compulsory licensing already there with the authorities, India has enough power to stop arbitrary pricing of medicines in India by global Pharma giants. Supreme Court verdict on Novartis is the befitting answer to the devious practice of Big Pharmaceuticals who try to constantly extend the life of a drug-patent on frivolous grounds. The decision will benefit the Indian pharmaceuticals companies and also those poor people who by and large depend on the generic form of original drug. This stellar judgment has set a precedent for ongoing and upcoming patent cases which will go a long way to protect the availability of cheap generic drugs for poor patients. It will also drive other developing countries to follow the suit set in by Indian Patent Act.

In 2005 India conformed to the World Trade Organization’s intellectual property standards (1995 TRIPS Agreement), and retroactively accepted applications for product patents from 1995 for scrutiny. It is then that Novartis sought patent for its breakthrough blood cancer drug Glivec but Indian Patent Office, as per the amended Indian Patents Act, section 3(d) rejected its patent plea stating that inventions that are mere "discovery" of a "new form" of a "known substance" and do not result in increased efficacy of that substance are not patentable. Glivec which is a highly effective treatment for leukemia is nothing more than an altered version of beta-crystalline form of the imatinib mesylate compound, thus doesn’t require a patent. Novartis further claimed against this judgment in Madras High Court and also in Intellectual Appellate Board but both the institution dismissed its petition on the same ground, which has now finally been rejected by Indian apex court as well.

Novartis including other multi-national pharmaceuticals are criticizing the ruling stating that Indian patent laws aren’t robust enough to protect intellectual property rights. But the criticism is unfair as drug-companies are known to tweak with the existing molecules to show novelty and thus try to get an extension of drug-patent, a practice popularly known as ‘evergreening’. India rather deserves praise that its patent act is strong enough to keep a check over this unjustified tendency of Big Pharma. They have also threatened India to not invest in Research & Development in the country but the fact that Indian pharmaceuticals market is world’s fourth largest by volume and fourteenth largest by value, hardly any drug industry can afford to treat India as pariah in pharma sector.

Drug patents which are meant for fresh and authentic innovation have only enticed big pharma companies to make super-profits at the expense of social good and well-being. If Novartis were to get its patent on Glivec, it would have forced Indian Pharmaceuticals companies to stop producing generic drugs, thus making the drug non-accessible to a good chunk of poor population in developing world as one tablet of Gleevec, patented in US costs around 1.2 lakh while its generic form, Glivec manufactured by an Indian pharma company Resonance is available at 30/- per tablet.

Supreme Court verdict on Novartis has established the sanctity of Indian Patent Laws and also sent a message across Big Pharma that its laws cannot be exploited. It has marked the beginning of a new era of patent system to regulate the pharma sector.

Affordable Sickness

How unfortunate it is that India who is called the ‘Pharmacy of the Developing World’ is not equipped-well at home to procure decent health facilities for its vast majority of population. Good number of people in this country becomes the victim of death knell simply because they are not provided with adequate medical attention. Only handful of the people has access to those top-class medical services which India likes to boast of. Poor can’t take advantage of these expensive medical amenities and end up in Govt. hospitals, mostly devoid of doctor and dose. How shameful it is that a good chunk of India can’t even afford to get sick!

In the backdrop of this sorry state of the nation, it is surely a commendable step taken by Gov. to allow reducing the prices of essential medicines. Recently Govt. has passed a long-pending bill named “National Pharmaceutical Pricing Policy (NPPP 12), concerned with the price control of 348 drugs enlisted in National List of Essential Medicine (NLEM). Once implemented, the prices of these medicines will go down by 50-70%. For the first time the cost of imported drugs, like insulin imported by Eli Lilly and Novo Nordik, has also been kept in its purview. Only new drug discoveries, new drug delivery systems (NDDS) and those which get their first patent in India will be exempted from price control for five years. Hence the new drug policy secures the sanctity of patent drugs and new inventions and at the same time protects the interests of those many people who can’t avail costly medicines.

Indian Pharma Industry is one of the fastest growing pharmaceutical markets in the world. It is world's fourth-largest in terms of volume and stands 14th in terms of value. The profitability of pharmaceutical industry will be reduced to some extent due to new drug policy but it won’t be as serious as being projected.  A preliminary working shows that prices of many leading brands will be slashed by 50 per cent to 80 per cent. This will reduce industry's profit by Rs 4,000 crore on domestic sale of Rs 67,500 crore per annum. Indian Pharma sector is growing at over 16% because of the strong growth in chronic segment in the domestic market. It is definitely a booming sector. India has the highest number of pharmaceutical manufacturers in the world: over 20,000. It must also be noted that price reduction will result into volume expansion and it can very well balance possible profit erosion due to price reduction of medicines.

Another criticism of NPPP 12 is that if profitability of pharma companies will spiral down, there would be less money to put in Research & Development. “In the past decade, the pharma sector has been spending more and more on R&D activities, while the returns have been minimal,” said D.G. Shah, secretary general of Indian Pharmaceutical Alliance (IPA) in an interview. However, It is a convenient and safest argument on the part of pharma companies sitting on high reserves.

A public health group AIDAN has filed a PIL in Supreme Court to bring down the prices of essential medicines. Hearing of the case is likely to happen in the second week of Jan 2013. By then Govt. might come up with new prices for all 348 drugs enlisted in NLEM. It is mandatory to not let pharma companies reign over this sector. Medicine is the ONLY commodity, purchasing of which is not decided by purchaser but by prescriber. One can imagine the grave scenario in the event of cartelization between producer and prescriber or for that matter among the companies themselves. Truly justified it is on the part of Govt. to intervene as 'health for all' is the fundamental duty of a welfare state.