Novartis ruling: The moral question

By Akrita Reyar | Updated: Apr 06, 2013, 19:09 PM IST

This week the Supreme Court rejected Novartis AG’s appeal challenging the Indian patent law which the company felt discouraged innovative drug discovery essential to advancing medical science for patients.

Additionally, the Delhi High Court rejected Merck’s plea for an interim injunction against the sale of Glenmark’s Zita and Zita-Met drugs meant for treating diabetes.

In context of the medicine Imatinib that is used by blood and stomach cancer patients, the Swiss multi-national company Novartis had sought clarification on mainly two sections — Section 3(d) and Section 3(b) that define the kind of products that won’t get patent protection.

Mostly, these sections cover modified forms such as salts, derivatives or polymorphs of known discovery products which are as effective or sometimes even more effective in treating diseases. Incidentally, the modified drugs also come much cheaper due to pre-existing formulae that have already been tested and established by the companies owning the original patent.

While both the judgements have come as a huge relief for patients, for many of whom it is a matter of life and death, pharma giants who had appealed have been left fuming as they feel cheated of the money that they hoped to earn by funding the invention of these medications in the first place.

At the heart of the debate is therefore the issue of securing intellectual property rights, money from which goes on to fund further pharma research, versus access to affordable medicines for patients in poor nations earning constrained incomes.

In this context it may be prudent to recall what William Easterly wrote in his book ‘The White Man`s Burden’. Arguing that even if it has well meaning intentions, the condescending West does not and cannot think of grassroot solutions for poor or developing countries. And mostly, the best ideas come from simple and easy to do and extremely affordable ideas that sprout from practical experience in poorer nations.

He says: "The West spent $2.3 trillion on foreign aid over the last five decades and still had not managed to get twelve-cent medicines to children to prevent half of all malaria deaths. The West spent $2.3 trillion and still had not managed to get four-dollar bed nets to poor families. The West spent $2.3 trillion and still had not managed to get three dollars to each new mother to prevent five million child deaths. ... It`s a tragedy that so much well-meaning compassion did not bring these results for needy people.”

This is precisely the point that one would want to make. The West has not been able to provide inexpensive options to alleviate suffering in poorer countries despite complex proposals. The fact is further brought out when he adds:

"Unfortunately, the West already has a bad track record of previous beautiful goals. A UN summit in 1990, for example, set as a goal for the year 2000 universal primary-school enrolment. (That is now planned for 2015.) A previous summit, in 1977, set 1990 as the deadline for realising the goal of universal ac¬cess to water and sanitation. (Under the Millennium Development Goals, that target is now 2015.) Nobody was held accountable for these missed goals. ...”

Besides ineffective models, there is an even harsher reality - despite all the research and technology available to the Western countries, the model of capitalism does not allow for compassion. Companies that have facilitated research or bought rights to produce medicines would not be in the business for philanthropic purposes but would rather go by commercial instinct that aims to maximise profits.

As per a newspaper report, Brian Druker, the joint developer of Gilvec, takes a balanced view. Supporting the SC ruling, he says he is against predatory pricing, but would not want the price of medication to be so restrictive that it inhibits investment in new drugs.

Besides, why can we not have different sources – other than profits of pharma companies alone – as investments to fund research? Government funding would be an obvious avenue. This would be similar to funding for education and healthcare. Or rather why not have huge corporates set up funds for such research just like they set up scholarships or funds to provide food and drinking water. Some such examples already exist but these ventures can be expanded.

Possibly the big billion dollar companies being born in developing world these days could also come forth and extend a helping hand. Or the MNCs which are hugely depending on large population markets to support their bottomlines could commit to pay back before being allowed entry.

Another system could be that of dual pricing where medicines are offered at different prices in different countries just like McDonald burgers and Coke are. This way big pharma companies could think of providing at least life saving drugs at subsidized prices in the developing world.

Why should we not also focus on naturopathy and other indigenous medicinal methodologies of ancient civilisations that are far cheaper to produce and distribute as they are often made from natural and easily available ingredients.

These could prove to be valuable alternatives but remain untested or untried due to suspicion about their effectiveness and lack of organised system of production and usage.

When the modern world throws up interesting challenges, we could do with some bold and new age ideas to come up with some middle path or completely novel solutions.

However, till such time that effective alternatives are found to costly patented medicines, there will be no easy answers to several questions, particularly of the kind related with who pays for research versus good of millions.

Like to so many things in life the answer for this too will eventually be found in the shades of grey.