India defends Novartis ruling but what does this mean for the country?
Last week I covered India?s landmark ruling against granting Novartis patent protection for its Leukaemia and gastrointestinal cancer drug “Glivec”. The ruling received both domestic and international criticism that drove India?s trade and industry minister, Anand Sharma, to defend India?s judiciary decision by claiming that the law was followed to the letter. With so much at stake can India afford to oppose the Pharmaceutical Industry? This has been the topic of much discussion over the past week with people weighing in on both sides of the argument. What is frequently overlooked by both parties is what effect with this have for affordable medication in India?
Generic drugs favour patients, not profits
The overwhelmingly prominent argument for favouring generics is the benefits that it confers to increasing the accessibility of life-saving treatments for those without the financial means to purchase branded medication. In a recent interview with Bloomberg Indian generics “Taj Pharma” CEO A.K. Singh said:
“the decision will have a positive impact on drug affordability, accessibility and availability of this drug in India for cancer (myeloid leukemia) patents, as Glivec (imatinib) costs more than Rs.1,000,000 for monthly treatment compared to Rs.10,000 for our generic imatinib tablets”.
Will favouring generic drugs offer any other benefits? The ruling cemented India?s stance against evergreening, the practice of slightly modifying the drug formula, which has been an integral part of the Pharmaceutical Industry?s development strategy. However, with reports of the EU, Australia, and Canada considering following India?s decision the likelihood that this model can be maintained in its current form is slim. Therefore, if Pharmaceutical MNCs cannot rely on profits derived from patent-protected modified drugs it is argued that they will have to redirect their focus on avenues of highly innovative research to guarantee revenue returns.
Patent protection drives innovation
Novartis was very critical of India?s ruling claiming that by not offering IP protection the Pharmaceutical MNCs have few incentives for research and innovation within the country. Whilst this point holds true, the possibility that MNCs will avoid India?s $13 billion-a-year drugs market altogether is as unlikely as the concept that Pharmaceutial MNCs with halt their global drug development strategies. So, if India can provide necessary healthcare for its population whilst protecting truly innovative drugs, what does it have to lose? Chris Hamer, an experienced patent attorney at Mathys & Squire, recently pointed out:
“This stance could lead to a significant increase the pricing of drugs in Indian territories during the original patent term. Essentially, prices can only go up if companies cannot expect patent protection for further drug developments.”
Thus, it is argued, that unless India finds a way to support Pharmaceutical MNC innovation it will face reduced domestic R&D and increased patent-protected drug prices.
Is India?s generic drug viewpoint the solution for affordable medication?
The focus on Novartis? patent dismissal has garnered much attention, however, it has deflected attention away from underlying problem; India?s view that healthcare is an expense, not an investment. India?s healthcare investment stands at 4.1% GDP (according to data from The World Bank), a figure significantly below the 17.9% invested by the US or the 9.5% invested by Spain, that leaves India?s healthcare system in a state of permanent crisis. Without proactively investing in healthcare policies aimed at preventing chronic diseases India is facing an increased disease burden that will maintain its dependence on blockbuster drugs. If innovative drug prices do rise and generic medication is unable to support chronic disease management what will happen to affordable medication? Without combining generic drug manufacturing with pharmaceutical innovation support within a few years India will return to the same dilemma that it faces today, namely that it is unable to provide adequate healthcare for its citizens.
– Jonathan Mackinnon