The developed world is concerned over the deteriorating environment for intellectual property protection in India, particularly of pharmaceutical patents. Both sides of the debate present arguments which they see as legally-endorsed and it is time to place the key issues in perspective, to see what is black and white and what is grey. This is not a fight between the poor and the industry or even between patented medicines and generics. It is a difference of view between those that are investing in research to create intellectual property and those that have no regard for its protection?be they regulators, competitors, legislators or activists.
Pharmaceutical research is cyclical, recurring and commercially-funded. Patents developed historically in order to protect the research cycle and keep it moving. Without patent protection, research would come to a halt. Questions on how long this protection should last can be discussed as a corollary, but we cannot question the rationale for patent protection.
In India, patent protection requires a greater commitment from all stakeholders. The indiscriminate use of compulsory licensing must not be allowed to make a travesty of intellectual property protection. India is the world?s generics power house, but from where did the ?seeds? of this industry come? It is not in India?s best interest to allow this debate to be shaped by those who do not see that the commercial and business concerns of both local and multinational pharmaceutical companies are at stake, unless respect for intellectual property rights is built into the regulatory framework in an inviolable manner. Indian regulators have taken some enlightened and encouraging decisions of late. We believe it is time again for this resolve and integrity to be on full display.
In this context, there are some sticking points on which Indian regulators need to take a fair stance. Compulsory licensing is one and Section 3 (d) of the Patents Act is the other. The Indian regulatory framework allows the grant of a compulsory licence under Section 92 of the Indian Patents Act 1970 in circumstances of national emergency or extreme urgency and under Section 84, after 3 years of patent protection, if the patented medicine is not available at a ?reasonable price?. The issue of a compulsory licence can be an appropriate response to legitimate health emergencies but such a measure cannot serve as a suitable long-term solution to the broader problems of access to medicines. Assessment of the policies and decisions related to compulsory licence need to be thoughtfully made on a case-by-case basis, taking into account a number of factors. In no case, should a compulsory licence be granted without giving an opportunity to the patent-holder to provide information on how it has, in partnership with other stakeholders, tried to address the healthcare challenges and increase access by taking an innovative and more importantly a sustainable approach.
It is a myth that patents block access to life-saving drugs, because only about 5% of medicines from pharma MNCs in India are under patent protection. And where these patented products are beyond the reach of Indian patients, the companies have implemented robust access programs to ensure that these drugs are available for free or for a small fraction of the original price.
For example, 95% of Indian patients who were prescribed Novartis’s Glivec received the cancer medicine for free. The industry has also made significant investments in the research and development of new medicines to address important healthcare needs of Indian patients. In 2012, eight pharmaceutical companies and four research institutions working with the Bill & Melinda Gates Foundation launched a ground-breaking partnership designed to accelerate the discovery of essential new treatments for tuberculosis, which affects two million new patients each year in India. They also support programmes to increase hepatitis awareness in remote areas. These efforts include disease education, vaccination and programs to help prevent mother-to-child transmissions, which are the most common means of transmission of hepatitis. The industry understands the importance of access and is working closely with the Indian government and other stakeholders to find appropriate healthcare solutions for patients. The research-based pharmaceutical industry is engaged in finding new cures for still unmet medical needs across the world. There is a huge unmet need in cancer, diabetes and mental illnesses and dengue remains a threat to 40% of the world?s population. There is no question that there has to be access to medicines for everybody. But equally, if there isn?t a return on investment, how will innovators justify investing in new medicines? Protecting intellectual property will help bring new solutions to treat patients suffering from critical and rare diseases and new medicines to save and improve lives.
A poor IP framework can impede the development of new medicines over the long term by creating an environment that inhibits the pharmaceutical industry from investing in innovation. Section 3(d) of the Indian Patent Act?which prohibits the patenting of new forms of existing drugs unless they show improved efficacy and provide additional therapeutic benefits?also undermines innovation. It disallows much of the incremental innovation done on existing treatments from being patented in India. Yet, it is incremental innovation that has delivered outstanding benefits to patients the world over?whether in the treatment of HIV/AIDS or drugs developed for malaria and other tropical diseases.
Innovation is critical to meeting increasing health needs and is particularly relevant in the context of evolving healthcare systems worldwide. Indian decisions that weaken intellectual property protection fail to recognise that all innovation is valuable, both breakthrough discoveries as well as improvements to existing therapies. If India, a leader among emerging markets, shows scant respect for patent laws, the danger is that the growth of local companies in these countries and the overall economic growth will remain stunted. India?s IP ranking by the Global Intellectual Property Center stands testament to the fact that the country needs to improve its IP regime and promote innovation to attract world-class research to address healthcare challenges in India.
Alternatives to exceptional measures and the use of imbalanced policies exist. We should aim to jointly address India?s healthcare challenges through concerted efforts. Public-private partnerships, affordable publicly-supported health insurance and a robust central procurement policy are much more likely to lead to positive outcomes for Indian patients.
Ranjana Smetacek
The author is director general, Organisation of Pharmaceutical Producers of India
