BY INVITATION. Innovation can support ‘Make in India’

Prime Minister Narendra Modi recently completed a successful three-nation tour. His objective was to attract investment and technology for his 'Make in India' initiative, also showcased at the Hannover Messe. This vision to transform India into a global manufacturing hub presents huge potential for the pharmaceutical sector. However, the success of the ‘Make in India’ campaign will depend on how quickly India can strengthen its Intellectual Property (IP) regime

Economic research consistently confirms that developing countries benefit tremendously from respecting IPR. Stronger IP protection will reduce business uncertainty and increase investor confidence. Greater foreign investments will augment partnerships with foreign firms and lead to more technology transfers.

Pro-innovation policies help in advancing the development of quality and innovative medicines for Indian patients. There are huge unmet medical needs and therapeutic areas that need to be addressed with innovation-driven cures. Clearly, 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? According to a 2014 Tufts Study, the average cost of developing a drug, including the cost of failure, is pegged at $2.6 billion. Protecting intellectual property will help bring new solutions for rare diseases and new medicines to save and improve lives. Access to healthcare extends beyond the cost of medicine, to the proximity, quality and functionality of the infrastructure that supports that access. More than affordability, the barrier to access is the inability to pay out-of-pocket and the lack of insurance cover.

It is a myth that patents block access to life-saving drugs. Only 5 per cent of medicines from pharma multinationals are patent protected in India and, where such products are beyond the reach of Indian patients, companies have robust access programmes to ensure these drugs are available free or for a fraction of the original price. Since the introduction of Highly Active Antiretroviral Treatment (HAART) in 1995, the HIV/AIDS death rate has dropped nearly 85 per cent. Since peaking in the 1990s, cancer death rates have declined nearly 22 per cent. Approximately 83 per cent of survival gains in cancer are attributable to new treatments, including medicines. Five years ago, treatment options available for hepatitis C cured just 41 per cent of patients. Today, a range of available treatment options offer cure rates upwards of 90 per cent, in just eight weeks.

A robust IPR framework promotes the development of new medicines and encourages the industry to invest in innovation. Decisions relating to Compulsory Licenses need to be made on a case-to-case basis. The flexibility in law should be used judiciously, only for humanitarian non-commercial use, in treating diseases which fall in the category of epidemic or communicable diseases and taking into account several factors.

The Draft IPR Policy presents a positive step towards an IP regime that has the potential to support and derive a number of economic and socio-cultural benefits. The research-based pharma industry is encouraged by the view expressed by Prime Minister Modi, on the eve of World IP day, that India’s patent laws should be brought on par with global standards to make Asia’s third largest economy a hub for outsourced creative services. The ‘Make in India’ vision lists a vibrant Intellectual Property Rights (IPR) regime as one of its stated goals. With the right IPR policies in place, creating sustained business certainty, India will be in a better position to foster a local innovative biopharmaceutical industry, building on the many elements that already make India attractive as a hub for biopharmaceutical R&D.

The writer is Director General, Organisation of Pharmaceutical Producers of India