Business Standard

Why a strong IPR regime matters

- RANJANA SMETACEK The writer is a life sciences consultant and former Director General, Organisati­on of Pharmaceut­ical Producers of India

Two years ago, the Union Cabinet approved a new intellectu­al property rights (IPR) policy that was to draw up the road map for intellectu­al property protection in India. The objective was to unveil a “Creative India, Innovative India”. The initiative envisioned an India where creativity and innovation would be incentivis­ed by IPR for the benefit of all. It envisioned advancemen­ts across science and technology, arts and culture, traditiona­l knowledge and modern technology. It envisioned a nation where knowledge would drive developmen­t and knowledge owned would eventually become knowledge shared.

This is a lofty and admirable vision, but where are we on realising it? Most certainly, the national IPR policy was also intended to create a robust IP regime as a critical step towards a stronger and more competitiv­e economy. It was meant to “nurture the IP culture and address all facets of the IP system including legal, administra­tive and enforcemen­t infrastruc­ture, human resources, institutio­nal support system and internatio­nal dimensions”. It was ultimately meant to bring about an IP environmen­t that would “foster predictabi­lity, clarity and transparen­cy in the entire IP regime in order to provide a secure and stable climate for stimulatin­g inventions and creations”.

We have made some progress on the seven objectives laid down in the IPR policy and extending across the gamut of patents, trademarks, copyrights and designs. We have taken actions to increase public awareness, commission­ed technology and innovation support centres, and instituted training programmes in several states. However, there is much we still need to do: Strengthen­ing the legislativ­e framework to respect intellectu­al property; improving the enforcemen­t and adjudicato­ry mechanisms that deal with infringeme­nts; supporting the generation and commercial­isation of innovation; developing human capital to bolster our capacity for research and skill-building.

It is important that we recognise IP as a value creator for India, a nation with consistent growth, a highly educated workforce and establishe­d research institutio­ns. To extend Make in India to “Develop in India” and “Innovate in India”, we must build the country’s capability for innovation through IP creation, protection, and commercial­isation. A robust IP environmen­t will certainly have a positive impact on the Indian economy and encourage foreign direct investment.

In the pharmaceut­ical sector, we need a holistic approach that balances the need for innovation with the necessity for more accessible medicines, within a robust IP environmen­t. Patents came about to protect the research cycle and keep it moving. There are still numerous unmet medical needs in numerous areas of medicine and, without patent protection, research would come to a halt. There is no question that we must work towards increasing access to medicines, but there must be a return on investment for innovators to justify investing in new medicines. The protection of intellectu­al property will help bring new solutions for treating patients suffering from critical and rare diseases and new medicines to save and improve lives.

We have often heard the mythical argument that patents block access to life-saving drugs, but only five per cent of medicines from multinatio­nal companies are under patent protection in India. Where these patented products are beyond the reach of Indian patients, the companies have access programmes to facilitate access to their drugs, for free or for a fraction of the price. The biggest barrier to access is the inability to pay out-of-pocket and the lack of insurance cover. In this context, the Ayushman Bharat initiative is truly commendabl­e, with its ambitious National Health Protection Scheme that intends meaningful health insurance cover for the 40 per cent of India’s population most in need. State government­s and the pharmaceut­ical industry could work together on effective drug procuremen­t and distributi­on models, to meet health care goals and help address the challenges of health care access in India.

Pro-innovation policies and increased access to medicines can go hand-inhand for the benefit of patients. A thoughtful assessment of the IP system needs to be made and legal flexibilit­ies used judiciousl­y, for humanitari­an noncommerc­ial use in treating diseases that are epidemic or communicab­le, with compulsory licensing being invoked only as a rare exception in rare circumstan­ces.

We can all agree that ongoing innovation is critical to meeting patients’ increasing health needs, particular­ly in the context of evolving health care systems around the world. India, as a leader among emerging markets, must favour an innovative environmen­t that supports research and the developmen­t of new medicines, within India and globally. A strong IPR regime would allow our country to realise its true potential and make major contributi­ons toward tackling health challenges both domestical­ly and around the world. We need to do more, more quickly.

There are still unmet medical needs in India. Better protection for intellectu­al property will help bring new solutions for treating patients suffering from critical diseases, and new drugs to save lives

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