Create the framework

Working in a federal structure is important for new innovations to be implemented. The partial divide between the Centre and state becomes a barrier to eradicating diseases in an effective manner. One must also bolster the growth of small and emerging research laboratories and start-ups, and realise that innovations can evolve even from small institutions, and can be leveraged on a large scale, especially in areas of health.

The core hurdles

However, to translate research and new discoveries into the required health products, more often we need a strong infrastructural framework wherein the public and private sectors work in tandem to develop synergies. For this, we need to build a health-care ecosystem that offers positive investment returns and ensures patent rights of inventors, and keeps the cost of innovation under check through the right implementation of supportive policies and various economising channels.

Therefore, more than price regulations what we need is a sustained effort towards addressing the core issues that slow down innovations and bring up the cost, such as underinvestment in research and development, ambiguous and weak intellectual property rights (IPR), lengthy drug clearance policies, poor supply systems and imperviousness to public-private partnerships.

Also, with the recent tax reforms, it is always good to improve a fractured system but without affecting innovation. The hope through tax reform was that the cost of pharmaceutical products at the consumer level would be reduced, but the burden seems to have increased. Such a scenario calls for immediate interventions to boost stronger pharmaceutical collaborations without compromising innovation.

In the market-driven Indian health-care industry, sustained innovation is impossible without ensuring returns on investments. This essentially means having robust IPR and patent policies. Allowing inventors to earn profits during the term of the patent will help sustain future investment in research and development and reward investors for their investments in innovations.

However, despite announcing a new IPR policy in 2016, India remains near the bottom of the 2017 International Intellectual Property Index. While India’s score has improved marginally, evidently a lot has to be done to bring about consequential changes in the overall IP framework.

Policies and transparency

India’s stance towards IPR has been a major snag in attracting foreign investors. To bolster investor confidence in the Indian market we need an IPR framework which offers predictability, clarity and transparency. A world-class drug regulatory framework implemented by strong drug regulatory authorities is imperative to reap the benefits of innovations. We need policies which appropriately value new biomedical innovations and incentivise continued investment in research and development. Alongside, we also need more transparency in clinical trial-approval procedures to ensure prompt access to life-saving drugs while maintaining their standards and accuracy.

Incapacities in drug clearance policies, whether making them too easy or too stringent, eventually defeat the long-term purpose of innovations. While weak policies can open the way to low quality or unsafe drugs in the market, outdated or unduly burdensome laws and regulations can add to the cost and delay access to life-saving drugs.

So, to sustain research and bring more effective and affordable drugs in the market, we need to strike a balance between inventor concerns and public interest. For inventors, their first priority is to sustain their undertakings, and for this they need an investment-friendly environment, backed with equitable IP rights and coherent regulatory laws. From the public health perspective, the end goal of research and development is to make new health-care technologies effective, safe, accessible and affordable for all.

Hopefully, with high possibilities of the introduction of better IPR policies and new laws on clinical trials, innovations in health care will get the much-needed push and the country will soon be able to realise the goals of universal health coverage.

N.K. Ganguly is former Head, Indian Council of Medical Research