“Strong patent laws will encourage innovation in the research based pharmaceutical industry”

Ranjana Smetacek,
Director General, Organisation of Pharmaceutical Producers of India (OPPI)
Ranjana Smetacek, Director General, Organisation of Pharmaceutical Producers of India (OPPI), in an exclusive interview with Mahesh Kallayil talks about the need for strong IP law and balancing innovation with access and affordability of medicine.

What is your take on the curtailing of the NPPA's pricing powers ?
Today, India is the most competitive pharmaceutical market in the world, with a flourishing generics industry and multiple alternatives for each drug available at different price points. Arbitrary moves to fix prices harm the investment climate, hamper employment generation and mar India's image as a business friendly country.

Most importantly, the assumption that patients will have increased access to medicine as a result of price reduction, through price fixing, is unfounded. On the contrary, price fixing could have a negative impact on the market, compromising quality and, perhaps, even availability.

Is there any truth to reports in some media circles regarding the timing of the NPPA's powers being withdrawn and how it was intended to please the American Pharma giants ahead of the PM's Visit to US?
Obviously, we aren't privy to the government's thinking on this. However Government's withdrawal of the May 2014 Internal Guidelines is not surprising. The July decision to cap the prices of 108 drugs went against the National Pharmaceutical Pricing Policy (NPPP) 2012, which was deliberated by a group of ministers and approved by the nation's highest policy making body, the Cabinet. NPPP 2012 clearly rules that all essential drugs are under price control while those outside the National List of Essential Medicines (NLEM) 2011 should not be under a controlled regime and their prices should be determined by market forces.

How would you like to respond to the widespread allegations from the US-based pharmaceuticals giants that the current IP regime in India is not TRIPs-compliant?
Since 2005, the patent regime in India has allowed the patenting of drugs, with India being a signatory to TRIPs. Where India makes a commitment, it is important that it honour those commitments and be seen as welcoming of innovation. The GIPC (Global IP Center) has, in its second edition of the Global IP Index report, once again ranked India at the bottom. Perhaps we have assumed certain flexibilities under TRIPs that do not exist.

Is the government's decision to set up a bilateral committee with USA to review Indian IP law a sign of India bowing to the mounting pressure from Big Pharma?
Again, we are not able to comment on why Government chooses a particular course of action. However, we see this as a positive step. It is important to recognise that IP is an important subject for a wide range of businesses, beyond the pharmaceutical industry, that are dependent on innovation and technology. It is our Prime Minister's declared position that Government is intent on improving India's business climate. Thus it is not surprising, that when there is an issue of concern to two nations, they engage in dialogue.

Would you agree with the notion propounded by some industry think tanks that a stringent IP regime based on US interests will deter many small and medium Indian generic manufacturers who will eventually be wiped out from the emerging markets?
Strong patent laws will encourage, stimulate and sustain innovation in the research based and technology intensive pharmaceutical industry. Adherence to and implementation of world class patent laws will encourage investment and technology transfer and stimulate local research by Indian and International companies. This will benefit the Indian pharmaceutical industry and lead to newer and better medicines for Indian patients. There are still huge unmet medical needs in cancer, diabetes and mental illnesses for which we need to continue research for innovative drugs.

Do you think that the Indian government is doing enough to promote generic drugs especially in an open market like India where Big Pharma is foraying aggressively with huge capital investments?
We feel a holistic approach is needed to expand healthcare in India. There is a need to balance innovation with access and affordability, within a robust IP environment. Access to medicines extends beyond issues of cost to the proximity and functionality of the infrastructure that supports that access. More than affordability, the barrier to healthcare access is the lack of insurance cover. The BJP Manifesto laid out a vision of universal healthcare that is not only accessible and affordable but also aims to reduce out–of-pocket expenses for the common man. Healthcare access for all Indians will require an integrated approach with all the stakeholders playing a role. OPPI member companies are more than willing to step forward and play their part.

How would you like to react to speculation about the government's recent pitch to expand the list of life saving drugs, amid severe criticism over NPPA's extending price control to non-essential drugs?
There is no question that quality medicines must be made available to the most vulnerable sections of the population. Government could work with the pharma industry on innovative procurement schemes and with the insurance sector to enhance the patient’s ability to pay. It is critical that Government build a collaborative environment, partnering and engaging with all stakeholders to find holistic solutions to India’s healthcare challenges . Arbitrary price fixation is not a sustainable solution! It would be more helpful if the focus is on ensuring health insurance for all, declared as a priority by Government. Ultimately, the health of the pharmaceutical industry is critical to the health of our nation!