A few days before Prime Minister Modi’s first visit to the US as PM, pharmaceutical companies in India were pleasantly surprised when the country’s drug pricing authority, the National Pharmaceutical Pricing Authority’s (NPPA) withdrew a set of internal guidelines which allowed it to monitor the prices of drugs that were previously out of its purview citing public interest. (See report: http://pharma.financialexpress.com/latest-updates/4448-nppa-withdraws-internal-g-lines-on-drug-pricing)
These guidelines were challenged in court by industry associations like The Organisation of Pharmaceutical Producers of India (OPPI) and Indian Drug Manufacturers’ Association (IDMA), as they impacted drugs outside the National List of Essential Medicines (NLEM).
Industry has reacted positively but cautiously to the news. Ranjana Smetacek, Director General, OPPI commented that the move meant that they industry is being heard (by the Government) and they look forward to working with the government toward a common goal. “We are still trying to understand the precise impact of this order on our member companies,” according to the statement.
Daara B Patel, Secretary-General, IDMA too reacted positively saying that the Government’s decision will be beneficial to both industry as well as to patients as companies will not be reluctant to manufacture medicines put under DPCO regime and patients can avail them without any hurdles.
Though no reason has been given for the withdrawal, can be it be a mere coincidence that the U-turn came a few days before the Prime Minister’s visit to the US? It is still unclear if price cuts already announced will be reversed or if the decision will prevent the NPPA from using the public interest clause again on non-NLEM products.
Push from the top
The PM’s trip to the US, in end September, comes after his successful trip to Japan and Chinese President Xi Jinping’s visit to India. The momentum of the first trip impacted the hype around the Chinese delegation’s visit and much was made of the many MoUs signed between the two countries. Though incursions of the Chinese PLA on the border took away some of the sheen from these MOUs, there are two MoUs which raised some hopes among pharma companies in India.
One MoU was part of the effort to balance the long standing trade deficit, currently skewed in favour of the dragon nation. Along with pharma, agri products and IT services are the sectors where China has agreed to take specific measures to enhance market access. Another MoU was a work plan on drug administration and cooperation between the drug regulators of both countries on drug standards, traditional medicine and drug testing. Both sides will exchange delegations to enhance cooperation in these area. These two MoUs address two of the major pain points: market access and approvals, faced by Indian pharma companies trying to make inroads into the China market. Proper and speedy implementation of both MoUs could have a very positive impact on pharma companies in India. Currently, only a handful of Indian pharma companies, including Dr Reddys Laboratories, Ranbaxy, Sun Pharma & Aurobindo are present in China. (See story: http://pharma.financialexpress.com/latest-updates/4435-indian-pharma-could-gain-from-china-india-mous)
These MoUs are in line with PM Modi’s past record of nurturing an industry-friendly environment. But will this stance see him bend where he needs to stand tall? For instance, on the intellectual property rights (IPR) issue, the US has been castigating the country’s IP laws, and in May this year, was all set to list India on the Special 301 list of IP defaulting nations. However, objections from two stronger industries, defence and software, overrode the pharma industry’s objections. India escaped being on the Special 301 list and was instead classified as a “priority watch list country.”
In a press briefing on September 8, Commerce and industry minister Nirmala Sitharaman had indicated that the Government would roll out a revised policy on IPRs and this has raised concerns that the Government considering a change of stance. She has been quoted as saying, “There are different laws (on patents, copyrights, trademarks and geographical indication), but we don’t have a comprehensive IPR policy clearly spelling out our regime for the entire world to know. As a result we have had arbitration matters and court cases on many IPR matters. The lack of a clear policy is hurting us,” the minister said. (http://indianexpress.com/article/business/economy/govt-signals-ipr-recast-ahead-of-modis-us-visit/)
She clarified that the IPR policy would not be restrictive or regressive, but would only “give clarity and consistency without any overlap or contradictions. It is also to protect at an international level India’s IPR interests, our heritage, our achievements in pharma, especially generics, the advances we make in science and technology, as well as the patents we file.”
Even with these clarifications, sections of the industry are not convinced. In a widely circulated open letter to Modi’s government on the decision to review India’s position on IP laws, a range of stakeholders have urged him “during his visit to the US, not to make any legal or political commitment that compromises flexibilities in the Indian Patents Act for facilitating access to medicines and safeguarding public health, which is based on policies and principles approved by Indian Parliament and is fully consistent with international laws.”
The stakeholders range from public health organisations like Jan Swasthya Abhiyan, Dr Amit Sengupta of Jan Swasthya Abhiyan, Leena Menghaney of Campaign for Affordable Trastuzumab and Malini Aisola of Oxfam India. Legal aid groups like Prof Dinesh Abrol, Convener, National Working Group on Patent Laws, Ramya Sheshadri, Lawyers Collective as well as patient groups like Manoj Pardesi, National Coalition of PLHIV in India (NCPI+) and Network of Maharashtra by People Living with HIV/AIDS (NMP+) and Kausalya of Positive Women Network are signatories to the letter.
Scientists, diplomats and academicians like Dr Nityanand, Eminent Scientist, Former Director Central Drug Research Institute, S P Shukla, Former GATT Ambassador and Secretary, Ministry of Health and Family Planning, Prof Muchkund Dubey, President Council for Social Development, New Delhi and Former Foreign Secretary, Government of India, BL Das, Former GATT Ambassador, Dr Biswajit Dhar, Professor, Centre for Economic Studies and Planning, School of Social Sciences, JNU and Prof BS Chimni, Centre for International Legal Studies, School of International Studies, JNU too are among the signatories.
Will the PM be able to find common ground to address concerns of these stakeholders as well as balance diplomatic ties?