Strong government leadership as well as flexible intellectual property systems are needed in order to effectively combat drug-resistant tuberculosis (DR-TB) and HIV and also antimicrobial resistance and non-communicable diseases. This is true not only for India but also countries which rely on affordable generic medicines made in India.
India is the world’s principal producer and supplier of quality generic medicines which include antibiotics, and TB, malaria and HIV treatments in developing countries. Yet, India has, in recent years, repeatedly been singled out by the United States government and the multinational pharmaceutical industry for what they characterise as the insufficient enforcement of the multinational pharmaceutical industry’s intellectual property (IP) and India’s independent patent examination system. Pressure has been building up in the Ministry of Commerce and Industry and, in particular, the agency that administers IP laws and policy — the Department of Industrial Policy & Promotion (DIPP). U.S. demands for more stringent IP enforcement, fast track examination of patent claims of companies and a moratorium on compulsory licensing have dominated DIPP’s discussions with stakeholders in the past year.
PR disaster as fallout
The dispute over medicines and patent enforcement with the U.S. has resulted in a global public relations disaster for the government with the recent revelation in the media that U.S. industry lobby groups such as the U.S.-India Business Council (USIBC) and U.S. Chamber of Commerce received verbal, private assurances from Indian officials that India “will not use ‘compulsory licensing’ (CL) to create price-lowering competition for patented medical products”.
The USIBC made another arrogant revelation: that it had conducted “trainings” for India’s patent examiners. The training by a group that also receives funding from pharmaceutical companies, compromises the independence of the patent examination system, which was designed with the social objective of stopping drug giants from indulging in “evergreening”, a strategy by which patent holders seek multiple 20-year patents on the same product, extending the period of monopoly and exclusivity.
Ironically, DIPP’s attempt to pacify U.S. pharmaceutical companies comes at the worst possible time, when there is growing criticism in the U.S. and the European Union of an ever-upward spiralling of drug pricing for products protected by lengthy IP monopolies, which threaten people’s access to health and the sustainability of health services. At the domestic level, India’s Ministry of Health & Family Welfare, for the first time in decades, faced the issue of access to “single source patented medicine” for the new tuberculosis (TB) drug Bedaquiline, patented by Johnson and Johnson. In the absence of domestic suppliers of affordable generic versions of the medicine, India’s TB programme was forced to rely on a donation from the United States Agency for International Development (USAID). The revelations also contradict past diplomatic commitments which include the one at the recent India-Africa Forum Summit (IAFS) —thus undermining India’s soft power with developing countries — where the country is recognised as the “pharmacy of the developing world”, championing the cause of low-cost generic production of lifesaving medicines for emerging economies.
Despite a hasty clarification from the government’s Press Information Bureau, that India has the freedom to grant compulsory licences and to determine the grounds upon which such licences are granted, experts working on IP and the right to health believe that the damage has been done. The Health Ministry’s recommendation for a CL on expensively priced monopoly medicines like the anti-cancer Dasatinib, are unlikely to be pursued by DIPP, even though the price can be lowered by over 90 per cent with the introduction of generic competition. The generic industry does not have faith that the Patent Controller will review its CL applications independently, free from pressure to reject them on trivial grounds. The U.S. pharmaceutical industry is confident that it has successfully created a chilling effect on Indian authorities who will not process any more CLs on their patented blockbuster medicines.
In the area of intellectual property, public health and access to medicines, the Narendra Modi government should consider its independence, including from the U.S. and its pharmaceutical industry lobbyists, to be of the utmost importance. To do otherwise is to impede India’s progress towards adopting legal flexibilities allowed under international trade rules to protect domestic access to as well as international trade in generic medicines. This in turn will threaten to undermine access, for millions of people in the developing world, to affordable treatment.