Access to low-cost quality medicines plays a critical role in public health systems. In the last decade, the public health challenges facing developing countries have expanded beyond infectious diseases to non-communicable diseases (“NCDs”) in large part due to changing lifestyles and environmental risks. The World Health Organisation estimates that 80 per cent of all deaths from NCDs occur in low- and middle-income countries like India.
Affordable prices for medicines are vital to ensure that governments can progressively realise the sustainable development goal of universal access to health care. In particular, low-cost, quality generic medicines have played – and continue to play – a critical role. Generic medicines are essentially identical versions of a branded medicine which can be manufactured without a licence from the innovating company and are marketed after the stipulated time under the patent laws. They are sold under non-proprietary names rather than brand names.
Generic drugs cost a fraction of the monopoly prices charged in countries like the United States, and the presence of multiple generic competitors in India has reduced the price of cancer and HIV treatment by as much as 90 to 1,000 per cent. For instance, first-line HIV treatment that costs over Rs.16 lakh annually to treat just one patient in the U.S. costs the Indian AIDS programme approximately Rs.7,000.
Access to quality generic treatment is particularly important for households that pay for medicines out-of-pocket. When poor households lack access to affordable generics, they must forego treatment, sell precious assets, or make difficult choices between paying for medicines and other basic necessities like food, clothing and children’s education.
India’s crucial role
India is at the centre of the world's generic drug production as it is one of the few countries with the technical capacity to produce raw materials, also known as Active Pharmaceutical Ingredients (API), and formulations of newer medicines as generics. Medicines produced by generics companies in India are among the most affordable in the world. When generic substitutes are not available in India --- for instance due to patent monopoly --- it leads to high pricing of medicines as only the proprietary companies can manufacture them. They become inaccessible to manufacturers at large and their high prices place them out of reach for the majority of patients who need them.
The Ministry of Commerce must be cautious of Free Trade Agreements (FTAs), such as the ones it is presently negotiating with the European Union as well as the Regional Comprehensive Economic Partnership (RCEP), that further strengthen or extend intellectual property monopolies. These will subsequently delay generic competition and the associated drop in prices, which will have a negative impact upon access to affordable medicines from domestic producers.
Parliament’s inclusion of public health safeguards in its patent law through an amendment in 2005 set a progressive precedent for the entire world. It substituted Section 3(d) of the Patents Act such that frivolous changes which did not increase the efficacy of a medicine would not make it eligible for a patent. Through this it protected generics from the deadly practice of ‘evergreening’, where pharmaceutical companies endlessly extend patents based on frivolous modifications to their drugs that have little to no effect at best and are active health hazards at worst. The use of these safeguards by patient groups, courts and the patent office has now become a target of the multinational pharmaceutical lobby which seeks to get rid of them so it can pursue its goal of profiting from higher medicine prices. This can be seen as the reason behind intensified pressure from the U.S. against affordable medicines that are ‘made in India’.
The U.S. Trade Representative operates under the office of the American President and is somewhat like India’s Ministry of Commerce and Industry, mainly responsible for foreign trade. It prepares a report known as the ‘Special 301 Report’ where it has a ‘Priority Watch List’ where it lists countries whose intellectual property laws it dislikes. This is generally used to threaten and intimidate countries and is a pressure tactic to get them to change their laws so they are to the U.S.’s liking.
This year the U.S. Trade Representative released its report on April 26 --- World Intellectual Property Day --- and put India on the ‘Priority Watch List’. This move is to create pressure on the Ministry of Commerce and Industry and force it to comply with its demands on Intellectual Property (IP) enforcement so U.S.-based pharmaceutical companies can reap super profits.
Not satisfied with this move, the U.S. Trade Representative is now coming up with an ‘action plan’ for India with concrete benchmarks to hold India ‘accountable’ for IP-related trade practices that disadvantage American companies. The Indian government should reject such blatant interference in our internal policies on intellectual property. Commerce Minister Nirmala Sitharaman has rightly pointed out that the Special 301 Report is inconsistent with the WTO’s norms which clearly state that any dispute between two countries needs to be referred to its Dispute Settlement Body and unilateral actions such as the Report are not tenable.
India must clearly reject the intellectual property laws which the United States is trying to force on us. These have led to an unprecedented health crisis in the U.S. itself, with spiralling prices of medicines under lengthy and multiple IP monopolies, with American insurance companies struggling to manage the cost of reimbursing expensive new medicines, all of which threaten people’s access to treatment. Current U.S. intellectual property laws have done nothing but enable pharmaceutical companies to charge exorbitant prices for medicines, such as over $1,00,000 annually for new cancer medicines and $1,000 a pill for new hepatitis C treatments. This has made health care simply out of reach for the vast majority of Americans and the issue of affordable health care has dominated the primaries in the ongoing American presidential elections. This failed model, which has allowed companies to profit from human misery and is even rejected in its own country, is not worthy of our consideration.
India’s laws and policies on the other hand are entirely compliant with the World Trade Organisation’s trade rules on intellectual property (TRIPS), promote generic competition and limit abusive pharmaceutical industry practices including patent evergreening. They follow a middle path between granting monopoly patent rights and public health imperatives. Far from modifying our IP policy, we should be proud of the fact that our country has a vibrant pharmaceutical sector that has become the ‘pharmacy of the developing world’ supplying affordable, life-saving medicines used to treat communicable and non-communicable diseases in many developing countries.
B Vinod Kumar is a Member of Parliament and Lok Sabha Deputy Floor leader of the Telangana Rashtra Samithi.
