Millions of people rely on affordable generic medicines produced in India, also known as the ‘pharmacy of the developing world.’ For example, more than 80% of the HIV medicines MSF uses to treat over 200,000 people are Indian generics. Generic competition, primarily in India, has helped bring prices for the standard HIV drug cocktail down by 99%, from more than $10,000 in 2000, to roughly $100 today, enabling global treatment scale-up to over 14 million people.
India was able to freely produce these medicines because it didn’t grant medicines patents until 2005, when it was obligated to start doing so under international trade rules. When India amended its patent law, it decided to put people’s lives over pharmaceutical profits by including public health safeguards, such as strict standards on what deserves a patent, and the use of compulsory licences. While India does grant patents, it is trying to strike a balance between providing intellectual property protection on innovative medicines and having the flexibility to protect the constitutional right to life.
But India’s patent law has long been a target of the multinational pharmaceutical industry; the industry has been working hard to stamp out generic competition from India, pushing for changes in India’s drug registration system and amendments to its patent law so that patent monopolies are more easily handed out. After seven years of legal wrangling, the Novartis case, over a patent that was rejected for not meeting India’s patentability criteria, was settled in April 2013 and was the highest-profile attack on India’s patent law (read more below). Despite the Swiss company losing in the Supreme Court, the attempts to change India’s laws continue.
India is currently facing pressure from the US, the European Union, Switzerland, and Japan, backed by multinational pharmaceutical companies, to change its intellectual property (IP) policies to offer more monopoly protections to multinational pharmaceutical companies at the expense of public health safeguards. If the Indian Government caved into this pressure, it could severely restrict access to affordable medicines in the future, and could be disastrous for millions of people around the world and for treatment providers like MSF, who rely on affordable Indian generic medicines. Here’s an overview of the pressure India is up against:
THE US government, backed by a strong pharmaceutical lobby, stepped up its attacks on India’s patent law after India issued its first compulsory licence for a medicine priced out of reach of 98% of the population. Attacks and criticism also followed in the wake of the Indian Supreme Court’s landmark decision in 2013 to uphold the rejection of a secondary patent to Novartis for a life-saving drug. In addition to unilateral strategies such as the US Trade Representative (USTR)’s Special 301 Report and Out-of-Cycle Review, the US has also been using bilateral avenues such as the US-India trade policy forum and bilateral investment treaty (BIT) for engagement on IP. Further, several Members of US Congress have requested two US International Trade Commission (USITC) investigations into India’s trade policies, including for IP. The pressure is clearly increasing for the Indian government and judiciary to weaken its patentability standards and practices, to create new regulatory barriers to generic competition, and to limit the use of public health safeguards.
THE EUROPEAN UNION had been pushing India to adopt stricter intellectual property measures than it is required to do under international trade rules, through a trade agreement it has been negotiating with India since 2007. Pushback from the Indian government and civil society led those trade talks to be stalled for several years, but indications are that the EU wants to re-start the talks with the new Indian government soon. The negotiating text includes harmful provisions that could potentially block the export of generic medicines from India; allow medicines to be delayed, seized, detained and destroyed; and embroil third parties, including suppliers of active pharmaceutical ingredients used to produce generic medicines and treatment providers like MSF, in court cases simply for buying or distributing generic medicines.
THE REGIONAL COMPREHENSIVE ECONOMIC PARTNERSHIP (RCEP) is a regional trade agreement being negotiated between the ten ASEAN (Association of Southeast Asian Nations) countries and Australia, China, India, Japan, New Zealand and South Korea. In the RCEP negotiations, Japan is playing a leading role in pushing stringent standards for IP that will undermine and delay access to affordable generic medicines. The leaked text of a proposal put forth by the government of Japan to the Working Group on IP includes harmful intellectual property provisions such as patent term extensions, data exclusivity and lowering patentability criteria, all of which extend monopoly protection beyond what is required by existing international agreements. These provisions also create new kinds of monopolies, even after patent-based monopolies have expired or in cases where they never existed. Unless damaging IP provisions are removed by countries like India before negotiations are finalised, the RCEP agreement could become one of the most harmful trade agreements ever for access to medicines.
A GROUP OF EUROPEAN COUNTRIES – Switzerland, Norway, Iceland and Lichtenstein – who make up the European Free Trade Association (EFTA), have been negotiating a free trade agreement with India since 2007. The EFTA negotiations, led by Switzerland, have been on hold for the last few years, but are expected to restart soon. The leaked text has shown that text proposed by Swiss negotiators would require India to lower its patentability criteria, in a bid to get the legal framework for examining patent applications in India relaxed. If Switzerland succeeds, multinational pharmaceutical companies are likely to obtain secondary patents far more widely in India, effectively blocking generic competition.
SWISS PHARMACEUTICAL COMPANY NOVARTIS first took the Indian government to court in 2006 over its patent law because Novartis wanted a more extensive granting of patent protection for its products than offered by Indian law. The company had been refused a patent in India on a cancer drug it produces. In a first case before the High Court in Chennai, Novartis claimed that the Act did not meet rules set down by the World Trade Organization and was in violation of the Indian constitution. Novartis lost this case in 2007, but launched a subsequent appeal before the Indian Supreme Court in a bid to weaken the interpretation of the law and empty it of substance. All of Novartis’s claims were rejected by the Supreme Court in a landmark decision announced on 1 April, 2013.