Don’t shut down the pharmacy of the developing world

Shailly Gupta, Deputy Head, MSF Access Campaign (India) emphaises the need to ensure availability of affordable medicines within public health programmes, which is the need of the hour

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Shailly Gupta

One of the fastest-growing economies in the world, our country is known globally as the homeland of the famed Taj Mahal and for its strong cultural heritage. However, and more significantly, India has had a far-reaching positive global impact through its supply of vast quantities of low-cost, good-quality generic medicines, which have saved or prolonged the lives of millions of people.

Amongst a handful of developing countries with a huge production capacity to manufacture quality-assured generic medicines, India did not grant patents on medicines till 2005 and thus, its generic companies produce some of the cheapest life-saving drugs in the world. Known as the ‘pharmacy of the developing world’, the country played a major role in scaling up treatment to 17 million people across the world by lowering the price of antiretrovirals (HIV medicines) from $10,000 per patient per year in 2001 to less than $300. As a medical treatment provider, Doctors Without Borders/ Médecins Sans Frontières (MSF) relies on affordable, quality generic medicines to treat a number of diseases. In fact, 97 per cent of the medicines used by MSF to treat HIV are generics sourced from India.

When the country amended its patent law to comply with international trade rules in 2005 and started granting patents for pharmaceuticals, Indian parliamentarians ensured the inclusion of public health safeguards by granting patent monopoly rights only to genuine inventions. India’s patent law strives to strike an even handed balance between providing patent protection on innovative medicines and the necessity to protect public health needs. India’s public health safeguards have guaranteed fewer patents in India, more generic competition and thus, more affordable medicines for people and governments in developing countries. In contrast, countries like the US have patent laws that blindly favour pharma companies over generic competition, allowing multiple and extended monopolies on the same medicine, which, in turn, lead to exorbitant prices for lengthy periods of time.

Multinational pharma corporations view robust, affordable generic medicines produced and marketed by Indian suppliers as an enormous threat to their profits. Pressured by these corporations, foreign governments have utilised various platforms—including diplomatic talks, bilateral and regional trade deals—to coerce the Indian government to amend its patent policies to offer more patent protections and restrict generic competition.

One such trade deal is the Regional Comprehensive Economic Partnership (RCEP). Big Pharma is attempting to restrict access to low-cost, life-saving medicines and jeopardise public- health via the RCEP negotiations that were initiated in 2012 between 10 ASEAN countries and six trading partners – India, China, Australia, New Zealand, Japan and South Korea.

Like several other free trade agreements, the RCEP, too, is being negotiated behind closed doors with no inputs from public health stakeholders. An online leaked draft text of this trade deal reveals that Japan and South Korea have proposed several provisions that go far beyond the World Trade Organisation (WTO) requirements and seek to extend patent monopolies of pharma corporations. This includes provision for extending patent terms for an additional five years beyond the present 20-year limit. Another proposed harmful provision is introduction of data exclusivity to defer the registration or marketing approval of generic versions of medicines by several years which will effectively provide a backdoor monopoly status to pharma corporations – even for older medicines that do not deserve a patent.

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If accepted, both provisions will delay the entry of affordable versions of medicines in the market and eventually, in the absence of generic competition, keep prices high for longer periods of time. In India, where people pay nearly 70 per cent of health expenses out of pocket and rarely have health insurance, high prices of life-saving medicines will keep them out of reach of the most vulnerable sections of society. With emerging public health challenges and the increasing burden of tuberculosis, hepatitis, and cancer in our country, the need to ensure the availability of affordable medicines within the public health programme is certainly the need of the hour.

In the current economic landscape, the RCEP trade deal has been lauded as it will bring in huge investments, infrastructure and jobs to India. However, what is largely being ignored is that corporations are utilising such trade deals to disguise their attack on public welfare sectors such as healthcare and access to essential medicines.

This attempt to surreptitiously convert public healthcare into a commercial enterprise will allow medicine to be treated as any other profitable commodity, subject to monopolies and elevated product pricing. Consequentially, India’s revolutionary low-cost generic industry that stems from its public health-oriented patent policies will be shut down to make space for profit-focussed multinational corporations. Elevated levels of intellectual property rules in RCEP can dismantle the public health system of many developing countries and restrict governments’ capacities to protect public health in not only India but in other developing and least-developed nations of Asia and Africa.

So far, India has stood firm against the inclusion of these harmful patent provisions. With the next round of RCEP negotiations set to take place in Japan in March, MSF, as a treatment provider that relies on affordable medicines sourced from India, hopes that India, along with other ASEAN countries, does not agree to a final text unless all provisions that go beyond international trade rules are removed. In its place, the trade deal negotiating text should ensure the protection of existing public health safeguards and enable developing countries like India to effectively balance its patent system with public health needs.

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