(c)Mudit Mathur
9 July 2015AsiaYuanqiong Hu

Under pressure: India’s progressive IP policies

India, with its progressive public health policies and patent laws, has long been known as the ‘pharmacy of the developing world’. With good reason: more than 96% of the antiretroviral medicines used to treat HIV purchased by donors for developing country treatment programmes are Indian-sourced generics. At Médecins Sans Frontières (MSF), we rely heavily on Indian generics to support the treatment of more than 200,000 people living with HIV/AIDS.

India has maintained a robust generic medicines industry thanks to its patent laws, which balance intellectual property protection with public health. In the decades leading up to 2005, India did not grant product patents on medicines. This allowed for the production of low-cost generic versions of medicines that were patented in other countries.

Competition among generic producers in India has brought the price of medicines to treat diseases such as HIV, hepatitis and cancer down by more than 90 percent. India has therefore become a key source of essential medicines at an affordable price, such as antiretroviral medicines—and has played a crucial role in the fact that today, nearly 14 million people living with HIV in developing countries receive life-saving treatment.

As a member of the World Trade Organization (WTO), India was obliged to start granting pharma patents in 2005 and has since granted thousands of patents for medicines. However, when amending the country’s patent law to comply with the new WTO rules, Indian law makers decided to set the bar high for what merits a patent in the interest of public health. India also avoided introducing any IP rules for pharmaceuticals which exceed obligations under the WTO TRIPS Agreement. India generally awards patents for new pharma compounds.

The amended patent law was specifically designed to limit a common pharma industry practice known as ‘evergreening’. Evergreening is when companies try to extend their patent monopolies by additional years—in some cases as many as 20—by making modifications to existing medicines (eg, combining multiple existing medicines into one pill). Evergreened or ‘secondary’ patents are routinely granted in wealthy countries, but India chose to prioritise public health over pharma industry interests. This public health approach to setting strict patent standards is in line with international trade rules and has helped foster the robust generic competition that keeps medicine prices low.

However, India’s progressive IP policies—and its status as pharmacy of the developing world and lifeline for millions of people—are now under threat.

These threats to India come from multiple fronts. The US has been putting bilateral pressure on India to change its patent laws and IP policies for years, including placing the country on its Special 301 Report priority watch list. Countries on the Special 301 priority watch list are those laid open to increased unilateral scrutiny of their IP policies and could be subject to trade sanctions by the US.

More recently, the US government, backed by its pharma lobby, has held congressional hearings into India’s policies and asked India to dilute its patentability standards and implement patent linkage.

Patent linkage can delay generic drug approvals by linking the regulatory approval of a generic medicine to any patent granted on any aspect of the drug. This allows enforcement of weak secondary patents, interfering with judicial discretion in patent disputes and ultimately even undermining compulsory licencing.

Harmful provisions

In Europe, while trade negotiations with the EU and the European Free Trade Association group of countries—Iceland, Lichtenstein, Norway, and Switzerland—have been stalled for as long as two years, both negotiations could soon restart. In the EU-India free trade agreement negotiations, harmful provisions that could be reintroduced in new trade talks include IP enforcement and investment provisions which could have serious negative impacts on generic competition in India.The potential consequences of these provisions include legitimate generic medicines being blocked from leaving India, or being seized in transit in Europe, or third parties, including treatment providers such as MSF, being embroiled in court cases simply for buying or distributing generic medicines.

“The US government, backed by its pharma lobby, has held congressional hearings into India’s policies and asked India to dilute its patentability standards and implement patent linkage.”

In Asia, the Regional Comprehensive Economic Partnership (RCEP) agreement promises, if current provisions stand, to be one of the most harmful agreements ever for access to medicines, on a par with the Trans-Pacific Partnership, currently being negotiated by the US, Japan and nine other countries from the Asia-Pacific rim.

RCEP negotiations involve India, China, Japan, South Korea, Australia, New Zealand and the ASEAN group of countries. Japan and South Korea have proposed provisions designed to undermine competition from generic medicines manufacturers, particularly from India. For example, data exclusivity would allow companies to get a de facto monopoly through the back door, even for drugs that do not merit a patent under India’s law, by restricting the ability of drug regulatory authorities to register generic drugs until and unless companies replicate expensive and unethical clinical trials.

Japan is also pushing provisions for IP enforcement including for goods in transit that are of great concern for purchasers of medicines, such as MSF, as they increase the risk of medicines being seized at Indian borders or beyond.

Another proposal from Japan in the RCEP negotiations would be to loosen the requirement of companies disclosing sufficient information on a patent application. Currently, countries have the ability to reject a patent application if there is not enough disclosure of the product in the application. Japan is seeking to dilute this flexibility in order to allow countries to grant more patent monopolies.

We’ve seen how provisions such as data exclusivity can harm access to affordable medicines. A 2006 Oxfam study looked at the consequences for access to medicines after a free trade agreement was reached between the US and Jordan, a middle-income country, in 2001. The agreement included data exclusivity and restrictions on parallel importation and compulsory licencing. Looking at 108 drugs that were released to the market in Jordan, only five had patent protection, and of the remaining 103, 79% had no generic competitor (despite the existence of generic competition elsewhere), due solely to data exclusivity.

The study also found that a drug used to treat hypertension in Jordan was priced nearly 400% higher than the same drug in Egypt, where a generic version was available. Both countries have a high incidence of heart disease.

Millions of people around the world—and treatment providers such as MSF—rely heavily on generic medicines produced in India. The pressure the country is under to change its patent laws and ‘reform’ its progressive IP policies is of grave concern.

In June MSF launched a campaign highlighting this pressure from the EU, US and others, urging the Indian government, and in particular Prime Minister Narendra Modi, to resist it. Called the #HandsOffOurMeds campaign, it uses social media, especially Twitter, where Modi has 12 million followers, to deliver the message urging Modi and the Indian government not to cave in to this pressure. Too many lives are on the line for them to do so.

Yuanqiong Hu is the intellectual property advisor for  Médecins Sans Frontières’s Access Campaign, based in Geneva, Switzerland. For more on the #HandsOffOurMeds campaign, visit  handsoff.msf.org or  msfaccess.org

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