Keep Off Indian Drug Patents Law, US Lawmakers Who Lobbied Modi Are Told

In their letter, many individuals and organisations stated that a country with as much poverty as India should not enforce patents on drugs and vaccines the same way industrialised countries have.

U.S. President Donald Trump (R) greets Indian Prime Minister Narendra Modi during their joint news conference in the Rose Garden of the White House in Washington, U.S., June 26, 2017. REUTERS/Kevin Lamarque

U.S. President Donald Trump (R) greets Indian Prime Minister Narendra Modi during their joint news conference in the Rose Garden of the White House in Washington, U.S., June 26, 2017. REUTERS/Kevin Lamarque

New Delhi: On the day before Prime Minister Modi met President Trump, four US lawmakers wrote a strongly worded letter to their president, asking him to push India to relax its barriers on trade and investments. Their letter made specific mentions of India’s regulations with regard to pharmaceutical patents and price control on medical devices.

“We write to you ahead of the upcoming visit by Prime Minister Narendra Modi to urge you to prioritise the elimination of Indian trade and investment barriers that significantly harm American businesses and workers,” their letter said.

By the end of Modi’s three-country tour, which was played at high volume in the Indian media, several individuals and organisations globally, have now written a response-letter, saying they find the efforts by these four lawmakers to pressure India to change its stand on drug patents, to be “appalling.”

They wrote to Senator Ron Wyden, one of the signatories of the initial letter, saying, “The practical effect of the type of trade pressures you advocate is to enhance the monopoly power and raise the prices of new drugs for cancer and many other diseases. This is appalling.”

They also cited India’s status as a developing country, with a per capita income that is nearly 35 times lesser than the US and explained, “A country with as much poverty as India should not enforce patents on drugs and vaccines the same way as high-income industrialised countries.”

The letter from the US lawmakers to Trump was written on June 25. The four members of Congress who signed it are Orin Hatch, Ron Wyden, Kevin Brady and Richard Neal. They serve as chair and ranking members of the Senate Finance and the House Ways and Means Committee.

This response-letter has been signed by members of the Global AIDS Coalition, Knowledge Ecology International, Union for Affordable Cancer Treatment, Yale Law School, Yale School of Public Health, Cornell University and Maastricht University, to name a few. In India it has been signed by the All India Drug Action network and SpicyIP.

US pressure on Indian pharmaceutical patents and medical devices

The letter to Trump was written with concerns on India’s protections across sectors, including in information technology, biotechnology, agriculture, services, manufacturing, solar energy and even the illegal practice of cam-recording films in Indian cinema halls.

However, the letter was also clear to mention thrice, India’s protection of its pharmaceutical and medical device industry through Indian patent laws and price regulation. “India’s weak standards and insufficient enforcement remain an area of concern for US rightholders, including with respect to pharmaceutical patents,” said their letter.

The health professionals responded to this in their letter saying, “India is the most important source of low cost drugs in the world, and a critically important source of affordable generic products in many developed and developing countries.”

On medical devices, Senator Wyden and others specifically criticised the recent capping of the price of coronary stents in India – a move lauded several times by Modi himself. They called India’s price regulation, which is done by the National Pharmaceutical Pricing Agency, a “non-transparent and arbitrary system.”

“According to some US producers, India’s arbitrary system has forced them to sell certain products at a loss in order to retain access to the Indian market,” said their letter. Abbott and Boston Scientific Corporation are two American stent-makers who have been trying to withdraw their stents from India, following India’s decision to bring stents under price control.

The pressure on this issue has also recently come from 18 other members of the US Congress. Reuters reported that these 18 lawmakers tried other channels to exert pressure on India’s price control – they wrote to the Indian ambassador in Washington in May, saying they were troubled by India’s price caps on stents, and urged India to reconsider this decision. “The sudden and unprecedented nature of the decision threatens citizens’ access to the newest and most innovative medical technologies and raises strong concerns about the business environment in India,” said their letter.

Pushing for ‘free and fair trade’

“Increasing Free and Fair Trade” was a key section of the Indo-US joint statement released after Modi’s visit to the US. The two countries have now agreed to “undertake a comprehensive review of trade relations with the goal of expediting regulatory processes,” so that it “advances the principles of free and fair trade.”

This issue of increasing free and fair trade, had been an explicit one in the letter by the four lawmakers to Trump as well- they said that Modi’s visit gives Trump an opportunity to press India for results on this.

“While Indian businesses continue to benefit from open US markets, India has failed to eliminate, or even address concretely, multiple trade and investment barriers that have been the focus of recent bilateral and multilateral fora,” they wrote. They called India’s protection unjustified.

To make their point, they appealed to an issue close to Modi: India’s rankings in the World Bank’s ‘Doing Business’ report, which has ranked India 130 out of 190 countries. This is the lowest for any G20 country.

The Trump administration has patents on their mind anyway

According to reports from the US press, Trump is looking poised to head in this direction of pressuring down patent regulation in countries like India. In leaked documents obtained by Kaiser Health News and New York Times, it appears that a draft executive order on drug prices is currently going to push for extending the life of patents in foreign markets. The explanation offered by the leaked document is to ensure that, “American consumers do not unfairly subsidise research and development for people throughout the globe.” India is already under some pressure from the regular rounds of talks at the Regional Comprehensive Economic Partnership (RCEP), where Korea and Japan are pushing for longer patents.

Indian law has strict patent criteria that prohibits patent holders from extending their monopolies. This means that generics can enter the market faster. If the pressure from the US, RCEP and other parties is successful, this will only make drugs more expensive, and globally.

It is not just developing countries who will suffer from high drug prices- “The US suffers when it promotes strong drug monopolies,” says James Love, Director, Knowledge Ecology International. India being a leader in the production of generic medicines, as well as an important destination for foreign medical patients, he says,  “US patients won’t have the option of travelling abroad to get an affordable treatment, such as for hepatitis C drugs, if the foreign markets for affordable drugs, including but not limited to India, are all shut down.”

In a statement prior to Modi’s meeting with Trump, Médecins Sans Frontières (MSF) “urged Modi to stand strong and protect India’s role as the “pharmacy of the developing world.” They warned that the US could pressure India to change is drug regulation and patent system and this could result in millions in the US and globally, losing their access to affordable medicines.

MSF provides health services for more than 300,000 people living with HIV and 97% of the medicines here are Indian generics. MSF also sources vaccines and other essential medicines from India, in the treatment of diseases like tuberculosis and hepatitis C. “The United States has a history of pressuring India to change its pro-public health stance on intellectual property,” says Leena Menghaney, South Asia Head for MSF’s Access Campaign. “At MSF, we have seen the enormous impact low-priced medicines can have one people’s lives. For example, by striking a balance between industrial production of drugs and public health, HIV regimens that were priced at $10,000 per person per year 15 years ago now cost $100 per year – that’s a 99% reduction in price, thanks to generic competition,” she says.

Jessica Burry, Pharmacist for MSF’s Access Campaign said, “People all over the world rely on affordable medicines from India, and we will not stand idly by if the US continues to try to shut down the pharmacy of the developing world.”