Author: Leena Menghaney

Delhi’s RCEP Talks on Intellectual Property Shouldn’t Forget India’s Role as ‘Pharmacy of the World’

India must resist pressure and make sure the deal doesn’t limit the production of life-saving generic drugs here or abroad.

India must resist pressure and make sure the deal doesn’t limit the production of life-saving generic drugs here or abroad.

Marking the 25th anniversary of dialogue relations, Delhi declaration reaffirmed closer cooperation for ASEAN, India. Credit: Twitter/ASEAN

India has a real opportunity this week to push back on pressure from other countries and pharmaceutical corporations that want to limit its ability to produce affordable, lifesaving medicines, and vaccines that are relied upon by millions of people worldwide.

Regional Comprehensive Economic Partnership (RCEP) negotiators from member countries of the Association of Southeast Asian Nations (ASEAN) and its trading partners – Korea, Japan, China, India, Australia, and New Zealand – are meeting in .between February 5-10, 2018, to discuss the intellectual property (IP) chapter of the potential regional trade deal that covers nearly half of the world’s population. The outcome of this IP discussion could have detrimental effects on public health. India – which is considered the “pharmacy of the developing world” since it manufactures and sells many affordable versions of some of the world’s most-needed medicines – must resist pressure and make sure the deal doesn’t limit the production of life-saving generic drugs here or abroad.

As they delve into the IP chapter this week, negotiators must keep in mind that the decisions they make aren’t just minor policy changes, but have life or death consequences for millions of people. Masked as promoting “free trade,” this agreement is set to protect pharmaceutical corporations and allow them to block other developers from making and selling affordable drugs and vaccines. As a result, fewer people, governments, and treatment providers will be able to get the medicines they need.

Also read: India Will Not Cross Red Lines on Generic Drugs in RCEP, but Stay Vigilant, Say Officials

Médecins Sans Frontières (MSF)/Doctors Without Borders sees first-hand every day how high-price, patented drugs and vaccines leave people struggling to find a way to pay for medicines or simply go without and hope for the best. People living with HIV, drug-resistant tuberculosis (DR-TB), and hepatitis C, as well as children desperately in need of pneumonia vaccines, should not have to wonder if or when they’ll be able to afford the medicine that could save their lives.

Across the globe – in high-, middle- and low-income countries – spiralling medicine prices are now threatening the financial sustainability of government health programs. For example, we’ve seen the high prices of vaccines against pneumonia – the world’s leading killer of children under five – hamper immunisation programmes. South Africa spends more than 30% of its vaccination budget on purchasing Pfizer’s pneumonia vaccine alone. Pharmaceutical corporations launch medicines at absurdly high prices, such as the hepatitis C drug sofosbuvir, which drug maker Gilead priced at nearly $84,000 for a 12-week course of treatment in the United States, where one in five people fail to fill prescriptions because they cannot afford to.

RCEP, TRIPS, healthcare, medicines

Patents on the first two new TB drugs developed in approximately 50 years – delamanid and bedaquiline – are set to expire in India by 2023 but could be artificially extended by the provisions currently laid out in RCEP.  Credit: Reuters

According to a leaked draft of RCEP’s IP chapter, South Korea and Japan are helping pharmaceutical corporations expand their monopolies on expensively-priced drugs and forcing all negotiating countries to follow suit. For example, patents on the first two new TB drugs developed in approximately 50 years – delamanid and bedaquiline – are set to expire in India by 2023 but could be artificially extended by the provisions currently laid out in RCEP. This means scaling up DR-TB treatment in high-burden countries would be even more difficult, if not impossible, despite the fact these essential medicines are of critical importance for public health.

Additionally, negotiators are considering new registration-related monopolies including data exclusivity, which could apply to new formulations of older medicines, even when patents no longer apply or exist. This gives corporations a new way to keep prices high and block generic competition.

Also read: Out-of-Sight RCEP Negotiations Threaten Public Health and Access to Medicines

India’s role in this public health fight cannot be stressed enough; MSF has seen time and time again how more lives can be saved and improved when affordable medicines are produced in India and, itself, relies heavily on such medicines to do its medical work around the world. In fact, two-thirds of the medicines MSF uses to treat people with HIV, tuberculosis, and malaria are generics made in India.

MSF began providing antiretroviral (ARV) treatment for HIV/AIDS with generics back in 2000 – a time when pharmaceutical corporations were charging more than $10,000 per patient per year. Competition among generic manufacturers in India has brought the price of HIV treatment down by more than 99% to less than $100 per patient per year in some cases, revolutionising HIV treatment and allowing it to be expanded to more than 21 million people across the developing world. Today, MSF treats 285,000 people in HIV/AIDS projects in 21 countries, mostly with generic drugs made in India.

India must call for the suspension of harmful IP measures in RCEP. These provisions closely mirror those originally proposed in the Trans Pacific Partnership (TPP) agreement, which were later suspended after outcry from public health advocates about the damaging implications of these policies for access to medicines.

Pressuring countries like India to go beyond patent standards required by the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property (TRIPS) – referred to as “TRIPS plus” – is a direct threat to countless people all across the globe who have the right to live long and healthy lives. Negotiators should use their meeting this week to truly put the needs of the people they serve before the private interest of multinational pharmaceutical corporations.

Leena Menghaney is South Asia Head for Médecins Sans Frontières (MSF)/Doctors Without Borders’  Access Campaign.

How US Interests Threaten Indian Healthcare

At this crucial juncture, acceptance of US demands on IP enforcement will have a distressing effect on the availability of next generation generic medicines from India

At this crucial juncture, acceptance of US demands on intellectual property enforcement will have a distressing effect on the availability of next generation generic medicines from India.

A patient in South Sudan holding her anti-retroviral drugs. Credit: UNDP/Brian Sokol

The bio-pharma industry’s interests are getting in the way of global health care. Credit: UNDP/Brian Sokol

As Prime Minister Narendra Modi wrapped up his visit to the United States with an address to the US Congress, it should be a matter of concern for people in India that Washington is trying to push its broken intellectual property system on our government – a system of ever-expanding intellectual property (IP) barriers that have caused medicine prices to skyrocket, leaving American patients empty-handed with US insurance companies struggling to manage the cost of reimbursing expensive patented medicines.

These policies, which don’t even domestically work for people in America, should not be forced on people living in India or anywhere else in the world.

Current US IP laws enable pharmaceutical companies to charge exorbitant prices for medicines. For instance, it costs over $100,000 annually for new cancer medicines and $1,000 per pill for the new hepatitis C treatments.

The patent-based innovation system, which is essentially a market and not health-driven model, has also not guaranteed innovation for major diseases. Public health challenges – for example drug development of new antibiotics, antimalarials and research into effective rapid diagnostic kits for TB – are ignored and shelved by the pharmaceutical industry. The billions of dollars of profits from spiraling high drug prices, rather than funding research and development are being diverted to share buybacks and dividends, designed to boost executive pay.

Paradoxically, the US not only insists on turning a blind eye to the ‘access and innovation’ crisis but actually demands new and detrimental IP laws in countries that manufacture and widely use low cost generic medicines to deliver health, worsening an already tragic situation, with millions of people driven into debt with rising out-of-pocket healthcare costs.

Unfortunately, US bio-pharma industry interests are getting in the way of global health care.

India unreservedly produced generic treatments before 2005 when its affiliation with the World Trade Organization necessitated it to start granting patents. This new product patent system first affected cancer patients who are unable to afford expensive, patented cancer medicines costing lakhs per month. In 2012, India issued its first compulsory license (CL), a tool used by governments to override a company’s patent to allow for generic competition. The compulsory license brought down the cost of sorafenib tosylate, a kidney and liver cancer drug, by 97%.

The US government has continuously pressured India to ease the grant of patents to its companies, up the ante on IP enforcement and to put a moratorium on CLs to ensure that US-based multinational pharmaceutical companies enjoy their monopolies without any checks for abuses. Earlier this year, India was once again placed on the US Trade Representative (USTR)’s “Special 301” Report. This coercion has persisted via multiple avenues of bilateral engagement on IP, including the existing US-India Trade Policy Forum and the creation of a new high-level IP working group, which was announced jointly by President Barack Obama and Prime Minister Modi in September 2014.

Modi’s visit comes barely a month after the Indian Patent Office caved in to US pressure and granted US-based pharmaceutical company Gilead Sciences a patent for its hepatitis C drug sofosbuvir – a drug that studies show costs the manufacturer about $100 per 12-week treatment course to make but is sold for $1,000 per pill in the US. The decision comes a little over a year after India initially rejected the patent, which led to increased pressure from the US to grant more patents to its pharmaceutical companies. This step backwards takes away a lifesaving option for patients in many hieric medicines from India.

Indian officials must resist US pressure that undermines its supply of generic drugs, especially during high-level bilateral visits including Modi’s current visit to the US. It must find a strategy to diplomatically reject the IP laws and practices of the US that have led to an unparalleled global health crisis and instead continue to strike a balance between industrial production of generic drugs and the IP system, a policy that has ensured 99% reduction in the cost of medicines to save and improve millions of lives across the world.

Leena Menghaney is Regional Head – South Asia at Médecins Sans Frontières’ Access Campaign.