Over the last one decade India has emerged as the pharmacy of the world. Nearly 17 million people in developing countries receive low-cost medicines from India. It’s a very good thing, but unfortunately, one facing constant threats.
After India joined the World Trade Organisation in 1995, it signed several trade agreements with it and the member nations including the US and the European Union, both of which have constantly been pressuring India and lobbying for strong intellectual property rights through free-trade (FTAs) and bilateral agreements.
“And while it opened new markets for India, in hindsight, it also allowed them ways to pressure India to change its intellectual property rights (IPR) rules, thus threatening India’s generic drug market,” says Loon Gangte, regional coordinator of International Treatment Preparedness Coalition (ITPC), South Asia. ITPC works towards enabling people in need to access optimal HIV treatment.
India has always been at loggerheads over foreign governments over patent issues and is quite assertive about its rights, as Firstpost writer Shreerupa Mitra-Jha explained earlier this month.
What’s the connection between drugs and IPR
A patent on a drug allows a company to get exclusive license to manufacture and sell a drug at a price it seems fit, for 20 years, according to TRIPS agreements signed between the WTO members.
But, Gangte, who is one of the founding members of the Delhi Network of Positive People (DNP+), and has been working with people with HIV/AIDS at the grassroots level through his other organisation for the past 19 years in not against patents.
“A patent as such is not a bad thing. And, why should a company who spend billions of dollars in research be forced to sell a medicine at a loss? However, lately drug companies have been making small changes in their medicines and re-applying for fresh patents thus extending their control on a drug. They also charge exorbitantly for the drugs. This is wrong and must be stopped. Certain essential medicines, especially those that can save millions of lives, should be made available at as low a cost as possible,” adds Gangte.
So, far the Indian government has been very strict with its stand of not letting these external forces affect the Indian generic drug industry, but with the Narendra Modi government pushing India as the next manufacturing hub, India’s IPR rules are likely to change in order to attract more MNCs. Our stand is changing. And how long will India manage to retain its stand remains unclear.
A crucial example is how Gilead managed to get the patent to manufacture its anti-Hepatitis C drugs sofosbuvir (Sovaldi©). In 2015, the company applied for a patent to manufacture sofosbuvir in India, but it was rejected because of the high prices of the pill. It costs $1,000 a pill in the US.
But in 2016, India’s patent office, reportedly under pressure, approved the patent to make Sovaldi, right before US president Barack Obama was to visit the country. Mandakani Gahlot and Vidya Krishnan has an interesting account on how the patent was won in an article on The Caravan.
“We are fighting the patent award in court,” says Gangte, adding, “Currently with generic drugs the cost for an 84-day treatment comes to be around Rs 20,000. With Gilead’s patent for Sovaldi, it will become very expensive, not just in India but across the world. They are already charging $1,000 a bill in the US, which brings the cost for an 84-day course to $84,000. It’s very expensive.”
Not to mention, the company had signed a deal with seven generic drug companies licensing them to sell generic versions of sofosbuvir and ledipasvir in 91 low income and least developed countries while preventing them from exporting the medicine to countries like China (30 million people with HCV), Brazil (2.6 million), the Philippines (1.9 million), Turkey (1.5 million), Thailand (1.4 million) and Mexico (1.1 million) and developed countries.
India’s HIV amendment bill has a crucial loophole
Patents, however, not the only problem that is worrying people with HIV/AIDS, and the organisation fighting for their rights. The government of India earlier this month introduced some crucial changes through the HIV Amendment Bill 2016, offering more privacy to people with HIV/AIDS. However, it left a crucial thing out: a guaranteed treatment.
Though the bill states that the state governments and the Central government will work towards creating an infrastructure offering diagnostics services while towards prevention of HIV/AIDS and offer treatment, the bill doesn’t make it mandatory on the government. And that, says Gangte, is worrying, especially when People with HIV/AIDS are heavily dependent on ARV drugs.
Currently, there are more than 30 different types of ARV — a first line, second line, and so on — and, the treatment changes constantly as the virus keeps developing resistance to the medicines. There are more than 1 million people receiving free medicine through ART centres in India, and without any guarantee to receive treatment, there’s a constant fear among those with HIV/AIDS.
“If you say that we will provide medicine as far as possible, you retain the right to withdraw treatment. This bill offers a legal loophole for the government and politicians to wash their hands off at any time. It is supposed to protect the people, but instead, it’s protecting the politicians and the government. The government must accept and confirm that it won't live us half-way. People with HIV/AIDS don’t need the treatment for just a month or a year, but through their lifetime. Once you start, you must continue, or you don't start at all,” says Gangte.
India’s weak intellectual property rights rules are termed as one of the reasons why foreign companies are not willing to come to India. But should trade take priority over lives? Especially, when they are already battling an incurable virus is a question worth pondering.