LSIPR 50 2018: Levelling the medicines playing field

Generic production in India has become vital to the supply of quality and affordable medicines to people in the developing world. But with a population of 1.3 billion people, and many living in poverty, India is a country where many need, but don’t have, access to medicine.

Médecins Sans Frontières (MSF) set up the Access Campaign in 1999, shortly after the non-governmental organisation (NGO) was awarded the Nobel Peace Prize for its pioneering humanitarian work in more than 80 countries. The campaign works to improve access to, and the development of, lifesaving and life-prolonging medicines, tests, and vaccines.

Leena Menghaney, regional head of the Access Campaign, is a lawyer by training but her role at MSF also involves policy development and campaigning. Her day-to-day work is varied but the objective is clear: to make sure as many people as possible, all over the world, have access to the medication they need. In that sense, she says, her work is very “futuristic”.

A large problem, particularly in India, is the affordability and exclusivity of drugs. Menghaney explains that it’s important to have a balanced IP policy to foster healthy generic competition; she describes her work as “the daily grind of access” insofar as all her efforts point towards wider drug availability.

“The danger of having a completely lopsided IP policy is that you could quickly cut down competition and affect millions of lives,” she warns, as the people who need drugs aren’t able to access them due to their cost. With generic competition this problem is minimised, she claims.

On one hand, MSF is working drug by drug, trying to get patented medicines into the public domain so that they can be mass-produced and widely accessed. On the other hand, there is a much larger framework to consider in terms of life sciences developments and public health considerations.

Menghaney explains that India is “constantly pressurised” in relation to its IP policy from organisations such as the World Intellectual Property Organization, the US government, the European Union and national trade representatives.

“India is the place where people like to give advice to the government” but MSF is able to present a more neutral position than most, she adds. MSF works with “everybody,” Menghaney says, but one thing it refuses to do, is accept funding from pharmaceutical companies.

“We are independent and neutral,” she says. “Our funding is independent and we will not be influenced.”

When considering which patents to oppose the NGO bases its decision on medical priority, “by seeing what affects people the most”.

Indian patent law

MSF’s Access Campaign played an instrumental role in campaigning for the inclusion of public health safeguards in India’s Patent Amendment Bill 2005. “India’s patent law was something that would protect generic competition and promote access worldwide; we wanted to defend it,” Menghaney explains, to ensure it remained that way.

The law extended patent protection to pharmaceutical areas not previously covered by patents in India: it allows patents to be granted for entirely new medicines, meaning that Indian generic manufacturers cannot develop more affordable versions of the drugs.

MSF was keen to ensure that people in the developing world, in need of medicine, did not get priced out of the drug market by patent-owning pharmaceutical companies; however, following the introduction of the 2005 bill, those needing access to medicines must rely on the use of compulsory licences by governments to allow generic production and competition.

Nevertheless, Menghaney says, MSF was successful in securing some public health safeguards in the new law. For example, the bill made it possible for Indian generic companies to continue producing drugs they had already marketed at the time of the new law, even if a patent were to be awarded to another company later.

It also allowed anyone to challenge a patent application pre-grant, to prevent patent owners from creating a monopoly by filing for new patents when the initial one expires. This element of the bill was tested in a landmark lawsuit brought by pharmaceutical company Novartis at India’s Supreme Court in 2009, following multiple appeals before the Madras High Court in the three years prior to that.