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.

“MSF stood by the new law when Novartis challenged the Indian IP Office’s refusal to grant a patent for Glivec (imatinib), a blood cancer drug, in 2005, on the grounds that it was a modification of an existing drug rather than a new invention,” Menghaney explains. The case reached India’s Supreme Court in 2013; it held that Novartis had failed to prove improved therapeutic efficacy.

“Ultimately big pharmaceutical companies want the blockbuster model where they earn millions of dollars from a few bottles of medicines or a few vaccines,” she alleges, whereas MSF would rather promote medicines which have the potential to save millions of lives in developing countries.

Is MSF about to file any patent oppositions, and does it have a close eye on anything in particular? “Absolutely. A close watch is kept on a lot of diagnostic drugs and vaccines, and MSF will continue to challenge patents when necessary,” she says. “We must complete the work we started.”

Patent searching

A core project the Access Campaign has supported is MSF’s patent opposition database. The database allows anyone to search for patents in every jurisdiction and, with the tutorials provided on the website, learn how to file an opposition.

“It’s not just expensive to challenge patents, it’s technical and scientifically challenging too,” she notes.

In particular, the online database draws attention to the fact that many medicines protected by patents are not truly ‘new’ and, if challenged, will likely be deemed unpatentable. Typically, the medicine then becomes more affordable and accessible, says Menghaney.

“The whole idea of the database was to bring about more transparency around patents,” she explains, “by putting vital information in the public domain for people to share and collaborate.”

The need for teamwork

Given MSF’s support for generic medicines and patent oppositions, many might assume that the organisation is not a fan of innovation. Menghaney says that this couldn’t be further from the truth—MSF thinks about innovation, and how to address unmet needs for treatments and cures, “very seriously”.

MSF funds research into drugs for neglected diseases, while a current MSF project centres on researching solutions for diseases such as tuberculosis.

However, more institutional reforms need to be undertaken to stimulate innovation, she cautions, and governments need to work together and pool their resources to achieve reform.

Many countries have domestic goals for research and development but Menghaney says what is really needed is teamwork. Addressing public health concerns is such a big challenge and individual countries are not able to solve the problem on their own, Menghaney explains.

“Research and development is looked at from a nationalistic point of view, rather than dealing with international need,” she continues.

“Ultimately, public health needs to be prioritised. By pooling money, priorities, findings, and infrastructure, governments can yield better results. MSF is working with governments to support conversations seeking a solution on an international level to global challenges.”

Menghaney believes that by reforming the global IP system, innovation and access will surely follow.

“It’s not just about delivering medicine, but finding a solution to the wider need for innovation and drug development,” she concludes.