Why Indian Generics are Fundamental to Access
Why MSF relies on generic medicines from India
Médecins Sans Frontières Access to Medicines Campaign
Carmen Jose-Panti is 35 years old. She lives with her husband and her two children in Tete, Mozambique. She runs a small business from home selling domestic items like soap and salt, and attends night school.
A mother, a wife, a business owner, a student and a community member, Carmen is also HIV positive.
Having discovered she was infected with the virus in 2007, Carmen started antiretroviral treatment in 2009. Carmen is alive, healthy and able to contribute to her community because she takes generic versions of HIV medicines (antiretrovirals) made in India.
Carmen is one of more than 230,000 people worldwide living with HIV that receives treatment through MSF HIV programmes. A recent survey of the drugs MSF purchases for its field programmes shows that 97 percent of the drugs MSF uses to treat people living with HIV are generic medicines from India. It’s not just medicines for HIV that MSF turns to India for; more than three quarters (77 percent) of the medicines MSF uses to treat more than 23,000 people with TB, and nearly a quarter (22 percent) of the medicines used to treat 2.1 million cases of malaria are generics from India.
India delivers affordable medicines to the world
India is often known as the ‘pharmacy of the developing world’ for the amount of affordable generic medicines it supplies to developing countries – to people like Carmen in Mozambique. Generic medicines, cost a fraction of the monopoly prices charged in countries like the United States, and competition among Indian manufacturers has reduced the price of cancer and HIV treatment by as much as 90 to 1000 percent. For example, first line HIV treatment that costs over USD24000 annually to treat just one patient in the US, costs the Indian AIDS programme approximately USD 100 per patient.
India’s pro-public health approach to patents
How did India take on this role? While other developing countries had patents on medicines – resulting in market monopoly for over 20 years – India waited and didn’t introduce patents for medicines until 2005 – the WTO deadline. In 2001, three antiretrovirals to treat HIV were priced at over USD10,000 per patient per year. Millions of people living with the disease in Africa and other parts of the developing world died. Indian generics companies like Cipla then started producing a single pill containing three HIV medicines for just under one US dollar per day.
When WTO obligations forced India to start examining patent claims on medicines, lawmakers it did so in a way that what merited a patent had to meet strict criteria – weeding out weak claims – on new use and new forms of known medicines. Indian lawmakers also introduced other pro-public health provisions like compulsory licensing that would allow for the generic supply of patented medicines.
Without patents on many life-saving medicines before 2005, and subsequently a tough patentability criterion for pharmaceutical companies with safeguards against abusive practices such as ‘evergreening’, India’s generics industry developed and was able to produce medicines at prices significantly lower than the ones marketed by the multinational pharmaceutical companies. Today 16 million people – including Carmen – are receiving HIV treatment, the vast majority with Indian-produced generics. Today, standard HIV treatment with safer medicines continues to be affordable at around USD100 per person per year. Large-scale treatment of HIV with antiretroviral (ARVs) drugs has become a reality.
India’s generics under threat
But the laws and policies that enabled India to become the generics-producing powerhouse it is today, upon which millions of people rely, are constantly under attack.
The attacks on India’s production of generics started a few years ago, but have been growing.
India first came under pressure from major pharmaceutical companies like Novartis. In 2006, after being denied a patent on a crystalline form of the cancer drug imatinib in India, Swiss company Novartis filed a challenge on a part of India’s patent law, which would have dramatically impacted India’s ability to produce generics, as it would have been obliged to grant more patents on new forms of known medicines. The case lasted seven years and went all the way to India’s Supreme Court, but in April 2013, Novartis lost the case and India’s patentability criteria remained intact.
More recent efforts include the European Union negotiating a free trade agreement with India – seven years in the making and ongoing – in which the EU has pressured India to accept provisions that would severely curtail India’s supply of generics. While many of the worst provisions have been successfully negotiated out of the agreement following strong pressure from groups of people living with HIV and other diseases, as well as MSF, several still remain.
A further trade agreement involving countries across Asia – the Regional Comprehensive Economic Partnership – has wealthy countries Japan and South Korea pushing developing countries, including India, to introduce provisions that go beyond international trade rules and would provide more ways to block registration and supply of generic medicines.
Intense bilateral pressure has also come from the United States in recent years, with its pharmaceutical industry pressuring India’s officials to bring its IP policies and laws into line with standards seen in the US. So far, much to the frustration of the multinational pharmaceutical lobby India has resisted these calls to change its policies and laws.
Global health depends on Indian generics
Relying so heavily on generic medicines from India – they make up nearly a third of all the drugs MSF procures to treat HIV, TB, malaria and infections – MSF, through its Access Campaign, keeps a close eye on these developments in the country. Should the laws change, it would mean that needed newer generations of drugs wouldn’t be available as generics, leaving us being able to afford to treat far fewer people. It could also stop paediatric versions and combinations of medicines – which make treatment for our patients and the work of our medical staff much easier – from being produced. It would mean that in the future, our medical staff wouldn’t be able to provide the level of care that patients like Carmen deserve.
Leena Menghaney is a lawyer activist and South Asia Director of the Access to Medicines Campaign of Médecins Sans Frontières (MSF). MSF is an independent, international humanitarian medical organization.