Generics debate; Drug firm lawsuit threatens access to medicines

By Jennifer Cohn

Pamela Ndalo is HIV positive; she has been taking antiretroviral medicines for 7 years. Pamela is like thousands of HIV-positive Kenyans whose lives are sustained by taking the generic HIV drugs.  A case being brought against the Indian government threatens access to generic medicines for Ms Ndalo and others like her around the world.

The final hearings of the have been taking place for close to a month now at the Indian Supreme Court in the case of Swiss pharmaceutical company Novartis vs. the Indian government over an anti-cancer drug used in the treatment of blood and intestinal cancers.

In 2006 the drug company Novartis took the Indian government to court over its patent law, in a move that threatened access to affordable medicines produced in India for millions of people across the developing world. The company wanted to get the law changed so that they could more easily extend the patents on their products, and stop generic companies producing the same medicines at a fraction of the price.

In the same year, India turned down the patent application from Novartis on the anti-cancer drug in question, imatinib mesylate, marketed by Novartis as Gleevec, because it did not meet the criteria to merit a patent.

When designing its patent law, India decided that only drugs that show an improved therapeutic effect over existing ones deserve patents. This part of the law –‘Section 3d’ – intends to prevent companies from continually extending their 20-year drug patents by making minor changes or improvements – a process called ‘evergreening.’

The current case is challenging the Section 3d that requires significant innovation in a medication to warrant a new patent. As in the case of Gleevec, no significant improvement has been made, other than an addition of salt to the existing drug.

Forward-thinking

This case has much broader implications than simply affecting access to an affordable generic version of this one medication. The decision of this case may affect the entire generic drug industry in India.

 India is often called the ‘pharmacy of the developing world’ because it produces affordable generic versions of medicines that are used the world over.

As a medical humanitarian organisation, Médecins Sans Frontières (MSF) relies on quality, affordable generic medicines made in India to treat more than 80 per cent of the 220,000 people in its HIV projects across 23 countries, and uses Indian generics to treat many other diseases and conditions.

In Kenya, MSF treats people living with HIV at projects in the Kibera and Mathare informal settlements of Nairobi as well as in Homa Bay.

Overall there are approximately 560,000 people currently taking HIV treatment in Kenya and the vast majority of those patients take generics made in India.

The impact of generic competition over the years has seen a significant drop in the prices of ARV medication. Between 2000 and now, competition among generic manufacturers brought HIV medicine prices down by nearly 99 per cent from Sh800,000 per person per year to roughly $150 (Sh12,000) today.

This price reduction has helped scale up treatment to millions of those infected. Given the Government of Kenya’s ambitious and forward-thinking plans to further revise HIV treatment guidelines to include additional groups such as pregnant women, access to a reliable supply of affordable generic medicines becomes even more important. 

The current court case Novartis as brought against the Indian government threatens access to quality generics and the affordable prices that come from generic competition.

If Novartis wins this case, Section 3d of the Indian Patent Law could be overturned, allowing drug companies to use evergreening techniques to greatly extend patents for any type of medicine, including HIV medicines.

Public health disaster

The end result is there will be an increased number and extended duration of patents, this will prevent Indian generic makers from producing generic versions of medications for HIV, high blood pressure, diabetes and other diseases. Millions of people in low- and middle-income countries like Kenya will lose their ability to access affordable life-saving medications.

The potential repercussion of this case cannot be understated.

Turning off the major supplier of generic medicines to countries that need to treat large epidemics of HIV, drug-resistant tuberculosis and cancer will amount to a public health disaster for Pamela and millions like her around the world. MSF urges Novartis to drop its lawsuit and recognise the importance of protecting health and life over expanding patent rights.

 

The writer is Médecins Sans Frontières (MSF) Policy Advisor, Access Campaign. [email protected]