This week, in a closely-watched case, an Indian court ruled that the country's gigantic pharmaceutical industry may continue producing cheap generic drugs for diseases like HIV/AIDS, malaria, and tuberculosis. The case stemmed from the Indian Government's rejection of a patent application submitted by the pharmaceutical company Novartis for its new leukemia drug, Gleevec.
Monday's decision is a major development in the ongoing and often contentious debate over pharmaceutical patents and their impact on access to essential medicines, which has pitted aid agencies and developing countries against large drug companies and the governments of high-income nations.
The ruling is particularly important because Indian generic pharmaceutical companies are not only major domestic suppliers, but also provide cheap medicines to many countries in Asia, Africa and Latin America.
The humanitarian aid agency Doctors Without Borders applauded the ruling, saying that it will ensure that India, the "pharmacy for the developing world," can continue providing medicines for millions of patients who could not otherwise afford them. Novartis, on the other hand, claimed that the decision would hinder innovation, and "have long-term negative consequences for research and development into better medicines."
Novartis v. The Government of India
In issuing its rejection, the Indian government asserted that the leukemia drug Gleevec does not differ sufficiently from earlier versions of the drug. Under current Indian patent law, pharmaceuticals must be either a new invention or offer a significant improvement on existing medications to qualify for patent. Novartis, however, maintains that so-called "incremental innovations" are a well-established component of patent law, and the Indian rejection of their application on these grounds violates both the Indian Constitution and the country's World Trade Organization obligations.
Intellectual Property and Public Health
The ruling was an important one for India's leukemia patients, who pay only $260 for a one-month supply of the generic version of Gleevec, compared to $2,600 for the patented one.
However, this particular battle took on greater significance because a victory for Novartis in the Gleevec case would have set an important precedent preventing the production of many other generic medicines, greatly reducing the $5 billion Indian pharmaceutical industry's ability to supply aid agencies and low income countries with many of the drugs on which they rely. Doctors Without Borders for example, gets 84 percent of the HIV/AIDS drugs it distributes in its developing country clinics from Indian generics suppliers.
As the charts below illustrate, hundreds of millions of people worldwide lack the medicines they need. An inordinate number of them live in developing countries, and there are fears that if the deep price discounts offered by generics disappeared, this entirely insufficient level of access would erode even further.
Distribution by country income group of people without access to essential medicines, 1999
Distribution by country income group of people without access to essential medicines, 1999
The issue of drug patents is particularly relevant to the HIV/AIDS epidemic. AIDS is having a disproportionate impact on developing countries, which lack the means to provide life-saving treatment to their infected citizens.
According to the United Nation's Millennium Project's "HIV/AIDS, Malaria, TB, and Access to Essential Medicines, Working Group on Access to Essential Medicines" report, there are many causes for lack of access to essential medicines, including poor health system infrastructures, insufficient funding, and lack of research and development into diseases that primarily affect developing countries. However, the UN Working Group also cites high drug prices due to patent protection as another major barrier to access.
A Global View of HIV Infection
Source: UN Aids, 2007
In addition to India, Brazil and Thailand have also recently overriden patents in order to secure cheaper medicines for their populations. However, striking a balance between providing incentives for research and innovation and ensuring that essential medicines are available for all who need them continues to prove elusive.
Until these tensions are resolved, millions of people will continue to go without the medicines they need to survive.
Related Links:
MSF's Access to Essential Medicines Campaign
Institute for One World Health - Innovative Not-for-Profit Pharmaceutical NGO
EarthTrends
EarthTrends Data: HIV/AIDS variables
