Novartis denies access to generic medicines to poor countries

According to the WHO, 30% of the world's population still do not have regular access to essential medicines. 74% of AIDS medicines are still under monopoly (under patents) and 77% of Africans still have no access to AIDS treatment. There are many reasons for this, however generic competition is essential in bringing the prices down and ensuring access to medicines for all.

“Access to medicines in developing countries relies primarily on affordable generic versions of patented medicines. Novartis' court action directly threatens the ability for developing countries to access these medicines for their people” said Julien Reinhard, director of the Health Campaign at Berne Declaration.

The Indian legislation attacked by Novartis allows local companies to sell generic versions of the Novartis' cancer drug, Glivec®. Glivec® is 10 times more expensive than its generic equivalents. The Novartis Court action will have a much wider impact on other vital drugs for developing countries such as medicines for AIDS. It will also have an impact on developing countries that import generics from India. If Novartis is successful, it could jeopardize India's generic export industry. India is the world's leading exporter of generic medicines, with 67% of its exports going to developing countries.

According to Rolf Marti, director of the scientific secretariat of the Swiss Cancer Association: "Our objective is clear: all patients should have access to the most efficient medicines against cancer at affordable and socially acceptable prices. The behaviour of Novartis in the case of Glivec® in India goes in the opposite direction. Therefore, togethe with other organizations we are opposing the claims from Novartis."

In May 2006, Novartis took two cases to the Indian Courts to challenge a previous decision that rejected its patent application for Glivec®. This was a direct challenge to India's right to interpret the WTO TRIPS Agreement to protect public health. In a letter to Novartis, 52 eminent personalities and organizations from all over the world demanded that Daniel Vasella, CEO of Novartis, drop these actions in the interest of public health. To this day, Novartis has yet to respond to this letter.

“The Novartis case calls into question India's right to utilize the WTO TRIPS flexibilities which ensure better access to medicines for all.” said Céline Charvériat, Oxfam's Head of Make Trade Fair campaign.

Novartis court action challenges section 3(d) of Indian patent law that defines the scope of patentability of a new form or new use of an already existing substance. This law is in line with the TRIPS flexibilities available for developing countries to use in their own national legislation. To this day, no WTO Member State has contested these flexibilities. A WHO Commission, led by Ruth Dreifuss, reckoned this legislation was a good way to implement TRIPS flexibilities.

“If Novartis' challenge against the Indian patent law is successful, a key safeguard that can ensure the production of affordable medicines will be lost,” said Ellen't Hoen, Policy Director at MSF's Campaign for Access to Essential Medicines. “People the world over who rely on India as a source of their medicines may be affected if Novartis gets its way.”