TWN Info Service on Health Issues (February 07/07)

17 February 2007

Former Swiss President joins call for Novartis to drop its case in India

More prominent figures have joined the chorus of over 300,000 people worldwide voicing concerns about Novartisí legal challenge against the Indian government and its impact on access to essential medicines across the globe.

They include the former Swiss President, Archbishop Desmond Tutu, Stephen Lewis former UN Special Envoy for HIV/AIDS in Africa, and Dr. Michel Kazatchkine, the head of the Global Fund to Fight AIDS, Tuberculosis and Malaria.

The following story is reproduced with the permission of South-North Development Monitor (SUNS) #6192, 16 February 2007.

With best wishes
Evelyne Hong

India: Former Swiss President joins chorus against Novartis' patent challenge
By Kanaga Raja, Geneva, 15 February, 2007

The former President of the Swiss Confederation, Ms. Ruth Dreifuss, has joined a chorus of over 300,000 people worldwide in voicing concerns about the impact that Swiss pharmaceutical company Novartis' legal challenge against the Indian government could have on access to essential medicines around the world.

Dreifuss joins other prominent public figures including Archbishop Desmond Tutu, former UN Special Envoy for HIV/AIDS in Africa, Stephen Lewis, and the new head of the Global Fund to Fight AIDS, Tuberculosis and Malaria, Dr Michel Kazatchkine, in calling upon the company to drop its case against India.

At a media briefing on Thursday, Dreifuss said that in attacking not only the decision of the Indian authorities concerning the drug Glivec but also the Indian Patent law of 2005, Novartis intends to impede not only this country but also all others to make use of the flexibility inscribed in the TRIPS Agreement. It is a tentative intimidation of which the consequences go beyond the Indian case.

Dreifuss, who was Swiss President in 1999 and later chaired the 2004-2006 WHO Commission on Intellectual Property Rights, Innovation and Public Health, was joined at the media briefing by the Swiss-based NGO Berne Declaration, Oxfam International and the international medical humanitarian agency Medecins Sans Frontieres (MSF).

The NGOs emphasized that Novartis is challenging the right of countries to have patent laws that put the interest of people first, and called on the company to cease its legal action.

Novartis is seeking to overturn India's refusal to grant a patent on the cancer drug that the company markets as Gleevec/Glivec, and is also challenging the provision in the Indian Patents Act of 2005 which formed the basis for rejecting the Novartis patent.

If the provision were overturned, patents would be granted far more widely in India, heavily restricting the production of affordable medicines that has become crucial to the treatment of diseases across the developing world, the NGOs said.

In other countries where Novartis has obtained a patent, Gleevec is sold at $2,600 per patient per month, while in India, generic versions of the drug are available for less than $200 per patient per month.

There are an estimated 9,000 patent applications waiting to be reviewed by Indian authorities of which most are believed to be modifications of old drugs. If India is made to change its law, many of these medicines could become patented, making them off-limits to the generic competition that has proven to bring prices down.

Dreifuss and the NGOs were speaking on the same day that a scheduled hearing of the case was taking place in the Madras High Court in India.

[According to an update posted by the Indian NGO Lawyers' Collective on a list-server, the Madras High Court on Thursday heard arguments on certain preliminary matters in the Novartis case.

[According to the Collective, Novartis India and Novartis AG had filed applications to amend their petitions to ask for a declaration from the Court that section 3(d) of the Indian Patent Act was not in compliance with TRIPS and that it violates Article 14 of the Indian Constitution, which prohibits discriminatory and arbitrary state action. The CPAA and the generic companies had opposed the applications to amend. They argued that compliance of Indian law with TRIPS could not be agitated before the Indian courts.

[The Court ultimately allowed the amendment of the petitions, but ruled that all of the objections mentioned would be noted and heard during the hearing. The parties were also given the opportunity to file affidavits on Novartis' amended petition challenging 3(d) on the ground of Article 14.

[According to the Collective, the hearing was adjourned until Friday - since there was a strike by lawyers in Chennai (because of an unrelated altercation and dispute between the police and one of the senior lawyers of the High Court). On Friday, another preliminary issue of whether Novartis may convert its challenge to the Patent Controller's order from a writ to an appeal will be decided. The scope for a writ petition before the High Court is limited.]

At the media briefing Thursday, Celine Charveriat, Head of Oxfam's Make Trade Fair Campaign, said that mobilization and concerns over the Novartis action is growing worldwide. Thousands of patients and activists are mobilizing in India and demonstrating in front of the courts.

It is time for Novartis to act ethically and responsibly and drop the case, she said, pointing to the precedent of pharmaceutical companies trying to intimidate developing country governments as happened in South Africa in 2001. When the companies saw the extent of the mobilizations, they decided to drop the case.

She expressed hope that Novartis will do the same.

Dr Tido von Schoen-Angerer, Director of MSF Campaign for Access to Essential Medicines, said that MSF relies heavily on medicines that are produced in India. Eighty percent of patients in its AIDS treatment programmes are dependent on medicines that come from India.

To illustrate the importance of having affordable generic medicines, he referred to a recent trip he made to China where he saw a young man who had advanced AIDS and had developed an eye infection. The only treatment that could save his eyesight was a drug manufactured by the pharmaceutical company Roche. It was patented in China and sold for $9,000 per treatment.

When he raised the issue of the high cost of the drug with Roche, it said that it provides the drug to least developed countries at $1,800 per treatment. But even that price, Von Schoen-Angerer said, was high.

"This is what we are facing when we say that we are dependent on affordable medicines," he said, adding that unless there is generic competition, the price differentials that are offered by the pharmaceutical companies are not the solution.

He said that the issuing of compulsory licenses is one way to ensure generic competition and to bring drug prices down.

He also said that he had met with WHO Director-General Dr Margaret Chan and called on her to support the cause for Novartis to drop its case against India.

According to the NGOs, many developing countries rely on affordable medicines produced in India, and such medicines constitute over half the AIDS drugs used in the developing world. India has been able to produce affordable versions of medicines patented elsewhere because until 2005, the country did not grant pharmaceutical product patents.

"We are increasingly seeing the tools we need to treat people being taken out of our hands," said Dr. von Schoen-Angerer. "We are unable to afford the new medicines we need and not enough is being developed for the diseases that mainly affect people in developing countries."

Because of the global implications of Novartis' legal action in India, Swiss organizations, led by the Berne Declaration, urged the company to drop its case in an open letter to Novartis CEO Daniel Vasella sent in October 2006.

The letter was endorsed by over two-dozen Swiss health NGOs including the Swiss Cancer League and Swiss AIDS Federation, as well as Swiss opinion makers, including Ruth Dreifuss.

"It is not acceptable that in order to sell its medicines at high price to a minority of wealthy patients in India and in other developing countries, Novartis is ready to worsen access to affordable essential and life-saving medicines for people in developing countries," according to Julien Reinhard, Health Campaign Director at the Berne Declaration. "This behaviour is not socially responsible. It's time for Novartis to act responsibly and drop its case in India."

Meanwhile, a group of church leaders also called on Novartis to drop its case in India. In a press release issued on 14 February, Archbishop Desmond Tutu said: "People, not profits, must be at the centre of patent law for medicines."

Rev. Dr Ishmael Noko, General Secretary of the Lutheran World Federation, said: "Novartis' proclaimed mission is to 'ease suffering and to enhance the quality of life.' But this case is not about prioritizing life. It has every appearance of protecting wealthy corporate interests at the expense of the health of millions for whom access to affordable medicines is a matter of life and death."

Bishop Yvon Ambroise of the Commission for Justice and Peace of the Catholic Bishop's Conference of India said, " How can Novartis justify asking for the right to patent changes to a medicine that brings no new benefit."

"We support practices that encourage and reward real innovation and progress in improving health of people in need. We condemn practices that trivialize innovation for the sake of maximizing corporate profits," he added.

According to MSF, India is the main supplier of essential medicines for developing countries, where 67% of medicines produced in India are exported to developing countries.

Globally, 70% of the treatment for patients in 87 developing countries, purchased by UNICEF, the International Dispensary Association, the Global Fund and the Clinton Foundation since July 2005 has come from Indian suppliers.