Novartis’ ongoing law suit against the Indian government, which sees the company challenging the country’s patent law to protect its own profits, enters a crucial phase in Chennai this Thursday (15 February), when a verdict with huge implications for global health could be reached.
Although the case centres around a patent application for leukaemia drug Glivec, it has potential ramifications for millions of poor people worldwide. If Novartis is successful, the entire Indian generic drug industry, which is by far the biggest provider of affordable medicines for poor people, will be threatened.
At the same time, international development agency Oxfam, an outspoken opponent of Novartis’ legal action, has been targeted with more than 1,000 emails coordinated through the Max Foundation, a cancer organisation which is sponsored by Novartis.
Signatories of the emails, including doctors, cancer patients and patients’ relatives, were asked to express support for Novartis’ donation scheme, through which they are able to receive free Glivec. Their emails were then forwarded by the Max Foundation to Oxfam in what it believes is an attempt to deflect attention away from the wider implications of a Novartis victory in this case.
Jeremy Hobbs, Executive Director of Oxfam International, said:
“We realise that Novartis may not be aware of this campaign, which misrepresents the global weight of criticism against its actions, and diverts attention away from the real issue.”
“We are not – and have never been – opposed to Novartis’ donations programme, but such programmes can never hope to supply free medicines to all patients, for all diseases, throughout their lives.”
“If Novartis wins this case, countless medicines previously available cheaply to poor people will be patented and priced out of reach. The medicine cabinet will be firmly locked, and only companies like Novartis will hold the keys.”
India can legally refuse to grant patents for medicines on the grounds that they lack genuine innovation – a safeguard agreed by the World Trade Organization intended to stop the practise of ‘evergreening’, whereby a company can alter an existing medicine and then receive another patent, extending its monopoly and keeping affordable, generic versions of the medicine off the market.
India denied Novartis a patent for Glivec on these grounds, but instead of appealing only that decision, the company has gone much further and challenged the very constitutionality of the Indian law. If successful, Novartis’ actions could lead to a collapse of India’s entire generic drugs industry. For instance, there are an estimated 9,000 patent applications waiting to be reviewed by Indian authorities, of which roughly 7,000 are believed to be minor modifications of old drugs. If India is made to change its law, many of these medicines could be patented, and therefore off-limits to cheap generic competition.
Indian generic medicines are also critical to public health in other developing countries:
- India is the world’s biggest producer and exporter of generic medicines to developing countries, particularly in Africa, reaching millions of people;
- Around half of the essential medicines distributed by UNICEF in developing countries come from India;
- More than half the medicines now being used for AIDS treatment in developing countries come from India;
- 90% of anti-retrovirals used in Zimbabwe’s national treatment programme come from India.
The February 15 hearing goes to the heart of the debate around universal access to medicine: if Novartis wins its case, access to all of these vital affordable medicines for AIDS and other diseases will be jeopardized.
The Doha Declaration in 2001 recognized the right of all WTO members to use such legal flexibilities without fear of challenge. No country has challenged the legality of India’s law at the WTO. Moreover, the World Health Organization has said that ‘ever-greening’ is a threat to generic competition and has cited India’s law as an example of how a country could properly use the TRIPS flexibilities. In pursuing the case, Novartis is railing against this entire canon of international agreement.
The Novartis challenge comes at a time when the global pharmaceutical industry as a whole is facing difficulties. Patents on many blockbuster drugs are beginning to expire and not enough new medicines are in the development pipeline. Therefore companies are seeking to extend and protect their monopolies around the world in order to curb generic competition and maximize their profits on existing drugs.
Elsewhere, the Philippines is today (15 February) facing pressure from Pfizer not to use one of the TRIPS safeguards which allows Philippines to import cheaper versions of medicines to assess their safety and effectiveness. The aim of this process is to approve the medicine for sale early, so that it can be sold immediately upon patent expiration. If this assessment is not done prior to expiry of the patent, there can be a significant delay in introducing cheaper medicines of 18 to 60 months.
Thailand has also come under pressure from the United States and pharmaceutical companies for issuing compulsory licences for AIDS drugs (Efavirenz and Kaletra) and a drug for heart disease (Plavix).
“Novartis should be showing leadership in finding new solutions in a changing market place, rather than defending their vested interests and threatening the generic medicines that millions of people depend on,” Hobbs said.