India, Thailand and Philippines Face Court Challenges to Affordable Medicines
Pharmaceutical companies are now embroiled in three high-profile disputes over patents that could have a devastating effect on poor people’s access to affordable medicines, says international agency Oxfam.
The companies Novartis, Merck and Pfizer are challenging moves by India, Thailand and the Philippines respectively to use the public health safeguards in World Trade Organization (WTO) intellectual property rules to produce generic versions of patented medicines.
‘Poor countries are seeing their efforts to make medicines affordable undermined by Big Pharma’s army of lawyers, just as occurred with Canada’s legislation to allow exports of generic drugs, said Robert Fox, executive director of Oxfam Canada.
‘These three countries have taken important steps to use public health safeguards to reduce the price of medicines. They should be applauded, not bullied, said Celine Charveriat, head of Oxfam’s Make Trade Fair campaign.
See notes on cases below.
In a statement prepared for Oxfam, author John le CarrÃ© said yesterday:
‘Here is what I wrote five years ago in the Afterword to The Constant Gardener:
‘As my journey through the pharmaceutical jungle progressed, I came to realize that, by comparison with the reality, my story was as tame as a holiday postcard.
The reality today is worse. By imposing one-to-one deals on individual governments, Big Pharma is dishonoring hard-won international agreements designed to allow lifesaving generic drugs to be produced and marketed in countries where there is urgent and demonstrable need. The present posture of Novartis in India is a classic example of Big Pharma’s unbeautiful priorities. With unlimited legal resources Novartis is challenging India’s sovereign right under international law to supply cheap, non-patented drugs in situations where the public health is at risk. If the case succeeds, Novartis will have protected the health of its account books at the expense of those who will die because they can’t afford the drugs that could save them.
‘Since India is the main supplier of inexpensive medicines to the developing world, a victory for Novartis will also curtail access to affordable medicines in Africa and Asia as well, Charveriat added. ‘The only proven and sustainable way to get affordable medicines to people is by competition from generic producers.
Notes to editors on the three cases
Last week Thailand issued a compulsory license for efavirenz, a vital antiretroviral (ARV) for HIV. Merck sells efavirenz for $41 per patient per month while the generic equivalent costs $22 per patient per month. The compulsory license would temporarily override the patent belonging to Merck and enable Thailand to import generic efavirenz from India, while Thailand develops its own generic version. Since 2002 Thailand has used generics to slash the cost of HIV/AIDS drugs and become a world leader in treatment, with over 85,000 people getting ARVs – but the country now needs cheaper generic equivalents of new patented ARVs to continue treating those patients using the medicine and extend free treatment to new patients who need it.
However, Merck is resisting the compulsory license and has offered instead to discount prices or give a voluntary license. Oxfam says that neither option guarantees Thailand the sustainability or control to continue its successful HIV/AIDS program. Generic competition played an important role in reducing the price of first line ARV medicines from $10,000 per patient per year to $130 per patient per year. Although entitled, countries have rarely used compulsory licenses because pharmaceutical companies and rich countries, particularly the US, have promoted strict intellectual property protection in developing countries.
In the Philippines, Pfizer has taken the government to court in a bid to extend the monopoly protection on its hypertension drug Norvasc. Pfizer earns $60 million a year in the Philippines selling Norvasc at more than twice the price it charges in other countries – even though heart disease is the country’s number one killer and hypertension is a major cause of heart problems.
The Philippines imported a cheaper patented version of Norvasc from India in order to approve it for sale immediately upon the expiry of Pfizer’s patent in 2007. This would reduce the price by at least 90 percent. Despite this being legal under Filipino law and international trade rules, Pfizer sued the government in March this year, including asking for damages.
If Pfizer wins, it would introduce far higher levels of patent protection in the Philippines and encourage other pharmaceutical companies to file lawsuits to protect their patents and block generic competition. Pfizer says that it can discount the price of Norvasc in the Philippines by half, but this would mean the medicine would still be more expensive than the Indian-made versions. Four patients who will be denied access to Norvasc if Pfizer wins have now launched a civil action.
In India, the government is being taken to court by Novartis. The case began in 2005 when local cancer patient groups used Indian public health safeguards successfully to stop a patent for Glivec, a blood-cancer drug. This allowed Indian companies to continue making generic versions at $2,700 per patient a year, as opposed to Novartis having a monopoly priced version for sale at $27,000 per patient a year.
However, Novartis recently appealed and challenged India’s right to interpret intellectual property rules in a way that protects the public health of its citizens. This could jeopardize India’s generic industry, for both domestic use and export to developing countries. If Novartis wins, it would result in patents being given for drugs that are merely small modifications of existing ones, and stop generic competition.