The days of cheap treatments for millions of AIDS patients around the world are coming to an end, health agencies warned on Tuesday, after the Indian parliament passed a bill that makes it illegal to copy patented drugs.
The practice of copying patented drugs has made medicines affordable for patients around the world. The parliament's move was to fulfil India's commitment to the WTO's intellectual property regime.
The copycat drugs industry in India has forced down the annual cost of AIDS treatment from US$15,000 a patient to a little more than US$200 in less than 10 years.
The country's "generics" pharmaceutical industry now provides treatment to half the 700,000 HIV-infected people in developing countries.
The supply of cheap medicines was only possible because Indian law hitherto had no product patent constraints.
Critics say the new law will cut off the pipeline of inexpensive future drugs, such as the "three-in-one pill" of anti-retrovirals for AIDS sufferers.
"Under the new legislation we will see new medicines only available for the rich, while old treatments will be for the poor," said Ellen't Hoen, the director of policy advocacy and research at the relief agency Medecins sans Frontieres.
"Many people are building up resistance to the first generation of drugs and will need the newer treatments. But without the Indian drugs industry, where will they get cheap drugs from?"
Campaigners say African countries, where health budgets are already stretched. will find it almost impossible to fund the new medicines.
"In Cameroon we pay US$200 a year for each Aids patient's treatment, which is an Indian generic manufacturer's product," said Fatima Hassan of South Africa's Treatment Action Campaign. "The latest drugs are only supplied by western multinationals and they cost US$4,800 a year. We cannot afford those prices."
Under the legislation, if a generics manufacturer wants to copy a patented drug, the Indian government will have to issue a compulsory licence.
The patent holder gets a royalty, but does not have to consent.
But, Hoen says, there are two big problems with the new regime: pharmaceutical companies can tie up such licenses in court for years, and there is no ceiling on royalties.
"In South Africa, Glaxo tried to charge a 45 percent royalty. What we are looking at is a lot of work for lawyers."
Activists were hoping for a review of the bill and a longer public debate on the issues -- Indian MPs were given only a weekend to read the bill and a couple of days to debate it.
Although there were last-minute concessions, many within the industry say the bill bears the footprint of multinational drug companies who considered Indian generic manufacturers to be "pirates."
Ranjit Shahani, managing director of Novartis India, said: "[The bill] will move India towards the patent mainstream and support and encourage innovation and investments in research and development."
Many in the generics industry say what is being given away goes against the national interest. Yusuf Hameid, the head of Cipla, one of the main generic manufacturers of HIV drugs, says India can "not afford monopolies."
He added: "Medicines in India used to be unaffordable until we adopted our patent laws in the 1970s. Our population and pattern of diseases means we have to increase affordability and accessibility."
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