Licensing deal threatens cheap pharmaceuticals

Stella is four, and lives on HIV drugs. Next week, the EU may cut her supply.

Stella's life is in the balance. She was born, four years ago, HIV-positive. Her mother, Rebecca Mbabazi, 23, only discovered – like so many mothers in Uganda – that she had the virus when she was already pregnant.

Mother and daughter live in the verdant hills on the edge of Bwindi Impenetrable Forest in the remote west of the country. It is famed for mountain gorillas but during the 1990s became infamous for lethally high rates of HIV/Aids infections.

Like most little girls, Stella doesn't much like pills – she pulls a comic face when they are mentioned – but she takes them anyway, twice a day. They save her life. But for how long? If the European Union has its way, the supply of cheap drugs on which Stella depends could be cut off.

A collection of plastic bottles on the sideboard in the gloomy back room of her grandmother's house contains her life-savers. They are antiretroviral drugs (ARVs) that suppress the HIV virus and boost her immune system, slowing the onset of full-blown Aids. The brand on the pill bottles is not a household name. "Aurobindo" is one of the unheralded, generic drug producers in Hyderabad – an Indian city at the centre of a pharmaceuticals revolution that has saved millions of lives in places such as Bwindi and across Africa. In the past decade, companies such as this, mass-producing generic copies of Western drugs, have turned India into the "pharmacy of the developing world" and helped to bring affordable, high-quality medicines to many of the areas of greatest need.

More than 80 per cent of ARVs bought by donors for use in Africa come from India. Since 2003, the average cost of treating an HIV patient has fallen from nearly $500 a year to $70, says the International Aids Society. Since 2001, Indian generics have provided antiretroviral treatment for 4 million HIV-positive people in the developing world. They are the reason Stella is alive, and that she still has a mother and brother. But this remarkable progress is under threat.

Half a world away, the EU is preparing for trade talks with India in Brussels next week. Among the reams of small print are several clauses that seek to protect the intellectual property rights and commercial interests of European pharmaceuticals giants. If the deal is agreed, it would create a new patent-like barrier which threatens the flow of cheap, life-saving medicines to children like Stella.

The clause causing most concern is "data exclusivity", which would effectively block Indian producers from registering copies of foreign drugs, including those not protected by the existing patents system. This would mean delays of up to 10 years in delivery of generic versions of new, improved medicines and up to 15 years in the case of paediatric versions of the same drugs.

Médecins Sans Frontières (MSF), which treats hundreds of thousands of patients in the developing world, is campaigning against the changes and demanding talks with the EU. "It is a case where profits are coming before lives," said Dr Unni Karunakara, the MSF president. "We are talking about real lives. They may be hidden away in remote areas but they are real. There are millions of lives depending on these cheap drugs, so we're saying hands off our medicines."

He warns that "data exclusivity", and clauses that could see safe generics seized and destroyed as counterfeits at EU ports, will "criminalise" vital medicines and drive up costs for Indian manufacturers. Those costs would then drastically hit the ability of doctors in poor countries to offer free treatment.

EU officials insist the changes will not affect India's ability to export affordable drugs. "My position, and that of the EU, is very clear," Karel De Gucht, EU Trade Commissioner, said. "We are negotiating a free trade agreement between the EU and India. Any agreement will have no impact on the right or the capacity of India to produce generic medicines." But MSF is sceptical about those promises.

The implications of these talks will travel the thousands of miles to Uganda's capital, Kampala, and the 12-hour drive over rutted roads to where Stella and her family live. It was in places like Bwindi that rumours of a terrifying new disease, known locally as "slim", started to be heard in the late 1980s. Its victims wasted away, often dying behind closed doors, imprisoned by stigma. At its height, a quarter of Ugandans were infected.

Dr Richard Kazibwe, who runs the Aids programme at Bwindi Hospital, grew up in what he calls the "HIV generation". "When I was a kid I lost close relatives to HIV," he says. "People were dying like nobody's business and dying in a horrible way – slim to the bone."

The doctor, 28, says free ARVs made possible by cheaper drugs, and a US-led surge in donor funding, brought about a "transformation". "People's attitude to HIV is changing. They know that if you come and get tested you can get treated, but this is recent. When you had HIV in the 1990s,people would just forget about you."

Across Uganda, the roll-out of life-saving drugs has helped to bring infection rates down to below 7 per cent. Serious challenges remain and, after five years of historically high spending by the US and other donors, HIV funding has flatlined this year. The global financial crisis is hitting budgets and that already means intermittent supplies of ARVs at Bwindi.

Yet there is another big problem. Even if existing drugs keep coming at the same price, Dr Kazibwe explains, they will not solve the crisis. Growing numbers of patients on long-term courses of ARVs are developing resistance to the drugs. In the West, the failure of "first line" regimens is solved by switching to second or third line alternatives. A stream of new treatments helps HIV victims in the rich world to stay ahead of the mutating virus.

Dr Kazibwe points to a battered chart on the wall showing the dozen or so drugs that make up his dwindling arsenal. He draws a line through about a half dozen to show those which are no longer available or no longer work. "New mutations of the HIV virus are coming and if generic producers are blocked the whole battle against Aids will be lost," he warns.

Hope Tukahirwa, a voluntary Aids worker, is living proof of the ARV miracle. She is 47 and HIV positive. It is 11 years since her husband died of Aids and seven since the disease killed her son, Brian. It was only after her little boy died that she got tested. "Before, I was afraid to take the test as I thought that would mean I would die faster," she says. "I thought that if people knew they would ignore me or hate my kids."

Her three surviving children were nearly orphaned. She became seriously ill four years ago, just as treatment was becoming more widely available. "It changed from bad to good," she says. "I don't get sick very often any more. The only stress I have is finding money for school fees."

With income from a small farm, Hope managed to put her twin daughters, now 20, through school and into university. She admits "it is not easy" but says her children are her hope. She worries that the ARV drugs will stop coming. "In the old days, people were dying like rats. The drugs were too expensive and if it happened again we would be back in the old days."

Muhumuza Gervis, a teacher, was a skeleton on the edge of death when he began taking ARVs. He and his wife, who is also HIV positive, support six children. He remembers first hearing about miracle drugs that were keeping rich Ugandans alive in Kampala. But there was no way even at a "fair price" that a teacher could afford them.

"If the ARVs are not free there will be no way of surviving," he says. After four years, Muhumuza's drugs are no longer working. He is one of a growing number of drug-resistant patients at Bwindi. Any delays in the flow of cheap new drugs will be a death sentence for him and many thousands like him.

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