How the world's drug firms sacrificed profits in the battle against Aids

Being handed an HIV-positive diagnosis is no longer a death sentence in the West. HIV/Aids, though a chronic illness, is manageable. With varying combinations of antiretroviral drugs (ARVs) and careful monitoring by the medical profession, an HIV/Aids patient can expect to live for many years.

Yet in the developing world the picture is entirely different. Communities are being wiped out and economies destroyed. In Sub-Saharan Africa, where 25.3 million people are estimated to have been affected, life expectancy, which had risen from 44 to 59 between the 1950s and 19902, has dropped back to below 45.

Wind back six years and the big pharmaceutical companies were being blamed for the chaos brought on by the onslaught of Aids in the developing world.

There was a siege of bad publicity. The public couldn't understand why highly profitable drug companies were allowing millions to die because they insisted on upholding their patents and wouldn't give away free drugs. By not allowing poorer countries to make cheaper generics of AVRs, they were accused of having blood on their hands.

Drug firms argued that giving away free drugs was detrimental. It takes a massive $800m and 10 to 15 years of research and development to get a drug to market. If firms do not make a profit from their products, research and development (R&D) dries up and there are no more developments for the greater benefit of mankind. It is vital for the survival of a company that intellectual property is protected.

As Richard Ley, a spokesman for the Association of the British Pharmaceutical Industry, says: "It would be easy for us to dump lots of medicine and say we have done our bit but that is no going to solve any problems."

One pharmaceutical analyst pointed out that if you give drugs away for free you are faced with the problem of "flowback". "If you have free access to HIV treatments it can find its way into other markets pretty quickly," he said.

Jon Pender, the director of government affairs access issues and intellectual property at GlaxoSmithKline, the UK's largest drug company, formed from the merger of Glaxo Wellcome and Smithkline Beecham in 2000, said the tie-up between the firms came at the time of the highly politicised debate on Aids, when the drug firms were being demonised. It was an opportunity to change tack.

The new chief executive Jean Pierre Garnier decided GSK was not going to focus on the world's richest nations. The industry's reputation had suffered but also the business model needed to be protected. So what solutions did the major drugs firms come up with?

In 2001, seven firms - GSK, Abbott, Merck & Co, Bristol-Myers Squibb, Roche, Gilead Sciences and Boehringer Ingelheim, joined forces with the UN to look at ways in which they could bring prices down in the developing world. Mr Pender said one step forward was the decision to sell drugs to developing countries at "not-for-profit" prices.

Further reaching still was the creation of a system of voluntary licensing, where companies were given the know-how to create AVRs without the need for a patent. GSK has so far granted seven voluntary licenses, including to Aspen Pharmacare, Africa's largest manufacturer of generic drugs.

"The need was so great out there that enabling more companies to supply these products, the better," Mr Pender said. "The firms see this as a commercial activity. They want to do something to improve the situation in Africa but it is a commercial opportunity."

However, having cheap AVRs does not solve HIV. What makes it different from other chronic yet treatable diseases is that strains of the virus become resistant and new drugs need constantly to be developed, fuelling the need for more money for R&D.

ARVs work by blocking viral replication within existing cells at different stages in the life cycle of the virus. Although US firm Merck & Co is the closest to a vaccine and is about to begin stage-three trials, this is still 10 to 15 years away. The pressure remains and the research continues. Just this week, a small Australian biotech, Virax, which has been working on vaccine development for 20 years, announced it has agreed funding with eight international mining companies, including BHP Billiton and Rio Tinto, for trials which will take place in South Africa for it's a HIV/Aids therapeutic vaccine.

The proposed trial will involve 140 HIV-positive subjects in five established HIV clinics. The chief executive of Virax, Dr David Beames, said: "The totally new and innovative funding model for the product development has enormous potential for application to a whole range of other diseases of the emerging/developing world that would otherwise be ignored.

"Southern Africa is the epicentre of the HIV pandemic. The sooner trials/drug development commences here the sooner it could, if successful would become available as a treatment."

Dr Vinh-Kim Nguyen, from the Department of Social and Preventive Medicine at the University of Montreal, who visited London this week to give a lecture at UCL, in the run-up to World Aids Day, said: "It is not the drugs companies that are the problem. They have to make money for their shareholders and provide drugs where there are markets and they do that well. The problem is when it comes to comes to global public health, there is no market for drugs for poor people."

Dr Nguyen argues that the whole structure and the way we deal with healthcare in the developing world needs to be rethought. Debt relief would go some way to solving the funding issue, he said.

"The real problem is governments," he said.

The most recent report from Unaids and the World Health Organisation revealed that the total number of people still infected stand between 34 millionand 47 million. In Asia and Central Europe new infections has risen by 70 per cent in two years. And although new infection rates are levelling out in some countries, such as Lesotho, in Uganda where the epidemic had been brought under control, rates are rising again. Some say this is due to a shift in American government policy away from giving out free condoms to promoting abstinence.

Justine Frain, from GSK's Community Partnership programme, says that a key aspect of the drug industry's response to the Aids crisis is providing funding to voluntary organisations that work on the ground. Stigma and discrimination are massive barriers to people getting tested. There are cases of HIV positive mothers continuing to breastfeed their babies as they do not want the community to know they are HIV positive, she said.

GSK works with NGOs across 20 countries and has spent £70m in 11 years on community projects. "This is a key aspect of GSK's response to Aids," Ms Frain said. "It is to support communities to help themselves."

Sine 2000, the global drugs industry has donated £2.5bn to the developing world to help treat 539m people through various projects.

Mr Ley, from the ABPI, said the fight against AIDS in poorer countries is made so much more difficult due to the lack of infrastructure, education and basic facilities. Malnutrition, the lack of clean water and the prevalence of TB and malaria compound the misery and ensure that once HIV takes hold, a victim can succumb far more quickly that in the west.

"To ensure that patients receive treatment the infrastructure needs to be there," Mr Ley says. "This is not something we can solve by ourselves as an industry. It can only be done in partnership."

The Aids pipeline

* There are 77 HIV/Aids medicines and vaccines in clinical trials or submitted for approval in the US alone

* Eighty-eight HIV/Aids medicines registered already, including 22 ARVs

* Nineteen vaccines are in the pipeline

* It costs $800m to develop one medicine

* Only one in ten vaccines in the pipeline will make it into an actual vaccine

* The US drugs industry spent $39.4bn on R&D in 2005

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