/ 2 April 2004

It’s about patents, not patients, for Aids drug giants

The United States, under pressure from its giant pharmaceutical companies, is trying to undermine the use in poor countries of cheap, copycat Aids drugs, made by ‘pirate”, generic companies but validated by the World Health Organisation (WHO), campaigners claim. US drug companies want the money promised for President George W Bush’s Aids plan to be spent on their products.

The US Department of Health and Human Sciences has now convened a conference in Botswana at the end of the month that will question the WHO’s approval process for generic drugs, known as ‘pre-qualification”.

If the cheap drugs, which sell for less than £165 a patient a year, are discredited and the more expensive brand-name drugs are bought instead, the limited money available for treatment will help fewer people and reduce the WHO’s hopes of getting three million on treatment by 2005.

‘It is not quality and safety and efficacy they [the US companies] are concerned about, but the protection of patents,” said Rachel Cohen of Médecins Sans Frontières (MSF) in the US. ‘The real reason this conference is being held is to come up with ways of undermining generic drugs.”

Plans to put millions of people on drugs to try to stem the Aids epidemic are based in most African countries on the purchase of cheap copies of drugs invented and under patent in the US and Europe. People with HIV need a daily cocktail of three drugs to suppress the virus in the body and stay alive and well.

Because the patents on the component drugs are held by different multinationals, only the generic companies make a basic three-in-one pill.

A very simple regime, taking one pill, twice a day, is considered to be most feasible in poor countries. Scientists working for the WHO have examined and approved certain generic three-in-one pills. About 50 000 people are already taking these generic Aids drugs.

MSF, which runs free Aids treatment programmes in Africa, gives them to about 9 000 patients. In Zimbabwe, it treats patients for between £109 and £136 a year. A programme by the US Centres for Disease Control uses brand-name drugs at £325 a patient a year. In addition, the patient has to take six pills a day, instead of two.

When Bush pledged £8-billion for Aids in his State of the Union address last year, and hailed the plunge in drug prices to £165 a year, it was assumed that the US would be willing to buy generics to make the money go further. However, Randall Tobias, former CEO of giant US drug company Eli Lilly and the man appointed to head the president’s Aids strategy, claims that generic drugs manufactured in other countries may not be made to the consistency and quality of those manufactured in the US. ‘It would be a disaster if we invested in drugs that were not consistent, don’t have all the right components — and we just don’t know whether some of these do or do not,” he told the US House of Representatives.

But WHO officials involved in approving the generic drugs defend their system, pointing out that the drug regulatory agencies of France, Switzerland, Canada and South Africa are among those involved in the process. —