WHO says AIDS fight will only be won with generic drugs

According to the World Health Organisation (WHO) the key to AIDS treatment in the developing world is generic drugs, but the target of 3 million people on therapy by the end of 2005 may now be unattainable.

Hans Hogerzeil, WHO director of medicines policy and standards, says around half of those on AIDS drugs in poor countries were taking generic tablets, made mostly in India.

Hogerzeil who was speaking at a pharmaceuticals conference in Malta, urged the United States to work with the world health body to include more generics in its AIDS treatment programmes, which currently mainly use more expensive branded medicines.

According to Hogerzeil the number of patients worldwide on generic antiretroviral drugs was increasing, despite a problem last year when the WHO delisted some Indian generics which had been proved to be not equivalent to their patented counterparts.

Hogerzeil said that although the suspensions were regrettable they had not been a major setback.

He says the first batch of delisted antiretroviral medicines from India's Cipla Ltd. was reinstated in November, after fresh tests, and others from Ranbaxy Laboratories should return soon.

The number of people in developing countries receiving treatment at the end of 2004 was 700,000, which is an increase of 75 percent from the year before. This is still but a fraction of those in need, and reaching the 3 million target by the end of 2005 may not be possible.

It will apparently also depend on developments in countries, like India, South Africa, Nigeria and China.

There is currently a gulf between the WHO's approach to selecting medicines for the developing world and that of the United States, which requires all drugs supplied through its AIDS programme to be approved by the Food and Drug Administration (FDA).

Hogerzeil said this has led to duplication and has hampered the U.S. efforts, since the FDA has approved only a handful of products, despite giving tentative approval to two more generics from India on Monday.

The WHO has around 80 on its list.

He recommends that recognition by the American programmes of the WHO pre-qualification would save time and give access to many more generics drugs.

He estimates that the arrival of Indian-made products that combine two or three medicines in one pill has brought the cost of first-line AIDS therapy in Africa down to around $140-$400 per patient a year.

Most brand-name drugs, by contrast, still cost $400-$600.

The next big challenge will be to cut the cost of paediatric formulations and second-line treatments, which patients need to receive once they develop resistance to initial therapy.

Treating children with AIDS in poor countries is currently costing $1,000-$1,500, reflecting an acute shortage of medication specially designed for children.

Hogerzeil says some Indian manufacturers are working on paediatric generics but there are very few available at the moment.