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Last Updated: Sunday, 7 September, 2003, 23:55 GMT 00:55 UK
Is the WTO drugs deal flawed?
By Ray Dunne
BBC News Online health staff

Aids activists protesting in South Africa
Millions of people need access to life-saving drugs
As crucial trade talks get underway in Mexico, a much-heralded deal to give access to cheap medicines was announced by the World Trade Organisation. But many aid agencies were much more sceptical.

"Betrayal. A severe disappointment and profoundly unfair."

That was the reaction of aid agencies to news that the United States and developing countries had finally agreed a deal aimed at providing cheap medicines to some of the world's poorest people.

While officials at the World Trade Organization were rubbing their hands in delight, aid agencies were wringing theirs.

Key issues at the trade talks

"The proposed deal is largely cosmetic and will not make a significant difference to the millions of sick people who die unnecessarily in the Third World every year," said Celine Charveriat of Oxfam.

"It offers little comfort for poor patients. Global patent rules will continue to drive up the price of medicines," said Ellen 't Hoen of Médecins Sans Frontières.

The reaction at WTO headquarters in Geneva was somewhat different.

"This is a historic agreement," said WTO director-general Supachai Panitchpakdi.

"It's good news for Africa and especially good news for the people of Africa who so desperately need access to affordable medicine," said Amina Chawahir Mohamed, Kenya's WTO ambassador.

So who is right?

The deal

Under the deal, developing countries will now for the first time be able to import cheap versions of drugs, their active ingredients and diagnostic kits.

The world's biggest killers
Tuberculosis kills 2m each year
Aids kills 2m each year
Malaria kills 1m each year
Source: WHO/UNAids
This includes drugs to treat "HIV/Aids, tuberculosis, malaria and other epidemics".

These countries are already allowed to manufacture cheap versions, so-called generic versions of drugs that are otherwise protected by 20-year patents.

However, since many of the world's poorest countries do not have the capacity to produce medicines millions of people are missing out.

This deal aims to resolve that problem. Countries will now be able to break patents on new drugs if they are being exported to developing countries.

Developing countries will have to provide evidence they cannot produce these medicines themselves and that the drugs are needed.

They will also have to take "all reasonable measures" to ensure drugs are not smuggled out of the country to markets in the West, which provide pharmaceutical companies with their profits.

In line with this, manufacturers, which are expected to be in India, Brazil, and perhaps South Africa, will be required to ensure the generic drugs look different to the expensive original.

The anti-HIV drug Viracept
Poor countries can't afford expensive new drugs
The drugs could have a different name, shape or colour and be in different packaging.

If all of these criteria are met, the WTO will then decide if the developing country can start importing drugs.

The deal is based on a gentleman's agreement of sorts.

To this end, many industrial countries have already opted out and have confirmed that they will not import cheap drugs under the deal.

Will it work?

But to work, developing countries will need to ensure drugs are being used appropriately and are not being smuggled abroad.

The pharmaceutical industry will also have to keep its word and not place undue pressure on developing countries or the WTO.

The WTO for its part will need to ensure the process is not overly-bureaucratic and that applications are deal with quickly.

It is the uncertainty around this process that has prompted aid agencies to criticise the deal.

This is a balanced agreement
Dr Harvey Bale,
International Federation of Pharmaceutical Manufacturers
They believe the deal could get tangled in red tape, leaving millions without the drugs they need.

They are also concerned the requirements may be too onerous for some poorer countries.

"That is patently absurd," says Dr Harvey Bale, director general of the International Federation of Pharmaceutical Manufacturers.

"Countries will have to show that it is the patient with Aids who will receive this drug and not a middle man who will use it to make a profit.

"That is not red tape, that is simple ethical behaviour. This is a balanced agreement."

However, others also have concerns.

"We only hope that it doesn't become tied up in red tape," says Dr Kgosi Letlape, chairman of the South African Medical Association. "Otherwise, it won't be worth the paper it is written on."

Although the WTO deal comes into effect immediately, it is by no means certain that crates of life-saving medicines will be making their way to developing countries any time soon.

Alongside the fears over red tape, there are also concerns that manufacturers of generic drugs are not overly excited at the prospect of tapping these new markets.

The need for profit

Countries in sub-Saharan Africa, for instance, are unlikely to generate huge profits for companies.

We have to hope that it doesn't become tied up in red tape
Dr Kgosi Letlape,
South African Medical Association
However, Aspen Pharmacare, South Africa's largest producer of generic medicines, has already indicated its readiness to export to other countries in the region.

It is planning to double production in the next year to between 5 billion and 7.5 billion tablets.

Time is of the essence. In the first eight months of this year, during which WTO talks on a drugs deal were stalled, an estimated two million Africans died.

Many of these deaths could have been prevented if they had access to life-saving medicines.

Figures like that highlight the need for swift action.

"This is something that should be done expeditiously," says Dr Kgosi Letlape.

"At least 600 people a day die from HIV/Aids in South Africa.

"More than half of those deaths could be prevented if we had access to anti-retroviral drugs to prolong their life.

"If drugs are made affordable, people can chose to live."

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