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USA: Bayer, Anthrax and the WTO

by Sarah BoseleyThe Guardian (UK)
October 24th, 2001

Three people have died of anthrax in the US. Two million die every year of Aids in Africa. The difference in numbers in huge, but the issue is the same -- patents. Is it right to ban cheaper copies of drugs when public health is at risk? And will the world wake up to the problem now the west has been hit?

In a post office in Brentwood, USA, whose only previous claim to out-of-the-ordinariness was that it sorts the mail that goes to important people on Capitol Hill, two men unwittingly inhaled lethal anthrax spores sent flying invisibly through the air by a letter-processing machine. In Johannesburg and Nairobi and countless other African cities and in smaller towns and in villages too tiny to be marked on most maps, thousands of men and women every day are unwittingly passing to each other a lethal virus, called HIV, which has in a few decades cut life expectancy in some countries by up to 42%.

Three men have now died of anthrax in the US -- the two postal workers and a Florida newspaper picture editor. Over two million Africans die of HIV/Aids every year. There is a huge disparity in the number of dead in each of these crises. What links them is a ferocious battle over the patents on the drugs that could keep them alive, granted to pharmaceutical companies to enable them to recoup the vast sums they spend on developing new medicines. Drug companies produce what they think the market will buy and charge what the market will bear. But there are many who say that in times of public health crisis -- be it an anthrax attack or an Aids epidemic -- patent protection must be torn down in the interests of public health.

A powerful antibiotic made by Bayer with the brand name of Cipro is the best chance of life for anyone who has inhaled anthrax spores. In the US it will be under patent until 2004. It is now in very great demand and the US government wants to stockpile 1.2bn pills. Bayer can produce about 15m a week.

The US is not the only country that wants a stash of Cipro, or ciprofloxacin, as it is known generically. Canada did not think twice. Faced with the likelihood of a limited supply from Bayer, it commissioned the Canadian company Apotec to produce a generic copy. It agreed to deliver 1m tablets by November 8.

The result has been uproar from all sides. Bayer threatened to sue the Canadian government for breach of patent, while the US, closest friend and staunch defender of the pharmaceutical industry and the patent system, has been acutely embarrassed. Yesterday the Canadian government backed down and promised to respect Bayer's patent until the Canadian expiry date of 2003, in return for an undertaking that Bayer would deliver the drugs within two days of any anthrax attack. It now faces paying for it twice because the contract with Apotec still stands, although the medicine will not be used unless Bayer fails to deliver.

The fiasco is embarrassing for the US government because Canada has until now been four-square behind the US-led efforts to enforce respect for patents in the developing world. Drug patents last for 20 years. Not all countries have recognised them in the past, but all the member states of the World Trade Organisation are being brought inexorably into line through an agreement called Trips (trade related intellectual property rights). By 2006, even the poorest member states in Africa will have had to pass their own national legislation to become Trips-compliant and fully signed-up respecters of patents on new drugs.

But for many years, the US has been acting as the industry's policeman, threatening trade sanctions against countries such as Thailand when it started to make cheap copies of drugs for the opportunistic infections that kill people whose immune systems are knocked out by HIV.

There are clauses within the Trips agreement that are intended as a get-out for countries facing a health crisis such as the Aids epidemic or -- just as easily argued -- tuberculosis and malaria. But when the South African government tried to pass legislation that would allow it to import drugs that are cheaper elsewhere, it first came under serious pressure from the US trade representative and then found itself in court. The spectre earlier this year of 39 pharmaceutical companies suing the South African government to prevent it importing affordably cheap medicines for the 25% of its people of working age who are HIV-positive and so doomed to an early death was impossibly for bad public relations. In the face of international public outrage, the industry backed down.

Nothing dramatic has happened in South Africa as a result. The president, Thabo Mbeki, is not a believer in the antiretroviral drugs that keep people with HIV alive in the north, so although the Indian generic drugs manufacturers have offered them at rock-bottom prices ($350 or 245 for a year's supply of a three-drug cocktail from Cipla, compared with nearly $10,000 or 7,000 for the branded drugs), they will not be turning up on the medicine trolleys of Johannesburg's state hospitals. The health ministry has, however, said it will be looking to obtain cheaper drugs for the minor infections that kill people with HIV.

Relatively little has happened in the rest of Africa either, in spite of the pharmaceutical industry's concern that allowing South Africa to get away with importing cheap drugs would give other countries ideas.

Jamie Love of the Consumer Project for Technology, set up in the US by former presidential candidate Ralph Nader, says that the court case in South Africa alarmed other countries, in spite of the result. "In South Africa they have a very expensive British system of litigation," said Love. "It's like the Ritz Hotel. Rich and poor have an equal right to rent rooms there, but they can't both necessarily do it. We have been arguing they don't want to have European laws -- they want to have African laws. Can they afford $1m to litigate a patent dispute? No. Do they have laws that would keep them out of a court? Usually not."

Ironically, he says, the US government can override patents with relative impunity. He has a very long list of examples on his website (www.cptech.org). Last month, he says, 178 compulsory licences (the permission to disregard a patent, which Canada gave to Apotec) were issued in the US with regard to software products. He also argues that the patent holder does not lose -- in the US at least -- because he will be compensated. But on drug patents, the US government never budges. Charles Schumer, a Democrat senator from New York, urged last week that the US should buy generic versions of Cipro, but Tommy Thompson, the secretary of health, has categorically said no, stating that the US had no legal right to break Bayer's patent -- something Nader and Love immediately disputed in a letter, citing the letter of the law. "By failing to act, you are putting Americans at risk," they said.

The growing concern over the anthrax attacks has brought the patent issue -- and the parallels between the US health crisis and the Aids epidemic which has so far killed 21.8m people, mostly in Africa -- to public attention in the US. That, hope organisations such as Oxfam and Medecins sans Frontieres, may put pressure on the US at next month's WTO ministerial meeting in Doha, Qatar.

Doha is important in the eyes of more than 60 developing countries that have come together to press for a declaration on Trips. They want it acknowledged that the patent rules can be set aside if the interests of public health -- such as an Aids epidemic -- demand it.

"It is nothing more than Canada instinctively did," says Sophia Tickell of Oxfam's policy department. "It has been very striking to us that when developed-country governments like Canada are faced with a situation where public health is under threat, it appears that it isn't very difficult to come to a decision to override the patent rules on public health grounds."

But, says her colleague, Michael Bailey, the US, backed by Canada, Switzerland and Japan, has opposed the declaration. The EU has been trying to broker a deal but officials have confessed themselves frustrated by what they have described publicly as "US intransigence". But Bailey thinks something may come out of the Cipro fuss and the anthrax fears. "It might encourage the US to be a bit more sensitive," he said. "It might increase domestic pressure on them to be more sensitive."

Ellen t'Hoen, of MSF, says that the US will have experienced a little of what developing countries suffer: "What is very telling is that now the US and Canada are facing a shortage and a problem of providing the medicines that the government thinks are needed to protect health, the patent is a barrier to doing that and they are looking for ways of overcoming that."

The populations of both countries are expecting their governments to take the necessary steps. There is another potential lesson from the Canadian experience -- that even a highly developed nation can be thwarted by the system when it tries to take steps to protect public health. That is just how the African nations feel. In just one more repercussion of September 11, the most sophisticated countries in the world are getting just a taste of what it is like to have a deadly illness on the move and lack the medicines to deal with it.

At Doha, there is everything to play for.





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