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Competitive Drugs Blocked: How Many More to Die Suffer Needlessly?

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As ironic as it may sound, trying to make profit where there is none to be made is absurd and common sense tell us that this should not even be tried, let alone taken into consideration when such overwhelming issue of human welfare as medecines affordability is at stake.


But then again to what extent our great "Democracies & Models of Civilization and Moral Values", influenced as issual by their corporate lobbies, would go when they see few millions more (out of hundreds of billions) under an imaginary threat?



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Poor people are needlessly dying because drug companies and the governments of rich countries are blocking the developing world from obtaining affordable medicines, a report says today. (The Guardian)



Five years to the day after the Doha declaration - a groundbreaking deal to give poor countries access to cheap drugs - was signed at the World Trade Organisation, Oxfam says things are worse.


The charity accuses the US, which champions the interests of its giant pharmaceutical companies, of bullying developing countries into not using the measures in the Doha declaration and the EU of standing by and doing nothing. Doha technically allows poor countries to buy cheap copies of desperately needed drugs but the US is accused of trying to prevent countries such as Thailand and India, which have manufacturing capacity, making and selling cheap generic versions so as to preserve the monopolies of the drug giants.


"Rich countries have broken the spirit of the Doha declaration," said Celine Charveriat, head of Oxfam's Make Trade Fair campaign. "The declaration said the right things but needed political action to work and that hasn't happened. In fact, we've actually gone backwards. Many people are dying or suffering needlessly."


The Indian generics firms make most of the cheap drug cocktails that are now being rolled out to people with HIV in Africa and are keeping more than a million people alive. They brought the price of a basic three-drug cocktail down from $10,000 (£5,250) a year to less than $150 (£79). But new Aids drugs will soon be needed because the virus will become resistant to the basic ones now in use - as has happened in the EU and the US.


Those newer Aids drugs, together with drugs for cancer and diabetes, are under patent. The Oxfam report points out that 4 million people were newly infected with HIV in 2005 and cancer and diabetes are expanding faster in developing countries than in the richer world.


The report says that, since the signing of the Doha declaration on November 14 2001, "rich countries have failed to honour their promises. Their record ranges from apathy and inaction to dogged determination to undermine the declaration's spirit and intent. The US, at the behest of the pharmaceutical industry, is uniqely guilty of seeking ever higher levels of intellectual property protection in developing countries."


The US has pursued its own free trade agreements with developing countries, tying them into much tighter observance of patent rights than anticipated at Doha. "The USA has also pressured countries for greater patent protection through threats of trade sanctions," the report says.


The drugs firms are also fighting to have patents observed. Pfizer is challenging the Philippines government in a bid to extend its monopoly on Norvasc, a drug pressure drug. Novartis is engaged in litigation in India to enforce a patent for Glivec, a cancer drug, which could save many lives if it were available at generic prices.


The Stop Aids campaign, a coalition of 90 NGOs of which Oxfam is a member, is calling for the government to champion the issue at the G8 summit next year. Three-quarters of HIV drugs are still under monopoly and unaffordable in poor countries, it said. More than 75% of those who need HIV treatment urgently are still not getting it. Only 8% of children with HIV are on drugs, which cost four times more than those for adults.


"Sadly, promising words have not translated into life-saving treatments and five years is too long to wait when the stakes are so high," said Steve Cockburn, campaign coordinator.


Case study


Premavati, a 60-year-old widow living in Delhi who is suffering from non-Hodgkins lymphoma, a cancer of the lymphatic system, has spent around $900 (£470) on medicines. "My husband died two years ago," says Premavati. "We have absolutely no savings. Of my two sons one is a casual labourer, the other has no job. My daughter is 30, has two children and is also a widow." She is one of 1.42 billion people in India who cannot afford the drugs they need to save their lives. Their country is the leading producer of inexpensive generic drugs but about 67% of the output is exported, and it is under pressure to stop copying new patented drugs. The future looks bleak for Premavati. "How will I raise the money for my treatment?" she says, "Already, I've spent what we had. If nobody helps I will just go back to my daughter and will have to die without medicines."

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Yusuf Hamied, generic drugs boss says he could save millions from death if the western giants would waive their patent rights and more governments would buy his drugs (The Guardian)



The drug barons consider him a pirate and a thief. Yusuf Hamied, a Cambridge-educated multi-millionaire who lives for the summer months in what used to be Lady Shirley Porter's London apartment, believes he is doing Ghandi's bidding. He manufactures perfect copies of many of the world's best and most important medicines and sells them at a snip. Dr Hamied and his family are certainly very rich but many poor people owe him their health, without which they would be destitute indeed.


The question of Dr Hamied's motivation is absorbing but at the end of the day irrelevant. What matters is that he exists. He single-handedly broke the cartel of the big drug companies by offering to supply Aids drugs at less than a tenth of their prices. That audacious offer at a big European Commission meeting on Aids in September 2000 ("you could hear the breath being sucked out of the room" said Bill Haddad, former New York Post investigative journalist turned US generics boss) made everything possible.


The assumption that Aids drugs were not for the poor - that they could not afford them and therefore that there was no point even thinking about ways to get people treated - was blown out of the water.


Now, in the post-Hamied era, the genie will not go back in the bottle. The big drug companies have been forced to drop their prices for these new and powerful drugs and offer them to a market they had no interest in developing - the impoverished African states where a whole generation of parents, teachers and workers are dying.


Dr Hamied's prices are still lower - his Bombay-based company, Cipla, offers a three drug cocktail for around $304 per year which used to sell for around $12,000 and would now cost $727 from the brand-name companies.


And yet his sales are few in countries where the need is desperate. Fewer than 50,000 people are being treated out of nearly 30 million infected with the lethal HIV virus in Africa, and - although Malawi is buying them - most of those are not getting Cipla's drugs.


Part of the reason is money - $304 is still impossible in countries with a per capita income of under $200 a year. But another part of it is a fight-back by the US and Europe based big-name pharmaceutical industry, which has long wanted to wipe the buccaneering generics companies off the face of the planet. Their long-term strategy to do that, through a World Trade Organisation agreement called Trips (trade related intellectual property rights) - which will sign up every nation to protect patents on new drugs for 20 years - is now in jeopardy because of the Aids crisis and Cipla's affordable medicines.


The drug giants have dropped their prices and argue that there is no need for generic piracy. But many of those who are concerned about the damage being wreaked on the economies of poor nations by a single virus have come to believe that it is not safe for the world to rely on voluntary price reductions by generous drug barons for desperately needed medicines to keep poor people alive and nations stable.


Campaigners in the US and Europe, as well as governments in developing countries, now see generics - or the threat of them - as the only way to get affordable medicines for all sorts of diseases that afflict the population of poor countries and damage their economies.


Just over a year ago, they secured an exemption clause to Trips, called the Doha Declaration, which allows developing countries to ignore patents and buy generics in a health crisis. Now the fight is on to decide in which countries and for which diseases poor people should be allowed cheap medicines - the US government, which champions the industry, wants to rule out such illnesses as asthma, diabetes and cancer and restrict the concession to the very poorest nations.


The crucial issue is whether the generics companies of India, Brazil and Thailand will be allowed to export to countries that cannot make their own cheap copies after the Trips patent rules bite in 2005. Unless they can, new drugs invented for Aids or other diseases will be untouchable and unaffordable in Africa for 20 years.


Cipla was set up as an Indian solution to India's health problems by Dr Hamied's father in 1935 when war stopped medicines arriving from Europe. Its website features a picture of Ghandi expressing his delight at visiting "this Indian enterprise".


In 1972, India passed a law which permitted medicines to be copied even if they were under international patent, as long as the process was not the same. There are now hundreds of generic companies in India - many of them tiny. Cipla is one of the biggest, with a market capitalisation, said Dr Hamied, of about $1.4bn.


"I don't want to make money on Aids drugs," he says. "I make enough money on other things. On this particular issue, can't we all pool our resources? I make 800 drugs. If I don't make money on six, why should I worry?"


Dr Hamied runs a free cancer hospital in India. There are reasons to believe in his altruism. "I'm not going to take it with me, so I have to leave it here," he says. But there's no doubt he stands to win all ways round.


His public stand has given Cipla excellent publicity. The World Health Organisation has endorsed the quality of his generic Aids drugs and approved his factories. And the fight over the Trips agreement could bring him a lot more business not only from the poorest countries but - and this is why the research-based companies are fighting so hard - also the massive developing markets of China and South America.


Dr Hamied, though, is frustrated. He is disappointed with the governments of Aids-hit nations, who are not placing orders for his drugs. "It is a joke," he says. "I should have the demand. Demand creates the incentive to produce, but with only 50,000 in the whole of Africa, where is the demand?" If demand grew as fast as the spread of the virus, he could not keep pace.


He would like see countries set up their own generics factories, and he has offered to show them how produce Aids drugs for free. The Global Fund should put up the money, he says. None of this happening.


Cipla sells a three-drug cocktail in one pill, called Triomune, to be taken twice day, which makes treatment much easier in poor countries. Malawi buys it for the couple thousand patients who can afford to pay $28 month, but its $196m from the Global Fund will only buy treatment for 50,000 more.


Dr Hamied will shortly launch the world's first once-a-day, three-drug treatment, called Odivir. It's clearly well suited to poor countries and it will be affordable, he says, but there's reason to suppose it will be taken up where other drugs have not been.


"India has four million cases and I'm breaking my head to make my government take a more active role," he says. "I offered totally free nevirapine (to prevent babies being infected by their mothers birth) and nobody takes it. It is up to the various governments to avail [themselves] of the opportunities offered. What has really saddened me is, firstly, the governments and, secondly, I have been totally disillusioned by the UN who talk, talk, talk and do nothing at all."


What, apart from lack of money in the poorest, is stopping the governments biting Cipla's hand off? The research-based pharmaceutical industry would say the political will is not there. But patents have been an issue. In Ghana, for instance, says Dr Hamied, it was GlaxoSmithKline that challenged the decision to import generic versions of drugs which were under patent there.


But there are countries where Aids drugs are not patented. According to Bill Haddad, who has voluntarily taken up Cipla's cause in the US, "the governments are too scared of the US government to buy generics". The US trade representative bats for the giant pharmaceutical companies. Whatever the WTO trade rules say about allowing countries to buy generics a health crisis, he suggests, there are those would rather not risk the wrath and possible sanctions of the US.

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Wondered about how all these "Humanitarian" agencies always managed to degrade already dire situations?



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AHF Campaign


In August 2007 Cipla was confronted by a US-based group known as AIDS Healthcare Foundation (AHF) with a well-funded campaign of full-page ads in various Indian newspapers suggesting Cipla was pricing an AIDS drug called Viraday higher in India than in Africa.[2]


In response to AIDS Healthcare Foundation's claims Cipla issued a short statement pointing out that the company had not sold a single pack of Viraday in Africa. It also underlined that Cipla sells its other AIDS drugs to the Indian government at the same prices it sells to Africa, and questioned AHF's agenda.[3] According to AHF and news reports, Cipla threatened a defamation lawsuit against the organization.


On August 21, 2007 the Indian Monopolies and Restrictive Trade Practices Commission (MRTPC) announced that it would look into Cipla's pricing and claims made by AHF.[3]


On September 1, 2007, The Economic Times of Delhi wrote that:


It has now emerged that Aids Healthcare Foundation (AHF), the US-based NGO that accused Cipla of over pricing anti-AIDS drug, Viraday, in India is part funded by American anti-AIDS drug maker Gilead and the NGO's treasurer is a senior Gilead executive.


This is largely the reason why foreign and Indian NGOs such as Medicins Sans Frontieres (MSF), Delhi Network of Positive People (DNP+), Indian Network of Positive People (INP+), Sahara and others refused to be part of AHF's anti-Cipla campaign.


Cipla is also the only Indian company opposing Gilead's patent application for its blockbuster anti-HIV drug Viread in India. The hearing for the patent case of Viread is due in October. ... Says a head of an NGO, who did not participate in the anti-Cipla campaign: “There is a conflict of interest in the campaign. AHF is funded by multinational pharma companies. A senior Gilead executive is one of the directors of AHF and the campaign choose to target Cipla for over pricing at a time when it is fighting Gilead's patent case in India. There is a discomfort and many civil society groups decided to stay away from the campaign.”

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Interesting read.


"He would like see countries set up their own generics factories, and he has offered to show them how produce Aids drugs for free. The Global Fund should put up the money, he says. None of this happening"


I'm guessing it's the african governments(pressured by western corporations) stopping these generic factories from being built. If only africa had a competent leaders..


I'm sure there is some money to be made from selling generic drug, somalia seems like an ideal place to set up a generic factories, with minimal government interference.

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