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Clash over drug access at Australia AIDS/HIV conference
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01/08/2007
www.pharmatimes.com
A leading charity figure has claimed that some of the world's leading pharmaceutical companies have worked to prevent developing countries from reducing the price of high-cost medicines. "In some case, Ôbig pharma' has put profits before lives," said Andrew Hewett, executive director of Oxfam Australia, speaking at the International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention, held this month in Sydney, Australia.
The Australian government is committed to spending A$600 million over four years to treat and prevent HIV/AIDS in the region, but it has said little recently about the drug majors' impact on developing countries, said Mr Hewett. "If Australia fails to act to prevent the harmful actions of some pharmaceutical companies, taxpayer dollars will continue to be spent subsidising the high prices demanded" by multinational drug makers for antiretroviral (ARV) drugs, he said.
However, Mr Hewitt's comments were dismissed by Alan Moran, director of deregulation at the Institute of Public Affairs (IPA), an Australian free-market think-tank, who pointed out that a recent study by the Institute reveals that undermining patents can in fact have detrimental effect on developing HIV/AIDS medicines for the world's poor. In Thailand - which, says Mr Moran, is not "a particularly poor country," the military government has already forced drugmakers to dramatically cut the price of anti-AIDS medicines. The IPA study found that the company licensed by the Thai government is making "unconscionable" profits, and that other governments in developing countries exploit their citizens by taxing the drugs.
In the IPA report, entitled HIV/AIDS Medicines for All?, author Tim Wilson concludes: "India provides compelling evidence that undermining patents doesn't yield improved access to affordable medicines." He also believes that Thailand and Brazil's recent issuance of compulsory licenses for HIV/AIDS and heart disease medicines will "do little" to promote access to affordable medicines. In contrast, he says, enforcement of patent protections has many benefits for patents, not least in that it combats the development and use of counterfeit drugs. An Abbott official has said, It that "the patents of scientists and inventors must exist so that there are incentives for sustained research and development. Without this system, the miracle drugs the world enjoys today, including HIV medicines, would not exist."
Meantime, the nongovernmental organisation Medecins Sans Frontieres (MSF) reported at the conference that it had found dramatic price reductions for second-line ARVs over the last year, largely, it says, stimulated by the Thai compulsory license. However, MSF says it has also found that using the newer, less-toxic first-line combination now recommended by the World Health Organization (WHO), which are based on combinations including GlaxoSmithKline's Ziagen (abacavir) and Gilead's Viread (tenofovir disoproxil fumarate), the cost for patients goes up nearly 500%, from $99 to $487.
MSF worries over access to first-line treatments
"It's encouraging to see the price of second-line regimens finally starting to come down," said Karen Day, pharmacist with MSF's Campaign for Access to Essential Medicines. "But we are worried that the lack of competition and dramatically higher prices for the newly-recommended WHO first-line regimens could mean that people in developing countries may not be able to benefit from improved treatment that has been widely available in wealthy countries for years."
MSF also claims that the compulsory licenses issued by Thailand and Brazil have been far more effective in bringing prices down than negotiating price reductions with manufacturers or relying on companies' differential pricing schemes.
"Just one year ago, treating a patient with a second-line regimen containing lopinavir/ritonavir [Abbott's Kaletra] in Thailand cost $2,800 per year," said MSF spokesman Kannikar Kijtiwatchakul. "Thanks to competition since the compulsory license, treating that same patient with a second-line regimen will now cost $695 - four times less. But this is still far too expensive for the majority of people in Thailand, where the average annual salary is $1,600," he added.
The group adds that significant delays persist between when newer treatments become available in wealthy countries, and when they become available in the developing world.
"I work in Sydney and also have been treating patients with AIDS in countries like Malawi and Mozambique and the gaps I have witnessed are alarming," said Alexandra Calmy, HIV/AIDS Advisor for MSF's Campaign for Access to Essential Medicines. "At this conference in Sydney, we're seeing presentations on several promising drugs. These drugs should be available in Africa, Asia and Latin America at the same time as they are marketed in rich countries, not only after years of fighting for access to them. This means including the needs of people living in developing countries into the R&D plans from the beginning," said Dr Calmy. By Lynne Taylor
Thai government drugmaker all set to sue US lobby group
30/05/2007
Thailand's Government Pharmaceutical Organisation (GPO) says it will bring a 1 billion-baht lawsuit (around $30 million) for defamation against the lobby group, USA for Innovation, over the latter's claims that HIV/AIDS treatments produced in the country are substandard.
The GPO has already filed criminal charges against the US group's allegations, which were made in newspaper advertisements and on its website (www.usaforinnovation.org) earlier this month after Thailand's Public Health Ministry issued a compulsory licence for Merck & Co's antiretroviral Stocrin/Sustiva (efavirenz). In its advertising campaign, USA for Innovation says that a 2005 study by Mahidol University had found that GPO-vir, a generic HIV/AIDS treatment manufactured by GPO, had just 39.5%-58% resistance, one of the worst cases of HIV drug resistance in the world.
The group also points out that Thailand is now the only country in Southeast Asia to be included on the US government's Priority Watch List for intellectual property rights infringements. It attacks "Thailand's theft of American and European medical technology at the expense of the poor and sick," and claims that Thai Health Minister Mongkol Na Songkhla's actions have "hurt jobs, investment and access to safe medicines for the people of Thailand."
Announcing the lawsuit, GPO board chairman Dr Wichai Chokewiwat said that the Organisation's responses to USA for Innovation's attacks were necessary to counter its allegations and maintain the credibility of Thailand's medical agencies. The 1 billion baht being sought by the lawsuit relates to the GPO's annual medicines production capacity, which is estimated to be 5 billion baht, he added.
More compulsory licences to come?
Meantime, Health Minister Mongkol has said that he plans to issue two more compulsory licenses before the government elections are held in December. He declined to name the new products to be targeted, but said they will be treatments for the country's leading killer diseases, particularly cancer. With the licenses already issued - for efavirenz, Abbott's HIV/AIDS treatment Kaletra/Aluvia (lopinavir/ritonavir) and Sanofi-Aventis/Bristol-Myers Squibb's blockbuster anti-clotting agent Plavix (clopidogrel) - this will bring Thailand's total to five.
Mr Mongkol called on drugmakers to offer their products at "one price for the rich and one price for the poor," as this would create a "win-win for everyone." He also described as "fruitless" the talks aiming to resolve the compulsory license issue which were held earlier this month between Thai government representatives and US officials - the latter included Commerce Secretary Carlos Gutierrez, Deputy US Trade Representative John Veroneau and Pharmaceutical Research and Manufacturers of America chief executive Billy Tauzin, plus a number of legislators. By Lynne Taylor
Abbott slashes the price of AIDS drug Kaletra and waits for Thailand's reply
10/04/2007
Abbott Laboratories has decided to cut the price of its AIDS drug Kaletra by more than half in some of the world's poorest countries in a move that is being seen as an attempt to end the stand-off between the US drugmaker and Thailand which has overridden the firm's patents on the medicine.
Abbott said that it had been approached by the World Health Organization's director-general, Margaret Chan, to discuss "how to improve affordability and access while maintaining incentives to support developing new medicines" and has decided to offer Kaletra (lopinavir/ritonavir) to the governments of more than 40 low and low-middle income countries (as defined by the World Bank) and to non-governmental organisations for $1,000 per patient per year. This is "lower than any generic price available in the world today for this medicine," Abbott said, noting that it is approximately 55% less than the average current price for these countries.
The Illinois-based group said it is taking this action in order to further increase access and address the debate around pricing of HIV medicines. It added that "the patents of scientists and inventors must exist so that there are incentives for sustained research and development. Without this system, the miracle drugs the world enjoys today, including HIV medicines, would not exist."
Abbott went on to refer specifically to the situation in Thailand. Last month the firm said that it will not market any new drugs there following the government's decision to issue a compulsory license for Kaletra despite its valid patents but has now adopted what would appear to be a more conciliatory tone, saying that it "appreciates and fully respects the suggestion of director-general Chan that more work needs to be done with the government of Thailand to achieve a positive outcome." Meantime, Kaletra remains available in Thailand and will be eligible for the new price, though Abbott is not yet planning to sell a new heat-stable form of Kaletra in Thailand, which eliminates the need for expensive cold storage.
Suchart Chongprasert, an official from Thailand's Food and Drug Administration, told the Associated Press that "Abbott did not say that they wanted us to revoke the compulsory license. There was no condition. They were just here to offer the price reduction so that people can have access to their medicines." Dr Suchart added: "We want to thank the company for their understanding of our position and the offer that they made which will benefit Thai patients."
Abbott opens huge Humira facility in Puerto Rico
Meantime, Abbott has announced the official opening of its new state-of-the-art biologics manufacturing facility in Puerto Rico to support the long-term supply of its fully human monoclonal antibody Humira (adalimumab) and other future biologics. The new plant, in Barceloneta, is the firm's single-largest capital investment to date, costing approximately $450 million, and is now the main production facility for Humira, which has approvals for rheumatoid and psoriatic arthritis, as well as ankylosing spondylitis and Crohn's disease
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