TWN Info Service on Intellectual Property Issues (Sept06/02)

12 September 2006

LATEST NEWS ON TRADE AGREEMENTS, IP AND ACCESS TO MEDICINES

Please find below a selection of the latest news stories on free trade agreements, intellectual property and access to medicines. Several of these stories came about following the recent International AIDS Conference in Toronto.

Best Wishes
Sangeeta S.
Third World Network
Geneva

http://online.wsj.com/article/SB115749122365854275.html

AIDS SCIENTISTS CALL FOR RESIGNATION OF SOUTH AFRICA'S HEALTH MINISTER

By *MARILYN CHASE*

September 5, 2006 9:52 p.m.

International AIDS scientists, including an American Nobel laureate, sent a letter Tuesday to South African President Thabo Mbeki, protesting the government's unconventional stand on origins of AIDS, and calling for the removal of his health minister who supports a dietary regimen against the viral epidemic.

One of the most severely-stricken countries on earth, South Africa has 5.5 million people living with HIV, or 18.8% of its adult population, according to the United Nations Joint Program on HIV/AIDS.

Challenging the longstanding scientific consensus that AIDS is caused by infection with the human immunodeficiency virus (HIV), Mr. Mbeki's government has expressed skepticism, and his Health Minister Manto Tshabalala-Msimang recommends a diet of potato, lemon and garlic.

Years of public protest and private diplomacy aimed at reversing this policy have softened but not ended its stand. The controversy was reignited at the International AIDS Conference in Toronto last month, where South Africa's exhibit defiantly displayed the nutritional regimen.

Tuesday's letter was signed by 65 scientists from a dozen countries including Harvard University AIDS researcher Daniel Kuritzkes and Nobel Prize-winner David Baltimore of the California Institute of Technology.

While praising South African scientists and doctors for working to alleviate the suffering caused by AIDS, the letter charged that the minister's "pseudo-scientific" views had undermined those efforts. The letter added a commendable government plan to treat 380,000 people with drugs had so far reached fewer than half the target group.

One of the co-organizers of the letter, AIDS researcher John P. Moore of Cornell University's Weill College of Medicine in New York City, said there is "simply no scientific rationale" for touting food in lieu of drugs.

"To promote alternative medicines as AIDS cures in South Africa is to kill people," he added, "and it's time for AIDS scientists to stand up against this kind of quackery."

Reached by phone Tuesday evening in Cape Town, the presidential press secretary Mukoni Ratshitanga said that Mr. Mbeki was hosting a visit by Russian Federation President Vladimir Putin, and had no response to the letter, which he had not yet seen.

Late Tuesday evening, Charity Bhengu, a spokeswoman for the health minister, added she hadn't yet seen the letter either.

--William Echikson contributed to this article.

*Write to* Marilyn Chase at marilyn.chase@wsj.com

<mailto:marilyn.chase@wsj.com>^3

http://www.bilaterals.org/article.php3?id_article=5615

PATENT OR PATIENT? HOW WASHINGTON USES TRADE DEALS TO PROTECT DRUGS

The controversy over the impact of bilateral trade agreements on public health poses particular difficulties for the Geneva-based WHO, which is gearing up for the highly political election of a new director-general.

Financial Times | London | August 22 2006

By Alan Beattie, Andrew Jack and Amy Kazmin

William Aldis was agitated. As the World Health Organisation’s top man in Thailand, he knew Thai officials were hosting their US counterparts in the northern city of Chiang Mai to negotiate what to many outsiders might seem an entirely worthy objective: a bi­lateral free-trade deal.  But he saw dangers - and decided to make his views public.

The "lives of hundreds of thousands of Thai citizens" would be put at risk if negotiators accepted Washington’s demands for greater protection of drug companies’ intellectual property rights, he wrote in an article for a Bangkok newspaper.

That was in January. By the end of March, Dr Aldis - just 16 months into what is normally a four-year tenure - was abruptly transferred sideways to a job in India, raising concerns in Thailand about US efforts to curb the independence of the WHO’s public health professionals.

The spat highlighted the tensions generated by a US drive to strengthen patent enforcement and intellectual property rights protection around the world - a campaign backed by some of the powerful drugs companies that produce Aids medicines but opposed by many public health specialists, patient groups and developing nations.

On one side are those who argue that stronger patent protection will keep drug prices too high to meet the needs of developing-world patients. Pitted against them are others who insist innovation is under threat and the real problem in poor countries is a lack of hospital facilities and medical staff.

Widely discussed at last week’s world Aids conference in Toronto, the issue prompted a petition signed by Médecins sans Frontières, the doctors’ aid organisation, and dozens of other groups calling for a moratorium on free-trade provisions that threaten access to treatments.

In it they demand that governments "protect the public from the potential negative consequences of bilateral and regional trade agreements on public health".

The controversy poses particular difficulties for the Geneva-based WHO, which is gearing up for the highly political election of a new director-general after the death in May of Lee Jong-wook. A WHO assembly is due to choose a successor in November.

Dr Aldis, in his article published in the English-language Bangkok Post and entitled "It could be a matter of life and death", warned that the concessions sought by Washington could hinder Thailand’s domestic production of generic drugs, particularly the life-saving medicines that will be needed to treat the 600,000 Thais living with HIV.

"The price of second- and third-generation HIV drugs will remain exorbitantly expensive," he wrote, adding that the Thai government - which has won accolades for its commitment to provide Aids drugs for all who need them - could thus find its public health system bankrupted.

After the article appeared, Kevin Moley, then head of the US permanent representation to the United Nations in Geneva, called on Dr Lee. Both verbally and in writing, he registered Washington’s displeasure with the statements of the WHO’s Bangkok representative.

One US official familiar with the discussions says: "For someone on the WHO payroll to criticise a bilateral negotiation is not appropriate."

Yet the subsequent abrupt transfer of Dr Aldis (himself an American) brought alarm in Thailand. "If outside political pressure can influence an organisation which is supposed to be dedicated to the health of the people, it is a really bad sign," says Jiraporn Limpananont, a pharmaceutical sciences professor at Bangkok’s Chulalongkorn University and an expert on intellectual property rights. "It will be a threat for people all over the world, not just for the Thai people."

At root, the dispute concerns US efforts to extend the patent protections laid down in existing multilateral trade pacts. Under the WHO’s "trade-related aspects of intellectual property" (Trips) agreement, countries can override drug patents by issuing a "compulsory licence" to manufacture or import cheaper copycat versions, if they judge there to be a public health emergency.

But a congressional mandate urges the US trade representative to push for stronger protection of intellectual property rights around the world, through bilateral free-trade agreements (FTAs). After signing deals with small economies such as Oman, Jordan, Morocco and Bahrain, Washington has turned its attention to more significant trading partners such as Malaysia and South Korea as well as Thailand.

These efforts have been given added impetus by the expiry next year of the White House’s "fast-track" trade promotion authority, which allows the administration to negotiate trade deals that Congress must then either approve or reject in their entirety. Last month’s indefinite suspension of the WTO’s Doha round of trade talks also re­focused US attention on its bi­lateral trade deals.

In their talks with Thailand, echoing the terms of similar deals, US negotiators have demanded that the authorities agree to grant pharmaceutical companies "compensatory" patent extensions in the event of "unreasonable" delays either in granting drug patents or approving a drug for market use.

They have also sought five years of "data exclusivity", which would prevent makers of generic drugs using the clinical trial data, or other scientific information, from another company to prove the safety and efficacy of a medication after it comes to market. Such data protection would have particular repercussions for Thailand, where some Aids drugs were never patented, as companies previously judged the potential market to be too small.

Last, the US has pushed Thailand to adopt more specific language on the terms and conditions under which it would engage in compulsory licensing of new drugs, although Washington promised to issue a "side letter" clarifying that the binding language in the bilateral trade deal was consistent with the WTO’s 2001 Doha declaration on Trips and public health.

Achara Eksaengsri, deputy director of research and development at Thailand’s Government Pharmaceutical Organisation (GPO), says the bilateral conditions would have a highly detrimental impact on Thailand’s ability to fulfil its pledge to provide drugs to Aids patients.

The Thai GPO is currently producing generic versions of older "first-line" anti-retroviral drugs for some 80,000 people and hopes to have 150,000 on treatment within two years. It also plans to provide generic "second-line" treatment using more sophisticated newer drugs for patients as required, an aim that would be hampered by conceding "data exclusivity" protection. "We have to plan how the government budget can support the Thai patients," she says.

In contrast, western pharmaceutical companies say that the protections are necessary to ensure they make adequate returns to encourage future research and development of drugs. They also argue that in the poorest countries most affected by Aids, they have made great efforts to help, offering discounted prices and waiving or not enforcing patents.

Harvey Bale, head of the International Federation of Pharmaceutical Manufacturers’ Associations, says his members have been made scapegoats for far broader problems that have hindered the scaling up of Aids treatment in the developing world. "The issue is getting people access to drugs," he says. "We’re still far short of the WHO’s target of 3m on treatment by 2005 and the pledge for universal access by 2010. The basic problem is infrastructure, accessibility of trained medical staff, clinics and diagnostics."

American trade officials say the provisions they seek in their bilateral deals in Thailand and elsewhere will not impinge on health. "There is no evidence that the FTA has damaged access to drugs or the local pharmaceutical industry," says one. "Since signing its FTA with the US, Jordan has seen a big rise in the number of launches of innovative pharmaceutical products, while its own generics sector has thrived."

But Jordan has scant influence on the international pharmaceuticals market. The big clash relates to larger countries such as China, India and Brazil, which offer more lucrative potential markets to the drugs companies - but which also have important domestic generic industries that threaten to undercut western drugs companies unless patent rules are toughened.

From their various perspectives, western drugmakers, generic producers and patient activists are all particularly focused on the recently developed second-line anti-retroviral drugs, still under patent. Demand for these is set to grow sharply in the next few years as patients develop resistance to their first-line therapies.

Under pressure from fledgling local pharmaceutical companies interested in innovation as well as international demands, India last year tightened its patent legislation. The previous generation of first-line Aids treatments had not been protected by patents, allowing companies such as Cipla and Ranbaxy to copy western drugs, offering them more cheaply in the developing world. For second-line drugs, that will be tougher.

A key test of the new regime is Kaletra, a drug developed by Abbott Laboratories of the US. The company has already clashed fiercely with Brazil, which last year threatened to issue a compulsory licence so the state-owned pharmaceutical company could produce Kaletra. That was out of concern that purchases for its ambitious Aids treatment programme would otherwise be too expensive.

"We are supportive of the Trips legislation but we view intellectual property as at the core of what we do," says Jennifer Smoter from Abbott.

Pedro Chequer, head of Brazil’s national Aids programme at the time, says government officials were subjected to intense lobbying at the highest levels: "I was told of meetings, phone calls from the Senate, Congress and the White House, with threats of direct retaliation."

The office of Brazil’s President Luiz Inácio Lula da Silva eventually backed away from issuing a compulsory licence, in exchange for Abbott’s agreement to a six-year contract offering the drug at a lower price while preserving its patents.

That is precisely the type of deal that could be compromised by FTAs.

"Compulsory licensing is a weapon," says one trade expert. "Developing countries can say: ’We are going to make this unless you cut your price.’ It’s a good weapon to use - that itself is a worthy thing to have."

Dr Achara says Thailand may request a compulsory license in three or four years’ time for Kaletra for the Thai GPO. But a Thai-US bilateral trade deal - talks on which are on hold, probably until after October, when the country is scheduled to rerun its general election - would weaken her hand, she fears.

Mr Bale warns that overriding patents may bring unintended consequences.

He suggests that the price, quality and capacity of local manufacturers may not meet the objectives sought. Conversely, Jim Kim, a former head of HIV/Aids at the WHO and still active in combating the disease, says:

"The pharmaceutical companies are saying it would be better for countries to use their discounted price schemes. But we’re already hitting supply problems, while demand for the drugs is growing steadily."

In practice, compulsory licences have so far been issued rarely and showdowns with countries where FTAs cover pharmaceutical products have not taken place. Furthermore, US policy is not entirely clear cut.

Even Jamie Love, a veteran critic of the US campaign for tougher intellectual property rights abroad, says: "There’s no doubt the bilateral agreements are designed to step back from Doha, making it harder to introduce generics. But it’s hard to say the US position is crystal clear. It depends who’s on the ground."

While US trade representatives push for tough patent rules in the interests of national pharmaceutical manufacturers, for example, Washington regulators at the Food and Drug Administration recently began approving foreign-made generic copies of anti-retrovirals. That allows for their purchase - at the expense of higher-priced US-made drugs - by Pepfar, President George W. Bush’s Aids fund for the developing world, which is under pressure to escalate treatment cost-effectively.

Still, as the burden of Aids continues to grow, so will the tensions between developed-world manufacturers and budget-stretched developing nations. One place where the debate will be played out is at the WHO.

Dr Lee, a cautious man, was wary of antagonising the US, to which he owed his election three years ago. In the contest to replace him, the candidates may find reconciling drug affordability and intellectual property to be among the trickiest stances on which they will campaign.

ABBOTT ACCUSED OF REFUSING ACCESS TO HIV DRUG

Lancet Infectious Diseases, Current Issue, Volume 6, Number 9, September

Khabir Ahmad

International charity, Médecins Sans Frontières (MSF), has accused pharmaceutical company Abbott of denying access to its tablet formulation of Kaletra (lopinavir/ritonavir) in Thailand and other developing countries.

³Despite repeated calls from MSF, many HIV experts and patient representatives from 18 different groups, the company has no plans to make the new version available in the country,² MSF's spokesperson, Nathan Ford, explained. MSF complains that Abbott's response has been that Thailand can make do with the old version that costs over US$3000 per patient per year, an amount more than double the average annual wage of an office worker, and well beyond the reach of most people with HIV/AIDS in Thailand.

³This is a clear example of why monopolies on medicines are dangerous, and why we need checks and balances. A single company should not be in a position to decide who gets what drug when,² Ford said.

The tablet form of protease inhibitor lopinavir/ritonavir needs no refrigeration and can be stored at temperatures of up to 30°C, fewer pills are required per day, and can be taken with or without food. By contrast, its old version Kaletra capsules did not offer these benefits and it was almost impossible to use them in many resource-limited settings with hot climates. Jiraporn Limpananont (Chulalongkorn University, Bangkok, Thailand) believes that the need for the new version in Thailand is very obvious: the average temperature in the country is about 30°C and poor compliance to antiretroviral is a big problem. ³So any refusal to register this version in Thailand must be condemned as a serious violation of human right to health,² she noted.

According to Limpananont, if Abbott cannot introduce the drug in the Thai market, it will automatically lose market exclusivity on this drug. ³So in this case I urge the Royal Thai Government to withdraw the patent and market exclusivity right on this drug,² she concluded.

But Abbott's spokesperson, Jennifer Smoter, dismissed accusations by MSF and others as ³completely false². ³We are registering the tablet formulation of Kaletra in China, Thailand, and Guatemala very soon. But in order to be able to register, we are waiting for a Certificate of Pharmaceutical Product

(CPP) that must be issued from Europe,² she said. MSF disagrees, maintaining that under WHO guidelines the CPP needs to be issued by the exporting country. If Abbott wants to export this product from the USA, the CPP could be issued by the US Food and Drug Administration, it said.

MEDICINE AND MARKETS

Published: August 24 2006 03:00

Source: http://www.ft.com/cms/s/77e9d28c-330c-11db-87ac-0000779e2340.html

Like a recurring nightmare, the conflict between pharmaceuticals industry profits and poor countries' desperate need to treat diseases such as Aids and malaria just will not go away. After bitterly dividing the World Trade Organisation, it is now threatening to break out all over again in the World Health Organisation.

The reason this time is US insistence, in bilateral trade talks, that developing nations agree to stiffer patent protection rules. As well as restricting competition by generic drug makers, the rules would, most crucially, set tighter conditions on poor countries' freedom to use compulsory licences to override patents and import essential medicines they cannot produce locally.

A hard US line on that issue also provoked a furore in the WTO, which was eventually settled by a compromise that protected poor countries' compulsory licensing rights. Although Washington claims its bilateral provisions are consistent with the WTO agreement, they look suspiciously like a backdoor way to circumscribe it, at the urging of US drug companies and their powerful allies in Congress.

The use of American political and industrial might to impose demands roughshod on weaker partners is an unedifying spectacle - the more so because the US itself toyed with compulsory licensing after its 2001 anthrax scare and has recently begun approving imported generic copies of Aids treatments. Given the rarity of compulsory licensing worldwide, the US campaign also looks like an overreaction.

That said, there is a genuine problem at the heart of the dispute. The industry's incentive to innovate would be weakened if widespread erosion of patent protection enabled generic drug makers to eat away its profits. However, the moral and practical case for providing poor countries with access to essential medicines, at a price they can afford to pay, is equally compelling.

Public criticism has shamed some western drugs companies into stepping up research into diseases found mainly in very poor countries and selling them medicines at discounted prices. But the results so far have barely dented the problem. Other solutions are needed. Some can come from more innovative co-operation between business, aid organisations and community groups, notably to improve health systems and medicines supply. Philanthropic bodies, such as the Bill & Melinda Gates Foundation, can contribute towards the cost. But the scale of market failure also calls for a much greater commitment of public resources, to promote the development of treatments for diseases that are particularly common in poor countries and help pay for them.

United Nations members have pledged to ensure poor countries' access to affordable essential medicines, in partnership with industry. Better ways to honour that pledge must be found. Trade bullying of the weak by the strong is not one of them.

Copyright The Financial Times Limited 2006

MSF PRE RELEASE: WHO STICKS HEAD IN SAND OVER HIGH COST OF NEWER AIDS DRUGS

Must act to ensure long-term quality care for people with HIV/AIDS

TORONTO, 14 August 2006 – After nearly six years of providing antiretroviral treatment in developing countries, the international medical humanitarian organization Médecins Sans Frontières (MSF) expressed dismay at the political complacency surrounding the need to ensure that newer AIDS medicines are accessible for people living with HIV/AIDS in developing countries.

Data released by MSF at the XVI International AIDS Conference in Toronto clearly show how the high price of newer medicines is driving the cost of treatment up and threatening the sustainability of treatment programmes:

• in the MSF-supported programme in Khayelitsha, South Africa, 10% of patients at 3 years and 16% at 4 years need to switch to second-line; however, second-line treatment is five times more expensive than first-line.

• in Nigeria 8% of patients on treatment for 18 months need second-line, which costs over seven more than first line ($US 200 vs $US 1,473).

• in Guatemala, a second-line regimen costs US$6500 – 28 times more than the first-line.

The World Health Organization’s latest antiretroviral treatment guidelines for resource-poor settings released at the Toronto Conference recommend newer generation ARVs for both first- and second-line therapy. Because of patent issues, many of these drugs are not available from generic manufacturers. As a result, originator companies are able to charge prohibitively high prices and are often slow to make the drugs available in developing countries.

“We applaud the fact that WHO has expanded the drug formulary to include newer drugs into their guidelines. However, no mechanism exists to make those drugs available at a country level.” said Dr Alexandra Calmy of MSF’s Campaign for Access to Essential Medicines. “It is the responsibility of WHO to encourage governments to use the flexibilities in the WTO TRIPS Agreement, including issuing compulsory licenses to access generic drugs. Other actors, including the Global Fund and UNAIDS must also get serious about the fact that we’re facing a potentially major crisis unless they act now to bring down the cost of treatment.”

Generic competition has been a major engine driving down the price of first line drugs from over $US 10,000 per patient per year to under $US 140. Today, 50% of people in the developing world on ARVs rely on generic medicines from India. However, now that countries like India have to grant patents on medicines, sources of generic medicines are at risk of drying up.

Ensuring affordability of newer medicines is the only way to ensure long-term quality care for people with HIV/AIDS in the developing world. “I would not be alive today if I could not access second-line medicines,” says Ibrahim Umoru, a peer educator working for MSF in Lagos, Nigeria, who had to switch treatment in 2006 after having developed resistance to first-line. “I am in the very lucky minority. Most patients whose lives had been saved by first-line treatment will be abandoned the moment they need second-line drugs unless governments pull their heads out of the sand and start tackling this issue.”

COMPULSORY LICENSING SEEN CRUCIAL FOR TREATMENT

*By NATHAN FORD*

The convention centre for the XVI International Aids Conference in Toronto, Canada, looks like a giant shopping mall. Conveyor belts of people stream from one session to another, with celebrity names pulling the biggest crowds _ the two Bills (Clinton and Gates), Richard Gere _ as well as a whole host of UN acronyms and pharmaceutical companies. The general message conveyed by most is that things are going well, we just need more of the same. Activists and healthcare workers on the ground are more cautious about the claimed successes. The title of the conference, ''Time to Deliver'', appears to be directed at everything and no one. Amid the cacophony of press conferences and ever mounting mass of progress reports, statistics, and press clipping comes a report, ''The Economics of Effective Aids Treatment: Evaluating Policy in Thailand'', released by the World Bank, that sends a very clear wake-up call to the Thai government.

The report is the result of a three-year evaluation of the Ministry of Public Health's efforts to expand access to anti-retroviral therapy. It warns that unless urgent action is taken to ensure continued access to newer medicines, the cost of treatment is going to rapidly rise to such an extent that Thailand's treatment programme, hailed a success worldwide, will begin to unravel.

Currently, over 80,000 people in Thailand are receiving treatment. This achievement was only made possible because of the local production of generic medicines by the Government Pharmaceutical Organisation, which has allowed treatment costs to come down to around 1,200 baht per month. According to the World Bank study, the treatment programme is highly cost-effective.

HIV/Aids is a chronic disease requiring lifelong treatment. This means ensuring access to a range of newer medicines to overcome side-effects that some patients may experience over time and the problem of drug resistance _ an inevitability in any HIV/Aids programme.

The problem is that these newer medicines are patent-protected, and much more expensive than the standard treatment that people start out with.

Unless something is done to bring down the price of newer medicines, the cost of the government programme will, according to the World Bank, increase five-fold in the next 15 years.

Take the example of one key anti-retroviral medicine, Lopinavir/ritonavir. Until recently, the price of Lopinavir/ritonavir, a key medicine used in the developed world for patients who develop resistance to the first line of treatment, was priced at around 125,000 baht per patient per year in Thailand. A group of Thai physicians and academics, together with patient groups and also Medecins Sans Frontieres (MSF), a non-governmental organisation which has been supporting HIV/Aids programmes in Thailand since 1995, has been pushing the manufacturer, Abbot, to lower the price of this drug since the beginning of the year. In a move motivated more by good PR than concern for public health, the company announced at the Toronto conference that it would lower the price of this drug to 88,000 baht. But this is still far too expensive for Thailand, meaning the drug remains out of reach.

Action can be taken to reduce these costs. The World Bank report points out that by exercising compulsory licensing to reduce the cost of second-line therapy by 90%, the Thai government would reduce its future expenditures by 127 billion baht up over the next two years. This is not an unreasonable goal: thanks to generic competition, the cost of first-line treatment has been pushed down from over 400,000 baht per patient per year to around 14,400 baht _ a 97% reduction in price. But doing so will provide strong political resolve, and it is not something the pharmaceutical companies and the US government are keen to see happen. The current US-Thai FTA negotiations threaten to seriously hamper access to affordable generic versions of these drugs. In these negotiations the US is pushing regulations that will limit the ability of the Thai government to override patents _ the very mechanism that has allowed Thailand to scale up treatment in the first place.

The World Bank has given Thailand a clear message that compulsory licensing should be considered if long-term care for people with HIV/Aids can be guaranteed. The recent removal of the WHO representative in Thailand for suggesting that compulsory licensing should be considered an option for securing affordable second-line medicines, shows how little progress has been made at the international level to confront these major political barriers. Thailand must show political strength to follow the World Bank recommendations. We cannot afford to do otherwise.

Nathan Ford heads the Medecins Sans Frontieres'

Manson Unit in London.

MSF DEMANDS ACTION FOR HALF A MILLION TRAGIC AIDS INFANTS

Agence France Presse -- English

Isabel Parenthoen

Urgent action is needed to treat more than half a million children in need of AIDS drugs and slash the price of these life-saving treatments, a top medical relief agency warned Tuesday.

Doctors Without Borders (Medecins Sans Frontieres, MSF), said at the world AIDS conference that only five percent of 660,000 children around the world who desperately need antiretrovirals -- the so-called "cocktail" of AIDS drugs -- had access to them.

The Nobel Peace Prize-winning agency also lashed giant pharmaceutical firms for failing to invest in pediatric AIDS drugs. Most child victims of AIDS live in developing countries, and caring for them does little to swell corporate profits, it charged.

Many infant AIDS victims live in crushing poverty in developing nations and contracted the disease as infants from HIV positive mothers who themselves have no treatment or ante-natal care, MSF said.

Tragically, without medical care, half the children born with HIV die before the age of two.

"We know that treating children works, but with better tools, we could be treating so many more," said Moses Masaquoi, a doctor with MSF in Malawi.

"We see the number of children born with HIV constantly growing in Africa, because expecting mothers don't have access to ante-natal care and children born to HIV positive mothers are largely lost to follow-up.

"It is an enormous frustration that we meet in our daily work."

More than 2.3 million children are living with HIV, the majority in sub-Saharan Africa, where the disease has cut a swathe through poverty-stricken populations.

Of these, 660,000 have an immune system that has been badly compromised by HIV, exposing them to the risk of killer infectious diseases such as tuberculosis and pneumonia.

MSF warned that international agencies already battling AIDS have been late to spot the devastating toll among infected children, and said if the situation is not tackled soon, remedies will come too late.

Alongside the warnings, MSF released two studies which showed good results among HIV infected children treatment with antiretroviral drugs.

The potential benefits from such therapies however are limited as pediatric medicines are overpriced -- costing up to six times more than equivalent drugs for adults, the agency said.

MSF said treating children was fraught with challenges. Diagnosis is tough because antibody-detection tests used for adults are inappropriate for new borns and test results take too long to process.

The lack of pediatric doses means caregivers must split antiretrovirals used for adults -- an imprecise method of treatment.

For children who weigh less than 10 kilogrammes (22 pounds), even that strategy will not work. The only treatment option is a syrup that the agency said is difficult to measure, tastes bitter and often needs refrigeration.

"Sometimes it is not possible to treat children in the villages because you can't refrigerate a certain type of syrup, and the other one that does not have to be refrigerated provokes anaemia," said Myrto Schaefer of MSF in Australia.

"And then you have a baby of less than three kilogrammes who already has anaemia, and you can't give it to him!"

Adding to the frustration is the fact that the drugs that do exist for children are vastly overpriced.

"Because the vast majority of infected children live in poor countries, most pharmaceutical companies are hardly investing in developing pediatric formulations," MSF said in a press statement.

Fernando Pascual, an MSF pharmacist, said the price of some infant formulations is reaching record levels.

MSF released data on Tuesday showing that given the right treatment, at the right time, the youngest victims of the AIDS epidemic which has killed 25 million people, can be saved.

Figures showed that among 3,754 children under 13 years old in 14 nations, 80 percent were alive and continuing therapy after 24 months, with few adverse side effects, and patients' immune systems were improving.

THAILAND: TRADE DEAL COULD THREATEN HIV/AIDS TREATMENT ˆ HEALTH EXPERTS

[This report does not necessarily reflect the views of the United Nations]

BANGKOK, 31 August (PLUSNEWS) - Health professionals and activists fear a proposed bilateral trade deal between Thailand and the United States will hit the availability and price of life-saving HIV/AIDS drugs.

Thailand has won international accolades for its efforts to provide anti-retroviral drugs to people who need them. However, Washington has been pushing Bangkok to adopt new, stronger protections for pharmaceutical companies‚ intellectual property rights as part of the trade deal. The measures would go beyond those agreed by developing countries with the World Trade Organisation (WTO).

Public health experts have warned that the new rules, if accepted, could hamper Thailand‚s ability to produce cheap generic versions of second-line HIV/AIDS drugs, which were needed for patients resistant to first-line treatments.

They believe the Thai government would have to pay for more expensive drugs from Western companies, seriously straining its health system and finances.

Dr Achara Eksaengsri, deputy director of research and development at Thailand‚s Government Pharmaceutical Organisation (GPO), said the government had to plan how it was going to support Thai patients.

An estimated 600,000 Thais are living with HIV/AIDS, with 80,000 receiving inexpensive anti-retroviral drugs produced by the state-owned GPO. They are distributed through Thailand's national health system.

Thailand, which has committed to making HIV/AIDS drugs available to all who need them, hopes to have 150,000 receiving the medication annually within two years.

Socially marginalised groups, including ethnic minorities who lack Thai citizenship, face serious obstacles obtaining the life-saving medication, which is not readily available to those not entitled to participate in the country‚s low-cost health care scheme.

However, improved access to the drugs has helped reduce Thailand‚s mortality rate from HIV/AIDS, with deaths plummeting by 79 per cent.

The push for a trade deal has increasingly concerned health and intellectual property rights experts.

William Aldis, then the World Health Organisation's (WHO) representative in Thailand, publicly warned in January that the survival of "hundreds and thousands of Thai citizens would be put at risk" if Bangkok accepted Washington‚s intellectual property right demands.

"The price of second and third generation HIV drugs will remain exorbitantly expensive," Aldis warned.

Washington was angered by Dr Aldis‚ views.

In late March, Lee Jong-wook, the head of the US delegation to the UN in Geneva, called on the WHO to register Washington‚s displeasure with Dr Adlis' comments. A day later, Dr Aldis, 16 months into what is normally a four-year tenure, was transferred, raising deep concerns in Thailand about US efforts to curb the WHO's independence.

Jiraporn Limpananont, a professor at Chulalongkorn University‚s Pharmaceutical Sciences department and expert on intellectual property right issues, said the application and influence of such political pressure was a "really bad sign".

"It will be a threat for people all over the world, not just for the Thai people," Limpananont said.

Under the WTO's trade related aspects of intellectual property rights - or TRIPS - agreements, countries can override drug patents by issuing a Œcompulsory license‚ to manufacture or import cheaper generic versions of drugs in a public health emergency. The TRIPS agreement also sets out basic rules for respecting patents.

But in a series of trade agreements deal - some completed, some, like Thailand‚s, still under negotiation - the US has been pushing its trade partners to accept a package of intellectual property rights measures well beyond their WTO commitments.

A US official has described the adoption of such measures as "a potential deal-breaker".

During a recent HIV/AIDS conference in Toronto, Medécins Sans Frontières (MSF) and other groups called for a moratorium on such measures. The groups demanded governments protect the public from the potential negative consequences of such bilateral trade deals.

Washington has urged Thai authorities to agree to grant pharmaceutical firms "compensatory" patent extensions in case of "unreasonable" delays by Thai authorities either approving drug patents, or approving a drug for market use.

The US has also sought five years of "data exclusivity" to prevent generic drug makers from using clinical trial data and other scientific information from another company to prove the safety and efficacy of a medication for five years after the product hits the market.

US officials claim the proposed measures would not limit Thailand‚s ability to meet its citizens‚ health needs, while Western pharmaceutical companies say the protections - especially the compensatory patent extension and the data exclusivity - are necessary to ensure they make sufficient profits to encourage future research and development.

But Dr Eksaengsri said the measures - especially the data exclusivity clause

- would have a material impact on the state‚s ability to produce cheap generic versions of second-line HIV/AIDS drugs.

"Many years ago, Thailand was not a target for Western multinationals to file patents," she said.

But while the lack of patents gave the GPO freedom to develop generic versions, new protections on scientific data could restrict the GPO‚s operations.

Analysts said drug firms like Gilead, which was expected to soon begin providing the drug Tenofovir at a heavily discounted price to Thailand, had been forced to drop prices because they knew countries could produce or import generic drugs.

"I think the multinational companies reduce prices to Thailand because the GPO has the capability to produce drugs ourselves," Dr Eksaengsri said. "But if we cannot do it because of the trade negotiations, they can set any price that they like."

A foreign trade expert, who asked not to be identified, said compulsory licensing was a good weapon.

"Developing countries can say, 'we are going to make this unless you cut your price'. It‚s a good weapon to use - that itself is a worthy thing to have,‰ the expert said.