Thailand Stuns Drug Firms With Generic Licenses

[pampal]

While the development of medications and treatments have made premature death less premature, AIDS still leads to premature death in all cases. AIDS is an incurable, fatal syndrome in 100% of its sufferers.

Any links to these alleged cases of a definitively HIV+ person not developing into AIDS?

Millions of people with HIV have not developed AIDS - now are you asking for the longest survivor because that is meaningless

Its like the yearly clinical trials for Hep B immumogenicity - we "Believe" the vaccine lcovers for life and each year we test a cohort and they are still immune and its pushed out another year but how can we ever prove its for life till these cohorts do not contract Hep B and they all die a happy old age in 40+ years time

The same type of study will be going on somewhere with HIV patients responding to the retrovirals I would have thought but as of today you can not make the statement either way.

Its impossible to say scientifically until absolutely everyone ie 100% of all people who have HIV die of AIDS that HIV is a death sentence though and many are still going strong 15+ years later.

It6 is just not a proveable statement either way - many Dr's now thing if HIV as just another chronic disease like Diabetes which can be managed (with the proviso its infectious)

Then again if you look at the references in the Vaccine book I refer to above the evidence points to the more infectious it is the higher the viral load so if these drugs do indeed lower the viral load to very low amounts the person might not be as infectious as with a high viral load but must still practice safe sex.

I hope I have not rambled too much

Unfortunately, until such time as people have survived to a "happy old age," AIDS remains as I have reluctantly described.

Until such time as people have survived to a "happy old age," HIV+ remains as I reluctantly described as always leading to AIDS. While its encouraging that people have not developed AIDS for 16 years (per above link) and a few have even gone a little further, it remains an inadequate time.

In the history of diseases, it is a relative newcomer and much needs to be done to seek even better treatments, but as of now, no one has been cured of AIDS... no one has survived to a "happy old age" with AIDS, and no one that is HIV+ has lived to a "happy old age" without developing AIDS... thus my initial statement ... reluctantly stands true. I certainly hope for the day to come soon when it isn't.

* For the purposes of discussion, I'll accept your 40 years as the measurable amount of time to describe a "happy old age."

Magic Johnson of LA Lakers fame has been HIV +  since 1991 and he

hasn't gone into AIDS mode.

He looks healthy and is living is life well.

He must be in his late 40's or early 50's now.

[Meerkat]

Is this developing into a classic "Sovereign Nation stands up to Multinational Corporations" skirmish?

Thailand is only a small country (no bigger than France, and with only as many people as the UK), but there is the precedent of David having stood up to Goliath.

Three cheers for the Thai Government for having the guts that the French and UK (and other) Governments don't have.

Good luck to this older generation of Thais, taking on younger generations of the arrogant West.

If everyone took that attitude, there would be no new drugs produced to copy.

[sriracha john]

While the development of medications and treatments have made premature death less premature, AIDS still leads to premature death in all cases. AIDS is an incurable, fatal syndrome in 100% of its sufferers.

Any links to these alleged cases of a definitively HIV+ person not developing into AIDS?

Millions of people with HIV have not developed AIDS - now are you asking for the longest survivor because that is meaningless

Its like the yearly clinical trials for Hep B immumogenicity - we "Believe" the vaccine lcovers for life and each year we test a cohort and they are still immune and its pushed out another year but how can we ever prove its for life till these cohorts do not contract Hep B and they all die a happy old age in 40+ years time

The same type of study will be going on somewhere with HIV patients responding to the retrovirals I would have thought but as of today you can not make the statement either way.

Its impossible to say scientifically until absolutely everyone ie 100% of all people who have HIV die of AIDS that HIV is a death sentence though and many are still going strong 15+ years later.

It6 is just not a proveable statement either way - many Dr's now thing if HIV as just another chronic disease like Diabetes which can be managed (with the proviso its infectious)

Then again if you look at the references in the Vaccine book I refer to above the evidence points to the more infectious it is the higher the viral load so if these drugs do indeed lower the viral load to very low amounts the person might not be as infectious as with a high viral load but must still practice safe sex.

I hope I have not rambled too much

Unfortunately, until such time as people have survived to a "happy old age," AIDS remains as I have reluctantly described.

Until such time as people have survived to a "happy old age," HIV+ remains as I reluctantly described as always leading to AIDS. While its encouraging that people have not developed AIDS for 16 years (per above link) and a few have even gone a little further, it remains an inadequate time.

In the history of diseases, it is a relative newcomer and much needs to be done to seek even better treatments, but as of now, no one has been cured of AIDS... no one has survived to a "happy old age" with AIDS, and no one that is HIV+ has lived to a "happy old age" without developing AIDS... thus my initial statement ... reluctantly stands true. I certainly hope for the day to come soon when it isn't.

* For the purposes of discussion, I'll accept your 40 years as the measurable amount of time to describe a "happy old age."

Magic Johnson of LA Lakers fame has been HIV +  since 1991 and he

hasn't gone into AIDS mode.

He looks healthy and is living is life well.

He must be in his late 40's or early 50's now.

Then, he's been HIV+ for 16 years now so he's between a third of the way and half way to the 40 year mark.

[Plus]

What about claims that Thai copy of the drug is less effective and that HIV virus developed resistance to it, so that now Thais treated with Gipovir (sp?) initially to save costs now have to take a second line of drugs that are far more expensive than the initial patented drug? Will they make a cheap copy of that second line of drugs, develop resistance to it, then there will be no drugs to copy left, seriously.

It sound like a strong case against copying drugs in substandard factories.

How much of it is true? I've read at least two articles with these allegations.

[slimdog]

What about claims that Thai copy of the drug is less effective and that HIV virus developed resistance to it, so that now Thais treated with Gipovir (sp?) initially to save costs now have to take a second line of drugs that are far more expensive than the initial patented drug? Will they make a cheap copy of that second line of drugs, develop resistance to it, then there will be no drugs to copy left, seriously.

It sound like a strong case against copying drugs in substandard factories.

How much of it is true? I've read at least two articles with these allegations.

Like any drug the GPO/vir medication has it's good points and it's bad points.

The good points are:

Being a combination treatment, means that it is easy for the patients to take as prescribed (1 tablet every 12 hrs)

It's cheap enough to provide free of charge

For the majority of people it does what it is supposed to.

The Bad points:

The gpo tried to make a "one-drug-for-all medicine", which means that if someone builds up a resistance to one of the ingredients they have no choice but to go onto another form of medication.

Drugs like efavirenz (stocrin) are still classed as a first stage hiv medication, but they have to be taken with 2 additional medications which can be either seperate or in a combination tablet. The advantages of using medicines like stocrin are that various dosages or a combination of different stage one medications can be tried in order to get the required results.

Even when GPO/vir was first released they admitted that even should the medication be taken exactly as prescribed it was probable that it would only be effective for 5 - 7 years, for those who didn't take the medicine as prescribed, then the effictiveness was upto 2 years.

Edited February 15, 2007 by slimdog

[Plus]

How many people were affected percentage wise? How valid is the argument that cheap Thai generic medicine creates more problems than it solves? Is it because of substandard quality or would it be the case with patented drugs as well?

I understand that there aren't that many drugs available (and they should be cheap and generic, too) for those who developed drug resistance.

[HenryB]

Is this developing into a classic "Sovereign Nation stands up to Multinational Corporations" skirmish?

Thailand is only a small country (no bigger than France, and with only as many people as the UK), but there is the precedent of David having stood up to Goliath.

Three cheers for the Thai Government for having the guts that the French and UK (and other) Governments don't have.

Good luck to this older generation of Thais, taking on younger generations of the arrogant West.

If everyone took that attitude, there would be no new drugs produced to copy.

Any country could make new drugs however will they work. I think singers and actors in every country should start making their own drugs after all I see that they thin they are wonderful

[Prakanong]

What about claims that Thai copy of the drug is less effective and that HIV virus developed resistance to it, so that now Thais treated with Gipovir (sp?) initially to save costs now have to take a second line of drugs that are far more expensive than the initial patented drug? Will they make a cheap copy of that second line of drugs, develop resistance to it, then there will be no drugs to copy left, seriously.

It sound like a strong case against copying drugs in substandard factories.

How much of it is true? I've read at least two articles with these allegations.

You make a very good point - just because they can copy the compound the generics are often not as potent as the originals - the manufacturing process and equipment used is very important.

This is one reason in vaccines we do not have the "Patent cliff" that pharma does - entry costs are high and production facilities are not that easy to copy plus there is the adjuvent.

Edited February 15, 2007 by Prakanong

[Plus]

It's not my point, I just want to know how much truth is in this allegation. Personally I know next to nothing about HIV treatment.

[slimdog]

How many people were affected percentage wise? How valid is the argument that cheap Thai generic medicine creates more problems than it solves? Is it because of substandard quality or would it be the case with patented drugs as well?

I understand that there aren't that many drugs available (and they should be cheap and generic, too) for those who developed drug resistance.

It's difficult to come up with exact figures as to how many people are affected by resistance. One quite small study came up with the following:

According to assistant professor Dr. Wasun Chantrtita, a member of Mahidol University's faculty of medicine at Ramathibodi Hospital, a study of about 300 patients receiving the generic combination of three HIV/AIDS drugs found increasing resistance to the treatment. Forty-nine percent of patients were resistant to lamivudine, 39.6 percent to stavudine, and 58 percent to nevirapine. Resistant patients switched to a more powerful regimen costing Bt10,000 ($239 US) per month, compared to Bt1,000 ($24 US) for GPO-vir, developed by the Government Pharmaceutical Organization

source: http://www.thebody.com/cdc/news_updates_ar...resistance.html

As to your question about whether cheap Thai generic drugs have created more problems than they solve? Well for the people who have been prescribed the medication it was mostly GPO/vir or nothing. Do people get resistant to the original patented medicines? Yes but they are normally given alternative medications which the GPO/vir doesn't allow.

Lets hope that some form of co-operation can be initiated, the last thing that Thailand needs is for Pharmaceutical companies to stop providing needed drugs.

[cclub75]

in Asia/Africa where only the rich and not the average person can afford these life saving drugs.

-"National emergency" ? As ColPyat said, with Aids they could have a point (eventhough the mortality rate can not be compared with Africa). But drugs against heart diseases ? And even some antibiotics ?

-Compare Thailand with... Africa ? That's a utter joke. Thailand has money. Thailand has a medical system.

-The aim of this circus is to save... 24 millions dollars ? How many cars BMW has sold in Thailand in 2006 ? 3200. The foreign currency reserves of BOT has reached 65 billions USD...

-The health minister said to Reuters : "We have to do this because we have so many patients to treat with so little budget. We can't watch our people die and their patents have been here for so long". Big thai mouth, totally disconnected from reality.

The truth is : the thai elite is not willing to pay a little to save its citizen (I should write its slaves).

-The whole story can be compared with Capital control, FBA, Airport etc. Everything this gvt does is equal to a minigun aimed at their feet.

-Once again, Thailand's reputation is going to be tarnished.

[slimdog]

Whilst a lot of the figures point to doom and gloom, one thing which does have to be remembered is that Thailand's death rate from AIDS is actually comparable to first world countries such as U.K and France.

2004 - 2005 figures show approx 500,000 AIDS sufferers in Thailand

2004 - 2005 figures show approx 50,000 AIDS sufferers in the U.K

2004 - 2005 figures show approx 100,000 AIDS sufferers in France

Deaths due to AIDS in all these countries during this period was approx 1%. Obviously the numbers quoted are approx and could be out by as much as 100% for each country...

[wintermute]

I believe that patent theft will seriously hurt Thailand's future ability to procure new pharmaceuticals. These pharmaceutical companies are extremely powerful and they have their hands in many many things includings regular consumer goods and raw materials. I imagine that punitive actions will be taken in the corporate world through tariffs, "intellectual property" taxes, and export quotas for Thailand.

[ColPyat]

-The health minister said to Reuters : "We have to do this because we have so many patients to treat with so little budget. We can't watch our people die and their patents have been here for so long". Big thai mouth, totally disconnected from reality.

The truth is : the thai elite is not willing to pay a little to save its citizen (I should write its slaves).

Maybe the could have a higher budget if the would have increased the health budget instead of the massive increase in military budget.

[slimdog]

-"National emergency" ? As ColPyat said, with Aids they could have a point (eventhough the mortality rate can not be compared with Africa). But drugs against heart diseases ? And even some antibiotics ?

-Compare Thailand with... Africa ? That's a utter joke. Thailand has money. Thailand has a medical system.

-The aim of this circus is to save... 24 millions dollars ? How many cars BMW has sold in Thailand in 2006 ? 3200. The foreign currency reserves of BOT has reached 65 billions USD...

-The health minister said to Reuters : "We have to do this because we have so many patients to treat with so little budget. We can't watch our people die and their patents have been here for so long". Big thai mouth, totally disconnected from reality.

The truth is : the thai elite is not willing to pay a little to save its citizen (I should write its slaves).

-The whole story can be compared with Capital control, FBA, Airport etc. Everything this gvt does is equal to a minigun aimed at their feet.

-Once again, Thailand's reputation is going to be tarnished.

I'm not going to disagree with you on what you have stated. But for the record, I presume that the anti-biotics in question are probably going to be Bactrim which is one of the few anti-biotics which is good at clearing up pcp pneumonia (An AIDS related disease), and is also frequently given to people who have very low cd4 counts to assist their body's natural immune system.

[ColPyat]

I believe that patent theft will seriously hurt Thailand's future ability to procure new pharmaceuticals.

Sorry, but it is not patent *theft*, there are clear provisions under the WTO that allow countries in cases of national emergency to circumvent patent laws.

[Plus]

Drug companies will also find some WTO rules if they want to retaliate. The question is - would they want to? What would that achieve? Policy reversal? "Regime change" in Thailand? Bad publicity for themselves? The last one is more likely.

[Prakanong]

If a country cites a ublich health emergency there is no retaliation possible for drugs firms in the WTO Trips agreement.

With an infectious/contagious disease it is easier to make the case than for say heart disease which is often lifestyle.

Pharma selling cheaper to less developed markets is a win-win situation but the real fear is the drugs leaking back to higher priced developed markets.

I work in vaccines - not many copy cats there plus the majority are sold at a nominal price to developing countries and paid for by the likes of UNESCO and the EU

Edited February 15, 2007 by Prakanong

[dominique355]

I just came across this opinion published in The Nation by a specialist of the matter at issue:

http://www.nationmultimedia.com/2007/02/14...on_30026809.php

Looks like this is another hip shot from the Military Government, which will cost Thailand and the Thai taxpayer dearly.

[Plus]

That's one of the articles that prompted my question.

If the numbers given here are correct it looks like what was $24 two years ago cost 24+240 = 266 dollars for two patients (50% drug resistance). $130 per head in two years time, doesn't sound very cheap anymore. What was the cost of the original patented drug and it's resistance rate? Does it work out cheaper in the end? Did anybody calculated that beforehand? Did anybody took these calculations in account?

Why the quality of the drug wasn't raised to meet the standards? They had plenty of time.

I don't think addressing this kind of issues was high on the previous government agenda. Do people pay more now because someone wanted to make a big noise of making cheap drugs five years ago (or when the drug was lauched)?

I also doubt that the amount involved is as low as 24 million dollars. But again, the health system in Thailand has run deep into the red for the past five years, even 24 million is a big number when put into "costs saved" column.

Here's an interesting link on HIV vaccine development. I first saw it in the Nation (from AFP), and it was a bit more in-depth.

http://www.redherring.com/Article.aspx?a=2...tor=Biosciences

[MiG16]

out of curiousity....

how many here would be interested to attend a talk/seminar/discussion forum on this topic?

in bangkok.....

probably no charge or a very minimal amount.

and if you are interested...please do let me know of your background and why it interests you?

[slimdog]

No link I am afraid, but in todays edition of the Bangkok Post there was an article regarding efavirenz (stocrin)

US drug manufacturer Merck & Co announced a 14.5% reduction in the price of its HIV/Aids medicine efavirenz in Thailand and other countries hardest hit by the epidemic

The company said yesterday the price of the 600mg formulation of efavirenz had been reduced to US$ 0.65 per day or US$237.25 per patient per year, from US$0.75 per day. The new price is equivelent to 700 baht per patient per month.

[Jai Dee]

Thailand clarifies action on compulsory licensing

To counter criticism of its moves to override three drug patents held by international pharmaceutical giants, Thailand’s Public Health Ministry says it has published details of the official decisions to issue compulsory licenses for two AIDS treatments and a heart disease drug.

Health Minister Dr Mongkol Na Songkhla called a press conference Friday to launch the 80-page white paper outlining the government’s justifications and addressing critics’ concerns about the implications of such moves.

Dr Mongkol said that compulsory licensing was justified under the World Trade Organisation rules which allow governments to declare national emergencies and license the production or sale of patented drugs without the permission of the foreign patent owners.

According to the minister, Thailand’s annual health budget this year totals Bt170 billion, or 12 per cent of the national budget. Of this, Bt3.8 billion would be spent on treating people with HIV/AIDS alone. Unless prices were brought down, efforts by developing countries to widen access to necessary life-saving drugs would be in vain, he added.

“Medicine is ethical and moral goods, a necessity for life. You cannot treat it the same as other commodities. The right to life should prevail over commercial gains,” Dr Mongkol said.

Last month, the Public Health Ministry issued compulsory licenses for the heart disease drug Plavix, made by Bristol-Myers Squibb and Sanofi-Aventis and Abbott Laboratories' Kaletra to treat HIV/AIDS, after a similar move on another AIDS drug, Efavirenz, by Merck last November.

The licenses, which Thai health officials said would save the country up to 800 million baht ($24 million) a year, drew praise from AIDS activists but flak from Washington and the drug industry, which are urging the ministry to rescind them.

The three foreign pharmaceutical companies complained they were caught by surprise as the government overruled their patent rights without prior consultation or negotiation - a point strongly denied by public health officials who claimed they have repeatedly held talks with the patent holders over pricing, but without much progress.

In contrast, the compulsory licensing in November has allowed the state-owned Government Pharmaceutical Organisation to build up stocks of imported generic versions of Efavirenz – about 16,000 bottles so far.

The ministry’s white paper can be downloaded from its website at www.moph.go.th and the National Health Service Office’s website at www.nhso.go.th. A hard copy can be requested from the branches and headquarters of the National Health Service Office.

Source: TNA - 17 February 2007

[jdinasia]

Magic Johnson of LA Lakers fame has been HIV + since 1991 and he

hasn't gone into AIDS mode.

He looks healthy and is living is life well.

He must be in his late 40's or early 50's now.

Pardon me ..... but how do you know if Magic Johnson has moved from HIV+ to AIDS or not? I don't know his CD4 count ... what meds he is on etc etc! How would anyone know other than his Dr's etc?

Edited June 6, 2007 by jdinasia

[mumbu]

Edited June 7, 2007 by mumbu

[mumbu]

This thread mirrors the older one where I made a long post and I do not want to repeat it here.

Here are some more points:

1. Sanofi-Aventis is French, Roche is Swiss, Bristol and GK are Brittish. These are the names of companies mentioned on this thread. Thus, it is not just American patents are broken or considered to be broken by Thai junta installed government.

2. This year junta increased a military budget by more than one billion dollars. Only a very small fraction of this amount

could easily cover the cost of Aids medications in question. Judging from junta's successes in the deep South, the only justification for the increase of the military budget I can imagine if they plan to launch a war with Singapore (to return Thai satellites back).

3. The cost of inventing new drugs is getting much higher. Many new technologies are going to be involved which will make reproduction of new treatments very difficult (stem-cells research and other biotechnological breakthroughs).

That is where short-sighted actions of Thais (Brazilians who followed example of Thailand and broke the patent on eferenza) may back-fire. The drug companies may stop sharing forthcoming more advanced technologies with countries like Thailand and Thailand will not be able to reproduce it or buy generics.

4. In the shorter run US government already took some measures which will allow US to imposed tariffs on various Thai goods as a possible retaliatory measure.

I do not see how Thailand is going to win in the long run.

One hypothetical example. Thre is a fear that existing technologies for producing influenza vaccine may not be fast enough to track mutations of some potentially pandemic viruses like Bird flu. I know that thre is a government sponsored program in US to develop new technologies. I can imagine that such programs exist elsewhere.

What if US governmant will decide not to share such technologies with countries like Thailand? I am not expert here but what I am trying to say is that Thailand put itself in very dangerous waters. Thre are ways to punish it and temptation to do it very high taking into account the impudence with which junta is acting.

[jetjock]

This thread mirrors the older one where I made a long post and I do not want to repeat it here.

Here are some more points:

1. Sanofi-Aventis is French, Roche is Swiss, Bristol and GK are Brittish. These are the names of companies mentioned on this thread. Thus, it is not just American patents are broken or considered to be broken by Thai junta installed government.

2. This year junta increased a military budget by more than one billion dollars. Only a very small fraction of this amount

could easily cover the cost of Aids medications in question. Judging from junta's successes in the deep South, the only justification for the increase of the military budget I can imagine if they plan to launch a war with Singapore (to return Thai satellites back).

3. The cost of inventing new drugs is getting much higher. Many new technologies are going to be involved which will make reproduction of new treatments very difficult (stem-cells research and other biotechnological breakthroughs).

That is where short-sighted actions of Thais (Brazilians who followed example of Thailand and broke the patent on eferenza) may back-fire. The drug companies may stop sharing forthcoming more advanced technologies with countries like Thailand and Thailand will not be able to reproduce it or buy generics.

4. In the shorter run US government already took some measures which will allow US to imposed tariffs on various Thai goods as a possible retaliatory measure.I do not see how Thailand is going to win in the long run.

I have not read the previous threads on this topic but I found your point #4 very informative. In the US, the pharmaceutical industry has the biggest and most powerful lobby in Washington. It is always said that what the pharmaceutical industry wants-the pharmaceutical industry gets. Whether right or wrong, my guess is that the US will find ways to retaliate until the industry gets what it wants. In any event, it will be interesting to watch this play out.

[nick2k]

..the retaliation has already started. have you heard about what the shrimp association in the usa is doing? personally, I don't see why the usa should be buying shrimp from thailand if somebody in the usa can supply it. same with rice, and a whole host of other food products. if americans can provide it, why go outside the country?

american companies should be providing jobs to americans - FIRST!!!! ..before even considering other countries.

[nick2k]

I also think america should consider changing the laws on who can buy property in the usa. americans should be the only ones to own land. aliens should only have the right to lease land.

[Jai Dee]

US drugmaker Abbott, Thailand face off in AIDS drug patent stalemate

On the surface, it is a complex patent fight spanning thousands of miles (kilometers) and more than a dozen time zones.

But strip away the lawyers, government officials and fleet of executives, and the standoff between Thailand and Abbott Laboratories Inc. could determine how, and if, millions of people in developing countries get medicine in the future.

Thailand's government decided late last year to override a series of drug patents, but instead of creating a cheap solution to pay for medication for more than 500,000 Thai infected with HIV and AIDS, the military-installed government wound up embroiled in one of the most-watched patent disputes in recent years. Now it is blacklisted from receiving Abbott's new medications while faced with the prospect of economic sanctions.

"The stakes here are very high because many patients around the world are in need of newer drugs," said Michael Weinstein, president of the activist organization AIDS Healthcare Foundation, which supports the Thai government's decision.

At issue is how countries negotiate lower drug prices and how they use international trade rules to issue so-called "compulsory licenses" to scrap patents in favor of cheaper, generic medication. The debate also shows how vulnerable the pharmaceutical industry is to efforts by countries trying to override patents.

Health activists, meanwhile, applaud Thailand's action, saying compulsory licenses are a way for countries to cost-effectively treat the AIDS epidemic.

"Thailand's action, in our opinion, is exactly what developing countries should be doing to reduce the cost of medicines," said Rohit Malpani, trade policy adviser for the aid group Oxfam America.

The Thai action marked the first time a country used the measure for a "second-line" AIDS drug: Abbott's billion-dollar blockbuster, Kaletra. As HIV patients survive longer, people have become increasingly resistant to older first-line drugs. That means hundreds of thousands more patients will require second-line virus-fighting medicine by 2010 — drugs that can cost 10 times more than first-line treatments.

In Thailand, where the per capita income is $2,720 (€2,013) a year, patented Kaletra was sold for $2,200 (€1,628) a year before the company lowered its price tag to $1,700 (€1,258) in the fall.

Compulsory licenses are not illegal, but their use in medicine typically involves treating public health emergencies. After the Sept. 11, 2001, terrorist attacks, the U.S. threatened a compulsory license to ensure a supply of the anthrax-treating antibiotic Cipro.

Thailand's Public Health Minister Mongkol Na Songkhla said the decision to override patents is justified because the drugs' high cost constituted a health crisis. The country's AIDS budget — around $112 million (€83 million) — was only enough to pay for medicine for one-fifth of patients. The country has hinted cancer drugs could be next.

In response, Abbott pulled its seven drug applications pending before health regulators in Thailand — including one for Aluvia, a form of Kaletra developed for use in tropical countries — cutting off the country's 65 million residents from new medication developed by the North Chicago, Illinois-based company.

After issuing massive price cuts on Aluvia and Kaletra in dozens of developing countries, Abbott offered to resubmit a cheaper version of the drug to Thai regulators in exchange for continued patent protection.

"What motivated our action in Thailand was concern that compulsory licensing would be abused ever more widely, using HIV as an excuse," said spokeswoman Melissa Brotz. "Now that price has been taken off the table, it's clear that this continues to be about compulsory licensing and the potential for its abuse."

Company officials said they are continuing to negotiate with the Thai government, but so far the country has rebuffed any concessions.

"The excessively high drug prices have obstructed us from achieving real universal access," Mongkol said recently.

As the stalemate continues, experts said more countries could be emboldened by Thailand's strategy.

"It's a problem that will only increase," said Steve Brozak, an analyst with WBB Securities LLC. "The question becomes: Today HIV drugs, tomorrow, what?"

For drug companies, patents are an incentive to invest billions in future research and development and reward them for producing lifesaving products.

"This misguided focus on short-term 'budget fixes' could come at a far greater long-term cost, potentially limiting important incentives for research and development that are necessary to positively impact the lives of millions of patients worldwide," Pharmaceutical Research and Manufacturers of America President Billy Tauzin said in a statement.

Industry officials also caution cheaper, generic versions can be less effective or even unsafe for patients, especially in regions of the world where drug manufacturing is not stringently monitored.

Drug companies typically charge different prices for medication in various countries — sometimes giving away their products or selling them with little or no profit — depending on the average income of each nation.

The trend toward disregarding patents could become popular in middle-income countries in Asia and Latin America where tiered pricing means many drugs are more expensive than in poorer nations, but government officials say they are still unable to pay their share.

In early May, Brazil issued a compulsory license for Stocrin, a first-line AIDS medication made by Merck & Co., claiming a generic version known as efavirenz would save $240 million (€177 million) by 2012.

Brazil has threatened to override patents on HIV drugs before, including Kaletra's, but this marked the first time it followed through, even after Merck offered to cut its price by 30 percent.

Still, scrapping patents can carry costs — including threatened trade sanctions and the loss of access to a targeted company's medications.

This spring, the U.S. Trade Representative cited Thailand's "weakening of respect for patents" for its placement as one of a dozen countries on a "priority watch list." The designation could lead to sanctions if President George W. Bush's administration brings trade cases before the World Trade Organization.

AIDS activists, meanwhile, say Thailand is already receiving shipments of generic Kaletra. And observers say the standoff — and the questions it raises about access to medication in middle-income countries — may be far from over.

"I don't think anyone would argue that if there's a rampant AIDS epidemic in some poor country and they can't afford to buy the drugs, then the normal rules of commerce should be relaxed so people don't have to die," said Mark Waddell, a lawyer at Loeb & Loeb LLP who specializes in pharmaceutical patents. "No one is going to argue against that extreme of an example. But we're operating in a realm that's quite ambiguous."

Source: The Associated Press - Wednesday, June 6, 2007