Copy-cat Drugs

[chevykanteve]

This just out from the Chicago Sun Times. Interesting, to say the least.

Thailand violates drug patents for its own profit

May 5, 2007

BY PHILIP STEVENS

This week, the Office of the U.S. Trade Representative issued its annual review of the protection and enforcement of intellectual property rights across the world. Twelve countries with particularly egregious policies were placed on the report's Priority Watch List, and for the first time, Thailand was elevated to that classification.

This dishonor was expected. Over the last few months, the nation's military-appointed government has issued several ''compulsory licenses'' on patented medicines.

Citing a World Trade Organization rule that permits a country to breach patents during a ''national emergency,'' the Thai government has granted itself the right to produce copies of Kaletra and Efavirenz, two powerful HIV/AIDS antiretrovirals, and Plavix, the popular heart-disease drug. The government has claimed, with much praise from a broad coalition of health activists and nongovernmental organizations, that it would be unable to meet its commitment to universal health care without compulsory licensing.

The truth is that Thailand's decision has nothing to do with lowering costs or compassion. Instead, the Thai government appears to be violating patents for its own profit. And in doing so, the nation is putting Thai citizens at great risk.

Consider: Earlier this month, Abbott Laboratories announced that it would sell to Thailand and dozens of other low-income nations, Kaletra for $1,000 per patient annually. That's about 55 percent less than Kaletra's current cost and cheaper than every copy of the medicine available. In March, Merck similarly offered to drastically reduce the price of Efavirenz.

Yet Thailand has asserted that it will maintain compulsory licenses for both medicines.

Or look at the Global Fund, which recently announced that it would foot Thailand's entire bill for Efavirenz by purchasing a generic version of the drug from a World Health Organization-approved plant in India.

The Thai government rejected the Global Fund's offer, leaving Thai taxpayers to foot the bill for the drug's manufacture.

Clearly, this isn't about improving access to medicines for the Thai people. It's about establishing Thailand's state-owned drug manufacturer -- the Government Pharmaceutical Organization -- as a dominant regional manufacturer of copycat drugs. Only the GPO can sell copycat drugs to the Thai government, which excludes private manufacturers from receiving government contracts.

This leaves the GPO to reap all the cushy rewards, which flow right back to the government and provide further opportunities for the nation's politically connected to enrich themselves.

In 2005, the GPO made a profit of around $35.5 million and reinvested only about 2 percent of that sum into research and development. As one would expect, this money lines the pockets of Thailand's ruling class.

Further, when it comes to producing drugs, the GPO has a terrifying track record. In 2002, the Global Fund awarded Thailand $133 million to test and manufacture its locally produced HIV/AIDS medication, GPO-Vir.

Last August, however, the Global Fund was forced to withdraw its funding because the GPO's manufacturing facilities did not meet international standards and the GPO's drug had yet to gain WHO approval.

But it was too little too late. In July 2005, it emerged that GPO-Vir had caused a rise in drug-resistant AIDS cases because of its poor quality. Despite this track record, Thailand continues to administer GPO-Vir to its HIV/AIDS patients -- which, ironically, is making the virus even more deadly.

Yet instead of denouncing the Thai government's dangerous and self-interested policies, activist groups have urged it to go further and faster. Even worse, many U.S. lawmakers have piled on. Earlier this year, 22 members of Congress signed a letter to the U.S. Trade Representative expressing their support for Thailand's use of compulsory licenses.

The public-health impact, as the HIV/AIDS example suggests, will likely prove devastating.

By upgrading Thailand to the Priority Watch List, the U.S. Trade Representative has sternly condemned the Thai government's patent violations. U.S. policymakers should take this opportunity to trumpet the trade representative's report and denounce Thailand's behavior.

Philip Stevens is health program director at the International Policy Network, a London-based charity.

[KhunMarco]

This just out from the Chicago Sun Times. Interesting, to say the least.

Thailand violates drug patents for its own profit

May 5, 2007

BY PHILIP STEVENS

This week, the Office of the U.S. Trade Representative issued its annual review of the protection and enforcement of intellectual property rights across the world. Twelve countries with particularly egregious policies were placed on the report's Priority Watch List, and for the first time, Thailand was elevated to that classification.

This dishonor was expected. Over the last few months, the nation's military-appointed government has issued several ''compulsory licenses'' on patented medicines.

Citing a World Trade Organization rule that permits a country to breach patents during a ''national emergency,'' the Thai government has granted itself the right to produce copies of Kaletra and Efavirenz, two powerful HIV/AIDS antiretrovirals, and Plavix, the popular heart-disease drug. The government has claimed, with much praise from a broad coalition of health activists and nongovernmental organizations, that it would be unable to meet its commitment to universal health care without compulsory licensing.

The truth is that Thailand's decision has nothing to do with lowering costs or compassion. Instead, the Thai government appears to be violating patents for its own profit. And in doing so, the nation is putting Thai citizens at great risk.

Consider: Earlier this month, Abbott Laboratories announced that it would sell to Thailand and dozens of other low-income nations, Kaletra for $1,000 per patient annually. That's about 55 percent less than Kaletra's current cost and cheaper than every copy of the medicine available. In March, Merck similarly offered to drastically reduce the price of Efavirenz.

Yet Thailand has asserted that it will maintain compulsory licenses for both medicines.

Or look at the Global Fund, which recently announced that it would foot Thailand's entire bill for Efavirenz by purchasing a generic version of the drug from a World Health Organization-approved plant in India.

The Thai government rejected the Global Fund's offer, leaving Thai taxpayers to foot the bill for the drug's manufacture.

Clearly, this isn't about improving access to medicines for the Thai people. It's about establishing Thailand's state-owned drug manufacturer -- the Government Pharmaceutical Organization -- as a dominant regional manufacturer of copycat drugs. Only the GPO can sell copycat drugs to the Thai government, which excludes private manufacturers from receiving government contracts.

This leaves the GPO to reap all the cushy rewards, which flow right back to the government and provide further opportunities for the nation's politically connected to enrich themselves.

In 2005, the GPO made a profit of around $35.5 million and reinvested only about 2 percent of that sum into research and development. As one would expect, this money lines the pockets of Thailand's ruling class.

Further, when it comes to producing drugs, the GPO has a terrifying track record. In 2002, the Global Fund awarded Thailand $133 million to test and manufacture its locally produced HIV/AIDS medication, GPO-Vir.

Last August, however, the Global Fund was forced to withdraw its funding because the GPO's manufacturing facilities did not meet international standards and the GPO's drug had yet to gain WHO approval.

But it was too little too late. In July 2005, it emerged that GPO-Vir had caused a rise in drug-resistant AIDS cases because of its poor quality. Despite this track record, Thailand continues to administer GPO-Vir to its HIV/AIDS patients -- which, ironically, is making the virus even more deadly.

Yet instead of denouncing the Thai government's dangerous and self-interested policies, activist groups have urged it to go further and faster. Even worse, many U.S. lawmakers have piled on. Earlier this year, 22 members of Congress signed a letter to the U.S. Trade Representative expressing their support for Thailand's use of compulsory licenses.

The public-health impact, as the HIV/AIDS example suggests, will likely prove devastating.

By upgrading Thailand to the Priority Watch List, the U.S. Trade Representative has sternly condemned the Thai government's patent violations. U.S. policymakers should take this opportunity to trumpet the trade representative's report and denounce Thailand's behavior.

Philip Stevens is health program director at the International Policy Network, a London-based charity.

So we should believe the WTO and a pharma-corporation? And obviously the activists are just a bunch of morons who don't know how the world works...

I reserve the right to have a doubt about who's the bad guy in this matter...

[SiamSquare123]

taskin is busy bribing journos i see.

[Mid]

By upgrading Thailand to the Priority Watch List, the U.S. Trade Representative has sternly condemned the Thai government's patent violations. U.S. policymakers should take this opportunity to trumpet the trade representative's report and denounce Thailand's behavior.

International Policy Network

It is a non-governmental, educational and non-partisan organization.

right ................................................

[Ulysses G.]

And obviously the activists are just a bunch of morons who don't know how the world works...

That is not at all impossible in these kind of matters.

I'm not sure who to believe!

[AlexLah]

Quote:

Consider: Earlier this month, Abbott Laboratories announced that it would sell to Thailand and dozens of other low-income nations, Kaletra for $1,000 per patient annually. That's about 55 percent less than Kaletra's current cost and cheaper than every copy of the medicine available. In March, Merck similarly offered to drastically reduce the price of Efavirenz.

Yet Thailand has asserted that it will maintain compulsory licenses for both medicines.

Or look at the Global Fund, which recently announced that it would foot Thailand's entire bill for Efavirenz by purchasing a generic version of the drug from a World Health Organization-approved plant in India.

Go here and find the truth: http://www.abbott.com/global/url/pressRele...elease_0442.htm

This governement is sick and just the same as Thaksin, only want to pocket themselves.

It is all about money isn'it.

It really make me angry

Alex

[chevykanteve]

And obviously the activists are just a bunch of morons who don't know how the world works...

That is not at all impossible in these kind of matters.

I'm not sure who to believe!

I agree with you, Ulysses. It's the reason I made the post. That is, I'm not sure who to believe either and it's best to weigh both sides of the story. But that doesn't mean that I don't sympathize with the HIV and heart patients, who should --if there is any justice in this world-- be able to access these medicines cheaply or even for free (yes, free: I apologize to the pharmaceutical industry for using that four-letter word).

[Prakanong]

taskin is busy bribing journos i see.

Are there reds under your bed too?

If you see Thasksins hand in this its time to strap yourself in the strait jacket and head home for help - if course just because you are paranoid does not mean they are not out to get you - ROFLMA

[kmart]

I'm not sure who to believe in this story either. Big Pharma have always persued an agenda of mega-profits, and use teams of consultants, ad agencies, and spin doctors (and governments of other countries) to push this. Thailand on the other hand has a deserved notoriety for not paying the piper when it thinks it can get away with it....

I just pity the poor people who really need those drugs.

[Maestro]

This leaves the GPO to reap all the cushy rewards, which flow right back to the government and provide further opportunities for the nation's politically connected to enrich themselves

Having had a deep insight into the workings of the GPO (Government Pharmaceutical Organisation) for decades I have tried hard to find fault with the above statement but have been unsuccessful.

In July 2005, it emerged that GPO-Vir had caused a rise in drug-resistant AIDS cases because of its poor quality. Despite this track record, Thailand continues to administer GPO-Vir to its HIV/AIDS patients -- which, ironically, is making the virus even more deadly.

This is really sad, but it is true that by law Thailand’s Food and Drug Administration cannot hold the GPO accountable to the same standards that all other pharmaceutical manufacturers in Thailand have to meet.

From the Medicines Act B.E. 2510 (1967), as amended by the Medicines Act (No. 3) B.E. 2522 (1979):

Section 12. It shall be prohibited to produce, sell or import modern drugs unless a licence has been obtained from the Licensor.

Section 13. The provisions of Section 12 shall not apply to:

(1) the production of drugs by Ministries and Departments in the duty to prevent and treat diseases, the Thai Red Cross Association and the Pharmaceutical Organization...

.

The Medicines Act (No. 5) B.E. 2530 (1987) added the following paragraph to Section 13, but regrettably the quality of GPO-produced products still has not increased to the minimum level required of private manufacturers in all respects:

Person exempted under (1) and (5) shall have to comply with the criteria, procedures and conditions prescribed under Ministerial Regulations.

--

Maestro

[longway]

its one buch of tossers screwing over another bunch of tossers, if it wasnt for the patients who will deal with the consequences i would find hard to give a ratz ass.

btw ipn is a corporate finded 'think tank', maybe they are right, but they are part of the pr machine.

[TAWP]

Both sides are ruthless and as such they are more then happy to point out the other sides agenda or shortcomings.

Infact, if you read the things posted carefully you will notice that they don't contradict eachother, they just focus on how bad the other side is.

And I think they are both right.

[dominique355]

Consider this: WTO, resp. TRIPS allows compulsory licensing of a patent in case of a national emergency. High cost of a products is certainly not a national emergency in a country where the patients pay only 20 Bath for the treatment and the government the rest.

The Thai government is (ab-)using HIV/AIDS patients for their own financial profits.

Also the Thai government has totally failed to explain where is the national emergency regarding the PLAVIX heart disease drug.

And how about this?

Every year about 20'000 people die in Thailand in road accidents. Yet the government charges 300% import tax on saver import cars, denying thus the lower income class to buy a save car. Instead they have to buy these crap pick-ups. If the Thai government is would really be concerned about the life and the safety of its people, then there is a national emergency worth doing something about it.

With the bad reputation of Thailand regarding the respect of Intellectual Property Rights, this compulsory licensing of pharmaceutical patents can only lead to a disaster for both the patients and Thailand as a country.

[chevykanteve]

Consider this: WTO, resp. TRIPS allows compulsory licensing of a patent in case of a national emergency. High cost of a products is certainly not a national emergency in a country where the patients pay only 20 Bath for the treatment and the government the rest.

The Thai government is (ab-)using HIV/AIDS patients for their own financial profits.

Also the Thai government has totally failed to explain where is the national emergency regarding the PLAVIX heart disease drug.

And how about this?

Every year about 20'000 people die in Thailand in road accidents. Yet the government charges 300% import tax on saver import cars, denying thus the lower income class to buy a save car. Instead they have to buy these crap pick-ups. If the Thai government is would really be concerned about the life and the safety of its people, then there is a national emergency worth doing something about it.

With the bad reputation of Thailand regarding the respect of Intellectual Property Rights, this compulsory licensing of pharmaceutical patents can only lead to a disaster for both the patients and Thailand as a country.

"..is certainly not a national emergency in a country where the patients pay only 20 Bath for the treatment and the government the rest..." FOR AIDS DRUGS? REALLY??

[Maizefarmer]

Now now -lets be careful what we say about the current junta - remember it wasn't to long ago forum members had anything positive said (however ridiculous it was) allowed to remain on the forum, and anything that questioned the junta qucikly removed (however valid it was).

This of of course is much the same junta - sorry, government - in place to day.

If there is even a kernal of truth comments to date on the subject - it smacks of nepotism. The same old story: the cheeta doesn't change it's spots - and fom generation to generation they're just slightly re-arranged.

The other side of the coin is of course the prices charged by drug companies - in many cases quite out of context with what most Asians could be expected to pay - and that is what this is all about: drug companies who push the boat out then whinge when Asian goverments re-act.

It's fine balance between pharmacuetical production because you care about people, and a marketing stratergy to make as much money as possible.

American citizens will understand that - back home in the States we are subject to drug prices that the rest of the world would not be able to comprehend and some cases 5 to 10 times what they cost in Europe, and 10 - 20 times what they cost in Thailand. Actualy the USA accounts for about 5% of world drug sales, but around 25% of world drug profits!

MF

[chevykanteve]

Now now -lets be careful what we say about the current junta - remember it wasn't to long ago forum members had anything positive said (however ridiculous it was) allowed to remain on the forum, and anything that questioned the junta qucikly removed (however valid it was).

This of of course is much the same junta - sorry, government - in place to day.

If there is even a kernal of truth comments to date on the subject - it smacks of nepotism. The same old story: the cheeta doesn't change it's spots - and fom generation to generation they're just slightly re-arranged.

The other side of the coin is of course the prices charged by drug companies - in many cases quite out of context with what most Asians could be expected to pay - and that is what this is all about: drug companies who push the boat out then whinge when Asian goverments re-act.

It's fine balance between pharmacuetical production because you care about people, and a marketing stratergy to make as much money as possible.

American citizens will understand that - back home in the States we are subject to drug prices that the rest of the world would not be able to comprehend and some cases 5 to 10 times what they cost in Europe, and 10 - 20 times what they cost in Thailand. Actualy the USA accounts for about 5% of world drug sales, but around 25% of world drug profits!

MF

"..American citizens will understand that - back home in the States we are subject to drug prices that the rest of the world would not be able to comprehend..."

I'm American, but I do not and can not empathize with and/or otherwise appreciate that point. I spent some years in England on a British post-grad scholarship and during that time had several medical problems which the National Health Service took care of successfully and for free. The American AMA and their congressional "lobby boys" have Americans so hood-winked about health service that it's astounding.

[longway]

With the bad reputation of Thailand regarding the respect of Intellectual Property Rights, this compulsory licensing of pharmaceutical patents can only lead to a disaster for both the patients and Thailand as a country.

it may happen, but probably not. its sad that the thai govt is apparently doing this for the money, but i am not sure what is the truth with the propaganda being published by both sides.

at the end of the day is this dispute not a healthy thing, drug companies have a monopoly on life saving drugs and inevitably try to make as much money as they can off them, if there is a countervailing force that forces drug companies to compromise, then it is a sign there is a reasonable balance of power between drug company customers and the drug producers. they both need each other.

btw why are drug prices so high in the usa?