Thailand Stuns Drug Firms With Generic Licenses

[george]

Thailand stuns drug firms with generic licenses

BANGKOK: -- Thailand's army-installed government has issued licenses for cheap generic versions of a heart disease and an AIDS drug, the health minister said on Thursday, dealing a shock blow to foreign pharmaceutical firms.

"The laws have been signed and they are now effective," said Mongkol na Songkhla, who became health minister after a September 19 military coup. He cited the ballooning costs of treatment as the reason for the move.

"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," he told Reuters.

Under World Trade Organization rules, a government is allowed to declare a "national emergency" and license the production or sale of a patented drug without the permission of the foreign patent owner.

Drug companies reacted angrily to the announcement, saying they had been kept in the dark, and urged Mongkol to reconsider a decision they said could lead to many firms leaving the country.

"No company has received any contact," said Teera Chakajnorodom, President of the Pharmaceutical Research and Manufacturers Association (PReMA), an industry umbrella group. "It has stunned our industry."

"We've heard it's not just HIV drugs, it's also cancer drugs and cardiovascular drugs," he said. "This is very new and goes very far."

BLOW TO INVESTORS

Confusion remained about what drugs were affected.

Mongkol said the drugs were HIV-AIDS and heart disease treatments but declined to confirm newspaper reports they were Abbott Laboratories' Kaletra, and Plavix, a blockbuster anti-clotting agent sold by Sanofi-Aventis and Bristol-Myers Squibb.

In November, two months after the army's removal of Prime Minister Thaksin Shinawatra, the interim government issued its first compulsory license, to make a generic version of Efavirenz, an anti-retroviral.

That decision drew a swift riposte from U.S. drug maker and patent holder Merck & Co Inc. By contrast, AIDS activists applauded Bangkok for taking a bold stance.

The widening of compulsory licensing is another blow to foreign investors still reeling from capital controls imposed in December to stem a rise in the baht and a proposed tightening of laws governing overseas firms in Thailand.

PReMA said it had written to Prime Minister Surayud Chulanont on Tuesday asking that no more compulsory licenses be introduced beyond the one covering Efavirenz.

However, Mongkol, who met Sanofi-Aventis bosses on Wednesday, appeared to have brushed aside the plea and accused the industry of making excessive profits.

"They are reaping colossal benefit from us," he said, adding that copycat versions of the drugs from Chinese or Indian firms would cost as little as 10 percent of their original price.

Plavix is Bristol-Myers Squibb's biggest-selling medicine, with annual sales of $6 billion before a copycat Canadian-manufactured version hit the market briefly in August.

Paul Cawthorne, head of Doctors Without Borders in Thailand, said the government was spending 11,580 baht ($330) per patient per month for Kaletra and could cut that bill by two thirds if it switched to a generic manufacturer.

"That's a perfectly legal method for them to ensure access to essential drugs for Thai people," he said.

-- Reuters 2007-01-25

[ColPyat]

Under World Trade Organization rules, a government is allowed to declare a "national emergency" and license the production or sale of a patented drug without the permission of the foreign patent owner.

With AIDS they definately do have a case in declaring 'national emergency'. And in this regard it is the right decision. But the specific drugs have to be named.

But including medicine for heart deseases they don't have a case, and they will face justified criticism that will weaken their very strong case with AIDS drugs.

This could be handled far better.

[Dupont]

These drugs just materialised as well!

Nobody invented, researched, tested, trailed them, they just popped up so nobody should feel bad about stealing them. Mind you, if you had to rely on invention as opposed to copying and plagurism, we wouldn't have the wheel here yet.

Popped up, just like a load of tit for tat tariffs are going to pop on on Thai imports to the States.

I just hope that the USA recognises that poor people farm rice and that they try and not affect the poorest of our people.

Hub of counterfeiting anyone?

Edited January 26, 2007 by Dupont

[Mobi]

Under World Trade Organization rules, a government is allowed to declare a "national emergency" and license the production or sale of a patented drug without the permission of the foreign patent owner.

With AIDS they definately do have a case in declaring 'national emergency'. And in this regard it is the right decision. But the specific drugs have to be named.

But including medicine for heart deseases they don't have a case, and they will face justified criticism that will weaken their very strong case with AIDS drugs.

This could be handled far better.

That's the whole point isn't it?

Whatever these guys do - even if they have some justification - they only succeed in pushing things through in the most ham fisted fashion.

I wouldn't want to begin to argue the case for generic drugs in the developing world vs the super rich drug companies. That one is a can of worms. But with a little aforethought, the matter could have been handled in a much more delicate and diplomatic manner.

It's almost as though they really don't give a toss and are enjoying sticking their fingers up at the rest of the world.

Edited January 26, 2007 by Mobi D'Ark

[buriramboy]

i have to agree with the junta on this one, if it costs a thai person $330 a month to buy these drugs which is more than a lot of Thais even earn, plus depending on their illness they might not even be capable of working, and if taking these drugs or not is a matter of life and death or even prolonging someones life and giving them a better life then go ahead. the drug companies are some of the greediest b@stards in the world, while i understand they need a lot of money for R&D they still make staggering profits, there is no need for them to charge the prices they do to countries in Asia/Africa where only the rich and not the average person can afford these life saving drugs. especially if a generic version of the drug can be produced for 10% of the cost, a big difference paying $330 a month as to $33 a month. I think the first thing they've done i agree with.

BB

[Old Man River]

The good news is that I will be able to continue to purchase pirated movies for more years to come without fear that the government will hold any more of their half hearted crackdowns.

[ColPyat]

These drugs just materialised as well!

Nobody invented, researched, tested, trailed them, they just popped up so nobody should feel bad about stealing them. Mind you, if you had to rely on invention as opposed to copying and plagurism, we wouldn't have the wheel here yet.

Popped up, just like a load of tit for tat tariffs are going to pop on on Thai imports to the States.

I just hope that the USA recognises that poor people farm rice and that they try and not affect the poorest of our people.

Hub of counterfeiting anyone?

Sorry, but there is a WTO law that does allow governments to circumvent patent laws in times of national emergency, and get their supply from generic manufacturers. It is legal, even though the pharma companies might not like it.

And in case of AIDS, Thailand definately qualifies under that law, having about 500 000 to 1 million HIV infected of a population of about 65 million, and many of them very soon in need of cheap generic anti-retroviral medication. A supply that is threatened by the soon to come FTA between Thailand and the US.

The US, for example, has used this law during the anthrax paranoia after 9/11. Brazil has once threatened to apply this law regarding AIDS, and as a result the pharma companies have slashed their prices in half overnight to avoid Brazil setting an example.

[manjara]

Under World Trade Organization rules, a government is allowed to declare a "national emergency" and license the production or sale of a patented drug without the permission of the foreign patent owner.

With AIDS they definately do have a case in declaring 'national emergency'. And in this regard it is the right decision. But the specific drugs have to be named.

But including medicine for heart deseases they don't have a case, and they will face justified criticism that will weaken their very strong case with AIDS drugs.

This could be handled far better.

Absolutely, could have been handled far, far better.

I'm not sure that they would consider themselves arrogant, but that's how it will appear to the outside world.

Thailand cannot shut itself off, or flaunt international conventions.

There seems to be a feeling I am seeing in some thais at least, that they don't need the approval or help of the outside world.

Stupidity or arrogance ... call it what you will, but in the end, Thai people will be the losers.

They would have been perfectly justified in issuing a license for an AIDS generic, but only after consultation with the patent holders. i.e. 'make it cheaper or we'll take away your patent!'

Including a whole list of drugs is just asking for trouble, and the justification 'We need to help our people' is fine in the local context, but these drugs would not be available at all if the research had not been done by these foreign companies.

You can argue the case against patents, but if you agree that compnies need to be compensated by an exclusivity period for the research investment, then the Thais should abide by that principle or negotiate based on a real need (e.g. epidemic)

I'm beginning to think that we need a clarication of the 'sufficiency economy' term. Some members of the goovernment seem to be taking a very strange interpretation of it!

[Old Man River]

It's almost as though they really don't give a toss and are enjoying sticking their fingers up at the rest of the world.

Hence, my comment the other day on the current wave of nationalism. They really do not care and it can be seen in many different industries and not just as it relates to the new foreign business laws. These things come in waves, and will change as soon as the impacts are felt.

[chanchao]

With AIDS they definately do have a case in declaring 'national emergency'. And in this regard it is the right decision.

But including medicine for heart deseases they don't have a case, and they will face justified criticism that will weaken their very strong case with AIDS drugs.

A lot more people in Thailand die from heart disease than from hiv/aids related illnesses.

[John K]

generic runways too? Meaning if they are going to do it let it be quality drugs and not sugar pills.

[ColPyat]

generic runways too? Meaning if they are going to do it let it be quality drugs and not sugar pills.

Generic drugs are quality drugs. GPO-Vir, for example, developed and manufactured in Thailand, is the cheapest generic anti-retro-viral medicine in the world, and has saved the life of tenthousands here.

[ColPyat]

With AIDS they definately do have a case in declaring 'national emergency'. And in this regard it is the right decision.

But including medicine for heart deseases they don't have a case, and they will face justified criticism that will weaken their very strong case with AIDS drugs.

A lot more people in Thailand die from heart disease than from hiv/aids related illnesses.

It's a bit more complicated than that.

A lot more people would die in Thailand of AIDS if Thailand would not supply HIV infected with free anti-retroviral medicine, mostly GPO-Vir, and a few variants. The next generation of anti-retrovirals though will not be as cheap anymore, especially when the US - Thai FTA will be countersigned. And most HIV infected will very soon need these as they will have developed resistence to GPO-Vir.

Conservative estimates by the WHO speak of 500 000 to 1 million infected, who, without access to free anti-retrovirals, will die within a period of not exceeding ten years time. Price structures of pharma companies make it impossible for the Thai government to subsidise free medication.

Thailand may be the most successful country in the region in battling AIDS, but a lot depends on continued efforts to supply the population with free medicine.

[hammered]

In the case of AIDS related drugs it is a good and sensible decision, and as Colpyat has pointed out actually legal under WTO rules. I wont cry for the pharma companies who will continue to make fortunes on a variety of other fronts some of which too may seem ethically as questionable as making huge profits on AIDS to some of us. The amount some of these companies lose by this is probably less than they donate to Bush, the republican party (and to a lesser extent dems) and congressional lobbyists to insure total protection for them and their system.

[aqua4]

i have to agree with the junta on this one, if it costs a thai person $330 a month to buy these drugs which is more than a lot of Thais even earn, plus depending on their illness they might not even be capable of working, and if taking these drugs or not is a matter of life and death or even prolonging someones life and giving them a better life then go ahead. the drug companies are some of the greediest b@stards in the world, while i understand they need a lot of money for R&D they still make staggering profits, there is no need for them to charge the prices they do to countries in Asia/Africa where only the rich and not the average person can afford these life saving drugs. especially if a generic version of the drug can be produced for 10% of the cost, a big difference paying $330 a month as to $33 a month. I think the first thing they've done i agree with.

BB

Boo Hoo. It is because of the stealing of patents that there is so little innovation in the world. Do you really think they are going to spend money on researching cures for AIDS when every Tom Dick and Harry can just simply declare an emergency and copy which ever drugs they want for free? What would encourage ANY company to spend billions on R&D when someone will just come along and copy it for free. Why bother in the first place?

All fine and well he says that drugs companies are greedy, yet it is those same companies that our pensions and retirement plans invest in. They turn a profit, we get better retirement benefits. Who is greedy, the companies or us?

THESE illnesses that we are talking about is not the Bird Flu, Ebola or the West Nile virus, they are PREVENTABLE. The WHO clause is being read like most people read the bible. They interpret it the way it suits their needs or desires. The clause was originally for national emergencies for diseases that were not only contagious but also beyond control in terms of spread. The clause was to prevent mass contamination. Heart disease in Asia, maybe they should encourage people to eat healthy and not stick hamburgers in their faces at every opportunity. Was it not Thailand that spoke last year about the state of children's diets that are making them obese? Has the use of condoms not been advocated in Africa?

We infringe on others rights, those same rights we expect others will uphold in respect of our businesses. Yet because we suffer from tunnel vision, we demand that others surrender their rights to their intellectual property. Why? Simple because it is a short term solution to our greed and ineptness.

[ColPyat]

Boo Hoo. It is because of the stealing of patents that there is so little innovation in the world. Do you really think they are going to spend money on researching cures for AIDS when every Tom Dick and Harry can just simply declare an emergency and copy which ever drugs they want for free? What would encourage ANY company to spend billions on R&D when someone will just come along and copy it for free. Why bother in the first place?

All fine and well he says that drugs companies are greedy, yet it is those same companies that our pensions and retirement plans invest in. They turn a profit, we get better retirement benefits. Who is greedy, the companies or us?

THESE illnesses that we are talking about is not the Bird Flu, Ebola or the West Nile virus, they are PREVENTABLE. The WHO clause is being read like most people read the bible. They interpret it the way it suits their needs or desires. The clause was originally for national emergencies for diseases that were not only contagious but also beyond control in terms of spread. The clause was to prevent mass contamination. Heart disease in Asia, maybe they should encourage people to eat healthy and not stick hamburgers in their faces at every opportunity. Was it not Thailand that spoke last year about the state of children's diets that are making them obese? Has the use of condoms not been advocated in Africa?

We infringe on others rights, those same rights we expect others will uphold in respect of our businesses. Yet because we suffer from tunnel vision, we demand that others surrender their rights to their intellectual property. Why? Simple because it is a short term solution to our greed and ineptness.

Excuse me, but i don't think anyone disagrees that drugs for heart deseases should not be part of that law.

But in case of AIDS the WTO law is applied correctly. AIDS is contagious, has reached national emergency proportions, and supply of necessary, life saving medicine is threatened.

[John K]

generic runways too? Meaning if they are going to do it let it be quality drugs and not sugar pills.

Generic drugs are quality drugs. GPO-Vir, for example, developed and manufactured in Thailand, is the cheapest generic anti-retro-viral medicine in the world, and has saved the life of tenthousands here.

Please correct me if I am wrong, but consistency is important. It occurs to me I have seen stories that quality control is asleep at the wheel or just management not wanting to toss a weak or bad batch. The drugs are good if they are consistent and to specification. Thinking you are getting a full dose when in fact it is less is very disturbing. It tends to be a little more important than someone watering down a keg of beer particularly when it comes to HIV.

Edited January 26, 2007 by John K

[ColPyat]

generic runways too? Meaning if they are going to do it let it be quality drugs and not sugar pills.

Generic drugs are quality drugs. GPO-Vir, for example, developed and manufactured in Thailand, is the cheapest generic anti-retro-viral medicine in the world, and has saved the life of tenthousands here.

Please correct me if I am wrong, but consistency is important. It occurs to me I have seen stories that quality control is asleep at the wheel or just management not wanting to toss a weak or bad batch. The drugs are good if they are consistent and to specification. Thinking you are getting a full dose when in fact it is less is very disturbing. It tends to be a little more important than someone watering down a keg of beer particularly when it comes to HIV.

You are wrong.

Tenthousands of Thais do survive very well on their regular dose of GPO-Vir, supplied for free. That started under Thaksin, by the way, after GPO-vir and treatment of AIDS and related deseases was included in the 30-baht scheme, and without that, we would have those tenthousands of Thais dead already, and very soon between 500 000 and a million more.

Nobody disagrees that it would be nice to supply HIV infected with state of the art original medicine, but a country like Thailand can not possibly afford this, unless you can persuade the pharma companies to slash their prices.

The question here is either to let people die, or supply them with generics. The answer should be simple.

[John K]

generic runways too? Meaning if they are going to do it let it be quality drugs and not sugar pills.

Generic drugs are quality drugs. GPO-Vir, for example, developed and manufactured in Thailand, is the cheapest generic anti-retro-viral medicine in the world, and has saved the life of tenthousands here.

Please correct me if I am wrong, but consistency is important. It occurs to me I have seen stories that quality control is asleep at the wheel or just management not wanting to toss a weak or bad batch. The drugs are good if they are consistent and to specification. Thinking you are getting a full dose when in fact it is less is very disturbing. It tends to be a little more important than someone watering down a keg of beer particularly when it comes to HIV.

You are wrong.

Tenthousands of Thais do survive very well on their regular dose of GPO-Vir, supplied for free. That started under Thaksin, by the way, after GPO-vir and treatment of AIDS and related deseases was included in the 30-baht scheme, and without that, we would have those tenthousands of Thais dead already, and very soon between 500 000 and a million more.

Nobody disagrees that it would be nice to supply HIV infected with state of the art original medicine, but a country like Thailand can not possibly afford this, unless you can persuade the pharma companies to slash their prices.

The question here is either to let people die, or supply them with generics. The answer should be simple.

I stand by my statement that poor human decision making happens when profit and greed step in. Per my first post I made mention of runways. From what I gather substandard materials were substituted while the difference in cost was pocketed by someone. It has nothing to do with available materials. The same mentality in making drugs is my concern.

Edited January 26, 2007 by John K

[Gravelrash]

If a Drug Company came up with a cure for Bird Virus and were charging US$10,000 per capsule, there would be plenty of people who could afford it. But do you imagine any Western country would sit back and let that happen in the event of a pandemic? No way. It is all realtive to a countrys' populations ability to pay.

Many drugs are exteremely expensive in this part of the world relative to income, but tough luck, let your populations die even though generics are available. I wonder how the hard liners would feel if they were on a meagre income and their child were dying? Propbaly think, ah well, must consider the shareholders.

[ColPyat]

I stand by my statement that poor human decision making happens when profit and greed step in. Per my first post I made mention of runways. From what I gather substandard materials were substituted while the difference in cost was pocketed by someone. It has nothing to do with available materials. The same mentality in making drugs is my concern.

You are a funny one.

First you have heard that maybe there might be substandard processes involved in the making of drugs, then you extrapolate that because the airport had substandard materials it must be so with drugs as well. But you completely ignore the issue that there are between 500 000 or a million lifes at stake here.

Maybe you should start learning about the issue of AIDS and generic manufacturers in Thailand. WHO, MSF and every other organisation does praise Thailand for the development of GPO-Vir, and its supply to HIV infected.

If you have a better practical solution, then i guess that there are many poeple very interested.

And unless you have that, you should please understand that AIDS is a personal issue with people, such as me, because several members of my wifes family, and one of my best friends, survive only for one reason - because of a free supply of GPO-Vir.

So, yes, with great personal satisfaction i do support the descision of the government to use the WTO law in order to keep HIV infected supplied with medicine that they otherwise would not get.

[Jingthing]

Hmmmm.

This is not only a rich country vs. poor country issue.

There are 50 million Americans without health insurance and without insurance health care is expensive beyond belief there. The American Medical Association has declared that many thousands of Americans die every year because of this.

Maybe they should form their own nation and break the patents ...

To people who want to place blame on suffering people with diseases, you really shouldn't go there. Health care is about caring and healing, not blaming.

I don't believe it is practical or desirable to totally divorce the profit motive from medical research; but clearly the systems we have in place worldwide have alot to be desired, and people are dying because of it.

If what the Thai government did saves lives, I think they have a moral superiority to the interests of the drug companies profits. A father who steals rice to feed his starving babies is not a bad man.

Edited January 26, 2007 by Jingthing

[ColPyat]

Maybe they should form their own nation and break the patents ...

There are many americans who do not agree on their country's policies in many areas, maybe another revolution there is not too bad of an idea.

[gjones]

Thailand's army-installed government has issued licenses for cheap generic versions of a heart disease and an AIDS drug

So What!

Typical American protectionism – it’s becoming so transparent, I really don’t think these corporate giants care about the rest of the world as long as their companies make enough money to keep their politicians in power so their companies can control the entire world.

These drugs should be free for all, especially for the kids, and the research money in producing these drugs should have come directly from the government rather than the so called protective private companies that are sponsored by western governments.

Money spent elsewhere such as “defence” or war mongering is easily available. However as we all know it’s a fact that governments rather spend the tax payer’s money seeking destructive material than for health care for their own people.

I sincerely hope Thailand will continue to make cheap generic versions of most drugs and either give them for free or at an affordable price to those who live here.

Realistically, local people of developing countries just cannot afford the western prices sought by these giant pharmaceutical companies.

I think Thailand has done something good for it's pople

[popshirt]

A very good example is the drug manufactured by Roche called Pegasys (peginterferon alfa-2a) which is used to treat hepatitis B. An inordinate number of Thais over the age of 20 are infected with the hepatitis B virus but treatment is out of reach for all but a favoured few who can afford it. The alternative is cirrhosis, liver cancer, liver transplant, or early death. I am paying for this treatment for a young Thai man who has been infected since birth (his mother is quite ill from the disease, his sister refuses to be tested, and his father has, fortunately, developed antibodies). The cost for this drug treatment--through Chulalongkorn Hospital--is 42,000 BAHT PER MONTH and treatment may be required for up to 1 year. Of course there is no insurance. And there are really no viable alternatives. I am told that in northeast Thailand, Hep B is very nearly endemic amongst those who were born before babies were routinely vaccinated. A responsible government certainly should consider a generic product at lower cost.

[John K]

I stand by my statement that poor human decision making happens when profit and greed step in. Per my first post I made mention of runways. From what I gather substandard materials were substituted while the difference in cost was pocketed by someone. It has nothing to do with available materials. The same mentality in making drugs is my concern.

You are a funny one.

First you have heard that maybe there might be substandard processes involved in the making of drugs, then you extrapolate that because the airport had substandard materials it must be so with drugs as well. But you completely ignore the issue that there are between 500 000 or a million lifes at stake here.

Maybe you should start learning about the issue of AIDS and generic manufacturers in Thailand. WHO, MSF and every other organisation does praise Thailand for the development of GPO-Vir, and its supply to HIV infected.

If you have a better practical solution, then i guess that there are many poeple very interested.

And unless you have that, you should please understand that AIDS is a personal issue with people, such as me, because several members of my wifes family, and one of my best friends, survive only for one reason - because of a free supply of GPO-Vir.

So, yes, with great personal satisfaction i do support the descision of the government to use the WTO law in order to keep HIV infected supplied with medicine that they otherwise would not get.

We are talking about two things here, first I don’t disagree with you so lets get that straight. All I am saying is inconsistency is as a result of humans deciding they want to take short cuts and make a bigger personal profit.

Simply appearance is everything in Thailand, substance is another story. I personally have taken antibiotics here that were total duds and did nothing, in fact the condition actually got worse. I got a second batch from another manufacturer and the problem went away almost over night. Same antibiotics, same dosage. There is a set standard that should not change from company to company. If there is that much inconsistency then that is a concern I am expressing.

[aqua4]

But in case of AIDS the WTO law is applied correctly. AIDS is contagious, has reached national emergency proportions, and supply of necessary, life saving medicine is threatened.

Are you joking? AIDS is a lifestyle disease not a contagious disease per se. It appears to be a national crises because governments have failed to implement preventative steps. They failed alternatively neglected to prevent its spread, so give us a free cure. What sort of mentality is that?

Edited January 26, 2007 by aqua4

[aqua4]

Please correct me if I am wrong, but consistency is important. It occurs to me I have seen stories that quality control is asleep at the wheel or just management not wanting to toss a weak or bad batch.

Correct. Let us push crappy cheap drugs onto the market that makes the disease drug resistant. WHAT? You think that the companies that make generic drugs don't make a profit. They do!

[Mid]

But in case of AIDS the WTO law is applied correctly. AIDS is contagious, has reached national emergency proportions, and supply of necessary, life saving medicine is threatened.

Are you joking? AIDS is a lifestyle disease not a contagious disease per se. It appears to be a national crises because governments have failed to implement preventative steps. They failed alternatively neglected to prevent its spread, so give us a free cure. What sort of mentality is that?

victim of a lifestyle disease

[aqua4]

The question here is either to let people die, or supply them with generics. The answer should be simple.

The answer is simple. Prevention is better than cure. What happened to "Mr Condom" in Thailand? Under the Thai campaign of prevention, the HIV rates in Thailand came down while everywhere else it was raising? What did happen?

Was that campaign not stopped by the exact same people who now claim the high moral ground by breaking intellectual property rights? Boo Hoo.