Thailand Breaks AIDS Drug Patent

[Jai Dee]

Thailand breaks AIDS drug patent

Thailand's Health Ministry has announced it will break the patent of the anti-retroviral drug Efavirenz used to combat HIV/AIDS to allow for local production of the medicine, media reports said on Thursday.

The Government Pharmaceutical Organization (GPO) was expected to start making a generic version of the drug within six months following the ministry's decision Wednesday, said The Nation newspaper.

The GPO already manufactures a generic version of Nevirapine, one of the AIDS cocktails used to combat the pandemic but thousands of HIV-poisitive cases are known to be resistant to the drug.

Without access to a cheap version of Efavirenz, thousands of Nevirapine-resistant AIDS patient will likely die.

Public Health minister Mongkol na Songkhla said Thailand will not be breaking any international laws by producing Efavirenz locally, although the move is likely to spark a protest from Merck, Sharp and Dohm, the US pharmaceutical giant that owns the patent on the drug.

"Of course, the company will do something to oppose this but we're doing everything according to not only the country's law but also international law," Mongkol said.

Thailand has recorded 1,088,692 HIV/AIDS cases since the pandemic was first detected in the kingdom in the early 1980s.

Of the recorded cases, some 534,065 have already died.

Source: DPA - 1 December 2006

[Jai Dee]

Owner of Aids drug criticises Thai move to break patent

BANGKOK, Dec 1 (TNA) - U.S. pharmaceuticals giant Merck & Co Inc., which holds the patent on Efavirenz, criticised Thailand's Public Health Ministry decision to issue a five-year licence for domestic production and imports of a generic version of the anti-retroviral drug.

In a statement issued in Bangkok by its local representative, Merck said the government had made no attempt to consult the company.

"Issuing a compulsory licence is a serious decision that should be taken as a last resort when no other means exist to access essential patented technology," Merck said in a statement. The company said the authorities should review its decision.

Dr Thawat Suntrajarn, director-general of the Disease Control Department, told reporters that the decision was taken after careful consideration. An official notification letter has been sent out to the patent holder.

He said under the arrangement, the patent holder Merck & Co will be paid a royalty of 0.5 per cent on sales in Thailand.

"It's up to the company to decide if it wants to sue us. But we are acting within the law and with the benefits of AIDS patients in mind," Dr. Thawat said.

Despite the protest from the company, many aids activists and public health organisations hailed Thailand's move. On Wednesday, the Public Health Ministry announced it would undertake its patent-breaking first compulsory licensing for the government to improve access to a key HIV/AIDS medicine, Efavirenz.

Source: TNA - 1 December 2006

[Jai Dee]

Breaking Efavirenz's patent irks Merck

The pharmaceutical company that owns the high-priced HIV drug Efavirenz issued a statement yesterday, blaming the Public Health Ministry for deciding to break the patent on the drug without any attempt to ask for permission - or consult the patent owner.

But local and international Aids activists praised the move, saying it would improve access to a key HIV drug.

Merck Sharp and Dohm (Thailand), a branch of pharmaceutical giant Merck that owns Efavirenz, said while it recognised the Thai government's legal right to break the patent, "compulsory licensing should be the last choice".

Merck had planned to meet with the government to find an appropriate solution. The statement was issued after the ministry said on Wednesday compulsory licensing would take effect immediately to allow access to the live-saving drug at a lower price.

Thawat Suntrajarn, director general of the Department of Disease Control said: "After a discussion with the Council of State, we agreed that the patent with Merck provided us a chance to import the drug from other sources. The company has been informally informed about the decision and they have a chance to legally challenge us.

"We need to break the patent because the price is too high for the government to afford, as new Aids patients increase every year by tens of thousands," he said.

Medecins San Frontieres (MSF) praised the decision, saying it would improve access to a key HIV/Aids drug.

"Efavirenz is currently patent-protected in Thailand, and the resulting monopolistic situation is limiting supply and affordability," said David Wilson, MSF's medical co-ordinator in Thailand.

"The patent holder, Merck, has on several occasions been unable to supply Efavirenz. This has resulted in treatment interruptions, forcing several hospitals to supply sub-optimal dual therapy," he said.

Source: The Nation - 1 December 2006

[Jai Dee]

Merck to offer AIDS drug price cut to Thailand

Merck & Co. Inc. will offer to cut the price of a key anti-HIV drug in Thailand in an attempt to stop that country's government from using cheaper generic suppliers and overriding the U.S. drug giant's patents, the Financial Times reported on its website Thursday.

A spokesman for Merck's local unit, MSD Thailand, said the company would seek talks with health officials to propose discounts or a "voluntary" license to the Thai government pharmaceuticals organization to produce generic versions of its drug, Efavirenz.

Merck's move follows Thailand's surprise decision this week to threaten a "compulsory license" for Efavirenz to overturn Merck's patents, raising fears by western pharmaceutical companies of a significant challenge to their intellectual property.

Source: The Nation - 1 December 2006

[pumpuiman]

Awesome. Stickin it to de man!!

[Oleg_Rus]

"We need to break the patent because the price is too high for the government to afford, as new Aids patients increase every year by tens of thousands," he said.

We have to use pirate software - the price is too high. But we can offer software companies free SomTam and special discount on ikki-sticky rice.

Ok, I have to rob ppl on the street - my cost of living is too high... But I can spare them taxi money to get back home almost safe

What a crap!

[Old Man River]

How easy is it to break down the chemical composition of patented drugs? Hasn't Pepsi been trying to break down the formula of Coca Cola for many years?

[hammered]

How easy is it to break down the chemical composition of patented drugs? Hasn't Pepsi been trying to break down the formula of Coca Cola for many years?

For many many years the Indian pharmaceutical industry was analysing and reproducing patented drugs in cheap local forms with a very high degree of success, so I guess it cant be that difficult. I'm not sure if India still do this since they were negotiating a free trade agreement with theUS which may now be signed.

I'm not sure about the coke/pepsi comparison but it may be harder as the beverages probably involve a more complex mix of substances than most forms of medication.

[Old Man River]

How easy is it to break down the chemical composition of patented drugs? Hasn't Pepsi been trying to break down the formula of Coca Cola for many years?

For many many years the Indian pharmaceutical industry was analysing and reproducing patented drugs in cheap local forms with a very high degree of success, so I guess it cant be that difficult. I'm not sure if India still do this since they were negotiating a free trade agreement with theUS which may now be signed.

I'm not sure about the coke/pepsi comparison but it may be harder as the beverages probably involve a more complex mix of substances than most forms of medication.

Thanks Hammered. I wonder how this impacts bird flu medicine. If there is an epidemic in Thailand, will the manufacturer want to supply Thailand or maybe it won't matter if the Ministry will just copy the formula anyway.

Politically, this is very naive. Government sanctioned robbery of intellectual property rights will cost the country in the future.

[Scott]

What is the brand name of the drug?

I also have mixed feelings about this. I think most people want to see HIV/AIDS patients given access to medication, but not at the expense of the long-term implications for breaking copyright laws. The companies, and they are businesses out to make money, have to put a great deal into research and development of new drugs. They might not do that if they can't reap the benefits.

Gov'ts, by and large, have been very ineffective in developing drugs.

The other problem here is that it is the typical Thai excuse of "oh, we are poor and can't afford to pay for them." Billions of Baht in corruption, and other silly things, but no money for necessary treatment.

[hammered]

How easy is it to break down the chemical composition of patented drugs? Hasn't Pepsi been trying to break down the formula of Coca Cola for many years?

For many many years the Indian pharmaceutical industry was analysing and reproducing patented drugs in cheap local forms with a very high degree of success, so I guess it cant be that difficult. I'm not sure if India still do this since they were negotiating a free trade agreement with theUS which may now be signed.

I'm not sure about the coke/pepsi comparison but it may be harder as the beverages probably involve a more complex mix of substances than most forms of medication.

Thanks Hammered. I wonder how this impacts bird flu medicine. If there is an epidemic in Thailand, will the manufacturer want to supply Thailand or maybe it won't matter if the Ministry will just copy the formula anyway.

Politically, this is very naive. Government sanctioned robbery of intellectual property rights will cost the country in the future.

To be honest if there is a bird flu epidemic I doubt any drug company would be able to refuse to supply the drugs. The public and politcial pressure would be too high. I did hear something a while back that many countries had already copied the Tamiflu drug due to bird flu fears although I think in some cases the manufacturer actually allowed this under licence kind of after the fact. Intellctual property laws and drugs related to epidemics are a difficult area for all involved.

My guess is that if a drugs company wanted to punish a country breaching ip laws it would more likely withhold, or price extremely highly more normal drugs used for non-epidemic treatments where there would likely be little outcry worldwide.

[Scott]

I think the problem with some of this is that for the drug companies, they can make sure the supplies are there for countries that are compliant and they can conveniently run out of drugs for less compliant countries.

I don't think they would do that because most of these companies are businesses and they are interested in money, so all things being equal those who can pay will get the drugs.

[Old Man River]

How easy is it to break down the chemical composition of patented drugs? Hasn't Pepsi been trying to break down the formula of Coca Cola for many years?

For many many years the Indian pharmaceutical industry was analysing and reproducing patented drugs in cheap local forms with a very high degree of success, so I guess it cant be that difficult. I'm not sure if India still do this since they were negotiating a free trade agreement with theUS which may now be signed.

I'm not sure about the coke/pepsi comparison but it may be harder as the beverages probably involve a more complex mix of substances than most forms of medication.

Thanks Hammered. I wonder how this impacts bird flu medicine. If there is an epidemic in Thailand, will the manufacturer want to supply Thailand or maybe it won't matter if the Ministry will just copy the formula anyway.

Politically, this is very naive. Government sanctioned robbery of intellectual property rights will cost the country in the future.

To be honest if there is a bird flu epidemic I doubt any drug company would be able to refuse to supply the drugs. The public and politcial pressure would be too high. I did hear something a while back that many countries had already copied the Tamiflu drug due to bird flu fears although I think in some cases the manufacturer actually allowed this under licence kind of after the fact. Intellctual property laws and drugs related to epidemics are a difficult area for all involved.

My guess is that if a drugs company wanted to punish a country breaching ip laws it would more likely withhold, or price extremely highly more normal drugs used for non-epidemic treatments where there would likely be little outcry worldwide.

That does make more sense and I do hope you are right.

[slimdog]

Firstly:

The the brand name of the drug as used in Thailand is Stocrin

There is no reason why the government needs to break down the composition of the drug, as by law, all parmaceuticals sold in Thailand have to be approved by the FDA. For a drug to be licenced for sale the company has to give a comprehensive collection of data including the exact make up of the drug, any side effects, results of field studies etc.

What Thailand is proposing to do isn't new. At the moment there are about 20 different drugs manufactured in Thailand using the compulsory licencing act including the GPO/Vir AIDS drug. This will be the first time THIS government has done this, and it is in full compliance of the WTO treaty.

With people living longer due to ARV medication, there are now more people who are building up a resistance to certain ingredients of combination therapy. hiv/Aids patients will still need additional medication to Stocrin and some of these are already available in Thailand in generic form.

[farangsay]

I applaud the Thai authorities' pragmatism.

While the economics and the extent of the problem might not

be at the same level as black Africa is it moral to let your

people die because your health service cannot afford the

price of western produced drugs ?

On the subject of a bird flu pandemic firstly I'm still not

sure this is not another scare story. Secondly , and here

comes my cynical side , I wonder if somewhere in the

back rooms of big pharma companies have financial

projections been maid of the profits they could make

should it actally happen.

PS JD Good posting , four reports before anybody got

a chance to get a word in.

Edited December 1, 2006 by farangsay

[Mid]

I'm not sure about the coke/pepsi comparison but it may be harder as the beverages probably involve a more complex mix of substances than most forms of medication.

nothing too it ...

sugar

water

caramel

caffeine

CO2

google it ..................

marketing 101

apologies for the hi jack

mid

[Erwin1011]

Breaking Efavirenz's patent irks Merck

"We need to break the patent because the price is too high for the government to afford, as new Aids patients increase every year by tens of thousands," he said.

Source: The Nation - 1 December 2006

The real question is: What is the cost charged to the patient.

I'm currently under cancer treatment. the medicines prescribed and provided by the hospital are incredibly expensive. Looking for alternative providers has resulted in a cost differential of 45%. That means the hospital takes minimum a 45 % mark up.The alternative provider also need to make a buck, so were talking total markup roughly 50%+

I don't know how the pricing structure is for HIV drugs, but probably not far from the pattern above.

[Ijustwannateach]

I have little sympathy for the drug companies, who have poured megabucks into treatment and almost nothing into vaccines- guess which one is more likely to generate the most profit for them? I don't mind at all if their profit motive for generating treatment medications is removed entirely, and it would help if governments worldwide gave them a strong kick in the pants (in return for continued patent protections) for developing VACCINES subsidised by said governments.

[Cyberstar]

Didn't read the body and didn't read the responding posts - merely reflecting on nothing but the headline: "Thailand Breaks AIDS Drug Patent".

Well done, Thailand!!!!!

[pyros]

There is no difficulty at all making the beverage like coca cola or pepsi or any other brand . The thing is that if you use the same formula , i will still taste different because you do not know or cannot use the same manufacturing data. To this you also have to add that if you use the same mix , u are more then probably breaking the law ( patent ) and where is the value of this product ( i mean , people like the original and the brandname , sothey use that ) .

With drugs there is another thing . It is much harder to make , but the formula itself is allways known. There are allways several ways to make a kind of chemical , one more productive then the other but still ... The profit is there , and nobody cares about what brand they are getting if the product is the same .

Now there is allways a thing to remember , the company making the product in the 1st place , did all the research and did the NDA which is very expensive . The copier doesn't have to do that so their costs are a lot lower .

So for me the copying of medicines is not fantastic ( a very big downturn in the long run ) but is also very acceptable in some cases ... like this .

[Prakanong]

I have little sympathy for the drug companies, who have poured megabucks into treatment and almost nothing into vaccines- guess which one is more likely to generate the most profit for them? I don't mind at all if their profit motive for generating treatment medications is removed entirely, and it would help if governments worldwide gave them a strong kick in the pants (in return for continued patent protections) for developing VACCINES subsidised by said governments.

There is an incredible amount put into vaccine research - Bill and Miranda Gates have also helped a lot in many area's including Malaria.

We now now have vaccines for cancers coming to market and being researched - Cervical Cancer this and next year while therapeutic vaccines for lung and breast cancers among others are under trial.

It is true in the past there have been no "blockbuster" vaccines ie sales of 1 billion USD per year but Cervarix is targeted to be the first. - There is profit in vaccines and the major companies are expanding massively in this area.

Developing a vaccine for HIV is very difficult and eveb with all the money in the world poured into it might still take 15-20 years - there are some things that can just not be speeded up. I can assure you though there are many dedicated people working full time with total funding working to develop a vaccine. The company developing it would certainly eant their money back - charge a lot in the western world and give away in the developing world - differential pricing would occur just as it does for many vaccines.

[Prakanong]

"So for me the copying of medicines is not fantastic ( a very big downturn in the long run ) but is also very acceptable in some cases ... like this ."

Totally agree - there is a Public Health proviso in the WTO Agreements to allow countries to break patent in the case of a public health need. The USA threatened Bayer with this in the case of Cipro during the anthrax scare.

However - a general breaking of patents is not something I support. It does cost massive amounts to get a drug to market - 800 - 1000 million USD. You can slag big pharma but they do have shareholders and unless you advocate social ownership it is them who fund research (so0cial ownership would just not work and its only multinational organisations on a massive scale have the resources that can do this - imagine the UN or other body trying to manage this?)

I must admit to an interest in this though - I work in clinical trials for a very large pharma company

[Gary A]

If you do a lot of Googling regarding the giant drug companies, I doubt you would be able to work up any sympathy for them. You will find that research comes in quite low on their expenditure list. The biggest expense is advertising closely followed by the OBSCENE salaries they pay their hundreds of executives.

[Prakanong]

Well the shareholders certainly had something to say about JP Garniers rise - in fact they blocked it.

The fact still remains though that pharma is a business and as such it must maximise shareholder returns whilst also keeping an eye on CSR.

At the end a business decision will come down to funding the drugs with the most potential profits - there are of course items where scientists do research for research sake - they have to be kept happy to and to attract the best some are given free reign to research what they interests them (within business boundaries of course)

Bottom line is - do you think public ownership of Pharma R&D would produce any results - they will be dead in the streets first.

[Johpa]

The real question is: What is the cost charged to the patient.

I'm currently under cancer treatment. the medicines prescribed and provided by the hospital are incredibly expensive. Looking for alternative providers has resulted in a cost differential of 45%. That means the hospital takes minimum a 45 % mark up.The alternative provider also need to make a buck, so were talking total markup roughly 50%+

I don't know how the pricing structure is for HIV drugs, but probably not far from the pattern above.

If the pharmaceutical companies were only marking up drugs 50% one would not have the same drug costing 50% less in Canada than in the US. In reality, many drugs are maked up much higher, often reaching 70-90% margins. To avoid misunderstanding, a drug that costs $1 to produce a dosage and is sold for $10 a dosage is selling at a 90% mark-up.

Read Dr. Marcia Angell's book The Truth About the Drug Companies. Dr. Angell is the former Editor-in-Chief of the New England Journal of Medicine and is now teaching at Harvard University. After reading her book you will not want to shed a single tear for these corporations and you might see that there is a global industry whose greed equals the greed of Mr. Taksin.

[richard10365]

I'm glad Thailand broke the drug patent. I think if the big drug corporations want to do business in Thailand, they need to price their medicine according to the cost of living in a village. Thats where most of their patients would come from anyway.

[Patex]

...To avoid misunderstanding, a drug that costs $1 to produce a dosage and is sold for $10 a dosage is selling at a 90% mark-up...

In my understanding this would be a 900% mark-up

For example: Develop, produce and distribute something costs 1$ this will be the 100% we refer to

[Ta22]

WHAT is WORST .

ROBBING DURING FIRE ? ( USA )

OR

STEAL WATER TO SAVE FIRE ( THAILAND )

go think about it .

.

[Choscura]

why hasn't this been done sooner? there should be a new law: if there is a disease which is resistant to available drugs, a disease which has no cure (such as aids, tuberculosis, etc) and somebody holds a patent on that drug, the patent is void where epidemics are concerned (such as the thousands mentioned in the article who have drug-resistant strains of AIDS). I'm not saying they should get NO money for it, I'm saying that their single right to production should be void and the process for making the drug must be made known to any country or people group that has desperate need to produce it.

apparantly, the ministry of health agrees with this

[Dakhar]

I do believe pharm co. are the biggest lobby group in America today. I have actually met a few pharmacist that hate pharm co. They talk about pharm co. as if they are evil.

What Thailand is doing is in my book wrong... I guess in this case, two wrongs make a right?