Thailand Stuns Drug Firms With Generic Licenses

[sriracha john]

Reuters Update:

Thailand is the first developing country to invoke a 'compulsory licence' under World Trade Organization (WTO) rules for a non-AIDS related drug.

"The laws have been signed and became effective on Friday," Health Minister Mongkol na Songkhla told reporters on Monday.

Kaletra is made by Abbott Laboratories and Plavix is sold by Sanofi-Aventis and Bristol-Myers Squibb.

"We have to do this because we don't have enough money to buy safe and necessary drugs for the people under the government's universal health scheme," Mongkol said.

Thawat Suntrajarn, head of the Disease Control Department, said the drugs would initially be imported from India and then produced by Thailand's state-owned drug maker, which would cut the price for Plavix by 90 percent to 6 baht per tablet.

Under WTO 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.

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

[Mid]

Reuters Update:

Thailand is the first developing country to invoke a 'compulsory licence' under World Trade Organization (WTO) rules for a non-AIDS related drug.

"The laws have been signed and became effective on Friday," Health Minister Mongkol na Songkhla told reporters on Monday.

Kaletra is made by Abbott Laboratories and Plavix is sold by Sanofi-Aventis and Bristol-Myers Squibb.

"We have to do this because we don't have enough money to buy safe and necessary drugs for the people under the government's universal health scheme," Mongkol said.

Thawat Suntrajarn, head of the Disease Control Department, said the drugs would initially be imported from India and then produced by Thailand's state-owned drug maker, which would cut the price for Plavix by 90 percent to 6 baht per tablet.

Under WTO 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.

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

Hey SJ ,

is that a verbatim quote ??

what a nasty piece of journalism

[ColPyat]

Hey SJ ,

is that a verbatim quote ??

what a nasty piece of journalism

Why is that so, i would be interested to hear the reasons?

GPO (government pharmaceutical organisation), by the way is the state owned manufacturer here. It is also the manufacturer who has developed the ground breaking generic GPO-Vir, with which most infected are here in Thailand are presently treated.

[Mid]

Hey SJ ,

is that a verbatim quote ??

what a nasty piece of journalism

Why is that so, i would be interested to hear the reasons?

GPO (government pharmaceutical organisation), by the way is the state owned manufacturer here. It is also the manufacturer who has developed the ground breaking generic GPO-Vir, with which most infected are here in Thailand are presently treated.

opens with ' non-AIDS ' related ,

moves to Kaletra ...............

down the bottom we get back on topic ............' Plavix '

then the corporate squeal about freight ,

with a barely disguised ref to ' copycat '

spelling edit

Edited January 29, 2007 by Mid

[ColPyat]

opens with ' non-AIDS ' related ,

moves to Kaletra ...............

down the bottom we get back on topic ............' Plavix '

then the corporate squeal about freight ,

with a barely disguised ref to ' copycat '

spelling edit

Yeah, brought into these terms, it is a bit of a terminology easily to misunderstand, and leading the thing into a direction that the reader might get the impression that this basically right decision was not so.

As much as i criticise the present government, in this case i believe they have made a very good decision, that should be applauded.

[sriracha john]

Hey SJ ,

is that a verbatim quote ??

what a nasty piece of journalism

Why is that so, i would be interested to hear the reasons?

GPO (government pharmaceutical organisation), by the way is the state owned manufacturer here. It is also the manufacturer who has developed the ground breaking generic GPO-Vir, with which most infected are here in Thailand are presently treated.

opens with ' non-AIDS ' related ,

moves to Kaletra ...............

down the bottom we get back on topic ............' Plavix '

then the corporate squeal about freight ,

with a barely disguised ref to ' copycat '

spelling edit

It is verbatim, I simply dropped out the paragraphs that were included in their earlier breaking report that was posted and in the update, I included only the changes.

In its totality:

Thailand allows copycat AIDS, heart disease drugs

By Reuters

BANGKOK - Thailand's army-appointed government has approved generic, copycat versions of Kaletra, an HIV-AIDS drug, and Plavix, a blockbuster treatment for heart disease, in a move likely to outrage international pharmaceutical companies.

Thailand is the first developing country to invoke a 'compulsory licence' under World Trade Organization (WTO) rules for a non-AIDS related drug.

"The laws have been signed and became effective on Friday," Health Minister Mongkol na Songkhla told reporters on Monday.

Kaletra is made by Abbott Laboratories and Plavix is sold by Sanofi-Aventis and Bristol-Myers Squibb.

"We have to do this because we don't have enough money to buy safe and necessary drugs for the people under the government's universal health scheme," Mongkol said.

Thawat Suntrajarn, head of the Disease Control Department, said the drugs would initially be imported from India and then produced by Thailand's state-owned drug maker, which would cut the price for Plavix by 90 percent to 6 baht per tablet.

Under WTO 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.

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.

---------------------

While Reuters does not have the journalistic integrity of the Bangkok Herald-Examiner... I would never alter their reports.

Edited January 29, 2007 by sriracha john

[Mid]

thanxs SJ

[SeanBangkok]

i hope those criticizing thai government dont buy bootleg dvds in thailand.

[ColPyat]

i hope those criticizing thai government dont buy bootleg dvds in thailand.

That is a different case.

The move of the Thai government is perfectly legal under international law, and WTO, which has a provision for exactly such a case in their patent right laws. The pharmaceutical companies and their apologists might not like it, but the new law here is legal by any standards. Thailand is just the first country of the developing world that has actually applied this law, but that has more to do with the fact that the pharma companies have a huge lobbying budget, and not the legal situation, which is clearly on the side of Thailand.

That is why the statements here of the ones opposing this move are slightly out of tune with reality.

[slimdog]

Thailand is the third country in the region to use compulsory licensing for cheaper antiretroviral drugs after Malaysia and Indonesia. In 2003 the Malaysian government issued a two-year government-use order for imports from India. As a result, the cost of treatment at government hospitals dropped by an average of 81% per patient per month.

Indonesia issued a government-use order in 2004 to manufacture two generic versions and this will run until the end of the patent terms in 2011 and 2012 respectively. The Indonesian government, as in the Thai case, awarded 0.5% of the net selling value to the companies concerned. The price of one of the drugs (lamivudine) fell from a retail average of US$225 in 2000 to the current US$28 under the government scheme that is supplied by the domestic production. The cheaper drugs are used to treat almost 50% of those in need of AIDS treatment in 2006, compared to 3.5% in 2003.

Studies by WHO in 2005 and the World Bank last August have sounded the alarm bells on rising AIDS drugs costs in countries including Thailand. Both WHO and the World Bank recommended that countries use the public-health safeguards in the TRIPS Agreement and the Doha Declaration.

Taken in part from: http://www.twnside.org.sg/title2/resurgence/196/cover5.doc

[Prakanong]

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.

Exactly right on the money there and I know you do not like Big Pharma.

AIDS drugs OK - the rest take them to the WTO and rip them a new ###### with sanctions or fines

Edited January 29, 2007 by Prakanong

[Prakanong]

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.

We have a vaccine for H5N1 - its been trialled and it works - further trials begin in Asia very soon ie next two months

It will not be 10k or anywhere near a dose - it will probably be given away near cost

Now how long it will take to produce the mutated virus vaccine in enough volumes is anyones guess - plenty of govt's have booked their supply well ahead of time and essential services get it first - and us working for the company of course.

Before its there retrovirals will be used - these are limited and production can not be ramped up that much

Lets see Thailand copy the vaccine quickly enough!!!!!!

[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.

Exactly right on the money there and I know you do not like Big Pharma.

AIDS drugs OK - the rest take them to the WTO and rip them a new ###### with sanctions or fines

It's just a question of being reasonable. I may not like the pharma companies (or any sort of corporation), but by being a fanatic nothing will improve. Anybody reasonable, and reasonably familiar with AIDS, will understand that there is a strong case here that over-rules pure profiteering. Even the WTO, not exactly known for its anti-corporation view , has therefore made this provision.

But with drugs against heart deseases, even though it might nice to have all humanity supplied with medicine for free one day, they just do not have a case along present regulations. And that is what counts, present regulations, and not what i believe should be right. It does nobody any service if regulations are abused, it just weakens the cause and obfuscates the issue.

[Prakanong]

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.

Exactly right on the money there and I know you do not like Big Pharma.

AIDS drugs OK - the rest take them to the WTO and rip them a new ###### with sanctions or fines

It's just a question of being reasonable. I may not like the pharma companies (or any sort of corporation), but by being a fanatic nothing will improve. Anybody reasonable, and reasonably familiar with AIDS, will understand that there is a strong case here that over-rules pure profiteering. Even the WTO, not exactly known for its anti-corporation view , has therefore made this provision.

But with drugs against heart deseases, even though it might nice to have all humanity supplied with medicine for free one day, they just do not have a case along present regulations. And that is what counts, present regulations, and not what i believe should be right. It does nobody any service if regulations are abused, it just weakens the cause and obfuscates the issue.

Should we not be providing free food to the starving before we supply free drugs for mainly developed country diseases like heart disease??????????

In the race to slag big pharma some on here lose the polt (not you)

These same people are hardly socialists themselves and often cite their big business credentials and how well they do in Thailand ;-))))

[Prakanong]

To add a bit of counter balance from Business Week this week

"GlaxoSmithKline: Getting AIDS Drugs To More Sick People

When Jean-Pierre Garnier took over as CEO of GlaxoSmithKline (GSK) seven years ago, the company's reputation on corporate social responsibility was at its nadir. As part of a coalition of 39 pharmaceutical companies, the drugmaker was suing Nelson Mandela's South African government for voiding patents on prescription drugs. Mandela's top priority was giving desperately sick patients access to HIV treatments, and GSK—the world's largest supplier—was standing in the way. "It was a public relations disaster," Garnier concedes.

The experience convinced Garnier that GSK should lead the crusade to improve access to medicine. In 2001, GSK became the first major drugmaker to sell its AIDS medicines at cost in 100 countries worldwide. And it has granted eight licenses to local companies to produce generic versions of these medicines.

In fact, GSK sells 90% of its vaccines, in volume terms, at not-for-profit prices to customers in the developing world. In 2005, it set a new paradigm in the vaccine industry. It chose Mexico over other, wealthier nations as the launch pad for Rotarix, a new vaccine against gastrointestinal rotavirus. "We wanted to get the vaccine to the children who needed it most," Garnier explains.

Creating medicines for the Third World while still posting a profit required fancy financial footwork. GSK has formed 14 different partnerships with the World Health Organization and other nongovernmental bodies, and with philanthropies such as the Bill & Melinda Gates Foundation. These programs provided funding for research on two different HIV vaccines, new treatments for tuberculosis, and a pediatric vaccine against malaria. In the latter case, a collaboration with the Gates Foundation and a group called the Malaria Vaccine Initiative led to a vaccine that provides a minimum of 18 months of protection against malaria. It could be on the market within four years. "The commitment [of GSK] to developing a malaria vaccine is outstanding," says Dr. Tore Godal, the former head of the Global Alliance for Vaccines & Immunization (GAVI).

Garnier says efforts such as these give the company several advantages over its rivals. Top scientists are drawn to GSK because they want their research to make a difference. Doing good, and being admired for it, also boosts general morale at the company, he says. "This creates a more aligned and engaged workforce, which helps us outperform our competitors."

[ColPyat]

To add a bit of counter balance from Business Week this week

Impressive article.

There is hope.

[Prakanong]

To add a bit of counter balance from Business Week this week

Impressive article.

There is hope.

I knew a lot of the vaccines were given away at cost or at a nominal fee but 90% is more than I knew about.

The Malaria vaccine will be the same and money will be made from the private market ie travellers and those that can afford it - same with many other vaccines in developing countries.

[Prakanong]

To add a bit of counter balance from Business Week this week

Impressive article.

There is hope.

There is also a list of countries where some HIV drugs are made available at pennies a day but the GDP per capita has to be quite low.

I know this as I tried to get them for an AIDS Orphanage in Thailand but could not - if it was Laos or Burma then OK.

[ColPyat]

To add a bit of counter balance from Business Week this week

Impressive article.

There is hope.

I knew a lot of the vaccines were given away at cost or at a nominal fee but 90% is more than I knew about.

The Malaria vaccine will be the same and money will be made from the private market ie travellers and those that can afford it - same with many other vaccines in developing countries.

Would be interesting to know in how many companies such a shift in policy happened. That is definately something that goes in the right direction.

[ColPyat]

To add a bit of counter balance from Business Week this week

Impressive article.

There is hope.

There is also a list of countries where some HIV drugs are made available at pennies a day but the GDP per capita has to be quite low.

I know this as I tried to get them for an AIDS Orphanage in Thailand but could not - if it was Laos or Burma then OK.

Which is sensible.

One big obstacle with countries such as Burma is that anti-retros need a proper network and control for successful distribution. These drugs cannot be given away as candy. Otherwise you will have the same happening as with antibiotics and malaria, though with much more fatal consequences - rapid resistence would make the few available drugs ineffective before new drugs can be made available.

[sriracha john]

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.

Exactly right on the money there and I know you do not like Big Pharma.

AIDS drugs OK - the rest take them to the WTO and rip them a new ###### with sanctions or fines

It's just a question of being reasonable. I may not like the pharma companies (or any sort of corporation), but by being a fanatic nothing will improve. Anybody reasonable, and reasonably familiar with AIDS, will understand that there is a strong case here that over-rules pure profiteering. Even the WTO, not exactly known for its anti-corporation view , has therefore made this provision.

But with drugs against heart deseases, even though it might nice to have all humanity supplied with medicine for free one day, they just do not have a case along present regulations. And that is what counts, present regulations, and not what i believe should be right. It does nobody any service if regulations are abused, it just weakens the cause and obfuscates the issue.

Should we not be providing free food to the starving before we supply free drugs for mainly developed country diseases like heart disease??????????

In the race to slag big pharma some on here lose the polt (not you)

These same people are hardly socialists themselves and often cite their big business credentials and how well they do in Thailand ;-))))

Can you elaborate on the "Aids drug-yes, Heart disease drug-no" stance?

Heart attacks kill many Thais, same as Aids and the medications used to treat the disease are prohibitively expensive for the average Thai.

Making them generic would have a big impact on Thailand, just in terms of numbers provided with life-sustaining medications.

My own stance would be to say "yes" to both.

Edited January 29, 2007 by sriracha john

[Prakanong]

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.

Exactly right on the money there and I know you do not like Big Pharma.

AIDS drugs OK - the rest take them to the WTO and rip them a new ###### with sanctions or fine as

It's just a question of being reasonable. I may not like the pharma companies (or any sort of corporation), but by being a fanatic nothing will improve. Anybody reasonable, and reasonably familiar with AIDS, will understand that there is a strong case here that over-rules pure profiteering. Even the WTO, not exactly known for its anti-corporation view , has therefore made this provision.

But with drugs against heart deseases, even though it might nice to have all humanity supplied with medicine for free one day, they just do not have a case along present regulations. And that is what counts, present regulations, and not what i believe should be right. It does nobody any service if regulations are abused, it just weakens the cause and obfuscates the issue.

Should we not be providing free food to the starving before we supply free drugs for mainly developed country diseases like heart disease??????????

In the race to slag big pharma some on here lose the polt (not you)

These same people are hardly socialists themselves and often cite their big business credentials and how well they do in Thailand ;-))))

Can you elaborate on the "Aids drug-yes, Heart disease drug-no" stance?

Heart attacks kill many Thais, same as Aids and the medications used to treat the disease are prohibitively expensive for the average Thai.

Making them generic would have a big impact on Thailand, just in terms of numbers provided with life-sustaining medications.

My own stance would be to say "yes" to both.

OK but under the TRIPS agreement - WTO - countries can break patent laws in the case of a public health emergency

USA threatened Bayer with this and Brazil did in the case of HIV drugs

Now if Thailand were to declare a public health emergency for heart disease and be able to defend it go ahead

Should then the UK and USA declare a diabetes public health emergency?

What next?

I know its a subtle argument but there has to be patent protection except where there is a true emergency ie AIDS / Bird Flu Mutations etc etc

[Prakanong]

To add a bit of counter balance from Business Week this week

Impressive article.

There is hope.

There is also a list of countries where some HIV drugs are made available at pennies a day but the GDP per capita has to be quite low.

I know this as I tried to get them for an AIDS Orphanage in Thailand but could not - if it was Laos or Burma then OK.

Which is sensible.

One big obstacle with countries such as Burma is that anti-retros need a proper network and control for successful distribution. These drugs cannot be given away as candy. Otherwise you will have the same happening as with antibiotics and malaria, though with much more fatal consequences - rapid resistence would make the few available drugs ineffective before new drugs can be made available.

Exactly - we could air drop tonnes a day into many places but it would do more harm than good.

You need a health care delivery system and infrastructure or its no use having the drugs in the first place if they can not get to the people who need them and those people do not remain compliant to the drug regimen.

I just missed 4 days hypertension tablets while travelling as the country I was in did not have my particular type - I am usually 100% compliant and know the importance more than most so you can see how many in the underdeveloped world miss their's.

[sriracha john]

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.

Exactly right on the money there and I know you do not like Big Pharma.

AIDS drugs OK - the rest take them to the WTO and rip them a new ###### with sanctions or fine as

It's just a question of being reasonable. I may not like the pharma companies (or any sort of corporation), but by being a fanatic nothing will improve. Anybody reasonable, and reasonably familiar with AIDS, will understand that there is a strong case here that over-rules pure profiteering. Even the WTO, not exactly known for its anti-corporation view , has therefore made this provision.

But with drugs against heart deseases, even though it might nice to have all humanity supplied with medicine for free one day, they just do not have a case along present regulations. And that is what counts, present regulations, and not what i believe should be right. It does nobody any service if regulations are abused, it just weakens the cause and obfuscates the issue.

Should we not be providing free food to the starving before we supply free drugs for mainly developed country diseases like heart disease??????????

In the race to slag big pharma some on here lose the polt (not you)

These same people are hardly socialists themselves and often cite their big business credentials and how well they do in Thailand ;-))))

Can you elaborate on the "Aids drug-yes, Heart disease drug-no" stance?

Heart attacks kill many Thais, same as Aids and the medications used to treat the disease are prohibitively expensive for the average Thai.

Making them generic would have a big impact on Thailand, just in terms of numbers provided with life-sustaining medications.

My own stance would be to say "yes" to both.

OK but under the TRIPS agreement - WTO - countries can break patent laws in the case of a public health emergency

USA threatened Bayer with this and Brazil did in the case of HIV drugs

Now if Thailand were to declare a public health emergency for heart disease and be able to defend it go ahead

Should then the UK and USA declare a diabetes public health emergency?

What next?

I know its a subtle argument but there has to be patent protection except where there is a true emergency ie AIDS / Bird Flu Mutations etc etc

What is it about Aids that it can be regarded as a "public health emergency" that can't be applied to heart disease? Is it the number of cases? The impact on family structure? The impediment on life style after diagnosis? The mortality rate?

Why is Aids considered a "true emergency"?

[ColPyat]

Why is Aids considered a "true emergency"?

I guess, nasty and cold as it sounds, it's a numbers game and it is about stability, less the individual human tragedy.

You have between 500 000 and one million infected, some even say that it could be up to 2 million (most in their most productive age), who, without the drugs would all die within latest ten years time, most though with 5 years. The desease is contagious, and apart from the human tragedy such a massive wave of sudden and avoidable death would not just be a massive economical challenge, but would also lead very possibly to severe civil unrest. Which then would destabilise the whole region, and would naturally lead to further spread of AIDS, if not an explosion such as in some areas of Africa.

Edited January 29, 2007 by ColPyat

[ColPyat]

To add a bit of counter balance from Business Week this week

Impressive article.

There is hope.

There is also a list of countries where some HIV drugs are made available at pennies a day but the GDP per capita has to be quite low.

I know this as I tried to get them for an AIDS Orphanage in Thailand but could not - if it was Laos or Burma then OK.

Which is sensible.

One big obstacle with countries such as Burma is that anti-retros need a proper network and control for successful distribution. These drugs cannot be given away as candy. Otherwise you will have the same happening as with antibiotics and malaria, though with much more fatal consequences - rapid resistence would make the few available drugs ineffective before new drugs can be made available.

Exactly - we could air drop tonnes a day into many places but it would do more harm than good.

You need a health care delivery system and infrastructure or its no use having the drugs in the first place if they can not get to the people who need them and those people do not remain compliant to the drug regimen.

I just missed 4 days hypertension tablets while travelling as the country I was in did not have my particular type - I am usually 100% compliant and know the importance more than most so you can see how many in the underdeveloped world miss their's.

And with AIDS keeping up the regimen is vital. If the drugs are taken not strictly very soon resistency to that particular combination is built up, and the supply of different drugs, espcially cheap ones, is very limited. We are still only at the beginning of effective drug therapy.

The possible fast cross border spread of resistent mutants is a concern, from what i have gathered by speaking with the experts.

Here in Thailand, if infected on treatment are not keeping up their regimen, they will get taken off the dose, and once failed in one program, it will not be easy to get back into it.

Education of the infected is very important. There are many different simply to understand booklets, even for children.

[Jai Dee]

Thailand breaks patents of HIV, heart disease drugs

Thailand has paved the way for generic production of two drugs, one to treat HIV/AIDS and the other for heart disease, effectively breaking their patents, media quoted a Thai official as saying Tuesday.

The decision was justified under international trade rules because the drugs' high cost constituted a crisis for the country's health sector, said Mongkol Na Songkhla, Thailand Public Health Minister.

"We ask for the understanding of pharmaceutical companies. Much of our affected population cannot afford your drugs and we want people to have access to the medicines that they need," Mongkol said. "We are willing to negotiate with the companies if they are willing to give some discounts for the import of their originals."

According to the World Trade Organization's agreements on intellectual property, a government may issue a compulsory license in case of a national public health emergency. Such action has been taken by several countries, most notably Brazil and India, especially in the case of HIV medicines.

The decision was applauded by aid agencies and activists who said it would improve the lives of thousands of people, and set an example to other countries facing similar problems.

"It is a brave decision, despite both anticipated pressure from industry and possible threats to withdraw investments," said Kannikar Kijtiwatchakul, a campaigner in Thailand for Medicines Sans Frontiers, or Doctors without Border who welcomed the government's move.

"The authorities have engaged in dialogue with companies before, but the discounts have been marginal. The licenses will benefit a lot of people and will set an example to other countries who face the same problem," said Kannikar Kijtiwatchakul.

Source: Xinhua - 30 January 2007

[ColPyat]

Another interesting article that i have to ponder about a bit, which confuses a already confused issue even more:

http://www.asiasentinel.com/index.php?opti...1&Itemid=34

Safe at Any Cost?

Daniel Ten Kate

24 January 2007

Thailand’s generic AIDS drugs don’t meet international standards and so questions about their efficacy linger

On its face, the issue seems black and white: In issuing a compulsory license to import or produce the generic second-line HIV/AIDS drug efavirenz on November 29—two days before World AIDS Day—Thailand’s military government valiantly signaled its intentions to fend off pressure from Big Pharma and supply sick patients with affordable antiretrovirals.

Who in good conscience can say that’s a bad thing?

Look a bit deeper, however, and shades of gray start to emerge. In Thailand’s case, these mostly surround the operations of the Government Pharmaceutical Organisation (GPO), the historically corrupt state enterprise under the Ministry of Public Health.

Under the compulsory license, the GPO has the right to import the drugs or produce them domestically until 2011. It will be able to supply no more than 200,000 Thai patients—officials say about 20,000 need the drug now—and must pay a 0.5% royalty on sales to patent holder Merck, according to a statement signed by Thawatch Soontarajarn, a Health Ministry official.

“The price of the patented efavirenz is twice of those generics produced by WHO [World Health Organization] certified GMP [Good Manufacturing Practices] factories in India,” the statement says. “With this higher price, the budget allocated from the Thai Government can only cover some patients with Efavirenz, whereas the rest have to use other non-patented more toxic antiretrovirals.”

The concerns expressed by Thawatch for quality drugs are certainly laudable. But the emphasis on quality disguises the fact that the GPO facilities used to manufacture first-line AIDS drugs are still not up to the WHO’s standards after four years of production, even though the drugs are now also available from certified factories in India.

Moreover, it’s still unclear if the GPO intends to start making efavirenz locally in the same Bangkok factory that doesn’t meet WHO standards. GPO officials have already said they plan to start local production in June, at least two years before the government could complete construction on a long-discussed new production facility that meets international standards.

The question is whether the second-line drugs made in a factory that doesn’t meet international standards will do more harm than good for the thousands of HIV/AIDS patients that desperately need medication. This is the ultimate gray area, since it’s nearly impossible to quantify.

“Nobody would buy an airplane without wings,” Dr Lembit Rago, WHO’s Geneva-based coordinator for quality assurance and safety, said in a telephone interview. “Drugs should be treated the same way. But with drugs, it’s difficult to understand what makes them up to a certain standard of quality because there are so many elements involved. In certain cases, minor things are wrong, and in some, major things. Drugs that are not WHO pre-qualified may not directly kill people, but they could foster resistance to AIDS drugs.”

Critics argue that is exactly what happened in Thailand with GPO-Vir, a generic triple combination of first-line ARVs Stavudine, Lamivudine, and Nevirapine. The drug was introduced with great fanfare in March 2002 as the cheapest anti-viral treatment in the world.

Resistance Developing

In 2002, the Global Fund to Fight Aids, TB and Malaria pledged $133 million to Thailand to further test and procure GPO-Vir. The fund stipulated, however, that Thailand must buy ARVs and other drugs from WHO-approved companies in three years time. That same year, the GPO resolved to make its facilities WHO-compliant in two years.

A year after that, the Thai cabinet passed a resolution approving a proposal to build a new world-class facility that met international standards. The GPO had considered upgrading its existing plant, but that would require it to close for six months.

In 2004, the International AIDS Conference rolled into Bangkok with a theme of “Access for All.” Prime Minister Thaksin Shinawatra , who was deposed in a coup last September, pledged in a keynote address to supply drugs for free to HIV/AIDS patients in Thailand, Laos, Cambodia and Burma.

NGOs hailed Thaksin’s commitment, and extolled GPO-Vir as a breakthrough in price and access. And indeed, it was much cheaper.

GPO-Vir, taken twice daily, costs 40 baht ($1.10) per day. Similar patented drugs cost about 252 baht ($6.90) per day. Over a year, that’s a cost savings of about $2,120 per patient.

GPO-Vir certainly seemed like a godsend. After the AIDS conference, even the US said it wanted to buy the generic drug for its $15 billion program to provide relief to HIV patients in 14 African countries and Vietnam.

But though the commitments and pledges made for good headlines when the global AIDS spotlight shined brightly on Bangkok, GPO-Vir quickly lost some luster. The Global Fund quietly said it wouldn’t support Thaksin’s plans to distribute the drug to neighboring countries since it had not received WHO approval. And just last August, the fund withdrew support for GPO-Vir altogether because the GPO still had not brought its factory up to international standards. In addition, the US Food and Drug Administration still has not approved the drug for safety, making it ineligible for President George W Bush’s $15 billion AIDS relief program.

The drug’s efficacy started to be questioned in 2005, when a study by Mahidol University's faculty of medicine found that resistance to GPO-Vir had grown dramatically in the previous few years. In a survey of 300 patients using the drug, researchers found that 49 percent were resistant to Lamivudine, 39.6 percent to Stavudine and 58 percent to Nevirapine.

Increased rates of resistance meant that more people had to switch to more expensive, patented second-line treatments such as efavirenz. Merck says it supplies that drug for “no profit” at 1,400 baht for a month’s supply. The GPO says it can cut that in half with generics, saving the government millions of baht.

Compulsory Licensing

To be clear, the quality of Thai-produced generic drugs should not be confused with the issue of drug access. The Thai government was well within its legal rights in issuing the compulsory license for efavirenz without prior negotiations with Merck.

The World Trade Organization's agreement on Trade Related Aspects of Intellectual Property Rights, commonly known as TRIPS, gives countries the right to issue compulsory licenses for drugs essential to public health if they pay a royalty. And, in what AIDS activists see as the ultimate hypocrisy, the US has issued compulsory licenses routinely for other forms of intellectual property like satellite carriers, Internet access and file sharing.

Although Thailand has issued the compulsory license for efavirenz, it has yet to implement it. Indeed, the threat of a compulsory license may simply be a bargaining chip to prompt Merck to lower prices. Brazil has threatened compulsory licenses no less than three times on AIDS drugs, and each time reached a deal with Big Pharma.

To that end Merck said it would seek talks with health officials to propose discounts or a so-called “voluntary” license for the GPO to produce a generic version of efavirenz, which goes by the brand name Stocrin. These talks are apparently ongoing, as Thailand has yet to import generics from India two months after saying it would do so. NGOs are pushing for Thailand to implement the compulsory license to set a precedent for other governments.

The theoretical debate over intellectual property is hard to quantify because it contains many hypothetical questions. Certainly HIV patients in developing countries that need treatment now would see no harm in breaking patents to be able to afford the drugs that could extend and improve their lives. Major pharmaceutical companies retort that without guaranteed patent protection, they will have no incentive to research and develop new drugs—and, maybe one day, find a cure for AIDS. Whether that is an empty threat remains to be seen.

The debates over intellectual property typically play out at the WTO and on a bilateral level. In the stalled trade talks between Thailand and the US, for instance, access to the data used to make patented HIV/AIDS drugs proved a key issue in mobilizing resistance to a potential agreement.

But while AIDS activists tend to see big pharmaceutical companies as the enemy, they seldom lash out at companies in developing nations that provide generic drugs. Thailand’s GPO is a case in point. It nearly always receives plaudits for breaking patents, but gets little grief over the quality of its production facilities. Its medicines are also not required to receive national Food and Drug Administration approval.

“In some countries, the government is given some kind of immunity from regulators,” Dr Lembit said. “It’s like some people believe that everything that comes from the government must be good.”

Murky

Indeed, a cursory look at the GPO reveals a murky, corrupt state enterprise that looks like anything but David fighting Goliath.

In 2002, Auditor-General Jaruvan Maintaka issued a report saying the GPO sold about 60% of its medical products to government agencies at above market prices. In some cases, products were marked up 1,000 percent.

“The purchase of drugs through GPO still has many defects and gives officials the chance to reap personal benefits,” Jaruvan, Thailand’s top graft-buster who is now leading investigations against Thaksin, said at the time. “The drug purchasing process becomes intransparent, inefficient and wastes money.”

The report said that the GPO, dubbed the “skimming profits” agency by cynical Thai observers, pilfered about 486 million baht, or about $13.3 million, from government coffers each year from 1998 to 2002. When confronted with the report four years ago, the GPO immediately lowered drug prices across the board. In its defense, Managing Director Thongchai Thawichachat told reporters that the GPO sent 200 million baht annually to government coffers, and claimed its generic production of antiretrovirals saved the government 10 billion baht per year—a claim that certainly raised the ire of Western pharmaceutical firms in light of the corruption allegations.

In 2003, the GPO made a net profit of 624.2 million baht on revenues of 3.7 billion baht. A year later, revenues topped 4 billion baht, and rose to five billion in 2005. Profits for the GPO topped one billion baht in 2005, according to Anuthin Charnveerakul, the deputy public health minister under Thaksin, who also scolded the state enterprise for spending a mere 19 million baht—just two percent of net profit—on research and development.

Now the GPO plans to double revenue to 10 billion baht by 2010. Those plans include a new factory to produce generics that will comply with WHO standards. The plant itself would bring the GPO more than four billion baht every year, with 900 million baht in profits, according to Monkol Jivasantikarn, GPO’s managing director.

But for reasons that most attribute to corruption, bidding for the plant has been delayed for more than four years. Frustration mounted last year as Anuthin urged the GPO to build the factory before the Global Fund pulled funding for GPO-Vir in August. It still remains unclear when the factory will be built.

“When Thailand changed governments in September, they set up a new board, which wants some time to evaluate every new project,” said a GPO official, speaking on condition of anonymity. “I don't know how long it will be before the factory is built.”

AIDS activists have also been frustrated by the delay, but appeared reluctant to criticize the GPO.

“I think a lot of the delay is to do with purchasing a large area of land and building a large production facility,” said Paul Cawthorne, head of the Thailand office for Medecins Sans Frontieres. “Since it's a government department, the GPO can't just build like a commercial company would. They need to go through the nightmare bureaucracy of the Thai government. And of course in any big government program, there is a lot of room for corruption. I know they are trying hard, but the whole thing takes 20 times longer than it normally would.”

MSF, also known as Doctors Without Borders, loudly applauded the government’s decision to issue a compulsory license for efavirenz, and urged it to do the same for other AIDS drugs, like the combination of lopinavir/ritonavir, which costs about 7,000 baht per month in Thailand. The GPO plans to do just that. When announcing the compulsory license, Mongkol said the state enterprise would start making generic versions of patented antiretrovirals Indinavir, Saquinavir, didanosine and Lopinavir within two years.

Can the drugs be trusted?

With all this new production, can poor Thai patients be sure they are getting drugs of the highest quality? MSF and other activist groups say yes, as they vouch for the safety of GPO-Vir even though it has not met international standards. MSF has distributed the drug to nearly 100,000 people in Thailand, Burma and Cambodia.

“I think the drugs [produced by the GPO] are fine to be quite honest,” Cawthorne said. “We’ve had our own pharmacist check out the production site because we needed to see that the way the drugs are produced is up to a standard we felt happy with. So in fact for MSF we have no big concerns on the GPO’s antiretrovirals.”

Cawthorne dismisses allegations that GPO-Vir has caused increased resistance. The resistance has mainly grown, he and other AIDS activists say, because more drugs are being distributed, and more people are using them incorrectly.

“We think there are very little problems with resistance to first-line drugs, and when we've seen resistance, we’ve always been able to determine the reason why someone is resistant,” he said. “Perhaps someone has not taken the medicine correctly, or they’d been in surgery. There’s always been some other reason besides the drugs themselves.

“You can have the best drugs in the world, and if people don't take them properly, you'll have problems,” he added. “It takes a lot of patient education.”

GPO officials say the same thing. They claim that GPO-Vir poses no risk. They also downplay concerns that the WHO has not yet approved the drug.

“The approval of the facility is not related to the quality of the drug,” Achara Akesangsri, the GPO’s deputy chief of research and development, said in an interview. “We can ensure that our product has the same quality as those approved by the WHO.”

According to Achara, the WHO is in the process of auditing the firm that conducted bioequivalency studies for the GPO on the first-line generic drug. Those ensure that the drugs are essentially the same.

“The guidelines for the WHO are upgraded every year,” she said. “Some studies we did before the new guidelines of the WHO, so we need to update them.”

But although the GPO may claim GPO-Vir is bioequivalent to the brand-name drugs, the WHO says those statements need proof to back them up.

“A company will often say a drug is of good quality,” the WHO’s Dr Lembit said. “Well, why should we believe you when there are no studies to prove it?”

“Manufacturers, including those run by governments, are in business,” he added. “If they can sell drugs with less questions being asked, they will certainly do that. And if they can apply political pressure to stop people from asking questions, they will certainly do that as well.”

Lembit cites a recent case in Panama as an example of what can go wrong when governments don’t adhere to international standards in making drugs. In October, a cough syrup made in a government-run laboratory was found to contain diethylene glycol, a toxic chemical used in antifreeze and paint. About 30 Panamanians died as a result, and others were hospitalized.

“The Panama case is a good example of what bad drugs can cost people,” he said. “The disease was not deadly, but now these people are dead because of the drugs.”

Lembit declined to discuss why GPO-Vir has not received WHO approval, as the organization has a policy of only publicizing positive news. But when asked about Thailand, he said: “We’ve given a lot of technical assistance, but things have moved very, very slowly. This is a disappointment. There are a lot of ARVs moving around the world that are of a much lower quality.”

(In a later email, Lembit wrote: “In the case of Thailand, I want to say that I have a great respect for them and I would not like to offend them in any way. They have made certain progress and I hope they can speed up to make even more. We have been willing to help and we will continue to be willing to help all those who want to improve.”)

Although four years have gone by without GPO-Vir meeting international standards, Lembit says the process takes about three months if all the paperwork is in place. If something is not right, such as proper documentation for claims of bioequivalency, then the WHO tells the company and waits for new studies to be done or data to be compiled.

“The ball is mostly in the manufacturer’s court,” Lembit said. “If something is left out, we cannot continue with the process.

“We want to help the manufacturers,” he added. “We want the generic drugs to pass inspection. But manufacturers need to do their part as well.”

The WHO has approved 34 generic drugs or drug combinations for HIV/AIDS produced in 11 countries. Most are made in India, though others are made in South Africa, Spain and Puerto Rico. No Thai produced drugs have been prequalified.

The GPO may be forgiven for still producing GPO-Vir at its factories even though they could import a better quality generic version from India, as those drugs weren’t around when the state-run firm started production four years ago.

But efavirenz is a different story. Buying the drug from WHO certified factories in India would cost the same as drugs the GPO would produce locally. Moreover, since the drugs have WHO approval, the government could use Global Fund money to buy them. Therefore, the government would get higher quality drugs for HIV patients without having to pay for them out of government coffers. GPO’s generic efavirenz would not be certified by the WHO, and Thai taxpayers would have to foot the bill.

So why produce them locally?

“If we produce locally, we can ensure about the stock,” Achara said. “The drugs should be the same price as those in India.”

Irregular supply was one of the key reasons cited by MSF in its support of the GPO’s move to issue a compulsory license for efavirenz. But the NGO did not see supply as a reason for the GPO to produce efavirenz locally instead of importing the drug from India.

“I think the GPO will wait until the new factory is built before producing efavirenz locally,” MSF’s Cawthorne said. “The site they have at moment is already working at full capacity. They’re not going to be able to make efavirenz in the current site, because they can't expand the site. It’s quite urgent to get the new facility built.”

The GPO “might” start building the perennially delayed new factory later this year, Achara said. It would take two years to build, meaning the earliest Thai HIV patients are likely to get WHO-approved generic drugs—aside from a brief window in which the government may import them from India—will be late 2009.

“The new factory is a priority for the GPO,” Achara said. “But we have to go step by step.”

[Jai Dee]

HIV Network thanks govt for seeking ways to help HIV people

HIV Network of Thailand has submitted a letter to thank the government for seeking ways for HIV/AIDS people to have access to low-price medicine.

Mr. Wiratch Purahong (วิรัช ภู่ระหงส์ ), the chief of HIV Network of Thailand, has led members of the network and non-governmental organizations to thank the government for its measures pushing registering of HIV/AIDS medicine patent. He said that the government has shown its sincerity in helping solve their problems.

Dr. Mongkol na Songkhla (มงคล ณ สงขลา), Minister of Public Health, received the letter on behalf of the government, saying that the government will continue to work on all matters that would provide benefits to all people.

Source: Thai National News Bureau Public Relations Department - 30 January 2007

[Jai Dee]

Thailand to break AIDS, heart drugs patents

The Thai Public Health Ministry confirmed Monday that it has issued compulsory licenses for the production of two drugs, one for the treatment of HIV/AIDS and another for a cardiovascular drug, paving the way for immediate production and imports of lower-cost generic versions.

Thai Public Health Minister Dr Mongkol na Songkhla announced that the drugs are Kaletra, an AIDS drugs produced by US-based Abbott Laboratories and Plavix, the blockbuster anti-clotting agent, sold by France’s Sanofi-Aventis and US-based Bristol-Myers Squibb.

Dr Mongkol said the decision to break the patents was not taken lightly but the move was necessary to ensure that the affected Thai patients have access to cheaper generic versions of the life-saving drugs.

He added that generic production of Plavix, for instance, would reduce the cost from about 70 baht (US$2.06) a pill to less than six baht (18 cents).

This is the second time Thailand's military-backed government has broken an international drug patent in the interest of the health needs of the country's poor.

In November it introduced Thailand's first compulsory licencing for Merck's Efavirenz anti-retroviral AIDS treatment.

The move drew angry reactions from pharmaceutical companies but was applauded by AIDS activitists and aid agencies.

Dr Mongkol said the ministry is willing to meet the companies about importing their drugs at cheaper prices. But if talks collapse, Thailand is prepared to begin manufacturing the generic drugs, he stressed.

“We ask for the understanding of the pharmaceutical companies. Our people are very poor so they cannot afford your drugs. We want our people to have access to the medicines they need,” Dr Mongkol said.

The Government Pharmaceutical Organisation has been ordered to stock the active ingredients to prepare for the production of the drugs.

Thai public health officials maintained that international trade rules allow national governments to enforce compulsory licensing of patent-protected drugs in cases of national public health emergencies or crises.

More than 500,000 people in Thailand are living with HIV, according to UNAIDS, the UN agency that co-ordinates the global fight against the deadly virus.

And some 200,000 patients in Thailand who suffer from heart conditions have blood clotting problems that could be treated with Plavix, but only 20 per cent of them have access to the medicine, according to the Thai public health ministry.

Source: TNA - 30 January 2007