Thailand Stuns Drug Firms With Generic Licenses

[mumbu]

Thailand Asks Abbott, Merck, Sanofi to Cut Prices (Update2)

By Suttinee Yuvejwattana and Beth Jinks

June 6 (Bloomberg) -- Thailand's health ministry will buy patented AIDS and heart drugs from Abbott Laboratories, Merck & Co., and Sanofi-Aventis SA if they cut prices to 5 percent more than the cost of buying or making copies, an official said.

Meetings between the pharmaceutical companies and Thai health officials to prevent the country from making and buying generic copies ``haven't reached any conclusion,'' Siriwat Thiptharadol, director-general of Thailand's Food and Drug Administration and chief negotiator, told a press conference in Bangkok today. Merck, of Whitehouse Station, New Jersey, and Paris-based Sanofi offered additional supplies, he said.

Thailand says copying the drugs will allow the government to provide free medicine to a larger share of its poorest citizens. The Pharmaceutical Research and Manufacturers of America, a drug industry trade group, says taking that step would remove the incentive to invest in research, and that its members would retaliate by not introducing new drugs in Thailand.

``We are open for any negotiations,'' Siriwat said. ``If the drug firms agree to cut prices or offer interesting packages, we can always buy from them.''

The country, Southeast Asia's second-largest economy is considering buying generic versions or issuing licenses allowing the Government Pharmaceutical Organization to copy AIDS drugs Kaletra and its updated version Aluvia, made by Abbott, and efavirenz, marketed as Stocrin by Merck and as Sustiva by Bristol-Myers Squibb Co. It may also make clopidogrel, the heart medicine sold under the name Plavix by Bristol-Myers and France's Sanofi-Aventis SA, and cancer medicines.

Poorest Patients

The discounted medicines will only be provided to the poorest patients who cannot afford the patented originals, Siriwat reiterated.

Sanofi offered to sell Plavix at 27 baht (78 U.S. cents) per tablet with an added incentive of supplying 3.4 million tablets for the cost of 1 million, Siriwat said. Merck offered to sell its AIDS medicine for 726 baht per patient per month, and to supply a free liquid form of the drug for 2,500 HIV- infected children a year. Merck also offered to cover their diagnosis costs and train health workers in treating youngsters.

``Merck remains committed to finding a mutually acceptable agreement to help the country achieve its objective of treating people with HIV and AIDS,'' Merck spokeswoman Amy Rose said in a telephone interview today.

Third Reduction

Abbott, of Abbott Park, Illinois, has maintained its offer to supply Aluvia at $1,000 per patient per year, Siriwat said.

``This was our third price reduction in eighteen months of our own accord,'' said Abbott spokeswoman Jennifer Smoter in a telephone interview today. She also noted that the price of Aluvia had been cut by more than half from its original $2,200.

Thailand's health ministry will be ``flexible'' in considering the offers, Siriwat said. If the government runs short of needed drugs during negotiations it will ``order generic versions from India,'' he said. The supplies of AIDS drugs are expected to run out as early as July, Siriwat said.

Thailand has threatened to invoke a World Trade Organization provision called compulsory licensing which allows nations to break patents. The country this year joined China and 10 other nations on the U.S. government's list of the world's worst infringers of intellectual property rights, which could make it easier for aggrieved U.S. industries to argue Thailand should lose some trade privileges.

Public Health Minister Mongkol Na Songkhla met with Commerce Secretary Carlos Gutierrez and Deputy U.S. Trade Representative John K. Veroneau last month in an effort to avoid trade retaliation. He said the U.S. government didn't relent on their opposition to the compulsory licensing plan.

A spokesman for Bristol-Myers referred calls to Sanofi's U.S. office. Sanofi's U.S. spokesman referred calls to its corporate office in Paris. A call to the corporate office wasn't immediately returned.

To contact the reporters on this story: Suttinee Yuvejwattana in Bangkok at [email protected] ; Beth Jinks in Bangkok at [email protected]

Last Updated: June 6, 2007 16:51 EDT

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[Jai Dee]

NHSO denies buying recalled anti-HIV drugs from Roche

The National Health Security Office (NHSO) affirms it did not buy Roche’s anti-HIV drugs which have been recalled as Thailand’s Government Pharmaceutical Organization (GPO) can produce the drugs by itself.

Deputy Secretary-General of NHSO, Md.Winai Sawasdivorn (วินัย สวัสดิวร) denies that the organization purchased the nelfinavir drugs or Viracept for patients under the universal health security scheme. He adds that AIDS and HIV positive patients who receive medical assistance from NHSO use the nelfinavir drugs produced by GPO which pass international standards.

Md.Winai says further that NHSO provides anti-HIV medicines for patients in line with each patient’s condition as well as quality and safety of the drugs. Apart from those produced by GPO, NHSO purchase anti-HIV drugs from the SMD, Abbott, and Gilead.

In 2007, NHSO has provided the basic anti-HIV drugs for 100,000 AIDS patients and the stronger version of the drugs for 8,000 drug-resistant AIDS patients.

Source: Thai National News Bureau Public Relations Department - 08 June 2007

[Mid]

NHSO denies buying recalled anti-HIV drugs from Roche

the very fact that they need to make this statement is scary <deleted> .

[PeaceBlondie]

I started on Plavix on May 23, and it's costing over 90 baht per tablet, once a day. Is it going to be reduced in price in Thailand?

[Bottlerocket]

Why waste the money on 'em? People die, man. Too many here already. The world doesn't need cheaper drugs. It needs better education.

[geriatrickid]

I started on Plavix on May 23, and it's costing over 90 baht per tablet, once a day. Is it going to be reduced in price in Thailand?

On 30-Jan-2007 The Standard reported "the cost of Plavix is expected to drop from 120 baht (HK$27.89) a pill to only 6 baht to 12 baht."

Currently, generic versions of Plavix (where permitted e.g. Canada) are available at $0.90 to $1.75 per 75mg tablet. That's about B30- B50 average. Plavix name brand is available for about US$1.50 to US$3.50. B50-B120 Again for 75mg tablet.

(Differences due to discounts allowed for buying in bulk, e.g. 100 tabs, or because of health plan discounts)

I have the impression that pharmacists may be marking up their drug prices and letting the pharma companies take the heat.

There was an alternative solution and that was bulk buying discounts as practiced in Canada, some EU countries and by many US health plans. Canada is the leader in low prices because its provincial health plans sign agreements with set discounts. The state creates an economy of scale that in turn allows the private sector to cut its supply costs and lower the retail cost of drugs. The key requirement of such a process requires that there be integrity and honesty from both parties.

On a personal note please, make sure you advise your dentist that you are on the drug prior to any activity. So many people forget. And remember, no aspirin or other pain relievers without clearing with your physician first. (Sorry for nagging.)

[sriracha john]

I started on Plavix on May 23, and it's costing over 90 baht per tablet, once a day. Is it going to be reduced in price in Thailand?

Good news for you, PB....

Government to import generic version of heart drug

Health minister sticks to his guns over prices

Thailand plans to import a generic version of the heart drug clopidogrel, marketed as Plavix, from an Indian drug maker next month as price negotiations with patent holder Sanofi-Aventis have shown no signs of progress. ''If the price of the original heart drug cannot be reduced by more than this, any further negotiations may not be necessary. We will buy the generic version to treat patients instead,'' said Public Health Minister Mongkol na Songkhla yesterday. The heart drug produced by the Indian drug maker costs only about three baht per tablet and is still under the registration process with the Food and Drug Administration, he said.

Continued here:

http://www.bangkokpost.com/News/27Jun2007_news05.php

Edited June 27, 2007 by sriracha john

[geriatrickid]

Good news for you, PB....Thailand plans to import a generic version of the heart drug clopidogrel.The heart drug produced by the Indian drug maker costs only about three baht per tablet.

I disagree, Are you prepared to give the patient a guarantee that the efficacy of the drug will be the same? Have you seen the bioequivalency clinical trial data for some of the Indian generic products? The quality and standards of the overall Indian system are viewed as being significantly less than those of China. Until you can guarantee to me that there is an integrity within the supply chain, I would prohibit a patient from taking such generics.

A generic drug equivalency is only as good as the production and distribution chain of that drug.

The production of critical care medications requires very high standards right down to the use of pressured air flow systems to ensure contaminants are kept out of the production rooms. Just because workers wear white lab coats and little booties doesn't mean it's a clean process.

Surely the recent crises involving contaminated Chinese wheat gluten or glycol in Chinese manufactured toothpaste should cause you concern. The western purchasers had to organize the recalls. The western companies had to provide the lab studies and tracking. The Chinese tried to escape responsibility. It is no different in India.

What happens if there is a product recall in India? Do you know what happens? I don't. To the best of my knowledge, a QC system isn't even in place to allow that. Drugs should not be sold until every component and every stop in the production chain can be monitored and tracked. Until India achieves that, it's not worth elevating the patient's risk.

(Ed. Note: I do not own shares in any pharma company

[Bottlerocket]

Thailand plans to import a generic version of the heart drug clopidogrel, marketed as Plavix, from an Indian drug maker next month as price negotiations with patent holder Sanofi-Aventis have shown no signs of progress.

In the World Trade Organization rules it clearly states that a nation may produce the drug in the case of a national emergency for domestic use but is prohibited from manufacturing for export. I hope the trade sanctions are stiff and carry no exception.

[Bottlerocket]

Thailand plans to import a generic version of the heart drug clopidogrel, marketed as Plavix, from an Indian drug maker next month as price negotiations with patent holder Sanofi-Aventis have shown no signs of progress.

In the World Trade Organization rules it clearly states that a nation may produce the drug in the case of a national emergency for domestic use but is prohibited from manufacturing for export. I hope the trade sanctions are stiff and carry no exception.

[Bottlerocket]

Thailand plans to import a generic version of the heart drug clopidogrel, marketed as Plavix, from an Indian drug maker next month as price negotiations with patent holder Sanofi-Aventis have shown no signs of progress.

In the World Trade Organization rules it clearly states that a nation may produce the drug in the case of a national emergency for domestic use but is prohibited from manufacturing for export. I hope the trade sanctions are stiff and carry no exception.

[slimdog]

Thailand plans to import a generic version of the heart drug clopidogrel, marketed as Plavix, from an Indian drug maker next month as price negotiations with patent holder Sanofi-Aventis have shown no signs of progress.

In the World Trade Organization rules it clearly states that a nation may produce the drug in the case of a national emergency for domestic use but is prohibited from manufacturing for export. I hope the trade sanctions are stiff and carry no exception.

A company or other institution that locally produces generic versions of patented products under a government-use provision or a compulsory licence may export a portion of its output. This is permissible under the TRIPS Agreement, subject to certain restrictions. The ability to export can be significant to a producer, as it may need a larger market (beyond the local market, which is restricted, for example, by population size or by the limit of local demand) in order for its production to be economically viable. An unrestricted ability to export allows for better economies of scale (as per-unit costs are reduced when output increases).

However, there are restrictions on the quantity the drug manufacturer (under government use or compulsory licence) is allowed to export. The quantity allowed for export will partly depend on the grounds on which the compulsory licence was issued. The restriction arises because TRIPS Article 31(f) requires that the production under government use or compulsory licence shall be “predominantly for the supply of the domestic market”. This would mean that the compulsory licensee’s manufacturing output must be predominantly for the supply of the market in which he is based. This, in theory, could mean that only a maximum of 49% of the total manufacturing output can be exported.

source: http://www.twnside.org.sg/title2/chapter3.doc

Additionally, the EU are trying to get Article 31(f) altered so as to allow countries with no manufacturing facilities to issue a compulsory licence, and for the manufacture to be carried out in a 3rd country

[Jai Dee]

Abbot alleges double standards

Abbot Laboratories, the US drug manufacturer, yesterday criticised the government for a dramatic increase in military spending compared with public health.

The company's HIV communications director Dirk Van Eden said he was "disappointed" to see a 24-per-cent increase in defence spending compared with just 4.7 per cent for health in the next fiscal year.

However, Thai Aids activists slammed the comparison as "absurd". The problem is not about money but the need for access by infected people to life-saving medicine at reasonable prices, they said.

Thailand in January imposed compulsory licensing on some drugs including one of Abbot's products.

That means it can ignore the company's patents and produce or buy cheaper, generic versions itself. The generic version of the Kaletra lopinavir/ritonavir treatment is about 30-per-cent cheaper than the original drug.

"Under these circumstances, it's difficult for us to understand how Thailand can say it can't afford to pay for HIV drugs," Van Eden said from the United States. "Thailand's problem with its HIV budget is not poverty but priority."

Nimit Tien-udom, director of Aids Access Foundation said: "No matter how much money the government will allocate to HIV, it won't be enough to pay for the unreasonably expensive drugs. The problem is not about how much the government has to pay for HIV drugs but more about the fact that the company wants to sell us the drug at irrational prices."

Public-health officials added Van Eden had quoted wrong figures and was in "total ignorance of the health budget".

National Health Office secretary-general Dr Sanguan Nitayarumpong said money for HIV came from a separate fund that is not included in the annual budget of the Public Health Ministry.

Government funding of that increases every year, Sanguan said. Next year, money for drug purchases is Bt4 billion - a rise from Bt3.5 billion this year and Bt2.7 billion last year.

Abbot wants to persuade Thailand to cancel its plan to buy cheap, generic Kaletra from manufacturers in India. After Thailand imposed the compulsory licensing, Abbot offered to reduce the price of original drugs from US$2,200 (Bt74,800) per patient per year to $1,000. But, the Indian-made version will cost just $695 per patient per year.

Food and Drug Administration secretary-general and chief negotiator for drug prices, Dr Siriwat Tiptaradol, said the country was prepared to pay Abbot 5 per cent more than the cost of the generic version, nothing higher.

Van Eden said the company would continue to negotiate although it had reduced prices as far as it was prepared to - equal to those offered to 45 other middle-low-income countries.

Source: The Nation - 09 July 2007

[Mid]

Abbot Laboratories, the US drug manufacturer, yesterday criticised the government for a dramatic increase in military spending compared with public health.

nope , never saw that comming .......................

[Mid]

Cheap enough?

Sat, July 14, 2007 : Last updated 14:31 pm

With compulsory licensing imposed on its HIV/Aids treatment Kaletra, manufacturer Abbott says it will now offer the heat-stable version of the drug at prices competitive with generic versions.

The heat-stable version of Kaletra is called Aluvia, which has yet to be registered for sale in Thailand.

"The quotation for Aluvia may be low enough to compete with generic drugs," Dr Vichai Chokevivat said in his capacity as the chairman of the ministry's compulsory-licensing panel.

Food and Drug Administration secretary-general Siriwat Thiptaradol said the ministry was willing to reconsider compulsory licensing if original drug prices were no more than 5 per cent higher than generic versions.

The ministry enforces compulsory licensing on three medicines: Efavirenz, Plavix and Kaletra.

nationmultimedia.com

[Jai Dee]

Thai activists attack drug ban

Activists supporting HIV-positive people in Thailand demanded Tuesday at an international Aids conference in Australia that Abbott Laboratories stop blocking the distribution of critical Aids drugs.

Abbott and the Thai government have been embroiled in a long-standing battle over the costs of antiretroviral treatment, which enable those with HIV/Aids to live longer and more effective lives.

Thai activists claimed Abbott was blocking the distribution of Aluvia, a second-line drug crucial for those already developing resistance to first-generation treatment.

Aluvia is the only drug of its kind in the developing world, and is both heat resistant and food-independent. It can be stored without refrigeration and doesn't need to be taken with food, an important feature in poverty-stricken countries.

"For Thai people with resistant HIV, access to Aluvia is not a luxury. It is vital," said Kannikar Kijtiwatchakul of the Thai Network of People Living with HIV/Aids and also a campaigner for medical humanitarian organisation Medecins Sans Frontieres.

At the end of Tuesday's morning plenary attended by thousands of people, Kannikar appealed to scientists, researchers and politicians at the 4th International Aids Society Conference on Pathogenesis, Treatment and Prevention to sign a petition and support the cause of positive Thai people.

Thailand has approximately 500,000 people living with HIV/Aids, of whom 80,000 are on antiretroviral therapy. Of these, 8,000 have developed resistance to the toxic drugs and need to be put on second-line therapy, Kannikar said.

The cost of these drugs is becoming a major issue in the capacity of Aids-affected countries to deliver widespread and equitable treatment and care.

After several failed negotiations with Abbott since 2005, Thailand issued a compulsory license in January to overcome a patent barrier on second-line drug Lopinavir/Ritonavir. This enabled the country to either legally import it or produce it locally.

This was in keeping with World Bank recommendations that Thailand procure cheaper, generic versions of Lopinavir, activists said.

"In February, Abbott announced that unless the Thai government grants it an absolute monopoly on sales of Lopinavir, without any generic competition, then it would effect a blockade of Aluvia against all Thai Aids patients," Kannikar said.

Earlier, on Sunday, Abbott CEO Jean-Yves Pavee met with HIV activists from Thailand and HIV-positive group, Act-Up Paris. While it dropped a lawsuit against Act-Up for an attack on the Abbott website, the blockade against Aluvia continues.

"I'm living with HIV, and a few years ago an HIV drug by Abbott saved my life," Act-Up president Hugues Fischer said after the meeting. "From my point of view, for Abbott to be deliberately preventing the Thais from procuring a lifesaving HIV medicine is tantamount to murder."

According to an MSF report released Monday, entitled "Untangling the Web of Price Reductions," there have been dramatic price reductions for second-line drugs over the past year - largely a result of the compulsory license issued by Thailand.

The costs plummeted from $2,800 to $695 per year.

"But this is still far too expensive for the majority of people in Thailand, where the average annual salary is $1,600 per year," Kannikar said earlier.

Thailand is often upheld as a model of HIV treatment across the developing world, with its early campaigns for universal access to treatment, while simultaneously rolling out massive education and prevention programmes.

The Sydney Aids conference, which opened Sunday, features the latest developments in biomedical prevention, treatment and clinical practice.

Source: DPA - 24 July 2007

[dkstoney]

"For Thai people with resistant HIV, access to Aluvia is not a luxury. It is vital," said Kannikar Kijtiwatchakul of the Thai Network of People Living with HIV/Aids and also a campaigner for medical humanitarian organisation Medecins Sans Frontieres.

Well, I'm sure your government can just make it themselves. Good luck to ya. Abbot should just close shop and burn their formulae.

Oh, and the baht's 30 to a dollar now, surely that's a price reduction as well. Nope, gotta have more fighter jets and public surveillance cameras and sky train extensions and subways and priceless jewels for gifts to special people.

[Mid]

Thailand to broaden patent breaking policy

Will cover all state healthcare schemes

Thursday July 26, 2007

APIRADEE TREERUTKUARKUL

Thailand is pressing ahead with its policy on compulsory licensing (CL) with a plan to expand the policy to cover all state healthcare programmes, enabling more people to access affordable life-saving drugs. The plan, initiated by scholar-economist Ammar Siamwalla, was endorsed by the National Health Security Office board yesterday.

Currently, the CL policy on three important drugs for Aids and heart treatment _ Efavirenz, Kaletra and Plavix _ is basically limited to patients under the universal healthcare scheme run by the National Health Security Office (NHSO).

The Post Publishing Public Co

[PeaceBlondie]

Oh wait - is the CL pricing scheme only available for patients in the Thai public health scheme? What about a teaching hospital owned by the government? Will I have to stop paying 300 baht for my appointment, and get in the long lines for the free appointments?

But if this announcement says what it seems to say, is the Thai govt. going to do compulsory licensing for dozens of drugs? Is that legal under the WTO treaties? Wouldn't that be equivalent to saying, "Thailand is a poor third-world country whose govt. and taxpayers cannot begin to pay Western prices"?

[Plus]

Difficult to say. I understand that people visiting private hospitals are paying full price, not the CL price, and so are people covered by various other government related insurance schemes, like teachers and civil servants, which the Ministry wants to be included.

Privately insured patients will still have to pay in full.

[Jai Dee]

Update:

Group wants action against Abbott over drug moves

The Foundation for Consumers has filed a petition with the Ministry of Commerce asking it to revise a decision by its trade competition committee - because it failed to act against Abbott Laboratories for withdrawing life-saving drugs from the Thai market.

Foundation manager Saree Aongsomwang said: "We expect the committee to revise its judgement to protect the country's interests and the right to access essential drugs to save patients' lives, ahead of the benefit of a big company," she said.

The move follows a decision by the committee last month that Abbott's actions did not contravene trade laws because the new drugs had never been marketed here before and not selling them in Thailand would not restrict trade competition.

The committee also said it had not found any Thai consumers who had bought the drug directly from Abbott's parent company in the United States or people who were using the drug here.

Earlier, Abbott withdrew seven life-saving drugs from sale in Thailand in apparent retaliation for the Surayud government imposing compulsory licensing on its Aids anti-retroviral cocktail Kaletra.

Last April, the foundation and several non-government organisations lobbying for patients' rights to access patented medicines filed a complaint against Abbott with the trade competition committee.

Saree and 80 health advocates gathered in front of the Ministry of Commerce yester-day and presented the petition to the Commerce Minister.

They claimed the pharmaceutical company had violated the Competition Act by restricting access to a medicine readily available internationally.

The act says that a company with any form of business relationship with another entity outside Thailand shall not restrict the opportunity to purchase goods or services from outside the Kingdom.

Saree said she and her colleagues were now studying legal procedures, and if possible, she would take the case to the Administrative Court also.

She hoped to file a legal petition to the court within the next two weeks.

Source: The Nation - 18 January 2008

[geriatrickid]

Update:

Group wants action against Abbott over drug moves

The Foundation for Consumers has filed a petition with the Ministry of Commerce asking it to revise a decision by its trade competition committee - because it failed to act against Abbott Laboratories for withdrawing life-saving drugs from the Thai market.

The move follows a decision by the committee last month that Abbott's actions did not contravene trade laws because the new drugs had never been marketed here before and not selling them in Thailand would not restrict trade competition.

The committee also said it had not found any Thai consumers who had bought the drug directly from Abbott's parent company in the United States or people who were using the drug here.

D-OH That took care of that.

[Jai Dee]

Public Health Ministry to continue CL for four drugs

The Ministry of Public Health affirms the revision of compulsory licensing (CL) for four cancer drugs does not mean that it will cancel the existing drug compulsory licenses, adding that CL for AIDS and heart disease medicines will be continued.

Public Health Spokesman Md.Suphan Srithamma (สุพรรณ ศรีธรรมมา) discloses that the ministry’s meeting next week with relevant units will discuss the use of drugs under compulsory licenses and the budget.

The spokesman affirms the ministry and relevant units will carefully consider patients’ necessity for the drugs.

The Ministry of Public Health has issued compulsory licenses four AIDS and heart disease since January 24th last year.

Source: Thai National News Bureau Public Relations Department - 19 February 2008