No Agreement Reached About Compulsory Licenses For Patented Drugs

[Jai Dee]

Thai, U.S. Officials Have Not Reached Agreement About Compulsory Licenses For Patented Drugs, Thai Health Minister Says

Meetings held on Monday between Thai and U.S. officials concerning the issuance of compulsory licenses to produce several medications, including two antiretroviral drugs, in Thailand were "fruitless," Thai Health Minister Mongkol Na Songkhla said on Tuesday, the Bangkok Post reports. Mongkol and senior executives from Thailand's Public Health, Commerce and Foreign Affairs ministries met with U.S. officials on May 21 and May 22 to explain the country's policy on compulsory licenses (Treerutkuarkul, Bangkok Post, 5/23).

The Thai government in November 2006 and January issued compulsory licenses to produce lower-cost versions of Merck's antiretroviral Efavirenz and Kaletra, respectively. Since then, the government and drug companies have continued negotiations. Abbott earlier this month offered to sell Aluvia, an updated version of Kaletra, at a reduced price in Thailand on the condition that the country agrees not to allow generic versions of the drug into the market, Siriwat Thiptaradol, secretary-general of Thailand's Food and Drug Administration, said. Abbott offered to sell Aluvia for about 34,000 baht, or $1,000, per person annually. Indian generic drug maker Matrix Laboratories has offered to sell a generic version of Aluvia to Thailand for 24,324 baht, or $695, per person annually. Siriwat said that the offer would be considered by Mongkol. Under the terms of the offer, Thailand would have to agree not to seek compulsory licensing for Aluvia and the price of Aluvia could not be reduced any further (Kaiser Daily HIV/AIDS Report, 5/16).

After meeting with U.S. Commerce Secretary Carlos Gutierrez, Mongkol said that it is "clear" Gutierrez "represents the drug companies." During the meeting, Gutierrez said it is not the responsibility of pharmaceutical companies to absorb the burden of Thailand's health care system, the Post reports. Sens. Joe Lieberman (I-Conn.) and Frank Lautenberg (D-N.J.) responded similarly when discussing the issue with Mongkol, according to the Post. Talks with Deputy U.S. Trade Representative John Veroneau were more positive, the Post reports. According to Vichai Chokewiwat, chair of the Government Pharmaceutical Organization Board, Veroneau said that he understands the reasons behind issuing the compulsory licenses, adding that they are "very reasonable."

Rep. Henry Waxman (D-Calif.) also was supportive of Thailand's actions, according to the Post. "Thailand is an important U.S. ally that is trying to save the lives of its citizens," Waxman said in a statement. He added, "Accordingly, the U.S. should show compassion and provide support to our longtime friend rather than impose punitive actions" -- such as the Office of the U.S. Trade Representative's recent announcement that the country has been put on its Priority Watch List. According to Vichai, the Thai government will continue with its plans for compulsory licenses (Bangkok Post, 5/23).

Thailand Considers Revoking Compulsory License for Efavirenz

The Thai government is considering revoking its compulsory license for Efavirenz following recent talks with Merck, Mongkol said on Wednesday. According to Mongkol, Merck representatives have proposed several options for pricing of the drug that could benefit both sides. Mongkol did not give details about the options but said that they could serve as examples for other pharmaceutical companies whose patents have been overridden (Apiradee, Bangkok Post, 5/24).

PhRMA CEO Meets With Mongkol To Discuss Compulsory Licenses

In related news, the Pharmaceutical Research and Manufacturers of America might call on the Bush administration to take increased action against Thailand if the country continues to issue compulsory licenses, PhRMA CEO Bill Tauzin said recently, The Hill reports. According to The Hill, Tauzin and Mongkol met on Tuesday to discuss the compulsory licenses. Tauzin said that his meeting with Mongkol was open and beneficial and that Mongkol emphasized Thailand sees the issuing of the compulsory licenses as rare, The Hill reports.

According to Tauzin, PhRMA hopes that Thailand will consult with U.S. pharmaceutical companies to lower drug costs without having to issue compulsory licenses. He added that if Thailand continues to issue compulsory licenses for drugs protected by patents, the group will advocate for penalties, including those that could eliminate trade preferences allowing some Thai imports to enter the U.S. duty free (Swanson, The Hill, 5/23). "We can and will continue to have discussions with our own government and officials around the world to promote intellectual property protection," Tauzin said (Pierce, United Press International, 5/23).

NPR's "Morning Edition" on Monday reported on efforts by Brazil and Thailand to purchase generic versions of antiretrovirals. The segment includes comments from Mongkol; Antonio Patriota, Brazil's ambassador to the U.S.; Tauzin; and Jeffrey Sturchio, vice president for corporate responsibility at Merck (Wilson, "Morning Edition," NPR, 5/21). Audio of the segment is available online.

Source: Medical News Today - 29 May 2007

[Jai Dee]

Thailand ‘frees’ 2 more drugs

Thailand, which has overridden international patents on three drugs in the past year, plans to issue two more local licences this year for copycat versions of medicines, health minister Mongkol na Songkhla said on Monday.

The new licences would be for the country’s top killing diseases, especially cancer, Mongkol told reporters, but declined to name them.

“In the remaining six months I have left, we will do it on the drugs that are needed to save the lives of the poor,” said Mongkol, referring to the term of the interim army-appointed government due to expire after elections in December.

“Altogether, we will impose compulsory licensing on up to five necessary drugs,” said Mongkol, who failed to win a sympathetic ear from trade officials in Washington last week.

Thailand is negotiating with French and American makers of two HIV/AIDS drugs and a heart medicine to lower their prices after Bangkok overrode patents.

The compulsory licensing, which Thailand says is legal under the World Trade Organization’s rules, has drawn flak from global drug makers and Washington, but applause from HIV/AIDS advocacy groups.

Mongkol urged drug companies to charge a range of prices for one medicine so that rich and poor would have the same access to the same drug.

“This is not a threat, but an appeal to the drug companies to have sympathy for the poor. One price for the rich and one price for the poor. At the end, it will be win-win for everyone.”

Mongkol said there was progress in haggling with two makers of the three drugs to get prices down closer to their generic equivalents, but not with Abbott Laboratories , which makes the HIV/AIDS drug Kaletra.

Abbott refused to budge on its offer of $1,000 per patient per year for a heat-stable version of the drug during negotiations with Thai officials this month.

Aluvia is needed badly in tropical Thailand because it does not require refrigeration like Kaletra, eliminating the need for costly cold storage.

Abbott recently cut its price for Kaletra and Aluvia to $1,000 per patient per year in 40 low- and middle-income countries, but Thailand says it is still too expensive. Mongkol said Thailand would not scrap compulsory licensing on the three drugs even if the patent owners agreed to sell their products at prices close to generic ones because the rules allowed Thailand to buy generic versions.

“We can’t leave generic drugs out of our purchases. Without them, patented drug makers will put price pressure on us again,” Mongkol said.

Source: Reuters - 29 May 2007

[Jai Dee]

Pledge to license vital drugs

Govt will use policy only when necessary, Mongkol tells forum

Public Health Minister Mongkol na Songkhla yesterday said his ministry would enforce compulsory licences on more necessary medicines.

Speaking at a public forum, he disclosed that he would announce the compulsory licences on drugs for killer diseases such as cancer, after the United States Trade Representative (USTR) released its update about the Generalised System of Preferences (GSP) programme.

Designed to promote economic growth in the developing world, the programme provides preferential duty-free entry for more than 4,650 products from 143 beneficiary countries and territories.

Earlier this year, the USTR downgraded Thailand's trade status to Priority Watch List citing widespread property-rights violations.

Thai business entrepreneurs have expressed concern that the USTR may deprive them of some privileges.

"We will enforce compulsory licences only where necessary without causing damage to patent holders," Mongkol said.

The public forum was held at Parliament House. The National Legislative Assembly's committee on public participation, Chulalongkorn University's Pharmaceutical Science Faculty and the National Health Security Office organised the event.

Mongkol said the GSP update was expected around July.

Currently, the Public Health Ministry has already enforced the compulsory licence on Aids medicine efavirenz owned by MSD (Thailand).

"Negotiations are ongoing satisfactorily," Mongkol said.

The Public Health Ministry has also announced that it will enforce compulsory licences on Aids drug Kaletra and the heart medicine Plavix.

Mongkol said there was little chance of striking successful negotiations with the patent holders of these two drugs, because they still quoted a price much higher than generic drugs.

Associate Professor Wittaya Kulsomboon of Chulalongkorn University said the US had enforced compulsory licences much more than Thailand did.

"Why didn't the same move in the US attract criticism?" he said.

However, Bantoon Wongsilachote of the Thai Chamber of Commerce said it would be more appropriate to involve the Intellectual Property Department or the Commerce Ministry in licensing.

In a related development, Government Pharmaceutical Organisation chairman Dr Wichai Chokewiwat said the Thai government would soon purchase Aluvia - which can be used in place of Kaletra - from India. "Aluvia is easier to maintain in Thailand's weather," he said.

He said the government would likely purchase Clopidogrel - the generic name of Plavix - also from India.

Wichai said it would take about one month to register Aluvia and Kaletra with the Food and Drug Administration.

Source: The Nation - 29 May 2007

[dkstoney]

Associate Professor Wittaya Kulsomboon of Chulalongkorn University said the US had enforced compulsory licences much more than Thailand did.

"Why didn't the same move in the US attract criticism?" he said.

What compulsory licensing is he talking about? Can anyone cite the examples to which he's referring? When did the US ever steal a patent?

[highdiver]

Associate Professor Wittaya Kulsomboon of Chulalongkorn University said the US had enforced compulsory licences much more than Thailand did.

"Why didn't the same move in the US attract criticism?" he said.

What compulsory licensing is he talking about? Can anyone cite the examples to which he's referring? When did the US ever steal a patent?

By IBNlive.com

Friday May 18, 02:32 AM

New Delhi: If the United States has its way, Yoga may no longer remain an Indian treasure. The US Patent office has granted American companies patents and copyrights to Yoga .

And that's not all. A Los Angeles based Yoga guru, Bikram Chaudhury, has claimed intellectual property rights over 26 asanas, which he says are postures developed from the ancient tradition.

The question that was being debated on India 360 was: US based lifestyle gurus are patenting age-old Yoga asanas. Can wisdom be patented?

Hoslistic Health Guru Mickey Mehta tried to answer this very question saying, "It's ridiculous and unfortunate that if anyone practices a Yoga asana that has been patented by Bikram Chaudhury, he or she could well be granted a legal notice.

so next time you will want to do yoga you will need to pay royalties to USA or you will be breaching pattent.

[Jai Dee]

U.S.-Thai relations strong

What a longtime friend and ally of the United States needs is a hand up, as it tries to regain its health. Thailand will soon celebrate 175 years of cordial relations with the U.S., a record perhaps unrivaled by any other nation.

Today we are a partner in the worldwide fight against terrorism. We have strong trade ties, both export and import. U.S. businesses invest profitably in Thailand. We support each other militarily. Thailand is a favorite travel destination for millions of Americans.

Yet recently the Kingdom of Thailand has received criticism, much of it unwarranted, from some individuals and lobbies trying to influence the policy direction of U.S. government agencies toward Thailand.

This has largely followed the military intervention of 2006, and ignores the necessary adjustments of our government since then, as we work to return to free elections and democratic institutions, for which a clear timetable had been announced and is conscientiously followed. This was a short-term military intervention to break through a dangerous political stalemate in Thailand, and our political process and development now continue at a rapid pace.

Many of the attacks on Thailand stem from our government's decision, acknowledged as legitimate, to seek affordable prices for lifesaving drugs against HIV/AIDS and another major disease. Some of these attacks are bizarre, as in one advertisement that took a joke quite seriously and literally. It seems a Thai official had remarked, facetiously, that we should kidnap tourists for ransom to buy the drugs needed for our people's health. One would think that, just as leading U.S. politicians occasionally make jokes that backfire, a critic would realize this is only a misguided attempt at humor. Yet, there in black and white, was the quite-serious allegation that Thailand's government had threatened to kidnap tourists.

In fact, after initial disagreement, Thai officials and representatives of the leading drug companies sat down and made progress in resolving the dispute.

Other inaccurate information has been a distortion -- why, we don't know -- of our government's budget expenditures. We don't, for example, spend more on defense than on education or health, as has been charged. The Thai government's education budget ranks first in our country, more than $10 billion, or 22.7 percent of our expenditures. Our health-care budget is the second-largest item: $4.4 billion, or 9? percent of total expenditures. Defense is fifth or sixth at $3.4 billion, or 7.3 percent of the budget.

Thailand is well along the route promised for our return to democratic government. We have drafted a new Constitution that will be submitted to voters in a plebiscite. If for some reason it isn't approved, we will work on another Constitution, and another, for we are committed to our historic democratic principles. Elections are pledged to be held by the end of this year, and we are committed to holding them.

The Thai government and the Thai people are strong supporters of the United States, not only in Asian affairs but in every international respect. There is a large diaspora of Thai-Americans in the United States. We continue to enjoy a high level of trade and investment. We welcome American visitors, a most important segment of our tourism and travel industry.

In turn, Thailand needs and wants the support of the United States as we move purposefully and speedily in our return to democratic government and institutions.

Such is the norm for Thailand, and we believe the people and government of the United States will now respond to Thailand, as always, with true understanding, interest, friendship, mutual respect and support. Our historic relationship has earned no less.

Krit Garnjana-Goonchorn is the ambassador of Thailand to the United States.

Source: Washington Times - 29 May 2007

[dominique355]

Associate Professor Wittaya Kulsomboon of Chulalongkorn University said the US had enforced compulsory licences much more than Thailand did.

"Why didn't the same move in the US attract criticism?" he said.

What compulsory licensing is he talking about? Can anyone cite the examples to which he's referring? When did the US ever steal a patent?

By IBNlive.com

Friday May 18, 02:32 AM

New Delhi: If the United States has its way, Yoga may no longer remain an Indian treasure. The US Patent office has granted American companies patents and copyrights to Yoga .

And that's not all. A Los Angeles based Yoga guru, Bikram Chaudhury, has claimed intellectual property rights over 26 asanas, which he says are postures developed from the ancient tradition.

The question that was being debated on India 360 was: US based lifestyle gurus are patenting age-old Yoga asanas. Can wisdom be patented?

Hoslistic Health Guru Mickey Mehta tried to answer this very question saying, "It's ridiculous and unfortunate that if anyone practices a Yoga asana that has been patented by Bikram Chaudhury, he or she could well be granted a legal notice.

so next time you will want to do yoga you will need to pay royalties to USA or you will be breaching pattent.

Obviously there is some confusion here about what is Copyright, what is a patent and what is a license and specifically a compulsory license.

I doubt very much that a Patent can be issued on a asana (which is a posture, a physical position). Of course, anyone can apply for a patent, even for an invention such as the "wheel" or the "perpetuum mobile", but it most likely won't be delivered.

Then, the USPTO cannot "grant" any copyrights.

So this example does not show an compulsory license the US Government has issued.

What we are talking about here is the situation where a company owns a patent for a pharmaceutical product and where a government is claiming "national emergency" to issue a compulsory license on this patent to a third party, because otherwise the national emergency cannot be coped with.

Obviously, not any situation where several individuals need a medical treatment is a national emergency. There must be a situation, which is different from what is "normal" or "usual", it must be a situation, which threatens the very existence of the country. Otherwise every and any patent for a pharmaceutical products can be expropriated at any time.

Also, the financial burden for a government to pay for this medicine is a "national emergency" only if the financial collapse is threatening.

Neither is the case in Thailand, neither for HIV/AIDS, nor for heart diseases, nor for cancer.

Shall we see Minister Mongkol in a frenzy to issue dozens of compulsory licenses, because his approach to the problem is that he will be in charge only until December and ... "Après moi le déluge" or in plain English: I don't give a sh..t what happens after me.