http://www.keionline.org/index.php?option=com_content&task=view&id=168
His Excellency
Mr. Samak Sundaravej
Prime Minister
Government House
Nakornpratom Rd.
Dusit, Bangkok
Thailand 10300
His Excellency
Mr. Chaiya Sasomsap
Minister of Public Health
Tiwanont Rd.
Talad Kwan District
Nontaburi Province 11000
Thailand
March 4, 2008
Re: Thailand Compulsory Licenses and public health
Dear Prime Minister Sundaravej and Minister of Public Health Chaiya Sasomsap:
We are writing to address an issue of the utmost importance. Specifically, we urge the Thailand government to support its earlier decision to use TRIPS flexibilities and issue compulsory licenses on medicine patents.
Knowledge Ecology International (KEI) is a not-for-profit organization based in Washington, DC and with offices in Geneva and London, with extensive experience in providing technical assistance to governments and international organizations in the promotion of public health and advocating for the protection of patient interests.
Every sovereign government that grants patents on inventions also provides mechanisms for compulsory licenses. While the grounds for issuing a compulsory license differs from country to country, there is widespread agreement that such licenses are consistent with international law, particularly in, but not limited to, cases involving public health.
We are attaching a report on the use of compulsory licenses by other countries. It not only reports on compulsory licenses on medicines in developing countries, but also on the granting of compulsory licenses in high income countries, such as three recent compulsory licenses on medicines issued in Italy, and dozens of compulsory licenses issued in other fields of technology, such as software, digital television receivers, and automatic transmissions.
[KEI''S VAUNTED REPORT IS INACCURATELY PORTRAYS WHAT A COMPULSORY LICENSE IS AND IS NOT. MR. LOVE CONTINUES TO CONFUSE de jure COMPULSORY LICENSES WITH de facto COMPULSORY LICENSE, AND THEN EXAGGERATES ACTIONS THAT DO NOT CONSTITUTE de facto COMPULSORY LICENSES. HE ALSO MISLED THE THAI GOVERNMENT TO BELIEVE THAT COMPULSORY LICENSES ARE PERFECTLY LEGAL ANYTIME A GOVERNMENT SUBJECTIVELY DETERMINES THERE TO EXIST A PUBLIC INTEREST. THE WTO TRIPS AGREEMENT DOES NOT SAY THIS]
The United States will soon have a new president. All three of the leading candidates, Senators McCain, Obama and Clinton, are critics of the pharmaceutical industry. All three candidates care about access to medicine, and all three candidates are looking to repair and enhance the standing of the United States in the world community. Thailand should not assume that it will suffer if it stands by its earlier decision to issue compulsory licenses.
[BEG TO DIFFER: NOT ALL THREE OF THE CANDIDATES ARE WILLING TO FORCE U.S. CITIZENS TO GIVE AWAY THEIR PRIVATELY OWNED PROPERTY - DRUG PATENTS - TO SUIT THE NEEDS OF A THIRD COUNTRY, AND THEREBY ENDANGER U.S. DRUG INNOVATION PIPELINES. THOUGH, WE ARE WILLING TO BET WHICH TWO OF THE CANDIDATES WOULD BE WILLING TO DO SO!!]
On the other hand, if Thailand now backs down and cancels the compulsory licenses, it will be perceived as an acknowledgment that Thailand did something wrong earlier. It will make it much more difficult to issue compulsory licenses in the future, and it will undermine the relationship between Thailand and suppliers of generic medicines. If Thailand reverses its position, other developing countries will be deterred from using compulsory licenses, and Thailand will be seen as aligning itself with large pharmaceutical companies, against the interests of the poor.
[WELL, IF THE SHOE FITS, WEAR IT! YES THAT IS EXACTLY THE POINT - THE THAI GOVERNMENT WOULD VIOLATE INTERNATIONAL LAW (THE TRIPS AGREEMENT) BY ISSUING THOSE COMPULSORY LICENSES. THE TRUE QUESTION IS WHETHER THE GOVERNMENTS OF THE PATENT HOLDERS HAVE WHAT IT TAKES TO DEFEND THEIR CITIZENS' INTERESTS.]
Members of the U.S. Congress are monitoring the USTR and the Department of State to ensure that the US government respects the 2001 Doha Declaration on TRIPS and Public Health, and does not bully Thailand on this issue. Many public health and development organizations, including KEI, are supportive of the use of compulsory licenses to increase access to medicines in developing countries. Thailand has much to gain by supporting it's earlier decision, and very much to lose by repudiating that decision.
[YES, THAT IS TRUE. MEMBERS OF THE 110TH CONGRESSIONAL MAJORITY HAVE INTRODUCED LEGISLATION THAT WOULD CHANGE U.S. LAW TO PERMIT THE U.S. GOVERNMENT TO DECLARE COMPULSORY LICENSES THAT 'TAKE' U.S. DRUG PATENTS (EXCLUSIVE PRIVATE PROPERTY) AWAY FROM THEIR PRIVATE OWNERS FOR THE BENEFIT OF THIRD COUNTRIES SUCH AS THAILAND, THEREBY ENDANGERING THE U.S. INNOVATION PIPELINE!!]
Sincerely,
James Love
Knowledge Ecology International
Saturday, March 8, 2008
KEI Encourages Thai Taking of Private Drug Patents For Government's Own Public Use: Misleads About Law of Compulsory Licenses
Indian Pharma Company Refuses to Register Drug in Thailand Due to Risk of Patent Compulsory License
Chaiya favours CL on cancer drugs - for now
Bangkok Post.com
March 3, 2008
Public Health Minister Chaiya Sasomsap insisted on Monday that he intends to persevere with the policy of issuing compulsory licences (CL) for key cancer drugs - but the government may still decide to cancel the patent-busting measure.
Mr Chaiya, who has ordered a review of CL policies on drugs for heart disease, spoke on Monday with representatives from the labour union of the Government Pharmaceutical Organisation (GPO), which is theoretically to break patents and manufacture generic copies of expensive drugs eventually.He said the issue will be finalised within two weeks, and insisted he will not withdraw the CL ordered on cancer drugs for poor patients.
He said, however, that the final decision on the issue rests with the Commerce Ministry. The public must await the results from the commerce ministry.
Rawai Phupaka, chairman of the GPO Labour Union said that an Indian drug company postponed drug registration in Thailand for another 25 months pending the public health ministry's final decision
on the CL.[EVEN THE INDIAN PHARMA COMPANIES ARE RELUCTANT TO REGISTER THEIR DRUG PRODUCTS IN THAILAND DUE TO THE LACK OF RESPECT FOR PRIVATE PROPERTY-BASED PATENTS. THE IMPRUDENT THAI GOVERNMENT POLICY WILL THUS HARM THE WELFARE OF THAI CITIZENS!]
The postponement, he pointed out, might cause the GPO substantial monetary damages. Until it is able to manufacture the drugs itself, the GPO is to import and resell Indian-made copies of the drugs. (TNA)
Friday, March 7, 2008
In the Thais' Eyes, Drug Patent Holders Must Fund Governments' Political Healthcare Promises
Head of Thailand's Food and Drug Administration resigns after one week
The Associated Press
Monday, March 3, 2008
BANGKOK, Thailand: The recently appointed head of Thailand's Food and Drug Administration resigned Monday amid controversy over the new government's plan to review a policy of overriding patents on several expensive cancer-fighting drugs.
Chatree said he decided to resign because he felt "uncomfortable with the politics," explaining that critics had brought up old, unproven allegations linking him to corruption in a computer procurement project in 2003. He called the allegations "politically motivated and groundless," without elaborating.
Chatree's predecessor, Siriwat Thiptharadon, was transferred to an inactive post last Tuesday by the new government of Prime Minister Samak Sundaravej. Siriwat called his transfer unfair, charging it was because he supported compulsory licensing of drug patents.
Compulsory licensing is intended to make some drugs more affordable by taking away the patent holder's ability to control the drug's price, a benefit of being a drug's exclusive supplier. International trade rules allow a government to issue a compulsory license to manufacture a generic version of a drug only in case of a national public health emergency.
[APPARENTLY UNDER THAI LAW, AS CALLED FOR BY HEALTH ACTIVISTS WHO LOBBIED TO REMOVE THE NEW FDA ADMINISTRATOR, DRUG INNOVATORS THAT DARE TO EXERCISE THEIR PATENT RIGHTS IN THAILAND ARE AUTOMATICALLY DEEMED ILLEGAL MONOPOLISTS. IN OTHER WORDS, A PATENT HOLDER'S EXERCISE OF THE EXCLUSIVE RIGHT TO SELL, DISTRIBUTE AND IMPORT A NEWLY PATENTED DRUG THAT HAS NO COMPETITOR IN THE MARKETPLACE, PROVIDES AMPLE BASIS FOR THE THAI GOVERNMENT TO DECLARE THAT A 'PUBLIC INTEREST' HAS BEEN VIOLATED. CONSEQUENTLY, THE THAI GOVERNMENT, PROMPTED BY ACTIVISTS BELIEVES IT IS PERMITTED TO 'TAKE' IT AWAY FROM THE PATENT OWNER VIA ISSUANCE OF A COMPULSORY LICENSE !!]
Siriwat was the architect of the government's policy leading to the issuing of compulsory licenses on Jan. 4 for four cancer-fighting drugs.
In the past two years, the Thai government has also issued compulsory licenses for several drugs used to treat AIDS and heart disease, drawing criticism from companies holding patents on the drugs.
The drug companies dispute whether the circumstances in Thailand qualify for such licenses.
Newly appointed Public Health Minister Chaiya Sasomsup said Monday the ministry will review the licensing policy on the cancer-fighting drugs, while ensuring patients have affordable access to the medicines.
[AT WHOSE COST, THAT OF THE DRUG COMPANIES?? ARE PATENT HOLDERS, AS A MATTER OF INTERNATIONAL POLICY, NOW RESPONSIBLE FOR FUNDING GOVERNMENTS' PUBLIC HEALTH CARE PROMISES??? WHY DOESN'T THE GOVERNMENT JUST TAKE OVER THE PHARMACEUTICAL BUSINESS & ELIMINATE FREE ENTERPRISE ALTOGETHER??]
He said that if negotiations fail to get drug companies to lower their prices, compulsory licensing would be maintained.
Chaiya earlier said the government planned to review the drug licensing policy because U.S. drug manufacturers might ask Washington to apply trade sanctions against Thailand.
The four drugs issued compulsory licenses on Jan. 4 are Novartis' Imatinib and Letrozole, Sanofi-Aventis' Docetaxel, and Roche's Erlotinib.
Novartis AG and Roche Holding AG are Swiss, and Sanofi-Aventis SA is French.
Saturday, March 1, 2008
Health Activists Out to Destroy US Patent System & Give Away US Drug Technologies to the UN: Candidate Hillary Clinton Approves
http://www.huffingtonpost.com/james-love/access-to-medicine-in-dev_b_89151.html * March 29, 1998, Donald McNeil, for the New York Times, "South Africa=E2=80=99s Bitter Pill for World's Drug Makers." A long (more than 2,= 900 * April 11, 1999, Lisa Richwine for Reuters, "Groups say U.S. Hurts World Access to AIDS Drugs." The first U.S. wire service article on the trade dispute, Lisa addressed a wide range of technical issues and topics, including even Donna Shalala's refusal to allow Thailand to use the NIH owned patent on ddI. * April 28, 1999, Merrill Goozner in the Chicago Tribune, "Third World Battles for AIDS Drugs." This long article ran on page one above the fold, with a photo, and was the winner of a Washington Monthly journalism award. The Goozner article was reportedly read by President Clinton on Airforce One, causing him to use the White House staff to immediately track down Sandy Thurman (who was taking a bath in a Hotel) to talk about the issue. Interesting fact: It was in this article that Goozners mentioned the TRIPS provision on national emergencies, leading to thousands of subsequent news stories which implied incorrectly that compulsory licensing could only be done in cases of national emergencies.
Access to medicine in developing countries -- hoping for 'change'
Posted February 29, 2008 09:53 AM (EST)
For his first seven years, Bill Clinton pursued an aggressive policy of imposing tough intellectual property rules for developing countries, most importantly in the area of new medicines, which were seen as an important U.S. export. In 1994, I began a long effort to address the flaws in this policy, working first with (Huffpo blogger) Rob Weissman, Ralph Nader, and soon a few global public health groups, like Health Action International and MSF, and local public health groups in Thailand and South Africa. In 1998, through 1999, a global campaign advocating the use of compulsory licenses on medicines was launched. By June of 1999, a small but very motivated and informed group of U.S. AIDS activists began a campaign to disrupt the Gore campaign for President, to protest Gore's direct involvement in bullying South Africa over proposed changes in its patent laws.
With very few exceptions,* the U.S. new media had largely ignored this issue, until it became an unexpected but real problem for Al Gore. For the first time, the U.S. public had some information about why the U.S. is resented around the world, on this topic. The United States Trade Representative and the U.S. Department of State, directed by President Clinton and Vice President Gore, were forcing developing countries to impose tough and costly monopolies on medicines, and directly reducing access to medicines needed to prevent death and suffering. As an aside, it was through this issue that I met Arianna Huffington. Although she was then known mostly as a right wing allay of Newt Gingrich, she began writing about the dispute over drug patents in Africa, and more generally about the nature of corporate power, and her columns on this topic helped change U.S. trade policy.
Both Gore and Clinton responded to the pressure from AIDS activists (people like Paul Davis, Asia Russell, Mark Milano, Eric Sawyer, Bob Lederer and many other brave and selfless persons whose names I am ungratefully neglecting) and groups like ours, and by 1999, U.S. trade policy was significantly modified, most dramatically in a well received speech delivered by Bill Clinton on December 1, 1999, on world AIDS day, at a chaotic WTO meeting in Seattle. Gore flipped too, and made peace with the AIDS activists, who then supported his run against George W. Bush.
The changes in Trade policy announced by Bill Clinton in December 1, 1999 began a moderation of a very bad trade policy, but only partly. For example, in January 2001, in his last ten days in office, Bill Clinton authorized a WTO case against Brazil, in order to stop Brazil from issuing compulsory licenses on patents for the AIDS drug efavirenz, an action dubbed "the Merck case" by USTR.
George W. Bush's election was initially not a disaster on the access to medicines issue. Bob Zoellick, then the head of USTR, initially retained the Clinton changes in trade policy, and to make a very long story short, in November 2001, agreed to the Doha Declaration on TRIPS and Public Health, which called for implementing patent laws in manner to promote "access to medicine for all." Unfortunately, drug company CEOs then began meeting directly with Karl Rove, and a much reigned in USTR began a long pro-big-pharma drift that now features regular bullying of developing countries on the drug patent issue.
Looking back, on his worst days, George W. Bush has had a better trade policy on medicine patents than Bill Clinton did on his worst days. But looking forward, it is quite important that the next president make some big 'changes', and allow countries like India, Brazil, Thailand and others to issue compulsory licenses on drug patents.
[ARE THESE THIS THE TYPE OF 'CHANGE' PROMOTED BY THE 'GREAT OBAMA' - GIVING AWAY FUTURE AMERICAN INGENUITY??]
More important, we need to create a new global trade policy based upon public health needs, looking to treaties on research and development, rather than the ever tougher intellectual property rules. Resolutions that would support these changes included Senate Resolution 241, and House Resolution 525.
[SENATE RES. 241 - SPONSORED BY DEMOCRATIC SENATOR SHERROD BROWN (OH): A resolution expressing the sense of the Senate that the United States should reaffirm the commitments of the United States to the 2001 Doha Declaration on the TRIPS Agreement and Public Health and to pursuing trade policies that promote access to affordable medicines. See: http://www.govtrack.us/congress/bill.xpd?bill=sr110-241]
[HOUSE RES. 525 - SPONSORED BY DEMOCRATIC CONGRESSMAN THOMAS ALLEN (ME): Expressing the sense of the House of Representatives that the United States should reaffirm the commitments of the United States to the 2001 Doha Declaration on the TRIPS Agreement and Public Health and to pursuing trade policies that promote access to affordable medicines. See: http://www.govtrack.us/congress/bill.xpd?bill=hr110-525 .]
[***THIS IS ACTUALLY A POLICY OF GIVING AWAY AMERICA'S FUTURE TECHNOLOGICAL INNOVATION & ECONOMIC GROWTH TO THIRD COUNTRIES WHICH WILL HOBBLE U.S. LIFE SCIENCES COMPANIES AND RESULT IN ADDITIONAL LOSS OF AMERICAN JOBS AND LOWER STANDARDS OF LIVING***]
We now have three leading candidates for President, and none of them have agreed to co-sponsor Senate Resolution 241. But we have "hope" for good things.
[THIS IS MOST LIKELY BECAUSE THEY DON'T WISH TO BE CRITICIZED, ONE WAY OR THE OTHER, DUE TO ACTIVIST CAMPAIGNS LAUNCHED BY BOTH THE 'EXTREME' DEMOCRATS & THE 'EXTREME' REPUBLICANS].
Hillary has clearly been influenced by a combination of her own sensitivities to the health issue, and the increasingly deep commitment of Bill Clinton, as an ex-president, to address concerns about access to medicine in developing countries. Like many liberal Congressional Democrats, Bill Clinton has often embraced a policy of AIDS exceptionalism on these issues, which focuses on the needs to AIDS patients, but does not necessarily extend this concern to other health problems, such as the need for developing countries to have access to new treatments for cancer or heart diseases.
But many activists believe that Hillary will be very good on this issue if she becomes president. My own 16 year old son actually talked directly to Hillary about this topic, during a February 7 visit she made at an Arlington High School. Senator Clinton took a moment to personally express her support for poor patients having access to new medicines, and she endorsed the use of compulsory licensing of patents to make this possible.
[***BY FAVORING THE ISSUANCE OF COMPULSORY LICENSES AS OFFICIAL U.S. POLICY, FOR THE BENEFIT OF NON-U.S. CITIZENS ABROAD, MRS. CLINTON IS NOW ON RECORD FOR PROMOTING THE DEMISE OF U.S. CONSTITUTIONALLY PROTECTED PRIVATE PROPERTY RIGHTS IN INDIVIDUAL DISCOVERIES & INVENTIONS QUALIFYING FOR CIVIL RIGHT PROTECTION UNDER THE U.S. PATENT LAWS, AS AMENDED, SINCE THE FOUNDING OF OUR NATION. IN OTHER WORDS, SHE HAS DECLARED, CONTRARY TO U.S. HISTORY & SUPREME COURT JURISPRUDENCE, THAT PATENTS ARE NOT PROTECTABLE PRIVATE PROPERTY UNDER THE 'TAKINGS' CLAUSE OF THE 5TH AMENDMENT TO THE U.S. CONSTITUTION.***]
AIDS activists have had some luck in getting Obama to offer some encouraging words on this topic, as it relates at least to AIDS, and his very bright Senate staff has given meetings on the topic, and seem sympathetic.
For both Hillary and Obama, I should emphasize that huge efforts have so far have failed to get either candidate to co-sponsor Senate Resolution 241. This is not entirely encouraging. But we have hope.
John McCain has shown a lot of independence from big pharma on domestic issues, like parallel trade in medicines (importing cheaper brand name drugs from Canada or Europe to benefit U.S. consumers). But he has yet to directly address the trade issue in a constructive way, and the best that can be said is that his unhelpful statements reflect a lack of understanding. But, we hope that if he becomes president, he will do the right thing.
This is a very important issue. Thailand is today being pressured by the U.S. Department of State and the USTR to abandon compulsory licenses it had earlier issued on patents on drugs for AIDS, heart disease and cancer. Brazil is being pressured to not issue a compulsory license for the Gilead drug tenofovir. Chile has been pressured over it's efforts to import generic versions of an expensive leukemia drug. The USTR is pressuring dozens of Latin American countries to abandon a pro-public health position in a far ranging negotiation on public health, innovation and intellectual property at the World Health Organization. The U.S. government is trying to stop the World Health Organization from offering useful technical assistance on patent issues to poor countries, and opposes many measures that would promote greater access to safe generic medicines.
These issues don't directly concern U.S. voters, but they are extremely important. We are creating new global norms that will last several decades, and impact billions of persons throughout the world. For people who don't follow this issue very closely, this is what is at stake. People who live in developing countries typically have average incomes of anywhere from 1 to 20 percent of the US. And, within developing countries, unskilled workers are far below the average. With monopolies, drug companies typically choose prices that are only affordable for the richest 1 to 20 percent of the populations. With generic competition prices fall a lot (More than 95 percent for many important drugs), and access is much better.
[NO. WHAT IS AT STAKE IS AMERICA'S FUTURE INNOVATION & COMPETITIVENESS, BECAUSE ACTIVIST GROUPS LIKE THE ONE JAMIE LOVE OPERATES ARE CALLING FOR U.S. LIFE SCIENCES COMPANIES TO GIVE AWAY THEIR NEW DRUG DISCOVERIES & INVENTIONS TO THIRD COUNTRIES AND WILL HAVE INADEQUATE PROFITS TO REINVEST INTO FUTURE DRUG RESEARCH & DEVELOPMENT. ALSO, U.S. TAXPAYERS WILL BE DIRECTLY AFFECTED, BECAUSE THESE COMPANIES WILL BE FORCED TO RAISE THE COSTS OF THEIR NEW DRUGS IN THE U.S. TO COMPENSATE FOR THE LOSS OF THEIR PRIVATE PROPERTY ABROAD. IN OTHER WORDS, AMERICANS WILL BE CALLED TO SUBSIDIZE THE ENTIRE WORLD'S HEALTH NEEDS BASED ON GENERAL COMMUNITARIAN PRINCIPLES OF PUBLIC INTEREST. SO MUCH FOR THE QUALITY OF LIFE AMERICANS WILL NEED TO SACRIFICE UNDER SUCH PROPOSALS...]
In the global battle over access to medicines, what side are these candidates on? And what changes will they made if elected?
[APPARENTLY, ACTIVISTS, HILLARY CLINTON & BARACK OBAMA ARE AGAINST THE INTERESTS OF AMERICA'S SMALL AS WELL AS LARGE INVENTORS]
********************************************************
Journalists who wrote about US trade disputes before the 1999 Gore Zaps February 29th, 2008 James Love
-------------
In a blog posted today on the Huffington Post, I could have, should have, elaborated a bit on the few U.S. journalists who had written about the trade disputes involving patents on medicines, before AIDS activists began their zaps of Gore's presidential campaign in June of 1999.
I can recall (help me if I am forgetting someone) four journalists who were ahead of the curve. Each had to sell their institutions on the news value of the stories, and have continued excellent reporting on these issues.
words) and informative article about the dispute over parallel trade, written more than one year before others wrote about the dispute.
* May 24, 1999, Sabin Russell, in the San Francisco Chronicle, "New Crusade to Lower AIDS Drug Costs: Africa's needs at odds with firms' profit motive." A front page story by a knowledgeable reporter on AIDS and other health issues.
