Letter to Editor from Thai Network of People Living with HIV/AIDS, concerning "Bangkok's Drug War, Round Two"
Thu, 6 Mar 2008
Dear Editor,
I am one of the 'packhounds' that you accuse of spreading scare stories in your editorial (Bangkok's Drug War, Round Two) of 27 February 2008. My organization, which consists of people living with HIV/AIDS in Thailand, supports access to necessary drugs for all Thais, not just the rich minority that can pay the prices charged by pharmaceutical companies enjoying monopoly patents.
[THE THAI GOVERNMENT HAS THE LEGAL & POLITICAL RIGHT TO DEVELOP AN HIV/AIDS UNIVERSAL ACCESS TO MEDICINES PROGRAM AT ITS OWN EXPENSE. BUT IT DOES NOT HAVE THE RIGHT TO DEMAND FINANCIAL SUPPORT FROM FOREIGN INVESTORS; OTHERWISE IT RISKS TRIGGERING CAPITAL FLIGHT].
Your article is sadly misinformed. What you call the 'loophole' of compulsory licensing (which is what has kept some of my friends alive) is in fact a piece of international law that was heavily negotiated and agreed by all member countries of the WTO.
[THIS IS NOT TRUE. THERE WAS NEVER A CONSENSUS ON THE SCOPE OF THE COMPULSORY LICENSING PROVISIONS WHICH HAS BEEN EXPLOITED BY FOREIGN GOVERNMENTS AT THE INSISTENCE AND ENCOURAGEMENT OF ACADEMICIANS AND NGOS].
The Thai government did not 'seize' patents; it used the same legal right that many other countries have used, including the United States, whose threats of trade sanctions so worry the new Thai Minister of Public Health.
[WHEN HAS THE UNITED STATES ACTUALLY ISSUED A DE JURE COMPULSORY LICENSE?? PLEASE DO NOT RELY ON THE MISLEADING INFORMATION PROVIDED BY KEI'S JAMIE LOVE].
You claim that the need for access to life-saving HIV, heart disease and cancer drugs is not a clear emergency in Thailand. Cancel the free distribution of drugs made possible through compulsory licences and thousands of Thai will be dead in weeks. The emergency is clear enough to them.
[WITH THIS RATIONALE, ANY DISEASE THAT INFLICTS A SUBPORTION OF A POPULATION WILL BE DESIGNATED AS AN 'EPIDEMIC' UNDER THE EVOLVING WORLD HEALTH ORGANIZATION STANDARDS AND THEN DECLARED A 'HEALTH EMERGENCY' FOR PURPOSES OF TRIPS!!]
And you claim that 'the other side of the argument' is 'missing'. Given the intense lobbying of the new Minister by what you call 'Big Pharma', supported by the US government and enjoying far richer resources than my organization can muster, this is hard to swallow.
[PHARMA COMPANIES HAVE LEGAL ECONOMIC RIGHTS TO DEFEND THEIR EXCLUSIVE PRIVATE PROPERTY, AN ECONOMIC ASSET AGAINST GOVERNMENT EXPROPRIATION. WHY IS IT WRONG FOR THEM TO PROTECT THEIR PRIVATE INTERESTS???]
It took my organization and our allies (in the government, the media, and academia, as well as in other NGOs) a long, long time to get our government to exercise its legal right to compulsory licensing.
Please do not misrepresent our case, bully our government or call us names.
Virat Purahong,
The chairperson of Thai Network of People Living with HIV/AIDS (TNP+)
494 Soi Nakornthai 11
Ladproa 101 Road,
Klongjan, Bangkapi
Bangkok, Thailand 10240
Tel (66)2377-5065 Fax (66) 2377-9719
E-mail : tnpth@thaiplus.net
Saturday, March 8, 2008
Thai Health Activists Are Misled To Believe Their Government is 'Licensed' to Steal Private Drug Patents From Foreign Investors Pursuant To WTO Law!!
A One-Side Argument Will NOT Ensure the Health of the Thai People
http://online.wsj.com/article/SB120406606358794697.html?mod=opinion_main_europe_asia
Bangkok's Drug War, Round Two
THE WALL STREET JOURNAL ASIA
February 27, 2008
Thailand's military government may be gone, but its war on drug patents is still very much alive. Just ask the new Health Minister, Chaiya Sasomsup, who is thinking about restoring intellectual property rights to their rightful owners -- the pharmaceutical companies.
Mr. Chaiya, who took office this month, is trying to clean up the mess bequeathed by his predecessor, Mongkol na Songkhla. Citing a World Trade Organization loophole, Dr. Mongkol seized patents on Merck's HIV/AIDS drug Efavirenz in 2006. In 2007, he took another HIV/AIDS patent -- Abbott Laboratory's Kaletra -- and Sanofi-Aventis's patent for a heart drug, Plavix. His last act before leaving office last month was to sign an order to seize four cancer drug patents: two from Novartis, one from Sanofi-Aventis, and one from Roche.
Mr. Chaiya is worried both about Thai patients' access to new drugs and trade sanctions against Thailand for seizing patents. Fair enough: The WTO provision Dr. Mongkol used specifies patent seizures are allowed only after "efforts to obtain authorization from the right holder on reasonable commercial terms and conditions," or in cases of "national emergency." It's unclear that Thailand's actions fit either circumstance.
But woe be to Mr. Chaiya to utter such heresy in Thailand, where nonprofit groups such as Oxfam 
What's missing here is the other side of the argument.
Many drug companies tier their pricing, charging developed countries more and developing countries such as Thailand, less. Thailand also faces a range of delivery problems that raise the ultimate cost of drugs to consumers, including high taxes on imports. Not least, seizing patents also puts patients at risk of importing nonbranded, lower-quality drugs.
Mr. Chaiya's job is to look after the health of the Thai people, not the political motivations of NGOs. It's clear what serves Thais best: drug companies that are incentivized, through the profit motive, to research and develop new drugs.
Thai Government Commissions Two-Week 'Study' To Find Country-Wide Cancer Health Emergency: Seeks To Justify Compulsory Licenses
http://nationmultimedia.com/2008/03/03/national/national_30067110.php
No cancellation of CL for cancer drugs : Chaiya
by Pongphon Sarnsamak
The Nation.
March 3, 2008
"The use of compulsory licensing must be continued alongside the negotiation with pharmaceutical companies to reduce the price of drug products," he said.
The Health Ministry has to retain compulsory licensing as an important tool to help give patients access to livesaving drugs. But the drugs, upon which compulsory licensing was imposed by his predecessor, Dr Mongkol Na Songkla, had not yet been approved by the previous Cabinet, he said.
Moreover, the Ministry of Commerce had informed him that the compulsory licensing of cancer drugs would affect Thailand's international trade, particularly with the United States, which may designate a country as a "Priority Foreign Country" if it has an adverse impact on relevant US products.
This was the reason why the Health Ministry earlier announced a revision of the compulsory licensing enforcement for cancer drugs.
The drugs for which compulsory licensing was imposed on January 4 are docetaxel, sold as Taxotere by Sanofi Aventis; erlotinib, sold as Tarceva by Roche; and letrozole, sold as Femara by Novartis. All are expensive and the poor could not afford for treatment.
"Some information and the process of the recent imposition of compulsory licensing for cancer drugs was not legal because it was not imposed by Cabinet resolution," he said.
To implement compulsory licensing and not affect international trade, Chaiya had assigned the National Health Security Office, the National Cancer Institute and health experts to calculate the total number of patients suffering from leukaemia and breast, lung and gastric cancer, which would help the ministry estimate the budget for imported drugs.
A study is now in process and is expected to conclude in the next two weeks. The results will then be submitted to the Cabinet for a decision on this controversial issue.
However, he said it is the duty of the Minister of Commerce to make the decision to revoke or retain compulsory licensing.
Government Pharmaceutical Organisation chairman, Vichai Chokewiwat said the recent imposition of compulsory licensing for cancer drugs could not be revoked by the Ministry of Commerce because the 1992 Patent Law's Article 51 allows any Ministry to announce compulsory licensing for the noncommercial use without approval by the Ministry of Commerce.
He said if the government makes a decision to cancel the recent compulsory licensing it would violate the constitution and the National Health Security Office Act, which appoints the government to provide cheap drugs and effective treatment for patients.
KEI Encourages Thai Taking of Private Drug Patents For Government's Own Public Use: Misleads About Law of Compulsory Licenses
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
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)
Thursday, February 7, 2008
Activist NGOs Call For Developing Country IP & Economic Welfare (More 'Balance' Needed In IP and Trade); Not For R&D and Business Skills Training
http://www.ip-watch.org/weblog/index.php?p=898
Intellectual Property Watch
29 January 2008
NGO Panel: More Balance Needed In IP And Trade; Disclosure May Not Be Enough
By Catherine Saez
A more balanced international regime for intellectual property rights and trade is needed to rectify the current system, which too strongly favours developed countries, developing country panellists said at a recent event.
But some say that a proposed requirement to disclose the origin of genetic material and associated traditional knowledge in patent applications would not be sufficient to improve this balance.
The current patent system has been seen as the primary enabling mechanism for biopiracy, the misappropriation of genetic resources, said panellist Xuan Li, coordinator of the innovation and access to knowledge programme at the intergovernmental South Centre. The World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) also has allowed the misappropriation of genetic resources, she said.
[THIS IS PATENTLY UNTRUE AND SMACKS OF SOCIALIST PUBLIC GOODS IDEOLOGY TO DISGUISE PATENT PIRACY PREDILECTIONS]
Li made the remarks at a 24 January event organised by the South Centre and the Center for International Environmental Law (CIEL), held alongside a weeklong meeting of the UN Convention on Biological Diversity (CBD) working group on access and benefit sharing (ABS).
A Chinese official on the panel also raised these concerns and said that TRIPS is sometimes unbalanced and privileges the holder of IP.
[THE CHINESE ARE DISINGENUOUS, CONSIDERING THEY WISH TO DEVELOP THEIR OWN TEMPORARY INTELLECTUAL PROPERTY MONOPOLIES]**
A more balanced system should be devised in the future that would be more favourable to developing countries, the official said, adding that an amendment to TRIPS Article 29 on a mandatory disclosure requirement (see South Centre paper [pdf]) is proposed by developing countries including China, in order to bring the agreement more in line with CBD principles, like benefit sharing.
[CHINA TENDS TO PLAY BOTH SIDES OF THE FENCE]**
The protection of biodiversity and the rights of indigenous peoples are being analysed at several international fora. Approaches to the disclosure of origin issue have been raised at the WTO, the World Intellectual Property Organization (WIPO), and the CBD.
As the CBD is a prior treaty to TRIPS, under the Vienna Convention, TRIPS needs to be compatible with the CBD mandate, said panellist Dalindyebo Shabalala, director of the IP and sustainable development project at CIEL.
[THIS ALSO IS UNTRUE - THE LATEST TREATY IN TIME ON THE SAME OR SIMILAR SUBJECT MATTER USUALLY SPEAKS TO THE MORE MODERN INTERPRETATION OF TERMS AND REFLECTS THE MORE MODERN THINKING OF TREATY PARTIES - ESPECIALLY IF THE MORE RECENT TREATY TERMS IN QUESTION ARE MORE SPECIFIC THAN THOSE OF THE EARLIER TREATY ON THE SAME OR SIMILAR SUBJECT - THUS, THE TRIPS RULES ARGUABLY SUPERCEDE THE MORE GENERAL CBD RULES]
The ABS working group was established by the CBD Conference of the Parties at its fifth meeting in May 2000, with a mandate to develop guidelines and other approaches to assist parties and stakeholders with the implementation of the access and benefit-sharing provisions of the convention.
Another mandate was given to the working group in 2004 to elaborate and negotiate an international regime on access to genetic resources and benefit sharing with the aim of adopting an instrument to effectively implement provisions in Articles 8 and 15 and the three objectives of the convention. These include conservation of biological diversity, sustainable use of its components, and fair and equitable sharing of the benefits arising out of the utilisation of genetic resources.
In the second mandate of the ABS working group, WIPO was asked to play a significant role in CBD deliberations. Some industrialised countries have sought to have WIPO play the role of the major provider of technical expertise on IP-related issues such as the protection of traditional knowledge and disclosure of origin, according to Shabalala.
However, the processes at WIPO do not fully reflect the human rights dimension of the protection of indigenous/traditional knowledge associated with genetic resources, as the delegates and the secretariat have a lack of experience on human rights and environmental issues, he said. According to Shabalala, other United Nations agencies also have competence in understanding IP issues, such as the World Health Organization or the United Nations Conference on Trade and Development.
Concerning a certificate of origin for resources, Pierluigi Bozzi of the Economics Department at the University of Rome put into perspective the importance of knowing the precise origin of genetic resources in the context of the CBD. “The unlawful removal of a resource becomes visible only after the event and in times and places far from the original context,” he said.
[THIS IS TYPICAL EUROPEAN POSITION FAVORING 'GEOGRAPHIC INDICATORS' AND RULE OF ORIGIN AS A MEANS OF DISGUISED TRADE PROTECTIONISM]**
The real asset of the ascertainment of the place of the origin of genetic resources would be to bring management and control of a biological element back to its own ecosystem, allowing the country to bear the responsibility for the knowledge and the management of that specific biological component. This would also allow the benefits and incentives to be spread across the entire value chain, not only to the end of it, according to Bozzi. The fair and equitable sharing of the benefits is a “prerequisite” to realise the two first objectives of the CBD (conservation and sustainable use of biodiversity), he said.
[THIS IS A PRESCRIPTION FOR STATE-CENTRALIZED OWNERSHIP OF THE COMMONS - RES COMMUNIS - AND THUS A MANDATE FOR WELFARE STATE SOCIALISM]
The indigenous perspective on disclosure seems somewhat different, according to Le’a Malia Kanehe, legal analyst at the Indigenous Peoples Council on Biocolonialism. She said that several problems had been identified with disclosure, such as trans-boundary people or biopiracy having taken place prior to the CBD. The latter case would mean that genetic resources would be ex-situ, outside of indigenous control. But the main concern of the indigenous peoples, according to Kanehe, is to find out if disclosure really addresses the rights and interests of indigenous peoples, particularly in the case where national law does not recognise indigenous peoples’ rights.
[NOW, THIS IS A LEGITIMATE CONCERN]
An ongoing international project to develop prior art databases of traditional knowledge for patent examiners also is potential dangerous as they might become a “shopping list” of traditional knowledge over which indigenous people could lose both ownership and control (IPW, Biodiversity/Genetic Resources/Biotechnology, 19 December 2007; IPW, Subscribers, 17 December 2007). An international patent system might not be consistent with local customary laws, she said. Indigenous people should have the choice whether or not to commercialise their knowledge. “We don’t want to be third-party beneficiaries,” she said.
[THIS ARTICLE'S PORTRAYAL OF THE CURRENT PRIVATE PROPERTY-BASED GLOBAL IP STANDARDS AS UNFAIR TO DEVELOPING COUNTRIES IS NOT ONLY WRONG, BUT ALSO REFLECTS AN IDEOLOGY PREDISPOSED AGAINST PRIVATE PROPERTY IN FAVOR OF 'PUBLIC GOODS'.
THIS IS ESPECIALLY TRUE CONSIDERING THAT ALL WHICH IS NECESSARY TO PROECT THE RIGHTS OF INDIGENOUS AND OTHER DEVELOPING COUNTRY CITIZENS WHO ARE 'INVENTORS' AND PROPERTY HOLDERS IS A NATIONAL 'RULE OF LAW' FRAMEWORK THAT RECOGNIZES AND PROTECTS EXCLUSIVE PRIVATE PROPERTY RIGHTS IN PATENTED DISCOVERIES AND DERIVATIVE INNOVATIONS.
WHAT IS CRUCIAL AND IMPORTANT IS THAT THE DISCOVERIES CAN BE REDUCED TO THE UNIVERSAL STANDARD FOR PATENTABILITY: NOVEL, USEFUL & UNOBVIOUS. TO SUGGEST THAT ANY EFFORT TO REDUCE TRADITIONAL KNOWLEDGE TO SUCH A STANDARD WOULD, IPSO FACTO, SHORTCHANGE INDIGENOUS PEOPLES IS CLEARLY INACCURATE AND FALSE.
THE COMMONS IS OWNED BY NO ONE, NOT EVEN THE STATE, THOUGH THE STATE CAN ACT AS 'TRUSTEE' FOR ITS CITIZENS IN PRESERVING AND PROTECTING THE PUBLIC GOOD DERIVED FROM THE USE OR NONUSE OF THE COMMONS. WHILE THE STATE MAY FAIRLY CHARGE AN ACCESS FEE TO 'TAKE' FROM THE COMMONS, IT SHOULD NOT BE ENTITLED TO ANYTHING MORE THAN AN ADMINISTRATIVE FEE. IT SHOULD NOT BE ENTITLED TO DERIVE A ROYALTY STREAM FROM THE HUMANLY MANIPULATED PRODUCTS DERIVED FROM NATURE, UNLESS THE STATE HAS BEEN INVOLVED, SCIENTIFICALLY AND/OR ECONOMICALLY IN SOME OF THE HUMAN MANIPULATION OF THE NATURE THAT RESULTS IN MARKET-RELEVANT INNOVATIONS .
ONLY TO THE EXTENT THAT FLORA EXTRACTED FROM THE 'COMMONS' (NATURE), PRESUMABLY WITH STATE OR INDIGENOUS PEOPLE CONSENT, CAN BE PROVEN TO HAVE BEEN SUFFICIENTLY MANIPULATED BY HUMANS IN SUCH AS WAY AS TO MAKE IT NOVEL, USEFUL AND UNOBVIOUS, CAN THE RESULTING DISCOVERY/INNOVATION BE PATENTED AND LATER COMMERCIALIZED FOR PROFIT AS PRIVATE PROPERTY.
CONSIDERING ITS MANY INACCURATE STATEMENTS, THE ADVICE GIVEN IN THIS ARTICLE BY THE AUTHOR, IF FOLLOWED, WILL ACTUALLY DEPRIVE DEVELOPING COUNTRY CITIZENS OF THE OPPORTUNITY TO INNOVATE THEMSELVES. BY FOCUSING ON ALLEGED 'BIOPIRACY' RATHER THAN HELPING DEVELOPING COUNTRY INVENTORS TO BECOME SKILLED IN RESEARCH & DEVELOPMENT AND ENTREPRENEURSHIP ACTUALLY FOSTERS GREATER STATE WELFARE AT THE EXPENSE OF INDIVIDUAL WELFARE WHICH IS NOT ENHANCED AS A RESULT.
LASTLY, THIS ARTICLE SEEMS TO PROMOTE A 'NEGATIVE PARADIGM' OF SUSTAINABLE DEVELOPMENT INSOFAR AS IT ADVOCATES IN FAVOR OF STATE-CENTRED OR EVEN SUPRANATIONAL UN-CENTERED GOVERNANCE THAT DIMINISHES INDIVIDUAL GROWTH AND OPPORTUNITY FOR THE SAKE OF THE 'PUBLIC GOOD'. HENCE, UNDER THE PROPOSED SYSTEM INDIVIDUALS WILL NEVER BE ABLE TO REALIZE THEIR HUMAN POTENTIALS.]
Friday, January 25, 2008
KEI Anti-Patent Activist Praises Thailand For Planning to Issue 4 Cancer Drug Compulsory Licenses
http://www.bangkokpost.com/News/25Jan2008_news15.php
[Thai] Government approves four cancer drugs: Compulsory licensing a must, says Mongkol
January 25, 2008
Bangkok Post
APIRADEE TREERUTKUARKUL
The outgoing military-appointed government will go ahead with the implementation of compulsory licensing (CL) for four cancer drugs, Public Health Minister Mongkol Na Songkhla said yesterday. The minister did not disclose the names of the drugs listed for compulsory licensing, simply saying the decision had been made on Jan 4 following a proposal submitted by the sub-panel chaired by Government Pharmaceutical Organisation (GPO) board chairman Vichai Chokewiwat.
The Vichai [VICHY] panel has advised the public health minister to issue compulsory licences for the breast cancer drug Letrozole and the leukaemia drug Imatinib, both produced by Novartis, the breast and lung cancer drug Docetaxel, produced by Sanofi-Aventis, and lung cancer drug Erlotinib, made by Roche.
The objective is to seek cheaper generic forms of the drugs for treating patients under the universal healthcare scheme, thereby saving the government huge sums of money.
Dr Mongkol said he had thoroughly considered the pros and cons of applying CL to such cancer drugs.
''We would not do it if it's not necessary. But we don't have time for more negotiation. We did the best we can,'' he said, adding that health officials had met patent owners for at least 13 rounds of negotiations over prices without making any significant progress.
The minister said he was certain that generic versions of cancer drugs would be of high quality and that patients under the universal healthcare scheme would receive the best benefits from the state policy on CL.
Letters stating the necessity to bypass patents of cancer drugs would be sent to all sectors involved _ the GPO, the Department of Intellectual Property and pharmaceutical companies owning the patents to the drugs by next week as he would soon finish his term, he said.
''I have faced pressure from several sides by making such a decision, but I am happy that poor patients will not go bankrupt due to the cost of cancer treatment,'' he said.
Cancer ranks as the number one cause of death in Thailand. The male population suffers mostly from lung cancer, whereas breast cancer is the major cause of death among women.
Meanwhile, pharmaceutical giant Sanofi-Aventis has threatened legal action against an India-based generic drug maker chosen to supply Thailand with a generic version of the heart drug Plavix.
Withit Artavatkun, managing director of the GPO board, said the threat was the latest in a series of attempts by the patent owner of Plavix to interrupt the country's CL policy.
Plavix, a blood thinner, is used to treat coronary artery, peripheral vascular and cerebrovascular diseases.
''Sanofi-Aventis' threat will not affect the procurement agreement as the first batch of two million heart drug tablets will be arriving by next week,'' said Dr Withit.
The India-based Zydus Cadila firm was chosen ahead of the other potential supplier Emcure Pharmaceuticals, also based in India, because Emcure had not yet provided bioequivalent documents essential for a registration grant from the Food and Drug Administration.
However, Dr Withit believed a threat from the patent owner was one of the main reasons that delayed Emcure's decision to supply a copycat version of the heart drug to Thailand.
The company last year also sent a letter to Emcure, claiming that selling generic versions of the medicine to Thailand was illegal as the country had not made public its decision to override the patent.
However, the GPO managing director said the ministry had officially declared its policy on the compulsory licensing of Plavix for over a year.
Tuesday, January 22, 2008
German Pharmaceutical Company Chooses NOT to Register Drug in Brazil Due to Risk of Patent Expropriation
Boehringer Refuses to Register Tipranavir in Brazil Because of Patent Law
By Michel Lotrowska
Sem Fronteiras Campanha Acesso a Medicamentos Essenciais / Access Campaign for Essential Medicines
January 21, 2008
Company refrain from launching and anti-aids drug because it disagrees with the patent law of the country ESTADO DE S PAULO -19TH FEBRUARY FABIANA LEITE
Although [l]egal, the decision not to register a drug is harmful for patients that need it to go on with their treatment.
The pharmaceutical laboratory Boehringer Ingelheim decided not to launch a medicine against aids in Brazil. The medicine called tipranavir is used in patients that are resistant to most other drugs against the disease. By not registering the medicine in the country, the company makes it difficult for patients who need it to have access as a last treatment alternative no medicine can be sold, offered by the Public Health System - SUS, without registration.
Recently, the Public Prosecutor of the State of SE Sao Paulo went to court to get this medicine as well as another one, recommended for a patient that has the immune system extremely weak and that already doesn’t respond to other medicines. The man has no money to import the drug. The court was favourable to the request, but the order has not arrived yet to the State Authorities of SE Sao Paulo, that will be obliged to import the medicine. The patient is only using some antibiotics says the public prosecutor Felipe Pereira.
The laboratory BI renounced to register the drug and the decision was unilateral. It conditioned the registration to the guarantee that the patent would be honored. As the government has a process for this, the president of the laboratory decided not to register, although the local office was trying to. The laboratory really decided not to register because of lack of guarantee of the patent. It was an extremely wrong decision, affirms the infectologist Adauto Castelo Filho, [who] was involved in the group of specialists that was analyzing studies with the medicine in Brazil.
According to Castelo, the decision was taken already in the middle of 2006, before the compulsory license of other medicine against aids, efavirenz, that took place in May last year. Nevertheless, this decision was never turned public. Partners of the company, nevertheless, affirmed to the newspaper that the compulsory licensing buried the possibility of the medicine be made available in Brazil. But also the fact that the Brazilian market for the medicine is not a priority for the company weighted in the decision of denying access to Brazilian patients of the drug being sold in Europe and the US.
BI pointed out they respect the Brazilian legislation and promised to bring the product in the country. The substance tipranavir, being an important medicine to control the infection (...) is in the relation of launching of the company that is programmed for the next years, in Brazil, informed the company (one of the 20 big one in the world) in a release. Nevertheless, every launching of BI is part of a chronogram guided by global strategies of the company, and, therefore, that can possibly be altered. According to the company, 92 patients that were part of a study with the drug in Brazil keep receiving the drug, paid by the lab.
The decision not to register a drug is a right of the patent holder. Nevertheless, currently, even without the guarantee of the exclusivity of production of a medicine in the country, other pharmaceutical companies don’t stop offering their products. The launching is usually done before the end of the analysis done through a long process implemented but the Patent Office (INPI) and the Local Drug Regulatory Authority (ANVISA) through the prior consent.
The decision of the company is not new in the pharmaceutical world. Others already denied to launch medicines in countries where the patent legislation is considered bad for its business, like Thailand, that already issued compulsory licenses.
NEGOTIATION IS LACKING
Castelo Filho calculates that between 2 and 3 thousand patients could benefit from tipranavir. For him, there was a lack of negotiation between the Brazilian Government and the Ministry, that would not have worked hard enough to bring the drug, that is very expensive. The Aids program is bringing very soon another drug for cases of resistance, Darunavir.
