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




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.

* 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
words) and informative article about the dispute over parallel trade, written more than one year before others wrote about the dispute.

* 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.

* 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.

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.]

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.

Former ITSSD Intern Reveals How American & European Activists and Politicians Attack U.S. Intellectual Property Rights

The New War on Drugs:
Activists and Politicians Attack Intellectual Property Rights

Capital Research Center - Organizational Trends

January 2008

http://www.capitalresearch.org/pubs/pdf/v1199294989.pdf

America’s pharmaceutical industry is the envy of the world and the savior of millions of sick people. But activist groups, many of them founded by Ralph Nader and funded by liberal foundations, are campaigning to limit the industry’s incentives to produce new life-saving drugs. Their strategy focuses on undermining the intellectual property rights that protect pharmaceutical innovation.

By Karl Crow


Karl Crow is a 3rd Year student at Temple University's Beasley School of Law. In 2007 he was an intern at the Institute for Trade, Standards, and Sustainable Development (ITSSD) in
Princeton, New Jersey.

Open Source for Cost Effective Drug Discovery

Dr. Samir K
Brahmachari,

the new Director-General of the CSIR is all set to unleash the open source revolution in drug discovery and biotechnology. The Economic Times Reports: “For the first time ever, India plans to launch an innovate drug discovery programme roping in global IT firms, researchers, companies, and young minds at scientific laboratories to invent drugs at a fraction of the cost of an MNC-developed drug. Drug discovery has hitherto been the forte of MNC pharma giants.The government has begun discussions with Sun Microsystems to set up web-management tools for an ‘open source’ drug discovery project, which works similar to a popular online encyclopaedia formed by articles contributed and edited by the brightest minds worldwide.

The first project would be to develop medicines for tuberculosis and later extend to other diseases like malaria and AIDS.Under the proposed project, researchers attached to institutions like the Royal Society of UK, Imperial College of London, Medicine Sans Frontiers and various Indian universities will have an opportunity to work on a drug discovery process even at an individual level. What’s more, the contribution would also fetch reward and recognition. Corporates like the Kinetic Group, entities like the Welcome Trust and various corporate groups would sponsor these rewards.

The project is likely to be implemented either by the Council of Scientific and Industrial Research (CSIR) itself or the Institute of Genomics and Integrative Biology.‘We have already built a database of the requirements for developing drugs for infectious diseases. This would be hosted online, where individual experts could contribute in solving specific aspects of the drug discovery. Specific contracts will then be assigned to individual contract manufacturers and clinical research organisations,’ the project’s architect and CSIR’s new director general Samir K Brahmachari told ET.

‘The chemical entities thus developed will instantly become generics as the knowledge will be in public domain. This is diametrically opposite to the concept of intellectual property protection, which involves legal expenses to bar others from applying their minds on the invention,’ Mr Brahmachari said. Mr Brahmachari also heads the department of industrial research. ‘When a thousand young students contribute in solving a complex puzzle, we are empowering them to be the knowledge leaders of tomorrow.

For researchers at state-owned laboratories, it offers an exiting challenge of social importance,’ he added. It is likely that generics makers, like Ranbaxy and Cipla, could be more interested, than MNCs, as it would be volume-based. MNCs are more keen on low-volume high-value brands.If successful, the project would also challenge MNC drug makers claims that they invest billions of dollars in risky experiments hoping to develop one useful drug.

The project will get one-third funding from the government, one-third from international sources and the rest from philanthropic entities.” Sounds like a fantastic idea! Dr. Brahmachari’s open source strategy appears not only to challenge the notion that patents are necessary for innovation, but also the notion that investment for mass production needs monopoly incentives through patents. Look out for Spicy IP’s interview with Dr. Brahmachari in the coming week!