Friday, March 21, 2008

Russia Can Secure Greatest Biotech Market Advances Following US, Not EU Innovation Model

ITSSD: Russia Can Secure Greatest Biotech Market Advances Following US, Not EU Innovation Model

PRINCETON, N.J., March 21 /PRNewswire-USNewswire/ -- In a short article published today by the Washington Legal Foundation, US international trade and business lawyer Lawrence Kogan and Russian Government lawyer Yelena Bakulina highlight the common bases in Russian and US history that have triggered new thinking in Russia about how to use privately owned patent rights and cooperative government-university-industry technology transfer arrangements to secure successful market commercialization and peaceful adaptation of publicly-owned bio-warfare technologies.










The article arose from Kogan's June 28, 2007 presentation at a symposium convened by the Vyatka State University, Kirov, Russia, [http://www.vshu.kirov.ru/] as part of a longstanding joint Russian-US cooperative nonproliferation program overseen by the International Science and Technology Center (ISTC), Moscow, Russia. [http://www.istc.ru/]







According to Bakulina and Kogan, "The [US] federal government['s]...transference of innovation from energy, space, and defense to that of the private sector, and...the American experience in innovation and intellectual property may be advantageous to use in Russia..."

Furthermore as the authors note, "The Kirov Region certainly has the potential to develop effective innovation systems supported by the investment and protection of privately owned intellectual property in the sphere of modern high tech technology. If properly managed...this could create jobs, know-how and other economic and social benefits in the Kirov Region."


"Such an approach," adds Kogan, "would allow Russian biotechnology markets to leapfrog those of the European Union to capture a greater share of the global marketplace for biomedical and bioenvironmental products and processes. Unfortunately, the current EU innovation model is fixated on governmental market control via regulation rather than on market facilitation via economic incentives that ease the burdens and costs of doing business," emphasizes Kogan. "The EU Commission is more obsessed with dictating the rules of the game to ensure 'parity-over-progress' than with providing hi tech European businesses operating in the biotech sectors with
the necessary property rights-based enabling environment and economic freedom to grow and prosper. "Consequently," Kogan notes, "EU biotech and pharma companies have increasingly relocated operations to the US."


The Institute for Trade, Standards and Sustainable Development (ITSSD) is a non-partisan non-profit international legal research and educational organization that examines international law relating to trade, industry and positive sustainable development around the world. This and related ITSSD articles are accessible online at:
http://www.itssd.org/Publications/03-21-08balukina.pdf; http://www.itssd.org/ and http://itssdinternationaliprights.blogspot.com/.


CONTACT: ITSSD, +1-609-951-2222, info@itssd.org

Tuesday, March 11, 2008

The Thai 'Takings' Trap



Thai Ministry to Recommend Ignoring Patents on Cancer Drugs

By NICHOLAS ZAMISKA


The Wall Street Journal


March 10, 2008 2:42 p.m.


HONG KONG -- Thailand's new health minister announced Monday that he would urge the Thai government to continue to ignore patents on several cancer drugs, disappointing big pharmaceutical companies that had hoped Bangkok might roll back a policy of overriding patents in the name of public health.


The drugs' makers include Roche Holding AG and Novartis of Switzerland and Sanofi-Aventis of France.


Suphan Srithamma, a spokesman for the Thai health ministry, said that Minister Chaiya Sasomsup has decided to support the previous government's decision to ignore four cancer drug patents in a bid to cut the cost of medicines for the Thai people. The health ministry will make its recommendation to the Thai cabinet Tuesday, according to Dr. Suphan.


Thailand's previous health minister, Mongkol na Songkhla, decided in early January to issue compulsory licenses for four drugs: Novartis's imatinib, also known as Gleevec; Novartis's breast cancer drug letrozole, whose brand name is Femara; Sanofi-Aventis's docetaxel, marketed as Taxotere and used to fight lung and breast cancer; and Roche's erlotinib, whose trade name is Tarceva.


Novartis proposed that same month to offer Gleevec free of charge to poor Thai patients, possibly making a compulsory license unnecessary, according to the ministry of health. A Novartis spokeswoman wasn't available for comment.


Martina Rupp, a spokeswoman for Roche, based in Basel, said the Swiss company's Thai subsidiary is currently in talks with the government "to support greater access to medicines for Thai patients." Ms. Rupp added that Roche "has been, and always will be, open to discussion and dialogue with the appropriate authorities."


Jean-Marc Podvin, a spokesman for Sanofi-Aventis in Paris, said that his company hasn't yet received definitive word from the Thai government, but that "we still remain optimistic" about the negotiations. Mr. Podvin added that Sanofi has "some concerns about the quality of the generic" version of docetaxel, which had world-wide sales of 801.87 billion in 2007, that would be used to replace Sanofi's drug in Thailand.


[SHORT-SIGHTED EUROPEAN DRUG COMPANIES THAT CONCEDE THEIR PATENT RIGHTS TO THE THAI GOVERNMENT, AS AN OPPORTUNITY FOR PHILANTHROPY AND POSITIVE PUBLIC RELATIONS, JEOPARDIZE THE PRIVATE PROPERTY BASIS FOR PATENTS, AND HARM THE OVERALL PURPOSE OF INTELLECTUAL PROPERTY INTERNATIONALLY]


[ALTERNATIVELY, DUE TO THE PRESSURES OF EUROPE'S CULTURE OF CORPORATISM, WHEREIN COMPANIES SET INDUSTRIAL & TECHNOLOGY POLICY WITH GOVERNMENT, THESE EUROPEAN DRUG COMPANIES MAY ACTUALLY BE ASSISTING SOME WITHIN THE EU COMMISSION TO DIMINISH THE VALUE OF PATENTS, FOR POLITICAL PURPOSES. THIS SOUNDS FANTASTIC, BUT IT IS NOT OUT OF THE QUESTION].


Teera Chakajnarodom, president of the Pharmaceutical Research and Manufacturers Association --the multinational drug industry's trade group in Bangkok, which counts among its members the three European drug companies whose patents are at stake--condemned the Thai health minister's move.


"This is not good for the country. The image of Thailand will drop further," he said. "They should bring back the image of Thailand as a country that respects" intellectual-property rights.


Ever since a bloodless military coup in Thailand in September 2006, the military-installed government had been battling big pharmaceutical companies, threatening to sidestep their patents on drugs for AIDS and other diseases if they didn't drop the price of their medications. The Thai government argued that since the country's poor population couldn't afford the lifesaving drugs, and the government didn't have sufficient funds to cover their cost, drug companies should put public health before profit and cut the cost of the medications.


The drug companies argued that they had already made price concessions and needed to profit from their inventions to maintain the incentive to innovate. After the country's democratic elections last December, which ushered in a new government, hopes were raised that the new officials would soften the country's hardball tactics, which some within the international drug industry had feared might encourage other developing nations to follow suit and ignore drug patents.


Although members of Thailand's new government worried that the country could face harsh action from the U.S. government unless they rescinded the compulsory licenses, U.S. officials familiar with the situation say there wasn't any plan to retaliate against Thailand.


--James Hookway in Bangkok contributed to this article.


Improve Europe's Business Climate Plus Adopt Regional Patents: This Will Spur Company R&D Investment!!

Improving the Business Climate Will Spur European Company R&D Investments



By Lawrence A. Kogan





March 10, 2008




The synopsis provided by Bruno van Pottelsberghe in his recent Financial Times Leaders & Letters article “Europe must use its head on academic research” (3-7-08) is true concerning the unrealized potential of Europe’s antiquated R&D framework and the lag that it places upon the region’s technological and economic growth, inconsistent with the stated political goals of the Lisbon Agenda.
[SEE: http://www.ft.com/cms/s/0/85f21278-eb97-11dc-9493-0000779fd2ac.html ].


Professor van Pottlesberghe is most correct when he states, “the bottom line is that the EU needs now to adopt a common European patent - under discussion for 30 frustrating years- and spend more, and more wisely, on academic research...” I previously drew a similar conclusion in my article (“European universities learn importance of technology transfer” 9-29-06) in explaining why North American universities’ technology transfer offices had realised ‘a sixfold return’ in R&D spending, far greater than those realized in Europe.



Apart from the monies dedicated to R&D, I then stated that “Due credit must be given to the underlying US common law legal system, which recognises and protects temporary but exclusive private intellectual property right ownership in the know-how that underlies and is reflected in such research. Private intellectual property (e.g. a patent) is important precisely because knowledge is an intangible good that is not readily susceptible to valuation.”
[SEE: http://www.ft.com/cms/s/0/6b48c96c-4f99-11db-9d85-0000779e2340.html ].


However, that is the reality in North America, not Europe. The present ‘free movement of knowledge / ‘fifth freedom’ movement which increasingly pervades European public consciousness is likely to derail the enactment of region-wide patent legislation, just as it already impairs new thinking on how to spur the growth of innovative companies to carry that R&D to market.



I would thus add to my earlier conclusions the observation that government R&D spending and protection of patents alone cannot provide the necessary stimulus for business-driven innovation. What is also essential is the enactment of laws that facilitate entrepreneurship; i.e., the taking of economic risks, such as business formation and expansion, and incentives to reinvest company earnings.



In other words, apart from political rhetoric, European governments must create an actual economic enabling environment that promotes ‘doing business’ in Europe and then get out of the way. Unfortunately European countries, apart from Denmark, Ireland and the UK, which have reduced government funding of R&D, have not been too skilled in this endeavor.



If the 2007 World Bank’s Doing Business Report is any indication, it is only these countries that made it into the ‘top 10’ rankings. Indeed, a review of the report will show that, with respect to each of the following key metrics, most EU member states were laggards - the costs of: starting a business, dealing with licenses, workers, property rights, obtaining credit, protecting investors, paying taxes, cross-border trade, enforcing contracts, and closing a business. http://www.doingbusiness.org/EconomyRankings/Default.aspx?direction=desc&sort=1



To be more specific, only three EU member states besides those mentioned above made it into the ‘top 20’ - Finland (13), Sweden (14) and Estonia (17), while most of the remainder made it into the ‘top 50’ - Latvia (22), France (31), Slovakia (32), Portugal (37), Spain (38), Luxembourg (42), Hungary (45), Bulgaria (46), Romania (48) – with some even falling into the ‘top 100’ - Italy (53), Czech Republic (56), Poland (74) and Greece (100)!



Arguably, this report strongly suggests that the inability of EU member state governments to promote business-friendly enabling environments may correlate positively with EU business’ relatively low investment in research. Therefore, before the participants at this week's grandiose EU summit commence their obsessive over-thinking about the European R&D model, they should also consider how to improve the climate for business. Perhaps, this may provide the true answer to the principal question posed by Professor van Pottelsberghe: “What, then, should the EU and governments do to get business to invest more in research?”

Sunday, March 9, 2008

Europe Must Use Its Head On Academic Research

http://www.ft.com/cms/s/0/85f21278-eb97-11dc-9493-0000779fd2ac.html


Europe must use its head on academic research


By Bruno van Pottelsberghe


Financial Times - Leaders & Letters


Published: March 7 2008


The European Union summit next week is set to decide that the main policies of the much-maligned Lisbon strategy, which aims to make Europe the world's most innovative region, should be carried through until 2010.


And why not? Though average growth is sluggish, the EU has created almost 6.5m jobs in the past two years and 5m more are expected by 2009. Average unemployment is expected to fall to below 7 per cent this year, the lowest since the mid-1980s. The Lisbon benchmark of getting 70 per cent of the adult population into work by 2010, which escaped the EU's recent purge of targets, no longer looks impossible.


[ONE MUST SERIOUSLY QUESTION WHETHER THE JOB GROWTH HAS BEEN IN THE GOVERNMENTAL SECTOR]


So far, so good. But one vital Lisbon policy area is going backwards: research and development.


As the European Commission itself concedes, the proportion of the EU's gross domestic product spent on R&D has actually dropped since the Lisbon strategy was launched. After flatlining for two decades, research spend fell from nearly 2 per cent in 2000 to 1.85 per cent in 2006, thus moving the EU further away from its target of 3 per cent (recently trimmed to 2.6 per cent) by 2010. But what is a target for overall R&D spending worth? Missing the target is bad enough. But publicly missing the wrong target is perverse.


Europe's spend is well below the US's 2.5 per cent and Japan's score of more than 3 per cent. China has engineered a dramatic increase, from nearly nil 10 years ago to 1.5 per cent in 2006. Of course, there are big differences between EU member states. Finland and Sweden leapfrogged the 3 per cent target several years ago. But the vast majority of EU countries spend well below 2 per cent of their GDP on R&D. Does this matter? Yes and no.


No EU member state fulfils the original commitment that governments should finance one third of investment in R&D, or the equivalent of 1 per cent of GDP. Many have reduced their support over the past 10 years, including the UK, Germany, France and the Netherlands. This matters. EU governments should increase their spend and honour their promise. Failure to do so ultimately means lower growth.


As for business, spending varies widely between countries, but these variations are to a great extent attributable to differences in technological specialisation. If a country specialises in information and communication technologies (such as Finland) one would expect a higher R&D intensity than for a country specialising in finance (eg Luxembourg) or tourism. Thus measuring EU countries' private R&D spend against a common benchmark makes little sense. Also, governments cannot decree business spending from on high: it does not respond to policymakers' targets.


What, then, should the EU and governments do to get business to invest more in research? When industrial specialisation is taken into account, only Sweden and the US outperform other countries. According to a Bruegel policy brief ( Europe's R&D: Missing the Wrong Targets ), two factors may explain this and point to what the EU's policy focus should be.


For the US, its large, homogeneous market radically improves the expected return on research activities and hence fosters business R&D spending. Europe does not benefit from such a scale effect despite its larger size because its market is still highly fragmented.


Market size may explain the US R&D spend, but it does not explain the Swedish case. One clue: Sweden has a very high level of spending on academic research, the highest as a percentage of GDP in the whole Organisation for Economic Co-operation and Development area. This strong emphasis on academic research is a stimulus for business R&D: universities generate new ideas, then business is attracted in to develop them, individually or in clusters, foreign or local. The European countries with the highest academic R&D intensities are also those with the highest business R&D intensities.


True, the EU has recognised the need for free movement of knowledge, the "fifth freedom", and has pushed for a new European Institute of Innovation and Technology. Both initiatives may bear fruit in time. But the bottom line is that the EU needs now to adopt a common European patent - under discussion for 30 frustrating years - and spend more, and more wisely, on academic research. These two steps would do more for the success of the Lisbon strategy - and for the EU's credibility - than maintaining top-down targets for business spend on R&D.


The writer is a senior fellow at Bruegel, the Brussels-based think-tank and professor at Université Libre de Bruxelles


Copyright The Financial Times Limited 2008

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!!

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

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 and Doctors Without Borders have inculcated the public with scare stories about how Big Pharma has it in for Thai consumers. The NGO packhounds immediately flooded the Thai media with scare stories about Mr. Chaiya's proposal, forcing him to do a political backstep last week and say compulsory licensing policy has been "maintained." The matter is still under review.


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 Public Health Ministry will not revoke the recent enforcement of compulsory licensing for cancer drugs and will retain it as a key mechanism to negotiate with drug firms to reduce product prices, said Public Health Minister Chaiya Sasomsab Monday.

"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

http://www.bangkokpost.com/breaking_news/breakingnews.php?id=126289


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

http://www.iht.com/articles/ap/2008/03/03/asia/AS-GEN-Thailand-Drug-Patents.php


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 Banchuen was named secretary general of the FDA last week, making him the government's chief negotiator with multinational drug companies over pricing and licensing terms.


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




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.