Another Likely Casualty of Obama's Healthcare Plan: The US Proprietary Software & ICT Industries and Millions of Highpaying US Jobs

As will be reported in future blog entries, European governments are working collaboratively with the international open source community, certain industry members and academicians to persuade the U.S. government to express a clear preference in federal government procurement regulations for royalty-free open source software based on royalty-free patented technologies disclosed ex ante in open technical standards. The ultimate objective of such stakeholders is to migrate the US government away from proprietary software and information & communication technology (ICT) systems to free of charge open systems.

Aside from the fact that, by expressing an official preference for royalty-free open source software and royalty-free patent-based software and ICT technologies, the US government will knowingly be changing the conditions for competition and thus reshaping free markets, and, by virtue thereof, would effectively be participating in the 'creative destruction' of the VERY internationally competitive US proprietary-based software and ICT industries, it will likely also be violating at least two World Trade Organization (WTO) Agreements - the multilateral Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement and the plurilateral Government Procurement Agreement.

This blog entry is dedicated only to establishing the facts underpinning how the Obama administration has decided to promote royalty-free patented and copyrighted software and ICT technologies over similarly situated proprietary products when evaluating competing bids for US federal government healthcare contracts, incidental to the administration's efforts to secure passage of already controversial federal universal healthcare legislation. It does not address the facts surrounding European government practices concerning such products, nor the WTO legal issues. Those discussions will be reserved for future blog entries.

THE FACTS:

Indeed, these stakeholders recently formed a nonprofit organization called Open Source for America, “a broad cross-section of more than 50 companies, academic institutions, communities, related groups and individuals that serve as a unified voice for the promotion of open source in the U.S. Federal government sector.” [1]

“More than 70 major companies, academic institutions and high profile technologists have launched a campaign to educate US government agencies about the benefits of open source technology. Announced earlier at the O'Reilly Open Source Convention, groups such as Google, RedHat, Novell, Linux, Mozilla, Sun Microsystems and the Electronic Frontiers Foundation have teamed up to create Open Source For America. The joint effort is a coalition aimed at lobbying the US Federal government to consider using open-source software over proprietary code… Nevertheless, lobbying will be no easy feat…[I]n the past government officials have expressed security concerns with open source code. Critics argue that exposed source code can be examined by attackers and therefore poses a risk. Nevertheless, another argument for exposed code can be made in ensuring security. By moving away from proprietary software models and giving free access to a system's source code, governments are no longer dependent on a select few contractors for their defense. Instead, an entire programming community can be deployed to defend against attacks. One of the government's key open source projects is actually with the National Security Agency. The agency already employs open source technologies to address multi-level security on government machines through SELinux.” [2]


A review of the Open Source for America website reveals that OSA's mission is to: 1) "effectuate changes in U.S. Federal government policies and practices so that all the government may more fully benefit from and utilize free and open source software” – in other words, it is to cause the U.S. Federal government to migrate from proprietary software to open source software; and 2) “participate in standards development and other activities that may support its open source mission." [3] OSA cites successful OSS projects with the U.S. National Security Agency [4], the U.S. Navy [5] and the U.S. Veterans Administration, the latter of which specifically entailed the creation of a national Veterans healthcare patient e-records system – the open source-based VistA electronic health record system. [6]


["January 31, 2008 - WorldVistA announces the release and availability of WorldVistA EHR VOE/ 1.0, the only open source EHR that meets Certification Commission for Healthcare Information Technology (CCHIT^SM) ambulatory electronic health record (EHR) criteria for 2006. WorldVistA EHR VOE/ 1.0 is based on and compatible with the U.S. Department of Veterans Affairs (VA) world renowned EHR, VistA®. After completion of the VOE project, WorldVistA made additional enhancements and successfully submitted WorldVistA EHR for certification by CCHIT. As a CCHIT Certified^SM product, WorldVistA EHR VOE/ 1.0 has been tested and passed inspection of 100 percent of a set of criteria for functionality (ability to create and manage electronic records for all patients, as well as automating workflow in a physician's office), interoperability (a first step in the ability to receive and send electronic data to other entities such as laboratories), and security (ability to keep patients' information safe)." See WorldVistA EHR, WorldVista.org website at: http://worldvista.org/World_VistA_EHR]


Apparently, during 2006, VistA received the U.S. Department of Veterans Affairs Innovation award, and was recognized as “help[ing] VA save 6,000 lives by improving rates of pneumonia vaccination among veterans with emphysema, cutting pneumonia hospitalizations in half and reducing costs by $40 million per year…In addition to saving money, VistA save[d] lives and ensure[d] continuity of care even under the most extreme circumstances. Many of the thousands of residents who fled the Gulf Coast because of Hurricane Katrina left behind vital health records. Records for the 40,000 veterans in the area were almost immediately available to clinicians across the country, even though the VA Medical Center in Gulfport, Mississippi, was destroyed and the New Orleans VA Medical Center was closed and evacuated.” [7]

And, not surprisingly, Advanced Micro and Sun Microsystems, two promoters of royalty-free OSS and open standards in Europe, are founding OSA members [8], while Rishab Aiyer Ghosh, UNU-MERIT researcher and author of several studies recommending European Union government migration to royalty-free open source software and open standards, is a member of OSA’s Board of Advisors. [9].


What is more, it appears rather clear that President Obama, like European leaders, favors the use of open source software (e.g., VistA) over comparable proprietary software, to create a national federal government-directed e-healthcare system within five years. [10]

For example, during January 2009, it was reported that, “the House Ways and Means Committee [had] completed the Health Information Technology for Economic and Clinical Health Act (HITECH) [11], as part of the American Economic Recovery and Reinvestment Plan (ARRA). The HITECH had “codifie[d] the Office of the National Coordinator (ONC) “responsible for creating a nationwide health information technology infrastructure”, and provided that “the National Coordinator shall support the development and implementation of a qualified electronic health records (EHR) platform (imagine an open source software as a service system for the country), unless the Secretary of HHS determines that the needs concerning EHRs are met in the private market.” [12]

For example, during April 2009, despite industry misgivings about VistA’s reliance on commercially unproven open source software, [13] it was reported that,


“President Obama announced the government will use open source software to create a national electronic health records system for the military. By pursuing two open source options -- the Department of Veterans Affairs' VistA medical records system and Connect from Sun Microsystems -- proponents hope the Obama administration is sending a signal that open source software could become a vital part of national reform. How big a role open source may play could be determined by a study in its formative stages now. The American Recovery and Reinvestment Act [P.L. 111-5] calls for a study of open source health IT to be completed by October 2010.[14] How that study is formed and who takes charge may have a lot to do with open source's fate.


…Although both the VistA and Connect systems predate his administration, Obama's willingness to pursue them with a relatively loud public endorsement gives open source advocates reason for hope…’ Eventually, health IT is going to have to be open source to be interoperable. That seems like the only logical place to start,’ said Mike Doyle, president and CEO of Medsphere Systems Corporation, a provider of open source health IT… VA's VistA system, considered by many to be one of the nation's most advanced EHR systems, can share data between any VA hospital or health care facility around the world, according to VA officials. The larger, newly announced system will add DOD to the equation, allowing military personnel to be electronically entered and followed in the system from the start of their military life to the end.” [15]

Another open source advocate/ journalist, however, expressed a less sanguine view towards the President’s communication. He believes only that


“The President promised to ‘link’ the VA’s current VistA system with the military’s AHLTA system, and he promised our heroes interoperability, but that is all. The same is true in the larger health IT stimulus plan, HITECH. CCHIT [the Certification Commission for Health Information Technology][16] still controls functional requirements needed for certification, which in turn is needed to get paid. But as Fred Trotter notes, whether CCHIT will actually certify open source solutions remains unclear [17]…So far, under the Obama Administration, open source has been riding momentum generated during the second Bush Administration [17A]…What open source seems to be getting from the Obama Administration is a shot, a chance, a foot in the door. But there is a big distance between being allowed to present and being given a contract…What we need are policy statements favoring a ‘build’ process over a ‘buy’ process, and demanding open standards, preferably royalty-free standards, for government contracts. We don’t have them yet, so the jury is still out on the Obama Administration and open source in health IT.” [18]

In fact, the federal government’s release during early April 2009, for download and public use, of the “federally developed, free and open-source software…called Connect, revealed such a 'build process.” “[Connect was] created under the auspices of the Federal Health Architecture initiative led by the Office of the National Coordinator at HHS…[According to Robert Kolodner, the outgoing head of the ONC…The result is a software gateway made available to ‘any public or private-sector organization that wants to use the solution in the future to tie into the NHIN’”. [19]


A second provision within the American Recovery and Reinvestment Act of 2009 (ARRA) has “earmarked nearly $20 billion in stimulus funds as an incentive for hospitals to use electronic records by 2011. And it will penalize those who don't use them, cutting a percentage of their Medicare payments starting in 2015…[which amounts to] about $6 million by the fourth year for the same hospital.” [20] Apparently, the costs of installing and implementing VistA and its ‘enhanced’ version OpenVistA continue to be debated, with proponents arguing that such software would be less expensive, more reliable and easier to install than competing proprietary health IT solutions. [21] At least one major healthcare IT industry association, the Healthcare Information and Management Systems Society (HIMSS), [22] has come out in support of these final provisions. [23]

Previously, however, HIMSS vigorously opposed a provision introduced during September 2008 by California Congressman Peter Stark, Chairman of the House Ways and Means Health Subcommittee, which would have explicitly “create[d] a low-cost, open-source EHR system—much like the one used in the Veterans Affairs Department—as an alternative to vendor-developed ones.” [24] The relevant portions of the Stark bill read as follows:


“(A) The National Coordinator shall provide for coordinating the development, routine updating, and provision of an open source health information technology system that is either new or based on an open source health information technology system, such as VistA, that is in existence as of the date of the enactment of this title and that is in compliance with all applicable standards (for each category described in paragraph (2)(A)) that are adopted under this subtitle. The National Coordinator shall make such system publicly available for use, after appropriate pilot testing, as soon as practicable but not later than 9 months after the date of the adoption by the Secretary of the initial set of standards and guidance under section 3003(c)…(B) In order to carry out subparagraph (A), the National Coordinator shall establish, not later than 6 months after the date of the enactment of this section, a consortium comprised of individuals with technical, clinical, and legal expertise open source health information technology…(D) In this paragraph, the term ‘open source’ has the meaning given such term by the Open Source Initiative.” [25]

As industry correctly emphasized, “the Stark bill would have ‘dismantle[d]’ previous government work done by the American Health Information Community and undercut open-market principles with the called-for development of a low cost, open-source health IT system.” [26]


Notwithstanding these political sensitivities, Senator Jay Rockefeller (D Va.) subsequently (during April 2009) introduced the Health Information Technology (IT) Public Utility Act of 2009. This piece of legislation called for the creation of a Federal Consolidated Health Information Technology Board within the office of the National Health Coordinator. [27] It also “called for the government to create an open-source electronic health-records solution” [28] and to “offer it at little or no cost to safety-net hospitals and small rural providers.” [29]

“The Health Information Technology Public Utility Act of 2009 will build upon the successful use of ‘open source’ electronic health records by the Department of Veterans Affairs as well as the ‘open source exchange model,’ which was recently expanded among federal agencies through the Nationwide Health Information Network-Connect initiative. Open source software refers to a computer program with unrestricted source code that does not limit the use or distribution by any organization or user. Senator Rockefeller continued, ‘Open source software is a cost-effective, proven way to advance health information technology – particularly among small, rural providers. This legislation does not replace commercial software; instead, it complements the private industry in this field – by making health information technology a realistic option for all providers.’”[30]

Indeed, the Rockefeller bill is viewed by members of the open source community as a broad nuanced “resurrection of an open-source support provision in healthcare IT legislation proposed last year by Rep. Pete Stark (D-Calif.) [which]…ran into opposition from the Healthcare Information and Management Systems Society [HIMSS] and wound up being deleted from the IT provisions of the American Recovery and Reinvestment Act of 2009.” [31] However, whether S.890 and the ARRA will succeed in promoting widespread use of electronic health records may ultimately depend on State privacy laws. [32]

The parallels between the health IT interoperability frameworks proposed by the Obama administration and the European Union and some of its Member States are not coincidental. The EU policy objective of ensuring ‘interoperability’ has been similarly applied beyond the ICT sector to more broadly “facilitate the implementation of EU policies and initiatives” [33] relating to other industry sectors, such as healthcare – i.e., “ehealth interoperability”. [34]


For example, it would appear that Europe’s e-Health Action Plan “Advocates the development of common interoperability approaches and standards for patient identifiers, medical data messaging, [and] electronic health records”, [35] based on adoption of Open Source reference implementations for care services…[and]…open and more free access to future and existing e-Health standards…taking inspiration from models such as the World Wide Web Consortium.” [36] And, it would seem that, in addition to the emphasis placed on information-based ICT and ehealthcare product-service standardization, other product-service industry sectors have also been targeted for ‘interoperability’ standardization improvements to ensure universal access to ‘essential services’ and so-called ‘user rights’. [37] These sectors include energy, transport and broadcasting, among others. European “public authorities [have] classif[ied these product-services] as being of general interest and subject to specific public service obligations. This means that it is essentially the responsibility of public authorities, at the relevant level, to decide on the nature and scope of a service of general interest.” [38]


[See also ITSSD Comments Concerning SCP/13/2 - STANDARDS AND PATENTS, submitted to the World Intellectual Property Organization Standing Committee on the Law of Patents (March 23, 2009) at: http://www.itssd.org/ITSSD%20Comments%20-%20SCP%2013-2%20Standards%20and%20Patents%20-%203-23-09%20-%20II.doc ; Executive Summary of ITSSD Comments Concerning (SCP/13/2) Standards and Patents, Institute for Trade, Standards and Sustainable Development, submitted to the WIPO SCP (March 23, 2009), at: http://www.itssd.org/Executive%20Summary%20of%20ITSSD%20Comments%20-%20SCP%2013-2%20Standards%20and%20Patents%20-%203-23-09%20-%20II.doc ].


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[1]See Open Source for America Welcomes Lucid Imagination as Its Latest Member in Advocating Open Source in the U.S. Federal Government, MarketWire (July 22, 2009) at: http://socialmedia.ulitzer.com/node/1044612 .


[2] See Dana Oshiro, Open Source for America: The New Government Accountability, Read, Write Web (July 22, 2009) at: http://www.readwriteweb.com/archives/open_source_for_america_the_new_government_account.php .


[3] See Our Mission, Open Source America website at: http://www.opensourceforamerica.org/mission.


[4] See NSA – The National Security Agency’s Challenge, Open Source America website at: http://www.opensourceforamerica.org/case-studies/nsa .


[5] See US Navy Story, Open Source America website at: http://www.opensourceforamerica.org/case-studies/navy.


[6] See Veterans Administration, Case Studies, Open Source America Case website at: http://www.opensourceforamerica.org/case-studies .


[7] See VA Receives 2006 Innovations in Government Award, Office of Public and Intergovernmental Affairs, United States Department of Veteran Affairs, Press Release (July 10, 2006) at: http://www1.va.gov/opa/pressrel/pressrelease.cfm?id=1152.


[8] See About Us, Open Source America website at: http://www.opensourceforamerica.org/about .


[9] See Board of Advisors, Open Source America website at: http://www.opensourceforamerica.org/board .


[10] See K.C. Jones, Obama Wants E-Health Records In Five Years, Information Week (Jan. 2, 2009) at: http://www.informationweek.com/news/showArticle.jhtml?articleID=212800199 .


[11] See Health Information Technology for Economic and Clinical Health Act or HITECH Act, House Committee, Ways and Means, at: http://waysandmeans.house.gov/media/pdf/110/hit2.pdf . The HITECH Act comprises Title IV - Health Information Technology of the American Recovery and Reinvestment Act of 2009. See The American Recovery and Reinvestment Act of 2009, online at: http://waysandmeans.house.gov/media/pdf/110/sbill.pdf.


[12] See John D. Halamka, The Greatest Healthcare IT Generation, Technology Review (Jan. 19, 2009) (emphasis added) at: http://www.technologyreview.com/blog/guest/22513 .


[13] “The VA's system, dubbed VistA for the Veteran's Health Information Systems and Technology Architecture, includes those benefits and another that private commercial vendors don't have: standardization that allows hospitals to share information seamlessly. So when you break your leg in Vail, Colo., doctors there can easily retrieve your complete medical biography from your doctor in Minneapolis if both are using an open system. Much in the same way Microsoft guards its proprietary software, commercial systems made by vendors including McKesson Corp. and Cerner Corp. are proprietary technology that don't always allow them to easily talk to other vendors' systems. By contrast, open source providers can share information freely and a worldwide network of software developers, WorldVistA, has emerged to offer new features, much like the community that supports the free Linux computer operating system. But commercial vendors, noting a common complaint against open-source software that is developed by engineers here and there, say that they can provide a more reliable soup-to-nuts system and offer many features that users of the VA system have to tack on, notably billing and financial programs that commercial hospitals need to run their business. PricewaterhouseCoopers consultant Dan Garrett says that while the VA software holds promise for some hospitals, it has not been widely commercially proven, unlike vendor systems.” See Laura Landro, An Affordable Fix for Modernizing Medical Records (April 30, 2009) at: http://online.wsj.com/article/SB124104350516570503.html .


[14] See Section 4104(b)(1) - STUDY AND REPORT ON AVAILABILITY OF OPEN SOURCE HEALTH INFORMATION TECHNOLOGY SYSTEMS, of TITLE IV—MEDICARE AND MEDICAID HEALTH INFORMATION TECHNOLOGY; MISCELLANEOUS MEDICARE PROVISIONS of the American Recovery and Reinvestment Act of 2009, P.L. 111-5 (Feb. 17, 2009) accessible at: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_bills&docid=f:h1enr.pdf . The study will focus on the following issues: “the current availability of open source health information technology systems to Federal safety net providers (including small, rural providers); (ii) the total cost of ownership of such systems in comparison to the cost of proprietary commercial products available; (iii) the ability of such systems to respond to the needs of, and be applied to, various populations (including children and disabled individuals); and (iv) the capacity of such systems to facilitate interoperability (emphasis added). “Not later than October 1, 2010, the Secretary of Health and Human Services shall submit to Congress a report on the findings and the conclusions of the study conducted under paragraph (1), together with recommendations for such legislation and administrative action as the Secretary determines appropriate.” Id., at Section 4104(b)(2).


[15] See George Lauer, Military E-Health Record Plan Gives Open Source a Boost, iHealthBeat (April 16, 2009) (emphasis added) at: http://www.ihealthbeat.org/Features/2009/Military-EHR-Plan-Gives-Open-Source-a-Boost.aspx .


[16] CCHIT “is a nonprofit, 501(c)3 organization with the public mission of accelerating the adoption of health IT…CCHIT [has been] certifying electronic health records (EHRs) since 2006, [and]…established the first comprehensive, practical definition of what capabilities were needed in these systems. The certification criteria were developed through a voluntary, consensus-based process engaging diverse stakeholders, and the Certification Commission was officially recognized by the Federal government as a certifying body… In February 2009, Congress acknowledged the value of certification in the language of the American Recovery and Reinvestment Act (ARRA) aimed at stimulating the nation’s economy. The law offers a multi-year series of incentive payments to providers and hospitals for the meaningful use of certified EHR technology.” See About the Certification Commission for Health Information Technology, Certification Commission for Health Information Technology website at: http://www.cchit.org/about .


[17] “As open source gains popularity, it'll have to contend with certification issues. By its nature, the community-based technology is constantly evolving, which makes it difficult to certify by today's standards. The Certification Commission for Healthcare Information Technology (CCHIT) is currently the main certifying body for EHRs, but its criteria do not accommodate the open source approach, critics say.” See Cheryl McEvoy, Open Source EHRs Set to Grow Advance Web (June 17, 2009) at: http://health-information.advanceweb.com/editorial/content/editorial.aspx?cc=200988 .


[17A] See, e.g., Comments of the Initiative for Software Choice Regarding MITRE’S Use of Free and Open Source Software (FOSS) in the U.S. Department of Defense/ Open Source FAQ Comments (Nov. 26, 2002) at: http://www.softwarechoice.org/download_files/MITRE.Final.Web.pdf (“[T]he ISC does not believe that the DoD should openly promote the use of OSS because in each instance, the DoD should choose the software that best meets its needs and acquisition requirements for the particular environment in which the software will be used… Each software development model – i.e., OSS, hybrid and proprietary – provides its own mix of benefits to the industry, government and taxpayers. No one benefits when otherwise viable software options are completely removed from competition and evaluation by procurement officials… Perhaps more troubling, however, is the framing of the hypothetical itself, which suggests a certain mutual exclusivity not mirrored in the software industry. The hypothetical perpetuates the ‘either-or’ supposition being advanced by the marketers of OSS products and services that OSS and proprietary products cannot – or rather, should not – operate together, in heterogeneous environments. Though the viral nature of some OSS licenses, such as the GNU General Public License (GPL), remains a point of concern for many in the industry (even the Study cautions against accidentally invoking the GPL), it is clear that all models can ‘get along.’ The ISC believes that painting the hypothetical in such stark terms serves only to divide communities that, on their own, already co-exist. Together, the entire industry has benefited and evolved through vigorous, hyperactive competition.”). See also MITRE, Use of Free and Open Source Software (FOSS) in the U.S. Department of Defense, Version 1.2.04 (Jan. 2, 2003) at: http://www.terrybollinger.com/dodfoss/dodfoss_pdf.pdf .


[18] See Dana Blankenhorn, What Obama promised open source health IT, ZDnetHealthcare (April 21, 2009) (emphasis added) at: http://healthcare.zdnet.com/?p=2164 .


[19] See Joseph Conn, Feds Release Open-source NHIN Gateway Software, ModernHealthcare.com (April 7, 2009) (emphasis added) at: http://www.modernhealthcare.com/article/20090407/REG/304079996 .


[20] See Laura Landro, An Affordable Fix for Modernizing Medical Records supra. See also Section 4102 - INCENTIVES FOR HOSPITALS, of of TITLE IV—MEDICARE AND MEDICAID HEALTH INFORMATION TECHNOLOGY; MISCELLANEOUS MEDICARE PROVISIONS of the American Recovery and Reinvestment Act of 2009, P.L. 111-5, supra.


[21] “Mike Kappel, senior vice president of government and industry relations at McKesson, says once hospitals pay companies to deploy the VA software and the necessary service, training and upgrades it requires, the cost won't be much different than that of a commercial electronic medical- record system. Big vendors can work with hospitals to provide more reliable systems within their budget, he adds. Many start-up companies adapting VistA for commercial use, including Blue Cliff Inc., MELE Associates Inc., Sequence Managers Software and Medsphere Inc., say their systems will still be less expensive for hospitals to deploy. Medsphere, which put together the system for Midland Hospital, says OpenVistA enables hospitals to run system checks for security problems and bugs. And Chief Executive Mike Doyle says the open-source software community can quickly share information and patches to fix or correct them. Medsphere Chairman Kenneth Kizer, the former undersecretary for health at the VA who oversaw the development of VistA before joining the company, says its enhanced version of the software, called OpenVistA, ‘can be installed in one-third the time and for about one-third the cost of the big-name proprietary systems.’” See Laura Landro, An Affordable Fix for Modernizing Medical Records supra.


[22] “The Healthcare Information and Management Systems Society (HIMSS) is the healthcare industry’s membership organization exclusively focused on providing global leadership for the optimal use of healthcare information technology (IT) and management systems for the betterment of healthcare.” See About HIMSS, at: http://www.himss.org/ASP/aboutHimssHome.asp .


[23] “HIMSS supports the provision to require the Secretary, along with federal counterparts, to conduct a study on the availability, costs, and benefits for providers concerning open source health IT. HIMSS agrees the Secretary ought to make recommendations for such legislation and administrative action, as appropriate. Open source technology provides valuable options for the healthcare industry and health information exchange. HIMSS recommends the Secretary to assess the costs of implementing open source and explore how best to utilize its benefits.” See The American Recovery and Reinvestment Act of 2009 - HIMSS Legislative Overview, Policy Implications, and Healthcare Ramifications (March 10, 2009) at p.115 at: http://www.med.miami.edu/hipaa/public/documents/HIMSS_ARRA.pdf; HIMSS Open Source Fact Sheet at: http://www.himss.org/content/files/HIMSSOpenSource.pdf ; Evaluating Open Source Software for Health Information Exchange, HIMSS Healthcare Information Exchange Open Source Task Force White Paper (June 2008) at: http://www.himss.org/content/files/HIE_FY08_Open_Source.pdf .


[24] See Matthew DoBias, Stark Offers Bill to Expedite E-record Adoption, ModernHealthcare.com (Sept. 16, 2008) (emphasis added) at: http://www.modernhealthcare.com/article/20080916/REG/309169997.


[25] See H.R.6898, Section 3001(a)(4)(A),(B) and (D) - FEDERAL OPEN SOURCE HEALTH IT SYSTEM, of the Health-e Information Technology Act of 2008, (emphasis added) at: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_bills&docid=f:h6898ih.txt.pdf .

[26] See Matthew DoBias, HIMSS Letter Opposes Pieces of Stark's IT Legislation, ModernHealthcare.com (Sept. 26, 2008) at: http://www.modernhealthcare.com/article/20080926/REG/309269993. See also George Lauer, Industry Gives Stark's Health IT Bill Mixed Reviews, iHealthBeat (Oct. 1, 2008) at: http://www.ihealthbeat.org/Feature/2008/Industry-Gives-Starks-Health-IT-Bill-Mixed-Reviews.aspx .

[27] See Section 3 (a) of the Health Information Technology (IT) Public Utility Act of 2009 (S.890) at: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_bills&docid=f:s890is.txt.pdf .


[28] Id., at Section 3(c).


[29] See Rockefeller Introduced Legislation Calling for Universal Adoption of Electronic Health Record, Press Release, United States Senator Jay Rockefeller for West Virginia, at: http://rockefeller.senate.gov/press/record.cfm?id=311951 .


[30] Id (emphasis added). “The legislation—the first Rockefeller has introduced on open-source technology—springs from the successful experiences of West Virginia providers with open-source healthcare IT systems…Seven state hospitals in West Virginia are running on a version of VistA developed by Medsphere Systems Corp. and about 30 to 40 federally qualified healthcare clinics in the Mountain State run on RPMS...In West Virginia, the RPMS software is distributed to the clinics via an application service provider, or ASP, model of delivery supported by the not-for-profit Community Health Network of West Virginia, based in Scott Depot.” See Joseph Conn, Bill Would Boost Open-source EHRs for Rural Use, ModernHealthcare.com (April 28, 2009) at: http://www.modernhealthcare.com/article/20090428/REG/304289994 .


[31] “People in the open-source community who were excited by Stark’s bill see the stimulus language as ‘a vague reference to open source,’ [Peter] Groen [director of the Shepherd University Research Corp., Shepherdstown, W.Va.] said. Having seen the legislature maw, chew up and spit out the earlier version of an open-source funding bill, Groen said he’s hopeful about the Rockefeller bill, but wary about getting his hopes up too high. ‘It’s similar in nature, which is why it always leads me to be cautious,’ Groen said. ‘The open-source community still could use as much of a boost as they could get in terms of funding, political support, visibility, you name it. This is just one more piece of the puzzle. Who knows if this will ever pass, but it might influence other legislation’” (emphasis added). Id. “The most recent gust of federal support hails from West Virginia; Sen. John D. Rockefeller IV proposed legislation in April that promotes open source technology as a way to help providers -- especially small and rural organizations -- launch EHRs that meet government requirements. The Health Information Technology Public Utility Act calls for a new grant program to fund open source implementations and continued conversations among open source suppliers. The legislation now awaits debate…‘I think it's a broader move and a very wise line of thinking at the federal level to support open-source projects,’ said Rick Jung, chief operating officer, Medsphere Systems Corp., noting that the Nationwide Health Information Network, a government pilot for health information exchange, was recently open sourced. It's proof the industry is at a ‘tipping point,’ according to Jung” (emphasis added). See Cheryl McEvoy, Open Source EHRs Set to Grow supra.


[32] See Sindya Bhanoo, EHR Adoption Inhibited by State Level Privacy Laws, The Industry Standard (May 13, 2009) at: http://www.thestandard.com/news/2009/05/13/ehr-adoption-inhibited-state-level-privacy-laws .


[33] See Francisco García Morán, European Interoperability Strategy, European Commission Directorate General, Informatics (June 13, 2008) at p. 2, at: http://ec.europa.eu/idabc/servlets/Doc?id=31154 ; Francisco García Morán, Proposal for a Community Programme on Interoperability Solutions for European Public Administrations (ISA), European Commission Directorate General, Informatics (June 20, 2008), at p.2, at: http://ec.europa.eu/idabc/servlets/Doc?id=31160 .



[34] See Flora Giorgio-Gerlach, European Commission Strategy for European eHealth Interoperability, DG Information Society and Media, ICT for Health, European Commission (Oct. 2008, Calliope, Crete, Greece) at: http://www.calliope-network.eu/Portals/11/assets/documents/Crete_Presentations/CAL%202008-10-09%20s11%20Giorgio%20%20EC%20Strategy%20Interoperability.pdf .


[35] Id., at p. 8 (emphasis added).


[36] See COMMUNICATION FROM THE COMMISSION TO THE COUNCIL, THE EUROPEAN PARLIAMENT, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS COM (2004) 356 final (4/30/04), “e-Health - Making Healthcare Better for European Citizens: An Action Plan for a European e-Health Area”, at pp. 16-17, at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2004:0356:FIN:EN:PDF . “The exchange of experience in the use of open standards and open source solutions among health administrations in Member States should be promoted.” Id., at p. 17.


[37] See COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS COM(2007) 725 final (11/20/07), “Accompanying the Communication on ‘A Single Market for 21st Century Europe’ - Services of General Interest, Including Social Services of General Interest: A New European Commitment”, at pp. 7-10, at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2007:0725:FIN:EN:PDF.


[38] Id., at pp. 3-4.


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http://www.sun.com/aboutsun/pr/2009-04/sunflash.20090406.1.xml

Nationwide Health Information Network Relies on Sun's Open Source Software - NHIN-CONNECT Gateway Solution Links Federal, Local and Private Sectors

SUN System News

April 8, 2009

The Nationwide Health Information Network (NHIN) is an open technology platform using Sun's open source software to connect federal government agencies and health information exchanges via NHIN-CONNECT - a software enabling interoperability across the healthcare sector.

NHIN-CONNECT uses Sun's GlassFish, the Java Composite Application Platform Suite (CAPS) SOA Platform, and the Sun Java Identity Management suite. The United States Department of Health and Human Services (HHS), whose goal is to support the secure exchange of interoperable health information within the federal government and with the tribal, state, local and private sectors, has a commitment to using open source technologies and to enabling increased efficiency, better patient care and improved population health.

Sun reports that the initial demonstration of NHIN-CONNECT involved four major government agencies and 16 private sector organizations, and within six months they were able to share information with the private sector through the NHIN.

"Our progress with the NHIN shows that President Obama's commitment to healthcare reform can become a reality quickly. Here we have the public and private sectors working together as a community to help realize this key vision," said Joe Hartley, vice president of Global Government, Education and Healthcare for Sun Microsystems, as part of the Healthcare Information and Management Systems Society (HIMSS) Conference held April 4-8 in Chicago. "Sun has already seen first-hand the impact of open source technology on healthcare information sharing, and has enjoyed working closely with other vendor partners and federal agencies to make Obama's goals a reality today."

By the end of this year, Sun expects six federal agencies will be participating in NHIN-CONNECT. The goal is for CONNECT to be a platform on which the government and industry can innovate, empowering federal agencies to address the citizen-centric initiatives that are part of the 2009 development plans while also allowing the industry to build better interoperable solutions for the healthcare sector.

Sun anticipates the CONNECT software will be available for download by stakeholders throughout the health information exchange community once it is finalized.

"NHIN is a poster child for all of the benefits that open source software and open standards provide," said Bill Vass, president and COO of Sun Microsystems Federal, Inc. "The federal government has built a working prototype capable of being deployed across multiple agencies in a matter of months with minimal costs. The open nature of the IT foundation is critical to ensuring that government can work with the private healthcare sector to revolutionize the nation's healthcare system."

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http://www.outlookseries.com/N/Infrastructure/3138_HHS_Taps_Sun_Nationwide_Health_Information_Network_NHIN.htm

HHS Taps Sun For Nationwide Health Information Network NHIN

April 7, 2009

Open source software from Sun Microsystems is enabling the United States Department of Health and Human Services (HHS) to build a secure, open technology platform to connect federal government agencies and health information exchanges in a "network of networks"--the Nationwide Health Information Network (NHIN)--built over the Internet.

The goal of NHIN is to support the secure exchange of interoperable health information within the federal government and with the tribal, state, local and private sectors to enable increased efficiency, better patient care and improved population health.


"NHIN is a poster child for all of the benefits that open source software and open standards provide," said Bill Vass, president and COO of Sun Microsystems Federal, Inc. "The federal government has built a working prototype capable of being deployed across multiple agencies in a matter of months with minimal costs. The open nature of the IT foundation is critical to ensuring that government can work with the private healthcare sector to revolutionize the nation's healthcare system."


As a key member of the NHIN consortium, the federal government needed to build a comprehensive gateway to connect its 26 NHIN member agencies to the NHIN infrastructure, hence the name CONNECT. The HHS has a commitment to using open source technologies to ensure the CONNECT gateway can cost-effectively support the wide variety of operating systems used by the different agencies.


"Our progress with the NHIN shows that President Obama's commitment to healthcare reform can become a reality quickly. Here we have the public and private sectors working together as a community to help realize this key vision," said Joe Hartley, Vice President of Global Government, Education and Healthcare for Sun Microsystems." Sun has already seen first-hand the impact of open source technology on healthcare information sharing, and has enjoyed working closely with other vendor partners and federal agencies to make Obama's goals a reality today."

Brazil, India & Other Developing Countries Seek Compulsory License to Steal U.S. Patented Climate Change Technologies

http://www.ecoearth.info/shared/reader/welcome.aspx?linkid=132796

http://online.wsj.com/article/SB124760260278140953.html

Fighting Climate Change With Patents


By Tim Wilson


Wall Street Journal Europe


July 15, 2009

GENEVA -- World leaders are talking a lot about climate change, not least in their flashy statement on controlling global temperatures at the recent Group of Eight summit in Italy. One of the smarter ways they can put this determination into effect will be to protect the intellectual property of green innovators from a growing onslaught by developing-world politicians and mistaken activists.

Intellectual property rights are the underappreciated link in the environmentalist chain. By rewarding inventors and entrepreneurs, well-enforced patents provide the right incentives for the innovation that will produce technologies necessary to manage climate change. Yet this fact is getting lost. Access to low carbon technologies has become a central issue in international climate change negotiations as rich countries put more pressure on the poor to cut their emissions. Understandably the poor aren't prepared to do so unless they are given cheap access to technologies. Patents are increasingly viewed as the main obstacle to cheap technology transfer.

Preview

So a representative of the Brazilian government, Haroldo Machado Filho, this week told a World Intellectual Property Organization conference in Geneva that leaders should consider the possibility of allowing "compulsory licensing" for green technologies.

This would be a new loophole in international intellectual property rules that would allow developing-country governments to break patents "for the public good"; such a loophole already exists for pharmaceuticals.

In a similar vein, Indian Climate Change Minister Shri Ramesh asserted late last month that access to intellectual property for low-carbon technology is a "global public good." This kind of thinking lays the intellectual groundwork for patent violations down the road.

Most worrying, opponents of patents have succeeded in having included in the current negotiating text for a post-Kyoto agreement paragraphs to undermine patents. The final text won't be finalized until at least the December U.N. Copenhagen meeting, but current proposals range from "compulsory licensing" to the "creation of a global technology pool for climate change" that would socialize intellectual property.

These proposals fundamentally misunderstand why low-carbon technology is expensive. A January report by Copenhagen Economics, a consulting firm, found that the high prices are most likely a result of the immaturity of technologies, not patents. New technologies are generally more expensive when there are fewer products competing in the market. As more technologies are innovated the price is likely to drop. Most promising green technologies are so new they simply haven't had time to decline in price yet.

The Copenhagen Economics report also notes that weakening intellectual property for green technologies would be bad for the developing world countries whose governments advocate such measures. A growing number of patents on these technologies are held by developing-country innovators. China is one of the largest owners of solar and fuel-cell technology patents. The balance is still in favor of developed-world innovators, but the gap is narrowing fast. Allowing entrepreneurs in poorer countries to profit from their discoveries will be good both for the environment and for developing-country economies.

Undermining patents won't help access to technologies, but it will stop the next generation of technologies being invented, and with it a long-term solution to achieving the twin goals of developing countries to reduce emissions and alleviate poverty. Rather than breaking patents, policy makers could re-evaluate tariff regimes and other barriers that can add up to 165% to the cost of some imported green technologies, according to a 2007 World Bank study. The best path to a green future is not to break free-market principles, but to return to them.

Mr. Wilson is director of the Institute of Public Affairs in Melbourne, Australia.

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http://www.twnside.org.sg/title2/intellectual_property/info.service/2009/twn.ipr.info.090609.htm

No patents on climate-friendly technologies, says South

SUNS #6718

by Sangeeta Shashikant


Third World Network


June 12, 2009

The Group of 77 and China as well as several developing countries in their individual capacity have ma de proposals calling f or climate-friendly technologies to be excluded from patenting.

In their text submitted Wednesday, the G77 and China proposed that "All necessary steps shall be immediately taken in all relevant fora to mandatorily exclude from patenting climate-friendly technologies held by Annex II countries which can be used to adapt to or mitigate climate change". [Annex II of the Convention contains a list of 24 developed countries with financial obligations].

The "no patents" proposal is one of several other ambitious proposals put forward by developing countries to address the intellectual property barrier to the transfer of and access to environmentally-sound technologies for climate mitigation and adaptation (ESTs).

The proposals were submitted on "Enhanced action on development and transfer of technology", one of the five building blocks of the Bali Action Plan (BAP) adopted by Parties tothe UN Framework Convention on Climate Change (UNFCCC) in December 2007. These proposals were added during the discussion of the text of the Chair of the Ad-hoc Working Group on Long-Term Co-operative Action (AWG-LCA) in the informal plenary on 10 June.

The work of the AWG-LCA is to implement the Bali Action Plan in order to enable the full, effective and sustained implementation of the UNFCCC through long-term cooperative action now, up to and beyond 2012.

Developing countries also called for: (i) the adoption of a Declaration on IPRs and Environmentally Sound Technologies in relevant fora; (ii) the use to the full flexibilities contained in the TRIPS Agreement including compulsory licensing to access intellectual property protected technologies; (iii) steps to ensure sharing of publicly funded technologies and related know-how; and (iv) the creation of a "Global Technology Pool for Climate Change" that ensures access to technologies including on royalty free terms.

The call for bold action to deal with IPRs, an obstacle to the transfer of and access to ESTs, follows heated debate that took place last Saturday, largely along North-South lines.

Developed countries, in particular Japan, Canada, Australia, Switzerland and the US insisted on strong IPR regimes, even opposing the use of compulsory licensing, which is allowed under the TRIPS Agreement (See SUNS #6716 dated 10 June 2009). The developed countries also questioned the need for new institutional arrangements, in particular, the technology mechanism that has been proposed by the G77 and China.

On the other hand, developing countries had argued that there was a need for patent exclusion on climate technologies, given the need for a global and systemic response to address the global challenge of climate change, adding that the current TRIPS flexibilities were inadequate.

The Philippines proposed that: "All necessary steps shall be immediately taken in all relevant fora to mandatorily exclude from patenting environmentally sound technologies which can be used to adapt to or mitigate climate change".

The Philippines also proposed that: "Biological resources including microorganisms, plant and animal species and varieties, and parts thereof that are used for adaptation and mitigation of climate change shall not be patented".

Bolivia proposed that Parties should "take all steps necessary in all for a to mandatorily exclude from patenting in developing countries environmentally sound technologies to adapt to or mitigate climate change, including those developed through funding by governments or international agencies" and "to revoke in developing countries all existing patents on essential/urgent environmentally sound technologies to adapt to or mitigate climate change".

It also proposed text that "nothing in any international agreement on intellectual property shall be interpreted or implemented in a manner that limits or prevents any Party from taking any measures to address adaptation or mitigation of climate change, in particular the development and transfer of, and access to technologies".

Other developing countries have also made proposals reflecting a similar sentiment as follows:

"[[LDCs][Countries vulnerable to the adverse effects of climate change] should be exempted from patent protection of climate-related technologies for adaptation and mitigation, as required for capacity building and development needs.

[Genetic resources, including germplasms of plant and animal species and varieties that are essential for adaptation in agriculture, shall not be patented by multinational or any other corporations.]]]"

Aside from the "no patents" proposal, the Chair's text as well as the various submissions of countries during the technology debate also contains other proposals to address the IPR barrier.

Some of the proposals envisage bolder actions to overcome the IPR obstacle, such as "Limited/reduced time for patents on climate friendly technologies".

The Philippines proposed language to improve the Chair's text that supported the use of TRIPS flexibilities as well as to ensure the sharing of publicly-funded technologies and related know-how. It proposed the following:

"Specific measures shall be taken and mechanisms developed to remove existing barriers to development and transfer of technologies from developed to developing country Parties arising from intellectual property rights (IPR) protection, including:

(i) to use to the full flexibilities contained in the Trade Related Aspects of Intellectual Property Rights (TRIPS) including Compulsory licensing to access intellectual property protected technologies;

(ii) take steps to ensure sharing of publicly funded technologies and related know-how including by making the technologies available in the public domain at an affordable price and on terms and conditions that promotes access for developing countries".

The Philippines also proposed the "adoption of a Declaration on IPRs and Environmentally Sound Technologies in relevant fora to inter alia reaffirm the flexibilities in the TRIPS Agreement and enhance the enabling environment for implementing these flexibilities".

The Chair's text had "Compulsory licensing for specific patented technologies" as a specific measure to remove IPR protection barriers to technology development and transfer.

The G77 and China proposed the "creation of a Global Technology Pool for Climate Change' that promotes and ensures access to intellectual property protected technologies and associated know-how to developing countries including on non-exclusive royalty-free terms in order to provide better information service and reduce transaction costs".

The Philippines made a similar proposal in its submission including an additional paragraph that states: "All necessary measures and actions shall be immediately taken to facilitate technology pools that include associated trade secrets and know-how on environmentally sound technologies and enable them to be accessed, including on royalty-free terms for developing countries".

The technology pool proposal is similar to a proposal in Bolivia's submission. The Bolivian proposal also speaks of immediately creating and providing "new and additional financing that is adequate, predictable and sustainable for joint technology excellence centres in developing countries, to enable entities in these countries to do research and development especially on adaptation as well as mitigation technologies" and "to ensure that any technology transfer to developing countries is appropriate for the developing countries concerned in order to enable its effective utilization".

(The immediacy is based on the mandate of the AWG-LCA to enhance implementation of the Convention "now, up to and beyond 2012".)

The Chair's text also contains a proposal for "The Executive Body on Technology", "to establish a committee, an advisory panel, or designate some other body, to proactively address patents and related intellectual property issues to ensure both increased innovation and increased access both for mitigation and adaptation technologies".

It further states that the committee/panel should:

"(a) Actively engage enterprises and institutions in both developed and developing countries; (b) Develop a clear framework for evaluation and determining when intellectual property becomes a barrier to international technology research, development, deployment, diffusion and transfer and provide options for corrective action; ( c) Make recommendation back to the UNFCCC COP or COP/MOP on barriers that may require further actions".

There are also proposals in the Chair's text that mention "Preferential pricing", "Differential pricing between the developed and developing countries", "promoting innovative IPR sharing arrangements for joint development of Environmentally Sound Technologies", and "Promoting Joint technological or patent pools for the development and transfer of technologies to the developing countries at low cost". +

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http://www.scidev.net/en/climate-change-and-energy/adaptation/opinions/cooperation-not-compulsion-on-clean-tec hnology-tra.html

Cooperation not compulsion on clean technology transfer

by Dalindyebo Shabalala

Science and Development Network

3 June 2009

Compulsory licensing of clean technologies will only be needed if developed countries duck UNFCCC obligations, says Dalindyebo Shabalala.

Developing countries will need 'clean technologies', such as micro-wind energy, if they are to play an active role in combating climate change over the coming decades. The question is how to access these? The answer lies in genuine cooperative technology transfer between the developed and developing world.

Compulsory licensing, where governments allow manufacturers to produce patent-protected goods for domestic use without the patent owner's consent (sometimes with payment),is one option. It has worked well for medicine, though developing nations have had to fight hard to access some key drugs. And some countries, including Thailand, have suffered severe political penalties, such as threats to remove or suspend trade preferences.

Many in the climate change debate argue for new and more flexible compulsory licences for clean technologies, especially given potential demand in developing countries and the short time frame for action.

A last resort?

Individual countries could unilaterally use existing World Trade Organization rules for compulsory licences to access key clean technologies. But that — and any new licensing system — should only be needed if industrialised nations fail to meet their technology transfer and financing commitments under the UN Framework Convention for Climate Change (UNFCCC).

Some proponents of new compulsory licensing for climate-related technologies have misunderstood key differences between the access to medicines debate (under the TRIPS Agreement) and technology transfer, under the UNFCCC.

Whereas TRIPS contains just one relatively weak commitment to technology transfer that only refers to least developing countries, the UNFCCC addresses it extensively, giving clear guidelines, especially on financing, for developed and developing countries.

And there are other factors that compulsory licences may not resolve. For example, for many climate technologies, such as micro-hydroelectric, wind and solar, the major cost may not be the intellectual property (IP), but the actual hardware and maintenance.

More than access to the actual technologies, developing countries need access to the skills, know-how and capital that can help them use, reproduce and adapt clean technologies. Compulsory licences — except those granted for competition reasons — may not transfer this tacit knowledge, which is often protected by trade secrets.

UNFCCC obligations

Under the UNFCCC, industrialised countries are committed to providing and financing technology transfer, regardless of patents. They are obliged to make available funds and mechanisms to ensure access, distribution and uptake of environmentally sound climate-related technologies in developing countries. For example, the [UN] Montreal Protocol — an international treaty to protect the ozone layer — pays for licensing fees at reasonable costs. Countries remain free to exercise compulsory licences when companies refuse to license their products.

The Montreal Protocol — and the UNFCCC — also account for IP market failures, where patented goods or knowledge become unaffordable for most relevant consumers. Under them, developed countries guarantee to transfer technologies, including paying for licences, if the technology in question exists and is unavailable in the national market at an affordable cost.

Unlike compulsory licensing, this commitment represents a cooperative approach. Only if this fails will developing countries, left to their own devices, have to resort to unilateral measures.

Those engaged in the current UNFCCC negotiations are well aware that agreeing a workable mechanism for technology transfer is essential. It is crucial for strategies to successfully combat climate change after 2012 (when the first commitment period of the Kyoto Protocol ends).

Lessons from Montreal

The Montreal Protocol shows technology transfer can be successfully addressed. What is needed is a fully funded financing mechanism that pays the full costs of accessing technologies, especially patent licences and accompanying services. And there must be a fair mechanism for managing intellectual property barriers, such as refusals to license, unreasonably high licensing costs, restrictive licensing practices, and other issues.

Developing countries at the UNFCCC are proposing a Technology Cooperation Mechanism that draws on experiences of the Montreal Protocol. Developed countries, who have not yet proposed any mechanisms themselves, need to acknowledge the success of experiences such as the Montreal Protocol and actively join with developing countries in seeking a cooperative and good faith solution. Only then can developing countries begin to effectively take on the challenge of reducing greenhouse gas emissions and adapting to climate change.

In the meantime, developing countries will continue to use compulsory licensing as a bargaining chip.

But we should all hope that unilateral measures remain nothing more than that. If developing countries have to resort to large-scale compulsory licensing to acquire climate-related technologies, it will signify a fundamental breakdown in the global climate policy regime. Developing countries will have been left on their own to sink or swim in a deluge of someone else's making.

Dalindyebo Shabalala is director of the Intellectual Property and Sustainable Development Project at the Center for International Environmental Law (CIEL). The views expressed in this piece do not necessarily reflect the views of CIEL or its funders.

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http://nopr.niscair.res.in/bitstream/123456789/4193/1/JIPR%2014(3)%20241-246.pdf

http://nopr.niscair.res.in/handle/123456789/4193

Diffusion of Climate Friendly Technologies: Can Compulsory Licensing Help?

By Nitya Nanda,


Centre for Global Agreements, Legislation and Trade, Resources and Global Security Division, The Energy and Resources Institute (TERI), India Habitat Centre, New Dehli 110 003


14 Journal of Intellectual Property Rights 241


May 2009


Abstract:

Countries often resort to compulsory licensing to promote diffusion of technologies, particularly when intellectual property rights (IPR) holder is considered to have abused its dominant position. However, use of this instrument is often difficult due to legal, political and operational problems. In this context, this paper reviews global regimes as well as national regimes in major jurisdictions, governing use of compulsory licensing. It also examines functional requirements and market conditions for compulsory licensing to work.


Based on these, it concludes that the global IPR regime under the WTO needs a mechanism similar to that has been developed for pharmaceutical products, and a more flexible regime even in that, as most countries do not have domestic manufacturing capabilities, if compulsory licensing has to work for the diffusion of climate friendly technologies. However, even such a flexible mechanism may not be adequately effective due to highly concentrated market structure of these technologies, particularly in developing countries.