Resumen Ejecutivo. En 2006 el CECTE concentró sus actividades en las siguientes áreas:

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1 El Comité Nacional de Ética en la Ciencia y la Tecnología (CECTE) es un espacio de argumentación crítica y transdisciplinaria sobre problemas relevantes para la integridad y el progreso de la ciencia y la tecnología. En este carácter ha elaborado un método y un lenguaje para afrontar el análisis de cuestiones éticas involucradas en la producción y aplicación de conocimientos científicos y tecnológicos en los distintos campos de la investigación, en el funcionamiento de las instituciones de investigación y en la formación de los futuros científicos y en las relaciones entre la ciencia y los otros sectores de la sociedad. El CECTE fue creado en abril de 2001 mediante la resolución 004/2001 de la Secretaría de Ciencia, Tecnología e Innovación Productiva (SeCyT), y su funcionamiento fue confirmado por las resoluciones 031/2002 y 600/2004. Resumen Ejecutivo En 2006 el CECTE concentró sus actividades en las siguientes áreas: Controversias éticas involucradas en el acceso al conocimiento científico y tecnológico. El CECTE recibió una solicitud de intervención vinculada con este tema que ha sido motivo de estudio y debate en los últimos años en ámbitos como la UNESCO, el International Council for Science (ICSU) y la Academia Nacional de Ciencias de EE.UU. El CECTE decidió que su relevancia amerita un tratamiento a nivel regional; lo propuso como primer punto para el programa de trabajo Bilateral Argentino Brasileño de Etica en la Ciencia y la Tecnología y organizó una reunión de especialistas e investigadores argentinos y brasileños como primer etapa de un análisis crítico sobre el tema. (ANEXO I) Cuestiones éticas involucradas con el financiamiento de la investigación científica y tecnológica realizada en instituciones públicas. En particular se respondió a dos pedidos de opinión sobre iniciativas de la SECyT y a un pedido de opinión sobre una situación vinculada con la aplicación de las recomendaciones elaboradas por el Comité en 2005 (caso ) sobre investigaciones que incorporan financiamiento extranjero proveniente de fuerzas armadas, organismos de seguridad, o de instituciones que tengan entre sus objetivos declarados el desarrollo de armamentos. (ANEXO II) Fortalecimiento regional de la ética de la ciencia y la tecnología. A través de la Dirección de Relaciones Internacionales de la SeCyT se concretó la aprobación del Programa de Trabajo Argentino Brasileño de Etica en la Ciencia y la Tecnología; y se organizaron dos eventos binacionales. (ANEXOS III y IV)

2 Asimismo, en cumplimiento de su obligación de atender solicitudes de análisis de cuestiones éticas en el campo de la investigación científica y tecnológica y el posible efecto de sus resultados en la sociedad, el CECTE tiene un convenio firmado en septiembre de 2002 con la Comisión de Ciencia y Tecnología de la Cámara de Diputados de la Nación para la elaboración de recomendaciones no vinculantes sobre proyectos de ley relacionados con estos temas. En el 2006, a pedido de la Comisión de Salud de la Cámara de Diputados de la Nación, el CECTE estudió un proyecto de ley sobre Funcionamiento de los Comités de Ética en Salud y elaboró recomendaciones (caso ) y participó de reuniones de discusión sobre dicho tema. (ANEXO V) En cumplimiento de su obligación de dar publicidad a sus acciones y difundir información sobre la ética de la ciencia y la tecnología, el CECTE comenzó en el 2006 un proceso de modificaciones de su portal ( y abrió un concurso de proyectos para mejorar su accesibilidad y la interacción con los lectores que será implementado en el primer cuatrimestre de Programa para el Fortalecimiento de la Ética en la Investigación Científica y Tecnológica: El 28 de marzo de 2006 se formalizó la entrega al CECTE de un subsidio para financiar un programa de actividades vinculadas con la promoción de la dimensión ética. El subsidio de cien mil pesos es administrado por la Unidad de Vinculación Tecnológica Innova-T y durante el año fue utilizada la suma de veintinueve mil tres cientos setenta y cuatro pesos con cincuenta y seis centavos. (confrontar Programa y detalle de gastos en el ANEXO VI). Integrantes del CECTE Roberto Fernández Prini, Químico, Profesor Emérito Facultad de Ciencias Exactas y Naturales de la UBA; Investigador Superior del CONICET, Director Instituto de Química Física de los Materiales, Medio Ambiente y Energía (FCEyN-UBA); Miembro Correspondiente Academia Nacional de Ciencias Exactas, Físicas y Naturales. Samuel Finkielman, Médico, Profesor Titular Consulto Facultad de Medicina UBA; Investigador Principal CONICET(r); Director Unidad Hospitalaria Instituto de Investigaciones Médicas "Alfredo Lanari" UBA. Stella González Cappa, Microbióloga; Profesora Consulta, Facultad de Medicina, UBA; Investigadora Principal CONICET. Noé Jitrik, Escritor y crítico; Investigador Principal (r) CONICET; Docente y Director Instituto de Literatura Hispanoamericana, Facultad de Filosofía y Letras, UBA. Aída Kemelmajer, Jurista, Miembro de la Academia Nacional de Derecho y Ciencias Sociales de Buenos Aires; Academia Nacional de Derecho y Ciencias Sociales de Córdoba; Real Academia de Madrid; Ministra de la Suprema Corte de Justicia de Mendoza; 2

3 Profesora Titular Universidad Nacional de Cuyo; Profesora Invitada Universidades de París II y XII (Francia), Génova y Bologna (Italia); Profesora Honoraria Universidad de San Marcos Lima, Perú. Alberto Kornblihtt, Biólogo; Profesor Titular Plenario FCEyN UBA; Investigador Principal CONICET; Director Departamento de Fisiología, Biología Molecular y Celular FCEyN UBA. Ernesto Maqueda, Físico, Comisión Nacional de Energía Atómica; Investigador Principal CONICET. Armando Parodi, Bioquímico; Investigador Superior CONICET, Presidente Fundación Instituto Leloir; Miembro de la Academia Nacional de Ciencias, Academia Nacional de Ciencias Exactas, Físicas y Naturales; Third World Academy of Sciences, Academia de Ciencias de América Latina, American Academy of Microbiology; Extranjero de la Academia Brasileira de Ciencias y de la National Academy of Sciences, EE.UU. Fernando Ulloa, Médico Psicoanalista, Profesor Titular Honorario de las Facultades de Psicología de la UBA y de la Universidad de Tucumán. Especializado en metodología clínica y psicoanálisis de las instituciones, derechos humanos y salud pública, coordina programas de atención a grupos vulnerables en varias provincias del país. Coordinadora: Otilia Vainstok, Socióloga Matemática, Profesora Titular UBA; FCEN, UBA. Colaboraciones y agradecimientos El CECTE deja constancia de las contribuciones aportadas durante 2006 por los especialistas Salvador Bergel; Sandra Díaz; Karen Hallberg; Matthias Kaiser; Noemí Nicolau, Víctor Penchaszadeh y Héctor Sejenovich. 3

4 1. Ética en el Acceso al Conocimiento Antecedentes. En el mes de agosto de 2004 una empresa privada de origen nacional hizo llegar al CECTE una solicitud para que interviniera en calidad de testigo en un litigio legal. El Comité estudió el pedido y tomó dos decisiones. En primer lugar, consideró que a pesar del interés del tema para el desarrollo de la ciencia y la tecnología y, en el caso concreto en cuestión, para la salud y el bienestar de la población, el CECTE solo podría oficiar en un litigio judicial bajo la figura del amicus curiæ, en respuesta al pedido expreso de un tribunal. En segundo lugar, estableció que el acceso al conocimiento científico y tecnológico de dominio público involucra cuestiones éticas que son de su competencia e incorporó el tema al plan de trabajo propuesto para el Programa Argentino Brasileño de Ética en la Ciencia y la Tecnología. A fin de efectivizar tal decisión en junio de 2006 organizó una reunión con el Presidente de la Sociedad Brasileña para el Progreso de la Ciencia, doctor Ennio Candotti, los doctores Salvador Bergel y Carlos Correa y, por el CECTE, Samuel Finkielman, Stella González Cappa, Aída Kemelmajer y la Coordinadora, Otilia Vainstok. Los participantes acordaron un programa de actividades destinadas a promover el debate crítico sobre la ética del acceso al conocimiento de dominio público que incluyó: i. la elaboración de un documento de discusión sobre el estado de situación del acceso al conocimiento de dominio público cuya preparación quedó a cargo de Carlos Correa; y, ii. la organización de dos reuniones binacionales, la primera en octubre en Buenos Aires, donde se analizaría el documento, y la segunda en noviembre en San Pablo, donde se aprobaría el texto final El Documento Base: introducción y sinopsis de las conclusiones preliminares 1. El conocimiento puede calificarse como bien público por dos características básicas y fundamentales: por un lado es libremente accesible y por el otro no es excluyente. Los derechos de propiedad intelectual (DPI) brindan derechos exclusivos a innovadores y creadores sobre el uso de sus innovaciones o creaciones y generan un mercado de bienes de información. En la práctica la expansión de los derechos exclusivos ha generado situaciones que entran en colisión con necesidades sociales fundamentales y/o derechos individuales como la salud pública o el derecho a la libertad de expresión. Se define como dominio público a los bienes intangibles que no están sujetos a derechos de propiedad intelectual, esto significa que nadie puede limitar el uso de la información de dominio público basándose en normas de propiedad intelectual. Durante los últimos siglos, la acumulación de un amplio y sólido dominio público de la información ha sido el pilar de del desarrollo de la ciencia y las innovaciones. Las condiciones y circunstancias 1 Confrontar ANEXO I. 4

5 que contribuyeron a la creación de un dominio público de datos científicos que nutrió a la ciencia y a la innovación en la actualidad están en peligro. En particular, existe una tendencia generalizada a promover la mercantilización de la información científica. Al mismo tiempo, la legislación en materia de propiedad intelectual se ha expandido de manera permanente en todas las direcciones, amenazando el delicado equilibrio entre los derechos de exclusividad y las excepciones y limitaciones de los derechos de autor, y angostando de manera peligrosa el campo del dominio público. La Directiva sobre Bases de Datos de la Unión Europea es un ejemplo de esta tendencia. La Directiva origina un derecho sui generis para impedir la extracción y reutilización de la totalidad o parte de las bases de datos, y brinda medios legales a los productores de dichas bases para que exploten hechos y datos que, previamente, fueron de dominio público. La Directiva tiene consecuencias prácticas significativas para los usuarios de datos en general y para el campo de la ciencia y de la investigación en particular. La Directiva sobre Bases de Datos de la Unión Europea excede principios básicos de la legislación de derechos de autor y trasgrede algunos límites fundamentales. Además de no acatar la dicotomía idea/expresión y hecho/expresión, crea un derecho exclusivo sobre ciertas formas de inversiones, independientemente de la existencia o inexistencia, de un considerable nivel de contribución creativa y, al mismo tiempo, permite que el titular del derecho extienda dicho derecho exclusivo a perpetuidad. El acceso al conocimiento y a datos científicos también puede verse considerablemente limitado por los efectos prácticos y jurídicos de las medidas de protección tecnológica (MPT) y la legislación antielusión, como la Ley de Derechos de Autor del Milenio Digital de los EE.UU. y la Directiva de la Sociedad de la Información de la Unión Europea. Esta legislación permite a los titulares de derechos de autor el control de usos no autorizados de sus obras en el ámbito digital. Pero este control ampliado que proveen excede los derechos exclusivos tradicionales que se otorgan en virtud de la legislación en materia de derechos de autor y origina importantes desequilibrios entre los derechos exclusivos y usos públicos privilegiados y restringe severamente la amplitud del ámbito de dominio público. Fundamentalmente, las nuevas formas de protección pueden impedir el acceso a información empírica y a datos científicos que ya pertenecen al dominio público. Otro ejemplo de la tendencia hacia la privatización de la información es el de los regímenes sui generis que otorgan exclusividad sobre los datos de prueba de productos farmacéuticos y agroquímicos. En los países que reconocen esta exclusividad se restringe el uso de estos datos de naturaleza científica que podían ser utilizados libremente en el paradigma convencional de la protección intelectual. Varios países en desarrollo se vieron forzados a aceptar dicha restricción bajo amenaza de sanciones comerciales o en el contexto de la negociación de tratados de libre comercio. Las consecuencias de la 5

6 exclusividad en el uso de datos pueden ser significativas, en particular para la salud pública, dado que demora la competencia y reduce el acceso a los productos protegidos (impide la producción de genéricos). Diversas iniciativas han surgido para proteger y ampliar el dominio público. Algunas de las presiones hacia la privatización del conocimiento, en general, y del conocimiento científico en particular, pueden ser contrarrestadas mediante la adopción de alternativas basadas en la cooperación y en un modelo de libre acceso donde los derechos de propiedad no predominen. También se deben enfrentar las presiones para la adopción de regímenes de exclusividad de datos a fin de garantizar la competencia y proteger los intereses públicos en áreas vitales para la población y la economía. En resumen, el informe plantea el significado y el papel del conocimiento de dominio público, y el de la información y datos científicos, en particular. Describe el proceso de angostamiento del dominio público y las crecientes limitaciones en el acceso al conocimiento y a los productos que de él derivan. Enumera algunas de las razones que explican por qué tales procesos no solo afectan a la comunidad científica sino a la sociedad en su totalidad. En este sentido define como desafío fundamental la adopción de medidas que impidan un mayor debilitamiento del dominio público y garanticen que el uso de la información científica no sea limitado artificialmente por nuevas medidas proteccionistas. La internacionalización del modelo legislativo y de las medidas antielusión desarrollados en los EE.UU. y en Europa ha generado una tendencia que limita a escala global el acceso y la genuina utilización de la información. Es posible que se obstaculice o se impongan pagos para acceder a datos científicos que actualmente pertenecen al dominio público. Este proceso puede profundizar la gran brecha tecnológica que existe entre los países en desarrollo y los países desarrollados. Para los primeros, es fundamental asegurar la preservación y el uso legítimo del ámbito digital -tanto a nivel nacional como internacional- de dominio público. En el caso de los datos de prueba relacionados con la aprobación de productos farmacéuticos y agroquímicos debe garantizarse su disponibilidad a fin de permitir que salvaguardando su calidad y bioequivalencia los países más pobres puedan producir tales productos. Los regímenes que se proponen asegurar el uso exclusivo de datos, que no está fundado por las normas internacionales vigentes, pueden llegar a reducir significativamente el acceso a los medicamentos -aún cuando no exista protección patentaria- y consecuentemente agravar los serios problemas que aquejan a la salud pública de los países en desarrollo. 6

7 El cierre creciente del acceso a datos e información introduce graves preocupaciones éticas en relación al cumplimiento de principios de justicia y equidad que proteja el derecho de los más vulnerables a recibir los beneficios de la ciencia y la tecnología. La sociedad civil y los gobiernos no pueden ser testigos pasivos del proceso de expansión de la apropiación privada. Dicho proceso puede afectar, de manera radical, el necesario equilibrio entre los intereses públicos y privados en áreas cruciales para el desarrollo físico, científico, cultural, económico y social de los países menos desarrollados y, en particular, de sus sectores empobrecidos La Reunión Binacional. El 2 y el 3 de octubre de 2006 se realizaron las Primeras Jornadas de Ética en el Acceso al Conocimiento, organizadas por el CECTE en cooperación con la Sociedade Brasileira para o Progresso da Ciência (SBPC). Esta actividad dio comienzo a las acciones previstas en el Programa Bilateral Argentino- Brasileño de Ética en la Ciencia y la Tecnología acordado entre los Ministros del sector en noviembre de 2004, que entró en vigencia el 25 de septiembre de La reunión fue inaugurada por el Secretario de Ciencia Tecnología e Innovación Productiva, Ing. Tulio Del Bono y participaron el Presidente de la Agencia Nacional de Promoción Científica y Tecnológica, Dr. Lino Barañao, investigadores, especialistas y funcionarios de Argentina y Brasil y el Director del Comité Nacional de Ética en la Investigación en Ciencia y Tecnología de Noruega, Dr. Matthias Kaiser. La delegación brasileña estuvo integrada por el Presidente de la SBPC, Dr. Ennio Candotti; por los representantes del Ministerio de Ciencia y Tecnología, Dres. Aline Fernandes, Asesora de Asuntos Internacionales, y Marcio Rojas da Cruz; la responsable del Sector de Ciencia y Tecnología de la Embajada de la República Federativa de Brasil en Argentina, Ministra Andréia Rigueira; y los investigadores Dres. Hernán Chaimovich, Director de la Academia Brasileña de Ciencias, Vicepresidente del International Council For Science (ICSU) y Presidente del InterAmerican Network of Academies of Science; Luiz Otávio Pimentel, Director del Departamento de Propiedad Intelectual y Transferencia de Tecnología de la Universidad Federal de Santa Catarina, Lisbeth Cordani (SBPC)y Fermín Roland Schramm, Presidente de la Fundación Oswaldo Cruz (Fiocruz). Por Argentina participaron los miembros del CECTE, Dres. Roberto Fernández Prini, Stella González Cappa, Noé Jitrik, Aída Kemelmajer, Alberto Kornblihtt, Ernesto Maqueda, y la coordinadora Otilia Vainstok; los Dres. Ricardo Calandra; Florencia Luna y María Donadio Maggi, en representación del CONICET; Salvador Bergel y Carlos Correa, ambos de la Universidad de Buenos Aires; Noemí Nicolau de la Universidad Nacional de Rosario; y Mabel Berardoni, Asesora Legal de la Subsecretaría de Políticas, Regulación y Fiscalización del Ministerio de Salud de la Nación. 7

8 Durante la reunión Matthias Kaiser expuso sobre las implicaciones éticas de los cambios en los modos de producción del conocimiento y planteó algunas posibles acciones acerca del tema. En la presentación del documento preparado para la reunión, Carlos Correa desarrolló el concepto del conocimiento como bien público y describió las actuales tendencias a su privatización. La ponencia dio lugar a una extensa discusión sobre la noción de dominio público y las iniciativas para preservarlo, los procesos de creación, difusión y apropiación de datos científicos producidos por entes privados y públicos, los rasgos del sistema sui generis de protección de bases de datos establecido en Europa y los efectos de las medidas tecnológicas de protección al acceso a tales datos. Salvador Bergel, Noemí Nicolau, Roberto Fernández Prini y Alberto Kornblihtt hicieron breves presentaciones vinculadas con los aspectos éticos de la reiteración de los datos de prueba en seres humanos y en animales; el acceso al conocimiento desde la óptica del derecho del consumidor de los países periféricos; cuestiones vinculadas al patentamiento y las diferentes propiedades de las sustancias químicas conocidas en la macro y nanoescalas; y el patentamiento de genes y se leyó un trabajo preparado por Sandra Díaz del Instituto Multidisciplinario de Biología Vegetal de la Universidad Nacional de Córdoba sobre la apropiación privada de organismos biológicos, procesos y genoma que tradicionalmente pertenecían al dominio público. Durante las jornadas, que contaron con las relatorías de las doctoras Stella Maris González Cappa y Aline Fernández, se analizaron los aspectos conceptuales y las controversias éticas involucradas en el acceso al conocimiento científico y se acordaron los ejes de las Segundas Jornadas que se realizarían en San Pablo, Brasil en noviembre de La reunión de San Pablo fue postergada por pedido de la contrapartida Brasileña para diciembre de 2006 y luego para abril de Cuestiones éticas involucradas en el financiamiento de la investigación científica y tecnológica realizada en instituciones públicas. El CECTE en el 2005 trató el tema de las investigaciones que incorporan financiamiento extranjero proveniente de fuerzas armadas, organismos de seguridad, o de instituciones que tengan entre sus objetivos declarados el desarrollo de armamentos y elaboró sus recomendaciones (caso ) (ANEXO II). Sin embargo durante 2006 el tema continuó exigiendo la atención del CECTE que dedicó gran parte de las reuniones plenarias de marzo, abril, junio y noviembre a pedidos de opinión sobre iniciativas de la SECyT relativas a posibles regulaciones en el campo de las 8

9 investigación con financiamiento extranjero proveniente de fuerzas armadas et al. y a un pedido de opinión sobre una situación particular en este mismo tema. El CECTE consideró que las situaciones planteadas se encontraban encuadradas en las recomendaciones generales oportunamente elaboradas por el Comité. Por tal motivo, sugirió que la SECyT recurriera a las recomendaciones del caso número sobre Investigaciones realizadas en instituciones científicas públicas financiadas por organismos de fuerzas armadas de otros países y en relación a la situación particular derivada al CECTE, reiteró que las regulaciones que se impongan a los proyectos de investigación con tal financiamiento atañen a decisiones institucionales y entran en el terreno de las políticas de Estado que deben responder a las preocupaciones de la comunidad científica, de las instituciones científicas nacionales y de la sociedad en su conjunto y exigen un exhaustivo debate crítico público. 3. Fortalecimiento regional de la ética de la ciencia y la tecnología Programa Argentino- Brasileño de Ética en la Ciencia. En Noviembre de 2004 los Ministros de Educación Ciencia y Tecnología de Argentina y de Ciencia y Tecnología de Brasil firmaron un convenio de cooperación que incorporó un programa conjunto en el campo de la ética de la ciencia y la tecnología. En agosto de 2005 se preparó a pedido de la Dirección de Relaciones Internacionales de la SeCyT una propuesta de trabajo que luego de varios meses de estudio por parte de investigadores y funcionarios brasileños logró integrarse en un Programa de Trabajo Binacional que entró en vigencia el 25 de septiembre del (ANEXO II) 3.2. Segunda Reunión argentino-brasileña Ciencia, Tecnología y Sociedad. En junio de 2006 el CECTE participó en la Segunda Reunión argentino-brasileña Ciencia, Tecnología y Sociedad, organizada por la Revista Ciencia Hoy, la Asociación Argentina para el Progreso de la Ciencia (AAPC), la Sociedade Brasileira para o Progresso da Ciência (SBPC) y la Secretaría de Ciencia, Tecnología e Innovación Productiva, que tuvo lugar en el Museo Argentino de Ciencias Naturales Bernardino Rivadavia. El CECTE organizó un encuentro sobre Ética y nanociencias y nanotecnologías (NyN) que forma parte del programa de actividades del CECTE para 2006 y de la propuesta del Programa Argentino-Brasileño de Ética en la Ciencia y la Tecnología. En la mesa redonda participaron los Dres. Karen Hallberg, (Instituto Balseiro, Centro Atómico Bariloche); Aída Kemelmajer (CECTE, CSM; UNCU); Otilia Vainstok (CECTE); Ennio Candotti, Presidente de la SBPC; y Paulo Martins, Instituto de Pesquisas Tecnológicas de São Paulo. (Anexo III) 9

10 ANEXOS 10

11 Anexo I PROTECTING THE PUBLIC DOMAIN: ACCESS TO AND USE OF SCIENTIFIC DATA AND INFORMATION 2 FIRST DRAFT RESTRICTED CIRCULATION La versión original se redactó en inglés para permitir su discusión internacional, también se preparó una traducción al español de carácter preliminar. Carlos M. Correa Universidad de Buenos Aires September Study prepared for the Comité Nacional de Ética en la Ciencia y la Tecnología, with the collaboration of M. D. Kralj. The author is solely responsible for the opinions expressed in this paper. 11

12 Summary Abstract Executive Summary 1. Introduction 2. The expansion of intellectual property rights 3. Public domain and scientific data and information A. The legal protection of databases B. TPMs and anti-circumvention legislation Digital Millennium Copyright Act The EU Information Society Directive The Internet Treaty and free trade agreements C. Protection of test data for pharmaceuticals and agrochemical What are test data Production of test data Sui generis protection of test data The TRIPS standard on data protection Controversies about interpretation Public health and ethical implications 4. Initiatives to counteract the tendency to broader proprietary rights Open-source software The open-content movement Generation of and access to biomedical data 5. Main Conclusions References Annex 1: Annex 2: Annex 3: Glossary on types of intellectual property Geneva Declaration on the Future of the World Intellectual Property Organization Adelphi Charter Ref. Comité dominio público Eli

13 Abstract This document elaborates on the concept of knowledge as 'public good' and on the trend towards its privatization as a result of the expansion of intellectual property. It also examines the notion of 'public domain' and its growing erosion. The analysis is focused on the creation, diffusion and possible appropriation of data of scientific nature produced by public and private entities. The analysis also includes the case of test data necessary for the marketing approval of pharmaceutical and agrochemical products. The document considers some initiatives taken to counterweight the described trends towards appropriation of data and information. Executive Summary Knowledge can be categorised as a public good because it has the two basic and fundamental particularities: non-rivalry and non-excludability. Intellectual property rights (IPRs) provide innovators and creators exclusive rights over the use of their innovations or creations, thereby allowing for the generation of a market for information goods. However, some of these exclusive rights collide with certain fundamental social needs and/or individual rights, such as public health or the right to freedom of expression. A robust and vast public domain for scientific data has been the supporting pillar of science and innovations over the last centuries. The public domain is traditionally defined as consisting of those intangible goods not subject to intellectual property rights, which means that, nobody can limit the use of public domain information by relying on intellectual property rules. The fact that science and innovation have been supported by a robust and comprehensive public domain for scientific data was due to the combination of several particular circumstances now under threat. Moreover, a generalised tendency to promote the commodification of scientific information and data is taking place. Apart from economic and technological pressures, intellectual property law has been steadily expanding in all directions, threatening the delicate balance between exclusive rights and copyright exceptions and limitations and dangerously diminishing the scope of public domain. The EU Database Directive illustrates this tendency. It creates a sui generis right to prevent extraction and re-utilization of the whole or part of the database providing database producers with the legal means to exploit facts and data that were previously part of the public domain. The practical implications of the Directive for users of data in general and for the field of science and research in particular are significant. The EU Database Directive goes far beyond basic principles of copyright law and infringes on some fundamental limits. Apart from failing to comply with the idea/expression fact/expression dichotomy, it creates an exclusive right over certain forms of investments independently of whether there is a considerable level of creative contribution, and at the same time makes it possible for the right holder to extend that exclusive right in perpetuity. Access to scientific data and knowledge can also be considerably restricted by the legal and practical effects of technological protection measures (TPMs) and anti-circumvention legislation, such as the US Digital Millennium Copyright Act and the EU Information Society Directive. This legislation has provided copyright holders with tools to control unauthorized uses of their works in the digital environment. The extended control they provide exceeds the traditional exclusive rights granted under copyright law in several ways leading to significant imbalances between exclusive rights and public privileged uses, thereby seriously shrinking the scope of the public domain. Most importantly, the new forms of protection can impede access to factual and scientific data and information in the public domain. Another example of the trend towards appropriation of information is provided by the sui generis regimes that grant exclusivity with regard to test data of pharmaceutical and agrochemical products. While these data, of a scientific nature, were free to use under the conventional paradigm of intellectual property protection, their use is restricted in those countries that recognize such exclusivity. Several developing countries have been forced to do so under threat of trade sanctions or in the context of negotiations of free trade agreements. The consequences, particularly for public health, of data exclusivity may be significant, as it delays competition and reduces access to the protected products. There are various initiatives that have emerged to protect and enlarge the public domain. Through a collaborative basis and an open access model in which property rights are not in a central position, alternative paths may alleviate some of the pressures under which knowledge in general, and scientific knowledge in particular currently labour. It is also important to avoid succumbing to pressures to adopt data exclusivity regimes, in order to ensure competition and protect public interests in vital areas for the population and the economy. 13

14 1. Introduction In his paper called Knowledge as a global public good, Stiglitz recalls Jefferson s expression He who receives an idea from me, receives instruction himself without lessening mine; as he who lights his taper at mine, receives light without darkening me" as an accurate and early mirror of the modern concept of public good (1999:1). Jefferson was the first United States Patent Commissioner 3. Economists state that knowledge can be categorised as a public good because it has the two basic and fundamental particularities that differentiate public goods from private goods: non-rivalry and non-excludability. Knowledge is non-rivalrous since it can be enjoyed by many people at the same time with no additional cost; and knowledge is also non-excludable because its enjoyment by one person does not exclude others from enjoying it too. As an example, once a particular scientific theory is created and divulged it can be learned by many at a zero marginal cost and its consumption does not mean the impossibility of another enjoying that knowledge as well. Economic analysis has highlighted the intrinsic problem that these two characteristics of public goods may bring about with regard to the incentives to produce such goods. The standard argument is that the very nature of knowledge makes it particularly difficult to stop free-riders from enjoying the good without paying for it, thereby affecting the creator s or producer s ability to obtain an economic reward for the use of his work or production. As a consequence, the argument follows, there is little or no incentive to provide public goods privately and some of them could end up in short supply. Historically, governments have found two alternative paths to address this problem. One possibility was to finance the production and delivery of public goods either directly or through the granting of funds or subsidies to third parties that would produce or deliver the goods themselves. A second option was to modify this natural situation by bestowing artificial proprietary rights on public good producers as a way of allowing them to exert some control over the use of their creations. As Stiglitz put it when referring to knowledge in particular, the strategy was to increase the degree of appropriability on the return of knowledge by using patents and copyright protection (1999:6). Thus, intellectual property rights (IPRs) 4 provide one means to address the dilemma of public goods appropriability by granting creators exclusive rights over the use of their creations and introducing an artificial scarcity that permits the generation of a market for information goods (Ganley, 2003). Scherer explained the economic logic of the patent system as follows: Society desires the superior products and more efficient processes associated with technological change. Ideally, it would like to realize all the benefits from a given innovation as quickly as possible. This implies swift, widespread imitation of the innovation and a rapid decline in prices until production and necessary marketing costs are barely covered. But absent governmental or other subsidies, inventors and especially innovators are unlikely to bear the costs and risks of developing and introducing a new technology unless they can expect to be sheltered from the imitative swarm for a sufficiently long time to recoup or more than recoup their early investment By inhibiting and delaying imitation, patent grants prevent the premature erosion of innovators profits and hence instil expectations in the minds of would-be innovators and inventors that their efforts stand a good chance of being rewarded 5. The role of IPRs has often been examined in terms of the tension between static and dynamic efficiency 6. In order to encourage competition through innovation, competition based on price and 3 In a letter to Isaac McPherson of August 13, 1813, Jefferson further argued: "That ideas should freely spread from one to another over the globe, for the moral and mutual instruction of man, and improvement of his condition, seems to have been peculiarly and benevolently designed by nature, when she made them, like fire, expansible over all space, without lessening their density at any point, and like the air in which we breathe, move, and have our physical being, incapable of confinement or exclusive appropriation. Inventions then cannot, in nature, be a subject of property" quoted in The Complete Jefferson, Saul K. Padover, ed. (New York: 1943). 4 See in Annex I a glossary of intellectual property rights. 5 Scherer, 1977, p Static efficiency is achieved when there is an optimum utilization of existing resources at the lowest possible cost. Static efficiency may be subdivided into: (i)production efficiency, which includes technical and nontechnical operating efficiencies, together with transaction cost and X-efficiency savings; (ii)allocative efficiency is the allocation of products through the price system in the optimum manner required to satisfy consumer demand. Dynamic efficiency is the optimal introduction of new products or products of superior 14

15 quantity may need to be temporarily restrained. This reduces static efficiency, which is best served by competition, but increases the possibility for innovators to recover their investment in research and development bolstering, as a result, dynamic efficiency. Although there are several shortcomings to this approach as examined below, it made clear that IPRs were granted to benefit society and not the private holders of the rights. Accordingly, IPRs were based on a balance between public and private interests. This paper examines the legal barriers created to the access to and use of factual and scientific data in general and, in particular, test data relating to pharmaceutical and agrochemical products. It first considers the erosion of the public domain through the expansion of intellectual property rights (IPRs). Second, it briefly examines new legal and technological means that limit access to scientific data and information. This is explored on the basis of three examples: the sui generis rights conferred in Europe with regard to data bases, technological measures that prevent access to information (even in the public domain), and new forms of data exclusivity regarding information about the efficacy and safety of pharmaceutical and agrochemical products. Third, the paper considers initiatives to counterweight these trends towards appropriation of scientific data. 2. The expansion of intellectual property rights In the last twenty years an expansive wave of protectionism has dramatically changed the balance between public and private interests in IPRs. While initiated in developed countries, the protectionist wave has extended to developing countries through coercion (via mechanisms such as the Special Section 301 of the US Trade Act) multilateral agreements (notably the WTO TRIPS Agreement) and free trade agreements. As a result, knowledge is increasingly subject to a tough protectionist regime in a world that, paradoxically, proclaims the benefits of free trade. The new IPRs regimes have been shaped by a narrow industry interests, without little or no consideration about their likely implications on development and, particularly, the poor (Sell, 2003).. Abundant evidence shows that IPRs systems evolved in developed countries as they improved their economic and technological capabilities. Thus, United States provided weak copyright protection all over the IXX Century and many European countries and Japan only introduced pharmaceutical patents when their industries were strong enough to benefit from them. Quite obviously, in a world with drastic asymmetries in the capacity to generate science and technology, IPRs benefit some firms, countries and groups and disadvantage others. The global expansion of IPRs has involved almost all areas of knowledge. Some of its manifestations include: - the application of patents to new fields, such as living materials, computer programs and business methods; - the patenting of upstream scientific results and research tools; - the extension of copyright to computer programs; - the creation of new, sui generis regimes for the protection of integrated circuits test data for pharmaceuticals and agrochemicals unoriginal databases, including on scientific and factual data. Prof. Boyle has eloquently depicted these developments as follows; As intellectual property protection has expanded exponentially in breadth, scope and term over the last 30 years, the fundamental principle of balance between the public domain and the realm of property seems to have been lost. The potential costs of this loss of balance are just as worrisome as the costs of piracy that so dominate discussion in international policy making. Where the traditional idea of intellectual property wound a thin layer of rights around a carefully preserved public domain, the contemporary attitude seems to be that the public domain should be eliminated wherever possible. Copyrights and patents, for example, were traditionally only supposed to confer property rights in expression and invention respectively. The layer of ideas above, and of facts below, remained in the public domain for all to draw on, to innovate anew. Ideas and facts could never be owned. Yet contemporary intellectual property law is rapidly abandoning this central principle. Now we have database rights over facts, gene sequence, business method and software patents, digital fences that enclose the public domain together with the realm of private property... the list continues. And while quality, more efficient production processes and organization, and (eventually) lower prices over time. See, e.g. UNCTAD, 1997, p. 5, 8 and 9. 15

16 these rules differ from nation to nation, the pressure is to harmonize them only upwards, adopting the strongest protections of facts, the longest copyright terms, the greatest scope of patentability (Boyle, 2004: 2). Changes also affect how the conventional modalities of IPRs protection are applied. Thus, copyright had traditionally developed a friendly approach to science, research and education by recognising a set of defences and exceptions for those purposes. These exceptions (such as fair use in the field of copyright), generally allowed users to carry on certain activities without the right owner s consent. They ensure a balance between exclusive rights and fundamental freedoms, and are as indispensable to a successful copyright regime as are exclusive rights (Vinje, 1999). However, these exceptions are now under serious threat by the direction that copyright law has been taking over the recent years. In particular, as discussed below, new modes of control for the access to knowledge, such as technological protection measures (TPMs) have been adopted nationally and internationally. These measures can limit access to information, even if in the public domain. In the area of patents, follow on research has been exempted in some jurisdictions from patent rights under research or experimentation exceptions. They cover in some countries research on an invention, as opposed to research with it (Correa, 2005). In the United States, however, case law has moved in a different direction: research without the authorization of the patent owner is only narrowly admitted. The Federal Circuit Court of Appeals held in Madey v. Duke that regardless of whether a particular institution or entity is engaged in an endeavour for commercial gain, so long as the act is in furtherance of the alleged infringer s legitimate business and is not solely for amusement, to satisfy idle curiosity, or for strictly philosophical inquiry, the act does not qualify for the very narrow and strictly limited experimental use defence. Moreover, the profit or nonprofit status of the user is not determinative 7. Another worrying development is the extension of the term of protection, notably for patents, copyright and related rights. It has been noted, for instance, with regard to copyright that copyright term limits are now absurdly long. The most recent retrospective extensions, to a term which already offered 99% of the value of a perpetual copyright, had the practical effect of helping a tiny number of works that are still in print, or in circulation. Estimates are between 1% and 4%. Yet in order to confer this monopoly benefit on a handful of works, works that the public had already paid for with a copyright term that must have been acceptable to the original author and publisher, they deny the public access to the remaining 96% of copyrighted works that otherwise would be passing into the public domain. Before the Internet, this loss though real would for most works have been largely a theoretical one. The cost of reprinting an out-of-print book or copying and screening a public domain film was often prohibitive. But once one adds the Internet to the equation, it becomes possible to imagine digitizing substantial parts of the national heritage as it emerges into the public domain, and making it available to the world. Now this is truly fulfilling the goals of copyright: encouraging creativity, and encouraging access. It has positive effects on education, on development and on creativity. Instead, the process of international harmonization grinds on, relentlessly extending copyright terms retrospectively, locking up cultural and educational materials that could and should be available to the world (Boyle, 2004: 6). These developments substantially erode the public domain. This concept has traditionally been defined as consisting as the pool of information not subject to intellectual property rights, that is, information that can be freely used without authorization by or payment 8 to third parties (Van Caenegem, 2002:1). Information in the public domain is: (i) (ii) (iii) information for which IPRs protection has expired, information that was eligible for protection but which lost it because of a failure to comply with certain formal intellectual property requirements, information that is outside the scope of intellectual property law because it is not eligible according to the law USPQ2d 1737 (Fed. Cir. 2002). 8 Exceptionally, in some countries the reproduction of artistic works that have fallen into the public domain is subject to payment to the State ( public domain payant ). 16

17 It has been noted that information is not in the public domain by its public good nature or even by its governmental origin but as the result of a network of formal and informal social agreements, explicit or implicit but entrenched in common law and in the culture of a society (Forero Pineda, 2004:40). The scope of the public domain can, hence, be more or less broad, depending on the modalities and scope of appropriation determined by the States law. 3. Public domain and scientific data and information Scientific knowledge and data are cornerstones of scientific advancement. Science has been based on the availability of information, on open access to that information, and on transparency. Such access results in further growth of science as well as technology and applications (Menon, 2004: 5). What others have discovered and collected before, constitutes a significant and fundamental basis upon which contemporary researchers and scientists rest their inquiries and works. From this perspective, science is essentially a social endeavour that has been traditionally based on a collaborative basis. Since knowledge and data are basic pillars of research and innovation, broad and affordable access to them by other researchers and users must be ensured. It has been broadly pointed out that a robust and vast public domain for scientific data has been the supporting pillar of science and innovations over the last centuries. This was largely due to the combination of several particular circumstances that Reichman and Uhlir clearly detailed referring to the U.S case. Some of these circumstances can be summarized as follows: - The government itself has been an important producer of scientific information and data and has renounced to claim proprietary rights on them allowing broad public accessibility; - The government has given funds to universities and other scientific research institutions provided that they follow an open access policy with the resulting information and data; - Data and facts as such were not protected under classical patent and copyright paradigms; and - There was a strong collaborative and open attitude inside the scientific community regarding sharing information and data (Reichman & Uhlir, 2005: 1-2) Recent decades have seen different pressures on these conditions as a generalized tendency to promoting the commodification of scientific information and data took place. As Reichman describes it there has been a marked tendency to shift the production of science-relevant databases from the public to the private sector (2004:74). In part, this was due to governmental cuts on research expenditure, which affected not only its own production but also the amount of money given to non-governmental scientific institutions which have an open access policy (Reichman & Uhlir, 2005:2-3). Moreover, in 1980, the Bayh-Dole Act in the US allowed universities to exploit their research results from projects carried out with federal funds. The purpose of this legislation was to encourage the academic community to give licenses for their inventions to private companies, as a way to motivate private investors to pick up where government sponsors left off and transform new discoveries into commercial products (Rai & Eisenberg, 2003:1). Similar developments have taken place in other countries, often influenced by the US model. In addition to these pressures, as mentioned, intellectual property law has been steadily expanding in all directions, threatening the delicate balance between exclusive rights, exceptions and limitations, and dangerously diminishing the scope of public domain. On the one hand, the term of protection has been extended once and again. On the other, more and more types of information have become subject matter for protection, and the scope of exclusive rights has enlarged, covering new forms of communication and uses. As noted by Reichman and Uhlir, traditional intellectual property laws, especially copyright law, excluded facts and data as eligible subject matter. Even when facts and data were embodied in some copyrightable works of authorship, such as historical or scientific works, well-established limits and exceptions to copyright protection allowed researchers to access, use and extract data for personal use and for public research purposes. However, recent developments in intellectual property laws in most developed countries now make it possible to assert and enforce proprietarial claims to virtually all the factual matter that previously entered the public domain once it had been disclosed (2005:4-5). The European Database Directive that will be commented on below is a good illustration of the new tendency towards the appropriation of data. It creates new proprietary rights for database producers providing them with the legal means to exploit facts and data that were previously part 17

18 of the public domain. Moreover, as will be explained, the Directive opens the door for perpetual protection. By the same token, the technological revolution has brought about significant and unprecedented opportunities and challenges. The emergence of digital devices allows users to make perfect copies of a digitalized work and disseminate those copies to millions with only the click of a mouse. For the scientific and research community in particular, this means an immense opportunity for storage of data, easy access to scientific data and knowledge around the world and invaluable tools to foster collaboration and exchange among researchers. But at the same time, all the new technological possibilities threaten the basis of the copyright system making it extremely easy to disseminate an unauthorized perfect copy of a work to millions at hardly any cost. This threat has encouraged right holders to use technological protection measures (TPMs) to build fences around their works disseminated in the digital network environment to prevent unauthorized users not only from using them but also from accessing them (which was unprecedented in the analogue world). TPMs are a good example of the paradox of the technological revolution; as David explains it has the potential to enormously improve access to information and, at the same time, it affords the technological means of inhibiting access in ways that were never before practical (2001:6). In the following sub-sections we analyze some of the legal mechanisms that threaten to seriously diminish the scope of the public domain and to undermine the balance between exclusive rights and other fundamental social needs and individual freedoms. A. The legal protection of databases Probably one of the most interesting examples of the generalized tendency of commodification and commercialisation of information is the Database Directive issued by the European Council in According to the Directive, a database is a collection of independent works, data or other materials arranged in a systematic or methodical way and individually accessible by electronic or other means 9 that requires an investment of considerable economic, human and technical resources 10. Considered as fundamental tools for the development of an information market within the Community 11, the EU decided that their creation, maintenance and dissemination should be emphatically encouraged through the granting of particular proprietary rights to database producers. The EU regarded databases as valuable tools for the information society and decided to provide producers with further incentives to generate and disseminate them through the granting of exclusive rights, even in cases in which they did not enjoy copyright protection. Accordingly, the Directive declares that databases that are the result of a substantial investment, either in qualitative or quantitative terms, are protected, in the sense that their producers will hold a sui generis right to prevent extraction and re-utilization of the whole or part of the database 12. Extraction should be understood as the permanent or temporary transfer of whole or part of the contents of a database to another medium by any means or in any form (for example, copying it). Re-utilization is any form of making available to the public the contents of the whole or part of the database (for example distribution of copies 13 ). The practical implications of the Directive for users of data in general and for the field of science and research, in particular, are significant. Apart from being vital tools for the development of an information market, databases can be seen as containers of information and data that are essential for other fields of development, such as, science, education and health. As Lederberg stated data are the building blocks of knowledge and the seeds of discovery.they provide the quantitative basis for testing and confirming theories and for translating new discoveries into useful applications for the benefit of society. They are also the foundation of sensible public policy in our democracy (in Reichman and Uhlir, 1999:11). This fact had been traditionally contemplated by intellectual property rules and constitutes the basis of probably one of copyright law s most fundamental principles: the idea/expression or fact/expression dichotomy, according to which it is the form of expression of a particular idea or data which is protected by the law, but never the idea or the data itself, which is considered as part of the public domain. As Justice Sandra Day O'Connor stated in the renowned case Feist 9 See article See article See article See Article See article

19 Publications, Inc. v. Rural Telephone Service Co. 14, the primary objective of copyright is not to reward the labour of authors, but to promote the Progress of Science and useful Arts. To this end, copyright assures authors the right to their original expression, but encourages others to build freely upon the ideas and information conveyed by a work. This principle, known as the "idea/expression" or "fact/expression" dichotomy, applies to all works of authorship. As applied to a factual compilation, assuming the absence of original written expression, only the compiler's selection and arrangement may be protected; the raw facts may be copied at will. This result is neither unfair nor unfortunate. It is the means by which copyright advances the progress of science and art 15. The idea or fact/expression dichotomy is important because it balances a variety of interests that copyright law regimes need to conciliate in order to achieve their aim of promoting creativity, science and innovation. It was Melville Nimmer who first observed in 1970, that since copyright protected particular forms of expression but not the ideas underlying that expression, copyright law was in the USA in accordance with First Amendment requirements regarding freedom of speech. Some years later, the US Supreme Court in the case Harper & Row Publishers v Nation Enterprises explained that First Amendment protections were already embodied in Copyright Act s distinction between copyrightable expression and uncopyrightable facts and ideas 16. For the scientific and research community these exclusive rights over databases represent a tremendous obstacle for their daily work since much of their research and studies are based on data previously collected, which is generally used as a starting point to a new research path. Those supporting the granting of exclusive rights to non copyrightable database producers alleged that they are necessary to provide incentives for their creation, and that, if not, no one will invest time, money and other valuable resources to produce them. Opponents of this model, on the other hand, repudiate this stating that these claims are mere conjectures and that there is no convincing proof to show that exclusive proprietary rights are actually fostering database production. There is also another worrying disposition of the Directive from the perspective of our analysis and it is related to the term of protection. The Directive establishes a period of fifteen years, but the term can be renewed in the case that any new substantial investments (for example in the form of updates or maintenance) is made. As a consequence, databases can be under perpetual protection and may never become part of the public domain. Besides, as an unfruitful attempt to prevent right holders from certain abuses in the exercise of their exclusive rights, the Directive declares that the extraction or re-utilization of an insubstantial part of a database should be permitted. However, as almost every commentator on the Directive has pointed out, the practical effect of this disposition is weak since the line between substantial and insubstantial use or extraction is not an easy one to draw, bringing users the risk of uncertainty. With regard to exceptions, the Directive does not contemplate any mandatory exception to extracting or reutilizing contents of a database for scientific, research of educational purposes. The Directive only authorises Member States to provide exceptions for cases of private purposes, teaching or scientific research and public security or an administrative or judicial procedure 17. Apart from failing to observe the idea/expression fact/expression dichotomy, the Directive creates an exclusive right independently of whether there is a creative contribution and, at the same time, makes it possible for the right holder to extend his exclusive rights in perpetuity. As noted by Reichman and Uhlir, How the Directive will actually affect science in any given country will thus depend on a number of imponderable variables. Nevertheless, we can say that this regime radically breaks with the historical limits of traditional intellectual property laws by protecting aggregates of information as such, potentially forever, without requiring any significant level of creative contribution. It affects all research by establishing a monopolistic barrier to the flow of upstream information, which has always been a free input into the information economy (2005: 7). The implications of the model of protection developed by the European Directive may be far reaching, and impede access even to government-created data, which have been an important 14 Feist Publications, Inc. v. Rural Telephone Service Co. 499 U.S. 340 (1991). 15 See Paragraph Harper & Row v. National Enterprises, 471 U.S. 539 (1985). 17 See article 9. 19

20 component of the public domain. In fact, the impetus behind the actual use of database protection is commercialization of government data; There is a serious move on the part of European government agencies in the area of meteorology to assert database protection of government information. At a recent meeting attended by Mr. Weiss in Geneva, there was a demand that the U.S. Weather Service "dumb-down" their web page and explicitly identifies the origin of the data sets used. This is extremely hard to do in integrated systems such as this. They also demanded that if academia or business want the data, they must go back to the originating country 18. In sum, the EU Database Directive -as well as other similar proposals for database protection in the US and other parts of the world- goes far beyond basic principles of copyright law and infringes on some fundamental rights to get access to data and information in the public domain. B. TPMs and anti-circumvention legislation Access to scientific data and knowledge can also be considerably restricted by the legal and practical effects of TPMs and anti-circumvention legislation, such as the Digital Millennium Copyright Act in the US (DMCA) and the Directive on the harmonization of certain aspects of copyright and related rights, in the European Union ( the Information Society Directive ). As a solution to protect their works from unauthorized uses in the digital environment, right holders started to use TPMs which are computer programmes that regulate access and use of digitalized works. TPMs are mainly of two types: access control measures such as passwords and digital signatures that secure access to content, and copy control measures such as content scrambling systems for DVDs that prevent third parties from exploiting the exclusive rights of right holders (Shah, 2004:1). However, these blocking technologies can be removed or circumvented by other technologies especially designed for that purpose and right holders realised that a legal back up for their TPMs would protect them from circumvention activities. As Dussollier metaphorically expresses it, building a technical fence around works was not considered as sufficient. Electrifying it by making its circumvention a criminal act was needed (1999:1). Digital Millennium Copyright Act In October 1998, the US Congress passed the DMCA. Section 1201 regulates two kinds of TPMs: access control devices and copy control devices and deals with two types of prohibited acts: acts of circumvention of TPMs (anti-circumvention provisions) and acts preparatory to circumvention such as manufacturing or importing of devices that are used to circumvent TPMs (anti-trafficking provisions). The DMCA establishes that to circumvent a technological measure means to descramble a scrambled work, to decrypt an encrypted work, or otherwise to avoid, bypass, remove, deactivate, or impair a technological measure, without the authority of the copyright owner and that a technological measure `effectively controls access to a work if the measure, in the ordinary course of its operation, requires the application of information, or a process or a treatment, with the authority of the copyright owner, to gain access to the work. One of the most significant aspects of this definition is that it seems to cover all acts of circumvention carried on without the copyright holder s consent. Consequently, the DMCA prohibits the act of circumvention per se independently of whether there is a copyright infringement or not. The DMCA provides copyright holders with tools to control unauthorized uses of their works in the digital environment. Such control exceeds the traditional exclusive rights granted under copyright law in several ways, leading to significant imbalances between exclusive rights and public privileged uses. 18 National Aeronautics and Space Administration, Washington, D.C., February 2, 1999, Minutes, Update on OMB/OIRA: Priorities and Plans Scientific Data in the 21st Century - NIST Standard Reference Data and CODATA NIST Information Services in the Information Era NASA Systems and Technologies Update, 20