Pharmaceutical patents and the right to access to medicines in Central America

El vínculo entre la propiedad intelectual y el derecho a la salud se ha convertido en un tema de debate central desde la conferencia ministerial de la Organización Mundial del Comercio (OMC) en 2001. En efecto, a pesar del amplio reconocimiento del derecho a la salud en la escena internacional, la cuestión de la protección efectiva y la aplicación del derecho en cuestión es tema de un debate constante. El objetivo de las patentes farmacéuticas, es proporcionar al inventor un conjunto de derechos exclusivos durante un período de tiempo determinado a cambio de la divulgación pública del medicamento recién protegido. El régimen de monopolio establecido conduce a un aumento significativo de los precios de los medicamentos, convirtiéndolos así en bienes de lujo. Esta situación suscita diversas cuestiones sobre la relación entre el derecho a la salud y las patentes de los medicamentos, entre otros, especialmente en el caso de los países en desarrollo (América Central).Desde el punto de vista jurídico, hay tres esferas principales del derecho internacional que son pertinentes para la cuestión actual: en primer lugar, el acceso a los medicamentos constituye una parte integrante del derecho a la salud, a fin de permitir que todos los seres humanos reciban atención médica, independientemente de su situación económica. Por consiguiente, en los debates actuales se discute si los medicamentos, como bienes esenciales, pueden y deben ser patentables para garantizar el acceso a los medicamentos a la gran mayoría de las personas. Este trabajo comienza, examinando el marco legal relacionado con el derecho a la salud a la luz de los principales tratados internacionales y regionales (PIDESC - Convención Americana sobre Derechos Humanos). El segundo capítulo se centra principalmente en la regulación internacional de la protección de la propiedad intelectual de los productos farmacéuticos de acuerdo con los tratados y la práctica pertinentes. Así, el capítulo ilustra las principales teorías sobre la antinomia normativa entre los tratados y proporciona un análisis del Acuerdo sobre los ADPIC. Se hace hincapié en las llamadas flexibilidades del Acuerdo sobre los ADPIC, así como en una visión general de la subsiguiente Declaración de Doha, ya que ambos marcos son de importancia central para las empresas farmacéuticas. El capítulo concluye con el análisis de la región centroamericana, que tiene como objetivo estudiar cómo los acuerdos comerciales regionales obstaculizan la protección del derecho de acceso a los medicamentos de las partes interesadas. Así pues, se presentan dos estudios de casos para ilustrar casos concretos en los que las denominadas disposiciones ADPIC-Plus han retrasado tanto a Guatemala como a Costa Rica en el cumplimiento adecuado de sus compromisos en materia de derechos humanos. Por último, en el tercer capítulo se aborda un aspecto igualmente valioso de la cuestión que se examina, es decir, la responsabilidad de las empresas farmacéuticas en materia de derechos humanos. Esos agentes económicos, desempeñan un papel fundamental para garantizar la protección del derecho de acceso a los medicamentos, ya que son los titulares y principales defensores de la protección de la propiedad intelectual de los medicamentos. En esta sección se ilustran las teorías más reconocidas sobre la personalidad jurídica internacional de esas entidades económicas peculiares con arreglo a un enfoque deductivo. De hecho, partiendo de un análisis general de las empresas multinacionales, limitando la búsqueda a fin de determinar si las empresas farmacéuticas tienen o no obligaciones en materia de derechos humanos.The bond between intellectual property and the right to health has become an area under discussion of central concern since the debates at the 2001 World Trade Organization (WTO) ministerial conference. Indeed, despite the extensive acknowledgement of the right to health at the international stage, the issue of giving effective protection and implementation of the right at stake, is under a constant debate. The aim of pharmaceutical patents is to provide the inventor with a set of exclusive rights for a determined period of time in exchange for the public disclosure of the newly released drug. The monopoly regime established leads to a significant increase in drugs prices, hence turning medicines into luxury goods. Such a situation triggers a variety of questions on the relationship between the right to health and patents on medicines, inter alia, in the case of developing countries (Central America). From a legal point of view, three major spheres of international law are relevant to the current issue: human rights law, international trade law and international responsibilities of non-State actors. In the first place, access to medicines constitutes an integral part of the right to health, in order to permit all human beings to receive medical care, regardless of their economic status. Accordingly, current debates argue whether drugs, as essential goods, can, and should, be patentable in order to secure access to drugs to the vast majority of people. This work starts by examining the legal framework related to the right to health in the light of the main international and regional treaties (ICESCR-American Convention on Human Rights). The second chapter mainly focuses on the international regulation of intellectual property protection of pharmaceutical products on the grounds of relevant treaties and practice. Thus, the chapter illustrates the main theories regarding normative antinomy between treaties and provides an analysis of the TRIPS Agreement. The emphasis regards the so-called TRIPS’ flexibilities as well as an overview of the subsequent Doha Declaration, both frameworks being of central importance for pharmaceutical companies. The chapter concludes with the analysis of the Central American region, which aims at examining whether the aforementioned CAFTA Agreement hindered the protection of the right to access to medicines for the parties concerned. Two case studies are, thus, provided in order to illustrate concrete instances in which the so-called TRIPS Plus provisions have delayed both Guatemala and Costa Rica in properly fulfilling their human rights undertakings under international law. Lastly, the third and final chapter addresses an equally valuable aspect of the issue under examination, namely the human rights responsibilities of pharmaceutical corporations. Such economic actors play a crucial role in ensuring the protection of the right to access to medicines, since they are the holders, and principal defenders, of IP protection for drugs. This section illustrates the most acknowledged theories on the legal personality of such peculiar economic entities under a deductive approach. In fact, starting from a general analysis of multinational corporations, the chapter narrows it down in order to determine whether or not pharmaceutical corporations are burdened with human rights obligations

Appropriability of Technical Innovations: An Empirical Analysis

Appropriating the economic returns from technical innovations is very important for individual inventors and innovators, as well as for technical change in individual markets and for the whole economy. Since appropriability is difficult to measure directly, many researchers have been trying to investigate it indirectly and qualitatively by examining the effectiveness of various means of appropriability. The most important of these means are patents, secrecy and lead time and related advantages. The purpose of this paper is to investigate empirically the effectiveness of different means of protecting the competitive advantages of technical innovations in Switzerland. The analysis is based on a survey conducted in 1988 among 358 Swiss experts, mainly R&D executives from selected firms. They represented 127 different lines of business, mainly in the manufacturing sector. The results can be summarized as follows: 1. For process innovations lead time is generally considered as the most effective means of appropnability. For product innovations superior sales and service efforts are viewed as the most effective means, followed by lead time. 2. For both product and process innovations patents are generally considered to be the least effective means of appropriability. 3. Patents as a means of appropnability in the Swiss context are only effective in a few industries: in chemicals, including drugs, and in some cases in the machinery and electrotechnics industries. 4. The ability of competitors to "invent around" patented innovations and the perception that patent documents require "disclosure of too much information" are considered as the most important constraints on the effectiveness of patents. 5. Inventors and innovators have manifold reasons for patenting their new ideas. Although patents may not provide adequate protection against imitation, they can contribute to enhancing the patent-holders' negotiating position towards third parties. This can be the case in negotiations either with other firms (for example about R&D-related agreements, fusions, take-overs etc) or with governmental agencies (for example concerning access to foreign markets)

Patent First, Litigate Later! The Scramble for Speculative and Overly Broad Genetic Patents: Implications for Access to Health Care and Biomedical Research

One of the theoretical premises of the patent system is that it enhances the dissemination of valuable information by assuring creators of new inventions a limited monopoly for the exploitation of their inventions. As a tool of state policy, the patent system seeks to catalyze the industrialization of the state, disclosure of information by inventors, and ultimately, the enrichment of the public domain in a manner that benefits both the inventor and the Society. Consequently, the patent system is often characterized as a form of contract between the inventor and the state. As a consideration for disclosing the secret of the invention, so this theory says, the state grants the inventor limited monopoly over the use of the invention. The implicit assumption in this Simplified theoretical construction of a complex system is that the inventor and the society benefits mutually from the bargain

Patent First, Litigate Later! The Scramble for Speculative and Overly Broad Genetic Patents: Implications for Access to Health Care and Biomedical Research

This paper will not directly address the ethical considerations of allowing patents on human genetic sequences, although this continues to be a controversial debate in itself. Rather, the aim is to consider the legality of such gene patents and the effects such patents have on biomedical research and health care delivery in definitive terms through an analysis of current developments and research relating to the subject. The operation of current intellectual property regimes regulating such patents will be examined, and amendments to these legal systems will be considered. An emphasis will be placed on identifying practical concerns rather than broad, general issues that do not directly address practical implications. In concluding our analysis, we propose a set of policy options which the patent system and public institutions may pursue to mitigate the excesses of an exuberant and liberal patent system

Patent Law and TRIPS: Refining the Patent Law of Iraq to Ensure Compliance with TRIPS

Currently Iraq is not one of the members of the TRIPS Agreement, but in the accession process since 2004. Therefore, Iraqi Patent and Industrial Design Law No. 65 of 1970 has to be aligned with the TRIPS Agreement in order to fulfill the accession requirements. Hence, this research is comprised of legal comparative and analytical study to the significant provisions of the Iraqi Patent and Industrial Design Law No. 65 of 1970, before and after amendments among themselves and in comparison, to the provisions of the TRIPS Agreement. In this context the research finds out that the law No. 65 of 1970 through its amendments has attempted to conform to the TRIPS Agreement. Nevertheless, the research concludes that the Iraqi patent law needs further amendments in order to benefit from all the flexibilities that offered by the TRIPS Agreement to the member countries

The international political economy of intellectual property rights: The TRIPs agreement and the advanced pharmaceutical industry in Europe.

The thesis explores the manner in which the R&D-based pharmaceutical industry in Europe organised and operated between 1995 and 1999 in order to secure its interests with regard to the agreement on trade-related aspects of intellectual property rights (TRIPs) of the World Trade Organisation (WTO). The TRIPs agreement represents a major increase in the global protection of intellectual property rights (IPRs). In fact, the agreement contradicts the general direction of the WTO, i.e. trade liberalisation, since it increases the monopolistic features of international trade in knowledge products. The research was motivated by one basic and fundamental question: why and how is such a strong international intellectual-property agenda in place. A pure economic approach does not provide a sufficient and satisfactory explanation for the creation of IPRs. For example, economists cannot conclude whether patents confer a net benefit or entail a net loss to society. This is due mainly to the structural trade-off built into the patent system: that by aiming to increase the amount of available knowledge in the future, the system represses the free and widespread use of available knowledge in the present. The international IP system, as exemplified by TRIPs, is even more difficult to explain in purely economic terms, particularly with respect to the uneven distribution of IPRs between "northern" and "southern" countries. The importance of IPRs to future economic growth, foreign direct investment and technology transfer is also in dispute. As an alternative to an explanation based on global welfare, the thesis suggests that a dynamic approach, based on the international political economy of interest groups and systemic outcomes, provides a better starting point for explaining how the international intellectual property agenda (TRIPs) was determined. This approach is tested here by focusing on the strategies, organisation, and actions of the R&D-based pharmaceutical industry in Europe and its IP allies, which aimed at preserving and exploiting the TRIPs agreement. Using their highly sophisticated and well-coordinated organisational build-up, the advanced pharmaceutical industry in Europe and its IP allies were able to mobilise regional authorities, such as the European Commission, in order to protect their current international IP achievements. This was despite opposition to the TRIPs agreement from developing and least-developed countries, which became particularly fierce in 1999

History of Construction Cultures Volume 1

History of Construction Cultures Volume 1 contains papers presented at the 7ICCH – Seventh International Congress on Construction History, held at the Lisbon School of Architecture, Portugal, from 12 to 16 July, 2021. The conference has been organized by the Lisbon School of Architecture (FAUL), NOVA School of Social Sciences and Humanities, the Portuguese Society for Construction History Studies and the University of the Azores. The contributions cover the wide interdisciplinary spectrum of Construction History and consist on the most recent advances in theory and practical case studies analysis, following themes such as: - epistemological issues; - building actors; - building materials; - building machines, tools and equipment; - construction processes; - building services and techniques ; -structural theory and analysis ; - political, social and economic aspects; - knowledge transfer and cultural translation of construction cultures. Furthermore, papers presented at thematic sessions aim at covering important problematics, historical periods and different regions of the globe, opening new directions for Construction History research. We are what we build and how we build; thus, the study of Construction History is now more than ever at the centre of current debates as to the shape of a sustainable future for humankind. Therefore, History of Construction Cultures is a critical and indispensable work to expand our understanding of the ways in which everyday building activities have been perceived and experienced in different cultures, from ancient times to our century and all over the world

The concept of 'Genetic Modification' in a Descriptive Translation Study (DTS) of an English-Spanish corpus of Popular Science Books on Genetic Engineering: Denominative Variation, Semantic Prosody and Ideological Aspects of Translation Strategies

El objetivo general consiste en examinar el concepto de 'modificación genética' a través de tres fenómenos lingüísticos: la variación denominativa, la prosodia semántica y los aspectos ideológicos de las principales estrategias de traducción. Para estudiar la variación denominativa se han seleccionado dos términos técnicos 'DNA' y 'gene/s' y dos subtécnicos 'food/s' y 'crop/s'. Para el estudio de la prosodia semántica se han analizado las concordancias de 'genetic' + N y 'genetically'`+ Adj. La comparación de las variantes denominativas y las prosodias semánticas en un corpus paralelo inglés-español de ingenería genética arrojan resultados sobre los aspectos ideológicos de las principales estrategias de traducción encontradas en el corpus.Departamento de Filología Ingles