IPR, Innovation, Human Rights and Access to Drugs - An Annotated Bibliography - Health Economics and Drugs Series No. 014
(2003; 82 pages) View the PDF document
Table of Contents
View the documentAcknowledgements
View the documentAbbreviations and acronyms
View the documentIntroduction
View the document1. General articles
Open this folder and view contents2. Country studies by region
Close this folder3. TRIPS, drugs and human rights
View the document3. 1 TRIPS and patents
View the document3.2 Research and development
View the document3.3 Human rights and access to drugs.
Open this folder and view contents4. Electronic information
View the documentOther documents in the EDM Health Economics and Drugs Series
View the documentBack cover

3.3 Human rights and access to drugs.

Cullet P. Patents and medicines: the relationship between TRIPS and the human right to health. International Affairs, January 2003, 79(1): 139-160.

The question of access to drugs in developing countries is at present largely influenced by the TRIPS Agreement. TRIPS compliance in the field of health requires substantial changes in existing patent laws in some countries. These changes must be analysed in the context of the spread of epidemics, such as HIV/AIDS, and in relation to other international obligations that states have, for instance, regarding the human right to health. IPR treaties have a significant impact on the realization of some human rights, such as the right to health. This article examines the extent to which the TRIPS Agreement encompasses flexibility for developing countries to be able to foster greater access to medicines. The article also examines these issues from the point of view of human rights and considers, in particular, how the relationship between human rights and intellectual property can be addressed in international law.

Elliot R. TRIPS & rights: international human rights law, access to medicines, and the interpretation of the WTO Agreement on Trade-Related Aspects of IPR. Montreal: Canadian HIV/AIDS Legal Network, 2001.

Acknowledging the massive impact that the interpretation and application of the TRIPS Agreement could have on millions of people around the world, this report attempts to widen the debate by examining it from a human rights perspective. It aims to set out the basis in international law for demonstrating that the binding legal obligation of states to realize human rights has general primacy in international law and that the TRIPS Agreement should therefore be interpreted in a manner consistent with this obligation. The author first examines the existence, nature and scope of states' obligation under international law to respect, protect and fulfil the right to health. The author then illustrates, by referring to the Vienna Convention on the Law of Treaties and the United Nations Charter, how state obligations under international human rights law have pre-eminence over other international law dispositions (such as trade agreements). The third part of the document is largely devoted to a discussion on how the TRIPS Agreement could be interpreted in a more flexible way and, based upon existing WTO jurisprudence and Articles 8 and 27 of the TRIPS Agreement, in a manner allowing states to satisfy their legal obligations as regards international human rights law. The author supports a major flexibility in the interpretation and implementation of the TRIPS Agreement in developing countries, recalling that if the founding treaty of the WTO states that the Organization itself and economic and trade relations are aimed to raise standards of living and sustainable development, TRIPS should therefore be interpreted accordingly. In conclusion, the report recommends that states formally recognize, within the WTO context, the primacy of their legal obligation to respect, protect and fulfil human rights, including the human right to health. As regards the interpretation of the TRIPS Agreement, the report considers that WTO's Dispute Settlement Body should prefer any reasonable interpretation of the Agreement that is consistent with state obligations under international human rights law. Finally, the report suggests that the TRIPS Agreement be amended in order to include express reference to state obligations under international human rights law, and that a clause be included recognizing the non-binding nature of any obligation under the Agreement that would require a state to act in breach of its obligations under international human rights law.

Evans T. A human right to health? Third World Quarterly, 2002, 23(2): 197-215.

A right to health is one of a range of socio-economic rights for which states accept an obligation under international law. However, the politics of rights has meant that socio-economic rights are rarely given the same status as liberal freedoms associated with civil and political rights. This article discusses the liberal rationale for rejecting socio-economic claims as rights and examines the basic rights challenge to liberal arguments. Given the dominance of liberalism, the article concludes with an examination of the potential for promoting a right to health within the context of globalization.

Gathii JT. Rights, patents, markets and the global AIDS pandemic. Florida Journal of International Law, Spring 2002, 263-346.

This article seeks to provide new arguments for those initiatives which try to provide access to or increase the affordability of drugs and health services, particularly for low-income consumers affected by life-threatening diseases. According to the author, it is possible to combine a market-based approach with a human rights one. Moreover, the use of market-based arguments contributes to expanding the traditional registry of legal and social causes. To illustrate the necessary combination between market-based and other approaches, the article develops three different strategies to achieve the stated goals of access and affordability. The first strategy consists of using social and economic rights clauses in constitutional charters, as in South Africa. The author examines the obstacles and challenges of the rights-based approach characterized by this strategy, particularly in developing countries. The second strategy is derived from a market-based argument, the author attempts to establish the TRIPS consistent possibilities that are available for combining pharmaceutical producers and consumers, especially low-income ones. The article recalls how the TRIPS regime was specifically designed to offer protection both to producers and consumers of intellectual property items. In this sense, the author signals how, within the private property model of the TRIPS Agreement, there are two clashing perceptions of the notion of property: one perceives it as market commodity and the other sees it from a public policy perspective. According to the article, it is possible to combine both approaches while examining the available scope for developing countries for setting their own patent legislation. The third proposed strategy is also related to a market-based argument and is related to the US FDA framework of control which, according to the author, constitutes an important obstacle for the entry of new drugs into the market, particularly generic version of branded drugs or applications which have been approved in other countries. The article considers that the best strategy to overcome a system which was built to benefit big pharmaceutical companies would be a consumer-driven, anti-cartelist strategy to put to an end pharmaceutical industry concentration. In this sense, the author mentions the Pfizer v. India case at the US Supreme Court to show how anti-trust and trade laws can be combined. The author perceives competition in the pharmaceutical industry as one of the best ways to ensure access and affordability of drugs for low-income consumers and an effective pricing mechanism. The article concludes that any increase in IPP would have a negative impact on competition. The author finally considers the potential for market-based arguments to advance legal and social cases while demonstrating the feasibility of assimilating diverse intellectual approaches.

Heywood M. Drug access, patents and global health: " chaffed and waxed sufficient". Third World Quarterly, 2002, 23(2): 217-231.

In July 2000, the UN Committee on Economic, Social and Cultural Rights issued a General Comment on the Right to the Highest Attainable Standard of Health. In its paragraph 10, the Committee makes the following admission: "Since the adoption of the International Covenant on Civil and Political Rights and the International Covenant on Economic, Social and Cultural Rights in 1966 the world health situation has changed dramatically and the notion of health has undergone substantial changes and widened in scope. More determinants are being taken into consideration, such as resource distribution and gender differences. A wider definition of health also takes into account such socially related concerns as violence and armed conflict. Moreover, formerly unknown diseases, such as HIV and AIDS, and others that have become more widespread, such as cancer, as well as the rapid growth of the world population, have created new obstacles for the realization of the right to health which need to be taken into account when interpreting article 12". The need to understand why and how "the notion of health has undergone substantial changes and widened in scope", the forces that are contributing to this redefinition, and the implications for governments, multinational pharmaceutical companies and ordinary people is the subject of this article. In particular, global health is assessed according to the extent of global access to life improving-medicines, and the surmountable barriers that prevent this.

Joseph S. Pharmaceutical corporations and access to drugs: the "fourth wave" of corporate human rights scrutiny. Human Rights Quarterly, 2003, 25, 425-452.

Access to essential medicines is a human right which is currently compromised by the high prices charged by pharmaceutical corporations, which are facilitated by the global protection afforded to pharmaceutical patents by TRIPS. However, pharmaceutical patents are arguably justified as they promote R&D in the industry. The arguments for and against patents are examined in this article, along with the salient human rights duties of pharmaceutical companies and governments, as well as recent victories in the battle for access to essential drugs in the developing world. Alternative strategies for facilitating access to essential medicines, without compromising R&D, are put forward.

OHCHR/UNAIDS. HIV/AIDS and human rights. International guidelines. Geneva, United Nations, 1998.

This is a joint effort by the Joint United Nations Programme on HIV/AIDS and the Office of the United Nations High Commissioner for Human Rights to address and provide assistance to states, NGOs and individuals on human rights issues affecting HIV-positive people, such as discrimination, education or access to drugs. Through 12 clearly formulated guidelines it offers guidance on how to respond to the human rights implications of the AIDS pandemic. Of special significance is Guideline 6 (Regulation of Goods, services and information) which refers to legal and economic obstacles to access to drugs and the necessity to overcome them. This guideline was the object of a specific debate during the Third Consultation on HIV/AIDS and Human Rights (Geneva, July 2002) where it was reformulated into access to prevention, treatment, care and support as a step forward in linking human rights and access to drugs.

Toebes B. The right to health as a human right in international law. Ed. Antwerp, Intersentia, 1999.

This book identifies one of the main obstacles to the enforceability of the right to health as its vague formulation and lack of clarity about its real content. Even though the human right to health is present in almost all major international human rights treaties, it has not been clearly established what individuals can expect or what states are obliged to provide for according to those treaties. The author analyses the current implementation practices by treaty monitoring bodies by providing an in depth evaluation of reporting dynamics. Interestingly, the book pays attention to justiciability issue through a detailed description of international and national case law by judicial and quasi judicial bodies. On the basis of these findings, the author finally outlines the content of the right to health, describing at the same time the resulting obligations on the part of states.

Walker S. The implication of TRIPS: ethics, health and human rights. Journal of Human Development, 1 January 2001, 2, 109-114.

According to this article, it is only recently that intellectual property is being addressed from a human rights perspective. Yet, the human right to the protection of intellectual property dates back 50 years to the basic human rights text - the Declaration on Human Rights of 1948. This right was included under Article 15 of the International Covenant on Economic, Social and Cultural Rights. The monitoring committee of the Covenant recently began to examine this article as a means of exploring the human rights dimensions of the protection of intellectual property. In order to speak about the human rights implications of IPP of pharmaceuticals, it is necessary to focus on the question of access to HIV treatments. This article develops the three most important questions: why access to anti-HIV treatment should be considered as a human rights issue; what would define a human rights approach to the IPP framework; and can IPP be considered as consistent with state obligations established under international human rights law.

WHO. 25 questions & answers on health and human rights. Geneva, WHO Health & Human Rights Publication Series, Issue No.1, July 2002.

This is the first issue of a WHO series specifically focused on a rights-based approach to health topics. This publication seeks to clarify some key concepts and notions critical for a better understanding of the right to health and its implications for policy makers, health workers and patients alike. What are human rights and how health care can be effectively framed within them is one of the questions that find an answer in this publication, which is intended to be used as an education tool and an advocacy resource. It offers brief, concise explanations about each concept providing a non-specialized reader with a comprehensive view of what is implied by a rights-based approach to health. It represents a clear sign of WHO's commitment to the promotion of the human right to health, understood as a fundamental and universal human right.

Wojahn PL. A conflict of rights: intellectual property under TRIPS, the right to health and AIDS drugs. UCLA Journal of International Law and Foreign Affairs, Fall-Winter 2001-2002, 463-497.

Modelled on the intellectual property laws of the United States of America, the TRIPS Agreement established global standards for stringent protection of patents for new pharmaceutical developments. Stringent IPR, however, are in direct conflict with the international right to health, established by the International Covenant on Economic, Social and Cultural Rights, ratified by over 130 countries. The Covenant specifically states that the right to health requires states-parties to take the necessary steps for the "prevention, treatment and control of epidemic, endemic, occupational and other diseases" and "the creation of conditions which would assure to all medical service and medical attention in the event of sickness". Strict protection of IPR raises the price of pharmaceuticals, blocking access to these drugs for many people in developing countries who need them to survive. Certain provisions of the TRIPS Agreement, however, allow countries, in cases of national emergency, to permit private manufacturers to produce generics, subject to certain conditions, through compulsory licensing. In addition, countries can use parallel importation or importation of competing, generic goods from other countries, to provide cheaper access to life-saving drugs. Although there are many uncertainties in TRIPS relating to when and under what conditions compulsory licensing and parallel importation are permitted, the whole framework can be interpreted to allow these strategies in order to provide greater access to, for instance, antiretroviral drugs. This article explores an interpretation of TRIPS which would comply with the right to health, while examining whether the exceptions to strict IPP will adequately address the need of developing countries to provide the medical resources required by the right to health.


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