(2003; 82 pages)
3. 1 TRIPS and patents
Bartlelt S. Compulsory licences pursuant to TRIPS Article 31 in the light of the Doha Declaration on the TRIPS Agreement and Public Health. The Journal of World Intellectual Property, March 2003, 6(2): 283-310.
With the adoption in November 2001 of The Doha Declaration on the TRIPS Agreement and Public Health, WTO Members stressed the need for the TRIPS Agreement to be part of the wider national and international action to address problems afflicting many developing countries, such as those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics. Above all, the Doha Declaration addressed the problem that the instrument of compulsory licensing could become useless for those countries in need that have no production facilities, since Article 31 of the TRIPS Agreement requires that goods manufactured under a compulsory licence shall be "predominantly for the supply of the domestic market of the Member authorizing such use". In order to find a solution to this problem, a variety of proposals have been made, which are currently being discussed at the WTO TRIPS Council. The crucial point about implementing a solution is how far a compulsory licence for export could be subject to possible abuses, such as the re-exportation of the medicines to markets with higher prices, or the export to other countries which are not facing a public health crisis.
Bourgeois J, Burns TJ. Implementing paragraph 6 of the Doha Declaration on TRIPS and Public Health: the waiver solution. The Journal of World Intellectual Property, November 2002, 5(6): 835-864.
The magnitude of the HIV/AIDS pandemic in developing countries was not foreseen at the time of the conclusion of the TRIPS Agreement, and was one of the paramount concerns at the origin of the Doha Declaration on the TRIPS Agreement and Public Health. In paragraph 6 of that Declaration, WTO Members recognized that countries with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement. Accordingly, they instructed the WTO Council for TRIPS to find an expeditious solution to this problem and to report to the General Council before the end of 2002. In this article, the authors consider the options before the Council for TRIPS and conclude that a waiver under Article IX of the Marrakesh Agreement establishing the WTO is the most workable, transparent, sustainable and legally secure solution to the problem identified in paragraph 6, and will permit this issue to be dealt with as a matter of urgency.
Correa CM. Implications of the Doha Declaration on the TRIPS Agreement and Public Health. Geneva, WHO, Health Economics and Drugs, EDM Series No. 12, 2002.
This study analyses the antecedents and consequences of the Doha Declaration on the TRIPS Agreement and Public Health. The author highlights how the Declaration acknowledges the seriousness of public health problems faced by developing countries, such as AIDS, tuberculosis and malaria, while equally taking note of developing countries' concerns about possible implications of the TRIPS Agreement for public health in general. The report considers that the specific wording of protection of public health will be critical for future cases presented to the WTO panels and Appellate Body. The author highlights the Declaration's instruction to the governing body of the WTO to address the issue of use of compulsory licensing in countries with little or no manufacturing capacity or insufficient market demand. According to the report, critical factors for a sustainable IPP framework are, among others, a stable international legal framework, transparency and predictability of the applicable rules in the exporting and importing countries and the facilitation of a multiplicity of potential suppliers of the required medicines. The study considers that the apparent concession for an extension of the transitional period, established by Article 66.1 of the TRIPS Agreement, is deceiving as most developing countries already grant patents for pharmaceuticals. The report concludes by underlining how the Declaration acknowledged that differentiation in patent rules might be necessary to protect public health. The author considers the Declaration to be a strong political statement, which may be used by developing countries to adopt measures to ensure and improve access to health care, while recalling that, as a Ministerial Declaration, it will have legal effects both on administrators of the TRIPS Agreement and WTO bodies.
Correa CM. Protection of data submitted for the registration of pharmaceuticals. Implementing the standards of the TRIPS Agreement. Geneva, South Centre/WHO, 2002.
This report is focused on one of the most disputed patent-related issues: the protection of submitted data. As a condition for registering pharmaceutical products, national authorities normally require registrants to submit data relating to drug quality, safety and efficacy. A particularly important issue is the direct or indirect use of the data for subsequent registration of products similar to those originally registered. Article 39.3 of the TRIPS Agreement requires Members to establish protection for submitted test data. But this requirement is in fact narrowly drawn, and countries maintain substantial flexibility in its implementation. Article 39.3 does not require that protection be given to already public data. Protection is required only for new chemical entities. Members have considerable discretion in defining "new" and may exclude applications for second indications, formulations and dosage forms. The pharmaceutical industry and some countries have argued for much broader coverage of Article 39.3, and for a requirement that countries confer exclusive rights on originators of marketing approval data. However, these positions are not well grounded in either the text or negotiating history of TRIPS. TRIPS negotiators specifically considered and rejected language requiring grants of exclusive rights to test data. The author highlights the long-term implications of the so-called "TRIPS-plus" protection schemes for developing countries, illustrating the different choices that policy-makers have in order to protect the interests of the originators of data without undermining competitiveness.
Granville B. (editor). The economics of essential medicines. London, The Royal Institute of International Affairs, 2002.
This edited volume highlights the pressing issue of the availability of essential medicines in developing countries. It includes perspectives from developed and developing countries, the public and the private sector, and health service delivery, as well as R&D issues. It is noteworthy to mention that the contributors are representatives of the wide range of interested parties, such as international organizations (UNAIDS), government AIDS departments (Uganda), NGOs (Oxfam) and academic experts, guaranteeing different points of views and a combination of approaches.
Helfer L. Adjudicating copyright claims under the TRIPS Agreement: the case for a European human rights analogy. Harvard International Law Journal, Spring 1998, 39(2): 357-441.
This article focuses on the critical role played by the TRIPS Agreement within the WTO legal framework and attempts to shed light on the interpretation of WTO's dispute settlement procedures. It does so by linking them with the experience of other international and supranational courts and arbitration institutions, such as those established under the European Convention on Human Rights (ECHR). Initially, the author identifies the main weaknesses, contradictions and traits of the TRIPS regime, such as minimum standards, the relative autonomy of states/parties in its implementation or the different available approaches. The author highlights the systemic and structural similarities between the ECHR and the TRIPS Agreement that would allow for the development of a conceptual link between them which could be used by TRIPS jurists. Some of the main ECHR traits such as the nuanced legal doctrines present in the jurisprudence of the European Court or human rights issues are cited as examples of a possible common ground. The article is divided into four parts. Firstly, the author examines the TRIPS Agreement and its problems, establishing a comparison with its historical copyright predecessor, the Berne Convention. It illustrates how the lack of enforcement measures and the absence of meaningful dispute settlement procedures pushed the copyright framework into a period of crisis, accelerating the need for reform. The second part of the article is devoted to an analysis of the TRIPS Agreement, identified as the remedy for the previous crisis while being simultaneously considered as a source of new difficulties. According to the author, the link established between IPR and the WTO dispute settlement system, considered to be one of the main strengths of the new protection regime, is threatened by the danger of non-compliance by states/parties. In the third part of the article, the author identifies the methodological difficulties that TRIPS jurists might face during interpretation of the protection regime, suggesting a European human rights analogy that would take into consideration the structural similarities between the ECHR and the TRIPS Agreement and the interpretative methodologies specific to the ECHR. The fourth part of the article is devoted to the development of a comprehensive framework for TRIPS jurists to apply in international copyright disputes, particularly in connection with four types of situation: absence of national copyright laws, enforcement and copyright piracy issues, disputes about copyrightable material and minimum rights and the need to balance IPR and other societal values. The author concludes that TRIPS jurists might be ready to adopt different levels of deference to national decision makers depending on the type of dispute presented before them: ranging from no deference with those states that fail to modify their national laws to close examination of national legislatures, courts and administrative bodies in cases connected with patent holders exclusive rights. The article acknowledges the need to balance "copyright protection against other important societal values, including free expression, cultural values and human rights goals."
Panos Institute. Patents, pills and public health. Can TRIPS deliver? London, Panos Institute, December 2002.
Poverty and lack of access to health care are closely linked. Today, a third of the world's population has no means of obtaining essential medicines; a figure that rises to a half in the poorest countries of Africa and Asia. Ironically, it is in these countries that individuals have to spend the largest proportion of their incomes on health care. Many experts argue that the introduction of patent rules in developing countries will drive up the cost of medicines, especially for the complex drugs needed to treat HIV/AIDS and related illnesses. They also point out that patents prevent other companies from marketing cheaper "generic" versions of a drug, which can radically reduce prices. Supporters of patents reply that they are needed to protect drug company profits that pay for much-needed R&D of new drugs, and that inadequate public health systems, rather than the cost of medicines, are the biggest barrier to health care for the poor. This report examines the pros and cons of the TRIPS Agreement for the developing world. It outlines different ways of ensuring access to essential drugs for all, including the poorest. It also stresses the importance of ensuring a public debate in every country in order to put the issues of patenting, pills and public health under the spotlight.
TWN. TRIPS, drugs and public health: issues and proposals. Third World Network, Intellectual Property Rights Series No. 2, September 2001.
Millions of people die each year of diseases that are preventable or treatable and this health problem has reached crisis proportions in developing countries. Most patients in poor countries do not have access to the medicines they require to treat their ailments due to their high prices. These prices are set by producers who enjoy a monopolistic position over the manufacture and distribution of lifesaving drugs. Control is granted by the IPR framework, developed under the TRIPS Agreement. This report discusses the policy options permitted by the safeguards, in particular compulsory licensing and parallel importation, in order to secure access to affordable medicines. It equally makes proposals for clarifying these provisions to affirm the right of developing countries to invoke them with full flexibility. The report recommends that TRIPS rules be amended in order to ensure that the TRIPS Agreement does not represent an obstacle for those developing countries that take measures to protect public health and save human lives.
WHO. Network for monitoring the impact of globalization and TRIPS on access to medicines. Report of a meeting, Thailand, February 2001. Geneva, WHO, Health Economics and Drugs, EDM Series No. 11, 2002.
At a meeting held in Bangkok, Thailand, in February 2001, WHO, as mandated by resolution WHA52.19, initiated the process to monitor and analyse the impact of trade agreements on access to drugs in partnership with four WHO collaborating centres in Brazil, Spain, Thailand and the United Kingdom. The main emphasis of the meeting was to develop a framework of operations for a nascent network for monitoring the impact of globalization and TRIPS on access to medicines. The meeting established that the network, through the individual and collective work of the Collaborating Centres, would undertake research that shed light on four questions: How is patenting affecting drug pricing? How are patents and enhanced IPP affecting the rate of introduction of generic drugs? Are TRIPS and expanded IPP spurring development of drugs for neglected diseases? Are TRIPS and expanded IPP contributing to an increase or decrease in transfer of technology? The participants developed a harmonized model of selected indicators to be adapted according to the characteristics of different regions. These indicators are intended to offer important information, though of course not definitive answers, regarding the four questions, though they relate more to some of the questions than others (the template is included at the end of this report). This report seeks to explore one element of this stark reality: the lack of R&D into drugs to treat the diseases of the poor. When treatment options do not exist or are inadequate, a disease can be considered "neglected". The neglect is a result of market failure and public policy failure. Recent initiatives and policies seeking to redress the R&D imbalance are also outlined. Public-private partnerships (PPP) have been successful in mobilizing public and private sector expertise around certain diseases. Yet, to date, none of these provide an adequate strategy for developing drugs for the most neglected diseases. Recommendations for moving forward are presented, including the need for a well-defined and needs-driven research agenda be established at a global level.