(2003; 82 pages)
1. General articles
Abbott FA. First report (final) to the Committee on International Trade Law of the International Law Association on the subject of parallel importation. Journal of International Economic Law, winter 1998, 607-636.
This report approaches the exhaustion/parallel imports question in broad economic terms, asking whether there may be an economic and social welfare benefit to permitting holders of intellectual property rights (IPR) to block parallel imports that outweighs the potential harm to liberalized trade. It addresses each major form of IPR separately and concludes with respect to each form that the evidence of benefits that might flow from allowing parallel imports to be blocked is insufficient to justify the potential inhibition of trade. The report observes that most objectives that holders of IPR seek to achieve by the allocation of geographical markets can be attained through less trade-restrictive means, namely through the vertical allocation of distribution territories by contract. The interests of the developing countries are a focus of the report, which concludes that developing and developed countries are better served by open markets and the operation of comparative advantage. The report recommends that the WTO adopt a rule precluding governments from blocking parallel imports except in certain exceptional cases.
Bala K, Lanza O, Kaur SR. Retail drug prices: the law of the jungle. HAI News, April 1998, 1-16.
The retail prices of 21 commonly used drugs were collected in 39 countries, analysed, and the results are presented in this report. The authors assert that there are wide and indiscriminate variations in retail drug prices among developing and developed countries, with retail prices even higher for some drugs in least developed countries than in countries of the Organization for Economic Co-operation and Development (OECD). For example, the retail prices of 10 out of 13 commonly used drugs for which comparable data are available are more expensive in Tanzania than in Canada. In India, 100 tablets of Zinetac cost US$ 2 while, in Chile, 100 tablets of Zantac cost as much as US$ 196, the report states. The authors conclude that international price discrimination is a characteristic feature of the pharmaceutical world market. Policy measures should be implemented to make low-priced drugs freely available in all countries. Generic prescribing or substitution and parallel imports are two policy measures which, according to the authors, will allow consumers easy access to low-priced, quality drugs.
Bala K, Sagoo K. Patents and prices. HAI News, April-May 2000, 1-9.
This report is the result of a survey on the retail prices of 16 drugs at the leading retail pharmacy in 36 capital cities in July/August 1999. The authors claim that there are wide variations in retail prices between countries, ranging from 1:4 to 1:59. Multinational drug firms marketed their proprietary brands at widely different prices in different developing countries while the retail prices of generic equivalents did not show these very wide variations. Moreover, the average retail prices of some of the proprietary drugs are higher in the developing countries in Africa or Latin America compared to much more affluent OECD countries. The authors conclude that compulsory licensing and parallel imports are two provisions that should be in all national legislation on IPR.
Balasubramaniam K. Heads-TNCs win: tails-South loses or The GATT/WTO/TRIPS Agreement. Penang, Consumers International, Regional Office for Asia and the Pacific, April 1998.
The WTO TRIPS Agreement has a far-reaching impact on consumer health. This report warns that pharmaceutical and biotechnology industries have taken away the power of economic decision-making from national governments, which in turn will have a significant impact on people's health. It starts by describing the evolution of the TRIPS Agreement. The author then shows the possible impact of this Agreement on the pharmaceutical sector in developing countries. He asserts that developing countries will face considerable cost in terms of higher prices and payment of profits and royalties abroad. The poor's accessibility to essential drugs will be drastically reduced. Several strategies are suggested for developing countries to mitigate the negative impacts of TRIPS, including the provisions related to the principle of exhaustion of rights, compulsory licensing and the transitional period. Moreover, the author urges WTO to carry out a study on the impact of the TRIPS Agreement on transfer and diffusion of technology, foreign direct investment, R&D capabilities and drug prices in developing countries.
Bale HE. Patent protection and pharmaceutical innovation. New York University Journal of International Law and Politics, 1997, 29(1/2): 95-107.
This paper discusses briefly the major issues with respect to developing countries. The author insists on how pharmaceutical innovation is dependent on patent protection and on the benefits for the local industry and consumers, in terms of prices and of new drugs put on the market. Finally, the author regrets that the TRIPS transition provisions allow countries such as Argentina, India and the Republic of Korea "an unfortunate grace period, allowing them to exploit consumers".
Bale HE. The conflicts between parallel trade and product access and innovation: the case of pharmaceuticals. Journal of International Economic Law, winter 1998, 637-653.
In this paper, the case is laid out for restricting parallel trade in products protected by IPR, and pharmaceuticals in particular. The paper responds to three arguments made in favour of open parallel trade. First, it is argued that in the case of patented products with high fixed costs, such as pharmaceuticals, parallel trade may decrease global economic welfare. Attention is drawn to price controls within the Member States of the European Union (EU) as a distortion which is inconsistent with open market principles. Second, it is suggested that rules restricting parallel trade are a necessary corollary to pharmaceutical price discrimination in favour of developing countries. Finally, the paper indicates that restrictions on parallel trade in the pharmaceutical sector are necessary to protect the public against risks arising from inadequate supervision of the secondary market, such as risks from inappropriate repackaging, inadequate storage and handling procedures and counterfeit products.
Benkimoun P. Morts sans ordonnance. Paris, Hachette, 2002
This book seizes the struggle to improve and enlarge access to drugs in developing countries. The author identifies the actors, issues and interests that influence this process; their agendas, declared goals and hidden targets are presented as logical components of a market-driven humanitarian crisis. The WTO-sponsored TRIPS regime is singled out as one of the main obstacles to guaranteeing access to drugs at affordable prices where they are most needed. The author also refers extensively to the role played by the pharmaceutical industry and the type of strategies used in their desperate attempt to defend their monopolistic prerogatives and huge profits. The author accompanies the civil society movement (comprising, among others, NGOs, health professionals and grass root movements) that, both in industrialized and developing countries, has set up alliances and networks to defend the principle that human dignity and health should come before private interests and profits. This is a long battle, where small victories and painful setbacks do not count as much as the passing time with its deadly toll for those who might not be able to wait for much longer.
Braverman M, Holsomback T. Patent and trademark infringement involving generic drugs and medical devices - the potential liability impact on pharmacists. Journal of the Patent and Trademark Office Society, 1992, 74(1): 51-65.
The use of generic formularies, medical devices and unit-dose packaging often presents hospital pharmacies with potential infringement liability. In the USA, pharmacists can be held liable for patent infringement if they participate in "making, using, selling" an unpatented copy of a brand-name or medication or a medical device already protected by a patent. Selected patent and trademark infringements are discussed with regard to their impact on the practice of pharmacy. A variety of legal cases are cited and used as examples to evaluate the impact of patent and trademark infringement on hospital pharmacists in particular.
Bulard M. Les firmes organisent l'apartheid sanitaire. Le Monde Diplomatique, January 2000.
This article explores the issue of limited access to essential drugs, by providing various examples in the developing world. Inadequate R&D, and discontinued manufacturing of specific tropical medicines due to financial disincentives, are two of the many examples given. The author states that patent protection and international trade agreements can be seen as the tools of the pharmaceutical industry, so denying basic human needs by putting necessary treatment beyond the reach of the poor.
Challu PM. Adaptation of national legislation to the TRIPS Agreement of GATT's Uruguay Round, aimed at assuring inhabitants best accessibility to pharmaceuticals. Buenos Aires, Centro Industrial de Laboratorios Farmacéuticos Argentinos, 1995.
The TRIPS Agreement sets out with precision some of the obligations undertaken by WTO Members, while other obligations are subject to diverse interpretation frames and degrees of freedom. This opens up the possibility of analysing the best way to draw up laws that the countries must enact to fulfil the commitments undertaken in the Uruguay Round, so that they comply with the requirements of health and social policies. The author outlines the balance of objectives and interests within the TRIPS Agreement, which can be found in the preamble and general principles. This balance makes it possible to establish local rules that take into account the need to guarantee people the best possible access to drugs. The article therefore analyses the potentialities in the Agreement to minimize the monopoly conferred by a patent in order to improve the supply of and access to pharmaceutical products: exceptions to exclusive rights, increased supply through importation, compulsory licences, reaction to anti-competitive practices in licence contracts and transitional periods.
Challu PM. The consequences of pharmaceutical product patenting. World Competition, 1991, 15(2): 65-126.
This study presents the results of research based on historical statistical series. The results shed light on the various effects of a patent system. The first part analyses the benefits attributed to patenting pharmaceutical products and shows that patent protection is rather a reflection of the degree of economic development that a country has already achieved. The second part assesses the welfare loss experienced by consumers due to monopoly prices of patented drugs, and also the public cost, or the amount that must be spent by the public sector to maintain pharmaceutical consumption at a level equal to that which would occur in a fully competitive market. Finally, the study evaluates the costs that would be imposed on Argentina in order to adopt a product patent system.
CIPR. Integrating intellectual property rights and development policy. London, Commission on Intellectual Property Rights, September 2002.
This report is the result of the work of the ad hoc Commission on Intellectual Property Rights, created in May 2001 by the UK Department of International Development. It addresses a number of issues related to IPR and their impact on development in a variety of fields: health, agriculture, traditional knowledge, new technologies and patent reform. The Commission acknowledged the recent increase in the submission of patents, expressing concern about the low quality and broad scope of many of them. The Commission had set itself the fundamental task of considering whether the rules and institutions of intellectual property protection (IPP) can contribute to development and the reduction of poverty in developing countries. According to the report, the impact of IPP in developed countries also affects developing countries as, for example, most of the research on diseases that affect developing countries is conducted in developed ones. While accepting that the IPP system does provide incentives for research and innovation, the Commission noted that these incentives have different impacts depending on the economic and social circumstances of the country where they are being applied. It considers IPR as a public policy instrument which should be translated into a means for the promotion of human economic and social rights. The Commission stressed that under no circumstances should fundamental human rights be subordinate to the requirements of IPP. In this context, the report considered that a further extension of IPR should take into consideration the weaker position of developing countries and the need to explore how these countries could adapt their domestic IPP systems to their own conditions. The Commission concluded that IPP is not the only factor that affects poor people's access to health care but it can play a very negative role. Among the policies that both developed and developing countries can adopt to promote cheaper prices for medicines without adversely affecting the incentives for research on relevant diseases, the Report recommends the compulsory licensing mechanism while observing that, to date, the IPP system has done little to stimulate research on diseases that particularly affect poor people in developing countries.
Correa CM. Implementing the TRIPS Agreement: general context and implications for developing countries. Paper presented at a Seminar on Some Current Issues in the WTO, Geneva, 2 October 1997.
This is a background paper on the TRIPS Agreement that presents the context of, and reasons for, its negotiation, the issues at stake, and the North and South asymmetries with regard to IPR. The paper presents the main provisions of the Agreement regarding all kinds of IPR and concludes by discussing the implications for developing countries.
Correa CM. Implementing the TRIPS Agreement in the patents field: options for developing countries. The Journal of World Intellectual Property, 1998, 1(1): 75-100.
This article shows that, with respect to the specific area of patents, the TRIPS Agreement does not constitute a uniform law. It provides a number of minimum standards that will substantially increase the degree of harmonization in IPP, but it leaves considerable scope for national laws to define a number of important aspects. The room for manoeuvre left by the Agreement derives, in some cases, from the wording of its provisions, such as Articles 30 and 31, and in other cases from the absence of any specific rule. The author argues that developing countries can opt for a number of approaches aimed at fostering access to technology and promotion of innovation at national level in a way that is fully consistent with the TRIPS Agreement.
Correa CM. Integrating public health concerns into patent legislation in developing countries. Geneva, South Centre, June 2000.
Developing countries today face the complex challenge of implementing various international agreements, including the TRIPS Agreement. This document was prepared to assist them in adapting their laws to the standards set by TRIPS in relation to pharmaceutical products and processes, as such legislative reform can have a major impact on people's access to drugs and on public health policies. It includes chapters on patentable subject matter, scope of claims, patentability requirements, disclosure of the invention, exceptions to exclusive rights, examination and observation procedures, claim interpretation, and compulsory licensing. A model of legal options is presented in each chapter to provide elements for national legislation based on the existing Agreement provisions. According to the author, all the issues presented are important for the design of a public health sensitive patent law, but priority should be given to: (1) those relating to the patentable subject matter and the treatment of the specific cases concerning pharmaceuticals, (2) the crafting of exceptions to patents rights, especially for experimentation and early working, and (3) the development of a sound compulsory licensing system. The author asserts that national laws dealing appropriately with these issues would be an important step forward.
Correa CM. Intellectual property rights and foreign direct investment. International Journal of Technology Management (special issue on the management of international intellectual property), 1995, 10(2/3): 173-199.
This paper discusses the relationship between foreign direct investment and IPR. It aims to provide an analytical framework with which to understand this relationship and to deal with it. The multiple variables that affect the relationship, the industries involved and the degree of development of countries are considered first. The main developments at that time in national legislations and within WIPO, UPOV and GATT are outlined with regard to strategies and decisions for foreign direct investment. An analytical framework is then presented and the significant differences it exposes when applied to different types of intellectual property are exemplified by case studies.
Correa CM. Intellectual property rights, the WTO and developing countries: the TRIPS Agreement and policy options. London and New York, Zed Books Ltd., and Penang, Third World Network, 2000.
There are many minimum standards with which the countries that signed the TRIPS Agreement are obliged to comply. This book is the result of research undertaken by the author to explore the implications of the TRIPS Agreement, focusing on developing countries. It explores the possible room for manoeuvre these countries have at national level. Some aspects relating to the incorporation of the Agreement's provisions into national laws are also covered. The book looks at interpretation and implementation problems that have arisen. It presents some of these problems in the implementation process faced by developing countries, particularly in Latin American and the Caribbean. Finally, issues relating to the possible revision of the TRIPS Agreement and the revision of its implementation are described and discussed. An annex includes a report, (updated and revised by an Expert Group on the TRIPS Agreement and Developing Countries), on the options for implementing the TRIPS Agreement in developing countries.
Correa CM. Protection and promotion of traditional medicine. Implications for public health in developing countries. Geneva, South Centre, 2002.
This study highlights the value of traditional medicine (TRM) in developing countries while describing how it might be affected by the implementation of, among other things, the TRIPS Agreement. The author first identifies some characteristics of TRM relevant to IPP issues. He then considers the rationale behind the need for protection of TRM under IPR (either existing or to be created). Thirdly, he discusses the extent to which existing modes of IPR (notably patents, trade secrets, trademarks and geographical indications) may be applied to TRM. Particular emphasis is given to the discussion of patents, with the other forms of IPR being analysed more briefly. Fourthly, the study presents those policy options available for the protection and promotion of TRM in the broader context of health policy. Finally, the author raises the issue of IPR protection of TRM within the framework of public health policy, considering that "policies on TRM should aim at balancing considerations of equity and public health", protecting and rewarding knowledge without reducing access to TRM for those most in need.
Correa CM. The GATT Agreement on Trade-Related Aspects of Intellectual Property Rights: new standards for patent protection. European Intellectual Property Review, 1994, 16(8): 327-335.
The TRIPS Agreement is perhaps the most far-reaching international instrument ever adopted on IPR. This article analyses the main provisions of the TRIPS Agreement in the area of patents. Its purpose is to provide a preliminary interpretation of the most relevant aspects of the text, namely new patentable fields of technology, criteria of patentability, the non-discrimination clause, rights conferred and exceptions, conditions for patent applications, compulsory licensing, reversal of the burden of proof and transitional arrangements.
Correa CM. The Uruguay Round and drugs. WHO Task Force on Health Economics. Geneva, World Health Organization, 1997 (unpublished document WHO/TFHE/97.1).
The aim of this study is to examine the possible effects of the TRIPS Agreement on the development, production and marketing of drugs, as well as access to them. The author reviews the areas of intellectual property that are the most relevant to the pharmaceutical sector, namely patents and "confidential information" (trade secret). The provisions on transitional periods and on the mechanism for the settlement of disputes are also analysed. The last part of the study reviews the possible implications of the Agreement for innovation, foreign direct investment and the price of drugs. The analysis focuses on the effect of the new intellectual property rules in developing countries.
Correa CM. Trends in drug patenting. Case studies. Buenos Aires, Ed. Corregidor, 2001.
This study focuses on the shortcomings that cast doubt on the use of patents as a tool to protect innovation. The author highlights the low standards being applied to notions such as non-obviousness and usefulness in the examination and granting of patents, particularly in the field of drugs. It examines 9 specific cases: Paroxetine, Amlodipine, Alendronate, Clarithromycin, Omeprazole, Fluconazole, Ofloxacin, Fexodenadine and Recombinant Erythropoietin. On the basis of objective technical considerations, this analysis illustrate types of patenting that potentially divert patents from their real purpose of encouraging and providing reward to genuinely inventive efforts, while negatively affecting early access to cheaper alternative products for the public. The selected drugs represent a broad range of products whose value as medicines differs. Their common trait is the use of the occasionally excessive flexibility of the patent system to set up barriers to legitimate competition. Finally, as regards the issue of R&D of new drugs and its relation to patents, the author concludes that "a substantial part of the R&D budget that pharmaceutical firms claim is devoted to the development of new products is, in reality, allocated to developing a vast array of patents around existing products, with the clear intent of expanding and/or extending over time the exercise of exclusive rights."
Cosbey A. The sustainable development effects of the WTO TRIPS Agreement: a focus on developing countries. Proceedings of the Second Annual Sustainable Development Conference, Islamabad, Pakistan, 4-10 August 1996. Winnipeg, Canada, International Institute for Sustainable Development, 1996.
This paper examines the TRIPS Agreement and tries to analyse those areas in which the Agreement will impact, either positively or negatively, on sustainable development in developing countries. After brief introductions to the Agreement itself, and to the concept of IPR, the paper turns to examining the possible effects of the Agreement, focusing on agriculture and biodiversity, pharmaceuticals and copyrighted goods. It ends by proposing a number of policy actions which contribute to sustainable development in the context of the Agreement.
Csizer Z. Opportunities and risks to develop domestic pharmaceutical industry in Asia-Pacific developing countries. Paper presented at the UNCTAD Workshop on Expansion of Trading Opportunities for Asia-Pacific Developing Countries, Subic Bay, Philippines, 15-17 November 1995.
This paper provides an analysis of the challenges to the pharmaceutical industry such as the increase in R&D costs and competition from generic manufacturers. It also studies the implications of the Uruguay Round Agreements for the local pharmaceutical industry, in particular the TRIPS Agreement and its consequences in Argentina, Brazil, India and the United States of America.
Health Action International. Power, patents and pills: an examination of GATT/WTO and essential drugs policies. Seminar report, HAI-Europe, 1997.
This report by Health Action International (HAI) contains a brief description of the GATT and the WTO, their history and development, and the main provisions of the new trade agreements. The position of the consumer movement is presented, emphasizing the influence of the pharmaceutical industry lobbies on the establishment of development costs of pharmaceutical products. WHO's view on the WTO Agreement on Technical Barriers to Trade (TBT) and the TRIPS Agreement is set out. There is a description of the work of the WTO and its position in the pharmaceutical field. Finally, the view of an NGO is presented, stressing the unjustified advantage that the TRIPS Agreement gives to multinational corporations at the expense of developing countries and of public health.
Heath C. Parallel imports and international trade. International Review of Industrial Property and Copyright Law (IIC), 1997, 28(5): 623-632.
The courts in two industrialized countries, England and Japan, have recently confirmed the lawfulness of parallel importation of patented products in the absence of any indication to the contrary. Continental law follows a different philosophy and assumes absolute limits of IPR within the principle of exhaustion of rights. However, applying the principle of international exhaustion has sometimes been objected to by invoking the principle of "territoriality of patents" of the Paris Convention. The author analyses the parallel import provision of the TRIPS Agreement which, he recalls, is meant to remove trade barriers and to ensure a balance of rights and obligations. However, the author argues for harmonization on this matter as a conclusion.
ICDA. An alternative report on trade: an NGO perspective on international trade. Brussels, International Coalition for Development Action, February 1995.
The Uruguay Round deals that were finalized in 1994 include the little known (at that time) general Agreement on TRIPS. While representatives of big companies were sitting at the drafting table, little account was taken of the consequences of increased prices for medicines in the South. A preliminary assessment points to a negative outcome.
IFPMA. GATT/TRIPS and the pharmaceutical industry: a review. Geneva, International Federation of Pharmaceutical Manufacturers Associations, 1995.
This publication presents the view of the International Federation of Pharmaceutical Manufacturers Associations (IFPMA) on the TRIPS Agreement. It covers developments concerned with the general provisions, the rules relating to patents, the means of ensuring respect for IPR, the settlement of disputes and the transitional provisions.
IFPMA. The question of patents: the key to medical progress and industrial development. Geneva, International Federation of Pharmaceutical Manufacturers Associations, 1998.
This publication sets out to discuss many of the issues raised in discussions of patent issues. According to the authors, pharmaceutical patent protection brings a number of economic benefits: it is an indispensable element of economic development and growth; it encourages local inventors to disclose and commercialize their inventions; it improves a country's credibility and recognition as a dependable supplier; and it is an essential element in the provision of more cost-effective health care. Moreover, strong IPP is particularly important for pharmaceutical products, owing to their unique characteristics. The paper then discusses the "reality" of patent protection for pharmaceuticals in response to the fears and doubts expressed with regard to monopolistic price increases, foreign direct investment and the demise of the local pharmaceutical industry. Finally, an entire chapter is dedicated to the "long, expensive and painstaking journey" involved in the development of a new drug.
Institut Universitaire d'études du développement. Propriété Intellectuelle. Quels enjeux pour les pays en développement? Accord TRIPS - Brevetabilité du vivant - Accès aux médicaments et brevets. Dossier de l'Annuaire Suisse-Tiers Monde 1998. Geneva, Institut Universitaire d'études du développement, July 1999.
In this report, the authors focus on the question of IPP after the TRIPS Agreement was concluded in the framework of the Uruguay Round. What are the concerns of developing countries regarding this Agreement? The more advanced developing countries are afraid of increasing prices of products protected by patents - such as medicines - which they can produce by reverse engineering. Most of the developing countries are worried about the necessity to protect plant varieties with a patent or an efficient sui generis system and about the effects of such an obligation on their indigenous populations. The least developed countries are especially preoccupied by the new legislation they have to adopt and by the institutions they have to create or develop according to the terms of the Agreement. This report explores these problems, beginning with the articles analysing the potential effects of the TRIPS Agreement on developing countries.
Keayla BK. TRIPS Agreement on patent laws: impact on pharmaceuticals and health for all. Paper presented at the International Conference on Global Health Laws, New Delhi, India, 5-7 December 1997.
The Indian pharmaceutical industry made excellent progress within the framework of the 1970 patent law, as is evident from process research and production data. This paper deals extensively with the comparative analysis of the existing and the new patent system and the safeguards which have to be provided in the public interest to accomplish the goals of "health for all". The first part introduces the basic elements of the patent system and its history. The second part offers a picture of the global and of the Indian pharmaceutical market. Then, after a very detailed presentation of the framework of the TRIPS Agreement, the author demonstrates that this Agreement is indeed an extreme compromise of public interest and assesses what may be the impact on the availability of pharmaceutical products. He concludes with recommendations on the approach developing countries should adopt.
Kinnon C. WTO: what's in it for WHO? WHO Task Force on Health Economics. Geneva, World Health Organization, 1995 (unpublished document WHO/TFHE/95.5).
The WTO TBT Agreement is designed specifically to encourage application to traded goods of internationally agreed standards, including WHO's quality standards for pharmaceutical, biological and food products. The Agreement on Sanitary and Phytosanitary Measures (SPS) sets out to harmonize national measures to protect human, animal and plant life or health, stipulating application of the food quality standards drawn up by the WHO/FAO Codex Alimentarius Commission. By virtue of the General Agreement on Trade in Services, Members may open up their domestic market to foreign suppliers of hospital and medical services; and the TRIPS Agreement raises concerns about the continued accessibility of adequate drug supplies at reasonable cost in developing countries. Public health personnel may not always be provided with adequate information on an area that is not directly related to their work. With this in mind, this paper reviews the several agreements within the Final Act of the GATT Uruguay Round, which have implications for WHO's work, outlining their purpose, main provisions and obligations, with particular reference to developing countries. In each case, information is given on the WHO activity involved, pinpointing what is already being done to protect health, and, in some cases, how public health work can facilitate trade relations.
Kolker PL. Patents in the pharmaceutical industry. Patent World, January 1997, 34-37.
The pharmaceutical industry claims that patent protection of inventions is crucial and that healthcare innovation is indeed totally dependent on patents. This article considers why pharmaceutical R&D relies so much on patents, what constitutes effective patent protection for that industry and how the patent system might develop in the future, particularly in Europe.
Labonte R. World trade and investment agreements: implications for public health. Canadian Journal of Public Health, 1998, 89(1): 10-12.
Globalization puts pressure on governments' abilities to regulate taxes on wealth and labour, and on cultural and environmental as well as public health standards. Who will benefit from these new agreements? The need for a social clause campaign is growing.
Lobo F, Velázquez G. eds. Medicines and the new economic environment. Papers presented at the seminar on Social Studies on Health and Medicines, Madrid, 29-31 March 1995. Madrid, Civitas and World Health Organization, 1998.
This book incorporates all the papers presented in the Seminar on Social Studies on Health and Medicines held at the Universidad Carlos III, Madrid from 29 to 31 March 1995. Experts in health economics, medicines and from the pharmaceutical industry gave presentations and discussed the effects on health services of the new economic environment and of the changing situation in the international economy and the pharmaceutical markets. The book covers the role of the state and the reform of health care systems, together with the implications for medicines, drug regulation and changes in the structure of the pharmaceutical industry.
Love J. L'Europe et les Etats-Unis prolongent l'apartheid sanitaire. Le Monde Diplomatique, March 2003, 28-29.
According to the author, despite the promise made by the WTO in 2001 in Doha, Northern pharmaceutical companies and wealthy Western nations are still preventing Southern countries from accessing desperately needed drugs at an affordable price; wealthy countries such as Canada, the countries of the European Union, Japan and the USA, want to backtrack on the Doha Declaration on the TRIPS Agreement and Public Health of November 2001 and US intransigence scuttled last-minute WTO talks in Geneva in December 2002. The author says that the argument is about the right of countries to provide health care by overriding drug patents. Wealthy countries, which have a virtual monopoly on drug patents, compiled a list of suitable diseases: AIDS, tuberculosis, malaria and a few mainly tropical ailments of little commercial interest. They were trying to apply the Doha Declaration only to these diseases with no provision for cancer, diabetes or asthma. Paragraph 6 of the Doha Declaration called on the WTO Council for TRIPS to resolve restrictions on drug exports. When a country issues a compulsory licence for a patent, any generic copies made by local companies are assumed to be primarily for the domestic market. However, the author asks if countries manufacturing generic drugs cannot export them, how can a country without a domestic pharmaceutical industry acquire generic drugs? The author concludes by saying that the Doha Declaration was a good-faith effort aimed at removing the main legal barriers preventing developing countries from achieving universal access to medical care. However, since November 2001, it has been sabotaged by the world's wealthiest countries, best-off in living standards and health care facilities.
Mann J, Gostin LO, Gruskin S, Brennan T, Lazzarini Z, Fineberg H. Health and human rights. Health and Human Rights, Fall 1994, 1(1): 6-23.
Health and human rights are complementary approaches for defining and advancing human well-being. This article presents a three-part provisional framework for exploring potential collaboration in health and human rights. The first relationship involves the impact (positive and negative) of health policies, programmes and practices on human rights; the goal is to negotiate an optimal balance between public health goals and human rights norms. The second relationship posits that violations of rights have important health effects, generally unrecognized, that must be described and assessed. The third and most fundamental relationship proposes that promotion and protection of health are inextricably linked to promotion and protection of human rights and dignity. The interdependence of health and human rights has substantial conceptual and practical implications. Research, teaching, field experience and advocacy are required to explore this intersection. This work can help revitalise the health field, contribute to enriching human rights thinking and practice, and offer new avenues for understanding and advancing human well-being in the modern world.
Marks D. Life beyond the patent. Managing Intellectual Property, January/ February 1994, 13-19.
All inventors and manufacturers of new pharmaceutical products want to be able to maintain their exclusive right to exploit the invention by protecting it with a patent. However, manufacturers protest that they are unable to exploit the patent until they have obtained marketing authorization, and that therefore effective patent protection is reduced to eight or nine years. This article examines three ways in which companies can apply European and national law to breathe commercial life into a product beyond the patent term: patent term extension through Supplementary Protection Certificates, marketing exclusivity, and over-the-counter (OTC) switches.
Marques MB. Brazil-USA controversy on the impact of patenting in biotechnology: some relevant questions for pharmaceuticals. Science and Public Policy, June 1994, 165-172.
This study tries to identify some of the most relevant determinants and constraints that could, in a medium-term perspective, influence the diffusion of biomedical innovations in the health sector in Brazil. The controversy over IPR in biotechnology between Brazil and the USA is discussed at length, with the main arguments used, negotiation strategies and their legal challenges described. The author concludes that current harmonization trends in IPR do not discriminate developed from developing country competitors, and thus may jeopardize the development of local capacity in some newly industrialized countries like Brazil. The article concludes that these trends will be detrimental in the international legal and commercial framework, and that increasing difficulties in accessing scientific and technological information are likely.
Maskus KE. Price effects and competition aspects of intellectual property rights in developing countries. 1998 World Development Report. Washington, D.C., World Bank, 1998.
This paper focuses on concerns raised about the additional market power created by stronger property rights in technology and information. It sets out the basic theory of fundamental trade-offs posed by IPR in open economies. The limited evidence available on potential price impacts of stronger protection is reviewed in three key areas: pharmaceuticals, plant varieties and software. The paper also considers the role of IPR in supporting restrictive conditions in licensing contracts. Finally, it discusses aspects of competition policy that might be used to ensure that stronger IPR promote dynamic competition rather than foster competitive abuses.
Mayne R, Drahos P. Global intellectual property rights. Oxford, Oxfam, 2002.
This book analyses the impact of the TRIPS Agreement and suggests ways in which the intellectual property system can be changed to serve development goals. It synthesizes the views of academic experts and NGOs at the cutting edge of current campaigning and debate. IPR, such as patents, can reduce access to knowledge in genetics, health, agriculture, education and information technology, particularly for people in developing countries. The authors show how the new global rules of intellectual property have been the product of the strategic behaviour of multinationals, rather than democratic dialogue. The final section of the book suggests strategies to develop more flexible standards for poor countries and to keep knowledge in the public domain.
Merz JF. Disease gene patents: overcoming unethical constraints on clinical laboratory medicine. Clinical Chemistry, 1999, 45, 324-330.
The rapidly growing number of disease gene patents - patents that claim all methods for diagnosis of a particular genetic condition - threaten the ability of physicians to provide medical care to their patients. This article discusses some of the ramifications of creating a monopoly over a medical service, assesses the implications of disease gene patents for clinical laboratories, and proposes some strategies for responding to this new phenomenon. The analysis concludes with a recommendation that the patent law be amended to require compulsory licensing of medical process patents. Indeed, according to the author, "it is time to evaluate the need for such a provision for medical process patents in light of the serious harms to the practice of medicine, and arguably, to the public health, that may result from a refusal to license".
Mezrich JL. The patentability and patent term extension of life-saving drugs: a deadly mistake. Journal of Patent and Trademark Office Society, 1992, 74(2): 77-95.
This article discusses the unique situation of drug patents with reference to R&D costs and Food and Drug Administration (FDA) testing. It critiques the aftermath of patent term extension under the US Hatch-Waxman Act and the economic behaviour of pharmaceutical manufacturers, with a focus on life-saving drugs and the AIDS crisis. The author reminds readers that the consumer was meant to be the real winner of this reform and concludes that "maybe patenting is not a good idea in the area of life- saving pharmaceuticals".
Moufang R. Methods of medical treatment under patent law. International Review of Industrial Property and Copyright Law (IIC), 1993, 24(1): 18-50.
During recent years, case law in Europe has quite frequently dealt with the interpretation of the exclusion of medical methods from patentability. This article first presents the historic roots and development of the exclusion of medical methods, from national developments to European patent law harmonization. It then examines in detail the scope and limitations of the prohibition on patenting of surgical, therapeutic and diagnostic methods.
NERA, SJ Berwin & Co, YRCR Ltd. Issues of intellectual property protection. Policy relating to generic medicines in the OECD (Chapter 18). Final report prepared for the European Commission, DG III. December 1998.
All OECD countries surveyed have a standard "baseline" harmonization of patent law, largely as a result of implementation of the obligations set out in the TRIPS Agreement. EU Member States have achieved additional harmonization of extended patent term legislation. More significant variations exist between EU Member States and other OECD jurisdictions, as well as between the non-EU OECD States, as regards the scope and operation of permitted exceptions to exclusive patent rights, where different balances have been struck between the interests of patentees and the promotion of effective generic competition. Important differences also exist between European Patent Convention Contracting States and other OECD countries in respect of the scope of patentability of second medical uses for known drug substances, or the linking of the granting of marketing authorizations to non-infringement of the patent rights of the original patentee. Finally, the report does not find a significant bearing of compulsory licensing and issues of exhaustion of IPR on the development of the generic industry.
Netherlands Ministry of Foreign Affairs. Medicines for the poor. The WTO and the developing countries. Report of a public debate held on 16 December 1999. The Hague, Netherlands Ministry of Foreign Affairs, 2000.
This publication reports on an open discussion which gathered voices from some of the main actors involved in the issue of TRIPS and access to drugs: a developed country government, academic experts, the pharmaceutical industry and the international civil society. This variety is reflected in the different points of view expressed in connection with the enforceability of patent protection rights, the use of exceptional mechanisms such as compulsory licensing and parallel importing and the funding of R&D of new drugs. Held before the November 2001 WTO Ministerial Conference in Doha, the debate does not include any reference to the Doha Declaration on the TRIPS Agreement and Public Health. It does, however, reflect shared concerns such as the need for a greater involvement of the international community in the issue or the adaptation of the TRIPS Agreement to meet the domestic realities of developed countries. Other questions raised about pharmaceutical company investment levels in R&D and how they should be compensated are currently the object of another global debate.
Nogues J. Patents and pharmaceutical drugs: understanding the pressures on developing countries. Journal of World Trade, 1990, 24(6): 81-104.
This article offers a discussion on the question of why there are pressures on developing countries for introducing and/or reinforcing patent protection for pharmaceutical drugs. It first reviews the worldwide pattern of patent policies and the pressures from industrialized countries on developing countries for modification of patent laws relating to pharmaceutical drugs in particular. It then presents evidence on the relative importance of patents for the pharmaceutical industry. It discusses changes in effective patent duration as modified by regulatory policies. It finally presents evidence on the growing importance of competition between brand-names and the generic drug industry, and the impact of this competition on drug prices. The potential size of developing country markets for patented drugs is no longer trivial.
Nogues J. Social costs and benefits of introducing patent protection for pharmaceutical drugs in developing countries. Developing Economies, 1993, 31(1): 24-53.
In the Uruguay Round, industrialized countries proposed that developing countries extend patent protection to pharmaceutical drugs. By looking at the pharmaceutical industry, this paper argues that neither side has a strong case in its favour and that more research is needed before an economically sound decision is made. The paper starts by offering a political economy discussion of why industrialized countries have reached a consensus in favour of introducing patent protection for pharmaceutical drugs. The central point of the paper is then supported by further analysis that discusses the social costs and benefits of introducing patent protection for pharmaceutical drugs in developing countries.
OECD. Directorate for Science, Technology and Industry. Tableau de bord de l'OCDE de la science, de la technologie et de l'industrie. Vers une économie fondée sur le savoir. Paris, OECD, 2001.
This report of the OECD focuses on the knowledge-based economy and its implications for different fields and domains. It acknowledges the growing importance of R&D, closely linked to the innovation capacity, in contributing to economic progress. The report notes the existing disparities in terms of R&D investments between OECD members and industrial sectors, with specific mention of private pharmaceutical companies. Particular attention is devoted to R&D in the health domain and the linkage between R&D and biotechnological patents. The report illustrates the rise in public spending on health R&D in recent years, in contrast with the decline in funds devoted to defence research. It concludes by stressing the growing partnership between private companies and universities in the field of scientific research, a partnership and collaboration which is increasingly transnational, just like the property of most inventions.
Otten A. The implications of the TRIPS Agreement for the protection of pharmaceutical inventions. Proceedings of the International Conference of Drug Regulatory Authorities, Bahrain, 10-13 November 1996. WHO Drug Information, 1997, 11(1): 12-16.
The protection of pharmaceutical inventions was one of the key issues in the Uruguay Round negotiations as a whole and perhaps the key issue in the North-South axis of negotiations. It was the last issue to be resolved. At that time, it was clear that there would be no TRIPS Agreement without a commitment to make available patent protection for pharmaceuticals for 20 years. The question therefore was: on what terms would countries' delegations accept such an obligation, in particular in regard to matters such as the exhaustion of rights, compulsory licensing, the control of anti-competitive practices, test data protection and transitional arrangements? The paper takes up each of these aspects.
Oxfam. Dare to lead: public health and company wealth. Oxford, Oxfam Briefing Paper No. 1, 2001.
This is the first in a series of papers that analyse the human development impact of transnational corporations. It reviews the role of GlaxoSmithKline, a UK-based pharmaceutical company, and outlines what Oxfam views as the three critical challenges facing this and other global pharmaceutical companies wishing to increase access to medicines. The paper states that they must ensure that changes in global IPP do not increase the price of medicines in developing countries. Secondly, companies must meet the acute need for R&D into diseases associated with poverty. Finally, the paper highlights the need to curb corporate marketing and lobbying activities when they run "counter to the public interest". Oxfam believes that if companies fail to meet these challenges they face the threat of more stringent government regulation and loss of public support.
Oxfam. Fatal side effects: medicine patents under the microscope. Oxford, Oxfam, 2001.
The document argues that with millions already unable to afford essential medicines, and public health threatened by new diseases and drug-resistant variants of old killers, WTO patent rules will further reduce access to modern medicines for the poor. The report sets out Oxfam's concerns about the way management of the international trading system puts corporate interests before poverty reduction. It describes the health crisis in developing countries, before examining what Oxfam believes are the likely adverse effects of WTO patent rules on drug prices and on local pharmaceutical industries. The authors discuss the role of the government in filling the gaps in pharmaceutical research and increasing health sector support. The document concludes with a series of recommendations, focusing on TRIPS reform, and on the need for rich countries and transnational companies to stop pressuring developing countries on patent issues.
Oxfam. Formula for fairness: patient rights before patent rights. Oxford, Oxfam Company Briefing Paper No. 2, 2001.
Pfizer is the largest and most profitable multinational pharmaceutical company and, as such, is analysed in this Oxfam report, taking into consideration its position on TRIPS, generic licences and lobbying within the framework of corporate accountability and social responsibility. According to the report, Pfizer (the market value of which is larger than the combined national incomes of the eighteen biggest economies in sub-Saharan Africa) has not shown much flexibility on pricing and patent enforcement in poor countries. With regard to generics, its policy seems to be not to issue licences to generic manufacturers, the result being high priced drugs to which people in developing countries have no access. Pfizer had strongly lobbied the US Government to put intellectual property on the trade agenda and for the adoption of the TRIPS Agreement. It has, in addition, encouraged the US administration to take unilateral economic sanctions against those countries that it believes offer inadequate patent protection. The report issues some recommendations for the Pfizer management team in order to adopt a more constructive leadership role. Among other suggestions, it invites Pfizer to acknowledge that the price of life-saving medicines in developing countries is linked to patents and TRIPS and encourages it too participate in research programmes aimed at diseases that affect poor countries by contributing to the proposed global research fund.
Oxfam. Patent injustice: how world trade rules threaten the health of poor people. Oxford, Oxfam, 2001.
In this paper Oxfam argues that by restricting the right of governments to allow the production, marketing and importation of generic drugs, WTO rules will restrict competition, increase prices and further reduce the already limited access of poor populations to vital medicines. The paper states that the implementation of WTO patent rules is taking place against the backdrop of a sustained campaign led by the pharmaceutical industry. Oxfam believes this campaign may well erode the public health protection offered by safeguard provisions in patent legislation, such as compulsory licensing and parallel imports. The document looks at the role of public-private initiatives in making medicines more widely available. It argues that the main problem with them is that drugs are often offered in limited quantities, and at prices which compare unfavourably with generic-equivalent products. The authors make eight recommendations for immediate action to improve access to medicines.
Oxfam. US bullying on drug patents: one year after Doha. Oxford, Oxfam Briefing Paper N° 33, November 2002.
According to this Oxfam report, forty million people currently live with HIV/AIDS around the world and fourteen million people are dying each year of preventable infectious diseases, mostly women and children from developing countries. WTO patent rules, set out in the TRIPS Agreement, are acknowledged as further restricting poor people's access to life-saving medicines by raising their price. Yet the US Government's bilateral policy seeks even higher standards of patent protection for medicines. Oxfam commissioned a review of the US Government's bilateral policies on patents and medicines, looking also at the lobbying record of the giant pharmaceutical companies and their influence over US Government policies. The findings showed how, despite public pressure and the Doha Declaration on the TRIPS Agreement and Public Health, US bilateral policy on patents and medicines is still heavily influenced by the narrow commercial interests of the pharmaceutical companies. Contradicting one of the pharmaceutical industry claims, the report documents how the number of complaints against developing countries submitted by Pharma to the US Trade Representative remained unchanged during the period of time since the adoption of the Doha Declaration. The report concludes by issuing several recommendations to developed countries, such as making their bilateral policies fully compatible with the Doha Declaration and making expert guarantees, tax concessions and other government incentives. The report recommends that WTO play a more active role in ensuring developed country compliance with the Doha Declaration.
Panos Institute. Beyond our means? London, Panos Institute, 2000.
Two primary factors prevent widespread access to treatment for AIDS in the developing world: inadequate health services and lack of drugs. This report from the Panos Institute explores the problems of access to treatment for people living with HIV/AIDS. It puts the main focus on the issue of the high cost of treatment. The price of a drug charged to an individual, insurance company or government health service is determined by a series of factors, including the cost of R&D, manufacture, company overheads, distributor's costs and commission, taxes and fluctuating exchange rates. But the most important factor is the price the consumer can afford or is willing to pay. Uniform patent protection under the TRIPS Agreement is seen as one of several means the pharmaceutical companies use to protect their markets and their profit. The report discusses the possibility of using compulsory licensing for AIDS-related medicines, and other ways to bring down the price of pharmaceutical products. The author concludes that compulsory licensing, preferential pricing and parallel importation in themselves are not the complete solution to the problem of providing full access to treatment for AIDS. Questions of production capacity, national monopolies and manufacturing standards, and the threats of counterfeiting and the black market still need to be resolved. However, compulsory licensing, in particular, would seem to represent, on the one hand, no threat and, on the other, a potential source of income considerably greater than that which the pharmaceutical companies currently receive from most of Africa and Asia.
Pécoul B, Chirac P, Trouiller P, Pinel J. Access to essential drugs in poor countries: a lost battle? Journal of the American Medical Association, 1999, 281(4): 361-367.
While drugs offer a simple, cost-effective solution to many health problems, effective treatment for many diseases is lacking in poor countries. This article focuses on the problems of access to quality drugs for the treatment of diseases that predominantly affect the developing world. Poor-quality and counterfeit drugs are not rare in developing countries. Fluctuating production or prohibitive costs also account for the lack of availability of essential drugs. The development of field-based drug research is needed to determine optimum use and remotivate R&D for new drugs for the developing world. Potential consequences for the availability of old and new drugs are expected from recent WTO agreements.
Perez-Casas C. HIV/AIDS medicines pricing report. Setting objectives: is there a political will? Available on the web at http://www.accessmed-msf.org
The author stresses that prevention of HIV/AIDS is very important and should be a main strategy, but that treatment cannot be neglected. The high price of drugs is claimed to be a major barrier to appropriate treatment for people with HIV/AIDS. This study examines the price of HIV/AIDS-related medicines that are patented in many countries, and drugs that are no longer patented but still remain expensive (e.g. Ceftriaxone). It compares the USA price with the price in eight countries, and shows that prices are set differently in different countries. The author claims that the existence of market monopolies is the single most important determinant of these differences. The widely divergent prices found in the study put into question current drug price-setting mechanisms and highlight the lack of transparency with regard to the relationship between the productions costs and prices. According to the author, competition can be an important factor that can lead to dramatic reductions in price. This can be promoted by using three safeguards provided in the TRIPS Agreement, namely compulsory licensing, parallel imports and the 'Bolar' provision. The report concludes by saying that the means to dramatically reduce prices are within reach, but what is needed is the political will to mobilize resources on a global scale.
Raghavan C. Recolonization: GATT, the Uruguay Round and the Third World. Penang, Third World Network, 1990.
This book is an effort to place in the hands of the Third World public, and concerned groups, information on the Uruguay Round and its implications. It is not intended to be an academic or objective exercise, but has been written from a Third World perspective and is aimed at filling the gap in other publications. Part one deals with the political economy of the Uruguay Round and its broad implications in terms of South-North relations. Part two deals with the new themes on the agenda of the Round and their interlinkages. Part three looks at some of the traditional and old issues of trade and market access, particularly those of importance to the Third World countries. In this light, part four looks at issues with systemic implications. Part five deals with the progress in the negotiating processes in the first two years and the outlook in the light of the mid-term review. The book also updates the situation up to 1990 and presents some views on what positions the Third World countries should take.
Reichman JH. From free riders to fair followers: global competition under the TRIPS Agreement. New York University Journal of International Law and Politics, 1997, 29(1-2): 12-93.
The article identifies the sources of tension between developed and developing countries, and evaluates the impact of the TRIPS Agreement on developing countries' capacity to acquire the knowledge and skills they need to compete on the market of technological goods. It argues that developing countries have much to gain by accepting the challenge implicit in the Agreement to become fair followers in the worldwide quest for technical innovation. The author outlines a pro-competitive strategy for implementing the TRIPS Agreement in developing countries in five points: tilt their intellectual property laws in favour of local competitors; distance themselves from protectionist measures being adopted in the developed countries; institute incentive structures to stimulate innovation at the local level; resist any further elevation of international intellectual property standards beyond the TRIPS Agreement; and resort to the global information infrastructure to acquire scientific and technical knowledge.
Reichman JH. Universal minimum standards of intellectual property protection under the TRIPS component of the WTO Agreement. The International Lawyer, 1995, 29(2): 345-388.
According to the author, "the absorption of classical intellectual property law into international economic law will gradually establish universal minimum standards governing the relations between innovators and second comers in an integrated world market". This article provides a detailed and comprehensive picture of all the important substantive provisions contained in the TRIPS Agreement, including patents, trademarks and the ongoing trade-based initiatives, such as the compensation expected by developing countries and the uncertainties of the dispute settlement process. A section specifically discusses the issue of compulsory licences and the new dimension of the public interest exception under the TRIPS Agreement.
Remiche B, Desterbecq H. Les brevets pharmaceutiques dans les accords du GATT: l'enjeu? Revue Internationale de Droit Economique, 1996/1: 7-69.
The TRIPS Agreement is indeed a major event in the history of intellectual property law. This study examines the impact of this Agreement on patent law in the pharmaceutical sector in developing countries. It suggests reconsideration of the sensitive issue of the balance of interests that the patent system is designed to ensure. It analyses the various provisions of the TRIPS Agreement that leave a certain margin of freedom to Members in the organization of the patent system. The application of general principles, together with respect for conditions for the limitation of patent rights, allows a number of measures that may take into consideration national development and public health needs.
Revue Internationale de Droit Economique. Special edition: pharmaceutical patents, innovation and public health. Bruxelles, Revue Internationale de Droit Economique, 2001.
This special issue of the International Revue of Economic Law (RIDE) reproduces the main contributions to the symposium organized by the International Association of Economic Law (AIDE) in Toulouse at the end of January 1999 on the theme "Pharmaceutical patents, innovations and public health". Contributors include Carlos Correa, Claude Crampes, Vincenzo Di Cataldo, Jérôme Dumoulin, Jean-Christophe Galloux, Alain Gouyette, Georges Houin, Christian Huveneers, Jacques Larrieu, Marília Bernades Marques, Franz Muennich, Adrian Otten, Sylvaine Poillot Peruzzetto, Norbert Reich, Bernard Remiche, Frederick Scherer and Germán Velásquez.
Rozek RP, Berkowitz R. The effects of patent protection on the prices of pharmaceutical products: is intellectual property protection raising the drug bill in developing countries? The Journal of World Intellectual Property, 1998, 1(2): 179-243.
The authors studied prices of pharmaceutical products in nine developing countries with and without patent protection over a period of 11 years to determine whether enacting intellectual property law increases the price of drugs. Their conclusion is that escalating prices seem unlikely for a number of reasons: therapeutic competition among many pharmaceutical products, monopsony buyers and price-regulation schemes for pharmaceuticals in developing countries, and the fact that new intellectual property laws usually do not apply to existing products.
Rozek RP, Rapp RT. Benefits and costs of intellectual property protection in developing countries. Journal of World Trade, 1990, 24: 75-102.
The costs and benefits of patent protection is an issue that has been hotly debated for decades. The aim of this study is to assess whether denying patent protection to pharmaceuticals is a sensible public policy. The authors argue that there are substantial benefits for developing countries from IPP. Benefits, including investment and technology flow and enhanced prospects for economic growth, far outweigh the costs, in terms of lack of competition. The authors then conclude that protecting intellectual property should be a public policy goal of developing countries seeking sustainable economic growth.
Rozek RP, Rapp RT. Parallel trade in pharmaceuticals: the impact on welfare and innovation. NERA Working Paper No. 16, 1992.
Differences in drug price-setting across countries - with respect to political, social, economic, legal and regulatory factors - create opportunities for parallel trade. Parallel trade creates lower prices in the short-run in the high-price countries and offers potentially more profit opportunities to parallel traders. It can also increase competition in the market. However, according to the authors, there are some market situations in which parallel imports may reduce welfare and weaken the IPR of innovators. This paper, supported by the Pharmaceutical Manufacturers Association, argues why, in some situations, a policy that restricts either parallel trade or incentives for parallel trade will yield net economic benefits to society.
Rozek RP, Tully N. The TRIPS Agreement and access to health care. The Journal of World Intellectual Property, 1999, 2(5): 813-819.
Access to health care is a basic human right that should be applied to all. According to the authors, access to care is a complex problem that should not be examined solely in terms of pharmaceuticals or the impact of the TRIPS Agreement. This article argues that barriers which are not related to availability and prices of pharmaceuticals exist, and result in the restriction of access to health care. These can be classified into six main areas: physical, informational, financial, political, social and ethnic. The authors conclude that, in many instances, the prices of pharmaceuticals are not the cause of access problems. They also suggest that access problems in particular countries may differ. It is therefore important for WHO to identify the set of causes for access problems and formulate country-specific reform plans to improve access to drugs.
Savina J. The patentability of the second therapeutic application - why must the law be changed? Patent World, August 1995, 32-35.
Problems arise when a drug is already known for one or more therapeutic applications and another, hitherto unknown, curative or preventive property of that drug is subsequently discovered. This article addresses the legal difficulties raised by the patentability of the second therapeutic application with regard to the novelty and the industrial application of such an invention.
Schroeder L. Substance of the TRIPS provisions of the GATT as they relate to developing countries. Paper presented at the Drug Information Association Annual Meeting, Orlando, USA, 27 June 1995.
"The TRIPS Agreement meets the objectives that the United States established for the negotiation", says the author. This Agreement sets forth minimum standards for the protection of IPR and provides for effective enforcement of these rights internally and at the border. An enhanced dispute settlement regime is also available to address shortcomings in meeting TRIPS obligations. Obligations have to be met by all countries, within the transitional arrangements.
Sell S. Private power, public law. The globalization of intellectual property rights. Cambridge University Press, 2003.
This book shows how power in international politics is increasingly exercised by private interests rather than governments. To illustrate this point, the author uses the example of the TRIPS Agreement, adopted by the WTO in 1994, which dictated to states how they should regulate the protection of intellectual property. According to the author, final approval of the TRIPS Agreement resulted from lobbying by twelve powerful CEOs of multinational corporations (among them several major pharmaceutical companies) who wished to mould international law to protect their markets. This book examines the politics leading up to the TRIPS Agreement, the first seven years of its implementation, and the political backlash against TRIPS in the face of the HIV/AIDS crisis. Focusing on global capitalism ideas, and economic coercion, this work explains the politics behind TRIPS and the controversies created in its wake. It is an in depth study of the influence of private interests in government decision-making, and in the shaping of the global economy.
South Centre. Intellectual property rights and the use of compulsory licences: options for developing countries. Trade-Related Agenda, Development and Equity (T.R.A.D.E.) Working Paper No. 5. Geneva, South Centre, October 1999.
The possible use of compulsory licences as one of the tools to mitigate the impact of exclusive rights is receiving growing attention. This paper aims to provide concrete examples of how compulsory licences have been provided for in national laws. The author explores all the grounds and conditions under which such licences have been granted in specific instances. The emphasis of the study is on the ways in which compulsory licences have been actually provided for or used in order to satisfy diverse public interests. It focuses mainly on the application of compulsory licensing in the field of patents. Three main conclusions, particularly relevant for developing countries, are: (1) compulsory licences should be considered as an essential element in patent laws and other intellectual property regimes; (2) the grounds and conditions for compulsory licences should be carefully determined by national laws; (3) developing countries should preserve the maximum possible freedom under international rules to design their compulsory licencing systems according to their own interests and needs.
South Centre. The TRIPS Agreement: a guide for the South. The Uruguay Round Agreement on Trade-Related Intellectual Property Rights. Geneva, South Centre, 1997.
This document forms part of the programme of work carried out by the South Centre as a contribution to the Economic Agenda for Priority Action 1992-1995 of the Non-Aligned Movement. The document is intended as an introductory overview of the TRIPS Agreement for developing countries. In addition to highlighting some of the central issues for the South, the document draws attention to the aspects to which policy-makers and technical personnel should pay special attention when formulating policy and legislation in this field. In particular, the document points out that "maximum advantage must be taken of those areas where the Agreement leaves some room for choice in an effort to ensure that national policies and legislation are formulated in a manner that helps to achieve their development objectives". Also, it is suggested that there are a number of areas in which developing countries could cooperate to great mutual advantage, with respect both to the formulation of national legislation and the planned review of the Agreement.
Stolley PD, Laporte JR. The public health, the university and pharmacoepidemiology. Pharmacoepidemiology, third edition, 2000, 75-89.
Pharmacoepidemiology is the study of the effects of drugs on populations and of the factors influencing drug use. Its prime goals are the gathering of information leading to the protection of the health of populations, and improving the efficacy and safety of medicines. The authors state that in each country the ultimate effectiveness of drugs depends on a number of factors. These include the priorities of the pharmaceutical industry, local drug regulation and drug policies, drug supply, the priorities of the health care system, training and continuous education of health professionals, etc. These factors have a great influence on the patterns of prescribing, dispensing and use. The document argues that four processes have contributed to shaping globalization in the field of pharmaceuticals: the TRIPS Agreement, health sector reform and liberalization, moves to closer harmonization (in particular the International Conference on Harmonization) and pharmaceutical company mergers.
Subramanian A. Putting some numbers on the TRIPS pharmaceutical debate. International Journal of Technology Management (special issue on the management of international intellectual property), 1995, 10(2/3): 252-268.
This paper estimates the changes in prices, profits and social welfare arising from increased patent protection of pharmaceuticals in a number of developing countries. Two market structures are proposed (perfectly competitive market and Nash-Cournot duopoly) and comparisons are made between the situation where there is no patent protection and after the introduction of patent protection. Lags between the adoption of legislation and its impact are discussed and the effects of retroactive legislation compared with non-retroactive patenting. Prices of patented drugs in three countries (Argentina, India and Malaysia) are then compared and possible price changes discussed. Finally, for larger countries, or a group of small countries, the effects of patent protection are calculated for the same scenarios and the incentives for increased R&D are examined. The paper concludes that the effects of patent protection are sensitive to assumptions about market structure and price elasticity.
Tarabusi CC, Vickery G. Globalization in the pharmaceutical industry, part I. International Journal of Health Services, 1998, 28(1): 67-105.
This report provides an overview of the characteristics of the industry and current trends in its growth and structure: production and consumption, employment, R&D, capital investment, firm and product concentration and product competition, and pricing. A discussion follows on international trade covering intra- and interregional, intra-firm and intra-industry trade.
Templeman S. Intellectual property. Journal of International Economic Law, 1998, 603-606.
This paper discusses the nature of the rights characterized as intellectual property. The author asserts that the term intellectual property is a pernicious fiction because it serves to disguise the creation and enforcement of monopolies, which are contrary to the public interest. A number of specific recommendations to minimize the injurious effects of these monopolies are made. They include adopting a more receptive attitude toward compulsory licensing, examining patent holders' books to determine how monopoly profits are being spent, increasing attention to the impact of the TRIPS Agreement on developing countries and recognizing a universal doctrine of exhaustion of rights.
The Royal Society. Keeping science open: the effects of intellectual property policy on the conduct of science. London, The Royal Society, April 2003.
This report of the UKs independent scientific academy looks on how intellectual property policies impact on the evolution of scientific work, paying particular attention to three areas: patents, copyright and database copyright. While accepting the potential benefits of IPR for science by, for instance, stimulating innovation, the report also warns about the possible tensions created due to their monopolistic nature. As regards the current trend in British research funding, centred around wealth creation and associated IPR, the report demands that research be based on quality, as it is only high quality research that will, in the long-term, be beneficial for society. The climate of secrecy that patents might encourage can, according to the report, limit the free flow of ideas and information which are critical for productive research. At the same time, research may be constrained by patents being excessively broad, which could have a very negative impact, particularly in the early stages of development of a given discipline. With regard to the TRIPS Agreement, intended to harmonize intellectual property laws at the international level, the report wonders whether there is not sufficient flexibility or whether the flexibility accorded is sufficiently utilized. It notes that, for developing countries, the disadvantages of TRIPS implementation outweigh the possible benefits. It is required that developing countries not be obliged to implement legislation until they achieve a certain level of development. The report concludes that the original balance established by intellectual property law, where the right-holder obtains exclusive rights in exchange for rights to the society, should be improved in order to guarantee just sufficient incentive to encourage R&D by potential right-holders while retaining a high level of benefit for society. The report considers that new intellectual property legislation that unreasonably restricts freedom of access and use of information goes against this desirable balance.
Thurow L. Needed: a new system of intellectual property rights. Harvard Business Review, October 1997.
According to the author, "Fundamental shifts in technology and in the economic landscape are rapidly making the current system of IPR unworkable and ineffective. Designed more than 100 years ago to meet the simpler needs of an industrial era, it is an undifferentiated, one-fits-all system". Four main reasons explain the problems with the old system: the centrality of IPR, the decline of public knowledge, the emergence of new technologies and the globalization of the economy. Thus, a new system of IPR should strike the right balance between the production and the distribution of new ideas, but should also be really enforceable, quick and efficient. A revised system should reflect diverse interests, such as public versus private knowledge, developed versus developing countries and different types of industry, knowledge and inventors.
TWN. Options for implementing the TRIPS Agreement in developing countries. Report of an expert group on the TRIPS Agreement and developing countries. Penang, Third World Network, April 1998.
The expert group was convened by the Third World Network (TWN) with the objective of bringing together a team of individuals with in-depth knowledge of IPR in order to provide guidelines and proposals to policy-makers and the public in developing countries on the options available to them during the process of implementing the TRIPS Agreement. The TRIPS Agreement had been actively promoted by industrialized countries with the aim of obtaining worldwide protection for the innovations and technologies generated by their corporations. The implementation of the Agreement could have some serious adverse consequences for developing countries, including placing greater obstacles in the way of their technological development. This report points out the options available in various aspects of the TRIPS Agreement, and proposes recommendations on options which would be more appropriate to and consistent with the interests of developing countries. The report focuses on the provisions related to patents, undisclosed information, computer programmes and restrictive practices in contractual licences.
UNAIDS/WHO. Patent situation of HIV/AIDS related drugs in 80 countries. January 2000. Available on the web at: http://www.who.int/medicines or http://www.unaids.org.
The problem of affordability is a major factor contributing to the lack of access to drugs. Since patent protection allows exclusive rights to an invention and prevents generic competition, the question of whether a drug is under patent protection is of significant importance for drug procurement decisions. This document assesses the patent situation of HIV/AIDS related drugs, anti-infectives and antiretrovirals in about 80 countries for which data are available. It shows the approximate date on which the patent of each particular drug will expire, calculated from the date of application for the first patent.
UNAIDS/WHO. Pharmaceuticals and the WTO TRIPS Agreement: questions and answers. March 2000. Available on the web at: http://www.who.int/medicines or http://www.unaids.org.
This document provides the answer to some frequently asked question related to the TRIPS Agreement and pharmaceuticals. The meaning of TRIPS, its application, and the obligations for developing countries are explained in an easily understandable way. Further reading is also recommended
UNCTAD. The TRIPS Agreement and developing countries. New York and Geneva, United Nations Conference on Trade and Development, 1996 (UNCTAD/ITE/1).
This report provides an initial assessment of the costs of implementing and enforcing the specific IPR standards stipulated in the TRIPS Agreement. A preliminary section sets out the main findings and conclusions, the key issues and the role that international organizations can play in assisting developing countries in their efforts to implement the TRIPS Agreement. Part one assesses the economic implications of the Agreement for developing countries, focusing on market-related costs and benefits, as well as the direct costs stemming from the implementation of the TRIPS Agreement. It also summarizes the results of selected country case studies carried out for the purpose of this study. Part two deals with the main disciplines covered by the TRIPS Agreement. It highlights the principal provisions of each of the disciplines discussed, their main economic and legal implications, general issues arising from their implementation and the costs involved in their implementation. Finally, an annex provides an overview of the literature on the impact of introducing pharmaceutical product patents.
UNDP. Human Development Report 2001. Making new technologies work for human development. New York, United Nations Development Programme, 2001.
The 2001 edition of the Human Development Report of the United Nations Development Programme (UNDP) devoted considerable attention to the issue of TRIPS and patents in connection with the Millennium Development Goals. The report showed how IPR are being tightened worldwide. As signatories to the TRIPS Agreement, developing countries are now implementing national systems of IPR following an agreed set of minimum standards, such as 20 years of patent protection. In this new global regime, two problems are creating new hurdles for progress in human development. First, consensus is emerging that IPR can go too far, hampering rather than encouraging innovation and unfairly redistributing the ownership of knowledge. Second, there are signs that the cards are stacked against fair implementation of TRIPS. Views vary tremendously on the expected impact of the TRIPS Agreement on developing countries. Under TRIPS, countries can use compulsory licensing (permitting the use of a patent without the consent of the patent holder) in a number of circumstances, which they must embody in their own legislation. TRIPS also allows countries to choose whether or not to permit patented goods to be imported from other countries where they are sold by the same company but at cheaper prices. Yet, under pressure and without adequate advice, many developing countries have not included these possibilities in their legislation, or are challenged when they try to put them to use. In some circumstances, such as national emergencies, public non-commercial use and antitrust measures, the Agreement allows governments to issue compulsory licenses to domestic or overseas producers of generic drugs. First introduced in British intellectual property legislation in 1883, compulsory licensing has been part of the law and practice of many industrial countries for more than a century, including Australia, Canada, Germany, Ireland, Italy, New Zealand, the United Kingdom and the United States of America. In contrast, not one compulsory licence has been issued south of the equator. Why? Pressure from Europe and the United States of America makes many developing countries fear that they will lose foreign direct investment if they legislate for or use compulsory licences. Turning compulsory licence provisions into feasible policy options means creating a legal structure suited to developing countries.
Velásquez G. Hold-up sur le médicament. Le Monde Diplomatique, July 2003, 26-27.
This articles sets out the perception of essential drugs and medicines as public goods, to which no exclusive rights or patents shall be applied as they primarily belong to those who are most in need. The author looks at the current situation of the AIDS pandemic, but also at other illnesses that are much less publicised but are also taking a heavy toll in terms of human lives in developing countries. Bearing this in mind, the author expresses the need for a new approach to those drugs that can make a difference for millions of people, not only as regards distribution but also invention and production. This approach needs to be consistent with the global nature of the situation and the multiplicity of involved factors. He considers it critically urgent to change many of the apathy and discoordination patterns that contributed to the current extent of the AIDS pandemic.
Velásquez G, Boulet P. Essential drugs in the new international economic environment. Bulletin of the World Health Organization: International Journal of Public Health, 1999, 77(3): 288-292.
The new international economic and social context is likely to have an important effect on the equitable access of populations to health and to drugs, especially in developing countries. The new rules in the area of intellectual property could increase these countries dependence still further. In implementing the TRIPS provisions at the national level, developing countries should be aware that there are some options for ensuring access to essential drugs for the poorest populations, as some provisions of the TRIPS Agreement may be used to protect public health goals. Therefore, say the authors, each country's strategy in regard to globalization in the field of the production and distribution of drugs will have to be incorporated into its national pharmaceutical policy, a component of national health policy.
Velásquez G, Boulet P. Globalization and access to drugs: perspectives on the WTO/TRIPS Agreement. Geneva, WHO, Health Economics and Drugs, EDM Series No. 7 (Revised). 1999.
This book is divided into two sections. The first part aims to inform people with limited legal background about the impact of globalization, especially the TRIPS Agreement, on access to drugs. It includes an introduction to the international trade system and its development, followed by an analysis of the TRIPS Agreement in relation to drugs. The second part of the book contains presentations at a meeting of an ad hoc working group on the revised drug strategy, held in Geneva on 13 October 1998, from various stakeholders, including WHO, WIPO, WTO, the South Centre, HAI, IFPMA and the International Generic Pharmaceutical Alliance. The main recommendation of the book is that public health concerns should be a priority consideration when implementing the TRIPS Agreement.
Velásquez G, Correa CM, Weissman R. Cost-containment mechanisms for essential medicines, including antiretrovirals, in China. Mission report, Beijing, 11 to 13 December 2002. Geneva, WHO, Health Economics and Drugs, EDM Series No. 13, 2003.
The purpose of the Mission to the People's Republic of China was to explore, together with the Chinese authorities, the range of cost-containment options for antiretrovirals and other essential medicines, assessing the experiences of other countries in this domain and mapping out those options that are compatible with the TRIPS Agreement. Notions such as voluntary and compulsory licensing or government price controls are extensively developed. Experiences of other countries, such as Brazil and Indonesia, are used as possible useful examples for the Chinese authorities in their attempts to contain the cost of essential medicines at the national level. Special attention is paid to the right of countries to be protected in voluntary agreements for reduction of prices of medicines as well as practical aspects of the implementation of compulsory licensing. The report concludes by stressing the importance of public health considerations in the design of policies for cost-containment, while detailing some of the problems that may appear in the negotiation process for voluntary licences or voluntary price reductions.
Verma SK. Exhaustion of intellectual property rights and free trade - Article 6 of the TRIPS Agreement. International Review of Industrial Property and Copyright Law (IIC), 1998, 29(5): 534-567.
By bringing IPR within the context of the GATT/WTO, the exclusivity aspect of IPR has been made subject to the rules of international trade and competition. This study examines the issue of IPR exhaustion in the GATT/TRIPS context, and tries to analyse whether territorial exhaustion fits into the GATT stated objective of free trade, its legality under the GATT/WTO provisions, and its effects on developing countries. The author argues for world-wide rather than territorial exhaustion, for the sake of free trade and international competition. In this context, the study first briefly discusses the concept of IPR exhaustion and current practice thereon, as exhibited in the legal systems of the EU, Japan and the USA. That is followed by an analysis of the legal and economic commitments to international exhaustion within the GATT/WTO framework. Finally, the issue is examined from the point of view of developing countries.
Verma SK. TRIPS: development and transfer of technology. International Review of Industrial Property and Copyright Law (IIC), 1996, 27(3): 331-363.
At the time of writing the article, the operation of the new intellectual property regime had yet to be seen but, given the intense negotiations which accompanied its adoption, a few pertinent questions were asked about the efficacy of the new regime for developing countries. Patenting in pharmaceuticals is still open to considerable debate in most developing countries. Would the emerging new regime work in the national interest of the developing countries? Would it encourage the transfer of technology to them from developed countries and help them become competitive in world trade? Would it help in boosting the inventive and innovative capacity in these countries? These are some of the issues addressed in this article, which for this purpose explores at the outset relevant provisions of the TRIPS Agreement.
Warren A. A mouse in sheep's clothing: the challenge to the patent morality. European Intellectual Property Review, 1998, 20(12): 445-454.
With the debate on cloning still ringing in one's ears, it was not entirely unexpected that Dolly, the cloned sheep, would be the basis of a patent application. This article addresses the problems of applying a morality criterion through the patent system and looks to both the Oncomouse case and the impending patent application on cloning in order to consider whether the morality of patenting is being addressed on a realistic basis.
WCC. The implications of the TRIPS Agreement from the perspective of developing countries. Report from the Pharmaceutical Advisory Group of the World Council of Churches on 30 October 1997. Geneva, World Council of Churches, 1997.
According to the report, the meeting at the World Council of Churches (WCC) established that the protectionism promoted by the TRIPS Agreement works against the interests of developing countries. Speakers at the meeting included Professor Carlos Correa (Argentina), Dr Mira Shiva (India), Dr Zafar Mirza (Pakistan) and representatives from WHO and WTO. The report provides speakers' presentations, which include a background to the issues raised by the TRIPS Agreement, the effect of TRIPS on local manufacturing and concerns about justice following the TRIPS Agreement
Weissman R. A long, strange TRIPS. University of Pennsylvania Journal of International Economic Law, 1996, 17(4).
IPP has become a central part of the free trade agenda and of the global WTO agreements. This article considers how this state of affairs came to be and what it means for developing countries. Its crucial concern is with the range of pharmaceutical patent policy options that remain open to them. Part I provides some background on the range of possible patent regimes, to emphasize that there is no single approach to patent policy. Part II recounts the United States pharmaceutical industry's political offensive over the last 15 years, designed to ensure that all nations adopt restrictive patent laws. Part III undertakes a close analysis of the TRIPS Agreement and argues that, despite its appearing highly restrictive at first glance, the Agreement leaves in fact a number of options open to developing countries. Part IV considers the costs and benefits of some patent policy alternatives, especially compulsory licensing, and, in a concluding section, outlines a patent policy approach for developing countries that would better serve their national interests.
Wheeler C, Berkley S. Initial lessons from public-private partnerships in drug and vaccine development. Bulletin of the World Health Organization: International Journal of Public Health, 2001, 79(8): 728-34.
In recent years, venture capital approaches have delivered impressive results in identifying and funding promising health discoveries and bringing them to market. This success has inspired public sector experiments with ''social venture capital'' approaches to address the dearth of affordable treatment and prevention for diseases of the developing world. Employing the same focus on well-defined and measurable objectives, and the same type of connections to pool and deploy resources as their for-profit counterparts, social venture capitalists seek to use the tools and incentives of capitalism to solve one of its biggest failures: the lack of drugs and vaccines for diseases endemic to low-income populations. As part of a larger trend of partnerships emerging in health product donation and distribution, public-private partnerships for pharmaceutical development have led R&D efforts to generate more accessible and efficacious products for diseases such as malaria, tuberculosis, and AIDS. In this article, three R&D-focused partnerships are explored: the International AIDS Vaccine Initiative; the Medicines for Malaria Venture; and the newly-formed Global Alliance for TB Drug Development. The article highlights key elements essential to the success of these ventures.
Woodward D et al. Globalization and health: a framework for analysis and action. Bulletin of the World Health Organization: International Journal of Public Health, 2001, 79(9): 875-881.
Globalization is a key challenge to public health, especially in developing countries, but the linkages between globalization and health are complex. Although a growing amount of literature has appeared on the subject, it is piecemeal, and suffers from a lack of an agreed framework for assessing the direct and indirect health effects of different aspects of globalization. This paper presents a conceptual framework for the linkages between economic globalization and health, with the intention that it will serve as a basis for synthesizing existing relevant literature, identifying gaps in knowledge, and ultimately developing national and international policies more favourable to health. The framework encompasses both the indirect effects on health, operating through the national economy, household economies and health-related sectors such as water, sanitation and education, as well as more direct effects on population level and individual risk factors for health and on the health care system. Also proposed is a set of broad objectives for a programme of action to optimize the health effects of economic globalization. The paper concludes by identifying priorities for research corresponding to the five linkages identified as critical to the effects of globalization on health.
WTO/WHO. WTO Agreements and Public Health. A joint study by the WHO and the WTO secretariat. Geneva, 2002.
This report deals with the relevant WTO Agreements and the way they may influence health and health policies. Initially, the report examines the main WTO Agreements related to health and health policies, namely the Agreements on TBT, SPS, Trade in Services (GATS) and TRIPS. The TRIPS Agreement contains several provisions that enable governments to implement their intellectual property regimes in a manner which takes account of immediate and longer-term public health considerations. It also provides for some flexibility in its implementation by allowing countries to limit patent owners' exclusive rights, for instance by granting compulsory licences and allowing parallel importation of patented products. This flexibility was reaffirmed by the WTO Members at the Doha Ministerial Conference in November 2001 with the adoption of the Declaration on the TRIPS Agreement and Public Health. This Declaration was seen as an important step to prevent situations where countries have considered themselves under pressure, from industry and/or foreign governments, not to avail themselves fully of the flexibility provided in the TRIPS Agreement.