(2003; 82 pages)
Ahuja SD. GATT and TRIPS: the impact on the Indian pharmaceutical industry. Patent World, September 1994, 28-34.
This article from an Indian firm describes the discussions in India between Indian firms, the Government and the multinational drug industry on the issue of pharmaceutical patents and TRIPS. The author analyses the shortcomings of the 1970 Indian Patent Act vis-à-vis the TRIPS Agreement and the amendments necessary for compliance with the TRIPS provisions He then presents the status of pharmaceutical patents in the pre-GATT era and discusses the post-GATT implications, including the future for R&D.
Blakeney M. The impact of the TRIPS Agreement in the Asia Pacific Region. European Intellectual Property Review, October 1996, 18(10): 544-554.
The last decade has witnessed a virtual revolution in the protection and enforcement of IPR in the Asia Pacific Region. Almost every single country in the region has either replaced or substantially renewed its intellectual property laws. Counterfeiting and piracy in Asia were perceived as a damaging issue in international trade. The author notes that the special 301 Section of the United States Trade Act has been intensively used in the Region to support the views of the United States of America at the Uruguay Round negotiations and the adoption of the TRIPS Agreement. This article describes the various developments and law reviews that have occurred in each country of the Region, as well as on a regional basis.
Debroy B. Beyond the Uruguay Round: the Indian perspective on GATT. New Delhi, Response Books, 1996.
This book looks beyond the Uruguay Round and is an Indian perspective on the new GATT/WTO agreement. Beginning with a quick sketch of the current global economic scenario, the author explains the details of the individual WTO agreements, including TRIPS. A special chapter is devoted to patents and pharmaceuticals that are the subject of an amendment in India and to the resultant impact on the Indian pharmaceutical sector. The issue of the protection to be granted to plant varieties and microorganisms is also discussed.
Dubey M. An unequal treaty: world trading after GATT. New Delhi, New Age International Publishers, 1996.
This publication analyses the impact of the various WTO agreements and the WTO system on developing countries, with a special focus on India. A chapter is devoted to the TRIPS Agreement. It relates the history of the difficult negotiations leading up to the signing of the Agreement, and discusses the negative effects of the Agreement for developing countries in terms of development, technological dependence and losses. Finally, the author insists on the various possibilities for making the obligations under the Agreement more flexible.
GATT. Thailand restrictions on importation of and internal taxes on cigarettes. Report of the Panel adopted on 7 November 1990 (DS10/R - 37 S/200).
In this trade dispute between the United States of America and Thailand, the GATT ruled against the Thai efforts to ban imports of cigarettes when there was no equivalent measure taken against the sale of domestically produced cigarettes. However, this case is important for WHO's action in defending public health interests for two reasons. First, the GATT established a precedent in consulting WHO on a trade issue involving public health. Second, the GATT indicated that a ban on the advertising of cigarettes, while potentially harmful to the interests of importers who were not well known, was justified for public health reasons.
Henderson E. TRIPS and the Third World: the example of pharmaceutical patents in India. European Intellectual Property Review 1997, 19(11): 651-663.
The author reviews the TRIPS patent provisions and considers arguments for and against requiring less developed countries to implement Western levels of patent protection. She then addresses the particular example of pharmaceutical protection in India, by reviewing the country's current patent law and discussing the likely effect of TRIPS on the Indian pharmaceutical industry and the Indian population. The article concludes that "there are justifiable fears that patent protection will do more harm than good in developing countries".
Karandikar SM. Indian drug industry after GATT. Bombay, MVIRDC World Trade Centre, 1994.
This publication is a product of desk research and creative interaction with entrepreneurs, executives, scientists and doctors. It firstly presents the changing international environment with regard to the economic role of pharmaceuticals. It then introduces the public health scenario in India and the drug industry. The last part of the book focuses on the issue of GATT, patents and drugs, comparing the Indian Patent Act with other intellectual property instruments, and discussing the cost of new drugs and how to do without newer drugs.
Kettler H, Modi R. Building local research and development capacity for the prevention and cure of neglected diseases: the case of India. Bulletin of the World Health Organization: International Journal of Public Health, 2001, 79(8): 742-747.
This paper examines the proposal to build R&D capabilities for dealing with neglected infectious and tropical diseases in countries where they are endemic, as a potentially cost- and time-effective way to fill the gap between the supply of and need for new medicines. With reference to the situation in India, the competence and incentives required by companies are considered so that their strategy can be shifted from reverse engineering of existing products to investment in R&D for new products. This requires complex reforms, of which intellectual property is only one. The authors consider whether Indian companies that are capable of conducting R&D are likely to target neglected diseases. Patterns of patenting and of R&D, together with evidence from interviews conducted, suggest that Indian companies, like multinational corporations, are likely to target global diseases because of the prospect of much greater returns. Further studies are required on how Indian companies would respond to push and pull incentives originally designed to persuade multinational corporations to carry out more R&D on neglected diseases.
Kramer R. Growth is keynote in China. Les Nouvelles, December 1994, 175-181.
This article concentrates on the pharmaceutical industry's prospects with regard to China. The author explains why many international pharmaceutical companies are focusing their interest on China as one of the major pharmaceutical markets in Asia. Pharmaceutical patent protection is described as well as the place of OTC drugs, quality and drug lists, pricing, the strategy of pharmaceutical investment through joint ventures and the local pharmaceutical industry.
Krishna Iyer VR, Chinnappa Reddy O, Desai DA, Rajinder Sachar. Report of the People's Commission on GATT. The constitutional implications of the Final Act embodying the results of the Uruguay Round of multilateral trade negotiations. New Delhi, Centre for Study of Global Trade System and Development, 1996.
Concern over the impact of the Final Act of the Uruguay Round on India's sovereignty, democracy and the Constitution led to the creation in 1993 of a nonofficial judges' panel, entitled the People's Commission on GATT, to examine the constitutional implications of the Final Act. The report of the People's Commission begins with a detailed chronology of events which provides a basis for understanding the domestic and international context in which the Final Act was negotiated. A background is provided on the functioning of the previous GATT and the numerous rounds of negotiations preceding the Uruguay Round. The report describes the Indian Government's handling of the Uruguay Round and then examines the critical sections of the Final Act and their implications for the political economy. An annex reproduces the text of a paper on the Indian view of the future TRIPS Agreement presented at a meeting of a negotiating committee under the Uruguay Round (1989).
Kwon H. Patent protection and technology transfer in the developing world: the Thailand experience. George Washington Journal of International Law and Economics, 1995, 28: 567-606.
This paper explores the complex relationship between the protection of IPR and the process of international technology transfer to developing countries. It examines the impact of Thailand's patent reform in 1992 on the state of technology investment in the country. The study found that patent amendments have had little or no impact on the flow of technology transfer to Thailand via foreign direct investment. The lessons from Thailand have emphasized that the provision of increased patent protection involves substantial effort and risk for countries with underdeveloped and developing economies.
Lambert PH. Vaccines for the world: major challenges for the future. South-East Asian Journal of Tropical Medicine and Public Health, 1997, 28, suppl. 2, 122-126.
Vaccination is at a turning point. The global use of common infant vaccines has led to a remarkable decrease in the disease burden associated with measles, pertussis or diphtheria, while rapid progress is being made towards the eradication of poliomyelitis through mass immunization campaigns. However, new disease targets are now emerging and research priorities, at a global level, encompass the development of a series of new vaccines. Recent technological advances have made this possible but the challenge of universal immunization is likely to require particular approaches. For example, it will be essential, in the near future, to define optimal ways to use the capacity of the immune system to generate long-lasting protective responses against intra-cellular micro-organisms, to develop vaccines that are efficient soon after birth and to devise new systems to simplify immunization. It will also be a real economic challenge to ensure that new vaccines become available for those who are at the highest risk, usually in the least developed countries.
Otten A. The GATT/TRIPS Agreement and health care in India. National Medical Journal of India, 1995, 8(1): 1-3.
According to the author, much of what has been said about the implications of India's commitment to provide patent protection for drugs, and particularly regarding pharmaceutical prices, "has been alarmist and has created needless anxiety". This article sets out to provide a dispassionate examination of the facts. It indicates that any effect on prices will be very gradual and modest. Also, the author suggests that this issue be considered in the context of policies aimed at the better availability of drugs to treat diseases prevalent in India.
Pillai AM. Impact of GATT Agreement on drug prices. Journal of the Indian Medical Association, 1995, 93(3): 1-3.
The main concern expressed in India about the extension of product patents to pharmaceuticals relates to the increase in drug prices, limited local manufacturing, limited access to new technology and inhibited R&D. In this article, the author suggests that the adverse effect on the growth of the pharmaceutical industry can be reduced if the pharmaceutical industry, the medical profession and the policy-makers rise to the occasion and give a new direction to the drug industry regarding research, drug production and utilization.
Redwood H. New horizons in India: the consequences of pharmaceutical patent protection. Felixstowe, UK, Oldwicks Press Ltd, 1994.
The objective of this study is to examine an issue common to several developing countries, but specifically in relation to the situation in India. Part one of this book relates the rise of the Indian pharmaceutical industry and the decline of multinationals in India as a result of the Patent Act of 1970, and the dispute over pharmaceutical patent protection which led to the signing of the TRIPS Agreement. Part two analyses the facts, myths and expectations relating to the implementation of the TRIPS Agreement in India: the speed and depth of patent penetration of India's drug market, the effects on prices, and the expectations for R&D of new products. The last part explores possible future options for Indian pharmaceutical companies, the Indian Government and research-based multinational drug companies.
Sen B. The Uruguay Round: implications for world trade. New Delhi, Jawahar Publishers, 1996.
This book discusses the possible impact of the new WTO agreements on developing countries. With regard to the TRIPS Agreement, it focuses on patents for pharmaceutical and biotechnology products and their economic impact in respect of innovative capacity, foreign investment, technology transfer and domestic prices. The author also assesses the particular implications in India for pharmaceutical prices and the Indian drug industry, the impact on microbiology and the significance for plant varieties
Shah S. Illuminating the possible in the developing world: guaranteeing the human right to health in India. Vanderbilt Journal of Transnational Law, March 1999, 436-485.
Deprivations such as malnourishment and under-nourishment are currently endured by around one fifth of the world population; this article considers this fact to be a major human rights offence. Furthermore, the article amounts these deprivations as resulting in the systematic disempowerment of individuals as citizens. This set of circumstances partly explains the involvement of the human rights movement in the matter. According to the author, the recognition of the social right to health largely contributes to a greater sense of citizenship on the part of individuals. The second part of the article is devoted to the potential of social human rights and the positive impacts that they could have on the situation in the developing world. The author stresses the notion of state obligation, particularly with regard to guaranteeing human dignity. This obligation is explored in the third part of the article, with particular attention to the challenges posed by the implementation of social rights at the national level. The fourth part is entirely devoted to the notion of a human right to health and other social rights, taking into consideration not only the conceptual and practical problems posed but also the critical role of the right to health in the empowerment of individuals. The author identifies those conditions necessary for good health as also being essential for promoting human dignity. The final part of the article focuses on the experience in social rights (and the right to health) in India, noting the positive potential impact on economic institutions, social priorities and power imbalances. The author concludes that the Public Interest Litigation Scheme is being used by the Indian judiciary to recognize the rights of individuals to live with dignity. Acknowledging the right to health allows judges and courts to address human suffering through social entitlements and conditions. The article considers how the Indian experience could be useful for other countries learning how to make social rights justiciable and develop appropriate methods for their implementation and enforcement.
Shanker D. India, the pharmaceutical industry and the validity of TRIPS. The Journal of World Intellectual Property, May 2002, 5(3): 315-371.
This article deals with the attempts by developing countries to bring their patent regimes into line with the provisions of the TRIPS Agreement, e.g., in India, through the Second Amendment in 1999 of the Indian Patent Act, and how this development is viewed by pharmaceutical industries abroad (in particular Pharma), governments and supporting institutions. This analysis suggests that it is nearly impossible for developing countries to do so, as the interpretations of these provisions by the pharmaceutical industries, their supporting institutions and indulgent governments, are continuously changing. The issue of compulsory licensing and the effect of the WTO Panel Report in the Canada patent protection case on compulsory licensing have been analysed in detail due to their important consequences for patenting practices in developing countries. The article also analyses other developments, such as the removal of business methods from non-patentable items from the US Patent Act because of certain interpretations of that Act by the Court of Appeal which failed to acknowledge a number of US Supreme Court judgements; the article also refers to the partial modification of Section 48(3) of the UK Patent Act which removed local working conditions as a result of the WTO Act, 1999, and the introduction of computer programmes as patentable subject-matter, as well as many other indiscreet interpretations which were never part of the original TRIPS Agreement.
Steele P. Patenting of pharmaceuticals in Korea. Curr Opin Ther Patents 1994, 4(1): 1-5.
The patent system in the Republic of Korea has been integrated with international patenting since 1986. Therefore, the author investigates the number of pharmaceutical patents in the Republic of Korea, who files patent applications in that country and what types of invention dominate. In addition, he indicates how non-Republic of Korea companies protect their inventions and to what extent the Patent Cooperation Treaty (PCT) route is being used.
Supakankunti S et al. Study of the implications of the WTO TRIPS Agreement for the pharmaceutical industry in Thailand. WHO Regional Office for South-East Asia, 1999.
The TRIPS patent system is expected to have a strong impact on the health sector. It is argued that it may affect national drug production, drug prices, availability of essential medicines and pharmaceutical technology and numerous other factors in the developing and least developed countries. This study reviews the impacts of the 1992 Thai Patent Act, which first recognized drug product patents, on pharmaceutical industries in Thailand. It focuses on the foreign direct investment situation and the transfer of technology after the new Patent Act was promulgated. The study shows that, contrary to the claimed benefit of patent recognition, there has not been much technology transfer or foreign investment in the local drug industry since 1992. Pharmaceutical firms responsible for the invention are found to perform better than generic firms after 1989 and their share of the original drug market increased to 67% in 1997. The gap in equivalent prices between original and generic products is varied and unpredictable. The author proposes an "Eleven Ps Strategy" to alleviate the potential negative impacts resulting from the obligations set out in the TRIPS Agreement.
Tancer RS. The pharmaceutical industry in India - adapting to TRIPS. The Journal of World Intellectual Property, 1999, 2(2): 171-188.
India actively debated the enactment of a new patent law to comply with its obligations under the TRIPS Agreement. This debate reflected the ambivalence existing in India with regard to modifying a patent regime that has served the Indian pharmaceutical industry well since 1970. This sector has developed without the benefit of product patent protection, and delivered drugs at affordable prices. According to the author, a new patent law in compliance with the TRIPS Agreement may create uncertainties and some disruption to a status quo that Indians believe is working to their advantage.
Than Sein U, Chang Rim P. TRIPS and access to medicines. Regional Health Forum: WHO South-East Asia Region, 2001, 5(1): 49-61.
Written prior to the WTO Ministerial Conference in Doha in 2001, this article sheds light on the possible implications of the TRIPS Agreement on access to medicines. The article focuses on a detailed description of the TRIPS regime from a health policy perspective, paying particular attention to patentability clauses which could lead to monopolistic practices in relation to life-saving medicines. The authors warn about the danger of considering drugs and medicines as any other merchandise which are subject to trade laws and for which no exceptions or special situations are considered. They recall how, in different sessions of the World Health Assembly, the issue had been addressed amid lively discussions as evidence of the high stakes associated with the issue.
Watal J. Introducing product patents in the Indian pharmaceutical sector: implications for prices and welfare. World Competition, 1996, 20(2): 7-21.
The issue of prices of pharmaceuticals is very controversial in India. The present study, using a different methodology compared with previous studies, attempts to estimate the quantum of price rise if currently patentable drugs were to receive patent protection in India, and calculate welfare losses with such protection. It concludes that no more than 10% of the total pharmaceutical market is likely to be affected, and that the price increase will range between 0 and 64%.
Watal J. Pharmaceutical patents, prices and welfare losses: policy options for India under the WTO TRIPS Agreement. World Economy, 2000, 23: 733-752.
The implications of the TRIPS Agreement for drug prices is a major debate in the international arena. The current Indian Patent Act, which excludes the patentability of pharmaceutical products, is widely credited to be one of the factors that has brought Indian pharmaceutical prices down to one of the lowest levels in the world. This study simulates the maximum likely increase in pharmaceutical prices and the reduction of welfare in India from the introduction of product patents. It further analyses the extent to which policy measures such as price controls and compulsory licences can help to attenuate the adverse effects of patent monopoly. It shows that prices are likely to increase and welfare is likely to decrease if the country moves from the current market structure to a patent monopoly. Price controls and compulsory licences are believed to be effective in reducing prices and welfare losses. These two policy measures are justifiable and acceptable under current international law, the article states.
WHO/SEARO. The TRIPS Agreement and pharmaceuticals. Report of an ASEAN workshop on the TRIPS Agreement and its impact on pharmaceuticals. Jakarta, May 2000. Directorate General of Drug and Food Control, Jakarta and WHO Regional Office for South-East Asia, New Delhi, 2000.
This report gives an overview of the TRIPS Agreement and its possible implications for the pharmaceutical sector in developing countries - the issues and options. It sketches the broad picture in order to address these issues at national level and to draft legislation that balances the interests of producers and users of technology. Cooperation between the ministry of health, the ministry of trade and the intellectual property office is of the utmost importance. The first, and main, part of this report has been compiled on the basis of input from resource persons at the workshop. Section II provides essential background information on WTO and IPR, with substantial input from major stakeholders, since policy makers will encounter their important, differing and firm views and will have to take them into consideration. Section III deals with technical issues and how they translate into social and public health realities, and section IV provides initial reflections on how several of these concepts relate to the specific areas of TRM and biotechnology.
WHO/SEARO. The Uruguay Round and health. The agreement of the World Trade Organization: a review of its impact on health in countries of the South-East Asia Region. New Delhi, WHO Regional Office for South-East Asia, 1996.
This document is intended to serve as a brief for ministries of health in the Region which may help them identify measures necessary to deal with the impact of the WTO Agreements. It is an attempt to review both the possible impact of the Agreements and WHO's efforts to protect health in an environment of trade liberalization.
WHO/SEARO. TRIPS and the health sector in the South-East Asia Region. New Delhi, WHO Regional Office for South-East Asia, September 1998.
The TRIPS Agreement has serious implications for the health sector in the countries of the South-East Asia Region. SEARO has a vital role to play in helping Member States to understand the provisions of this Agreement. This paper outlines the salient features of the TRIPS Agreement and examines the patent situation in each country of the Region. It then assesses the implications of patenting of pharmaceutical products in Bangladesh, India, Indonesia, Maldives, Myanmar, Sri Lanka and Thailand, and the changes in national legislation, and discusses the role of WHO.
WHO/SEARO. WTO multilateral trade agreements and their implications on health - TRIPS. Report of a Regional Consultation, Bangkok, Thailand, 16-18 August 1999. New Delhi, WHO Regional Office for South-East Asia, 2000.
More and more countries realize the importance of the implications of the TRIPS Agreement on health. This book is a report from a South-East Asian Regional Consultation on the topic in 1999. There were several presentations and panel discussions on the topics of multilateral trade agreements, the current situation of patent legislation in the countries of the Region, the issue of biotechnology patents and the implications of the TRIPS Agreement on generic drugs and TRM. The impact of TRIPS for consumers and the use of the compulsory licensing system and parallel imports are further elaborated. Two case studies, from India and Thailand, are presented.
WHO/WPRO. Pharmaceuticals in the Trade Related Aspects of the Intellectual Property Rights (TRIPS) Agreement of the World Trade Organization (WTO). A briefing on TRIPS. Manila, WHO Regional Office for the Western Pacific, August 2000.
This report, written before the WTO Ministerial Conference in Doha in 2001, offers very practical and concise information about basic elements of the TRIPS Agreement, critical for a better understanding of its implications for public health. The document addresses the necessary combination between the implementation of TRIPS and other public policy objectives, such as consumer protection or guaranteeing access to essential drugs, while issuing a set of recommendations directed at national policymakers.
Wilson D, Cawthorne P, Ford N, Aongsomwang S. Global trade and access to medicines: AIDS treatments in Thailand. The Lancet, 1999, 354 (9193): 1893-95.
This article from Médecins sans Frontières (MSF) describes the problem of access to HIV/AIDS treatment in Thailand. It alleges that pressure from the USA is one important factor that has limited access to affordable treatment for Thai patients. The article concludes by emphasizing the importance for developing and least developed countries of understanding fully the implications of trade agreements.