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Increase in Global Access to Essential Drugs Sought

Increase in Global Access to Essential Drugs Sought Amsterdam—Globalization—the issue that elicited the December demonstrations in Seattle—is a force that now affects every person, every patient, every physician in the world. For physicians in the United States, perhaps the most relevant aspects of globalization concern current access to and prices of pharmaceuticals. Driven by economics and a trade orientation, the thrust for globalization comes from large corporations with strong support from some governments, notably that of the United States. The main instrument of globalization is the World Trade Organization (WTO), a body that resulted from the Final Act of the General Agreement on Tariffs and Trade (GATT) Uruguay Round, which was signed on April 15, 1994. The WTO has 135 country members, and 30 more wish to join. The GATT agreement ratified the worldwide implementation of a free-trade economy. View LargeDownload In the new century, globalization has focused attention on the effects of international rules regarding intellectual property rights. (Credit: Map Art) Shortly before the ill-fated WTO Ministerial Conference convened in Seattle, and in preparation for it, a group met here to consider the effect of the WTO and of international rules on intellectual property rights (that is, patents) on access to pharmaceuticals, particularly new drugs. Médecins Sans Frontières (the international medical aid organization that won the 1999 Nobel Peace Prize), Health Action International (an international network of consumer groups concerned with health and development working for rational drug use), and the Consumer Project on Technology (a Washington, DC–based part of the Ralph Nader organization), cosponsored a conference called "Increasing Access to Essential Drugs in a Globalised Economy." More than 350 people from over 50 countries, including policymakers, clinicians, and representatives of industry, nongovermental organizations, and consumer-oriented organizations, participated in the meeting on November 25-26. Relevant provisions Two types of provisions in the WTO agreement are particularly relevant for pharmaceutical policy: (1) those whose purpose is to put an end to protectionist measures (these provisions are probably particularly aimed at developing countries and seek to open all members of the WTO to the global economy); and (2) those that define as mandatory the protection through patents of new drugs and their respective manufacturing processes. This particularly applies to the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement. Implementation of the TRIPS agreement in national patent law is compulsory for all WTO members by 2006 at the latest. The implementation of the TRIPS agreement will have consequences for access to medicines, especially in developing countries. Increased patent protection will lead to higher drug prices, while the number of patented drugs of public health importance will almost surely increase in the coming years. These higher prices, along with other factors, will affect access to drugs. Enforcement of WTO regulations will have an impact on local manufacturing capacity and will remove a source of generic drugs, which are important everywhere but are especially so in developing countries. Furthermore, research and development by multinational pharmaceutical firms tends to neglect tropical diseases such as malaria. There is no reason to believe that the WTO provisions would lead to more industry investment in such diseases, so local innovation is of great importance. Austin Davis, MD, general director of Médecins Sans Frontières in the Netherlands, discussed these issues in his opening presentation. Davis acknowledged the industry position that protection for intellectual property is necessary to ensure continued innovation in the development of pharmaceuticals. However, he pointed to the results of a free-trade market that leads to technology being treated as a commodity rather than a means to serve people. Hakan Bjorkman of the United Nations Development Programme underscored the same point, emphasizing that the market is good for efficiency but not for equity, and proposing a focus on human rights as a framework for global governance. Others pointed to provisions of TRIPS that could be used to strengthen public health inputs. For example, Article 8 states that members may "adopt measures necessary to protect public health and nutrition, and to promote the public interest in sectors of vital importance to their socio-economic and technological development, provided that such measures are consistent with the provisions of this agreement." Evelien Herfkens, minister of development cooperation of the Netherlands, enumerated steps that must be taken to ensure a balance between the interests of industry and those of consumers. There are two specific ways to attenuate the possible harmful consequences of the intellectual property clauses of TRIPS that are allowed in the agreement, she said. These are the introduction of parallel imports, which means the holder of a patent cannot prevent a country from importing a drug from a subsidiary of the patent holder in another country in which the drug is cheaper, and compulsory licensing, which means that WTO members may, in certain circumstances, use the subject matter of a patent without authorization of the patent holder. One such circumstance is when the expense of a drug makes it impossible for poor countries where it is needed to purchase it. The most publicized example recently has been HIV infection, in which drugs to counter the virus and opportunistic infections are produced in some developing countries for a fraction of their cost on the international market. For example, zidovudine is produced in Thailand and India and fluconazole is produced in India. Thailand is currently seeking a compulsory license for didanosine. These provisions are not "loopholes," as some dissenters have said, but are integral parts of the negotiated agreement that should be actively used, many believe. Minister Herfkens stated that "We cannot accept the kind of bilateral dealing in which one country puts pressures on another," especially to prevent compulsory licensing. She was particularly critical of the United States for pressuring developing countries such as South Africa, Albania, and Sri Lanka by such means as meetings, letters, and the threat of trade sanctions. The South African case has been much reported since AIDS activists have demonstrated against Vice President Al Gore for putting pressure on that country not to include compulsory licensing and parallel import provisions in its proposed pharmaceutical law. Despite this stance of the US government, Carlos Correo, PhD, professor of law at the University of Buenos Aires in Argentina, pointed out that the United States has used compulsory licensing more than 100 times when patents were felt not to be favorable to the public good. In fact, the US Federal Trade Commission has sought compulsory licenses on a number of pharmaceutical products as recently as 1997 (further information is available on the Consumer Project on Technology Web site at http://www.cptech.org). Gro Harlem Brundtland, MD, director-general of the World Health Organization (WHO), in a video presentation to the meeting, emphasized that access to essential drugs is a key priority for the WHO. Last May, the World Health Assembly adopted Resolution WHA52.19 on the Revised Drug Strategy. This resolution gives the WHO the go-ahead to expand its work on a range of issues, including the effects of international trade agreements, that affect access, quality, and rational use of drugs. Brundtland said the WHO is working with the WTO to ensure pharmaceutical innovation coupled with reasonable prices of pharmaceuticals. She strongly endorsed compulsory licensing and parallel imports. However, Michael Scholtz, WHO executive director for health technology and pharmaceuticals, responding for WHO to questions, would not specify what actions the WHO intends to take with regard to the WTO. Some participants in the meeting criticized the lack of specificity in his remarks. Others, especially those from African countries, said they look to the WHO for leadership and expressed hope that the organization would take a strong position on these issues. A us consumer issue also The issues are also of importance to US consumers, who make up about 25% of the world market for pharmaceuticals. New drugs are already very expensive and are likely to become more so. People in the United States who lack comprehensive health insurance are especially at risk of not having access to new innovative drugs. There seemed to be a consensus among participants at the meeting that the WTO is here to stay, but that there is a need for more health and public health concerns. At the end of the conference, James Orbinski, MD, president of the International Council of Médecins Sans Frontières, read a statement from the conference organizers in which they asked the WTO to set up a working group on access to medicines that would include a strong role for the WHO. He said that his organization's Access to Essential Medicines campaign has three main objectives: negotiating exceptions from trade agreements for health purposes, overcoming barriers to access, and stimulating research and development on neglected diseases. Médecins Sans Frontières wants to see governments put on public record their active political support for the principle that health takes priority and that WTO rules must not be allowed to override public health needs. Acknowledging the concern about access to essential pharmaceutical products, President Bill Clinton told the WTO in Seattle last month that the US Department of Health and Human Services will work with the US Trade Representative "to make sure that our intellectual property policy is flexible enough to respond to legitimate public health crises." Simultaneously, the US Trade Representative announced that South Africa had been removed from the Special 301 "Watch List" for possible trade sanctions. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA American Medical Association

Increase in Global Access to Essential Drugs Sought

JAMA , Volume 283 (3) – Jan 19, 2000

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Publisher
American Medical Association
Copyright
Copyright © 2000 American Medical Association. All Rights Reserved.
ISSN
0098-7484
eISSN
1538-3598
DOI
10.1001/jama.283.3.321-JMN0119-2-1
Publisher site
See Article on Publisher Site

Abstract

Amsterdam—Globalization—the issue that elicited the December demonstrations in Seattle—is a force that now affects every person, every patient, every physician in the world. For physicians in the United States, perhaps the most relevant aspects of globalization concern current access to and prices of pharmaceuticals. Driven by economics and a trade orientation, the thrust for globalization comes from large corporations with strong support from some governments, notably that of the United States. The main instrument of globalization is the World Trade Organization (WTO), a body that resulted from the Final Act of the General Agreement on Tariffs and Trade (GATT) Uruguay Round, which was signed on April 15, 1994. The WTO has 135 country members, and 30 more wish to join. The GATT agreement ratified the worldwide implementation of a free-trade economy. View LargeDownload In the new century, globalization has focused attention on the effects of international rules regarding intellectual property rights. (Credit: Map Art) Shortly before the ill-fated WTO Ministerial Conference convened in Seattle, and in preparation for it, a group met here to consider the effect of the WTO and of international rules on intellectual property rights (that is, patents) on access to pharmaceuticals, particularly new drugs. Médecins Sans Frontières (the international medical aid organization that won the 1999 Nobel Peace Prize), Health Action International (an international network of consumer groups concerned with health and development working for rational drug use), and the Consumer Project on Technology (a Washington, DC–based part of the Ralph Nader organization), cosponsored a conference called "Increasing Access to Essential Drugs in a Globalised Economy." More than 350 people from over 50 countries, including policymakers, clinicians, and representatives of industry, nongovermental organizations, and consumer-oriented organizations, participated in the meeting on November 25-26. Relevant provisions Two types of provisions in the WTO agreement are particularly relevant for pharmaceutical policy: (1) those whose purpose is to put an end to protectionist measures (these provisions are probably particularly aimed at developing countries and seek to open all members of the WTO to the global economy); and (2) those that define as mandatory the protection through patents of new drugs and their respective manufacturing processes. This particularly applies to the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement. Implementation of the TRIPS agreement in national patent law is compulsory for all WTO members by 2006 at the latest. The implementation of the TRIPS agreement will have consequences for access to medicines, especially in developing countries. Increased patent protection will lead to higher drug prices, while the number of patented drugs of public health importance will almost surely increase in the coming years. These higher prices, along with other factors, will affect access to drugs. Enforcement of WTO regulations will have an impact on local manufacturing capacity and will remove a source of generic drugs, which are important everywhere but are especially so in developing countries. Furthermore, research and development by multinational pharmaceutical firms tends to neglect tropical diseases such as malaria. There is no reason to believe that the WTO provisions would lead to more industry investment in such diseases, so local innovation is of great importance. Austin Davis, MD, general director of Médecins Sans Frontières in the Netherlands, discussed these issues in his opening presentation. Davis acknowledged the industry position that protection for intellectual property is necessary to ensure continued innovation in the development of pharmaceuticals. However, he pointed to the results of a free-trade market that leads to technology being treated as a commodity rather than a means to serve people. Hakan Bjorkman of the United Nations Development Programme underscored the same point, emphasizing that the market is good for efficiency but not for equity, and proposing a focus on human rights as a framework for global governance. Others pointed to provisions of TRIPS that could be used to strengthen public health inputs. For example, Article 8 states that members may "adopt measures necessary to protect public health and nutrition, and to promote the public interest in sectors of vital importance to their socio-economic and technological development, provided that such measures are consistent with the provisions of this agreement." Evelien Herfkens, minister of development cooperation of the Netherlands, enumerated steps that must be taken to ensure a balance between the interests of industry and those of consumers. There are two specific ways to attenuate the possible harmful consequences of the intellectual property clauses of TRIPS that are allowed in the agreement, she said. These are the introduction of parallel imports, which means the holder of a patent cannot prevent a country from importing a drug from a subsidiary of the patent holder in another country in which the drug is cheaper, and compulsory licensing, which means that WTO members may, in certain circumstances, use the subject matter of a patent without authorization of the patent holder. One such circumstance is when the expense of a drug makes it impossible for poor countries where it is needed to purchase it. The most publicized example recently has been HIV infection, in which drugs to counter the virus and opportunistic infections are produced in some developing countries for a fraction of their cost on the international market. For example, zidovudine is produced in Thailand and India and fluconazole is produced in India. Thailand is currently seeking a compulsory license for didanosine. These provisions are not "loopholes," as some dissenters have said, but are integral parts of the negotiated agreement that should be actively used, many believe. Minister Herfkens stated that "We cannot accept the kind of bilateral dealing in which one country puts pressures on another," especially to prevent compulsory licensing. She was particularly critical of the United States for pressuring developing countries such as South Africa, Albania, and Sri Lanka by such means as meetings, letters, and the threat of trade sanctions. The South African case has been much reported since AIDS activists have demonstrated against Vice President Al Gore for putting pressure on that country not to include compulsory licensing and parallel import provisions in its proposed pharmaceutical law. Despite this stance of the US government, Carlos Correo, PhD, professor of law at the University of Buenos Aires in Argentina, pointed out that the United States has used compulsory licensing more than 100 times when patents were felt not to be favorable to the public good. In fact, the US Federal Trade Commission has sought compulsory licenses on a number of pharmaceutical products as recently as 1997 (further information is available on the Consumer Project on Technology Web site at http://www.cptech.org). Gro Harlem Brundtland, MD, director-general of the World Health Organization (WHO), in a video presentation to the meeting, emphasized that access to essential drugs is a key priority for the WHO. Last May, the World Health Assembly adopted Resolution WHA52.19 on the Revised Drug Strategy. This resolution gives the WHO the go-ahead to expand its work on a range of issues, including the effects of international trade agreements, that affect access, quality, and rational use of drugs. Brundtland said the WHO is working with the WTO to ensure pharmaceutical innovation coupled with reasonable prices of pharmaceuticals. She strongly endorsed compulsory licensing and parallel imports. However, Michael Scholtz, WHO executive director for health technology and pharmaceuticals, responding for WHO to questions, would not specify what actions the WHO intends to take with regard to the WTO. Some participants in the meeting criticized the lack of specificity in his remarks. Others, especially those from African countries, said they look to the WHO for leadership and expressed hope that the organization would take a strong position on these issues. A us consumer issue also The issues are also of importance to US consumers, who make up about 25% of the world market for pharmaceuticals. New drugs are already very expensive and are likely to become more so. People in the United States who lack comprehensive health insurance are especially at risk of not having access to new innovative drugs. There seemed to be a consensus among participants at the meeting that the WTO is here to stay, but that there is a need for more health and public health concerns. At the end of the conference, James Orbinski, MD, president of the International Council of Médecins Sans Frontières, read a statement from the conference organizers in which they asked the WTO to set up a working group on access to medicines that would include a strong role for the WHO. He said that his organization's Access to Essential Medicines campaign has three main objectives: negotiating exceptions from trade agreements for health purposes, overcoming barriers to access, and stimulating research and development on neglected diseases. Médecins Sans Frontières wants to see governments put on public record their active political support for the principle that health takes priority and that WTO rules must not be allowed to override public health needs. Acknowledging the concern about access to essential pharmaceutical products, President Bill Clinton told the WTO in Seattle last month that the US Department of Health and Human Services will work with the US Trade Representative "to make sure that our intellectual property policy is flexible enough to respond to legitimate public health crises." Simultaneously, the US Trade Representative announced that South Africa had been removed from the Special 301 "Watch List" for possible trade sanctions.

Journal

JAMAAmerican Medical Association

Published: Jan 19, 2000

Keywords: drugs, essential

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