TRIPS and it's ill effects
INTELLECTUAL PROPERTY AND PUBLIC HEALTH IN THE DEVELOPING WORLD
How come I can not patent a surgical procedure but a psychologist can copyright a survey instrument?
Did Chinese get royalties on paper and Gunpowder
Did Indians get rich on the invention of Zero and the decimal system?
"more restrictive intellectual property clauses were often accepted in exchange for foreign direct investment and technology transfers, as well as better trade balances, but in fact “they may allow right-holders to block competition and charge high prices in monopolistically controlled markets.”
“This may lead to particularly serious effects in the area of public health, where unsustainably high prices have become an issue of global concern.”
“Early in the AIDS epidemic, the US badly damaged its international credibility by standing with prescription corporations against people living with HIV and AIDS. Millions of people died for lack of access to existing treatment. We must learn from our mistakes,”
The establishment of the WTO has been an important exercise in a number of ways. First, it represents an entirely new chapter in the jurisprudence of post-World War II international organizations through the establishment of a multilateral trading system that provides a binding dispute settlement mechanism for its members.u Second, the WTO has also undertaken the onerous task of evolving a binding law of international trade among the member countries.u Third, the WTO has in many ways replaced the internal sovereignty of the member countriesæ This is because every member is required to adjust its domestic laws to conform to the WTO agreements.æ Indeed, as a founding member, Bangladesh's legal system has been subject to reorganization to satisfy the requirements Of the W TO.Z-Q The TRIPS Agreement is one of the most controversial agreements of the Uruguay Round in terms of its objectives and consequences, which established global minimum standards of IPR protection. It represents a major departure from previous international IPR treaties and agreements, which aimed not to standardize IPR legislation between countries but to guarantee non-discrimination under
to earlier international IPR agreements in three important ways. First, TRIPS makes it mandatory for WTO members to provide existing types of IPR protection that include patents, copyright, trademarks, trade secrets, industrial designs, layout designs for integrated circuits, and geographical indications, which removed the flexibilities in previous IPR agreements regarding the granting of [PRs based on the stage Of development Of a particular countryæ Second, it specifies the minimum standards for national IPR legislation, such as the extent of coverage, the terms of protection and the mechanisms for enforcement. Third, it brings national IPR legislation under the coverage of the WTO's dispute settlement procedures, which include the option of cross-retaliation in cases of non-compliance.
The TRIPS Agreement was the brainchild of an industry coalition of developed nations including the US, the European Union (EU) and Japan. The main impetus for the agreement came from the pharmaceutical, software and entertainment industries, with the chief executive officer (CEO) of Pfizer playing a lead role as chair of the Intellectual Property Rights Committee (IPC).2 The IPC was created during the Uruguay Round of negotiations with the goal of putting IPRs firmly on the agendaæ The pharmaceutical industry was primarily interested in eliminating what it felt was unfair discrimination against the patenting Of medicines, but it was also motivated to try to gain control over uses Of its clinical and regulatory data to delay registration of generic equivalents—in essence seeking another form of exclusive rights. One of the arguments advanced by the developed countries for including IPRs in the negotiations was that stronger IPRs would create an incentive for innovation and would stimulate the development of new technologies, such as patent protection for pharmaceuticals.æ This incentive for innovation would consequently encourage greater domestic and foreign investment in research into new pharmaceuticals and tropical The argument propounded was that foreign investment and technology transfer would, in turn, benefit developing
increase in research and development (R&D) investment by enterprises in developing countries because Of the non-existence Of technical infrastructure and financial and human resources. That is why "the non-patentability Of pharmaceutical products existing prior to the TRIPS Agreement gave developing countries the opportunity to progress and to acquire basic technology through reverse engineering before being able to invest in Consequently, almost 50 developing countries, which were not granted patent protection for pharmaceuticals during the Uruguay Round, fiercely resisted including pharmaceuticals under the patent regime, claiming that vastly higher drug prices would be associated with such patents.E Therefore, developing countries and the LDCs are apprehensive Of strong patent protection as it may be harmful to their pharmaceutical industries and may have
Historically, product patent protection was excluded in most developed countries as well. 37 For example, in France, product patent protection was prohibited under the law of 5 July 1844 and limited patent protection was only permitted on 2 January 1966.± In Germany, product patents were explicitly excluded under the law of 25 May 1877, but were then introduced from 4 September 1967.2 In Switzerland, product patents for pharmaceuticals were prohibited by the constitution and were only introduced in 1977.-u In Italy, pharmaceutical patents were prohibited until 1978.iL In Spain, product patents were introduced in 1986 just after its accession to the European Economic Community, and the relevant laws came into effect from 1992.2 The rationale behind the non-granting of product patent protection for pharmaceuticals in each of these example countries was to allow local pharmaceutical companies to imitate and produce patented medicines by using new processes.— Over the years, these developed countries gained self-sufficiency in pharmaceutical manufacturing and invested in which enabled and facilitated the transformation of their pharmaceutical industries into innovative and research-based industries by using imitated technology.± Now, given the advent Of TRIPS, the argument being mounted is that these countries are acting in a hypocritical way:they are supporting the implementation of IP protection for pharmaceuticals only after experiencing maturity for their own pharmaceutical industries.Lé For LDCs, the freedom to rely on imitated technology until such time as pharmaceutical production is at a similar stage of development—before the implementation of pharmaceutical patent protection—is no longer an option,E given the immediate obligation of WTO member countries to implement the TRIPS Agreement. In that context, the transitional period to implement the TRIPS Agreement or to implement the pharmaceutical patent provisions is quite meaningless for those countries that do not have the technological capabilities to produce generic pharmaceuticals.± Although Bangladesh is an LDC, it is in a somewhat unique position. Bangladesh has a considerable number Of generic producers who can reduce the price Of pharmaceuticals by utilizing the freedom Of imitation. Bangladesh
Bangladesh has a considerable number Of generic producers who can reduce the price of pharmaceuticals by utilising the freedom of imitation. Bangladesh also exports to the less regulated markets of Asia and Africa and to some countries in Europe. However, the apprehension is that after the introduction of pharmaceutical patents, as required by TRIPS, the local pharmaceutical industry will face the issue of survival. If the industry fails, there will be an effect on access to pharmaceuticals. Thus, multinationals and other large pharmaceutical companies in Bangladesh believe that by lowering protection for pharmaceuticals, Bangladesh has missed out on the opportunity to encourage an innovative and R&D-based Industry pharmaceutical emergencies and ensuring better access to medicines. In particular, three conflicting situations urgently raised the need to address ambiguity and inconsistency in the TRIPS agreement in the context of public health. First, in 1997 the South African government introduced the Medicines and Related Substances Control Act to ensure the availability and affordability of HIV/AIDS-related medicines. This law employed parallel imports and compulsory license, which triggered a legal battle between South Africa and 39 pharmaceutical companies, and involved strong pressure from the US government and trade bodies.±-é Second, in 2001 disputes erupted between the U.S. and Brazil regarding the compatibility Of the working requirements in the national patent law, in which the US government argued that the provision for granting compulsory licenses in case of the patent's non-working in Brazil within
the U.S. and Brazil regarding the compatibility Of the working requirements in the national patent law, in which the US government argued that the provision for granting compulsory licenses in case of the patent's non-working in Brazil within 3 years of its issuance was tantamount to a protective measure and hence inconsistent with the TRIPS Agreement.i-! Third, the anthrax scare after the September 11th, 2001 terrorist attack in New York had created a potential health threat, which caused developed countries like the U.S. and Canada to threaten to use compulsory licenses to stockpile an adequate supply of Cipro (an antibiotic used in the treatment of These measures by the US and Canada revealed "a hypocritical behavior [by them] in its eagerness to use the threat Of a compulsory license for what it perceived as a health emergency while on the other hand forcing developing countries to stick to restrictive patent laws in the face Of increasingly dire health crises" Considering the inconsistency and ambiguity Of how to define a national public health emergency, and on what grounds it might be permissible for a national v rnm n h TRIP A m n h
anthrax scare created an impetus to clarify TRIPS flexibilities. The African countries had a strong conviction that the TRIPS Agreement should not prevent them from using measures vital to ensure access to medicines and to fulfill
public health needsæ That is why the African group requested the TRIPS Council to arrange a special discussion on intellectual property and access to medicines.— During the discussion, the developing countries not only sought clarity through a declaration but support for their efforts to use the flexibilities in the TRIPS Agreement to deal with national public health needs.± But the meeting triggered strong protest from the U.S., which argued, along with Japan, Switzerland, Australia and Canada, that strict patent protection for pharmaceuticals was an important incentive for pharmaceutical innovation and hence vital for public health.± However, on 14 November 2001, the WTO Doha Ministerial Conference adopted a declaration on TRIPS and Public Health which offered a much-needed clarification, confirming that "the TRIPS Agreement does not and should not prevent members from taking measures to protect public health. Accordingly, the Agreement can and should be interpreted and implemented in a manner supportive of WTO
INTELLECTUAL PROPERTY AND PUBLIC HEALTH IN THE DEVELOPING WORLD
How come I can not patent a surgical procedure but a psychologist can copyright a survey instrument?
Did Chinese get royalties on paper and Gunpowder
Did Indians get rich on the invention of Zero and the decimal system?
"more restrictive intellectual property clauses were often accepted in exchange for foreign direct investment and technology transfers, as well as better trade balances, but in fact “they may allow right-holders to block competition and charge high prices in monopolistically controlled markets.”
“This may lead to particularly serious effects in the area of public health, where unsustainably high prices have become an issue of global concern.”
“Early in the AIDS epidemic, the US badly damaged its international credibility by standing with prescription corporations against people living with HIV and AIDS. Millions of people died for lack of access to existing treatment. We must learn from our mistakes,”
The establishment of the WTO has been an important exercise in a number of ways. First, it represents an entirely new chapter in the jurisprudence of post-World War II international organizations through the establishment of a multilateral trading system that provides a binding dispute settlement mechanism for its members.u Second, the WTO has also undertaken the onerous task of evolving a binding law of international trade among the member countries.u Third, the WTO has in many ways replaced the internal sovereignty of the member countriesæ This is because every member is required to adjust its domestic laws to conform to the WTO agreements.æ Indeed, as a founding member, Bangladesh's legal system has been subject to reorganization to satisfy the requirements Of the W TO.Z-Q The TRIPS Agreement is one of the most controversial agreements of the Uruguay Round in terms of its objectives and consequences, which established global minimum standards of IPR protection. It represents a major departure from previous international IPR treaties and agreements, which aimed not to standardize IPR legislation between countries but to guarantee non-discrimination under
to earlier international IPR agreements in three important ways. First, TRIPS makes it mandatory for WTO members to provide existing types of IPR protection that include patents, copyright, trademarks, trade secrets, industrial designs, layout designs for integrated circuits, and geographical indications, which removed the flexibilities in previous IPR agreements regarding the granting of [PRs based on the stage Of development Of a particular countryæ Second, it specifies the minimum standards for national IPR legislation, such as the extent of coverage, the terms of protection and the mechanisms for enforcement. Third, it brings national IPR legislation under the coverage of the WTO's dispute settlement procedures, which include the option of cross-retaliation in cases of non-compliance.
The TRIPS Agreement was the brainchild of an industry coalition of developed nations including the US, the European Union (EU) and Japan. The main impetus for the agreement came from the pharmaceutical, software and entertainment industries, with the chief executive officer (CEO) of Pfizer playing a lead role as chair of the Intellectual Property Rights Committee (IPC).2 The IPC was created during the Uruguay Round of negotiations with the goal of putting IPRs firmly on the agendaæ The pharmaceutical industry was primarily interested in eliminating what it felt was unfair discrimination against the patenting Of medicines, but it was also motivated to try to gain control over uses Of its clinical and regulatory data to delay registration of generic equivalents—in essence seeking another form of exclusive rights. One of the arguments advanced by the developed countries for including IPRs in the negotiations was that stronger IPRs would create an incentive for innovation and would stimulate the development of new technologies, such as patent protection for pharmaceuticals.æ This incentive for innovation would consequently encourage greater domestic and foreign investment in research into new pharmaceuticals and tropical The argument propounded was that foreign investment and technology transfer would, in turn, benefit developing
increase in research and development (R&D) investment by enterprises in developing countries because Of the non-existence Of technical infrastructure and financial and human resources. That is why "the non-patentability Of pharmaceutical products existing prior to the TRIPS Agreement gave developing countries the opportunity to progress and to acquire basic technology through reverse engineering before being able to invest in Consequently, almost 50 developing countries, which were not granted patent protection for pharmaceuticals during the Uruguay Round, fiercely resisted including pharmaceuticals under the patent regime, claiming that vastly higher drug prices would be associated with such patents.E Therefore, developing countries and the LDCs are apprehensive Of strong patent protection as it may be harmful to their pharmaceutical industries and may have
Historically, product patent protection was excluded in most developed countries as well. 37 For example, in France, product patent protection was prohibited under the law of 5 July 1844 and limited patent protection was only permitted on 2 January 1966.± In Germany, product patents were explicitly excluded under the law of 25 May 1877, but were then introduced from 4 September 1967.2 In Switzerland, product patents for pharmaceuticals were prohibited by the constitution and were only introduced in 1977.-u In Italy, pharmaceutical patents were prohibited until 1978.iL In Spain, product patents were introduced in 1986 just after its accession to the European Economic Community, and the relevant laws came into effect from 1992.2 The rationale behind the non-granting of product patent protection for pharmaceuticals in each of these example countries was to allow local pharmaceutical companies to imitate and produce patented medicines by using new processes.— Over the years, these developed countries gained self-sufficiency in pharmaceutical manufacturing and invested in which enabled and facilitated the transformation of their pharmaceutical industries into innovative and research-based industries by using imitated technology.± Now, given the advent Of TRIPS, the argument being mounted is that these countries are acting in a hypocritical way:they are supporting the implementation of IP protection for pharmaceuticals only after experiencing maturity for their own pharmaceutical industries.Lé For LDCs, the freedom to rely on imitated technology until such time as pharmaceutical production is at a similar stage of development—before the implementation of pharmaceutical patent protection—is no longer an option,E given the immediate obligation of WTO member countries to implement the TRIPS Agreement. In that context, the transitional period to implement the TRIPS Agreement or to implement the pharmaceutical patent provisions is quite meaningless for those countries that do not have the technological capabilities to produce generic pharmaceuticals.± Although Bangladesh is an LDC, it is in a somewhat unique position. Bangladesh has a considerable number Of generic producers who can reduce the price Of pharmaceuticals by utilizing the freedom Of imitation. Bangladesh
Bangladesh has a considerable number Of generic producers who can reduce the price of pharmaceuticals by utilising the freedom of imitation. Bangladesh also exports to the less regulated markets of Asia and Africa and to some countries in Europe. However, the apprehension is that after the introduction of pharmaceutical patents, as required by TRIPS, the local pharmaceutical industry will face the issue of survival. If the industry fails, there will be an effect on access to pharmaceuticals. Thus, multinationals and other large pharmaceutical companies in Bangladesh believe that by lowering protection for pharmaceuticals, Bangladesh has missed out on the opportunity to encourage an innovative and R&D-based Industry pharmaceutical emergencies and ensuring better access to medicines. In particular, three conflicting situations urgently raised the need to address ambiguity and inconsistency in the TRIPS agreement in the context of public health. First, in 1997 the South African government introduced the Medicines and Related Substances Control Act to ensure the availability and affordability of HIV/AIDS-related medicines. This law employed parallel imports and compulsory license, which triggered a legal battle between South Africa and 39 pharmaceutical companies, and involved strong pressure from the US government and trade bodies.±-é Second, in 2001 disputes erupted between the U.S. and Brazil regarding the compatibility Of the working requirements in the national patent law, in which the US government argued that the provision for granting compulsory licenses in case of the patent's non-working in Brazil within
the U.S. and Brazil regarding the compatibility Of the working requirements in the national patent law, in which the US government argued that the provision for granting compulsory licenses in case of the patent's non-working in Brazil within 3 years of its issuance was tantamount to a protective measure and hence inconsistent with the TRIPS Agreement.i-! Third, the anthrax scare after the September 11th, 2001 terrorist attack in New York had created a potential health threat, which caused developed countries like the U.S. and Canada to threaten to use compulsory licenses to stockpile an adequate supply of Cipro (an antibiotic used in the treatment of These measures by the US and Canada revealed "a hypocritical behavior [by them] in its eagerness to use the threat Of a compulsory license for what it perceived as a health emergency while on the other hand forcing developing countries to stick to restrictive patent laws in the face Of increasingly dire health crises" Considering the inconsistency and ambiguity Of how to define a national public health emergency, and on what grounds it might be permissible for a national v rnm n h TRIP A m n h
anthrax scare created an impetus to clarify TRIPS flexibilities. The African countries had a strong conviction that the TRIPS Agreement should not prevent them from using measures vital to ensure access to medicines and to fulfill
public health needsæ That is why the African group requested the TRIPS Council to arrange a special discussion on intellectual property and access to medicines.— During the discussion, the developing countries not only sought clarity through a declaration but support for their efforts to use the flexibilities in the TRIPS Agreement to deal with national public health needs.± But the meeting triggered strong protest from the U.S., which argued, along with Japan, Switzerland, Australia and Canada, that strict patent protection for pharmaceuticals was an important incentive for pharmaceutical innovation and hence vital for public health.± However, on 14 November 2001, the WTO Doha Ministerial Conference adopted a declaration on TRIPS and Public Health which offered a much-needed clarification, confirming that "the TRIPS Agreement does not and should not prevent members from taking measures to protect public health. Accordingly, the Agreement can and should be interpreted and implemented in a manner supportive of WTO
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