The WTO Medicines Decision: World Pharmaceutical Trade and the Protection of Public Health

2005 ◽  
Vol 99 (2) ◽  
pp. 317-358 ◽  
Author(s):  
Frederick M. Abbott
Keyword(s):  
Public Health ◽  
Intellectual Property Rights ◽  
World Trade ◽  
Access To Medicines ◽  
Trips Agreement ◽  
Compulsory Licensing ◽  
The World ◽  
Effective Use ◽  
Pharmaceutical Trade ◽  
Doha Declaration

On November 14,2001, the Ministerial Conference of the World Trade Organization, meeting in Doha, Qatar, adopted the Declaration on the TRIPS Agreement and Public Health (Doha Declaration). The declaration affirms that the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights “can and should be interpreted and implemented in a manner supportive of WTO Members’ right to protect public health and, in particular, to promote access to medicines for all,” and it reaffirms that the Agreement “provide[s] flexibility for this purpose.” The Doha Declaration mandated further negotiations on one important subject, providing in its paragraph 6: “We recognize that WTO Members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement. We instruct the Council for TRIPS to find an expeditious solution to this problem … .“

Compulsory Licensing in Canada and Thailand: Comparing Regimes to Ensure Legitimate Use of the WTO Rules

2009 ◽  
Vol 37 (2) ◽  
pp. 222-239 ◽  
Author(s):  
Kristina M. Lybecker ◽  
Elisabeth Fowler
Keyword(s):  
Developing Countries ◽  
Intellectual Property ◽  
Intellectual Property Rights ◽  
World Trade ◽  
Trips Agreement ◽  
Essential Medicines ◽  
Compulsory Licensing ◽  
The World ◽  
Aids Crisis ◽  
Doha Declaration

The tension between economic policy and health policy is a longstanding dilemma, but one that was brought to the fore with the World Trade Organization’s (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement in 1994. The pharmaceutical industry has long argued that intellectual property protection (IPP) is vital for innovation. At the same time, there are those who counter that strong IPP negatively impacts the affordability and availability of essential medicines in developing countries. However, actors on both sides of the debate were in agreement that something needed to be done to address the HIV/AIDS crisis, especially in developing countries. In response to sustained and significant pressure from civil society groups, members of the World Trade Organization agreed to the Declaration on the TRIPS Agreement and Public Health (the Doha Declaration) in 2001. The Declaration clarified that countries unable to manufacture the needed pharmaceuticals could obtain more affordable generics elsewhere if necessary.

Spain: Law 60/2003 of December 23, 2003 on Arbitration

2004 ◽  
Vol 43 (2) ◽  
pp. 484-508
Keyword(s):  
Public Health ◽  
World Trade Organization ◽  
World Trade ◽  
Trips Agreement ◽  
General Council ◽  
Pharmaceutical Sector ◽  
Compulsory Licensing ◽  
The World ◽  
Effective Use

Having regard to paragraphs 1, 3 and 4 of Article IX of the Marrakesh Agreement Establishing the World Trade Organization ("the WTO Agreement");Conducting the functions of the Ministerial Conference in the interval between meetings pursuant to paragraph 2 of Article IV of the WTO Agreement;Noting the Declaration on the TRIPS Agreement and Public Health (WT/MIN(01)/DEC/2) (the "Declaration") and, in particular, the instruction of the Ministerial Conference to the Council for TRIPS contained in paragraph 6 of the Declaration to find an expeditious solution to the problem of the difficulties that WTO Members with insufficient or no manufacturing capacities in the pharmaceutical sector could face in making effective use of compulsory licensing under the TRIPS Agreement and to report to the General Council before the end of 2002;

scholarly journals THE IMPACT OF TRIPS AGREEMENT ON ACCESS TO MEDICINES IN DEVELOPING COUNTRIES: LEGAL CHALLENGES FACED BY THE PHARMACEUTICAL INDUSTRY PARTICULARLY IN INDIA

2012 ◽  
Author(s):  
Kamini Shanmugaiah
Keyword(s):  
Public Health ◽  
Developing Countries ◽  
Intellectual Property ◽  
Pharmaceutical Industry ◽  
Intellectual Property Rights ◽  
Access To Medicines ◽  
Trips Agreement ◽  
Compulsory Licensing ◽  
Legal Challenges ◽  
The Impact

The impact of intellectual property rights in particular patent relating to public health has posed numerous challenges faced by developing countries who are members of World Trade Organisation (WTO). This paper examines the impact of TRIPS Agreement (Trade Related Intellectual Property Rights) in relation to developing countries in general with specification made to India. Significant changes brought about by the TRIPS flexibilities in particular usage of compulsory licensing and Bolar provision have to a certain extent benefited the developing countries in the field of public health during national emergency. The TRIPS flexibilities by way of amendment have helped countries that (do not possess manufacturing capacities) to import medicines. Some developing countries even utilised TRIPS flexibilities in an aggressive manner to enforce their right to have access to medicines from other countries for the benefit of their citizens. Further, TRIPs flexibilities have helped developing countries to manufacture generic products to make it affordable to the people. This paper specifically examines the impact of the TRIPS Agreement on Indian generic pharmaceutical industry and the legal challenges faced by Indian pharmaceutical industry after the implementation of product patent regime effective from 1 January 2005. The Patent Amendment Act 2005(India) will be looked into especially on the controversy in respect of Section 3(d) of the Patent Amendment Act 2005(India) on the requirement of patentability. The new Section 92A of the Patent Amendment Act 2005(India) on the grounds to invoke compulsory licensing will be analysed to see whether Indian government has applied restrictive or broad approach, as compulsory licensing is certainly an important legal

scholarly journals Access to Medicines, BRICS Alliances, and Collective Action

2008 ◽  
Vol 34 (2-3) ◽  
pp. 345-394 ◽  
Author(s):  
Peter K. Yu
Keyword(s):  
World Trade ◽  
Trade Agreement ◽  
Developed Countries ◽  
Access To Medicines ◽  
Trips Agreement ◽  
Essential Medicines ◽  
Regional Trade ◽  
The World ◽  
Doha Declaration ◽  
Special Arrangement

On December 6, 2005, shortly before the World Trade Organization (“WTO”) Ministerial Conference in Hong Kong, WTO member states agreed to accept a protocol of amendment to the Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPs Agreement”). This amendment sought to provide a permanent solution to implement paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health (“Doha Declaration”). If ratified, the new article 31bis of the TRIPs Agreement will allow countries with insufficient or no manufacturing capacity to import generic versions of on-patent pharmaceuticals.To facilitate the supply of essential medicines to countries with insufficient or no manufacturing capacity, article 31bis(3) creates a special arrangement not only for the affected countries, but also for those belonging to a regional trade agreement. Such an arrangement allows less developed countries to aggregate their markets to generate the purchasing power needed to make the development of an indigenous pharmaceutical industry attractive.

The Use of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health (2001): A Review of Implementation Experiences in the Developing Countries

2012 ◽  
pp. 186-209
Author(s):  
Alexandra Bhattacharya
Keyword(s):  
Public Health ◽  
Developing Countries ◽  
Transition Period ◽  
Access To Medicines ◽  
Trips Agreement ◽  
Compulsory Licensing ◽  
Trade Regime ◽  
Council Decision ◽  
Internal Barriers ◽  
Doha Declaration

Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health (2001) recognized the difficulty of some WTO member states in using the compulsory licensing flexibility allowed in the TRIPS Agreement due to their lack of local pharmaceutical manufacturing capacities. However, there has been almost no implementation by countries of the subsequent WTO General Council decision of 30th August, 2003 which was designed to resolve this Paragraph 6 issue. This is due to the existence of various impediments – generally in the form of external and internal barriers. A comparative analysis is undertaken of the implementation of the Council Decision in two countries with varying levels of development and with different obligations with regards to enforcement of the TRIPS Agreement. It is shown that external barriers such as proliferation of bilateral agreements have more impeding effect on developing countries such as South Africa which are already part of the full TRIPS compliance regime. Conversely, internal barriers such as institutional and structural drawbacks have more of an impact in Least Developing Countries (LDCs) such as Bangladesh which have been given a transition period for TRIPS compliance and are not yet fully susceptible to external pressures of the international trade regime. The increased preference of countries to use alternative innovative mechanisms such as the Medicines Patent Pool to improve access to medicine outside the framework of the global IP/Trade regime reiterates the unworkability of the Council Decision in promoting access to medicines.

scholarly journals Ch.7 Geographical Indications

2020 ◽  
Author(s):  
Correa Carlos Maria
Keyword(s):  
Intellectual Property Rights ◽  
World Trade ◽  
Geographical Area ◽  
Trips Agreement ◽  
Geographical Indications ◽  
The World ◽  
Basic Functions ◽  
The One ◽  
International Conventions ◽  
Paris Convention

This chapter describes how the adoption of the Trade-related Aspects of Intellectual Property Rights (TRIPS) Agreement represented an important step for the international recognition of geographical indications. Geographical indications have three basic functions. They provide information about the name of a product; the geographical origin of the product; and a given quality, reputation, or characteristics attributable to a geographical area. Although such indications were covered under some prior international conventions—such as the Paris Convention, the Madrid Agreement, and the Lisbon Agreement—the scope and membership of such conventions offered a protection considerably more limited than the one granted by the TRIPS Agreement. However, significant controversies still dominate the discussion of this issue at the World Trade Organization (WTO). In particular, disagreement exists about the modes of implementing the registration of geographical indications under Article 23.4 of the Agreement. Moreover, a number of developed and developing countries have proposed to expand to other products the special protection only available today for wines and spirits.

scholarly journals COMPULSORY LICENSING MECHANISM UNDER INTERNATIONAL AND NATIONAL LAW

2019 ◽  
Vol 23 (1) ◽  
pp. 62-79
Author(s):  
Aslan H Abashidze ◽  
Vladislav S Malichenko
Keyword(s):  
Access To Medicines ◽  
Russian Government ◽  
Strong Argument ◽  
Compulsory Licensing ◽  
The World ◽  
Life Threatening ◽  
Price Negotiations ◽  
The Impact ◽  
Doha Declaration

The article highlights the main steps in the formation of compulsory licensing mechanism before the establishment of the World Trade Organization, and analyzes the main provisions of this mechanism implementation under the TRIPS Agreement and the Doha Declaration. Based on the analysis of examples from different regions of the world, the article determines the main advantages of using compulsory licensing with regard to expand of access to medicines, possible impact on quality of the medicinal products being produced and the investment attractiveness of the countries applying this mechanism are assessed. The purpose of this article is to analyze the main approaches to the implementation of compulsory licensing in order to determine the most effective strategy for using this mechanism in the Russian Federation in order to expand the availability of drug therapy for the treatment of life-threatening diseases. Based on the impact of compulsory licensing implementation, the author concludes that it does not correspond to the objectives of the Russian pharmaceutical industry development identified as a priority by Russian Government. Despite a possibility of using compulsory licensing under regulation of many countries, this mechanism is implemented rarely. A possibility of issuing a compulsory licensing is a strong argument in price negotiations with producers. According to the authors position, implementation of compulsory licensing has to be preceded by cost containment mechanism, primarily based on negotiations with producers.

IV. Intellectual Property

2001 ◽  
Vol 50 (3) ◽  
pp. 714-724
Author(s):  
Joe McMahon ◽  
Catherine Seville
Keyword(s):  
Intellectual Property ◽  
Property Rights ◽  
World Trade Organization ◽  
Intellectual Property Rights ◽  
World Trade ◽  
Trips Agreement ◽  
Global System ◽  
The World

This Journal's previous piece on current developments in EC intellectual property noted that this area of law is dominated by the drive towards harmonisation.1 This drive continues, and its success has been such that it can now begin to be seen in an overarching context of globalisation. The idea of a unified global system for the protection of intellectual property now seems at least conceivable, even if not immediately achievable. It is even possible to state that some stages have been achieved on the journey, most notably the TRIPs Agreement. Since adherence to this is a requirement of World Trade Organization (WTO) membership, the arguments in its favour have suddenly become “persuasive”. It represents a tremendous achievement in terms of the protection and enforcement of intellectual property rights throughout the world. The World Intellectual Property Organisation's contribution here and elsewhere has been immense.

The Treatment of Public Health Measures Affecting Intellectual Property Under Multilateral and Plurilateral Trade and Investment Agreements

2019 ◽  
Vol 20 (5) ◽  
pp. 759-783
Author(s):  
Mark Davison ◽  
Patrick Emerton
Keyword(s):  
Public Health ◽  
Intellectual Property ◽  
Intellectual Property Rights ◽  
World Trade ◽  
Health Measures ◽  
The World ◽  
Regulatory Measures ◽  
Investment Agreements ◽  
Indirect Reference ◽  
Trade And Investment

Abstract This article considers the interpretation of provisions in international economic agreements that protect intellectual property as they relate to public health measures, and in particular to restrictions on the use of tobacco trademarks. A series of decisions, most recently the World Trade Organization (WTO) panel decision holding that Australia’s plain packaging measures for tobacco products comply with WTO obligations, allow for some generalisations. These include: (1) the nature of intellectual property rights is to confer a privilege of exclusive use on the rights-holder; (2) the interpretation of generally-worded treaty provisions is apt to be informed by recognition of the power of States to regulate for the purposes of public health; and (3) where provisions contain their own specifically-worded balancing tests, any direct or indirect reference to regulation for public health contained in the treaty is likely to be treated as weighing very heavily in favour of the legality of regulatory measures.

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