The TRIPS compulsory licensing regime and access to medicines

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.

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Negative-Emission Technologies and Patent Rights after COVID-19

Climate Law ◽

10.1163/18786561-10030001 ◽

2020 ◽

Vol 10 (3-4) ◽

pp. 225-265

Author(s):

Joshua D. Sarnoff

Keyword(s):

Access To Medicines ◽

Private Funding ◽

Compulsory Licensing ◽

Patent Pools ◽

Ex Post ◽

Patent Rights ◽

Ex Ante ◽

The Cost ◽

National Governments ◽

Negative Emission Technologies

Abstract Governmental and particularly private funding has recently and dramatically expanded for both beccs and dac technologies. This funding and the associated research, development, and deployment efforts will generate intellectual property rights, particularly patent rights in nets. As with access to medicines, the COVID-19 pandemic has highlighted concerns that patent rights may incentivize RD&D at the cost of affordable access to the relevant technologies. Further, access may be restricted to particular countries based on sovereignty concerns to seek preferential supply agreements through up-front funding. As a result, nations will likely turn to controversial ex-post measures, such as compulsory licensing, to assure access and to control prices of the needed technologies. The same concerns with patent rights likely will affect RD&D of nets. Although international ex-ante measures exist (such as patent pools) which would help to minimize these concerns, such measures may not induce the requisite voluntary contributions, or may fail to materialize due to political disagreements. Focusing on both US law and international developments, this article proposes various ex-ante measures that can be adopted by national governments and private funders to minimize the likely forthcoming worldwide conflicts that will arise over balancing innovation incentives for, and affordable access to, patented nets.

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COMPULSORY LICENSING AND ACCESS TO MEDICINES IN POST DOHA ERA: WHAT HOPE FOR AFRICA?

Netherlands International Law Review ◽

10.1017/s0165070x08000338 ◽

2008 ◽

Vol 55 (01) ◽

Cited By ~ 3

Author(s):

Ebenezer Durojaye

Keyword(s):

Access To Medicines ◽

Compulsory Licensing

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TRIPS to Where? A Narrative Review of the Empirical Literature on Intellectual Property Licensing Models to Promote Global Diffusion of Essential Medicines

Pharmaceutics ◽

10.3390/pharmaceutics14010048 ◽

2021 ◽

Vol 14 (1) ◽

pp. 48

Author(s):

Shiri Mermelstein ◽

Hilde Stevens

Keyword(s):

Intellectual Property ◽

Access To Medicines ◽

Essential Medicines ◽

Empirical Literature ◽

Future Research ◽

Middle Income ◽

Compulsory Licensing ◽

Parallel Import ◽

Policy Tool ◽

Trade Offs

Governed through the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) since 1995, the current medical R&D system requires significant trade-offs between innovation and high monopoly prices for patented drugs that restrict patient access to medicines. Since its implementation, few amendments have been made to the original TRIPS agreement to allow low- and middle-income countries (LMICs) to facilitate access by generic manufacturers through flexible provisions, such as compulsory licensing and parallel import. Although a useful policy tool in theory, the routine use of TRIPS flexibilities in LMICs in the procurement of new essential medicines (EMs) is regarded as a ‘last resort’ due to strong political response in high-income countries (HICs) and new trade agreements’ restrictions. In this context, access-oriented biomedical Public-Private Partnerships (PPPs) have emerged. More recently, leading multilateral health organizations have recommended different types of intellectual property (IP) interventions, voluntary biomedical patent pools, as strategies to reduce prices and increase the diffusion of novel EMs in LMICs. Nevertheless, the recent Ebola and COVID-19 outbreaks highlight growing concerns regarding the use of TRIPS flexibilities and the limited success of voluntary mechanisms in promoting access to medicines in the Global South amidst health crises. This review aims at describing the state-of-the-art empirical research on IP-related options and voluntary mechanisms applied by emerging PPPs to guarantee timely and affordable access to EM in LMICs and reflect on both models as access paradigms. Some suggestions are put forward for future research paths on the basis of these analyses and in response to contemporary debates on waiving key IP rights on COVID-19 therapies, diagnostics, and vaccines.

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The TRIPS Article 31 Tug of War Developing Country Compulsory Licensing of Pharmaceutical Patents and Developed Country Retaliation

10.31228/osf.io/6cxaj ◽

2018 ◽

Author(s):

Lucas Volman

Keyword(s):

Developing Countries ◽

International Law ◽

Free Trade Agreements ◽

Developed Countries ◽

Access To Medicines ◽

Developed Country ◽

Pharmaceutical Patents ◽

Compulsory Licensing ◽

The Right ◽

Restrictive Measures

My dissertation examines compulsory licensing under Article 31 of the TRIPS Agreement by looking at the use of such licensing by developing countries, as well as retaliatory and restrictive measures imposed by developed countries. In doing so, it looks at the right to health, and price and intellectual property considerations for access to medicines in developing countries. It further explores the TRIPS compulsory licensing rules themselves to present compulsory licensing as a legitimate, and at times necessary, policy measure under international law. Then, it examines how compulsory licensing has been used and restricted since TRIPS, and how the compulsory licence relates to voluntary licensing and international free trade agreements, both of which are factors for the development of compulsory licensing strategies in developing countries.

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

The American Journal of International Law ◽

10.2307/1562501 ◽

2005 ◽

Vol 99 (2) ◽

pp. 317-358 ◽

Cited By ~ 58

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 … .“

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COVID-19, IP and access: Will the current system of medical innovation and access to medicines meet global expectations?

Journal of Generic Medicines The Business Journal for the Generic Medicines Sector ◽

10.1177/1741134321993182 ◽

2021 ◽

Vol 17 (2) ◽

pp. 61-70

Author(s):

Olga Gurgula ◽

Wen H Lee

Keyword(s):

Public Health ◽

Open Innovation ◽

Current System ◽

Access To Medicines ◽

Medical Innovation ◽

Short Term ◽

Compulsory Licensing ◽

The Past ◽

Innovation Model

The COVID-19 pandemic has exposed the fundamental flaws in the current system of medical innovation and access to medicines, which require urgent attention from the global community. This is prompted by the experience of the past decades, which has proven that this system was ineffective in securing adequate access to medicines for all. The understanding of the deficiencies of the existing system is crucial today, as it may help to design effective approaches for improving access. This article will also consider mechanisms that may be implemented by governments for the protection of public health. These include short-term mechanisms, such as compulsory licensing and government use, as well as the long-term design of a new innovation model, including state-coordinated research of medicines and open innovation. The current system should be reconsidered to ensure the prompt development of COVID-19 therapy accessible to everyone and full preparedness for the pandemics of the future.

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