HIV and AIDS in Africa: Compulsory Licensing Under TRIPS and DOHA Declaration

2010 ◽  
Author(s):  
Ufuoma Barbara Akpotaire
Keyword(s):  
Hiv And Aids ◽  
Compulsory Licensing ◽  
Doha Declaration

How Much Time Before Attempting Compulsory Licensing of Pharmaceuticals? A Non-parametric Event History Model With P-splines

2018 ◽  
Vol 49 (1) ◽  
pp. 68-84
Author(s):  
Kyung-Bok Son
Keyword(s):  
Intellectual Property ◽  
Global Justice ◽  
Learning By Doing ◽  
Event History ◽  
Global Marketing ◽  
Compulsory Licensing ◽  
Country Level ◽  
The Difference ◽  
Justice Movements ◽  
Doha Declaration

Compulsory licensing (CL), provided by the Agreement on Trade-Related Aspects of Intellectual Property Rights, enables countries, including high-income countries, to ensure the protection of public health in the context of stringent intellectual property regimes. This study investigated associations between the time to attempted CL and a series of factors at the drug and country level. We used a dataset of all attempted CL that occurred from 1995 to 2014, calculated the duration as the difference in years between the year of global marketing of a certain drug and the year of attempted CL in a certain country, and applied a nonparametric event history model. We found that the Doha Declaration was quite effective in shortening the time to attempted CL. Additionally, even though global justice movements have encouraged some countries to attempt CL for various medicines since 2012, the time to CL attempts in this period became significantly longer compared to those that occurred immediately after the Doha Declaration. Our findings show that the subject of CL has not successfully expanded to oncology medicines from HIV/AIDS medicines and that recently approved medicines are not yet subjects of CL. Furthermore, our duration model suggests a learning-by-doing effect in attempting CL: previous experience of CL not only triggers CL for the same drugs in other countries but also accelerates CL for other drugs within the country.

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.

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.

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 … .“

TRIPs and Access to Drugs

2002 ◽  
Vol 37 (3-4) ◽  
pp. 85-104
Author(s):  
Manmeet Singh
Keyword(s):  
Developing Countries ◽  
Ivory Coast ◽  
Point Of View ◽  
The Other ◽  
Compulsory Licensing ◽  
Parallel Importation ◽  
The Government ◽  
Indian Law ◽  
The Impact ◽  
Doha Declaration

The Paper seeks to e,xamine the impact of obligations under the TRIPs Agreement on access to drugs. The issue of access has been addressed from the point of view of pricing. The spirit of the Agreement is embodied in Articles 7 and 8 and the argument advanced is that the Agreement be interpreted in view of the same. The paper examines the various options available within the framework of the Agreement. The most popular of these is compulsory licensing However, doubts persist as to when it would be possible to take recourse to such a measure. The other possible options under the agreement such as parallel importation and the now popular "Bolar Exemption" have also been examined. The Doha Declaration was hailed as a victory for the developing countries. However, in retrospect it seems that the celebrations were premature. More than one-and-a-half year have passed since the Declaration and the issue is still shrouded in controversy and negotiations are under a deadlock. Further, access under the existing Indian regime has been dealt with. The Patents Amendment Act 2002, which was enacted to bring Indian law in conformity with the Agreement provided for some of the tools discussed in the paper. The need for a comprehensive pharmaceutical policy was recently addressed by the Government and whether the policy is an effective tool or not is the question which needs to be answered. “We are called pirates, but who is being pirated? Patients in countries where there is a monopoly on these drugs.” At present, Zimbabwe, Uganda and the Ivory Coast would require to spend 265 per cent, 172 per cent and 84 per cent of their respective GNPs, just to buy drugs to treat their AIDS patients.

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 PELAKSANAAN COMPULSORY LICENSING PATEN OBAT-OBATAN BIDANG FARMASI DI INDONESIA DIKAITKAN DENGAN DOHA DECLARATION ON THE TRIPS AGREEMENT AND PUBLIC HEALTH

2017 ◽  
Author(s):  
Samariadi
Keyword(s):  
Public Health ◽  
Pharmaceutical Industry ◽  
Research Methods ◽  
Legal Research ◽  
Compulsory Licensing ◽  
Legal Reforms ◽  
Patent Medicines ◽  
The Government ◽  
Formulation Problem ◽  
Doha Declaration

Purpose of this study is firstly to find out implementation of compulsory licensing patent medicines in Indonesia’s pharmaceutical field linked Declaration DOHA, secondly to know resistance implementation of compulsory licensing to access drug in Indonesia, thirdly to know efforts should be done in implementation compulsory licensing as to support access public health. Author used legal research methods to get the result. Results of formulation problem, it can be concluded that, firstly implementation of compulsory licensing in Indonesia is still not maximized because only implement patent by the government alone, secondly obstacles in the implementation of covering obstacles in juridical aspect and non-juridical, thirdly attempts that should be done is to implement both compulsory licensing program which has been legalized by Indonesian patent legislation. Advice from author, firstly there should be legal reforms in Act Patent to enhance the article fully support access to public health, secondly their efforts to optimize pharmaceutical industry through appointment of other pharmaceutical industry to produce drugs Antiretroviral besides chemical pharma, thirdly government should enhance further technical provisions of compulsory licensing programs such as compulsory licenses, in order to assist the government to implement the mandate of the 1945 task in fulfilling rights of all people.

scholarly journals GOOD FAITH IN TRIPS COMPULSORY LICENSING OF PHARMACEUTICAL PATENTS: LESSONS FROM PREVIOUS PANDEMIC CASES

2021 ◽  
Vol 3 (2) ◽  
pp. 85-110
Author(s):  
Muhammad Ardiansyah Arifin
Keyword(s):  
Legal Framework ◽  
Good Faith ◽  
Vienna Convention ◽  
Patent Holder ◽  
Pharmaceutical Patents ◽  
Compulsory Licensing ◽  
Constitutional Review ◽  
Doing Business ◽  
Alternative Measures ◽  
Doha Declaration

The COVID-19 pandemic impacts the world of patents as countries prepare their legal framework to ease the process of compulsory licensing. Some like India and South Africa even went further by proposing a suspension for patents needed to combat COVID-19 which is still under discussion. It is a real possibility that a patented drug that is effective against COVID-19 would potentially see compulsory licensing in many countries its patent holder is doing business. This article discusses why compulsory licensing is an essential issue by examining its legitimacy, previous cases of compulsory licensing, and the conduct of states in cases of compulsory licensing issuance, particularly in examples of Thailand, Brazil, and India. The article will examine ways of remedy against compulsory licensing, including a theoretical possibility for constitutional review of treaties. The remedies discussed shall include international and domestic remedies, both litigation and alternative measures. The research shall use qualitative research methods with the use of primary and secondary legal sources. The result of this article found that a combination of soft law power of the Doha Declaration and the invocation of subsequent compulsory licensing cases be the support pillars of compulsory licensing practice. However, the practice of compulsory licensing both by the patent holder and the state actors is still not performed entirely in good faith according to the Vienna Convention of the Law of Treaties (VCLT) 1969 and the TRIPS Agreement. Hence, such patent holders need to be familiar with both international and domestic remedies, especially the possibility for constitutional review of treaties remedies.

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