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Intellectual Property and Public Health in the Developing World

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Monirul Azam

Abstract

Texte intégral

1This study explored how to design national patent laws and undertake the required institutional and infrastructural reforms that are optimal in terms of enabling developing countries and Least Developed Countries to promote innovation in their domestic pharmaceutical sectors and ensure access to medicines. Individual countries were free to determine their own patent laws prior to the establishment of the World Trade Organization. However, the Agreement on Trade-related Aspects of Intellectual Property Rights (the TRIPS Agreement), which is binding on all WTO members, aims at establishing strong minimum standards for intellectual property rights. Such minimum standards include the implementation of patent protection for pharmaceuticals. Bangladesh is a member of the WTO and, as an LDC, has been granted transitional periods until 1 July 2021 to protect IPRs under the TRIPS Agreement. Further, being an LDC, Bangladesh can also exploit the waiver for pharmaceutical patents until 1 January 2033. This study analyses experiences of implementing TRIPS-compliant patent laws in Brazil, China, India and South Africa, and explores potential policy options for the LDCs with a case study on the pharmaceutical sector in Bangladesh.

2Bangladesh has attained a degree of self-sufficiency with respect to the manufacture of pharmaceuticals: local industry now caters for 97% of local needs via the production of generic medicines that are free from the patent regime. However, this policy has both disadvantages and advantages. One advantage is the availability of lower-priced pharmaceuticals, and one disadvantage is that Bangladesh missed out on the opportunity to develop an innovative research and development (R&D)-based pharmaceutical industry. Further, the lack of a pharmaceutical patent regime over the years has created a vacuum in terms of the existence of relevant regulatory bodies (Patent Offices and the Directorate General of Drug Administration) and has also led to the local pharmaceutical industry being unprepared for the post-TRIPS situation. Brazil, China, India and South Africa were in a similar position prior to becoming TRIPS compliant, so those countries’ experiences are an important basis for the analysis of the transition to TRIPS compliance in pre-compliant countries. This study combines doctrinal analysis, comparative reviews and a case study, using a survey and interviews to answer specific research questions.

3The study examines three underlying research questions:

  1. What are the policy options used by Brazil, China, India and South Africa for the implementation of the TRIPS Agreement and preservation of the local pharmaceutical sector?

  2. What are the (potential) policies for the LDCs (such as Bangladesh) to promote their local pharmaceutical industry and access to medicines?

  3. What are the infrastructural and institutional issues that need to be addressed by the LDCs to deal with a post-TRIPS patent regime?

4To answer research question 1, the study used doctrinal analysis and comparative reviews, whereas to answer research question 2 it conducted a case study in selected LDCs (Bangladesh) using a survey instrument and interviews to examine the views of identified stakeholders such as the pharmaceutical industry, regulatory bodies in Bangladesh, public health groups and academics. Then, considering the findings in relation to research questions 1 and 2, and the perceptions of different stakeholders, this study further identified infrastructural and institutional issues that need to be addressed by the LDCs (such as Bangladesh) to deal with a post-TRIPS patent regime.

5This research makes a contribution to the body of knowledge on TRIPS and intellectual property in four ways, as this study:

  • analyses the contemporary literature examining TRIPS and its effect on access to medicines in developing countries and the LDCs, particularly India, Brazil, China, South Africa and Bangladesh;

  • presents a case study using a survey and interviews to evaluate the status of the pharmaceutical industry and perceptions of other stakeholders regarding TRIPS and its implementation in Bangladesh;

  • produces recommendations that may facilitate the utilisation of TRIPS flexibilities in the LDCs, such as Bangladesh, and

  • identifies the infrastructural and institutional issues that need to be addressed by Bangladesh in a post-TRIPS patent regime, efforts which may also be replicated by other developing countries and the LDCs.

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