Ethiopia's accession to WTO : its implication on access to affordable medicines

국문 초록 (Abstract)

무역관련지적재산권협정(TRIPS) 및 공중보건에 관한 세계무역기구(WTO)의 Doha 선언과 그 이후의 Paragraph 6 해석에 대한 결의문은 자국의 공중보건분야 특히 일반의약품에 대한 접근권을 보호하려는 회원국들에게 TRIPS의 신축성 (flexibilities)원칙을 확인시켰다.
이 논문은 이디오피아의WTO 가입에 따른 일반의약품 접근권에 대한 의미를 검토한다. 이디오피아의 WTO가입과 보건분야에 대한 함축을 바탕으로, TRIPS, Doha 선언, Paragraph 6 결의문 체제하의 신축성을 살펴본다. WTO 체제하에서의 신축성을 위해 필요한 법적 장치가 있다고 해도, 이디오피아의 제약산업은 제조능력이 없기 때문에 WTO에서 주창하는 유연성을 실현할 수가 없다. 이디오피아의 제약부문은 여러 가지 문제점에 직면하고 있는데 그 중에서 가장 큰 문제가 재정의 부족이다. 제대로 발전된 화학산업이 없을 뿐 아니라 전문인력의 결핍도 제약산업이 발달하지 못하게 된 원인이다.
더욱이 이디오피아의 특허법에 합당한 법적 장치가 없는 상황에서 또는 유연성 그 자체의 본질적 복잡성 때문에 이디오피아가 쌍방수입 (Parallel Importation) 같은 유연성을 실현하는 것은 어렵다는 점을 이 논문은 주장한다.

다국어 초록 (Multilingual Abstract)

The World Trade Organization’s Doha Declaration on the TRIPS agreement and Public health and subsequent Decision on the interpretation of Paragraph 6 affirmed the flexibilities available under the agreement on Trade Related Aspects of Intellectual property rights (TRIPS) to member states seeking to protect public health particularly access to affordable medicines.
The study reviews the possible implication of Ethiopia’s accession to the WTO on access to affordable medicines. The possible flexibilities that existed under the TRIPS, Doha declaration and Paragraph 6 decisions which are designed to enhance access to medicines are reviewed in light of their implementation to the health sector of Ethiopia upon acceding to the WTO.
While the necessary legal framework is available for most of the flexibilities under the WTO system, existing pharmaceutical industry in Ethiopia lacks a manufacturing capacity necessary the actual utilization of the flexibilities upon accession to the organization. The pharmaceutical sector is stranded with multifaceted challenges access to finance being at the top of the list. Absence of well-developed chemical industry as well as shortage of appropriate expertise has contributed to the underdevelopment of the industry.
Furthermore, the utilization of some of the flexibilities such as parallel importation is limited because of absence of the appropriate legal framework either in the Ethiopia’s patent law or due to the complex nature of the flexibilities themselves.

목차 (Table of Contents)

• I. INTRODUCTION 1
• A. Research questions 6
• B.Hypothesis 6
• C. Significance of the study 7
• D. Research Methodology and Analytical framework 8
• II. LITERATURE REVIEW 10
• A. The World Trade Organization 10
• B. Intellectual property rights (IPRs) 11
• C. Agreement on Trade Related Aspects of Intellectual Property (TRIPS) 12
• D. The Doha Declaration on the TRIPS Agreement and Public Health 16
• E. August 30, 2003, TRIPS Council Decision 17
• F. TRIPS and Public Health: the Debate 20
• III. IMPLICATIONS OF ETHIOPIA'S ACCESSION TO THE WTO ON ACCESS TO AFFORDABLE MEDICINES 26
• A. Background Information 26
• 1 .Geographical and Socio-Economic Information 26
• 2. Health Sector 27
• B. Implications of Accession to WTO on Access to Medicines 28
• 1. Accession and Patent Regime of Ethiopia 28
• 2. Possible Implications of Ethiopia's Accession to WTO on access to affordable drugs 31
• A. Compulsory License and Government Use of Inventions 38
• B. Paragraph 6 Decision 44
• C. Parallel Importation 47
• CONCLUSIONS 50
• RECOMMENDATIONS 52
• REFERENCES 54
• ABSTRACT IN KOREAN 61