Globalization and Access to Drugs - Health Economics and Drugs Series, No. 007: PART I: GLOBALIZATION AND ACCESS TO DRUGS: IMPLICATIONS OF THE WTO/TRIPS AGREEMENT: 2. Reading the TRIPS Agreement from the perspective of access to drugs: 2.8 How can the monopoly be limited?

Globalization and Access to Drugs - Health Economics and Drugs Series, No. 007
(1998; 97 pages) [French] [Spanish]

Table of Contents

Acknowledgements
Abbreviations and acronyms
PART I: GLOBALIZATION AND ACCESS TO DRUGS: IMPLICATIONS OF THE WTO/TRIPS AGREEMENT
	Executive summary
	Introduction
	1. Brief historical background to the international trading system
		1.1 The simultaneous creation of the GATT, the IMF and the World Bank
		1.2 The objectives, nature and functioning of the GATT
			Objectives
			Nature
			Obligations of the contracting parties
			The “Rounds”
		1.3 The Uruguay Round and the creation of the WTO
			The new global economic environment
			Long and difficult negotiations
			The results of the Uruguay Round: strengthening and enlargement of the multilateral trade system
			How does the WTO differ from the GATT?
		1.4 The protection of intellectual property rights before the WTO
	2. Reading the TRIPS Agreement from the perspective of access to drugs
		2.1 General presentation of the Agreement
		2.2 Fundamental principles and objectives of the Agreement: the necessary balance between intellectual property and accessibility
		2.3 Patents for pharmaceutical products and processes available all over the world
		2.4 Non-patentable inventions: biotechnology inventions
		2.5 Effects of protection: a monopoly of working for 20 years
			Attenuation of the monopoly through exhaustion of rights
			Strengthening the monopoly through the patenting of processes
			Extension of the duration of the monopoly
		2.6 Application of the TRIPS Agreement
			For industrialized countries: 1996
			For developing countries: 2000 or 2005
			For least-developed countries: 2006
		2.7 During the transitional period
			Establishment of a “mail-box” in 1995
			Possibility of exclusive marketing rights
			What happens to existing patents?
		2.8 How can the monopoly be limited?
			Exceptions
			Compulsory licences
	3. Conclusions: issues at stake and constraints on access to drugs
		3.1 The drug patents debate
		3.2 Some recommendations
	Definitions and terminology⁴
	Selected bibliography⁵
		GATT/WTO and the TRIPS Agreement
		The TRIPS Agreement and pharmaceutical products
		Country studies
PART II: PRESENTATIONS AT THE AD HOC WORKING GROUP ON THE REVISED DRUG STRATEGY HELD IN GENEVA ON 13 OCTOBER 1998
	1. Speech of the WHO Director-General, Dr Gro Harlem Brundtland
	2. World Intellectual Property Organization (WIPO)
	3. World Trade Organization (WTO)
		3.1 Pharmaceutical Patents and the TRIPS Agreement
		3.2 Overview of the WTO Agreement on Technical Barriers to Trade
	4. South Centre
	5. Health Action International (HAI)
	6. International Federation of Pharmaceutical Manufacturers Associations (IFPMA)
	7. International Generic Pharmaceutical Alliance (IGPA)
Other documents in the DAP - Health Economics and Drugs Series
Back cover

2.8 How can the monopoly be limited?

The anxieties and the extent of the reactions generated by the TRIPS Agreement are related to the requirement, new for some Member States, to recognize that the owners of new know-how in the pharmaceutical field are entitled to a monopoly of 20 years. Several experts from developing and developed countries fear a substantial increase in drug prices in countries that did not grant patents in the past.

However, the TRIPS Agreement expressly provides two means of obtaining exceptions and limiting the exclusive rights conferred by the patent on its owner. These two provisions may be used to ensure greater accessibility to essential drugs.