Globalization and Access to Drugs. Perspectives on the WTO/TRIPS Agreement - Health Economics and Drugs Series, No. 007 (Revised)
(1998; 97 pages) [French] [Spanish] View the PDF document
Table of Contents
View the documentAcknowledgements
View the documentAbbreviations and acronyms
Close this folderPART I: GLOBALIZATION AND ACCESS TO DRUGS: IMPLICATIONS OF THE WTO/TRIPS AGREEMENT
View the documentExecutive summary
View the documentIntroduction
Open this folder and view contents1. Brief historical background to the international trading system
Close this folder2. Reading the TRIPS Agreement from the perspective of access to drugs
View the document2.1 General presentation of the Agreement
View the document2.2 Fundamental principles and objectives of the Agreement: the necessary balance between intellectual property and accessibility
View the document2.3 Patents for pharmaceutical products and processes available all over the world
View the document2.4 Non-patentable inventions: biotechnology inventions
Open this folder and view contents2.5 Effects of protection: a monopoly of working for 20 years
Close this folder2.6 Application of the TRIPS Agreement
View the documentFor industrialized countries: 1996
View the documentFor developing countries: 2000 or 2005
View the documentFor least-developed countries: 2006
Open this folder and view contents2.7 During the transitional period
Open this folder and view contents2.8 How can the monopoly be limited?
Open this folder and view contents3. Conclusions: issues at stake and constraints on access to drugs
View the documentDefinitions and terminology4
Open this folder and view contentsSelected bibliography5
Open this folder and view contentsPART II: PRESENTATIONS AT THE AD HOC WORKING GROUP ON THE REVISED DRUG STRATEGY HELD IN GENEVA ON 13 OCTOBER 1998
View the documentOther documents in the DAP - Health Economics and Drugs Series
View the documentBack cover
 
For developing countries: 2000 or 2005

Developing countries have a period of transition of five years in which to meet all the obligations incumbent upon them under the Agreement, with the exception of non-discrimination between nationals and foreigners (national treatment), or between different foreign nationals (MFN treatment). By the year 2000, they should have introduced into their national regulations on intellectual property the various rules of the Agreement they accepted by acceding to the WTO.

However, the Agreement grants a further derogation to developing countries that did not issue patents before they joined the WTO, for example, for pharmaceutical products. In practice, a number of developing countries only granted patents for drug manufacturing processes, or possibly no patents at all in the pharmaceutical sector. In this case, Article 65.4 gives them an extra five-year period of grace to introduce patentability of these products in their legislation, which amounts to a total transitional period of ten years for developing countries in respect of pharmaceutical products.

However, given the substantial time that elapses between the application for a patent for a new pharmaceutical product and authorization to market that product, strict application of this provision would have the consequence that new patented drugs would not be marketed in developing countries until at least 2015 (2005 + about ten years of development prior to marketing).

In order to limit this effect, the TRIPS Agreement also has special transitional provisions (“mail-box” and “exclusive marketing rights” mechanisms - see below) for cases in which a State does not grant pharmaceutical products patents as of January 1995 and therefore has a period of ten years in which to do so.

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