Introduction

About the TRIPS Flexibilities Database

The TRIPS Flexibilities Database contains instances when authorities have invoked, planned to invoke, or have been asked to invoke a TRIPS flexibility for public health reasons, in particular to assure access to medicines. Not all instances listed have been executed. If you are interested only in instances where the flexibility has been executed you can use the filter in the 'executed' column.

The flexibilities included in the database are: compulsory licensing, including public non-commercial use (TRIPS art. 31), patent exceptions (TRIPS art. 30), the Least Developed Country transition provisions (Paragraph 7 of the Doha Declaration on TRIPS and Public Health) and parallel import (Paragraph 5(d) Doha Declaration).

More detailed information about TRIPS flexibilities for use in medicines procurement can be found in the 'Tools' section of the Medicines Law & Policy website. If you want to assess which tool would be best for your country's situation you can use this flow chart.

The TRIPS Flexibilities Database provides instances starting from 2001, the year in which the World Trade Organization adopted the Doha Declaration. It includes cases from low, middle, and high-income countries, and incorporates instances that are both executed and instances that are pending, not executed or suspended. We decided to include non-executed instances to capture the fact that also the mere threat of a TRIPS flexibility can have an effect.

We collected the instances presented in this database from the published literature, earlier overviews prepared by others, cases reported in the media or on specialised list serves, from individuals who shared information with us, and from documents held by medicines procurement agencies.

Some of the instances in the database refer in the 'royalty' column to the use of remuneration guidelines. This refers to the UNDP/WHO guide for setting royalties when issuing a compulsory license. That guide can be found here.

TRIPS offers other flexibilities than those included in this database. For example, countries are free to determine patentability criteria provided those are consistent with TRIPS and can offer (pre-grant) patent opposition mechanisms. Patent oppositions have been very important in efforts to assure access to certain high-priced medicines. Patent opposition cases are however not captured in this database. For information about them we refer to the patent opposition database. [See: www.i-mak.org and www.patentoppositions.org]

WIPO publishes a database on flexibilities in the intellectual property (IP) system that provides information about various categories of IP flexibilities in national and regional IP law. The database is available here.

We do not claim that this database is exhaustive. We intend to continue to update the database with new instances of the use of TRIPS flexibilities for public health as they occur. We therefore invite you to contact us with new cases, cases we may have missed, or with any additional information that may help to improve the database. You can write to us at: kaitlinmara@medicineslawandpolicy.net

The Database contains the following data fields: