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:

Where possible we present additional information in the profile of the instance, which you can access by clicking on any row in the table.

Tools for use of Flexibilities Research

The TRIPS Flexibilities Database

By Medicines Law & Policy Last updated: September 2025

Frequently Asked Questions

Guidance on using the database and understanding its scope and methodology.

Navigating the database

Clicking the title of each column ("Country", "Date", "Type of Flexibility", etc.) will sort the data by that column.

Not all columns fit comfortably on a screen at once. To show or hide columns, click or unclick the checkbox next to the desired information in the "Show / Hide Columns" panel at the top of the database.

Clicking on any row in the database will open a window with sources and any additional information Medicines Law & Policy has for that entry.

Methodology & scope

We decided to include non-executed instances to document the fact that the threat of the use of a TRIPS flexibility can provoke a response by the patent holder. For example, patent-holding companies have offered price discounts, drug donations, and voluntary licences in response to the initiation of a compulsory licence.

We can never be 100% certain that there was no patent. But the main reason was to document the fact that authorities resorted to TRIPS flexibilities without verifying whether they were in fact needed in order to not delay the procurement of medicines. This happened in emergency situations or in the procurement of ARVs at a time when it was important to provide legal certainty to medicines providers and not-for-profit procurement agencies.

We verified where possible whether there were relevant patents related to the products that were subject to the TRIPS flexibility measure. We mostly used the MedsPaL database. In some cases, the documentation provided by the authority gave information about the patent in question.

It was not always possible to verify whether patents were filed or granted, in particular when the TRIPS flexibilities were invoked for unidentified groups of products. Those cases are listed as 'unknown'.

We decided to include the patent information for LDCs to show the extent of medicines patenting in those countries. Many LDCs are members of regional patent offices such as OAPI and ARIPO. These regional patent offices provide an easy route for patent applicants to obtain patents in groups of countries, including LDCs.

No, one cannot conclude from the database that parallel import is not used. Countries may use parallel import in direct procurement by purchasing the originator product from a source abroad where the product is offered at a lower price, and do this without any publicity, as there is no need for any public declaration or decision to do so. For example, within the European Union parallel trade in medicines is very common. We did not attempt to capture those.

TRIPS flexibilities explained

The database references several different TRIPS flexibilities by the article in the relevant legal agreement. These are explained briefly below; links are to the WTO Analytical Index, a guide on the application of each flexibility:

  • Art 30: Exceptions to patent rights granted by governments.
  • Art 31: Compulsory licensing, or legal use of a patent without permission of the patent holder, including public non-commercial use.
  • Art 31bis: Compulsory licensing primarily for export to a country where there is insufficient capacity to manufacture a needed product. This was previously referred to as the "Paragraph 6 system," for its mention in the Doha Declaration on TRIPS and Public Health.
  • Par7: Provisions specifically for Least Developed Country members, who are not required to grant or enforce patent rights on pharmaceutical products nor provide clinical test data protection until 1 January 2033. This transition date may be further extended upon request by countries.
  • Parallel import: Where a product is first launched in one country and then imported to a different country without the permission of the patent-holder. The patent rights are considered to be 'exhausted' after its marketing in the first country, so that it can be resold in the second country.

To learn more about which TRIPS flexibility might be appropriate in a given context, see this flowchart.

TRIPS contains many flexibilities; it was beyond the scope of the database to include instances of them all. However, we welcome suggestions and information about instances we may have missed or types of instances we should include as the database is updated. Please write to us at info@medicineslawandpolicy.net.