NAVIGATING THE LANDSCAPE OF TRADITIONAL MEDICINES AND TRADITIONAL MEDICINE PRACTITIONERS

Clinic: CTIL (National Law University, Jodhpur), Spring 2022

Non-Confidential Summary

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The advent of the WTO in 1995 brought about multiple changes to the manner in which WTO Member States could regulate matters affecting international trade in every sector, including pharmaceutical products and medical practitioners administering them. However, these rules do not completely address how traditional medicines and traditional medical practitioners’ practices are to be regulated, leaving this question largely subject to individual Member States’ discretion. Given the prevalence and increasing acknowledgement of the benefits of Ayurveda, Traditional Medicines (TM) including traditional Chinese medicines and ayurveda and other traditional, alternative, and complementary medical practices, specific regulations governing these practices and practitioners have been introduced in jurisdictions around the world. This report attempts to shed some light on the prevailing regulations in certain developed jurisdictions.

As a starting point, this Report refers to the rules under the WTO’s General Agreement on Trade in Services (GATS). It addresses the question of whether the GATS can be applied to traditional medicine practitioners by expounding upon the general rules to classify services within the GATS, and how medical services have been addressed within its comprehensive framework. This part of the Report also addresses how much discretion has been accorded to each Member State to develop governing rules in the context of health services, such that they could potentially include traditional medicine practitioners. Lastly, this part of the Report also addresses the relevance of the GATS to traditional medicine practitioners and the challenges faced in liberalising trade in this sector at a multilateral level.

The next part of the Report focuses on the rules governing trade in traditional medicines and the rules governing traditional medicine practitioners in five jurisdictions:

1. The European Union;

2. The United States of America;

3. The United Kingdom;

4. Australia;

5. Canada.

For each jurisdiction, this Report addresses certain key points. These include:

1. How terms related to traditional medicines and traditional medical practitioners have been defined?

2. The key institutions responsible for trade in traditional medicines and regulation of traditional medicine practitioners;

3. The requirements for manufacturing, import, and sale of traditional medical products;

4. The registration and/or licensing requirements for traditional medicines and traditional medicine practitioners;

5. Any relevant pharmacopoeia(s) that these jurisdictions refer to for supplementary rules on the regulation of traditional medicines and traditional medical practitioners.

This Report is principally descriptive in its scope and seeks to provide a comprehensive overview of the regulatory landscape at present. It offers a mechanism to compare and contrast the rules across each of these jurisdictions and seeks to act as a one-stop guide to understanding and navigating these rules.

Read the summary here.