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Clinic: CTIL, Gujarat National Law University, Spring 2023

Non-Confidential Executive Summary

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This report provides an in-depth analysis of Mutual Recognition Agreements (MRAs) and their different types, features, and implications. It analyses the WTO law on MRAs under the disciplines of General Agreement on Trade in Services, Agreement on Technical Barriers to Trade and Agreement on the Application of Sanitary and Phytosanitary Measures.

The report begins by shedding light on MRAs for medical goods and drugs, and practitioners administering them while specifically focusing on the MRAs entered into with respect to traditional medicines like Ayurveda on which only some countries have legal regimes, those with respect to the traditional medicines as well the qualifications of the traditional medicinal practitioners administering those traditional medicines. The ultimate question that this report analyses is how an MRA concerning Ayurveda would be structured when one of the partner countries does not have a domestic regime concerning it. Therefore, the report provides a template for MRA of Ayurvedic products as well as practitioners administering them, and clarifications to comments, a brief outline, and a proposed procedure.

The report includes model MRA for traditional medicines, which covers various aspects such as the scope of the agreement, definitions, conformity assessment procedure, management committee, monitoring of the agreement, exchange of information, data protection, alert system, and good manufacturing practice. Further, the report also provides model MRA for traditional medicinal practitioners covering aspects such as recognition of a Foreign Practitioner, undertaking of a Foreign Practitioner, and Implementation and Review. The report is a comprehensive guide for policymakers, regulators, and other stakeholders interested in understanding and implementing MRAs in various sectors, particularly in the pharmaceutical industry. The report emphasizes the importance of negotiations, impact assessment, dispute settlement, conformity assessment, and monitoring committees for the successful implementation of MRAs. It also highlights the need for data protection and good manufacturing practices in the context of Ayurvedic products. Consequently, this report highlights the potential benefits of MRAs in promoting regulatory cooperation and facilitating trade while also acknowledging the challenges and risks associated with such agreements.

Download the summary here.

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