Traditional Chinese Medicine and European Union Law: Cultural Logics, Product Identities, Market Competition, Legal Rechanneling, and the Need for Global Legal and Medical Pluralism
Peking University Law Journal, July 2014
62 Pages Posted: 9 Dec 2013 Last revised: 2 Nov 2015
Date Written: December 8, 2013
This paper explores the European Union (EU) regulatory regime for Traditional Chinese Médicine and its legal, cultural, economic , and international trade implications. The controversial Directive on Traditional Herbal Medicinal Products (THMPD) amended the European Community Code for medicinal products in 2004, with effect as of 2011. It set new standards for imports of herbal medicines, which previously had been exported from China mainly as food, food suppléments or other products. The paper analyses the new EU regime and evaluates it in the light of (a)the EU's policy objectives, (b) its role as a legal rechanneling device and effects on market competition, (c) the altered position of Chinese producers and exporters, (d) a general evaluation and (e) social solidarity ethics and pluralism. It concludes that the EU regulatory regime for TCM falls short on all counts. On the basis of this critical evaluation, the paper calls for greater medical and legal pluralism, stresses the need for increased participation of other countries in EU decision-making about medicines, and identifies priorities for further research.
Keywords: European Union law, Traditional Chinese Medicine, international trade, China, Good Manufacturing Practice, regulation, competition, public health, food law, legal pluralism, ethics
JEL Classification: A14, F10, F13, F14, I11, I18, K32, K33, L65, O31
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