Abstract

This paper explores the European Union (EU) regulatory regime for Traditional Chinese Medicine 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 supplements 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.

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