Comparison Study of Western Medical service versus Eastern medical service: Trade Barriers on Traditional Chinese Medicine in Europe

Abstract

한의학은 중국에서 중요한 상징으로 자리 잡고 있다. 한의학은 전체론적 접근 방식에 의존하고 서양 의학과 비교하면 문화적 역량을 보여주고 있다. 또한 수세기 동안 연습 되어 왔으며 특히 유럽에서 관심을 얻기 시작했다. 한의학은 유럽에서 좋은 기반을 확립하였고 이것은 유럽에서 표준화, 연구 및 규제 개선의 촉매제가 되었다. 주목이 집중되는 와중에도 불구하고 한의학은 현재 유럽에서 많은 어려움에 직면해 있다. 예를 들어, 한의학 등록을 유럽 지출의 가장 큰 장애물로 삼은 유럽연합2004/24/EC 의 지침에 따라 유럽으로의 한의학 수출은 더 어려워졌다. 현재 한의학은 안전 문제, 등록, 표시 등 여러 무역 장벽의 어려움을 겪고 있다. 이 논문은, 현재 유럽에 있는 한의학 시장의 무역 장벽을 법적 관점에서 분석하고 일본과 유럽연합의 상호인정협정 특징 도입이라는 방법과 개선된 평준화를 통하여 무역장벽 감소의 중요성을 시사한다. 주제어: 한의학, 유럽, 유럽연합 2004/24/EC, 무역장벽

Traditional Chinese Medicine (TCM) has been a significant symbol in China. TCM takes on a holistic approach when compared to Western Medicine, with elements of culture and history deeply rooted in the medicine. TCM has been practiced for centuries, and has recently started to gain popularity in the West, especially in Europe. It has established a good foundation in Europe, which became a catalyst for improving standardization, research and regulation. Despite the rising popularity, TCM is currently facing many difficult challenges in Europe. For example, exporting TCM to Europe became more difficult after the European Union (EU) Directive of 2004/24/EC, which made TCM registration the largest obstacle for entry into Europe. Moreover, there are trade barriers prevalent in the areas of

safety, registration, and labeling. This paper examines the trade barriers of TCM market occupied in Europe, followed by an analysis of such barriers from a legal perspective. The paper concludes with recommendations to lower the trade barriers, by suggesting improvement of standardization, in addition to proposing possible amendments in the Japan-EU Mutual Recognition Agreement.

Conclusion This paper reviewed the TCM in Western culture, primarily focusing on the trade barriers of TCM in the EU, and its legal implications it had on the TCM market. The EU Directive of 2004/EC/24, unintentionally created many difficulties for TCMs registering in the EU, especially in satisfying the burden of providing proof of use, at least 30 years of use and 15 years in the EU. Also, different registration procedures made the process harder and more expensive for TCM producers. As a result of this, the new regulatory regime removed many over-the-counter drugs and TCM products that have failed to register in the EU. Despite the rising demand of TCMs, the TCM industry is facing critical challenges in todays world. TCM doesnt have a reputable status in the Western society and emerging new drugs will make competition tougher. TCM practitioners and products need to accept the current obstacles and try to expand new footprints in the European market. In order to do that, China and the EU need to cooperate to discuss the future of TCM. One approach is to improve standardization of TCM in the EU market. TCM in EU is sold as dietary supplement or food supplement. Consumers doesnt have a set standard whether TCM is medicine or a supplement. In order to improve standardization, it needs to go through clinical trials and switch to evident based medicine. Since many TCM products are based on holistic approach and it doesnt have a clear evidence where the TCM recipes are came from. The second recommendation is to have China-EU FTA and implement Japan-EU MRA Sectoral Annex on GMP For Medicinal Products, to redefine TCM terminology. And by applying GMP, there will be better manufacturing process and quality control. Pending on the actions from China and EU, trade barriers of TCM may be lowered and with their combined efforts, TCM will bring about more trade opportunities in the future.