A Hard Pill to Swallow

by Cai Changchun

The Medicines and Healthcare Products Regulatory Agency（MHRA）， the UK governmental agency responsible for ensuring the effectiveness and safety of medicines and medical devices， recently announced that all traditional Chinese medicine （TCM） lacking official approval would be removed from store shelves nationwide by the beginning of next year. More immediately， all traditional Chinese medicinal institutions and some major TCM stores have been asked to report their inventory to MHRA. Actually， as early as 2004， EU released the Traditional Herbal Medicinal Products Directive， also known as Directive 2004/24/ EC， to prevent unlicensed TCM from being sold as food supplements in the EU market after May 2011.

A Steep Climb

In the opinion of Liu Zhanglin， vice president of China Chamber of Commerce of Medicines and Health Products Importers and Exporters， UKs MHRA is only taking EUs Directive 2004/24/EC a step further， rather than dropping a bombshell. However， Liu didnt mince words when describing the historical reasons influencing traditional Chinese medicines dire situation in overseas markets.

“Of all TCM manufacturers， Chengdubased Diao Pharmaceutical Group Co. is the only one to succeed in receiving authorization from the Medicines Evaluation Board of the Netherlands， making it the first TCM to be recognized as a therapeutic medicine in the European Union，” Liu illustrates while generating a rough sketch of the cost of TCMs approval in the EU. According to his estimates， each specific TCM product usually needs at least four to five million yuan （about US $650，000-800，000） to obtain approval， covering costs such as a million yuan （$160，000） to file and another four million yuan （$650，000） to upgrade production equipment and management to meet EUs strict standards for Good Manufacturing Practice （GMP）.

Furthermore， the shrinking market share of TCM in EU countries is actually pushing Chinese TCM manufacturers to give up applying for official approval. EU is clearly one of the largest herbal medicine markets in the world， making it a crucial target for Chinas exports of TCM. Data shows that the nations total export volume of TCM usually reaches $200 million annually， but only 10 percent goes to the EU market. In 2012， Chinas export volume of TCM to the UK totaled $1.62 million， a 70 percent drop from the previous year.

Cross-Culture Challenges

As a treasure of Eastern culture， the benefits of TCM are heavily utilized throughout China as well as much of Asia. However， in Western countries， TCM usually finds an awkward situation. Along with suspect trade barriers erected by some countries， TCMs floundering popularity is usually attributed to distinct differences in Chinese and Western medicinal theories. Duan Jinsheng， a veteran in Chinese medicine industry explains that unlike Western medicine， TCM is the fruit of Chinese medicinal theory， which relies greatly on subjective experience rather than clinical trials.“Although TCM modernization has made progress in terms of theoretical system building and scientific study in recent years， few breakthroughs has been reached to eliminate Western concerns about TCMs ambiguity in pharmacological properties， production standards， content， and physiological effects，” reveals Duan.

After working in TCM sales and inspection in European countries， Duan realized that Western medicine is more inclined to utilize a single medical substance to isolate side effects， whereas TCM employs multiple medical substances to balance effects.

Regardless of cognitive conflicts， TCM must still navigate myriad pharmacology checkpoints in order to be approved by the EU. According to Yuan Kelun， manager of a Guangzhou-based pharmaceutical company， information about a TCM products effects， active ingredients， heavy metal content， stability， and genetic toxicity is required. However， due to insufficient studies in fields of modern medicine， pharmacology and toxicology， TCM usually lacks sufficient data to pass EUs strict approval process.

A Long Way to Go

An expert in pharmaceutical trading， Liu Zhanglin suggests viewing MHRAs recent move as an opportunity for TCM to expand its international influence and end the awkward situation in European and American markets by investing greater efforts in obtaining official approval.

In terms of TCMs international status， Zhang Wensheng， a Beijing-based attorney specializing in medical cases， opines that Chinas TCM enterprises should begin by cultivating positive brand images through intensive market research and promotion.“Treatments born of the traditional Chinese medicinal system will not be accepted internationally without the penetration of traditional Chinese medicinal theory in Western philosophy，” he suggests.