By Xinhua writers Miao Xiaojuan, Shang Jun
BRUSSELS, April 29 (Xinhua) -- As Traditional Chinese Medicine (TCM) is expanding its presence in the global market, a disputed European Union (EU) herbal directive to be fully implemented on Sunday could be a stumbling block on the road.
Starting from May 1, herbal medicinal products, most of which have been sold as food supplements for decades in the EU market, will no longer be allowed unless they have obtained a medicine license, according to the EU Traditional Herbal Medicinal Products Directive adopted in 2004.
The directive introduced a so-called simplified registration procedure with a seven-year transition period for traditional herbal medicinal products to be licensed, including Chinese and Indian traditional medicines.
However, as the transition period is to expire on Saturday, no single Chinese herbal medicinal product has been granted the license.
"For the time being, we can only stock as many herbal medicinal products from China as we can," said Professor Lin Bin, director of a well-known TCM clinic in the Netherlands.
The directive stipulates that applicants must provide documents showing the product is not harmful in the specified condition of use, as well as evidence that the product at least has a 30-year history of safe use, including 15 years in the EU.
With a history of more than 2,000 years, TCM did not enter into the EU market until mid-1990s, and it has been imported into the EU and sold to European customers as food supplements instead of drugs.
Most Chinese producers and importers did not reserve the customs papers a decade ago, thus unable to prove the 15-year use of their products in European markets.
Several Chinese herbal companies had tried to go through the simplified registration procedure with their Ace products, but in the end they either failed or quitted midway due to lack of required documents or tight budgets.
"The directive itself was not targeting the TCM at all, but it is too difficult and expensive for TCM to register," Lin said.
The Commission stressed on Friday that the directive doesn't ban traditional medicine, vitamins, mineral supplements or herbal teas from the European market.
The Commission's health spokesman Frederic Vincent also said in an interview with Xinhua on Thursday the EU had no plan to ban anything from China and that the directive was to make sure EU citizens would be fully informed of what they were buying.
"The EU is fully aware of the importance of TCM and authorities from both sides also have some cooperation on this issue," Vincent said.
However, while acknowledging the good intention of the directive to regulate the EU's herbal market, campaigners and industry insiders argued that the new registration system was discriminative against the Chinese or Indian traditional medicine.
Even the Commission had admitted that the directive was not fit for the registration of Chinese or Indian medicine when exchanging views on the issue with the European Medicine Agency in Dec. 2008, Chris Dhaenens, president of the European Benefyt Foundation, a leading traditional medicine group, told Xinhua in an exclusive interview on Thursday.
"But they had no money or time to work out an alternative, and so it was left to the member states," he said.
The spokesman insisted each EU member state had to provide a registration system for herbal medicinal products, although it was up to them to decide if a product could be put on the market as medicine or food.
In countries like Belgium, France and Italy, herbal medicinal products must be registered as medicine while the registration procedure can be difficult and costly.
In the Netherlands and Czech Republic, all herbal products can still be put under the food category and there are barely any restrictions.
But even products from countries with liberal policies still cannot be sold to other EU member states where those products might be considered illegal since the enforcement of the directive.
In 2010, the value of TCM from Chinese mainland exported to the EU market reached nearly 2 billion U.S. dollars, about 10 percent of which were herbal medicinal products, or an increase of 10 percent year on year.
But the EU only claims 0.5 percent of China's total TCM export value, while Hong Kong, Japan and America are the three largest export markets for TCM from the Chinese mainland.
"It is not an EU habit to buy medicines from China ... For the time being it is a tiny issue," the spokesman said, adding that the TCM market in Europe is not as big as people are saying.
However, as health regulators in many EU member states seem to be fully implementing the directive and narrowing the backdoor of treating TCM as food supplements, experts said Chinese herbal companies should keep trying to obtain the license.
"In the long run, TCM has to go through medicine registration to be sold as medicine but not food, either the simplified one or standard one, for its growing future," Prof. Lin said.
Besides, traditional herbs and herbal non-medicinal products can continue to be sold as food supplements as the directive only regulates herbal medicinal products. But TCM is usually excluded from the medical insurance system in most EU countries.
"It Chinese herbal medicinal products can obtain a medicine license in Europe, it will be covered by local insurance system, which is a big step for TCM," Lin said.
The revenue of global herbal products has been increasing by 10- 20 percent every year, but China's TCM only takes up about 3 percent of the global market, and 70 percent of its exports are raw herbs with much less added value.
Lin suggested that domestic herbal companies in China should always seek cooperation with local competitors with a long-term vision, as well as establish partnership with prestigious R&D medical institutions in Europe in order to obtain the medicine license.
Some herbal medicinal products from the world's largest TCM producer Tongrentang, a Chinese pharmaceutical company founded in 1669, were reported to reach 15-year presence in the EU market soon.
As some TCM had been uncovered with problems of pesticide residues, excessive heavy metals and chemical composition, according to earlier reports, Prof. Lin urged some TCM companies to deepen internal reform and strengthen self-discipline.
Chinese TCM market also needs standardized regulation, he added.
"The directive could offer some rare opportunities for the TCM to enter into the EU market for the first time as medicine but not food. Anyway it is not a mission impossible," Lin said.