Bitter pill for traditional Chinese medicine

"Chinese medicine has also not been included in the UK's medical insurance system. As a result, British people whose incomes have fallen are reluctant to buy Chinese medicines."

The latest proposal will act as a knockout blow to the industry, Mei says. "According to my estimates, there are only 1,000 TCM clinics in the UK now. Most of them may find the going even more tough, especially as they try to cope up with the new standards, registration norms and so on."

Typically a TCM business consists of three parts, acupuncture and associated treatments, herbal medicines and industrially manufactured herbal products. If the MHRA proposal is implemented from next year, it will not affect the sales of loose or individual herbs and other self-made products. But TCM practitioners will be in a fix, Mei says, because they can no longer prescribe time-trusted Chinese medications.

"More than 40 percent of our patients take TCM capsules. If this regulation is implemented, then that section will lose access to their medication.

"A lot of the patients are frequent travelers and find it convenient to carry the medicines with them."

Mei says that although several TCM companies had attempted to complete the registration process, they failed to do so because they did not have the documents and money needed.

"TCM companies want to be licensed in Europe and the UK. But things are not that easy."

A big area of concern for most TCM companies is the mandatory stability studies for end products. Mei says that while these studies are possible for single ingredients or herbs, it is not easy for multi-herbal products.

"TCM companies also need to conduct toxicology tests to get a license. All the necessary tests and arrangements will cost upwards of 1 million pounds ($1.6 million) — and that too for just one TCM product."

Mei, who is also a participant in the MHRA consultations as a stakeholder, says that "although some companies have the money and means to get the stipulated tests done, it is often difficult to satisfy Western authorities on the stability and toxicology test results".

The EU directive was originally drafted in 2004 by MHRA and then proposed to the European Parliament, he says.

Regulatory concerns

The directive stipulates that applicants must provide documents showing the product is not harmful in the specified way it is used, as well as evidence that the product has a 30-year safety record, including 15 years in the EU.

Although it dates back millennia, TCM did not enter the EU market until the mid-1990s. Even then, TCM drugs were largely sold to EU customers as food supplements, rather than as drugs.

Chinese drug makers and importers did not preserve the customs papers from a decade ago, and are thus unable to prove the 15-year use record in European markets.

Robert Verkerk, founder of Alliance for Natural Health, an international campaign working in the natural health field, says: "In 2008, the European Commission provided a report on traditional herbal products. In its last paragraph, it indicated that the EU directive was not suitable for traditional medicine systems such as TCM."

The regulation had indicated that it would consider a new framework for traditional products if there was sufficient demand, Verkerk says.

"We have been doing a lot of work with the European Parliament. We created a strong core group of 40 to 50 parliamentarians to canvass support for our cause. However, it is frustrating to note that a change of guard at the top has pushed the whole issue onto the backburner."

However, the predicament of TCM professionals appears in stark contrast to the various government initiatives that encourage and urge them to get registered in Europe.

Various government and public research institutes have frequently encouraged TCM companies and clinics to register by creating expert teams, holding national meetings and publishing EU registration handbooks, according to sources from the China Chamber of Commerce for Import & Export of Medicines and Health Products.

Although the April 30, 2011, deadline has long passed, there were no efforts on the part of the TCM industry to step up the registration process, they say. However, industry sources maintain that the relatively small sales volumes in European markets were a big disincentive for companies to spend huge amounts on product registration.

In 2010, China's TCM exports to the EU were valued at 152 million pounds, accounting for 13 percent of total TCM exports. However, Ma says, the average cost for certifying and registering a TCM consisting of six herbs is about 300,000 pounds.

Ma says he has on several occasions urged TCM practitioners in the UK to jointly petition the MHRA to drop the plan. Mei says: "Personally, I think the MHRA should give us an extension of two more years so that we can sell our stocks."

Part of the problem is that Europe is one of the toughest drug markets to break into because of the stringent rules and regulations on safety.

The TCM industry and practitioners need to understand what is actually happening in both the European and UK laws that affect them, Verkerk says, adding that they also need to be proactive in trying to protect their future.

Although industrially manufactured herbal products are facing problems, TCM clinics are banking on acupuncture, massage and other treatment procedures to further expand in Europe.