According to the proposal the MHRA floated on July 9, the sale of all unlicensed manufactured herbal medicinal products will be halted in the UK from next year. The MHRA is a British government agency that is responsible for ensuring that medicines and medical devices used in the UK are safe.

The proposal is not targeted specifically at TCM. Andrea Farmer, MHRA's herbal policy manager, says: "The decision was taken on the basis of the Traditional Herbal Medicinal Products Directive,which stipulates that all the manufactured herbal medicines in the EU market should have a suitable product license." [More]

Changing times

The latest proposal will act as a knockout blow to the industry.If the MHRA proposal is implemented from next year,TCM practitioners will be in a fix, Mei says, as they can no longer prescribe time-trusted Chinese medications.

Several TCM companies failed to complete the registration process, as they did not have the documents and money needed.

● The mandatory stability studies for end products are not easy for muti-herbal products.

● "To get a license, all the necessary tests and arrangements will cost upwards of $1.6 million, and that too for just one TCM product," says Mei.

●"Though 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."

●Applicants must evidence that the product has a 30-year safety record, including 15 years in the EU. But, TCM did not enter the EU market until the mid-1990s and were largely sold to EU customers as food supplements. [More]

Regulatory concerns
 
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 like TCM."

"We have been doing a lot of work with the European Parliament. We created a strong core group of 40-50 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 into the backburner."

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

Nick Pahl, CEO of the British Acupuncture Council, the leading self-regulatory body for the practice of traditional acupuncture in the UK, says it has been estimated that the demand for acupuncture treatment has almost doubled in the past decade to more than 4.5 million treatments every year.