TCM makers in rough waters as EU directive threatens their survival

Traditional Chinese medicine (TCM) practitioners and importers are leaving no stone unturned to get the new European Union (EU) legislation on herbal medicines reversed, even as nations like Belgium, France and Germany started stepping up quality checks on herbal products from May 1.

The EU had in a regulation passed in 2004 stipulated that all herbal medicine companies operating or planning to operate in Europe must get their products/medicines registered by April 30 this year. From May 1, the sale of such herbal medicine products will no longer be allowed in the EU unless they have a medicine license.

Though the whole process has been envisaged to keep a lid on the quality of herbal medicines that flow into the EU, industry circles say that what it actually does is shut out TCM companies from the EU market due to the stringent quality standards and high registration fees.

Getting such a license is not only expensive but also technically problematic, they say.

Chris Dhaenens, who owns a TCM import company and is also president of Benefyt, a Netherlands-based foundation that represents and defends the interests of TCM companies in Europe, admits that the directive is aimed at harmonizing the European botanic medicine market. "But the results so far have been in the opposite direction," he says in an interview with China Daily.

Dhaenens says that the new legislation will be an expensive affair for most TCM companies as it costs nearly 150,000 euros to register a single product. "If a company has 800 products, its registration fees will far exceed its turnover. The registration fees also vary from nation to nation," he says.

The Alliance for Natural Health, a British group that representing herbal practitioners, estimates the cost of obtaining a license at between 100,000 and 150,000 euros per herb. The regulations also stipulate that TCM companies should furnish proof that their products have been sold in the EU market for a minimum of 15 years.

"Many companies are facing hurdles over the technical requirements stipulated by the European Medicines Agency, and are simply unable to afford the costs for the required quality control (especially stability) tests. Due to all these problems, not a single company has so far got the required registration," Dhaenens says.

The EU, however, says that its legislation on pharmaceutical products for human use also applies to traditional herbal medicines. However, in order to overcome the difficulties encountered by member nations to implement a uniform legislation, it came out with the current simplified registration procedure in 2004.

With the seven-year transition period for its Herbal Directive expiring on April 30 this year, the EU now says that only medicinal products that have been registered or authorized can remain in the EU market from May 1 onwards. The legislation provides the necessary guarantees for the quality, safety and efficacy of herbal medicines, it says.

"We have now reached the end of a long transition period which has given producers and importers of traditional herbal medicinal products the necessary time to show that their products have an acceptable level of safety and efficacy. Patients can now be confident about the traditional herbal medicinal products they buy in the EU," says John Dalli, European Commissioner for Health and Consumer Policy.

Dismissing claims that the legislation will keep several herbal medicines out of the European market, the EU says that Herbals Directive does not ban traditional medicines from the European market. On the contrary, it is a lighter, simpler and less costly registration procedure than for other medicinal products. To buttress its claims, the EU points out to the exceptionally long transition period of seven years given to companies for registering their products.

Such an approach was also necessitated due to the varying registration pattern followed by each European nation. The absence of pan-European rules had led to a "state of anarchy" in the markets, despite the fact that indigenous herbs have a 700-year history of use in Europe, it says.

Hidden agenda

Several sources, however, feel that the EU has not exactly been transparent in its approach. They allege that the legislation has been framed to protect the interests of several big multinational pharmaceutical companies who feel that the growing popularity of TCM in Europe may dent their profits.

"The multinationals stand to gain market share if TCM companies fail to pay the required high registration fees to access the EU markets," says an unidentified source from a TCM college in Europe, who also has close ties with European medicine regulators.

The big multinational companies are also using the services of highly paid lobbyists to canvass political support for their moves, say sources. The apprehensions that TCM products may soon disappear from Europe has also led to a decline in the student intake at TCM colleges in Europe, he says.

Thomas Brendler, chief executive of PlantaPhile Ltd, a European consultancy, however, says that guidelines will bring about consumer safety and assurance and also weed out products of questionable quality or with unreasonable health claims.

"The legislation is not an initiative or the result of intense lobbying by big pharmaceutical companies. All it does is to ask companies to follow the same rules that are mandatory for all EU companies and does not include like size or market share," Brendler says.