As a 2004 European Union (EU) directive on herbal medicine is to be fully implemented on May 1, herbal medicinal products without a license will no longer be allowed in the EU market, the European Commission said in a press release Friday.

The Traditional Herbal Medicinal Products Directive, adopted by the EU member states in 2004, introduced a so-called simplified registration procedure with a seven-year transition period for traditional herbal medicinal products to obtain a medicine license.

As the transition period is to expire on Saturday, herbal medicinal products from home and abroad, most of which have been sold as food supplements for decades, need to be medically registered or authorized by EU governments in order to remain in the market after May 1.

Instead of going through safety tests and clinical trials as regular chemical drugs, applicants are required by the directive to provide documents showing the herbal medicinal 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.

However, a wide range of eligibility and technical challenges along with prohibitive costs have so far prevented both local and outside herbal medicinal products from being granted the license.

Only a small proportion of indigenous herbal medicinal products have been approved for registration while not a single Chinese or Indian traditional herbal medicinal products have been licensed.

Lack of pan-European rules, EU member states had adopted different approaches to herbal medicine, thus creating a "state of anarchy" in the markets despite the fact that indigenous herbs had a 700-year history of use in Europe.

Although the directive was intended to harmonize rules of member states and build a level-playing field across the EU, critics argued that the directive may fall short of the aim and create more chaos and uncertainties for the industry.

DRAWBACKS

The directive has been under attack for being neither "adequate " nor "appropriate" due to its high registration cost for a single product and its lack of consideration about the Chinese and Indian traditional herbal medicine.

Chris Dhaenens, a licensed herbalist in Belgium and a shareholder of a medium-sized herbal importing company doing business with China and ten European countries, said the directive was only appropriate for companies carrying a few products and who could afford the registration costs.

"It is simply inaccessible to most players distributing high- quality Chinese or Indian herbal products in Europe," he said, adding that the registration fee for a single product could be as high as 150,000 euros.

The Alliance for Natural Health, a British-based group representing herbal practitioners, estimated the cost of obtaining a license at between 80,000 and 120,000 pounds (90,000 to 135,000 U.S. dollars) per herb.

Dhaenens, who is also the president of the European Benefyt Foundation, a leading traditional medicine group in Europe, argued that the directive only tried to regulate herbal products instead of its practitioners and the whole herbal system, as well as fell short to take the Chinese and Indian traditional medicine into full consideration.

Even the European Commission had admitted that the directive was not fit for the registration of Chinese and Indian medicine in an earlier exchange with the European Medicine Agency in Dec. 2008, Dhaenens revealed in an exclusive interview with Xinhua.

"But they had no money or time to work out an alternative, and so it was left to the member states," he said.

CHAOS

European Commission health spokesman Frederic Vincent said in an interview with Xinhua on Thursday that each EU member state had to provide a registration system for herbal medicinal products, acknowledging that the implementation rules as well as the registration fees could vary from one member state to another.

Some EU countries, however, seemed to have fallen behind. Lin Haoran, general manager of a herbal importing company in the Netherlands, told Xinhua that several applications from Chinese herbal companies to Hungarian and Swedish medical authorities had either been rejected or been put on a waiting list.

"Local authorities don't know how to deal with it. They don't have standards yet to approve our registration," Lin said.

Some medical organizations have also warned that the directive could drive hopeless patients to look for herbal medicines over the Internet, where huge risks could always been generated.

The spokesman insisted that it was up to the member states to decide if the herbal medicinal products could be put on the market as medicine or something else.

In fact, the status of Chinese and Indian traditional medicine varies from one member state to another. 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 Holland and Czech Republic, herbal products can be put under the food category and there are barely any restrictions. But products from countries with liberal policies still cannot be sold to other EU member states where those products might be considered illegal since the reinforcement of the directive, industry insiders said.

Thus, despite the fact that the directive is meant to harmonize rules, the current situation seems to be more complicated than ever, as Dhaenes said, "it has caused chaos, unfair competition and discrimination."

REMEDIES

The European Benefyt Foundation and the Alliance for Natural Health recently filed a law suit together to the European Court of Justice, the EU's highest judicial body, against the European Commission, demanding a revised legal framework for traditional herbal systems.

"The directive fails to provide a legal framework for herbal importing companies, which makes us 'illegal by default,'" Dhaenens said.

He called for a statutory regulation system for therapists in coordination with the regulation system for herbal products offered by the directive.

"We need special registration system for doctors who are qualified to make herbal prescriptions," he said.

Meanwhile, Dutch medical authorities have indicated unofficially that unregistered herbal medicinal products can still enter into local market as healthcare or food supplements in the near future, according to Professor Lin Bin, practitioner of Chinese traditional medicine in the Netherlands.

Although the door may not be shut off yet, Lin said, a better choice was for the Chinese traditional medicine to go through registration so as to reduce uncertainty for the future.

VietNamNet/Xinhuanet