Legal bid to save 1000s of traditional medicines under EU threat

By Mike Stones

- Last updated on GMT

Related tags: Herbal medicinal products, European union, Eu

The UK-based Alliance for Natural Health (ANH) is preparing legal action against a new EU law due to take effect on May 1 2011 which could ban thousands of traditional herbal medicines and threatens to drive consumers online to buy unregulated black market supplies.

The organisation’s science and communication officer Adam Smith told NutraIngredients.com: “We plan to take the EU to judicial review of this law and there could be a human rights issue if people are denied traditional products they want to use​.”

Fundraising is ongoing to raise £90,000 for the first phase of the legal battle, with a judicial review of the EU law at the Royal Courts of Justice in London. It is thought the dispute would then be referred to the European Court of Justice.

The Traditional Herbal Medicinal Products Directive (2004/24/EC) requires that traditional herbal medicinal products, some of which have been used in Europe for decades, must be licensed or prescribed by a registered herbal practioner to comply with the directive passed in 2004.

Inappropriate and expensive

ANH has already asked the EU to delay the implementation of the directive which Smith described as “inappropriate and exceedingly expensive​.”

In the UK​ (and in other EU countries) 1000s of non-European traditional medicines could disappear from the shelves forcing consumers to buy from the internet where safety and quality cannot be assured​,” said Smith.

The ANH estimates the cost of gaining a licence, which sets safety and quality standards similar to those required for pharmaceutical drugs, at between £80,000 and £120,000 per herb. Although supportable for big market products such as echinacea, it would prove uneconomic for most traditional Chinese and Indian medicines, containing a range of herbs, according to ANH, which represents herbal practitioners.

Consequently during the seven-year transition period since 2004, not one product used in traditional Chinese medicine or ayurvedic medicine has been licensed in the UK.

In addition to banning tried-and-tested non-traditional remedies used in Europe for decades, the legislation also threatens the introduction of products new to Europe.

To gain access to the EU licensing system all products must have been used safely in Europe for 15 years and elsewhere for 30 years​,” said Smith. That would rule out remedies, relatively new to Europe, but used safely in China and India for centuries, he added.

Clarification

Meanwhile, Patrick Coppens, director of the European Botanical Forum, shared ANH’s concerns about the new legislation.

There’s a need for clarification of the legislation which applies a bureaucratic legislative system to traditional products that have been used for hundreds of years​,” he told NutraIngredients.com.

Many companies involved in the supply and sale of tradition herbal medicines and other products are small and medium-sized companies which cannot afford the cost of complying with the new legislation, he said.

There’s a need to reflect on the usefulness of a law for the regulation of such complex issues – thereby bringing problems that are not necessary,”​ said Coppens.

Related topics: Regulation & Policy, Suppliers, Botanicals

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