A legal challenge to the European Union’s Traditional Herbal Medicinal Products Directive (THMPD) has been delayed but will definitely go ahead, according to the pro-natural health campaign groups behind it.
In a statement, the UK-based Alliance for Natural Health (ANH) and the Netherlands-based European Benefyt Foundation (EBF) admitted they were disappointed not to have succeeded in filing their bid to halt enforcement of the directive ahead of its full implementation on 30 April after a seven-year transition phase.
But they added: “The scale of the challenge and the need to co-ordinate activities, not only in the UK but also in other parts of the EU and beyond, has meant that we are delayed. In agreement with our lawyers at the leading London-based European law chambers, 11KBW, we feel strongly that we must do everything in our capacity to ensure that we are as carefully prepared as possible, particularly as we only get a single opportunity to take a challenge such as this.”
The THMPD is designed to provide a simplified, fast-track medicinal licensing process for herbal products that are able to demonstrate they are safe. However, ANH and EBF argue that the required level of toxicological data is not available for some traditional herbs used safely for thousands of years. As a result, they fear the new legislation will effectively outlaw traditional non-European healthcare systems such as Ayurveda and traditional Chinese medicine.
The ANH and EBF said: “The effect of full implementation of the THMPD will actually be protracted, given that the directive itself does not directly ban any product. Rather, herbal products are at risk of becoming illegal once member state competent authorities determine that ones selling as food supplements are illegal unless registered as medicines.
“We ask that you bear with us while we continue our work on the preparation of this pivotal challenge that will likely be seminal to how European authorities will treat herbal products from non-European traditions. We have never been more sure that the route we are taking now, through the courts, gives us the best chance of correcting a regulatory approach that is both unjustified and discriminatory.”