Brussels, Belgium—The European Union's proposed Traditional Herbal Medicinal Products Directive, now moving into the parliamentary debate phase, looks set to be as fiercely contested as the recently passed Directive on dietary supplements.
The new Directive aims to harmonise the regulatory structure of herbal medicines to enable freer movement of products within the EU, improve manufacturing standards and provide more consumer education.
But according to Pedro Vicente Azua, regulatory affairs director of the European Federation of Health Product Manufacturers (EHPM), the proposal is likely to ban many herbs currently in use and adversely gentrify the market.
"It is trying to create a new European category of medicine called traditional herbs with a simplified registration procedure," he said. "Our position is that the European solution is not the right solution because the herbal traditions vary greatly across Europe. We think the regulatory structures should be kept at a national level."
Azua also criticised the criteria necessary to get a herb approved under the proposed Directive.
"To be accepted, an herb has to have been used for 30 years inside the EU or for 15 years outside the EU plus 15 years inside the EU. There are a lot of herbs that are available as herbal medicines or food supplements that will never qualify for the Directive. So this is a worry for most of our members."
Azua said EHPM and other trade associations would continue lobbying for change as the draft proposal moves to the European Parliament and the European Council for further debate in the coming months. The entire process could take up to two years.
The chairman of the European Herbal Practitioners Association, Michael McIntyre, was less critical. He said he couldn't think of any herbs likely to be banned, adding, "One of the truly dangerous situations is that products that are unsafe find their way onto the market. That kind of thing is disastrous for the whole industry, so in that sense, I welcome some kind of controls."
The UK-based Medicines Control Agency also welcomed the proposed legislation. A spokesperson said, "The proposals will address the acknowledged weaknesses [in the current system] by balancing consumer choice and public safety."