Although six amendments to the European Union's proposed Traditional Herbal Medicinal Products Directive were recently passed by the European Parliament and are supported by the industry, the European Commission gave the thumbs-up to only half. The Commission's recommendations have increased concern that the proposed registration scheme for herbal products and ingredients would ban many that are currently available.
Pedro Vicente Azua, regulatory affairs director of the European Federation of Health Product Manufacturers, said it was unfortunate the Commission had taken a more conservative position on many of these points and had not supported some of the amendments that had significantly liberalised the original proposal.
Director of lobby group Consumers for Health Choice, Sue Croft, said, "We are very disappointed with the Commission's stance on this, especially after the Parliament had backed what we consider to be a range of very sensible amendments."
Although the legislation covers only a restricted sector of traditional herbal medicines and not other herbal products, many Members of the European Parliament, particularly from Ireland and the UK, remain concerned about the indirect effect of the Directive on products currently on the market.
The Irish Health Trade Association is concerned with the Commission's denial of the amendment that applies to traditional products as opposed to ingredients.
"The emphasis on products presents a further problem in relation to the availability of support data," IHTA stated. "Indeed, while there is likely to be a considerable amount of data available to support a long history of continuous medicinal use of many herbal ingredients, it is much less likely to be available for products."
One industry source played down the concerns, saying the Council of Ministers were just as likely to support the original amendments as they were the Commission's position.
The British Herbal Medicines Association (BHMA), which supports registration of any herbs sold as medicines, welcomed the amendments. "Most of the amendments make the Directive more flexible. We are encouraged by that," BHMA Chairman Simon Mills said. "There are a lot of inadequate herbal medicines on the market because there has been so little control. This Directive will ensure the public get access to reliable herbs.
"At the moment in the UK, you can put any herb in a bag and call it a medicine and sell it without a licence. This new Directive should take over from that unclear area, making the borderline between foods and medicines less broad."
The BHMA is working with the UK-based Medicines Control Agency to assist companies in preparing for the new legislative climate. "We are helping smaller firms to get tooled up so they can produce herbs to the required standard with the requisite science," Mills stated.
The Directive will soon go before the European Council of Ministers before passing back to the Parliament for a second reading and vote. The Directive is expected to become law by early 2004.