The Herbal Directive, a "sledgehammer to crack a nut"?

This was a question raised at the Natural & Organic Products Europe Show, Olympia, London, 5th of April 2009.

• Jen Tan of A.Vogel/Bioforce.
• Lynn Lord of Natures Aid.
• Sebastian Pole of Pukka Herbs
• Sue Croft of the Consumers for Health Choice.

In summary their responses were;

• Bioforce had established good procedures (such as Good Manufacturing Practice) right from the outset so meeting the criteria of quality was not an issue.
• However, many companies had not had the same foresight and therefore, would struggle to comply.
• Physicians want to use herbal remedies but have no idea how and whether or not there may be possible interactions with conventional medication etc. With the new directive coming into force by the end of April 2011, information in the form of Patient Information Leaflets, correct labelling and other supporting data will be readily available. This information will prove to be most useful for educating our physicians as well as the patients themselves thereby improving patient safety.

• To compile a dossier is likely to cost a minimum of £20,000 with these costs being dependent on the number and complexity of the active ingredients involved.
• Plus registration fees payable to the Medicines and Healthcare products Regulatory Agency (MHRA) which are for the initial submission and then maintenance of the herbal licence thereafter.
• One product alone could therefore cost c£50,000!

• It had been imposed on the industry and that it was definitely the proverbial "sledgehammer to crack a nut".
• Many herbal companies will simply close their doors in April 2011 resulting in the loss of numerous effective herbal remedies.
• The directive is completely unwieldy and would spell doom for the herbal industry.

• The herbal directive is too restrictive and inflexible which will result in many herbal companies being unable to comply.
• This in turn will take away the consumers right to have a choice, denying them access to the very herbal remedies they had chosen to take.

All four representatives were in agreement, however, that there was a need for some form of regulation in order to gain and maintain the confidence of the consumer. The extent of these regulations, however, was hotly disputed.

Greer Deal, Regulatory Compliance Consultant and Director of Global Regulatory Services, asked the panel about the 30/15 year rule i.e. a herbal remedy must demonstrate at least 30 years of traditional use with 15 of those years being within Europe. Bearing in mind Indian and Chinese traditional herbal medicines, she wondered if the panel thought it would make a difference if this rule was amended or even removed altogether. The panel were united in their response: yes, this one amendment would make a significant difference to the herbal industry. Jen Tan (A.Vogel/Bioforce) went on to say that the MHRA were becoming more lenient on this rule so if a company cannot comply with the 30/15 year rule this doesn't mean the end of their product as they may still be able to license their remedy through effective negotiation and communication. Not all EU Health Authorities are so understanding.

The key messages from this debate were as follows:

• the MHRA are more lenient with regards to the 30/15 year rule than other European Health Authorities.
• Herbal companies who do not have good procedures in place such as Good Manufacturing Practice will have their work cut out for them in order to comply.
• As of May 2011 if a herbal remedy doesn't have a licence it will be illegal to sell it and will have to be removed from the market.
• To ensure that licences are obtained in time for the April 2011 deadline (and to continue trading), companies need to submit their applications in June/July this year.
• To obtain a licence is costly, however, companies will end up with a more robust product and will soon get a return on their investment.
• Everyone agrees that the herbal industry should be regulated but the extent of this regulation continues to be debated.