Will Asian Traditional Medicines ‘grow’ in Europe?

There will be some who think I’m biased but I thought yesterday evening’s event on Asian Traditional Medicines kindly hosted by Clyde & Co in London was great. For those of you who couldn’t join us, you missed something special. Not many people were interested in the views across London (including the iconic landmarks of the London Eye, the Gherkin and the Shard) their attention was very much focused on the views being expressed inside Clyde and Co’s own impressive building. The howling gales outside didn’t dampen anyone’s spirits as, inside, things definitely hotted up!

So what was discussed? Professor Peter Hylands (Director, Centre for Natural Medicines Research, Kings College London) set the scene with an insight into Traditional Chinese Medicines (TCMs) and demonstrated how important these medicines are in China. Notably, the TCM industry in China has grown by 20% year on year for the past decade and they export 1 billion US dollars worth of traditional medicines to 164 countries. These are significant figures.

Peter then when onto to compare how TCMs are treated (in terms of their regulations) in China compared to Europe. In China they have an expedited approval process with various classes depending on the degree of refinement. In Europe there is no such process and, as a medicine, there are two options:

To follow the conventional pharmaceutical pathway and therefore, prove quality, safety and efficacy, or
To obtain registration as a traditional herbal remedy where efficacy is already proven by ‘traditional use’ with proof of quality and safety still a mandatory requirement.

Next he referred to the successful registration in The Netherlands of Diao’s Xin Xue Kang capsules in March this year. It is the first non-European traditional remedy to be registered in Europe under the Traditional Registration Scheme. Interestingly, it consists of only one herbal active (Dioscorea nipponica makino) and even that is an extract of the root! The original TCM was indicated to treat myocardial ischemia but for the purpose of European registration this claim has been diluted to “self-care medication to relieve headaches and muscle pain and muscle spasms in the neck, back and legs” – interesting.

Throughout his presentation, Peter made several references to quality and particularly emphasised the need to improve the quality of the literature for TCMs. Too often a paper will headline a TCM stating it’s effects are negative and yet, when you drill down into the data it becomes clear that the headline is merely ‘sensational’ with no scientific substance behind it. Of course, this reflects badly on TCMs as a whole.

Peter was then followed by Andrew Gallagher of Phynova, a company who is developing products based on TCMs. It was fascinating to hear about their experiences and the reality of developing these products. Again quality clearly underpinned everything they did. An attendee did ask how the plant material could be standardised when so much is dependent on growing conditions. Andrew went into great detail about how they comply with Good Agricultural and Collection Practice (GACP) and that they have really good relationships with suppliers. These suppliers are based all around China and their sites are continuously inspected, tested and growing conditions analysed so that they can harvest the raw material at the right time. GACP is a significant challenge to the industry because nature cannot be fully controlled. It is clear, however, that Phynova closely monitors growing conditions to maintain a high standard at all times.

Dr Ela Shah shared her experiences of being an Ayurvedic Medical practitioner providing background on the ancient system of Ayurveda. She explained how she has developed her own products having successfully treated patients for a range of conditions including psoriasis, eczema and urinary tract infections. Now, however, she is unable to provide the finished product because of the EU Herbal Directive coming into full force last year on 30 April which has made it illegal to do so. She highlighted her frustrations in being restricted in this way and is upset that her patients are denied the benefits of her products. She stated that her product portfolio is registration ready under the Traditional Herbal Registration Scheme but because of the enormous financial investment required to achieve registration, she cannot pursue her dream.

Dr Shah’s story is not uncommon. Time and again I have had conversations with individuals and small business owners who are distraught because they cannot afford registration. In their opinion, this leaves them with only one option: to close their doors and look for an alternative revenue stream. As you can see the EU Herbal Directive has had a significant impact on the herbal industry but not only for Asian traditional medicines but also for our own European traditional medicines.

Finally, I rounded off the evening of talks with an overview of the EU regulations which may be applicable to an herbal product. I made it clear that the Traditional Registration Scheme is not the only regulatory pathway to market. There are options, each with its own challenges: food supplements, foods with health claims, novel food, cosmetic, medicine and thinking more laterally, medical device and veterinary use.

I emphasised the importance of deciding on the intended use of your product as it is this that will most likely determine the regulatory pathway. Therefore, you need to consider:

How is it presented – topical, ingested, sprayed, swallowed?
What is the active herbal ingredient? History of medicinal and/or food use?
What is the potency of the actives?
How long has the product been used for? Does it comply with the 30/15 year rule? Is there history of significant consumption before 15 May 1997?
History of use? What evidence of traditional use is there: Brochures? Sales invoices? Literature? Expert Statements?
What claims, if any, do you want to make? Are these nutritional, health related or medicinal claims?

The presentations were then followed by a panel and Q&A session during which there was reference to ‘quackery’ medicine vs. analytical scientific evidence. This caused much debate so much so that this theme carried on during the networking afterwards! All of the speakers stayed on which meant that attendees were able to tap into their experience and expertise further. It really was an opportunity not to be missed.

It is clear that there are significant challenges for the herbal industry in Europe but, I believe that we will see growth again as opportunities are identified and companies become more confident in their approach to regulations.

My thanks to Clyde & Co for hosting the event; to Louis Turner of the Asia-Pacific Technology Network (APTN) for organising it; to all the speakers for their time and invaluable insights and of course, the attendees for listening, raising questions and sharing their own experiences. And, last but by no means least, my thanks to Bobby Deal (Managing Director of GRS) for his support and for being the event photographer - please click here to view the slideshow. ‘Til next time!

Author: Greer Deal, Director of Global Regulatory Services