Thousands of patients in the UK facing the decision about the banning of more than 200 herbal products. For some, this decision is discriminatory and shameful. The same measures are planned for the rest of the EU in accordance with new directive from 2004 (part which concerns herbal products) – from 1 May 2011 all herbal products in the UK must be licensed or prescribed by a registered herb practitioner. This is connected with the concern over adverse events in these products.
Remedies under threat
Cascara bark (Cascara sagrada, Rhamnus purshiana)
Helps stimulate a sluggish bowel.
Pau D’Arco (Tabebuia impetiginosa)
Anti-inflammatory, used for infection control.
Ashwagandha (Withania somnifera, or winter cherry)
Anti-inflammatory, for arthritis and boosting the immune system.
Skullcap (Scutellaria baicalensis/Chinese skullcap)
For anxiety, headaches and pain relief.
Meadowsweet (Filipendula ulmaria)
For stomach acidity, diarrhoea, headache.
Horny goat weed (Epimedium grandiflorum)
Used to enhance libido
Most of these products have been used on the UK for more than one decade.
The main reason why these product are so hard to license is their complex composition which make their testing very expensive and complicated. Also, it is very hard to patent these products because they grow in gardens.
The ANH estimates the cost of obtaining a licence at between £80,000 and £120,000 per herb. They say this is affordable for single herbal products with big markets, such as echinacea, a remedy for colds and flu, but will drive small producers of medicines containing multiple herbs out of business.
But academical experts and responsible people from MHRA (Medicines and HealtCare Regulatory Agency) also warn that being natural does not necessarry mean being safe for use and healthy. One of the examples is aristolochia, a banned toxic plant derivative which caused kidney failure in 2 women.
Experts from the Alliance for Natural Health (ANH) also warn that people might turn to the Internet if they are deprived from their herbal products by the official distribution channels. These products are very popular because they are consumed for the prevention purposes mainly. Furthermore, a review of the codes of conduct by which alternative practitioners were bound found the “vast majority” did not include an obligation to report adverse effects, he said. The only exception was the Chinese Herbal Medicine Code which advised members to report “cases of industrial poisoning or accident”.
Health Authorites in the UK seek an optional solution in order to help the patients but at the sam tim to respect the aplicable laws and to track the product safety.
So far the MHRA received 166 license applications for herbal products, 78 of whom have been granted. Registry of herbal specialists who prescibe such medicines are also necessarry and important.