TradeReg-Symposium 2013

by Dr. Mathias Schmidt (ANME+EUAA)

From 30 September to 2 October the symposium “TradeReg 2013: Regulation of Herbal and Traditional Medicinal Products – European and global strategies” took place in Bonn (Germany). During this three-day-symposium the regulatory approaches were presented for Europe and beyond the EU borders: there were, for example, presentations on the regulatory situation of herbal medicinal products in Brazil, Japan, Canada or the United States of America.

Of course, a major emphasis went to the collected experience with the registration of traditional herbal medicinal products in Europe.In view of the current European situation many participants had hoped for answers to pressing questions, especially with respect to the transfer of unregulated food supplements to the market segment of regulated traditional medicinal products. This hope was, however, deceived: ultimately the messages gave more information on what is not possible than aids to the question how manufacturers of food supplements could make practical use the so-called facilitated registration.

1st European Herb Gathering, 4-7 October 2012, Lesachtal, AT

Rural Actors for Health

• Herbs play an important role for health
• Traditional knowledge about the use of plants is acknowledged as intangible cultural heritage (recognized by UNESCO). This represents a strong commitment to safeguard this knowledge and the benefits it can provide for public human health.
• The cultivation, processing, selling and use of herbs is strongly restricted by regulations
• It is often rural actors, mainly women, who are the holders of knowledge how to cultivate and process plants and how to use them. These actors play an important role in the economic balance of rural regions. The cultivation and processing of plants is an important cornerstone of multifunctional agriculture.

 Report

The precarious status of ! herbal products in the EU"

by! The Herbal Working Group of the CAM Stakeholder Group !
Presenter: Robert Verkerk PhD - Alliance for Natural Health International!
Also on behalf of:
! EHTPA - European Herbal & Traditional Medicine Practitioners Association!
EITAM - European Initiative for Traditional Asian Medicine!

Use of herbals in the EU!

• Market reports consistently show herbal medicine most popular form of complementary medicine used in Europe !
  Germany and France = market leaders!
• Herbal medicines widely used across the EU e.g. 2009 UK MHRA* showed that over a quarter of the UK population had used a herbal remedy in the previous 2 years !
• Consumers relying on the legislators to provide them with a full range of traditional herbal medicines. Failure to achieve this will force consumers to buy from unreliable internet sources or back-street traders".

EC Directive 2004/24/EC - Traditional Herbal Medicinal Products Directive - THMPD!

Original goal of THMPD: safe and ready access to traditional herbal medicinal products (THMPs) in the EU. To date only around 200 THMPs in 27 MSs registered since 2004.!
The THMPD has failed to provide for THMPs from systems of traditional medicine, such as Ayurveda (from the Indian subcontinent) or traditional Chinese medicine (TCM).!
THMPD does not clearly define the borderline between traditional herbal medicines and botanicals in food supplements!

More

Herbs to combat the threat of microbial resistance to antibiotics

A paper from the European Herbal and Traditional Medicine Practitioners Association (EHTPA) for the House of Commons Select Committee on Science and Technology’s antimicrobial resistance (AMR) inquiry.

Executive Summary:

In light of growing concerns relating to microbial resistance to antibiotics increasing attention is being given to the role that herbal medicines may play as autonomous anti-bacterial agents or as adjuvant treatments used to potentiate conventional drugs. This paper selectively reviews the evidence for herbal medicine as a valuable resource to combat bacterial resistance to antibiotics and suggests that further research is warranted.

1. Synergy is an important characteristic determining the medicinal action of many herbal medicines occurring at pharmacodynamic and pharmacokinetic level^{1 2} and a number of papers have been published investigating potential benefits conferred by the synergism of phytoconstituents^{3 4 5 6}. In particular, researchers have demonstrated that combining antibiotics with plant medicines can enhance the action of antibiotics thereby overcoming antibiotic resistance⁷.
2. This is achieved in three main ways: firstly by means of a combined phytochemical and antibiotic attack on the bacterial cell wall - epigallocatechin gallate (EGCG) as found in green tea and carob powder is effective in this regard. Secondly, antibiotic resistance can be overcome by inhibition of enzymes that are generated by bacteria for the deactivation of antibiotics (again EGCG is active here) or by thirdly by disabling an efflux pumping system developed by several bacteria in order to prevent potentially destructive compounds such as antibiotics from penetrating into the bacteria, or to expel the antibiotics out of the bacteria cell once they have invaded it⁸.

More