In 2004, the European Union enacted Directive 2004/24/EC*, relating to the regulation of traditional herbal medicinal products. The Traditional Herbal Medicinal Products Directive, (or ‘THMPD’, which I always seem to read as ‘Thumped’ in my brain…) will take full effect on 30 April this year. This change in law will subtly affect those of us who purchase herbal remedies. Herbalists will now have to be registered, together with the medicines that they dispense, and this means it will no longer be possible to pop into a Chinese Herbalists and buy a bottle of strange-named something to get you through; instead certain remedies will only be available on prescription from registered practitioners.
The Medicinal Healthcare Regulatory Authority (MHRA) is a Government department which is responsible for ensuring that medicines and medical devices work and are safe. Products are registered with them in an expensive and time consuming process. Modern herbs which cannot show the required 30 years of traditional use (15 of which must be in the EU) will now not be sold on the basis of this new legislation.
All herbal medicines sold over the counter will need to be approved and registered by the MHRA, which should mean an end to unlicenced and potentially dangerous substances being marketed and sold as medicines. As more herbal medicines undergo clinical trials (or registration under the simplified ‘traditional use’ registration process) to ensure their effectiveness, GP’s will be able to prescribe them to patients as alternatives to pharmaceutical popular choices. Medicines registered under the THMPD will be marked with a ‘THR’ logo and brand marking. As the ‘Your Right to Choose Your Medicine‘ campaign site points out, this will provide assurance that the remedy is safe, but does not guarantee effectiveness.
The down side is that the clinical trials and registration will cost money. To date, not a single Chinese or Ayurvedic blend has made it to the registered lists. The Alliance for Natural Health International is mounting a legal challenge to the EU directive, saying that Chinese and Ayurvedic blends do not fit into the new system (the legislation appears to specifically exclude blended remedies from registration).
So, discussion time: do you already purchase herbal remedies from a herbailst practitioner? Will you continue to do so after the registration comes into full effect, or will you simply purchase your supplies over the internet? Do you think that the registration requirement is too draconian, and if so, would you propose a different system of regulation? Or do you think that the new rules are a welcome safeguard for patients?
[* Click HERE for the full text of the Directive – and good luck to you.]