Should herbal medicine-like products be licensed as medicinesBMJ 1995; 310 doi: https://doi.org/10.1136/bmj.310.6986.1023 (Published 22 April 1995) Cite this as: BMJ 1995;310:1023
- Peter A G M De Smet
- Clinical pharmacologist Drug Information Centre, Royal Dutch Association for the Advancement of Pharmacy, 2514 JL The Hague, Netherlands
Special licensing seems the best way forward
Herbal remedies form a potpourri that ranges from plants that people collect themselves and then take for health reasons to approved medicinal products. Many herbal products available in Britain fall between the far ends of this regulatory range: unlicensed preparations are thought to account for over 80% of herbal sales.1 European Union legislation requires herbal products to be authorised for marketing if they are industrially produced2 and if their presentation or their function, or both, bring them inside its definition of a medicinal product.3 Unfortunately, the drawing of sharp borderlines is difficult.
Many medicine-like products on the British herbal market remain unregistered for two reasons: acceptable data on efficacy, safety, and quality may not be available, and the licensing fee is high. Diluting requirements for registration would introduce double standards, which would be highly controversial. On the one hand, a single regimen for medicinal products offers undeniable advantages including equal treatment for all kinds of remedies and …