Madam, – In response to Dick Barton (April 25th), I would like to make a few points about the Traditional Herbal Medicinal Products Directive 2004/24/EC which was transposed into Irish law by Medicinal Products (Control of Placing on the Market) Regulations 2007.
Mr Barton makes the point that alternative health products such as herbal medicines work “really effectively”, are “safe and effective” and do not cause the “level of damage to human beings” compared to conventional medicines. He also states that the motive of this directive was to benefit “big pharma” and will, at a time of economic hardship, result in increased healthcare costs for financially pressed consumers.
First, unless a randomised controlled clinical trial has demonstrated efficacy no one can be reasonably sure beyond anecdotal evidence or hearsay that a treatment is effective. The vast majority of herbal medicines have not been subjected to the randomised clinical trials that their conventional medicinal counterparts have been. As a pharmacist who qualified in Ireland I would not feel comfortable recommending a herbal medicinal product to a cash- strapped patient if I myself was not convinced of the effectiveness of the treatment. Second, Mr Barton appears to be convinced that herbal medicinal products are invariably safe. This is not so. Herbal medicinal products contain plant chemicals that can exert a powerful effect on the body and like conventional medicines, have the capability to cause side-effects and interact with other medicines to potentially cause harm. Additionally they can also be contaminated with impurities, including heavy metals.
Contrary to the popular conviction propagated by persons such as Mr Barton, “natural” does not necessarily mean safe in the world of medicines.
Finally the spirit of this directive does carry public support in Europe and is not against the will of the “people who vote” in Europe as suggested by Mr Barton. In a UK Ipsos MORI report published in November 2008, 77 per cent of adults agreed it is important that herbal medicines are regulated. Features of regulation that British adults felt particularly important included a check that ingredients are safe before the product is allowed to be sold (83 per cent of all adults said this was either “essential” or “very important”). Herbal medicinal product manufacturers have been aware of this legislation since 2004 and have had plenty of time to register their products in Ireland.
The directive will ensure that herbal medicinal products will be manufactured to an acceptable quality and safety and under the traditional use provision, herbal medicine manufacturers will not have to prove effectiveness on the basis of its traditional use. Therefore the public will still have the choice of using such an alternative medicine (whether actually effective or not) and have the assurance that what they are buying has been deemed by the Irish Medicines Board to be manufactured to an acceptable standard. – Yours, etc,