PHIL COSTIGAN, General Secretary of the Irish Health Trade Association (IHTA), examines how laws controlling the sale of traditional herbal medicinal products are impacting the industry in Ireland.
Readers will be familiar with EU regulatory initiatives that emerged with the dawn of the 21st century. These were purportedly enacted to provide increased consumer protection and to stimulate enterprise and growth. Has this happened? In relation to herbal products let’s see how matters are progressing in Ireland…
The Traditional Herbal Medicinal Products Directive (2004/24/EC) introduced us to a simplified registration procedure – the THMP registration scheme. This directive was transposed into Irish law by the implementation of the Medicinal Products (Control of Placing on the Market) Regulations 2007 (S.I. No. 540 of 2007).
The registration take up has been slow, currently 39 TR authorisations have been granted. In January 2015, the Health Products Regulatory Authority (HPRA) published a listing of 56 medicinal herbs considered acceptable as THMPs. It is easy to come to the conclusion that this regulation has culled the wide variety of herbal products once readily available to the consumer. We ask, was customer safety really so compromised that such disproportionate regulation is justified?
The IHTA continues to push for improved processing of applications for THMPD under the HPRA so that more companies will invest in the market. In December 2014, the HPRA opened a public consultation on their Guide for Retail Sale of Herbal Medicinal Products. The Guide includes a decision tree and three lists as a reference to determine if a herbal product can be legally sold in Ireland.
List A identifies those herbal medicinal products that may be sold by a retailer, 68 in number. List B covers herbal products subject to prescription control. List C includes herbal substances which when contained in a product may render it a medicinal product. If in doubt retailers are directed to contact the Health Products Regulatory Authority (HPRA) or the Food Safety Authority of Ireland (FSAI) for advice. This is a most comprehensive listing covering 23 pages of listed substances.
Some products containing herbs or herbal substances may be sold legally as food supplements if they make no medicinal claims. These products must be notified to the FSAI and the duty to notify falls on the manufacturer if the product is manufactured in Ireland or on the importer if the product is imported into Ireland. The IHTA continues to push for greater efficiency and transparency in the FSAI’s notification system so that it is clear, to consumers and industry alike, what products are legal for the market.
We note that consumers are turning to the internet to source product. Their safety is compromised and compliant businesses are disadvantaged. The IHTA continues to push the regulators to engage in fair, equal and appropriate management of the marketplace, including the internet.
For our part the IHTA is self-governing. Members adhere to best distribution practice, their customers, the retailers of natural health products, can avail of technical and educational assistance from their suppliers ensuring that the consumer has access to informed purchasing choice.