The Irish Medicines Board is the relevant statutory authority in respect of this matter and I do not believe it is appropriate for the Minister for Health and Children to interfere with the board in the discharge of its remit in relation to medicinal products, howsoever these products may be described. It is important that the terminology employed is not interchangeable. If the board becomes aware in the course of its work that there are issues of concern in respect of public health which need to be addressed, it is the board's responsibility and duty to take whatever action is necessary to protect the health of our citizens. I do not believe that the position is negotiable.
It is important to point out that the basis upon which this issue arose was that the Irish Medicines Board received a product authorisation application in respect of a medicinal product which contained the herbal ingredient hypericum perforatum, otherwise known as St. John's Wort. The medical evaluation of that application revealed major deficiencies in the submitted information and the concerns of the board were conveyed to the applicants in the usual manner. The applicants involved decided to withdraw the application rather than respond to those concerns in the normal way.
As some of the board's concerns related to the active herbal ingredient generally, it took the view that products containing St. John's Wort should be recommended for prescription control in the interests of public health. That is the basis upon which it applied a prescription only status to it. What occurs in Germany and Northern Ireland on this issue does not come under the remit of the IMB. It is the statutory authority to deal with the issue, as established by the Oireachtas.
Every medicinal product must be authorised and it must meet the criteria of health, safety and efficacy. This product failed on the basis of public health. It is available on prescription as an over the counter product. I must take the board's advice seriously. An interim registration system has been established for other medicines which had traditional uses. It is more simplified in terms of meeting the criteria of health and safety because there is a difficulty in some instances where other products which do not relate to this issue are efficacious in that they do what they claim. There is an absence of clinical trials in regard to them.
These products are unlicensed. People in the industry want regulation and licensing. I am providing an interim licensing arrangement for all those products and a working group will work with the IMB and other interests, which are knowledgable in this area, to deal with that specific issue, which is historical. The board made a decision based on medical and scientific grounds and public health considerations given the interaction that takes place between St. John's Wort and other medicines. It is not appropriate for me to interfere with the independence of that authority.