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Dáil Éireann debate -
Thursday, 7 Mar 2002

Vol. 550 No. 2

Written Answers. - Medicinal Products.

Olivia Mitchell

Question:

315 Ms O. Mitchell asked the Minister for Health and Children his plans to draw up regulations or standards for alternative health products. [7864/02]

On Wednesday, 23 January 2002, I received the Irish Medicine Board's report entitled "Herbal Medicines Project Final Report". This report is currently being considered in my Department.

In June 2000, in the light of difficulties in the licensing of herbal medicinal products under current medicines legislation, particularly in relation to proving efficacy in accordance with existing EU requirements, I requested the Irish Medicines Board to develop a proposal for an interim national licensing system for ‘traditional and alternative medicinal products, including herbal medicinal products'. A herbal medicines project manager was appointed to the IMB in September 2000 and a press advertisement was placed on 29 September 2000 in three national newspapers outlining the aim of the project and inviting public comment on all aspects of a possible interim national licensing scheme for traditional, alternative and/or herbal medicinal products. The total number of submissions received by the IMB was 41, all of which were accepted and reviewed. In addition, the IMB formally contacted those organisations known to it to have an interest in herbal medicines as follows: Consumers for Health Choice – CHC; Health Products Alliance – HPA; Irish Association of Health Stores – IAHS; Irish Association of Medicinal Herbalists – IAMH; Irish Health Trade Association – IHTA; Irish Register of Chinese Herbal Medicine – IRCHM.

The Professional Register of Traditional Chinese Medicine, PRTCM, also contacted the IMB directly and was duly invited to make a submission.

As part of the consultation process, the public and interested parties were asked to make nomi nations for membership of anad hoc Scientific Committee on Herbal Medicinal Products – SCHMP. The intention was that this committee should comprise a panel of scientific experts having a special knowledge in herbal medicines and/or related areas and that its role would be to advise and assist the IMB in matters pertaining to the development of an interim national licensing scheme. Dr. Desmond Corrigan, director of the School of Pharmacy, Trinity College Dublin, was nominated by a member of the public to serve on the ad hoc SCHMP and was also proposed by the IMB. Dr. Corrigan is an acknowledged international expert in herbal medicine-pharmacognosy and has been involved in this area at a European level for more than ten years. On this basis, the IMB invited Dr. Corrigan to be chairperson of the ad hoc SCHMP. The establishment of this committee was considered important for the success of the project and a total of 15 names were proposed as part of the consultation process. In addition, the IMB nominated eight candidates for consideration by the chairperson. Dr. Corrigan suggested one additional nominee. From the suggestions received, the chairperson selected those people whom he deemed appropriate and who were available to join the committee. The members were chosen with a view to establishing a balanced committee consisting of people from a variety of backgrounds who would effectively reflect and represent the many views and opinions in this area.
It was the intention that thead hoc SCHMP be established as a group of experts and not as a group representing interested parties. Consequently, members with expertise in the following disciplines were appointed to the committee and were required to sign a confidentiality agreement and to declare any conflicts of interest: pharmacognosy; phytochemistry; complementary medicine; general and Chinese medicine; general and herbal medicine; herbal medicine; pharmacy and aromatherapy.
The committee had a total of seven meetings from December 2000 to September 2001.
The following organisations also agreed to participate in the consultation process: College of Anaesthetists of the Royal College of Surgeons of Ireland – RCSI; Consumers for Health Choice – CHC; European Herbal Practitioners Association – EHPA; International Society of Professional Aromatherapists – Irish Branch – ISPA; Irish and International Aromatherapy Association – IIAA; Irish Association of Health Stores – IAHS; Irish Association of Medical Herbalists – IAMH; Irish College of General Practitioners – ICGP; Irish Health Trade Association – IHTA; Irish Herbal Practitioners Association – IHPA; Irish Register of Chinese Herbal Medicine – IRCHM; National Institute of Medical Herbalists – NIMH; Pharmaceutical Society of Ireland – PSI;
In September 2001, thead hoc SCHMP agreed the final draft of the herbal medicines project report prior to its release for public consultation. This consultation process was available to the public through the IMB website for a period of four weeks from 1 November 2001 and following representations, I arranged for the closing date for public comment to be extended by a further four weeks to 27 December 2001. A total of 86 responses was received and these were all discussed by the committee and the IMB at a meeting in January 2002.
Both the report and the IMB/SCHMP review of responses received through the public consultation are available on the Irish Medicines Board's website.
The Deputy should be aware that it is not the intention of the IMB/SCHMP proposal that ‘safe and favourite' remedies would no longer be available for sale to the general public. On the contrary the IMB/SCHMP wishes to ensure the continued availability of safe traditional medicinal products for sale in pharmacies, health food stores and supermarkets. Under the proposed scheme the consumer will have an assurance that the registered traditional medicinal products they buy are: 1) produced to an appropriate quality standard; 2) safe under the proposed conditions of use; 3) can be expected to act in accordance with an established tradition of use; and 4) are appropriately labelled.
The Deputy should also be aware that a proposed EU directive on traditional herbal medicinal products was agreed by the European Commission on 17 January 2002. This proposal will now be sent to the European Parliament and Council. I understand that the IMB/SCHMP proposal for an interim national licensing scheme is broadly in line with the proposed EU directive. Both the IMB's proposal and the proposed EU directive are currently being examined in my Department. As a follow up to the publication of its report, I have requested the IMB to organise a seminar for interested parties which will offer further scope to review the report's implications.
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