Written Answers. - Alternative Medicines.
Pádraic McCormack
Ceist:
502
Mr. McCormack
asked the
Minister for Health and Children
his plans to extend the time limit for submissions on the proposed interim legislation on traditional medicine; and if he will make a statement on the matter.
[1311/02]
John Perry
Ceist:
514
Mr. Perry
asked the
Minister for Health and Children
if his attention has been drawn to the Irish Medicines Board's proposed regulations for the control of traditional herbal remedies; his views on the fact that if these proposals are strictly implemented it could result in the loss of many safe and favourite remedies, compelling some consumers back onto pharmaceutical drugs; and if he will make a statement on the matter.
[1373/02]
John Perry
Ceist:
522
Mr. Perry
asked the
Minister for Health and Children
if his attention has been drawn to the Irish Medicines Board's proposed regulations for the control of traditional herbal remedies; his views on whether, these proposals if strictly implemented, could result in the loss of many safe and favourite remedies; and if he will make a statement on the matter.
[1419/02]
Jack Wall
Ceist:
527
Mr. Wall
asked the
Minister for Health and Children
his views on documentation (details supplied) regarding the EU directive on licensing traditional medicine.
[1481/02]
Gay Mitchell
Ceist:
531
Mr. G. Mitchell
asked the
Minister for Health and Children
if he will make a statement addressing the concerns of a person (details supplied) in Dublin 6W in relation to herbal remedies.
[1537/02]
Denis Naughten
Ceist:
534
Mr. Naughten
asked the
Minister for Health and Children
the reason the Irish Medicines Board intends to introduce regulations for herbal medicines; the reason the closing date for public comments on the proposed regulation was set during the Christmas period; his plans to extend the time for the submission of public comments; and if he will make a statement on the matter.
[1540/02]
Liam Lawlor
Ceist:
554
Mr. Lawlor
asked the
Minister for Health and Children
if he will respond to the concerns of a person (details supplied) regarding the perceived unfairness in the composition of the advisory board on alternative medicine and in relation to the anticipated directive from the European Union.
[1763/02]
Seán Ryan
Ceist:
689
Mr. S. Ryan
asked the
Minister for Health and Children
his plans to introduce legislation or regulations regarding traditional medicines; if the Irish Medicines Board has submitted draft proposals to him in this regard; if he will meet representatives of the Health Food Association to enable them to make a submission in regard to this issue; and if he will make a statement on the matter.
[2797/02]
I propose to take Questions Nos. 502, 514, 522, 527, 531, 534, 554 and 689 together.
I am pleased to inform the Deputies that 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 light of difficulties in the licensing of herbal medicinal products under current medicines legislation, in particular 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 alter native 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, the Health Products Alliance, the Irish Association of Health Stores, the Irish Association of Medicinal Herbalists, the Irish Health Trade Association and Irish Register of Chinese Herbal Medicine. The Professional Register of Traditional Chinese Medicine 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 nominations for membership of anad hoc Scientific Committee on Herbal Medicinal Products. The intention was that this committee should comprise of 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 SCHMB 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: pharmac ognosy, phytochemistry, complementary medicine, general and Chinese medicine, general and herbal medicine, herbal medicine and 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 the College of Anaesthetists of the Royal College of Surgeons of Ireland, Consumers for Health Choice, the European Herbal Practitioners Association, the International Society of Professional Aromatherapists – Irish Branch, the Irish and International Aromatherapy Association, the Irish Association of Health Stores, the Irish Association of Medical Herbalists, the Irish College of General Practitioners, the Irish Health Trade Association, the Irish Herbal Practitioners Asociation, the Irish Register of Chinese Herbal Medicine, the National Institute of Medical Herbalists and the Pharmaceutical Society of Ireland.
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. I understand that both the report and the IMB-SCHMP review of responses received through the public consultation have now been placed on the Irish Medicine Board's website.
The Deputies 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 produced to an appropriate quality standard; safe under the proposed conditions of use; can be expected to act in accordance with an established tradition of use; and are appropriately labelled.
The Deputies 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.
Like the Deputies, I have also received many representations about this proposal and I will be considering these in the context of our examination of the IMB report and the proposed EU directive.
