Gay Mitchell
Ceist:8 Mr. G. Mitchell asked the Minister for Health when he expects the report of the Food Safety Advisory Committee to be available; and if he will make a statement on the matter.
Ceisteanna — Questions. Oral Answers. - Food Safety Advisory Committee Report.
Michael Finucane
Ceist:40 Mr. Finucane asked the Minister for Health when he expects the first committee of the food safety advisory committee dealing with non-medical preparations not covered by existing regulations to report in view of many borderline products causing confusion and inequity.
I propose to take Questions Nos. 8 and 40 together.
The subcommittee of the Food Safety Advisory Committee referred to was established to consider and make recommendation for policy in relation to "diet integrators" in the context of a discussion paper prepared by the EC "Diet integrators" is a term applied to products which do not fall clearly into the categories of foodstuffs or medicines. I expect to have the report of this sub-committee shortly.
Meanwhile, I should say that a memorandum is available from my Department outlining current policy in relation to the interpretation of the medical preparations licensing scheme as it affects borderline products.
I hope there will be the minimum of delay in this matter. Will the Minister accept that the definition of borderline products is causing considerable hardship for many companies operating in the State? There is a very thin line between what is considered to be a medical preparation and a dietary supplement, such as vitamins and nutrients. In view of the fact that there is now increased usage by the consumer of dietary supplements, such as vitamins, I put it to the Minister that there should be a clear demarcation between the two, given that under the regulations licences and certificates are required. This presents a problem for many companies which manufacture vitamins. Will the Minister outline a timeframe within which he will receive this report and give the House a commitment that he will act on it as quickly as possible since I hope he accepts there is confusion?
I am not sure there is confusion, but difficulties are being encountered. That is the reason the Food Safety Advisory Committee was asked to advise the Minister for Health and the Minister for Agriculture, Food and Forestry on these matters. I have asked that the report be presented to me as soon as possible and I have been advised that I will receive it in the immediate future. As I have indicated to the House, there are guidelines in relation to the interpretation of the medical preparations licensing scheme. It might be useful to circulate these guidelines. It is a complicated and long document which contains the definition of borderline products. It makes the definition reasonably clear. When I receive the report I will take whatever measures are deemed to be appropriate by the committee.
May I ask the Minister a related question? What procedures are followed in approving new drugs before they are placed on the market? I am referring in particular to a drug called prolastin which is available in the United States and other parts of Europe but not apparently here, except in exceptional circumstances. It is needed urgently for the treatment of a rare genetic disease which affects only a handful of people.
That is a specific question but perhaps the Minister may be able to refer to it.
Again, it is not directly related to the question which has been tabled, but there is a procedure which is followed by the National Therapeutic Agency in the validation of drugs. This procedure is followed in every country including the Food and Drugs Administration in the United States, in testing and validating any new drug before it is made available either for sale or on the GMS list.