asked the Minister for Health if he will clarify the details in relation to the recent decision to limit the accessibility of certain contraceptives; the reason this has been done; and if he will make a statement on the matter.
Written Answers. - Accessibility of Contraceptives.
250.
Regulations were made by the Minister for Health in 1984 in respect of the licensing, advertisement and sale of medical preparations. Under these regulations the National Drugs Advisory Board recommended to the Department of Health that on grounds of public health, safety and efficacy, copper bearing intrauterine contraceptive devices should be made subject to the same product authorisation licensing and control requirements as apply to drugs and medicines under the Medical Preparations (Licensing, Advertisement and Sale) Regulations, 1984. These particular devices are subject to such licensing requirements in many other countries.
The recommendations of the NDAB were accepted by my Department and it was decided that importers should only be permitted to import copper bearing IUCDs under the family planning legislation, if the products in question had been reviewed by the NDAB.
It was decided, with the agreement of the NDAB, to allow a pharmaceutical wholesaler to continue to import one well established copper bearing IUCD, in respect of which an application for a product authorisation had already been submitted to the NDAB by the manufacturer.
It is expected that a product authorisation will be made available to this product within the next 12-14 weeks and also to another copper bearing IUCD, in respect of which application for a PA has also been made to the NDAB.
No further applications have yet been made to the NDAB in respect of copper bearing IUCDs. The initiative in this matter rests with manufacturers and suppliers.
It was decided in 1987 to require that the pharmaceutical contraceptive preparations being imported under the family planning legislation, such as spermicidal creams and foams, should also be subject to review and approval by the NDAB.