Noel Ahern (Dublin North West, Fianna Fail)
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Question 151: To ask the Minister for Health and Children, further to Parliamentary Question No. 132 of 29 April 2010 in relation to medical products, if there is a procedure of approving a product on a case by case compassionate basis in advance of approval by the EU or Irish Medicines Board; if this product cannot be included in the general medical scheme on the recommendation of a consultant on a case by case basis when the drug has a very small potential market and the manufacturer has not made application; if an update on a product which is going through the EU approval system for some months can be given. [30926/10]

Mary Harney (Dublin Mid West, Independent)
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As I explained in a previous reply to the Deputy, pharmaceutical companies must apply to the Health Service Executive (HSE), for their product(s) to be reimbursed under the General Medical Services (GMS) Scheme and the community drugs schemes. Neither the HSE or my Department has a role in the decision by a company as to whether it makes such an application to the HSE. In order for a medicinal product to be considered by the HSE for reimbursement it must meet specified criteria. These include the following:

The product must be an 'allopathic' medicinal product authorised by the Irish Medicines Board or the European Commission.

The product must be such that it is ordinarily supplied to the public only on foot of a medical prescription.

The product should not be advertised or promoted to the public.

The medicine mentioned by the Deputy is not a licensed product and therefore is not eligible for reimbursement under the GMS or community drugs schemes. Neither the HSE or my Department has a role in whether a company applies to the Irish Medicines Board to obtain such a licence.

The HSE operates a protocol under which exempt medicinal products (unlicensed medicines), which satisfy specific criteria, are made available to patients. A key part of the protocol is that the medicinal product concerned should be such that no authorised medicinal product of essential similarity is available for prescription or supply under the GMS or community drugs schemes. An alternative to the medicine mentioned by the Deputy is licensed in Ireland and is reimbursable under the GMS and community drugs schemes.