David Stanton (Cork East, Fine Gael)
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497. To ask the Minister for Health the number of persons registered for the drug payment scheme; the number of medical card holders respectively who are currently being prescribed Nadolol to treat life-threatening cardiac conditions; the position regarding medical card holders and payment for Nadolol; if his Department or the Health Service Executive plan to review their positions in this regard; and if he will make a statement on the matter. [14152/15]

Kathleen Lynch (Cork North Central, Labour)
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There are currently no products authorised in Ireland containing Nadolol, nor are there any applications pending with the Health Products Regulatory Authority for such products.

Nadolol was previously authorised under the brand name Corgard, however, these authorisations were withdrawn by the marketing authorisation holder Sanofi in 2000. The product is however still authorised in some European countries. The Health Products Regulatory Authority has received notification from wholesalers that products containing Nadolol have been imported into Ireland under the notification scheme for exempt medicinal products.

The Health (Pricing and Supply of Medical Goods) Act 2013 sets out the rules and criteria around reimbursement of medicinal products. Under the Act the HSE can only add items to the reimbursement list which have a marketing authorisation.

In exceptional circumstances the Act authorises the HSE to fund reimbursement of items not on the reimbursable list for individual patients provided the patient requires that item for clinical reasons and that there is no listed item which is a suitable alternative for that item in so far as the patient is concerned.

The HSE has confirmed that it has funded Nadolol for individuals when applications are made which provide evidence which allow the HSE to utilise the exceptional criteria provided under the 2013 Act.

As the other issues raised in this question relate to the administration of the GMS and Community Drugs Schemes the question has been referred to the HSE for direct reply on those issues. If you have not received a response within 15 working days, please contact my Private Office and they will follow up the matter with them.

David Stanton (Cork East, Fine Gael)
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498. To ask the Minister for Health if he is aware of cases where patients with serious cardiac conditions who have been prescribed Nadolol are unable to access the drug due to the high cost or lack of availability; the options available to such patients; and if he will make a statement on the matter. [14153/15]

Kathleen Lynch (Cork North Central, Labour)
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There are currently no products authorised in Ireland containing Nadolol, nor are there any applications pending with the Health Products Regulatory Authority for such products.

Nadolol was previously authorised under the brand name Corgard, however, these authorisations were withdrawn by the marketing authorisation holder Sanofi in 2000. The product is however still authorised in some European countries. The Health Products Regulatory Authority has received notification from wholesalers that products containing Nadolol have been imported into Ireland under the notification scheme for exempt medicinal products.

The Health (Pricing and Supply of Medical Goods) Act 2013 sets out the rules and criteria around reimbursement of medicinal products. Under the Act the HSE can only add items to the reimbursement list which have a marketing authorisation.

In exceptional circumstances the Act authorises the HSE to fund reimbursement of items not on the reimbursable list for individual patients provided the patient requires that item for clinical reasons and that there is no listed item which is a suitable alternative for that item in so far as the patient is concerned.

The HSE has confirmed that it has funded Nadolol for individuals when applications are made which provide evidence which allow the HSE to utilise the exceptional criteria provided under the 2013 Act.