Dáil Éireann Debate, Wednesday - 20 March 2024
1376. Deputy Richard Boyd Barrett asked the Minister for Health if he is aware of the scopolinem patch; if there are plans to make it available for medical card users; and if he will make a statement on the matter. [12363/24]
View answerThe Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.
In line with the 2013 Act and the national framework agreed with industry, a company must submit an application to the HSE to have a new medicine added to the reimbursement list. Reimbursement is for licenced indications which have been granted market authorisation by the European Medicines Agency (EMA) or the Health Products Regulatory Authority (HPRA).
The Scopolamine (Scopaderm) patch is not licensed with the HPRA in Ireland and, therefore, cannot be added to the formal reimbursement list.
However, an application for the Scopolamine (Scopaderm) patch can be made on an exceptional basis under Discretionary Hardship Arrangements. This is in accordance with Section 23 of the 2013 Act, which provides for the supply of items not on the reimbursement List.
All applications under these arrangements are reviewed on an individual patient basis. The HSE must be satisfied that the patient requires the item for clinical reasons, and that there is no item on the reimbursement list which is a suitable alternative for that patient. In addition, as the Scopolamine (Scopaderm) patch is an Exempt Medicinal Product, the application must be consultant initiated.
