I propose to take Questions Nos. 551, 552, 598 and 683 together.
The HSE has statutory responsibility for medicine pricing and reimbursement decisions, under the Health (Pricing and Supply of Medical Goods) Act 2013. The 2013 Health Act specifies criteria for decisions on the reimbursement of medicines. I have no role in this statutory process.
On 11 June 2019, the HSE Leadership Team approved access to the drug Spinraza for children with Spinal Muscular Atrophy (SMA) Type I, II or III on an exceptional and individualised basis.
The HSE has indicated that since July, 11 children have been approved for Spinraza treatment in Temple Street Hospital. Application for approval is based on clearly defined criteria and clinical guidelines being followed in each case. All patients who have been recommended clinically have been approved to date.
The actual delivery of this drug to approved patients in a safe and sustainable way requires very specific and quite complex service arrangements, which requires a considerable amount of service planning and assessment of patients at an individual level.
I have been advised by the HSE that Children's Health Ireland is currently engaging on an individual basis with the families involved regarding each child's treatment plan.