Finian McGrath (Dublin Bay North, Independent) | Oireachtas source

I apologise for the absence of the Minister, Deputy Harris, who is unavailable this evening. I will represent him in this debate. I wish to thank Deputy Ó Caoláin for raising this very important issue. Spinraza is indicated for the treatment of 5q spinal muscular atrophy, SMA, a disorder characterised by progressive muscle atrophy and weakness. I appreciate that this debilitating and progressive condition places enormous pressure on SMA sufferers and their families and carers and that access to potentially beneficial drug treatments is an extremely important issue for people with SMA. Today, I met a family, Paul and Lorraine O'Malley from Mayo, and their lovely daughter, Grace, and I was really impressed by their compassion, sincerity and their urgent need. It is important that I record that in this House.

As Deputy Ó Caoláin will be aware, Ireland signed the existing BeNeLuxA initiative on pharmaceutical policy on 22 June 2018. This agreement is in line with the Minister for Health’s stated objective to work with other European countries to identify workable solutions in an increasingly challenging environment and to secure timely access for patients to new medicines in an affordable and sustainable way. In July 2018, two members of the BeNeLuxA initiative on pharmaceutical policy, Belgium and the Netherlands, completed a joint negotiation for the reimbursement of Spinraza. However, this joint negotiation process commenced when Ireland had just opened negotiations with Belgium, the Netherlands, Austria and Luxembourg with a view to joining the existing collaboration between these four countries. As a candidate country, Ireland was not notified, due to confidentiality arrangements, that negotiations were occurring for the reimbursement of Spinraza, and we were not party to the negotiations and proceedings that occurred.

As the Deputy is aware, the Oireachtas has put in place a robust legal framework in the Health (Pricing and Supply of Medical Goods) Act 2013, which gives full statutory powers to the HSE to assess and make decisions on the reimbursement of medicines, taking account of a range of objective factors and expert opinion as appropriate. The Act specifies the criteria to be applied in the making of reimbursement decisions, which include the clinical and cost effectiveness of the product, the opportunity cost and the impact on resources available to the HSE. In reaching its decision, the HSE will examine all the relevant evidence and will take into account such expert opinions and recommendations that are appropriate, including from the NCPE.

The HSE received an application for the reimbursement of Spinraza in July 2017. The NCPE conducted a health technology assessment on Spinraza and did not recommend the reimbursement of Spinraza at the submitted price. The application for the reimbursement of Spinraza is currently being considered by the technology review committee on rare diseases and the HSE drugs group. It is due to be considered by the HSE leadership team shortly, following which the final decisions will be notified.

See this speech in context