Kathleen Lynch (Cork North Central, Labour) | Oireachtas source

I thank the Senator for raising this issue. As usual, he probably raises the most pressing issues relating to health.

Decisions on which medicines are licensed for use in Ireland and which are reimbursed by the taxpayer are not political or ministerial decisions. These are made on objective, scientific and economic grounds by the HSE on the advice of the National Centre for Pharmacoeconomics. The HSE has statutory responsibility for decisions on pricing and reimbursement of medicinal products under the community drug schemes in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013. At the outset, I would like to clarify that Fampridine, brand name Fampyra, was never available to multiple sclerosis patients under the GMS and community drugs schemes. I am not suggesting that the Senator is saying that this is or was the case. However, I understand that the manufacturer of Fampridine supplied the drug free of charge to some patients who were prescribed the drug by their clinician. The manufacturer has stopped supplying the drug free of charge, thereby requiring these patients to finance the drug themselves if they wish to continue with this drug treatment.

The HSE received an application for the inclusion of Fampridine in the GMS and community drugs schemes. In accordance with agreed procedures, the National Centre for Pharmacoeconomics conducted a pharmacoeconomic evaluation of the drug. That evaluation published in 2012 concluded that it was unable to recommend reimbursement of the product as the manufacturer was unable to demonstrate sufficient effectiveness and a fair price for Fampridine in the Irish health care setting. On foot of this, the HSE decided that it was not in a position to add the drug to the list of reimbursable items supplied under the GMS and other community drug schemes. The manufacturer, Biogen Idee, submitted a new application to the HSE on 25 July last year for the inclusion of Fampridine in the community drug schemes. The HSE's corporate pharmaceutical unit has since been engaging with the company seeking improved commercial offerings and the HSE is now considering the outcome of those commercial engagements. The HSE has also had discussions with clinical experts regarding this drug, the outcome of which is also being considered. I want to assure the House that the HSE and I fully understand the concerns of patients regarding the availability of this drug. While I appreciate that some may take the view that the taxpayer should reimburse every licensed medicine for whatever the price the drug company demands, I hope it is appreciated that the better interests of the health service require that we only reimburse the most effective medicines and only at a fair price.The HSE's corporate pharmaceutical unit has since been engaging with the company seeking improved commercial offerings and the HSE is considering the outcome of those commercial engagements. The HSE has also had discussions with clinical experts on this drug, the outcome of which is also being considered. I assure the House that the HSE and I fully understand the concerns of patients regarding the availability of this drug. While I appreciate that some may take the view that the taxpayer should reimburse every licensed medicine for whatever the price the drug company demands, I hope it is appreciated that the better interests of the health service require that we only reimburse the most effective medicines and only at a fair price.