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

I thank the Deputy for raising this issue. He is right in saying that it has been raised on numerous occasions. It is not as if we are unaware of or sympathetic to the circumstances in which people find themselves. We have personal experience of this in that we know people who are desperately awaiting some relief in respect of this issue.

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, the brand name of which is Fampyra, was never available to multiple sclerosis patients under the general medical services and community drugs schemes. 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 patients to finance the drug if they wish to continue with the treatment.

The HSE received an application for the inclusion of Fampridine in the GMS and community drug schemes. In accordance with agreed procedures, the National Centre for Pharmacoeconomics conducted an evaluation of the drug. The evaluation, published in 2012, concluded that the centre 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 submitted a new application to the HSE on 25 July 2014 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 considering the outcome of these commercial engagements. It has also had discussions with clinical experts about this drug, the outcome of which is also being considered.

The HSE and I fully understand the concerns of patients about the availability of this drug, but it is not possible for the taxpayer to reimburse every licensed medicine at whatever price a drug company demands. It is important that we get the best possible price for this drug which is of benefit to some people. It is fully understood Fampridine benefits some, although not all, MS sufferers. At the same time, it is our duty to ensure we get the best possible price for the taxpayer in this instance. The negotiation process has concluded, but I am not saying that is the final word on the matter. We are looking at the outcome of the negotiations but have not yet come to a final decision.

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