Jim Daly (Cork South West, Fine Gael)
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The HSE has statutory responsibility for medicine pricing and reimbursement in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. The Act specifies the criteria for decisions on the reimbursement of medicines. The Minister for Health has no role or powers in respect of such matters.

Following detailed consideration of an application for the reimbursement of Spinraza and lengthy engagement with the company, the HSE recently decided that it was unable to reimburse Spinraza. The HSE concluded that the evidence for clinical effectiveness was still quite limited and that the price proposed by the manufacturer was not a cost-effective use of resources.

On 21 February, the HSE wrote to the company involved and informed it of the proposal to refuse to reimburse Spinraza at the current price offering. Under the terms of the Health (Pricing and Supply of Medical Goods) Act 2013, the company has 28 days from 21 February to respond or make representations to the HSE’s proposed decision.

The HSE remains open to considering any new evidence or information which emerges regarding the clinical effectiveness or price of this medicine during this 28 day timeframe. The Government hopes that the company will use this opportunity to come back to the HSE and that this can result in an acceptable outcome for both parties. Responsibility for progressing this issue is now firmly with the company.

Jim Daly (Cork South West, Fine Gael)
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The Deputy may well have a fair point. We are operating under the terms of the 2013 Act, passed by this House, which give the Minister no role or function in the negotiating process. In some other European countries, as I understand it, the relevant Minister is the decision maker. Perhaps Deputy Curran feels that system is more appropriate but that is a matter for this House to decide. We are operating under the existing law.

As already stated, the Minister has no role or function in the process at this point. It is exclusively the job of the HSE and the company to arrive at a solution. We are not aware of the terms or the price secured by other countries. The Government completely accepts that there is a need for this drug and wants to see this process ended as quickly as possible. As Deputy Curran knows, however, we have a responsibility to every child in the State. The drugs budget is finite. We must ensure that we do not pay over the odds for any one drug because this could result in other drugs not being made available to other very sick people.

Jim Daly (Cork South West, Fine Gael)
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I acknowledge, as I have done many times before, the consistency and sincerity of Deputy Curran in his genuine efforts and endeavours to keep this issue on the political front. The reality is that the Minister unfortunately does not have the power to instruct the HSE to approve this drug tomorrow. That does not exist under the law. As a House, if we want to address that issue, it is open to any Member to table legislation on it. I take Deputy Curran's point on reviewing it from the Department's point of view to see if there is a difficulty which should be addressed. We are allowing the company to come back to the HSE. The Minister does not have a role or function in that process. That will come to an end in the next few days. We have to await the outcome of that to see if there is a change. We appreciate that very real people are at the other end of this but we also have a responsibility and cannot allow a drug company to demand whatever money it wants for a specific drug no matter how high the demand for the drug is. We unfortunately have a responsibility to the public purse too.