Wednesday, 13 March 2019

Questions (7)

John Curran

Question:

7. Deputy John Curran asked the Minister for Health his plans to provide Spinraza for children with spinal muscular atrophy in view of the decision of the HSE not to provide same; and if he will make a statement on the matter. [12081/19]

View answer

Oral answers (6 contributions) (Question to Health)

The Minister of State will be aware that the HSE did not issue approval for Spinraza to be made available to children suffering with spinal muscular atrophy. However, a period of 28 days has been set aside for the company to engage further with the HSE on the matter. What engagements are under way? What are the Government's and the HSE's plans to make this drug available to this group of children?

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.

I thank the Minister of State. I am disappointed that the Minister for Health is not here today although that is no reflection on the Minister of State. I know that the Minister is away on St. Patrick's Day business but that would usually be accommodated by a change to the Parliamentary Questions rota. The parents of these children are very disappointed that the Minister is not here to respond, particularly as they were outside the Dáil two weeks ago and presented a petition containing over 100,000 signatures to him.

Most other EU countries have now made this drug available. The Minister of State has very clearly outlined the process involved here but my point is that it is clearly not fit for purpose. There is a major problem when 25 other European countries have a system in place which enables them to make this drug available but we do not. Our system is not working and I call on the Minister to review it because these children cannot be denied this drug indefinitely. This has gone on for too long and we need to find a solution. We have relied on procedure time and again. However, the procedure is failing us and we must change it.

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.

Maybe the 2013 Act is the problem. We have an issue in this country in that we are not able to provide a drug that most other European countries currently provide. We are an outlier on this. If it means reviewing the legislation, the Minister and HSE need to clearly identify the blockage. Why do we have a problem in this country that most other European countries do not have? Time is not on the side of these young people. I have read the review we got. I have two points relating to the rare disease technology review committee. It states that it supports the use of Spinraza in spinal muscular atrophy, SMA, type 1 patients, subject to STOPP-START criteria, and in SMA types 2 and 3 in patients under 18. The recommendation is quite specific. The report clearly identifies that there is no other treatment. These children grow weaker month by month and they and their families know that a drug is available. It is frustrating for them and I feel so bad for those parents, knowing that there is a solution to the problems they face, when we in this House cannot get our act together. I am not blaming the Minister of State personally but it is appalling that we cannot get our act together when every other European country can. We need the Minister to give a direct response. If that means bringing in amending legislation, please do that.

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. We unfortunately have a responsibility to the public purse too.