Simon Harris (Wicklow, Fine Gael)
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I begin by thanking Deputy McLoughlin for raising this issue and constantly advocating on behalf of the people of Sligo and bringing forward concerns of importance to them regarding health services to my attention. I greatly appreciate that. As the Deputy very eloquently outlined, medicines play a vital role in improving the overall health of patients and securing access to new and innovative medicines in a timely manner is a key objective of both the Government and Irish health service. However, the challenge, as always in delivering on this objective, is to do so in an affordable and sustainable way. Under the community pharmacy schemes alone, over 70 million prescription items will be dispensed in 2017 at an estimated cost of approximately €1.7 billion, taking account of both fees and ingredient costs. In addition, the HSE will spend in excess of €500 million in 2017 on medicines through a range of other schemes in hospitals and in other care setting, including nursing homes.

Expenditure on medicines represents one of the largest areas of expenditure across the health service and will continue to grow in the years ahead as our health service continues to meet the needs of our citizens. In addition, the pipeline for new medicines is very strong and it is estimated that in the region of 45 new molecules are due to receive market authorisation in Europe each year over the next five years. Innovation by pharmaceutical companies is delivering treatments and in some cases cures for diseases that were previously untreatable. This is most welcome and can absolutely have a transformative impact on the health of patients. However, as I have stated previously, the cost some companies are seeking to charge for their medicines may result in a position not just in Ireland but globally where certain treatments may never become available to patients. This is not just an Irish phenomenon but one evident globally and we must find that spot where we can manage to purchase drugs and do so in a way that is affordable and means we can purchase many drugs that we wish to for our patients. That is why it is essential that Ireland has a scientific, robust and evidence-based assessment process in place, rather than one where the Minister makes the decision. The evidence should be followed closely and this ensures decisions on the reimbursement of medicine are made in an objective and scientific basis, recognising the health needs of our population.

The Health (Pricing and Supply of Medical Goods) Act 2013 provides the legal framework in Ireland for such a process. This Act gives full statutory powers to the HSE to assess and make decisions on the reimbursement of medicines, taking account of expert opinion as appropriate. The HSE follows the process set out in the Act passed by this House for the assessment of all drugs.

With regard to the specific treatments mentioned by Deputy McLoughlin, it is important to state, as I have outlined, that it is a matter for the HSE and not me or my Department, to make decisions on drugs. However, in certain circumstances, as the Deputy correctly outlines, where the HSE wishes to fund a treatment but does not have the resources to do so, it may

inform my Department of its decisions. The HSE has received separate applications for the reimbursement of nivolumab for eight separate indications, including for use as a combination therapy. I am pleased to inform the Deputy that following an assessment by the HSE and consultation with the Department of Health regarding the funding implications, nivolumab has been approved by the HSE for the treatment of melanoma, renal cell carcinoma and Hodgkin's lymphoma. I understand the HSE expects the reimbursement of nivolumab for these indications to commence in the coming weeks. I know that is the information sought by the Deputy this evening. In addition, it is important to put on the record of the House that the HSE has decided not to support its use in the treatment of locally advanced or metastatic non-small cell lung cancer. The remaining applications are currently being considered in line with the decision making criteria and are at different stages of the assessment process.

I will be clear. Each of the conditions that my Department was informed of by the HSE and for which it sought reimbursement has now seen reimbursement agreed. The reimbursement for those conditions will take place in the coming weeks and patients should absolutely know that. On the floor of the Dáil I cannot determine any patient's clinical needs and that is a matter for doctors. I am clear in saying it is my responsibility to provide funding and ensure it is in place. In this case, the funding has been agreed with the HSE for nivo for those conditions and reimbursement will take place in the coming weeks.

Simon Harris (Wicklow, Fine Gael)
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I want to reassure Deputy McLoughlin and all patients that in so far as my Department has any role to play in terms of clarifying funding arrangements for drugs, it has discharged that in relation to nivolumab and eight other drugs in July. There is agreement between the HSE and my Department on the funding requirement for this and in that regard, the HSE has, in discharging its own legal responsibilities, now proceeded with the provision of nivolumab and eight other drugs and I expect that will be reimbursed in the coming weeks.

I cannot comment on individual cases for very obvious reasons, nor am I qualified to make decisions about individual patients' clinical needs. Obviously I send my best wishes to the constituent of Deputy McLoughlin and, indeed, any patient experiencing illness who wants to know about the availability of drugs.

There is an important point to be made in the context of the reference by the Deputy to private hospitals. The HSE provides drugs for the public health service. If a patient is in a private hospital or, indeed, with a private insurance company, it is a matter for the individual private hospital or insurance company to engage directly with drug manufacturers in the best interests of its customers and there is no need whatsoever for it to wait for the HSE reimbursement to have those conversations. There is absolutely no reason such engagement must await the HSE's finalisation of the reimbursement. That issue should be raised with private hospitals and insurance companies by public representatives. There is nothing to preclude a private entity making available a drug that is available in Ireland. It does not need to wait for the HSE to resolve the reimbursement situation. In such cases, it is important that hospital consultants and insurance companies should be clear and upfront with their patients that the availability of a treatment in the private facility is not decided by the HSE but is an individual decision that they could make in relation to their own facility.

In regard to public hospitals, the public health service and public patients, I want to assure people that nivolumab will now be funded by the HSE for the conditions I have outlined on the record of the House and will be reimbursed by the HSE. I expect that to take place in the coming weeks.