Paddy Burke (Fine Gael)
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I welcome the Minister of State at the Department of Health, Deputy Kathleen Lynch, to the House.

Michael D'Arcy (Fine Gael)
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I thank the Cathaoirleach for giving me the opportunity to raise this matter. I am not sure how much the Minister of State knows about this particular drug, Orkambi. There are a number of people in north Wexford who have children suffering from cystic fibrosis and they believe or expect that this drug could have a major impact on their children's lives. There has been some degree of misinformation about this issue and I ask the Minister of State to clarify the position of the Minister, the Department of Health and the HSE with regard to the status of this drug. Following the evaluation process, when will this drug come to the market? If it comes to the market, will it be made available to cystic fibrosis sufferers?

Kathleen Lynch (Cork North Central, Labour)
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I know a little bit about this issue because a very close friend of mine has cystic fibrosis and has benefited greatly from the drug Kalydeco which I and the former Minister for Health, Deputy James Reilly, approved and which approval we announced approximately two years ago. I am aware of the effects that very specialised drugs can have on relatively rare conditions. Cystic fibrosis is a relatively rare disease, although it is not so rare in Ireland, particularly in the south of the country.I thank the Senator for raising this matter. Decisions on which medicines are licensed for use in Ireland and reimbursed by the taxpayer are made on objective, scientific and economic grounds by the HSE on the advice of the National Centre for Pharmacoeconomics, NCPE. The NCPE conducts the health technology assessment of pharmaceutical products for the HSE and can make recommendations on reimbursement to assist the HSE in its decision-making process. The HSE has statutory responsibility for decisions on the 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. It is appropriate that there should be no political or ministerial decisions and that a scientific and evidence-based approach is taken to determining the extent to which patients can benefit from treatment with expensive new drugs.

As the Senator may be aware, Orkambi is a combination drug for the treatment of cystic fibrosis, CF, in patients with two copies of a specific CF gene mutation. The drug was approved by the US Food and Drug Administration in July 2015 and the European Medicines Agency on 19 November 2015. In other words, Orkambi has only been licensed for use in the European Union within the past few months. Its manufacturer, Vertex Pharmaceuticals, submitted a rapid review application to the NCPE on 26 November 2015. This rapid review represents the first step in a pricing and reimbursement application. The NCPE has completed the rapid review and recommended a full health technology assessment of the drug.

Based on pricing details in the rapid review file, the HSE estimates that reimbursement would cost approximately €90 million per year. However, the company has yet to submit a full pricing and reimbursement application to the HSE’s primary care reimbursement service. Since early 2013, the HSE has reimbursed more than €60 million for CF patients receiving Kalydeco and there are approximately 140 patients being treated with this drug. In the next decade the HSE expects to spend well over €200 million on this small but unique group of patients.

While I appreciate that some may take the view that the taxpayer should reimburse every licensed medicine for whatever price a drug company demands, the interests of the health service as a whole require that we only reimburse the most effective medicines and only at a fair price. I also appreciate and fully understand people suffering from cystic fibrosis will be most anxious for an early and positive decision on reimbursement for Orkambi. However, it would not be appropriate for me to appear to prejudge decisions which are for the HSE in the first instance under legislation passed by the Oireachtas in 2013. I trust that the Senator will understand the position.

Michael D'Arcy (Fine Gael)
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I thank the Minister of State for her clarification that the process is ongoing and that subsequent to its evaluation, a pricing conversation will be held with the manufacturer. However, I would like to hear her view. I am glad that she has come to the House to respond on this issue because I am aware of her role in the use of Kalydeco and the benefits to be gained from using it. If Orkambi can do what is said it can, I ask her to ensure an early and favourable decision is made on the issue. By all accounts, people suffering from cystic fibrosis could benefit enormously in terms of their quality of life. The Minister of State has been involved in a similar issue previously and I would like to hear her personal view in this instance which would be appreciated. She has said she has a close personal friend who is suffering.

I find it distasteful that before Christmas a Member of this House effectively misled people on this matter. There was a conversation about Commencement matters and a vote was taken. However, the message was sent that the use of Orkambi had been discussed in this Chamber, that we had voted on the matter and that Members on one side of the House had voted against making the drug available. That is reprehensible and not the way we normally do business. We should not and cannot go down the route of playing politics with people's illnesses. Many people were misled.

Kathleen Lynch (Cork North Central, Labour)
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Even if this House had voted differently, and I am not certain how they did vote-----

Michael D'Arcy (Fine Gael)
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Sorry. There was no vote.

Kathleen Lynch (Cork North Central, Labour)
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Even if a motion was put down and this House decreed that it should be made available, it would have no impact. That is not how the process works. It is not a political decision. It is very much a decision made on scientific and economic grounds.

I have been listening to the debate on this issue over the Christmas and new year period, and more recently. Even those who advocate on behalf of the CF community, some of whom I know, admit that this drug is too expensive. As regards to if and when it is approved, I have no opinion on that and I do not think it would be right for me to offer an opinion on it at this stage. This issue should be dealt with on a Europe-wide basis. Even though our CF numbers are exceptionally high, it is easy to take a small country like Ireland and pick us off saying, "There's our price and that's what we're getting." It is much easier to deal with a greater population base, so the EU should come together to negotiate the purchase price for all drugs on a Europe-wide basis.

As I said, even those advocating on behalf of the CF community admit that, as it stands, this drug is way too expensive. These people are not foolish; they know the consequences and the possible effect it could have. Equally, however, they understand that there is not a bottomless financial pit. While it is important for us to take on board what they are saying, we need to move swiftly towards the point where Europe negotiates with the pharmacological industry, rather than smaller countries and regions doing it alone, such as in Ireland, Northern Ireland, Luxembourg or Liechtenstein. If not, we will be left isolated and unable to negotiate a better deal for ourselves.