Simon Harris (Wicklow, Fine Gael) | Oireachtas source

I thank Deputy Collins and Deputy Kenny for raising this issue in the Dáil. I thank Deputies from all sides of the House who have consistently over a long period raised this important issue relating to cystic fibrosis patients. In raising this issue this evening, the Deputies have provided me with an important opportunity to provide an update in the Dáil on behalf of myself, the Minister of State at the Department of Health, Deputy Catherine Byrne, the Minister of State at the Department of Health, Deputy Finian McGrath as well as all of us in government.

I am pleased to inform the House and in particular cystic fibrosis patients, their families and friends, that the HSE and Vertex have this evening confirmed that an agreement has been reached in principle on the commercial terms for the supply to Irish patients of Orkambi and Kalydeco from next month, and for other treatments and age cohorts following market authorisation in Europe. I am keen to provide this update this evening to the House to offer reassurance to patients on this important matter and to inform them that the HSE and Vertex expect these medicines to be available from next month. I also wish to inform the Dáil that both parties are now working to finalise the contractual arrangements and complete approval processes in advance of 1 May.

I recognise the work the HSE has put into these negotiations over a long period. These were not easy negotiations. A large body of work needed to be done on this important matter. I want especially to acknowledge that this has been an extraordinarily difficult time for cystic fibrosis patients, their families and friends as they have been waiting for this process to conclude. I was determined that the process would conclude and that we would get the best possible arrangement for cystic fibrosis patients. In the past, this group of patients have not been properly and adequately catered for in terms of certainty of medicine supply.

However, I am sure that the Deputies will accept that, given the scale of the investment, the potential benefits for Irish patients and the impact of this decision on the health service overall, it is appropriate to allow the statutory process in this State to be concluded appropriately to bring certainty to matters. As Deputies are aware, the HSE has statutory responsibility for decisions on pricing and reimbursement of medicines in the community drug schemes in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. In reaching a reimbursement decision, the HSE must examine all the evidence that may be relevant in its view, and it has done so. The HSE takes into account such expert opinions and recommendations that have been sought at its sole discretion, for example, from the National Centre for Pharmacoeconornics.

I will outline the position on Orkambi for the treatment of cystic fibrosis patients aged 12 and older. Following an application by the company, the treatment was assessed in line with the statutory process, following which the HSE called on Vertex to re-enter negotiations. Further meetings were held with the manufacturer in December and early January. The discussions with the company broadened to include Kalydeco and further treatments for CF patients. I hope more iterations of drugs will come on stream and more iterations of drugs will be able to cater for other patients of other ages. It is important we get all these elements right in order that we not only have an arrangement for now but an arrangement that is future-proofed to meet the needs of all cystic fibrosis patients throughout the age spectrum.

Following detailed consideration by the HSE directorate, its legal representative and officials in my Department, further negotiations took place last week. Those discussions have continued up to this afternoon. I am pleased that we are now in a position to reassure people that we are in the concluding stages of the agreement, as I outlined earlier. Further work in the coming days will bring this matter to finality. These drugs will be available for Irish patients in this country from next month.

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