Minister of Health

Minister of Health

  • Cystic Fibrosis Ireland met with Minister for Health Leo Varadkar and senior officials for the Department of Health on Monday 25th January 2016.

     A delegation from Cystic Fibrosis Ireland and a member of our Medical and Scientific Council (clinician) and a patient with CF met with Minister Leo Varadkar on Monday 25th January 2016.

    The meeting was wide ranging but with most focus on:

    1. Access to new and innovative therapies for people with CF (in particular Orkambi);
    2. Concerns about chronic staffing shortages in CF centres; 
    3. The need for progress in relation to Beaumont Hospital (adult in patient rooms- 20 needed only 6 available) and Cork University Hospital (paediatric inpatient and outpatient facilities);
    4. Transplant issues (including pre and post- transplant rooms and the introduction of soft opt out organ donation).

    CFI is also seeking return of €800,000 we have paid to the government in VAT arising from huge fundraising efforts to improve 7 CF Hospital centres around the country. This would be reinvested in vital CF services, including for example Beaumont Hospital and Cork University Hospital, if returned to CFI.

    A detailed briefing paper was drawn up by Cystic Fibrosis Ireland for the meeting.


    The main outcomes of the meeting were as follows:

    • The Minister and his officials received first-hand information about the impact of Orkambi, including the dramatic reduction in exacerbations/hospitalisations resulting from the drug (40% decrease).
    • A petition signed by over 40,000 people supporting access to Orkambi was handed to the Minister demonstrating how strongly patients and the public feel about ensuring CF patients have access to Orkambi.
    • There was powerful testimony at the meeting from a patient with CF (Jillian McNulty) who has benefited from being on Orkambi as part of the clinical trials and who has remained on the drug since the trials. She has experienced a dramatic reduction in hospitalisations and a general improvement in well-being. This is also reflected in other patient testimonies CFI has received.
    • CFI pointed out that Orkambi is expensive because of the huge costs of developing this drug and the relatively few patients (worldwide) from whom the pharma company can seek to recoup their costs and to invest in further research. CFI supports the government in getting the fairest price for Orkambi.
    • There will be very significant savings to the government arising from the dramatic decrease in hospitalisations arising from those on this drug.
    • The Minister told CFI that if Orkambi was positively assessed by the National Centre for Pharma Economics/HSE, additional funding from government, on top of the present health budget, would be sought. (Thus this drug will not impact on other health services- CFI).
    • The Minister and his officials promised that Orkambi would be assessed fairly and as efficiently as possible and they are awaiting further documentation from the drugs company who have produced Orkambi.

    Other outcomes.

    • The Minister promised that an audit of staffing levels in CF centres would be undertaken as part of the National Clinical Programme and would be completed shortly. The outcomes would then be considered by government.
    • The Minister said that ‘soft opt out organ’ donation would in included in the Fine Gael Manifesto and (if elected) in the next programme for government
    • The Minister said he was concerned about the high level of VAT tax paid by CF for hospital buildings and this issue would be further investigated. He knew from experience it also affected other charities. 
  • Cystic Fibrosis Ireland welcomes the announcement from the Minister for Health regarding his intention to fund fertility treatment, inconjunction with planned Legislation. This is something that CFI has fought for some time & have written this Fertility & Cystic Fibrosis Submission, highlighting the need to provide state support to our members in relation to this treatment. We will of course be working to ensure that people with CF will be included as an eligible group in the new legislation.

    As you know, health legislation is notoriously slow to be enacted, so CFI will seek to work with other patient groups to ensure this issue is a priority for the new government, irrespective of who is elected.

    Many of you will be aware that CFI has a fertility treatment budget, however, demand has always exceeded our budget, so this will be welcome news to many of our members, as long as the legislation is enacted quickly and our members are eligible. We will seek to ensure it is in the new programme for government.

    To read the full press release from the Department of Health CLICK HERE & we continue to encourage our members to read 'Make CF a Priority in Election 2016' briefing document to communicate the challenges facing the CF community with your local representatives. 


  • Minister Simon Harris' comments

    Cystic Fibrosis Ireland (CFI) warmly welcomes the comments by Minister Simon Harris on RTE’s Sean O Rourke programme Monday 6 March 2017 which signifies that further significant progress has been made towards the approval of Orkambi and the extension of Kalydeco. While we will remain cautious until a final decision is made, we look forward to the Minister making a final ‘yes’ decision within the next few weeks. 

    You can watch the video on Facebook here.

  • Open letter to Minister for Health, Simon Harris TD

    29th November 2016

    Dear Minister,

    On behalf of Cystic Fibrosis Ireland we would ask to meet with you as soon as possible.

    We know from previous contact and your recent letter to us, that you are a compassionate and caring person, and we know your task as Minster for Health is a difficult one, including in respect of approving high cost innovative therapies.

    However, there is no disguising the reality that there has been considerable upset within the CF community in Ireland over the last couple of days which has not been helped by how the Orkambi 'decision' has been conveyed to patients. We note that you share some of our concern in this regard. This heartless form of communication to ill patients has since been compounded by the dearth of information that has been provided by the HSE to our patients since the 'decision' was leaked late on Saturday evening to a well-respected journalist.

    We note in your letter to CFI that you do not see this as the end of the process. We hope this means there is light at the end of this tunnel. However we remain very unclear to what you mean in practice. We would wish to discuss this further with you.

    In the absence of any communication from the HSE to us, we remain concerned that the impact of Orkambi appears to be 'talked down'. We would point out the following:

    Why would the HSE negotiate for 25 weeks/6 rounds of negotiations, if the HSE believed that Orkambi was not effective in the first place?

    In this context, we are further concerned that there appears to be no public acknowledgement by the HSE of the long term research data that was published on the 28th of October 2016 that confirmed:

    • A 40% decrease in hospitalisations
    • The retardation of the progression of CF for those on Orkambi
    • The reduction in other costs resulting from less hospitalisations and less dependency on other CF drugs

    We note that the highly respected Professor Stuart Elborn CBE formerly of Belfast City Hospital and now lead clinician in the lead CF hospital in the UK (Brompton Hospital in London) and Principal Investigator for the clinical trials for Orkambi stated on the 28th October 2016:

    "Long-term follow-up data has indicated that this treatment can prevent disease progression.

    "Initially, we were able to show that you can make people a bit better. Now we're seeing exciting and reassuring long-term improvement."

    "We hope this will lead to a further rethink about the long-term benefits," said Prof Elborn. "There are likely to be reductions in the cost of hospital visits and other treatments."

    "I'm really excited by the therapy and also the pipeline of other powerful drugs that could get us closer to a cure."

    (Source: 28.10.16 Press Association)

    To conclude, we would urge you as Minister to intervene and make Orkambi available for the 550 people who stand to benefit as soon as possible, even if this involves some further negotiations. We would also urge that negotiations for the extension of Kalydeco for 2-5 year olds commences as soon as possible. We will continue to lobby Vertex to significantly lower the cost of this important drug.

    Yours sincerely

    Philip Watt

    CEO Cystic Fibrosis Ireland 

  • Orkambi update

    CFI has recently written to the Minister for Health to urge once again that the negotiations on Orkambi and the extension of Kalydeco are concluded in a positive way for our members as soon as possible and to remind him and the government of the importance of these drugs to our members.

    Background note:

    Cystic Fibrosis Ireland has undertaken significant lobbying on this issue including:

    • Two meetings with the Minister for Health and Senior Officials
    • Meeting with 56 TD’s from all political parties
    • A comprehensive survey and submission to the National Centre for Pharma-Economics (NCPE)
    • Meetings with the NCPE
    • Media statements and coverage on both national TV and local and national radio and other advocacy at a local and national level.


    We acknowledge and thank patient advocates and parents who have been active on this crucial issue and we will bring you news as soon as we hear the outcome from the negotiations.

    Philip Watt

  • Orkambi Update - 30th November 2016

    The following are points made by Cystic Fibrosis Ireland in response to the public debate on Orkambi over the past few days.


    1. The Urgent need For Ministerial Intervention and Positive Response by Vertex

    2. The Efficacy of Orkambi

    Cystic Fibrosis Ireland urges the HSE to provide a more comprehensive and fairer public statement on the efficacy of Orkambi, particularly in relation to recent research that has shown that CF progression is slowed down by Orkambi and the impact of the 40% reduction in exacerbations.

    Orkambi (also known as ‘lumacaftor/ivacaftor’) is for people aged over 12 with two copies of F508-del gene alteration, which about 550 people in Ireland (compared with around 3,200 people across the whole of the UK).

    Declining lung function and exacerbations of Cystic Fibrosis is ultimately the main cause of death among people with cystic fibrosis. By reducing this decline, precision medicines like Orkambi can help people with cystic fibrosis stay healthier for longer. The gap in lung function widens for every year that someone eligible is not on Orkambi. This is particularly poignant where one sibling is on Orkambi and one is not.

    Orkambi reduces exacerbations by up to 40%- that is worsening of a condition that results in hospitalisations. Every time a person with CF experiences an exacerbation research has shown it can reduce their survival expectancy from 3-6 months.

    Cystic Fibrosis Ireland urges the Department of Health/HSE to take into account a recent study (28th October 2016) carried out over 96 weeks.

    Analysis of the 96-week PROGRESS extension study of the pivotal phase 3 TRAFFIC and TRANSPORT studies of Orkambi confirmed the safety profile, and mean lung function was maintained above baseline for up to 120 weeks and the 40% reduction in exacerbations.

    Professor Stuart Elborn formerly of Belfast City Hospital and now lead Cf adult consultant in the Brompton hospital commented:
    "Long-term follow-up data has indicated that this treatment can prevent disease progression.

    "Initially, we were able to show that you can make people a bit better. Now we're seeing exciting and reassuring long-term improvement."

    "We hope this will lead to a further rethink about the long-term benefits," said Professor Elborn. "There are likely to be reductions in the cost of hospital visits and other treatments."

    "I'm really excited by the therapy and also the pipeline of other powerful drugs that could get us closer to a cure."

    3. Meeting the Cost of Orkambi from Savings in the Drugs Budget

    CFI has acted responsibly at all times. We did not engage in advocacy over the 25 weeks that the HSE negotiated with Vertex, the pharmaceutical company. This was a deliberate strategy to support the HSE to obtain the best price possible for this important drug. We have called on Vertex to make significant reductions in price and to enter into shared risk agreements with the HSE, if these are the sticking points on which the negotiations have foundered.

    We would not expect the HSE to pay for a drug that does not work on some patients. We would question recent assertions that Orkambi only works on about one quarter of those taking part in clinical trials and we have sought expert opinion on this.

    IPHA agreement and related savings

    CFI notes from the Minister’s statement to the Joint Oireachtas Committee meeting in September 2016 re the IPHA agreement
    ‘The States team objective was to improve the assessment and reimbursement process for new drugs and to secure significant price reduction so as to enable continued access to new and existing drugs for Irish patients while reducing growth in the HSE’s overall drugs bill…..The new Agreement, which runs to the middle of 2020, is projected to result in savings – that is, expenditure foregone – of some €600 million from IPHA companies, with a further €150 million in savings anticipated from non-IPHA companies over the lifetime of the deal’.

    The Fight for Orkambi will continue

    CFI will continue to lobby the HSE/Department of Health and Vertex to reach a fair price on Orkambi.

    Philip Watt

    CEO, Cystic Fibrosis Ireland

  • Talks to Re-open on Orkambi: Important statements by Minister and Vertex, 7 December 2016


    Cystic Fibrosis Ireland (CFI) welcomes the statements by Minister for Health Simon Harris TD and from Vertex Pharmaceuticals that talks on Orkambi will reopen. CFI sincerely hopes that a settlement will be reached that will be fair to both the State and the pharma company and most important of all, which makes Orkambi available in Ireland to people with CF who stand to benefit from this important drug.

    Statement from Minister for Health Simon Harris TD, 7 December 2016 (see below)
    Statement from Vertex Pharmaceuticals, 7 December 2016
    Press report from Paul Cullen, Irish Times, 7 December 2016 (for information)


    Statement by Mr Simon Harris TD, Minister for Health on Orkambi
    7 December 2016

    Minister for Health Simon Harris has said he is pleased to learn that Vertex has responded to the HSE with a view to re-engage in negotiations with them on Orkambi. Speaking from a meeting with EU Health Ministers in Lisbon today (Wednesday) on drug price negotiations, the Minister said:

    "I have always said that Vertex need to re-engage in a meaningful way with the HSE that addresses the core issue of price and affordability. In that context the company must return to the table with a significantly better offer. This has not happened to date and I again call on the company to re-engage in a meaningful way. However, I was pleased to learn that Vertex has responded to the HSE today with a view to re-engage in negotiations with them on Orkambi.

    "In a meeting with some of my EU counterparts, I raised this issue of the unacceptably high price Vertex has put on this drug, making it inaccessible not just for Ireland's CF patients but for other patients around Europe. I intend to continue to intensify my engagement with colleagues in Europe and indeed other countries on this issue.

    "I want to see CF patients receive access to the best treatments possible. That remains my priority."