Dáil debates

Thursday, 17 December 2015

Topical Issue Debate

Medicinal Products Availability

5:50 pm

Photo of Eamonn MaloneyEamonn Maloney (Dublin South West, Labour)
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I dare say there is not a citizen in this State who is not conscious of cystic fibrosis, given its prevalence in this country. I understand that we have the highest rate of cystic fibrosis in the world but I cannot explain why that is the case. We are all aware of how this condition affects the individual and by extension, their families.

In terms of science and research, we all welcome the new Orkambi drug which has been developed to treat the condition. Evidence from the United States indicates that it can significantly improve the quality of life of cystic fibrosis sufferers.

Anything which alters this horrific condition for sufferers has to be welcomed.

The big issue for all of us, particularly the Minister and the HSE, is the cost of this drug, given that it is so expensive. The drug is currently being assessed. When will that assessment be presented to the Minister?

6:00 pm

Photo of Ruth CoppingerRuth Coppinger (Dublin West, Socialist Party)
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"Can someone please tell me why my life and the lives of CF patients in Ireland have a price tag on them?" That question was asked by Jillian McNulty, who has written to the pharmaceutical authorities in Ireland describing how her life was transformed while partaking in a trial of Orkambi over two years and how her condition has gone backwards and deteriorated since the trial ended. As we have the highest rate of cystic fibrosis in the world, with one in 19 people carrying one copy of the gene that causes cystic fibrosis, this is a major issue in Ireland. The Orkambi combination of drugs is beneficial for 60% of CF people, resulting in a 40% reduction in worsening symptoms and hospital admissions for those partaking in the trial. It results in an increase in lung function, an increase in weight and an increase in people's quality of life, delaying the need for lung transplants and lengthening life expectancy.

What exactly is the stance of the Government? Dismay was caused by the initial reaction of the HSE to the potential cost of Orkambi. How much value is the Government placing on the lives of cystic fibrosis patients? Orkambi was reportedly going to cost €92 million, which was compared to the cost of running Temple Street Hospital for a year. With only a few hundred people benefitting, it could not be afforded. I find that quite incredible. Irish Water, a company that nobody wants and nobody needs and a complete waste of money, spent €83 million on consultants last year, yet €90 million cannot be found for these patients.

We have to tackle the issues of the cost of drugs, who owns the drug companies, who conducts the research and the way people's lives are being placed in jeopardy by the profiteering of these companies. As my speaking time is running out, I will try to deal with this issue in my supplementary question. We have to deal with these companies that are profiteering from people's misery.

Photo of Leo VaradkarLeo Varadkar (Minister, Department of Transport, Tourism and Sport; Dublin West, Fine Gael)
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I thank the Deputies for raising this important issue. Decisions on which medicines are licensed for use in Ireland and which are 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 health technology assessment of pharmaceutical products for the HSE and can make recommendations on reimbursement to assist the HSE in its decision-making and negotiation process. The HSE has statutory responsibility for decisions on 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 these decisions be scientific and that an evidence-based approach be taken to determining the extent to which patients would benefit from treatment with expensive new drugs, whether the drug is effective and what a fair price would be.

As the Deputies will be aware, ivacaftor and lumacaftor, marketed as Orkambi, is a combination drug for the treatment of 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 by the European Medicines Agency less than a month ago on 19 November 2015. I am not aware of any public health service that currently reimburses it.

Orkambi's manufacturer, Vertex Pharmaceuticals, submitted a rapid review application to the NCPE on 26 November. This rapid review represents the first step in a pricing and reimbursement application. The company is expected to submit a full pricing and reimbursement application to the HSE's primary care reimbursement service in the very near future, although it has not yet done so. Based on pricing details in the rapid review file, the HSE estimates that reimbursement could cost approximately €90 million per year. Given the considerable budget impact, the NCPE is likely to require that a full health technology assessment of the drug be carried out before a recommendation is made. This is the normal process for approving expensive new technologies or medicines, and Orkambi will be assessed fairly and in the same way as other such drugs or technologies. As part of this work, the scientific evidence will be assessed independently and objectively to see if the suggested benefits in terms of life expectancy, quality of life, improved lung function and reduced hospital admissions stack up and, if so, to what extent.

Since early 2013, the HSE has reimbursed more than €60 million for CF patients receiving ivacaftor, marketed as Kalydeco, and there are now approximately 140 patients being treated with this drug. Over the next decade, the HSE expects to spend well over €200 million on this patient group alone. The HSE has also invested in other CF services. The Lieben building at Limerick University Hospital has been developed and commenced operations in November, providing a dedicated outpatient facility and nine isolation rooms. The HSE has made a total of €9 million available in 2015-16 for this facility, of which almost €2 million relates to the CF facility itself. A new CF facility also opened in the last couple of weeks at Cork University Hospital, funded through the voluntary Build for Life programme to the tune of €2 million and a further almost €1 million from HSE.

While I appreciate that some may take the view that the taxpayer should reimburse every licensed medicine for whatever price the drug company demands, the interests of the public, the health service and all patients require that we only reimburse the most effective medicines, and do so at a fair price. In the past, the carrying out of health technology assessments and subsequent informed discussions with manufacturers have ensured that the best value was achieved and health funding was used in the most effective way. In the last 18 months, this system has resulted in savings against the initial price submissions by companies of €19 million a year, and that saving is ongoing and recurs every year. The interests of neither patients nor the taxpayer are best served by just agreeing to whatever price a manufacturer deems appropriate on whatever evidence it happens to put forward. The opportunity cost is enormous, and overpaying for any new drug cost lives in itself, as the money thus used could have gone into other services such as ambulances, which would save lives, maternity services, which would save lives and prevent disabilities, and cancer screening, which would save lives, to give just three examples. I could equally give examples from the two Topical Issue debates prior to this. Deputy Dowds made a very strong case for greater investment in early supported discharge in cases of stroke, which would save lives and prevent disability. Before that, Deputy Stanton made the case for more investment in heart failure treatment, which would benefit many people at a very modest cost.

I appreciate and fully understand that people suffering from cystic fibrosis will be anxious for an early and positive decision in regard to reimbursement for this drug. However, it would not be appropriate for me to appear to prejudge decisions that are matters for the HSE in the first instance, under legislation passed by the Oireachtas in 2013. I trust the Deputies will understand my position on the matter.

Photo of Eamonn MaloneyEamonn Maloney (Dublin South West, Labour)
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I am in agreement with the Minister. I am on the record, as a member of the Oireachtas Joint Committee on Health and Children, as stating that the taxpayer should not be held to ransom by the pharmaceutical companies, as we have been in the past. I hope this is a view all Members hold. These companies exist and operate to make as much money as possible, and that is their primary concern.

I remember a discussion in the health committee with the Minister's predecessor in regard to attempts that were to be made on a European-wide basis to try to control the cost of drugs, which I believe would be an effective way of doing this.

In reference to the Minister's last paragraph, I do not expect him to prejudice what the HSE may decide, but can he provide any information that may give comfort to those living with this condition as to when the assessment may be done?

6:10 pm

Photo of Ruth CoppingerRuth Coppinger (Dublin West, Socialist Party)
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The Minister does not need to tell me about the pharmaceutical industry and how it is profiteering from people. In the United States currently, one company has raised the price of an AIDS drug by 5,000%. It costs $1 dollar to produce the drug, but the cost has been increased from $13.50 to $750. That is the kind of profiteering these companies engage in.

The company that makes Orkambi made the point that if it reduced the price of Orkambi and related drugs for minority illnesses, it could be swallowed up by bigger drug companies. We see from this that ordinary people are being held hostage by the profiteering of these companies under our capitalist system. That is why I am a socialist and why I believe health should be a priority. I believe research should be conducted in a unified manner, with results shared by different companies. It would be best if it was funded by the Government and it and our health service should also be funded by progressive taxation.

If a member of the Minister's family was ill, we would be moving heaven and earth to ensure this drug became available. The Minister must negotiate to reduce the price. The HSE seemed to come out with a prejudged decision that frightened and upset a lot of families with a cystic fibrosis sufferer. This is not good enough. The cost should not be €90 million, but we could compare that with the €7 billion in interest we are paying on a debt that was not the debt of the ordinary people of this country. We need a completely different type of health service. The pharmaceutical companies that are provided with big tax incentives should be taken over and run in the interest of ordinary people.

Photo of Leo VaradkarLeo Varadkar (Minister, Department of Transport, Tourism and Sport; Dublin West, Fine Gael)
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On Deputy Maloney's question, I am advised by the NTP that it plans on doing the health technology assessment in the first quarter of 2016, with a view to making a recommendation report in the second quarter. I will ask for that to be expedited, although there are other technologies and drugs in the pipeline also. However, it is important that everyone is treated equally and that no one group is given priority over another disease group. That would be unfair, but I know that is not what the Deputy is asking for. When the report is presented, the evidence will be assessed to see if it stacks up and a fair price will be calculated. This will then go to the HSE national drugs committee which will then try to negotiate a fair price for the medicine.

Deputy Coppinger referred to the possibility that the HSE may have prejudged the decision. I have spoken to the director general about that matter and we both agree this should not be prejudged and that the new technology and medicine should get a fair hearing and assessment, as has been the case in the past for any other new technology. Therefore, it is not being ruled out without being assessed properly. I am happy to clarify that is not the case. The Deputy asked what value the Government puts on the lives of people. The only fair thing for the Government to do is to put an equal value on the life of everyone. That is the only way resources can possibly be apportioned. Even the richest and most socialist countries in the world have limited resources. The important thing is to treat everybody equally and to value every life equally.

I totally agree with her on the conduct of the drug companies. We know what they do. They overcharge and use patients as pawns. In some countries - not here to the best of my knowledge - they even hire PR companies to coach and encourage patients to advocate on their behalf. I do not believe that has happened here, but it has allegedly happened in other countries. These people also pay themselves massive salaries, draw down massive profits and pay massive dividends. They are people whose bonus every year is based on how much they can overcharge a small country. They target small countries and get the small country to set the high price and then offer bigger countries slight discounts. This is a case of greed incorporated. While I am not a socialist, dealing with some of these companies would bring out whatever socialist instincts may be buried in me.

I believe that in the future these matters should be dealt with at European level and that we should task the European Medicines Agency with the role of deciding which drugs should be reimbursed and then use the buying power of a Union of 500 million people to ensure we get a fair price so that we can treat more people. Perhaps we could then set aside some funds to do some of the other things raised here today.

Finally, as the last man standing today on this the last day of the session and the last sitting of the year, I believe it is customary to say a few words of thanks to Deputies, ushers and the staff of the House. It has been a busy and interesting year and much good work has been done. On behalf of the Government and the whole House, I want to extend sincere thanks to all the staff of this building for the hard work they have done in the past year. I wish them all a very happy Christmas and a good new year.

Photo of Ruth CoppingerRuth Coppinger (Dublin West, Socialist Party)
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Hear, hear.