Cystic Fibrosis Treatment: Statements

I welcome the Minister, Deputy Simon Harris.

I thank the Seanad for giving me an opportunity to address this important issue. I look forward to listening to the contributions of Senators. I hope it is clear that everyone here shares the absolute objective of securing access to this medicine for Irish patients at an affordable price. Irish cystic fibrosis patients should have access to innovative treatments. This is the clear objective of the HSE which is negotiating on behalf of Irish patients. I consider it essential for the HSE to receive the full support of all public representatives in its efforts. When negotiations of this nature are taking place, we should not forget that the HSE is the only party in the room that negotiates on behalf of Irish patients. This is not about attacking big pharma. This is about supporting Irish patients and supporting the people who are working to get the very best deal for Irish patients.

It is unacceptable that cystic fibrosis patients have been used as pawns in this process. It is regrettable that many of them and their families have been put through a harrowing time. The company in this case has refused from the outset to put a fair and reasonable price on its treatment, in line with the price guidance provided not by the Government, the HSE or the Department of Health but by Professor Michael Barry and his team in the National Centre for Pharmacoeconomics. The company has refused to give absolute certainty to patients on managed access schemes or programmes that they will continue to receive their treatment for the rest of their lives, regardless of the outcome of the commercial negotiations with the HSE. It has actively sought to place Irish cystic fibrosis patients in the centre of its commercial negotiations with the HSE, with a view to maximising the return for its executives and shareholders. This type of behaviour is not unique to this drug, unfortunately, and is certainly not unique to Ireland. Similar pricing strategies have been employed in the past. My counterparts in other EU member states inform me that this type of behaviour is evident in their countries too.

As Senators will be aware, I attended a meeting in Lisbon yesterday to discuss drug pricing, innovation and the sustainability of European health systems. I took the opportunity to raise directly the situation in respect of Orkambi and the manner in which the company was treating cystic fibrosis patients and their families in Ireland. It is clear from my discussions with health Ministers from other countries that the current situation is not sustainable. Advances in medicines have played a key role in improving the overall health of Irish people. However, health care systems throughout Europe are quickly reaching a point at which patients cannot access new and innovative medicines because of the pricing strategies of manufacturers. Innovation is not of any use if patients cannot access it. As we have seen with medicines such as Orkambi, the price the company is seeking to charge means innovative products may never reach the patient. This is not acceptable. Equally, it is not acceptable that health systems are finding themselves unable to afford the prices being quoted. This can be viewed as a funding problem or a pricing problem, but my view is that it is primarily a pricing problem. If we are to ensure innovative medicines are available to patients with unmet needs, companies such as Vertex need to fundamentally reassess their pricing models. I appeal to them to do so.

I will focus on price because it is the main barrier to access in this instance. The National Centre for Pharmacoeconomics has independently assessed the evidence and benefits of this treatment. Based on a detailed examination of costs and benefits, including reductions in other treatments, the national centre considers that an annual price of €30,000 per patient would be appropriate. At this price, the HSE would pay €15 million a year for Orkambi, or €75 million in the next five years. This is a significant investment. Any public statement from the company on prices should be compared to these figures. There has been an attempt to undermine these figures as inappropriate for this type of treatment. I remind the House that at €30,000 per patient per year, this would be one of the most expensive treatments in Ireland. In fact, it would be sixth on the high-tech drugs list in this country. I am not in any way attempting to undermine the benefits of the treatment. I am doing the opposite - I am acknowledging its benefits for Irish patients. Unfortunately, the price the company has put on this product is many multiples of the figure I have mentioned. Despite the company's claims, in the absence of verifiable evidence to the contrary, it appears that the main driver of the price is an estimate of the maximum amount that this country can pay and is not connected to the health benefits of the treatment or the cost of bringing the medicine to the market.

There has been a significant debate in recent days on the outcomes-based model, which is something I support. To put it simply, it involves the company having the confidence in its product to provide the treatment for all eligible patients but not to seek payment until the treatment delivers benefits to Irish patients. The HSE has confirmed that Vertex has made it clear that it is not willing to engage in an outcomes-based model that addresses the HSE's core pricing concerns. This is very disappointing. If the company has the same level of confidence in Orkambi as many patients and all of us - we know that it can make a difference to people's lives - it is time for it to put the product where its mouth is and to engage in an outcomes-based model. Vertex should provide the drug for every patient who could benefit from it and we will pay based on who can benefit from it. It is very disappointing that the company is not in a position to do this.

As Vertex is refusing to release the HSE from commercial confidentiality requirements, the HSE cannot provide this House and, more importantly, cystic fibrosis patients with a transparent understanding of Vertex's proposals in the negotiations. Taking account of the outcome of negotiations and having considered the recommendations of the National Centre for Pharmacoeconomics and other expert advice, the HSE's drugs committee has not recommended reimbursement for Orkambi. Where do we go from here? I repeat that we all share a unified view of wanting to make the most innovative treatments, including Orkambi, available to Irish patients. I want to assure cystic fibrosis patients loudly and clearly in this House that this is not the end of the process. The HSE directorate will consider the drugs committee’s recommendation, taking into consideration the manufacturer's price offer. This decision will be made on objective scientific and economic grounds and in line with the Health (Pricing and Supply of Medical Goods) Act 2013, as passed by this and the other House. This is the next formal stage in the statutory assessment process. The HSE has made it crystal clear that it is open to meaningful engagement with the company.

Drug companies and public relations companies have gone into overdrive in their efforts to assert that I will not attend negotiations. I want to make it very clear that this is a complete misrepresentation. The law of the land, as passed in 2013 by Senators in this House and by me and my colleagues in the Dáil, makes it clear that the HSE is the body with statutory responsibility for decisions on pricing and reimbursement of medicines. It carries out the negotiations. However, I have been in regular contact with the HSE which is ready to make this happen. Vertex should do the same. It is not the case that there is one rule for Vertex and a different rule for every other drug company. Vertex must respect the laws of the country, our processes and democratic decisions. The HSE does the negotiations. It is time to stop the spinning. If the company spent less time spinning in the media and more time engaging in a meaningful manner, we could try to have this matter resolved. When the spinning stops, we can get back in the room, start the talking and get on with making this happen. I assure Vertex and, more importantly, cystic fibrosis patients that the people from the HSE who are needed to help to make these decisions will be in the room. We should not try to politicise this issue. I ask Vertex not to interfere with the political system and the rules of the country.

As I have mentioned, this issue is not unique to Ireland. I am looking at every option to make progress with this and other issues in relation to drug pricing in collaboration with other countries. This is a very viable option. I have contacted health Ministers in four other countries - the United Kingdom, Scotland, Canada and Australia - where Vertex’s very high pricing has prevented reimbursement for cystic fibrosis patients. I believe there is potential for joint co-operation in seeking to have a positive influence on the manufacturer's pricing strategy. As I have outlined, I raised this issue with health Ministers in Lisbon yesterday. I will continue to do so as part of moves to consider pricing for expensive drugs across Europe. Despite the claims of the company, there is very significant value achievable for patients and health systems from such collaboration. We should be working at EU level to that end. It is nonsense for companies to say it will take years. The company in this case is negotiating with many countries and has failed to conclude negotiations with Canada, Australia, the United Kingdom, Scotland, the Netherlands and Ireland. It is right and proper for countries to talk to one another to share information and try to adopt a common approach. All health Ministers in the European Union and beyond want to make this drug available to patients. We are charged with looking after the interests of patients in our respective countries.

I appreciate that this is a stressful time for cystic fibrosis patients and their families. I have had an opportunity to meet a number of them. I am in regular contact with some of them. I strongly urge Vertex to provide this drug at a fairer price for the benefit of patients as quickly as possible. As Professor Michael Barry said, it is time for the company to put patients first and significantly reduce its price to one that is fair, equitable and sustainable.

I fully support the HSE in its efforts to reduce the price of medicines in order that cystic fibrosis patients can be treated with it. I call on all public representatives, including Members of the Seanad, while rightfully highlighting the concerns of cystic fibrosis patients, to make sure that concern is not accidentally diverted in a way that is used to help Vertex rather than patients.

All Senators called will have five minutes to contribute. The debate is due to continue for one hour. We will have about nine slots. I will be strict on time because I see many Members indicating a wish to contribute.

I welcome the Minister to discuss this important issue. On Tuesday many of us listened in the AV room as Ms Jillian McNulty gave a heart-wrenching account of what her life was like living with cystic fibrosis. In Jillian's words, without Orkambi, she would not be here. Her lung function has improved by almost 10% and she has spent up to a year less in hospital. Her situation, unfortunately, is not unique. Ireland has one of the most severe strains of cystic fibrosis in the world and the highest incidence per head of population, which is three times the rate in the United States and the rest of the European Union. Ireland should be at the forefront of new technologies, research and strategies to deal with the condition, but we are not.

About 550 to 600 people in Ireland with cystic fibrosis have the potential to benefit from Orkambi. That is 600 lives which could be improved beyond recognition. I understand the Minister travelled to Portugal yesterday for an EU Health Ministers meeting on pharmaceutical drug costs. He sought the assistance of other EU nations to force pharmaceutical firms to slash exorbitant prices, which make it effectively impossible to access new treatments. We need to be realistic. Vertex Pharmaceuticals has asked the State to pay approximately €150,000 per person annually for the drug and HSE experts are saying a price of €30,000 would be fairer. The HSE has challenged the company to stop hiding behind confidentiality clauses.

I welcome the statement by Vertex Pharmaceuticals last night that said it would be entering into renegotiations with the HSE in an effort to reach an agreement on costs. The statement included the following: "Vertex has met with HSE representatives six times in five months, presenting a range of specific workable proposals that could expedite access for all eligible patients". Vertex has stated it has received no response from the HSE to date. The statement continued: "These proposals have included significant price reductions, guarantees of budget certainty, novel access schemes such as a risk-sharing agreement and ways to reduce the timelines on reimbursement decisions for patients in the future as new medicines become available". If that is true, it is simply shocking. The clock is, quite literally, ticking for the people concerned. It is a matter of life and death. On the one hand, Vertex invested millions in developing new ground-breaking drugs for cystic fibrosis and there are not many patients on which to make a return. Vertex claims it has to get its money back to reinvest in further research. On the other hand, the HSE has the right to get the best price for the product, which is fully supported by Cystic Fibrosis Ireland. We have to be mindful that this is the first drug to treat the underlying cause of the double delta-F508 strain of cystic fibrosis. The drug slows down the progression of cystic fibrosis and reduces hospital admissions by 40%. We all know that a hospital bed costs €1,200 per day. It may make the difference for a patient receiving a lung transplant or not. There is enormous human cost to the patient, as well as the financial cost to the State. At the end of the day, a solution needs to be found. If the two parties cannot reach agreement on price, consideration should be given to bringing in an international mediator to arbitrate on the matter to the satisfaction of all.

I will describe an anecdotal situation. In my area in the west there is a family of whom I am very much aware. A good few of the siblings have cystic fibrosis. One young girl lost her life to cystic fibrosis a number of years back. Her brother lost his life to suicide. He also had cystic fibrosis and suffered from a perceived lack of hope. Now that there is a drug that can help, let us all work together to ensure the people who deserve to get this drug receive it in a timely matter.

The very fact that the Minister is in the Chamber shows his commitment and concern on the issue of Orkambi. I compliment him on being present because, very often, senior Ministers send along a Minister of State to one of these events. Clearly, he is concerned. Professor Michael Barry spoke on "Morning Ireland" about a week ago. It is extremely difficult for a man in his position to come out and publicly explain why he cannot purchase a drug at the exorbitant cost being sought by the company, knowing in his heart of hearts that there are people listening who are desperate for the drug. It is absolutely terrible that a drug company played roulette with the patients it hoped to serve. From that point of view, Professor Barry and his team deserve our admiration for the work they do.

The Minister touched on my concern in his presentation. My concern is that, when it suits us, we live in a single market and when it does not suit us or certain interests, we do not live in a single market. We operate as a single market for agriculture, fisheries and all sorts of things. The drug companies seem to be different. I met a colleague from my old profession in Lanzarote some time ago. He bought his blood pressure tablets for the year at a cost of €14.95. He told me that the same tablets were costing him more than €1,000 in Ireland. Ultimately, it was not costing him but the State. I am delighted that the Minister is talking with his counterparts from all of the various jurisdictions to whom he gets the chance to talk. The time has come for the European Commission to look at competition and to state there is no competition in these situations. Drug companies, in effect, have monopolies until such time as the patent on a drug runs out or until a competitor develops a similar but slightly different product. I believe it is time the Commission told the companies that if they want to deal in Europe, they must deal with it. The European Unin could then divvy the drug out to the rest of the European community. I believe that is the way it should be done.

Pricing should be done on the basis of a single market. I am sure the Minister is aware of the fact that we now have people in my age group and upwards going on what they call their "medical holiday". They go to Spain to buy their drugs for the year. They take a week's holiday, fly with Ryanair to Spain and come back with change in their pocket from what they would have spent had they bought their drugs at home. That is not good. It is not good for the pharmacy business in Ireland, the people themselves or the Department of Health. I am sure the drugs are the same in Spain, but we do not know that for certain.

The representatives of a drug company had the notion to tell the Minister for Health that they would negotiate with him but not with some second or third party. How dare they? To whom do they think they are talking? The Minister has rightly pointed out that this House and the Lower House have passed laws in this country. We have decided who will do our negotiating for us. We will stand over it, regardless of any pressure that comes on us.

Yesterday I went out to the front gate to meet my sister who had travelled from Galway with her husband and her two sisters-in-law. They had all taken a day off work and lost money to come here. Thankfully, my sister's children are healthy, but her nieces and nephews were not and have passed away. There is cystic fibrosis on three sides of my family. If we look around Ireland, every family has been afflicted at some stage. It is almost as pervasive as cancer, to some degree. It is not something we can take lightly and I do not believe the Minister is taking it lightly. I believe we need to send a message from Seanad Éireann to Vertex, "Guys, you either deal with us or we will turn the PR machine against you." The offer that has been made by the country is reasonable. Drug companies must be entitled to a return on their investment which nobody is denying Vertex. However, €75 million over three years is an awful lot of money. The offer that has been made is one that Vertex should grab with both hands. Let other drug companies learn from this. Ireland will not be bullied into paying exorbitant prices. I ask the Minister to go back to his colleagues in Europe, particularly to Commissioner Phil Hogan, to ask if something can be done to turn the drugs and medicine industry into a single market.

I welcome the Minister. I appreciate him taking the time out of his busy schedule to come here.

This is an extremely important issue because people with cystic fibrosis face major challenges every day and we must do everything possible to assist them. We must also consider how to resolve this issue soon. Vertex has carried out major research, but someone cannot dictate the rules thereafter for access to the product. The Health Service Executive cannot disclose certain information under a confidentiality agreement. If Vertex is satisfied that it is truthful in everything it states,0 why can it not waive the confidentiality agreement and let the HSE release what has occurred at recent meetings? The negotiations started in 2012. Over 500 people could benefit from the drug. The National Centre for Pharmacoeconomics has checked and cross-checked the economics and its benefits. It has conducted several tests and assessments and its figures indicate that we should be talking about a cost of €30,000 per patient per annum, whereas the company states it should be €159,000 per patient per annum. We have to make sure we are not held to ransom.

The cost of pharmaceuticals in this country went from €570 million to over €2 billion in ten years. We now pay the highest cost per capita for pharmaceuticals of any European country. If we give in on this one, we set ourselves up for another series of increases in the cost of pharmaceuticals. The figure for 2015 is approximately €2.6 billion between hospitals, the drugs repayment scheme and private buying. That is a huge sum of money for a country this size. It is important to have some restraint in what the drug companies ask for. It is welcome that Vertex has agreed to come back into negotiations. Let us have all the information in the public domain. We need to prioritise coming to an agreement on this matter because there are over 500 people who need it, as do their immediate families who have to give them support every day. That is a huge strain on them. I hope we can conclude this matter.

If we pay out the €159,000 per patient per annum, that will set the tone for all future negotiations on new drugs. It also raises the question of where we cut health services. I agree with other speakers who have said that if a person is on this drug, it saves money on days spent in hospital. We have to make sure we are getting full value for money and helping people. We are prepared to pay extra to ensure the people affected get the benefit of the drug. The drug company has to be reasonable about what it wants in order to make sure people can access the product.

This is a heartbreaking but potentially lifesaving debate. Last week we heard the personal testimonies of distraught parents of seriously ill children whose survival they saw in the prescription of Orkambi. Yesterday there were hundreds of people, some of them extremely ill, outside Leinster House, dragged onto the streets to demand what could be a lifesaver for them. They are desperate people in desperate circumstances.

I do not envy the Minister or his position. We disagree on much politically but on matters such as this, politics is put to one side and we work together for a collective goal. The single biggest problem in providing this drug for cystic fibrosis sufferers is mass global pharmaceutical companies and their unrelenting quest for mega profit. These companies do not care about the hundreds of people who were outside these buildings yesterday or about Finn who is two and a half years old and has been hospitalised 38 times.

Disturbingly, the protests and personal stories probably help the drug companies and their financially unrealistic demands of governments around the world. They can literally charge whatever price they like for the drugs they produce in patent. Playing roulette and brinkmanship with people's lives on the basis of money is abhorrent and morally wrong. We need cool heads to prevail and a determination to deliver this life-saving drug to extremely ill people in a cost-effective manner. What is most important is that it is delivered and precious lives are saved.

I am under no illusion about the scale of this problem. Today it is Orkambi; tomorrow it will be the next life-saving drug. Shamefully, caught in the middle is a precious human life that needs to be saved. The HSE and the Department of Health need to establish a working group that will bring forward appropriate decision criteria for the reimbursement of orphan medicines and technologies. This approach should include an assessment system similar to that for cancer therapies established under the national cancer control programme, NCCP. This recommendation was contained in the national rare diseaseplan for Ireland 2014 to 2018. Two years into this period we learn that the terms of reference for the group are only being developed. We need to continue the plan without delay.

The cost of the drug, Orkambi, has been determined by the HSE at €392 million over five years. Vertex, the drug company, has seriously disputed this amount and it is publicly known that it is willing to negotiate. It needs to be transparent about how much it will accept for the drug. Ireland sets the cost per quality adjusted life at €45,000. This is a long way off the cited cost of €160,000. The large drug companies argue that the thresholds used to calculate cost effectiveness are too low.

Governments need to take back control of mass research. We cannot allow pharmaceutical companies hold the Government or any other government to ransom for profit, while playing with peoples' lives. Pharmaceutical companies, by their very nature and desire for high profit margins, are specifically targeting orphan drugs because of the small concentrated group of patients they can treat in line with the low volume, high margin business model they can manipulate. We are cognisant of the fact that Orkambi was rejected not because it did not work or because the authorities were not aware of the very real lives of Irish citizens and their debilitating illnesses such as cystic fibrosis but because of the huge price tag put on it by Vertex. We have to promote reviewing the ten-year exclusivity granted to pharmaceutical companies which, with generous tax credits, also face less intensive regulatory practices to get drugs off the ground. Once drugs are approved, pharmaceutical companies are effectively given a licence to print money. They have a ready made audience and provision of treatment becomes extremely emotive because of the rarity of the illnesses, backed up with strong, intensive lobby groups eager to secure previously unavailable treatments. This is done in good faith out of care for loved ones or to secure their own lives. The major problem is the despicable greed of the pharmaceutical industry.

Vertex states it has yet to turn a profit on the drug, but its trading figures tell a different story. The priority for us is to secure Orkambi for very ill citizens. We should create risk-sharing arrangements where the manufacturer must share risk with the purchaser, co-operate with other countries to negotiate more powerfully and increase bargaining power.

Co-operating with other countries will also enable us to present a larger patient pool.

I thank the Senator. There are others waiting to contribute and we have limited time.

There is another drug on the market called Kalydeco. I ask the Minister whether that product is in the mix in the negotiations.

I thank the Minister and his officials for coming to the House for this debate.

A number of Senators have spoken about people they know or people close to them who suffer from cystic fibrosis. Everyone in the House knows someone with the condition. I agree with the Minister that it is unacceptable that cystic fibrosis patients are being used as pawns. There is no doubt that they and their difficult situations are being brazenly used. It is hard not to come to the conclusion that there is something unorthodox, if not rotten, about the way some elements of the international pharmaceutical business operates in terms of pricing policy. Families who find themselves in this situation are going to look to the nearest point to them, namely, the HSE or the Minister to help them. It is great to see solidarity and understanding in the Seanad today in the sense that we all agree that we must deal with this collectively and must call out where the real issue lies.

The Minister has said he has been in contact with four other countries. I totally endorse the remarks made by Senator Gerard P. Craughwell. He rightly asked why, as members of the European Union, we cannot deal with drugs pricing across the whole European family. Today, tomorrow or next week, a family will be told that their little boy or girl has cystic fibrosis and the unedifying situation in which we find ourselves is horrendous in that context. It is bad enough to have to deal with such a serious condition but to be pawns in a game that seems to be just about profit is totally unacceptable.

I am very heartened by the tone and nature of the discussion we are having. I wish the Minister, his Department and the HSE the very best in their efforts to get the price of this drug down to an acceptable level. We have already put the slide rule over it and know what price is about right.

I welcome the Minister.

This is an extremely important issue. To bring it down to basics, people with cystic fibrosis did not wake up one morning and say, "I want cystic fibrosis." I know many people with the condition. I am thinking, in particular, of a woman in her early 20s. She is in college, bright and articulate. I have spoken to her about Orkambi as she would qualify for it. She is not looking for an improvement in her lung capacity but just wants it to be stabilised. If her lung capacity can be maintained at its current level, she can live a normal life and stay out of hospital. She is not looking for a rapid rate of increase in her lung capacity but for stability.

I have met representatives of Vertex, as have many others, and it must be said that without Vertex, Orkambi and Kalydeco would not be available. The company carried out the necessary research. The question is whether the charge for these drugs is effectively extortion.

Confidentiality is normal in commercial discussions, but in this particular case, the details should be made public. Furthermore, discussions must recommence with immediate effect because we are dealing with peoples' lives. As a society, we must make both moral and financial decisions. This is business and the best negotiators we have must be in the room with Vertex. The company must come to the table and make a deal that is fair. We need to put a results or risk-based model in place. We are not certain how many people would benefit from using Orkambi and must put a pricing structure in place that reflects this. The discussions are critical and Vertex must engage with a view to striking a price that is fair. The HSE must find a way to make Orkambi available to those who so desperately need it.

It is welcome that a new cystic fibrosis unit has opened in University Hospital Limerick. There are nine isolation beds in the unit, which is very significant. However, University Hospital Limerick urgently needs 96 new acute beds. The numbers going through the emergency department, an estimated 64,000 this year, are the highest in the country. In Cork there are 800 beds for an estimated 60,000 people, while in Limerick there are only 400 beds. I ask the Minister to provide money for University Hospital Limerick to enable the design process to begin before the mid-term capital review. The sum of €25 million is urgently needed.

I welcome the Minister and thank him, on behalf of all of those whom we represent, for his investment in this issue. I know that he is personally heavily invested in it as I have been following his progress on it for some time. For what it is worth, he has my support in the approach he is taking. I think it is the right, responsible and sensible approach to take. I hope he can find a way to ensure those who need this treatment so badly can receive it in a timely fashion. We all know people who suffer from cystic fibrosis. I know many people from my own immediate area with whom I would have gone to school and played as a child whose families have lost them to cystic fibrosis. It is a very debilitating and life-limiting condition. We all know about the disease and its impact on communities.

I have listened very closely not only in the Minister's pursuit of these issues in recent times but also to all sides of the debate. In this House there are not two sides to the debate. It is rare enough for that solidarity to break out in a Chamber that is, by definition, political but everyone is on the same page on this issue. There may be differing views on the tactical approach taken, but we all want the same outcome. I am glad that the tendency in this country to make emotive issues such this into political footballs has been avoided. We all need to express our solidarity with those whom we represent, those who need this drug and their families, while also taking a responsible approach. We are not just having a political discourse. We are being watched very closely, not just by the particular pharmaceutical company but also by many others, in our approach to the issue.

The Minister is absolutely right not to be making any political intervention as Minister for Health by dealing directly with the company. That would set a bad precedent. I have every confidence that the HSE has the capacity to deliver a result for the people. To use an appropriate analogy, I would never, in my time as Minister of State at the Department of Jobs, Enterprise and Innovation, have intervened in an industrial dispute. To do so would be to escalate it, which would be to nobody's benefit. I support the Minister's approach and the strategic approach of his Department. We all stand united behind the cause of assisting the Minister to achieve the right outcome for cystic fibrosis patients.

I thank the Minister for coming to the House.

I have three questions. First, how many countries have done a deal with the company? Second, have any of those countries done a deal on the basis of risk sharing? Third, what price did they end up paying? Obviously, these are benchmarks on which we could base our negotiations.

Many colleagues have touched on other issues to do with cystic fibrosis. One feature is the consequence of having a diagnosis and the fact that there is now hope for patients. There is a drug that offers hope for some, but it does not offer hope for all. That is where risk-sharing comes into play. That is where we could possibly improve and lengthen lives. We could not only lengthen lives but also improve the quality of life.

I thank the Minister for coming to the House to take this debate. He did not send anyone. He has come himself. He was sent out to bat on an equally tough issue in 2013 when it came to organ donation. The House was recalled at the time. We had a number of debates on radio, television and in other locations. As the Minister will recall from those debates, the system of organ donation in this country is a disaster. The EU regulation brought forward at the time was signed on the last day designated by the European Union for signature. The 27-page EU directive was the first tranche of legislation in the history of the State to do with organ donation.

Our system is so bad that 65 people per year are dying on the organ transplant waiting list. The figure does not include those who are taken off the waiting list because they are too sick or deemed to be too ill to receive a transplant. They do not even feature as a statistic in the organ transplant system. We have 650 people waiting for organ transplants. Some 500 of this number are awaiting a kidney transplant. If we simply reformed the organ donor system for kidney transplant alone, we would save over €1.3 billion in a decade. More important than saving such a vast amount of money is that we would be saving and transforming lives.

In the overall context of the debate, the drug Orkambi is one element. The question is how to pay for it, regardless of whether we decide to pay such a vast sum. I am not suggesting the amount in question should be paid this minute, but we need to know what other countries have done. That is why I have asked my questions. If the Minister does not have the answers to hand, I would appreciate it if he sent on the information to us.

I know that the Minister has met organ transplant organisations. The system is failing people from start to finish. The issue of organ donor co-ordinators was central. As a result of the debate in 2013, several were appointed. I will highlight how bad the system is. Some hospitals in the country have never asked any family to consider donating the organs of a loved one. Over the course of a decade not one organ donation has come from some hospitals in the State. Why is that? It is a systems failure from top to bottom.

An opportunity was missed at the time of the EU directive in 2013. I will not go into all elements of it now, but the opportunity forgone is not only relevant to this issue.

The answers to the questions will come from the evidence of what other countries have done, whether they have been involved in risk-sharing and what price they have paid. Furthermore, if we can get an EU solution, it will be all the better. The fact is that the drug gives hope. There is nothing worse than knowing that there is a solution and being denied that solution and, by extension, the hope a child or a loved one will be given a chance. That is all patients and families are hoping for.

I would hate to be in the Minister's position. A Minister of the Government is lambasted from all sides. Now, the Minister is in a situation where it is a life or death decision for people. It is no easy position to be in when that simple question is put in front of him. It is a complex question. Many issues must be weighed up, including the cost and the future impact in purchasing other drugs to treat other illnesses. This is for the families the Minister and all of us have met. It is a life or death decision. I hope the Minister will support them.

I welcome the Minister. I have no wish to be distracted from what we are discussing, but I listened to the last speaker discussing transplants. As the Minister of the day at the time, I know of the extra money and the transplant office put in place. I know of all the additional transplants that have taken place since; therefore, I would find it difficult not to respond. Notwithstanding this, there is a great deal more work to be done. That is part of what we are about today. All of these things have a cost and when budgets are tight – they are better now than they were some years ago – they become serious issues.

I am delighted that we are having the debate, but I am saddened that it is necessary. Science has a long and proud tradition in this country and across the globe of bringing new developments to improve the lives of people. Many scientists are seen as heroes, rightly so. While I do not expect us to go back to the days of Faraday and all of the discoveries he made which he shared freely with the world, I believe we have gone to the other extreme with Orkambi and the company Vertex. This is a political forum and I intend to take advantage of it to speak my mind. The company seems to be very much focused on extracting a price that it believes the market will bear, one that does not relate in any way to the patients for whom Orkambi is intended. The company was given considerable sums of money by charitable organisations throughout the globe and, I have no doubt, received much by way of grants and tax incentives such as those we give in this country. Ultimately, we have all invested heavily in this drug.

The goodwill and celebration we should be having today for citizens who suffer from cystic fibrosis and who could benefit from this drug are sadly soured by this situation. I am very much of the view that we have passed the tipping point and that the Minister now, rightly, should engage with our EU counterparts. When I was Minister for Health, an EU directive was passed at the European Council to allow EU member states to come together to purchase vaccinations. The move allowed smaller countries to gain from the buying power of bigger countries. I believe that will have to be activated in the case of orphan drugs. I know that this is something many will resist and that there are many vested interests against the idea.

I am not remotely against the pharmaceutical industry. I think we have a great industry in this country and those involved in it have been responsible. They drive a hard bargain, which is right, but it is important to point out that the organisation representing the companies, the Irish Pharmaceutical Healthcare Association, does not represent Vertex. Vertex is not a member of that group.

I think we have crossed the Rubicon. I wish to make it clear that I know that the Minister wants patients with cystic fibrosis to have this drug, as does the Government. As a doctor, I want my patients with cystic fibrosis to be able to avail of it. I would call the bluff of Vertex and call on the company to let us have an immediate response on whether it will be prepared to risk-share. We know that the drug can improve quality of life for one in four of those who have the genotype. It can work for them. If the company was to agreed to this, it would represent significant progress and a start.

It is important for everyone to acknowledge that the HSE is acting on behalf of the Government which is, in turn, acting on behalf of the people to get value for money and make the drug available for patients. The HSE needs our support. I see people trying to separate Professor Michael Barry from the HSE. He works for the HSE. He is the face of the HSE in that room doing his damned best on our behalf and that of patients to secure these live-saving drugs. If we pay out exorbitant sums, whose home help services are we going to cut? What wards will we not build? What vaccinations will we not make available? Opportunity cost is a factor.

I reassure those who suffer from cystic fibrosis and their families that I know that the Government and the Minister for Health, in particular, are very much on their side and battling for them to get this drug to improve their lives.

I ask that we all get behind the HSE, that we not be diverted and that we get a deal in order that the drug can be made available to the citizens who could benefit from it.

We will not stop here because next week there will be another drug and next year there will be five more. The current approach by certain pharmaceutical companies of seeing what the market will bear and demanding it because they feel they are in a position of monopoly cannot be allowed to pertain. Cognisance must be taken of the fact that many charitable organisations, patient advocates and governments in their own way put a lot of funding through companies to help them research these products.

I welcome the Minister for Health, Deputy Simon Harris. I compliment him on the interest he has shown in the provision of the drug, Orkambi, for cystic fibrosis sufferers. When he was in Limerick in early October to open the cystic fibrosis unit, he saw it at first hand and met many of the patients who were there. The main thing that a number of people who have come to my office wanted to stress was the quality of life of those who were suitable for taking the drug. There was a report issued on 28 October 2016 on people who were taking it, which showed that there had been a 40% decrease in the number of hospitalisations. The drug has slowed down cystic fibrosis for those currently on it. These are two very important points because if fewer people are being hospitalised because the drug is working for them, it frees up beds for others. There are more than 550 cystic fibrosis patients across the country. In the past people from Ireland travelled abroad because we did not have suitable treatment available in this country. I know people who went to America for treatment. We have come on so much in this country in terms of Beaumont Hospital and Cork and Limerick hospitals being centres of excellence. They are the hospitals where people go for treatment.

People are conscious of the fact that it is a large amount of money. Vertex Pharmaceuticals is looking for €159,000 a year per person for Orkambi when it has been said it should cost roughly €30,000. The Minister has the right approach in getting other European countries to come on board in negotiating and trying to get the price down. I hope a solution will be found to resolve this matter. Everybody here is of that way of thinking.

I compliment the Minister. The sooner the HSE and Vertex can come around the table to try to come to a successful conclusion the better. Vertex is holding us and the HSE to ransom. It is the one in the driving seat. It is looking for its price. It is incumbent on all of us to bring to bear as much pressure as possible to bring down the price. I agree with my colleague, Senator Kieran O'Donnell, on the 98 beds that are certainly very much wanted and needed at University Hospital Limerick.

There is no one else indicating.

I thank all Senators from all sides of the House for the great solidarity we have shown collectively with cystic fibrosis patients and the very clear message we have collectively sent to Vertex, the drug company. We want to make the drug available for people; we want to pay a reasonable and fair price, but we will not have extortion of the people and will not have cystic fibrosis patients used as pawns or held to ransom, as Senator Maria Byrne said.

I begin by urging Vertex to stop talking through the media and start talking again in a room with the HSE, the organisation that this and the other House have decided will negotiate on drug prices. That can start immediately. There should be no preconditions for the talks. There is no need for any faffing about. We need to get back on track with the negotiations and that can happen today.

Senator Keith Swanick referenced Ms Jillian McNulty and I, too, want to pay tribute to her. I am reluctant to name any one person because it affects so many people, but she has been a very vocal advocate on the issue. She has also been a vocal advocate full of common sense. She and many others with cystic fibrosis have better things to be doing than protesting outside the gates of Leinster House which none of us wants to see happen. We want the issue to be resolved.

A number of Senators mentioned the benefit of Orkambi. Let me be clear - I believe there is a benefit to Orkambi. I am not medically qualified to believe it, but I believe it because that is what the doctors tell us. That is what Professor Barry tells us. It is what the patients tell us. The benefit is beyond doubt, but that is not what the debate is about. It is about a fair price and making sure we do not have a company that has a monopoly and states it has this medication but we cannot have it for patients unless we pay a ridiculously large sum of money. I also agree with those who say companies must get their money back. Whatever one thinks of pharmaceutical companies, they are businesses and have priorities in that regard. However, the valid point was made by Senator James Reilly that lots of drug companies received research and development grants and tax incentives. This company, in particular, received a number of charitable contributions towards the development of the drug. Let us not get caught up in the idea that it has pumped loads of money in and that it must get all of the money back. It also must recognise that it received a lot of assistance, including from charitable sources, in developing the drug. That is important.

I thank Senator Gerard P. Craughwell for the tribute he paid to Professor Michael Barry. It is one that is very fitting. He is a man full of integrity who has worked tirelessly and has not been afraid to get out front and centre to explain the rationale. When I became Minister for Health, I said it was very important that we did not have politicians making clinical decisions. I would certainly rather have decisions and determinations made by somebody called Professor Barry than Minister Whatever. I thank him and his team for their ongoing work in a very difficult area.

I agree with Senator Gerard P. Craughwell and many other Senators, including Senators Maria Byrne, James Reilly, John Dolan and Máire Devine, on European collaboration, which is very important. We cannot just be in a Single Market for certain things when it suits us. This is an area where there are huge chances to make progress. It was palpable yesterday when I met a number of EU Health Ministers in Lisbon that they too wanted to become engaged. Already the Benelux countries have piloted the purchasing of a number of medicines - three I understand - through an arrangement. My officials are working with the Dutch to see if there is a potential for Ireland to get further involved in that group.

I also thank Senators for pointing out that, as a country, we have decided who does the negotiating and that no pharmaceutical company will make that decision for us. These are the rules of the land. If they want to negotiate in this country, they should come and respect the law of the land, just as we would respect the law of theirs. That is an important point.

On the confidentiality agreement and Senator Colm Burke's suggestion it be waived, that certainly would be very helpful. There is much misinformation and many reports that the company has stated one thing and that the HSE has stated another. That is just terribly confusing for everybody. I would like to see a situation where we could keep the likes of CF Ireland up to date with accurate factual information on the stage the negotiations are at and what the strategy is and where we would be able to ask them what its members thought. If Vertex was to waive the confidentiality agreement, it would be very helpful.

I agree with Senator Máire Devine. This is heartbreaking. Party politics aside, we all want to resolve this issue. The Senator's call for cool heads to prevail is valid. There is no need for preconditions, just the need for people to get back in the room. I will take on board the suggestion the Senator made about the assessment system in general. It might be useful to say there is a clear enough assessment process in place. The National Centre for Pharmaeconomics, NCPE, carries out the health assessment of the drug. It goes to a HSE drugs group which has clinicians on it. That group makes a recommendation to the HSE. It is only if the HSE does not have the money to purchase the drug or if it needs additional resources that it will come to the Minister of the day. Mounting pressure politically and engaging in that emotive debate by saying the Minister should go in and sort it out is very helpful for the drug companies. That is not what the law of the land states and it is not the process we have in place. If we deviate from it on this drug, where will we end up next week or the week after with another drug? I fully agree with those Senators who talk about risk-sharing or what we call outcome-based pricing. Clearly, this is a very innovative process. Vertex believes it will work for many patients. I believe it works for many patients. Let us pay for those for whom it works. It is regrettable that Vertex was not interested in that model, but let us hope it will re-engage. I encourage it to do so.

On the issue of University Hospital Limerick which was raised by Senators Kieran O'Donnell and Maria Byrne, there are pressures. I will examine the issues raised and revert to the Senators.

I genuinely thank Senators for their support.

Senator Mark Daly asked the clear question about what other countries had done a deal with Vertex on Orkambi. To the best of my knowledge, Austria very recently reached a deal to make the drug available to its public patients. I am not sure of the terms and conditions of the deal, but, as far as my research shows, no other EU country, or any other country, has managed to make the drug available to its public health patients through an agreed reimbursement price. We are, therefore, not on our own in that regard. That is the point - Ireland is not an outlier. Colleagues around the globe are finding the same pressures. It is, therefore, time for Vertex to reconsider its strategy in that regard.

I acknowledge the point made by Senator James Reilly about the drugs industry in this country. Not every drug company behaves like Vertex. That is an important point to make too. We have a drugs agreement in place that will see significant savings of €750 million. It was hard-fought for and negotiated by the HSE and officials in the Department of Health with the Irish Pharmaceutical Healthcare Association, IPHA. I acknowledge the IPHA's comments this week that it wants to be very clear that Vertex is not a member of its group and that it does not act or speak for it.

I will be happy to come back before the House to have a more substantial discussion on the issue of organ donation, as requested by Senators Mark Daly and James Reilly. That would be very useful.

I say to cystic fibrosis patients and their families that we are doing and will do everything we possibly can. Let the negotiations recommence without posturing, any faffing about or preconditions. However, I will not be bullied or intimidated by the drug companies. I will not ignore the laws of the land and stand for the exploitation of the country.

When is it proposed to sit again?

At 2.30 p.m. next Tuesday.

The Seanad adjourned at 3.30 p.m. until 2.30 p.m. on Tuesday, 13 December 2016.