Melanoma is a cancer predominately of the young with potentially many lost years of life and with devastating effects on many families. Ireland is the 14th most susceptible country to melanoma in the world. We are very far behind in terms of treatments for advanced or progressive melanoma and a proper national screening programme, which we do not have. If we had one, it would avoid many of the expensive immunotherapy treatments available. The problem is that, notwithstanding the very considerable advances that have been made in treatments which can extend life for people with melanoma, particularly advanced melanoma, we are far behind as a country. The drug, nivolumab, or nivo for short, is one treatment. In the European Union, only Ireland and Portugal have not approved this drug for reimbursement.

It is an extraordinary situation.

All EU countries, with the exception of Ireland, France, Italy and Portugal have decided to fund the combination therapy of ipilimumab, known as ipi, and nivolumab, known as nivo. This combination therapy has proven to be truly radical and transformative in medical research. Immunotherapy is the new revolution in cancer treatment but we have not approved these particular drugs, notwithstanding the fact they are licensed by the Food and Drug Administration, FDA, the European Medicines Agency, EMA, and by our own licensing authority, the Health Products Regulatory Authority, HPRA. Historically, survival rates were very low prior to the arrival of these particular treatments but since these treatments have come on stream, the impact has been quite transformative, particularly for patients with advanced melanoma. In Ireland, there may be up to 150 patients per year with advanced melanoma, 50% of whom could be suitable for the ipi-nivo combination.

The National Institute for Health and Care Excellence, NICE, in the UK is normally one of the slower agencies in this area but it has been one of the quickest out of the traps in approving this particular drug combination because of the data that has emerged. The most recent and dramatic data has come from the American Association for Cancer Research at its annual meeting in Washington showing positive responses among 60% to 70% of patients. This is very exciting but we are way behind. We have not approved nivo or the combination of ipi and nivo. Professor Carole Longson, the director of health technology at NICE, has said that after one of the fastest drug appraisals carried out by NICE, these promising new immunotherapy treatments for advanced melanoma look set to significantly extend the life of people with the condition. Dr. James Larkin, a melanoma specialist at the Royal Marsden hospital, was one of the leaders in a groundbreaking clinical trial of the combination therapy and 60% of his patients responded well to it.

I do not know why we are so slow in this area. I have been pointing out for more than two years that our system is not working. Since the enactment of the 2013 Act, it most certainly is not working and many patients are being left behind in respect of groundbreaking treatments that can prolong their lives and lead to significant remission.

I agree with Deputy Martin that the system we have had here for many years is not up to speed in the context of major new drugs that are approved by the FDA and similar authorities. Furthermore, being a small country, we do not have the financial reach to be able to provide for all new drugs that come on stream very quickly. The case made by the Deputy about melanoma is one of many such cases. I received a letter from a major pharmaceutical company recently about a number of drugs that are produced by the company that are not used in Ireland but which are exported around the world.

The recent situation in respect of Orkambi is instructive here. Orkambi is exceptionally expensive, for very good reasons. In that context, we had international collaboration looking at the whole question of the priorities attached to drugs, how they should be funded and the relevant costs that should apply. Rather than proceeding alone, as one country, this is the way to go in the future. In collaboration with a number of other countries, significant reductions were brought about in the cost of that particular drug, together with an analysis of the improvement in the quality of life that the drug would actually provide for cystic fibrosis sufferers.

The process in respect of melanoma is under way in the HSE and the relevant agencies. The point Deputy Martin makes is that we are not in a position to provide ultra-modern drugs that come on the scene which clearly bring about serious improvements in the lives of patients suffering from various ailments. I was struck by the fact that no sooner was the decision made, money provided and an agreement reached for Orkambi, another 35 to 40 new drugs were being named as coming on stream for different ailments, many of which were also very expensive.

We need to look nationally at the scale of what we provide for drug purchase in respect of a range of ailments, and internationally at whether we can collaborate with other countries on the purchase of modern drugs for specialised ailments, including various forms of cancer. Perhaps that is the way to go. I am quite sure there is a measure of agreement across the House on these matters. As the Deputy is aware, we do not have an endless pit of money. I think we can improve the way we deal with the provision of drugs, thereby leaving aside the priority attached to the drugs for which we can actually provide money.

There was a time when we were far more ahead of the curve in approving new technologies and treatments. We have fallen well behind in recent years. These approvals often get caught up in the system. This does not happen because of cost grounds initially. There is a suspicion that this might be the underlying reason, but it is never stated. There is significant evidence here. Why are Ireland and Portugal the only EU countries that do not approve nivo on its own? The combination of ipi and nivo is captivating cancer researchers around the world, particularly those involved in skin cancer research. The US Food and Drug Administration approved this combination in 2015 under an accelerated approval programme because the results showed rapid and deep regressions of patient tumours. These dramatic results captivated doctors and patients alike. People in Ireland need this treatment at the moment. Medical oncologists have told me that people in Ireland who have the resources to do so are paying €4,000 or €5,000 for this treatment. People who do not have such resources are considering whether they should sell their houses or take other steps to get access to the ipi-nivo combination. This is a real issue. Approximately 50% of the 150 people in this country who are diagnosed with advanced melanoma each year would be eligible for this treatment. This should be doable. In my view, something is not right somewhere in our system. We are way behind the curve when compared with other countries that are well advanced in approving radical breakthrough treatments for forms of cancer that were not treatable in the past.

The advances made over the years in medicine generally and in particular ailments have been astounding. The pipeline of new drugs coming on stream has simply exploded because of the research, the innovation and the work that is going into precise and specific elements for which drugs are now produced. The Health (Pricing and Supply of Medical Goods) Act 2013 sets out the legal and statutory process in this regard. The HSE makes the decisions here. We are awaiting a decision in the case of the melanoma drugs mentioned by the Deputy. As he has pointed out, responsibility for such decisions has been transferred from those involved in the political process to those involved in the quality-of-life process who have the clinical excellence and so on. There has been an explosion in the number of new drugs coming through the pipeline. Now that the Orkambi case has been settled, we are awaiting the provision of finance to provide between 30 and 40 new drugs to patients with particular ailments. The Minister for Health travelled to Malta earlier this month to sign the Valletta declaration, under which Ireland and seven other countries have agreed to work together on procuring, deciding on priorities and bringing about cost reductions so that more patients will be able to access new and specific drugs. I am sure that any Minister for Health would like to be able to say that as new drugs for particular chronic ailments, including melanomas, come on stream and are approved by the US Food and Drug Administration, he or she will be in a position to provide for those drugs. Even though cost reductions have been secured in the case of Orkambi for a very good cause - cystic fibrosis patients - I understand it is the most expensive drug in this country's history. The Minister and the Department are aware of this issue. I think that by bringing about international collaboration between the countries that have signed up to the Valletta declaration on joint procurement, we will bring about an improvement in this situation.

We are way behind on melanoma.

The assessment for the two melanoma drugs mentioned by the Deputy is under way with the HSE.

The Minister can give the Deputy more precise details of the work involved in or the point of that assessment.