Kate O'Connell (Dublin Bay South, Fine Gael) | Oireachtas source

To move away from the area of orphan drugs, I have a question that Mr. Flanagan might answer. If Mr. Flanagan was in the role then, he might remember that in 2013 Aspen Pharma significantly increased the price of several drugs. My understanding is that it was almost holding the HSE to ransom. There were long established drugs that would have to have been off patent then, including Purinethol, the cost of which went from €17.88 to €65. My understanding is that Aspen told the HSE it was increasing the price and if the HSE did not pay it, there would be no supply and the HSE paid up. This cost the HSE in the region of €200,000 annually. The year 2013 is some time ago, but what has the HSE done since then to prevent something similar happening again? I understand that only small quantities of Purinethol would be used in Ireland relative to more standard drugs. My concerns follow on from this.

When these drugs were in development stage, they would have had a nine year patent and would have had the benefits of high costs in their early years to pay for the research and development involved in them. They then go off patent or become a regular medicine, but a company can go in a full circle, come back to the HSE and charge a huge increase. What has the State done since 2013 regarding such drugs to prevent this happening again? I have a list of them before me which I can provide to the witnesses, although they no doubt know them. Aspen is being investigated by the European Commission but that does not help if the same problem could arise next week.

Orphan drugs are a necessary evil. Medications such as Sildenafil can sometimes go on to become blockbuster drugs which provide significant benefits to society. The incremental cost effectiveness ratio is set at about €40,000 to €45,000 which, from my reading, seems a low threshold. Does the HSE plan to increase the incremental cost effectiveness ratio to a level of, for example, €100,000, or at least something more appropriate to the current situation?

One of the witnesses said in their opening statement - it may have been Mr. Barry - that, ultimately, the final decision rests with the HSE. Who is that person in the HSE? My understanding is that the witnesses' area is well-resourced with highly qualified people to go through the processes. Why would we have the witnesses, who are a group of highly qualified people, go through this process and evaluate the data and information, but then hand it over to someone else? Is that person to whom the reports are given super-qualified? What is their special power that makes them capable of overturning the decision of the people here based on their qualifications to do the job? I am concerned about the process. From my reading, the people here could go through the whole process and support a drug which might solve a particular issue, but then this secret person in the HSE can reverse the decision, or say "Yes" as the case may be. Will the witnesses elaborate on this? The members of this committee have a duty to make sure that the witnesses before us are able to do their job properly.

There was a reference to Germany in an earlier question. The witnesses said that there is free access and free pricing in the first year in Germany, but what happens then? Do the witnesses have any information about what happens after the first year when everyone gets anything for any price at all? Is it the case that people are hooked on it, but what do they do after the first year? Do they cut off supply of 50% of these drugs to which there has been free access in the first year? Does it usually continue as it is? It must generate endless bills.

Will the witnesses outline what they need from us to get the best value for money for people in Ireland? It is a very emotive area because the situation is impossible in cases where patients might be offered another couple of years or months at a massive cost. I am very concerned that it would be a case that those who shout the loudest get the most, with the provision of certain drugs being improved because of calls to "Liveline". I am not comfortable with business being done in that way. What can we do to streamline this issue and ensure that people have equal access to treatment, rather than treatment being provided to those with the strongest lobby group or because they have the saddest story?