Alan Kelly (Tipperary, Labour) | Oireachtas source

It is obvious that we need an extensive national medicines policy to be driven at departmental level. It is to be hoped that will happen in the next Government. Mr. Judge stated that the Minister cannot get involved in drug reimbursement decisions. If that is so, what happened in the case of Orkambi? Did the Minister become involved contrary to the Act referred to by Mr. Judge or did he have no involvement? Is there a clause in the deal with the Irish Pharmaceutical Healthcare Association, IPHA, whereby drug cases may be referred to the Department in certain instances?

There was a case in Crumlin last week, and we heard earlier from the witnesses that genetic services in this country, which are intertwined with decision-making, are simply not up to the standard required. Is this accurate? I have spoken to people in the HSE who have said they have been trying to employ people for a number of years. The case last week has caused alarm. Is it the case that genetic services are not up to the standard required? That is my second question to Mr. Judge.

My next questions are probably a mix for the other three witnesses. The first concerns affordability, which is an issue in the case of orphan drugs. What is the HSE's position on biosimilars and biosimilar penetration? What are the expected savings in this regard for 2019? I presume that with the budget and projections, the HSE must put in something.

Fourth, what is the typical weighting price for tenders on drugs? How do we compare with other countries, such as Germany and the UK? I understand that in many cases the weighting they have on price in their tenders could be up to 80% while we are generally very low at 25%. Are we not losing money as a result of this?

My last question concerns pembrolizumab, the drug Vicky Phelan is on. I do not expect any of the four witnesses to criticise Government policy, but has any of them ever seen a similar case in which a decision was made to give a drug such as this, which is off licence, free of charge to one cohort of women or men outside of the normal Health Products Regulatory Authority, HPRA, procedure, which is to go two years? Would this be in any way normal? How can it be that Áine Morgan in Loughrea - this is all in the public domain, by the way - is fundraising to go on pembrolizumab? Ms Morgan has cervical cancer but is not one of the 221 women, yet Vicky Phelan, to whom I have spoken in depth about this and who is one of the 221 women, is getting the drug for free from the State. One cohort is getting it for free. Women in another cohort must get a clinician to say they need it, but they do not get it for free. The drug costs €8,500 every three weeks.

I put the following questions to each and every one of the witnesses. Do they believe this is equitable and fair or discriminatory? Do they believe it is legal? I certainly have issues with it. I cannot in any way justify how one can distinguish between two women who have cervical cancer such that one gets a treatment free of charge because of a decision made at Government level and another does not. I would like to hear the witnesses' views on this. I am aware this drug is used to treat other conditions and other cancers but I want to know specifically how within our drug administration policy this is equitable or fair. Have the witnesses ever seen this done before? I have spoken to many of their colleagues from different walks of life and there is deep unease in the HSE and other parts of the health service about this. Something will have to be done about it.

There are five questions to be answered.