John Brassil (Kerry, Fianna Fail) | Oireachtas source

Mr. Flanagan said that the current process focuses companies, so I wanted to focus the HSE as well. I want to get a negotiated settlement for this drug. I have a constituent in my village, who I did not realise until the AV presentation suffered from this condition. The boy's mother gave me a detailed breakdown of her day and how they deal with the diet and counting out 22 chips for the dinner, because that is allowed. Kuvan is not going to cure PKU but will increase the quality of life of the person. I would like to see this particular drug getting over the line and I hope it will.

Mr. John Hennessy mentioned the World Medical Association Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects, which I am glad he did. Let me draw attention to paragraph 34, which deals with post-trial provisions. It states:

In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial. This information must also be disclosed to participants during the informed consent process.

That is what the World Medical Association Declaration of Helsinki tells us about people on clinical trials and compassionate access programmes. We have a responsibility which paragraph 34 states in black and white: the host country government has a responsibility. In Parliamentary Question No. 435 on 3 October 2017, Deputy Brendan Smith asked the Minister for Health if persons currently using Respreeza will not be denied access to this medication; and if he will make a statement on the matter. In his reply, the Minister, Deputy Simon Harris, stated in the final lines:

The HSE has also advised that it has decided to continue with the provision of this treatment to this patient cohort only, for an initial period of two weeks.

The very obvious follow on question from that is that if the HSE agreed to provide the medication for two weeks, the HSE is accepting that the drug has use and is of benefit to these 21 people. I can see no other reason that the HSE would agree to extend it for two weeks. If one does not accept that there is some benefit, giving it for another two weeks is not going to make any clinical difference. To use a phrase that has been used in financial terms, the HSE has skin in the game. In my view, the response to the parliamentary question indicates the HSE has bought into this drug.

When the company agreed to provide the drug for six months free of charge, subsequent to this answer, they would be the sponsors, as referred to in the Helsinki Declaration, the researchers would be the Alpha One Foundation, and they are trying to put together a programme whereby the patients get the distribution and the administration of the drug. To me the HSE is just saying that it is not its responsibility, it is the responsibility of the researcher or the drug company but is not the responsibility of the HSE.

I have had several meetings and the officials have been very accommodating to me with any requests I have had and I appreciate that but I think taking into consideration what it states in the Declaration of Helsinki and the reply of the Minister, Deputy Simon Harris, I think the HSE has a responsibility and it needs to assist patients in getting the administration of this drug. It is not acceptable for the HSE to say that is the responsibility of somebody else. I respectfully ask that the HSE sorts out the issue in the coming days.

The drug is being provided free of charge for a period of six months. We are down to arguing on how it will be administered. That is a significant issue to the 21 patients because they will not know what day, time or week it will be administered, but know that the drug is waiting for them. That is not acceptable by any standard. We as elected members and members of the HSE really have a responsibility to put this right very quickly.