John Brassil (Kerry, Fianna Fail) | Oireachtas source

I will now turn to Mr. Judge's opening statement.

We have had much debate around the Act, its suitability and what it covers. The committee is really focusing in on orphan drugs, and drugs for rare and ultra-rare diseases. Having had two previous meetings with this group, the committee recommended that the 2013 Act should be reviewed. That was a recommendation of this committee.

In a debate in the Dáil on the drug Ocrevus, which is used to treat multiple sclerosis, MS, the Minister stated that if people in this House think that the current system is broken, we could start hearing what people want to replace it with. He stated on the record of the Dáil that also he thinks it is broken and that the conundrum is how to come up with a better model. I add to that the fact that, in 2017, of the 148 medicines that were designated orphan and subsequently received marketing authorisation by the EMA, 53 are available in Ireland, which equates to 35.8%. That is very much on the lower side compared to Germany, which has 133 of the 148 approved. We are right down on the lower side of things. We have an issue around reimbursement on orphan drugs. Earlier, Mr. Judge stated, "The Act provides for a fair, transparent and rigorous process of assessment [and] the Minister is satisfied that there are no legislative barriers to the reimbursement of orphan drugs." What has changed?