Dáil debates

Wednesday, 7 December 2022

Saincheisteanna Tráthúla - Topical Issue Debate

Medicinal Products

9:42 am

Photo of Neale RichmondNeale Richmond (Dublin Rathdown, Fine Gael) | Oireachtas source

Just to clarify, it is an ever-changing issue. Unfortunately, there are situations like this with drugs and many different treatments all the time. The Minister of State deals with these issues on a daily basis, as does the Minister for Health. The situation, in this case, is that because of the nature of the drug and the regulatory environment with the European Medicines Agency, there is a requirement for patients to get a prescription from their GP, but they need to have a consultation with a consultant first.

I note and welcome the Minister of State's comments. I hope, following engagement with the stakeholders, we can find an opportunity to provide timely treatment for the 1% to 2% of pregnant women who suffer from this debilitating condition. I highlight that the HSE has discretion in the area of exceptional patient-specific processes. We have seen it in the implementation and roll-out of other drugs for many other illnesses. It is about getting around the system of waiting for EMA regulatory approval. We saw it with Covid vaccines and we have seen it with many other medicines. The important point is that the condition is extremely time-sensitive. Women do not know if they are going to get hyperemesis gravidarum before they get pregnant. Often, the patient does not present with symptoms until the eighth or ninth week of pregnancy. There is a need to work quickly to treat the condition, so having to attend a consultant appointment not only delays treatment by up to four weeks but imposes a major cost on the women who simply have to get access to this drug. I ask the Minister of State, when she goes back to the Minister or, more pertinently, the HSE, to ensure that a system is put in place whereby there is no requirement for women to attend a consultant appointment in order to get a reimbursement. They should be able to get access to the drug through a GP because this is a time-sensitive exceptional need. I think all of us agree that Cariban is recognised as a safe drug. It is seen as such. We must ensure we put in place the process to get ahead of the delay on a wider regulatory matter.

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