Pat Deering (Carlow-Kilkenny, Fine Gael) | Oireachtas source

I thank the Ceann Comhairle for choosing this topic. The availability of orphan drugs has come to my attention and has been mentioned many times in this House recently. Orphan drugs are drugs specifically designed to diagnose or prevent life-threatening or chronically debilitating rare diseases. An increasingly common issue in Ireland is that drugs fail to secure reimbursement from the HSE. Many of these drugs are available around Europe. In most cases, Ireland is the only country that does not have these drugs available. While not every orphan drug proposed to the State would represent a workable agreement, there are growing discrepancies in availability and barriers to providing the latest medicines available to cure these rare diseases.

While there has been a rare disease plan in place in Ireland since 2014, and the Joint Committee on Health has been dealing with this regularly, there appears to be a breakdown in communications. It is caught between two stools. The HSE has statutory responsibility for the pricing of medicines. However, the HSE is governed by a policy set by the Government through the Health (Pricing and Supply of Medical Goods) Act 2013. The drugs seem to be falling through these two cracks and one does not seem to know how to handle the other. A framework exists whereby the State and industry agree a timeframe but unfortunately we are left with a slow, cumbersome situation. The child who may have a difficult diagnosis or who has a disease who is waiting to be cured could unfortunately have passed away by the time the medicine is made available, which is difficult for the family, especially if it is a child.

Will the Minister of State look at this again and whether the process of making these drugs available could be more streamlined if they are suitable? They should not go through this protracted and drawn-out process whereby the child or person might be diagnosed today and the drug may not be made available for a couple of years. The only way to deal with a particular diagnosis is to give care and attention efficiently and quickly. It is important that we have a fast-track approach to this issue. A number of issues have been debated over a period in this House. Different drugs have become available around Europe but not here in Ireland. That must be addressed. We should be on the same playing field as everybody else. If somebody gets sick in Ireland and the drug has to be available here, that person should not have to go elsewhere to avail of it or to cure the illness he or she may have. Could the system be changed to make it more user-friendly so that the process of this drug being approved and reimbursed by the HSE and Government can be fast-tracked to make sure that the person who requires this medicine can get it when he or she wants it?

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