Colm Burke (Fine Gael) | Oireachtas source

I wish to raise the issue of orphan drugs and rare diseases. Approximately 370,000 people in Ireland are affected one way or another by rare diseases but only 5% have a licensed treatment option. Our main problem relates to orphan drugs, namely, drugs that are made available, are still being worked on and are expensive to develop. Of the 148 orphan drugs available to people with rare diseases, only 53 have been licensed in Ireland. The number of these drugs available to people with rare diseases across Europe varies from 68 out of 148 in the UK to 133 out of 148 in Germany. I met people from the industry recently. The process in Ireland seems to be moving at a snail's pace.

People have complicated medical issues. Only ten people might be affected by a particular rare disease and they are trying to get access to a drug that would help them. From the time an application for approval is made, it takes on average two years for that drug to be approved. That is at least 50%, if not 60%, longer than any other successful drug licence application. The Minister must come to the House to determine what can be done to expedite this process. Why have we only 53 of the 148 available drugs when Germany has 133 available? Why is the process taking so long? We must examine this issue.

We made an agreement with the drug companies whereby the cost of pharmaceuticals was to be reduced by more than €600 million in a four-year timeframe. The idea was to use those savings to make orphan drugs available or to help pay for same. That does not seem to be occurring. We must expedite the issue and the delaying process should stop. We should approve the drugs and make them available for those who require them. Will the Leader ask the Minister to attend the House to address this issue and explain why approval for these products is taking so long?