Colm Burke (Fine Gael) | Oireachtas source

I thank the Minister of State for coming to the House and agreeing to respond to the issue I raised on orphan drugs. Yesterday, the health committee heard presentations from the HSE and the body which approves drugs under the reimbursement scheme. There were also presentations from other organisations which expressed their concerns about delays.

Orphan drugs are drugs for small groups of people who have rare diseases. The Minister of State was on the health committee with me and knows that there are over 6,000 rare diseases. There could be 20 or 25 people with a particular rare disease and the medication they require is what we mean by orphan drugs. Directly or indirectly, there are around 375,000 people affected because their child or relative has a rare disease so orphan drugs is a big issue.

Several organisations here have raised the delay in processing applications for drugs for approval under the reimbursement scheme. Some 148 different orphan medicines have been approved at European level. In Ireland, only 53 have received approval under the drugs reimbursement scheme. In England it is 68, it is 75 in Spain, 84 in Italy, 116 in France and 133 of the 148 have been approved for reimbursement in Germany. Those are big countries and so the market is quite big, so something that might affect 2,000 people in Germany might only affect 20 people in Ireland, so we are not in the same bargaining position.

I fully accept that all the processes in the HSE and the Department are complicated because we are dealing with pharmaceutical companies which are a powerful lobby group in their own way but the result is that people who need medication are left sitting there. The average timescale from the date of application for one of these orphan drugs to it becoming available under the reimbursement scheme is 23.6 months. That figure was worked out for me by the pharmaceutical companies.

I am asking the Minister that we could look at the mechanism for this assessment and that we try to put in place a procedure which can fast track it and deal with it in a far more efficient manner. I am not criticising anyone involved in this and I know it is a complicated area, made more complicated again by the number of people doing the assessment and the people who are producing the drugs. For instance, yesterday the health committee was told that there was one drug which, if given approval, will cost €1 million per annum per patient. That is the kind of money we are talking about at the higher end, but there are also many drugs at the lower end. We need to try to improve the processing mechanism and that is why I raise this matter.