Colm Burke (Cork North Central, Fine Gael) | Oireachtas source

The Mazars report was commissioned in 2018 and completed and furnished to the Department of Health in January 2020.Three years later, it has not been published. The report arose as a result of the 2018 examination by the health committee, of which I was a member, of the roll-out of orphan drugs and the delaying process that is in place. The health committee's report set out 15 recommendations. The Acting Chair, Deputy Durkan, and I are the only two members of the committee that produced the report in 2018 who are still on the committee. It is disappointing that the Mazars report has still not been published.

We have a problem in Ireland in that it takes, on average, 789 days from the time a drug for a rare disease is approved at European level to the time it is approved here. The average across Europe is 587 days. In Germany, it is 79 days and in Denmark, which is similar in size to Ireland, it is 274 days. We need to publish the Mazars report and make it available. We need to change the whole system to fast-track the roll-out of drugs for children or adults with rare diseases. The process has dragged on for too long. We need to look at other countries. In Scotland, the process for making available the drugs that people require, especially people with rare diseases, works very well. In some cases, there may be only ten, 15 or 20 people in the entire country who require a drug but it is an important part of the care and treatment they require. We seem to be stalling the whole process because although the drug will have been approved at European level, we go through a whole process all over again and the drug is not made available as a result. The 2018 report of the health committee made 15 recommendations, including the following:

The Committee recommends that the Department of Health engage with stakeholders, and in particular with patients during the drafting process of its review. The views of patients are vital to ensuring that the process benefits those in need of orphan drugs... The Committee recommends that the evaluation process for orphan drugs be fit for purpose.

The process is not fit for purpose and it is time it was reviewed and fast-tracked. Why do we have a scenario where a drug is approved at European level and more than 700 days later, that same drug may not be available in this country? This is hugely frustrating, especially for parents of young children who are waiting for long periods without a decision being made. I know there is a bargaining process in relation to price. It is sad that drugs bring produced in this country by manufacturers based here are not available for the people who require them. It is time we published the report and set about reforming the current system.

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