Ireland Lags Behind the Rest of Europe in Approving Rare Disease Drugs

According to a story from The Irish Times, a recent report issued by the Irish Pharmaceutical Healthcare Association (IPHA) indicates that Ireland trails many other European countries in approving new therapies for rare diseases as of the end of 2018. This is in spite of the fact that many of the most recently introduced drugs offer real advantages over older ones. The report shows that under a third of the rare disease therapies that are approved on other parts of Europe, such as Germany and the UK, are available to Irish citizens.

Falling Behind

In the report, the IPHA ranks different nations in western Europe by how many rare disease therapies they have approved. Ireland was well behind many other EU countries in the west, including Austria and Italy. However, the authors also iterated that there have been some companies that have yet to apply for regulatory approval in the country for selling their drugs. Since Ireland has a relatively small population, the limited size of the market may be a cause for hesitation. The limited patient population also keeps the prices of most rare disease drugs high.

The tragic result is that many rare disease patients from Ireland have significant difficulty accessing the treatments that can help them when there is one that is available. Considering the great cost of these drugs and the possible need to travel in order to obtain them, the expenses heaped on rare disease families in Ireland can be unbearable. In order to receive good care these barriers to treatment will have to be addressed.

Bringing Rare Disease Drugs to Ireland

Clearly something needs to be done in order to get more rare disease drugs on the market in Ireland and encourage drug companies to apply there. Perhaps and incentive-type program similar to the FDA’s Orphan Drug designation would be useful in Ireland. Such a program could make it easier and less expensive for rare disease drugs to get approved there and companies could be tempted with rewards such as market exclusivity periods.


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