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Dáil
‹ Questions on Promised Legislation

Biosimilar medicines access

Summary

John Brassil called for legislation to allow biosimilar products to compete more fully with biological medicines and to be made interchangeable. The Taoiseach said he was not sure legislation was needed and would ask the Health Minister to contact the Deputy.

My colleague, Deputy Billy Kelleher, via a Private Members' Bill in 2013, raised the issue of the need to change legislation to allow for the use of biosimilar products to compete with biological medicines. Ireland is probably bottom of the class in dealing with this issue. There are 28 products available in the European Union, of which Ireland only allows the use of 11. We need to change the legislation to allow biosimilar products to compete. We need to take them off the list of medicines which are not interchangeable. Physicians are currently not allowed to interchange. Physician-led interchangeability is also not allowed. One example is a product called Enbrel which is used in the treatment of arthritis. In August 48,000 boxes of Enbrel were dispensed. There is a biosimilar product available called Benepali, of which only 56 boxes were dispensed in the same timeframe. There are huge savings to be made. We discussed the product Translarna this morning and Respreeza yesterday. There are millions of euro to be saved if we act on this issue. A simple change to the legislation would help to bring such savings about. I ask the Taoiseach to activate it immediately to enable us to access the products we currently cannot access.

Comment on this
Leo Varadkar The Taoiseach Fine Gael

I am not sure legislation is required in this area. I would have to check that with the Minister for Health. I understand we use some biosimilars but I will ask the Minister for Health to contact the Deputy directly.

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