Ireland’s Department of Health is Requesting Comments Regarding its National Biosimilars Medicines Policy

Ireland’s Department of Health (the “Department”) recently reported on its website that it is “developing a National Biosimilar Medicines Policy to promote the use of biosimilar medicines and to create a sustainable environment for biological medicines in Ireland.”  The Department is now asking the public for its views regarding the use of biosimilars in Ireland.  In connection with its request, the Department published a Consultation Paper, titled National Biosimilar Medicines Policy, which discusses, among other things, the rationale behind the Policy, information regarding biologics and biosimilars, and international biosimilar medicine policies.  It states, for instance, that the Department is drafting the National Biosimilar Medicines Policy “in anticipation of the expiration of a number of biological patents over the next few years” and that the “policy will aim to increase biosimilar use in Ireland, by creating a robust framework in which biologicals and biosimilars can be safe, cost-effectively and confidently used in the health service.”  It also notes that while the European Medicines Agency has granted authorization for 28 biosimilars, only 11 biosimilars are currently available in Ireland.

The Consultation Paper asks the public to respond to specific questions regarding biosimilars.  For example, it asks “Before reading this consultation paper, were you aware of biosimilar medicines?”; “Do you think that pharmacy-led substitution of biosimilars should be implemented in Ireland?”; and “Considering what has been seen in other countries, should incentives and/or disincentives be used in Ireland to increase the uptake of biosimilars?”

The consultation period for the National Biosimilars Medicines Policy closes at 6 pm Friday, September 22, 2017.  Submissions will then be published on Ireland’s Department of Health website.