The Health (Pricing and Supply of Medical Goods) Act 2013 contains provision for the establishment of a List of Interchangeable Medicinal Products whereby items can be substituted at pharmacy level. Biological medicines are not permitted to be added to this list.
The existence of this clause does not affect physician-led interchangeability of biological and biosimilar medicines. The Health Products Regulatory Authority (HPRA) guidelines on biosimilar medicines clearly support physician led switching advising that, any change should be made in consultation with the patient. Thus there is currently no need for legislative change in this area.
The National Biosimilar Medicines Policy is currently being drafted by my Department. The National Biosimilar Medicines Policy will aim to better position Ireland to benefit from current and future biosimilar medicines. The primary objective of the policy will be to increase biosimilar use in Ireland, by creating a robust framework in which biologicals and biosimilars can be safely, cost-effectively and confidently used in the health service.
Having performed research on international best practice as part of the policy development process, my Department will now begin developing an appropriate policy framework to increase the usage of biosimilar medicines in Ireland.
I expect this policy to be published in early 2018.
