I propose to take Questions Nos. 607 and 608 together.
The use of biotechnology in the pharmaceutical field has led to the development of many new biological medicines, offering new treatments for a range of serious illnesses.
The manufacturing of a biological medicine is a complex process. Biosimilar medicines are similar but not identical to their reference biological medicines, and therefore are not considered in the same way as generic medicines. Under the Heath (Pricing and Supply of Medical Goods) Act 2013, biosimilars are not considered to be interchangeable, and therefore cannot be substituted for biological medicines.
It is likely that the use of biosimilar medicines will grow in Ireland in the coming years as the patents on biological medicines expire. However, promoting the increased use of biosimilar medicines must be carefully considered, and issues such as prescribing practices around biosimilars are currently under consideration by the Department.
The Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement of medicinal products under the community drug schemes in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013; therefore, the specific questions raised by the Deputy have been referred to the HSE for attention and direct reply.
If you have not received a reply from the HSE within 15 working days, please contact my Private Office and they will follow up the matter with them.