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, offering opportunities for the State to make further savings on the cost of medicines. The recently signed Framework Agreement on the Supply and Pricing of Medicines 2016-2020 with the Irish Pharmaceutical Healthcare Association includes a provision to take advantage of these new developments in the pharmaceutical industry. Under the new Agreement the price of a biologic medicine will be reduced by 20% and an additional rebate of 12.5% provided upon entry into the market of a biosimilar.
Officials in my Department are currently assessing the whole area of biosimilar medicines and are developing a national biosimilar policy. It is intended that this policy will examine different policy levers and tools that might be implemented in Ireland in order to increase the uptake of biosimilars in the health system in the coming years.
My officials will be working with the Health Products Regulatory Authority and the HSE to progress this agenda and will also examine the need for any legislative changes in this area. It is useful to note that the HSE's Medicines Management Programme issued a position paper last year supporting the appropriate introduction of biosimliars into clinical use in Ireland.
In relation to savings generated from the use of biosimilars I have asked the HSE to reply to the Deputy on this matter.
