Róisín Shortall (Dublin North West, Social Democrats)
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209. To ask the Minister for Health if his attention has been drawn to a recent article (details supplied); the rationale behind the 30% clause within the drug pricing agreement; the way this clause was negotiated; his views on concerns raised by the healthcare enterprise alliance in June 2016; and if he will make a statement on the matter. [6595/17]

Róisín Shortall (Dublin North West, Social Democrats)
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210. To ask the Minister for Health the steps he is taking to encourage prescription of generic and biosimilars when there are equivalent drugs on the market at less than 30% lower cost; and if he will make a statement on the matter. [6596/17]

Simon Harris (Wicklow, Fine Gael)
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I propose to take Questions Nos. 209 and 210 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, offering opportunities for the State to make further savings on the cost of medicines. The 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.

This component of the Agreement was considered in detail by the State negotiating team. The State team’s view, which was confirmed by our international consultants, was that this provision strikes the appropriate balance between reducing the originator price and enticing new entrants into the market.

Officials in my Department are currently assessing the whole area of biosimilar medicines and are developing a national biosimilar policy. This will require consideration of a range of regulatory, patient safety and health policy issues as well as an examination of 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.