Alan Kelly (Tipperary, Labour)
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178. To ask the Minister for Health if a rebate scheme formed part of the previous medicine pricing agreement, agreed between his Department and the Irish Pharmaceutical Healthcare Association, which applied up to November 2015; if so, the way in which this rebate scheme was applied and operated; the total revenues which were generated by these rebates over the lifetime of the agreement; the amounts raised during each year of the agreement; the way in which these moneys were collected; and if he will make a statement on the matter. [35286/16]

Simon Harris (Wicklow, Fine Gael)
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Under Clause 9 of the 2012 Framework Agreement on the Supply and Pricing of Medicines there is a rebate of 4% of the value of all medicines dispensed in the GMS and community drugs schemes. No rebate was payable in respect of those medicines covered by Clause 6 'Patent Expired Medicines' of that Agreement.

A full copy of the Agreement is available at: .

As the HSE was responsible for the implementation of that Agreement, I have asked them to reply directly to the Deputy on the other matters he has raised.

Alan Kelly (Tipperary, Labour)
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179. To ask the Minister for Health the way in which the rebate scheme which forms part of the current medicine pricing agreement, agreed between his Department and the Irish Pharmaceutical Healthcare Association, will apply and be operated; the total revenues which his Department anticipates will be generated by these rebates over the lifetime of the agreement; the amounts expected to be raised each year of the agreement by this rebate scheme; the way in which these moneys will be collected; if he will publish the details of same at the end of each year; and if he will make a statement on the matter. [35287/16]

Simon Harris (Wicklow, Fine Gael)
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The estimated value of the rebate, calculated under Clause 9 the Agreement, is €300 million. A copy of the Agreement is available at: .

The breakdown of the amounts expected to be raised each year are set out in the table below.

*Rounded to the nearest €5m

My Department, in consultation with the HSE and the Department of Public Expenditure and Reform, are currently monitoring the implementation of the Agreement and associated savings, and will give consideration to the publication of the savings achieved on a yearly basis.

The issues in relation to the application of the rebate and its collection across PCRS and hospitals has been referred to the HSE to respond directly to the Deputy, as this is an operational matter.

Alan Kelly (Tipperary, Labour)
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180. To ask the Minister for Health the way in which the HSE charges and calculates rebates for biosimilar drugs that are approved and for sale in the market; and if he will make a statement on the matter. [35288/16]

Simon Harris (Wicklow, Fine Gael)
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Details of the level of rebates and medicines to which it applies are set out in the new Framework Agreement on the Supply and Pricing of Medicines 2016-2020. The Agreement is available at:

.

The issue in relation to the calculation of the rebate by the Primary Care Reimbursement Service and hospitals has been referred to the HSE to respond directly to the Deputy as this is an operational matter.