Written answers

Tuesday, 10 October 2017

Department of Health

Generic Drugs Substitution

Photo of John BrassilJohn Brassil (Kerry, Fianna Fail)
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400. To ask the Minister for Health the timeframe for the publication and implementation of a new national biosimilar policy in view of the fact that the public consultation for same has now closed; and if he will make a statement on the matter. [42994/17]

Photo of John BrassilJohn Brassil (Kerry, Fianna Fail)
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402. To ask the Minister for Health his views on the introduction of prescribing quotas for biosimilars and-or gain share schemes for hospitals to increase usage of biosimilars, as recommended by leading biosimilar manufacturers; the measures which have been introduced to increase their usage; and if he will make a statement on the matter. [43000/17]

Photo of Simon HarrisSimon Harris (Wicklow, Fine Gael)
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I propose to take Questions Nos. 400 and 402 together.

Medicines play a vital role in improving the overall health of Irish patients. Securing access to new and innovative medicines, in a timely manner, is a key objective of the Irish health service. However, the challenge is to deliver this objective in an affordable and sustainable way.

To this end the IPHA Agreement included a specific provision in regards to biosimilar medicines whereby biological medicines receive an automatic reduction of 30% when a biosimilar equivalent comes to the market. The HSE included a savings target of €148m in the National Service Plan 2017 for drug related savings arising from the agreement and the launch of a biosimilar for Embrel in 2016.

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.

The public consultation for this policy was closed on 29 September and my officials are currently examining the 30 responses in depth.

Having performed research on international best practice as part of the policy development process, my Department will now begin the developing an appropriate policy framework to increase the usage of biosimilar medicines in Ireland. This will include an examination of the initiatives outlined by the Deputy.

I expect this policy to be published in early 2018.

Photo of John BrassilJohn Brassil (Kerry, Fianna Fail)
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401. To ask the Minister for Health if he has satisfied himself with the level of uptake of biosimilars here; the percentage usage and or market share of each biosimilar available here relative to its biologic equivalent; if not, the reason this data is not tracked; and if he will make a statement on the matter. [42999/17]

Photo of Simon HarrisSimon Harris (Wicklow, Fine Gael)
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The HSE has statutory responsibility for the operation and the administration of the community drug schemes, therefore, the matter has been referred to the HSE for reply to the Deputy.

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