Michael Harty (Clare, Independent)
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397. To ask the Minister for Health if the evaluation process for orphan drugs has changed since the Oireachtas Joint Committee on Health published its report on evaluating orphan drugs in February 2018; and if he will make a statement on the matter. [31424/18]

Michael Harty (Clare, Independent)
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398. To ask the Minister for Health if a review of the Health (Pricing and Supply of Medical Goods) Act 2013 Act has been carried out to identify potential legislative barriers to the reimbursement of orphan drugs and recommended legislative amendments as appropriate; and if he will make a statement on the matter. [31425/18]

Michael Harty (Clare, Independent)
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399. To ask the Minister for Health his plans to appoint an independent academic with knowledge of pricing and reimbursement systems for orphan drugs to conduct a review of the current process of evaluation and its role in orphan drug availability here; and if he will make a statement on the matter. [31426/18]

Michael Harty (Clare, Independent)
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400. To ask the Minister for Health if a specific budget for orphan drugs has been established; and if he will make a statement on the matter. [31427/18]

Michael Harty (Clare, Independent)
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401. To ask the Minister for Health if the QALY process for assessing orphan drugs has been revised; and if he will make a statement on the matter. [31428/18]

Michael Harty (Clare, Independent)
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403. To ask the Minister for Health if arrangements have been made with other EU states to align the assessment processes for orphan drugs; and if he will make a statement on the matter. [31430/18]

Simon Harris (Wicklow, Fine Gael)
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I propose to take Questions Nos. 397 to 401, inclusive, and 403 together.

The Oireachtas has put in place a robust legal framework in the Health (Pricing and Supply of Medical Goods) Act 2013, which gives full statutory powers to the HSE to assess and make decisions on the reimbursement of medicines, taking account of a range of objective factors and expert opinion as appropriate. 

The 2013 Act requires the HSE to have regard to both the clinical benefits and cost effectiveness  but it does not include provision for a different rule set when assessing orphan drugs.  However, both the National Centre of Pharmacoeconomics (NCPE) and HSE are mindful of the differences and challenges in terms of patient numbers when assessing this type of medicine.

This rigorous assessment process ensures that treatments that are clinical and cost effective are reimbursed. In circumstances where a company has failed to demonstrate the clinical benefit to support the price that they are seeking for the drug, the HSE reaches a decision not to reimburse the medicine.

In February I received the Report on Evaluating Orphan Drugs from the Joint Committee on Health.  Currently my Department is examining the Committee's Report and its recommendations. The report raises some significant policy issues which require careful consideration by my Department, the HSE and the National Centre for Pharmacoeconomics.  This process is underway and once completed I will be in a position to report back to the Joint Committee.