John Lahart (Dublin South West, Fianna Fail)
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2087. To ask the Minister for Health the recommendations made in a report by a company (details supplied) in respect of the HSE's systems, structures, processes and governance for reimbursing medicines; and if he will make a statement on the matter. [19794/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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Following a tender by the Office of Government Procurement, Mazars conducted a review of the governance structures around the HSE's drug reimbursement process. The report was submitted to my Department in January 2020.

The review made recommendations in respect of the HSE’s systems, structures, processes, governance arrangements and use of specialist resources in respect of the drug reimbursement process.

The report was under consideration by officials earlier last year, however the focus of the Department of Health changed to the immediate public health considerations of the COVID-19 pandemic and the preservation of life. This meant that this work stream was temporarily suspended to reallocate resources to support essential services.

My Department aims to complete its consideration of the report’s recommendations in the near future.

John Lahart (Dublin South West, Fianna Fail)
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2088. To ask the Minister for Health his plans to place tailored processes for the reimbursement in Ireland of licensed cell and gene therapies given the transformational impact of these treatments on patients and given that the State is already paying for them under the treatment abroad scheme; and if he will make a statement on the matter. [19795/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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As the Deputy will be aware, the Oireachtas 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 reimbursement of medicines, taking account of a range of objective factors and expert opinion as appropriate.

In line with the 2013 Health Act and the national framework agreed with industry, a company must submit an application to the HSE to have a new medicine added to the reimbursement list.

Reimbursement is for licensed indications which have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority.

In making a relevant reimbursement decision, the HSE is required under the Act to have regard to a number of criteria including efficacy, the health needs of the public, cost effectiveness and potential or actual budget impact.

HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE). The NCPE conducts health technology assessments (HTAs) for the HSE and makes recommendations on reimbursement to assist HSE decisions. The NCPE uses a decision framework to systematically assess a drug's clinical and cost effectiveness as a health intervention.

While the 2013 Health Act does not include provision for a different ruleset when assessing cell and gene therapies, the criteria that apply to the evaluation process allow the HSE to take account of evidence of the benefits associated with each given medicine.