Bernard Durkan (Kildare North, Fine Gael)
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579. To ask the Minister for Health the extent to which he can expedite access and reimbursement for new and orphan medicines with particular reference to an accelerated programme for testing and make such medicines available to the public as soon as it is safe to do so; if the new drugs targeting particular conditions can be made available sooner subject to the necessary tests; and if he will make a statement on the matter. [62795/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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The Health (Pricing and Supply of Medical Goods) Act 2013 gives full statutory powers to the HSE to assess and make decisions on the reimbursement of all medicines taking account of a range of objective factors, clinical benefits, cost effectiveness and expert opinion as appropriate.

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 HSE Drugs Group is the national committee which the HSE has in place to make recommendations on the pricing and reimbursement of medicines. The role of the Drugs Group is to make a recommendation to the HSE Executive Management Team (EMT) in relation to each individual application having considered the criteria under the 2013 Act.

The Drugs Group considers the NCPE assessment, the outputs from commercial engagements, patient interest group submissions, any inputs provided by the Rare Disease Technology Review Committee (RDTRC) and any other pertinent information in advance of providing its recommendation to the HSE EMT.

As the decision-making authority within the HSE, the HSE EMT decides on the basis of all the demands with which it is faced (across all services) whether it can fund a new medicine, or new uses of an existing medicine, from the resources that have been provided to it in line with the 2013 Act.

The HSE strives to reach reimbursement decisions on all medicines, including orphan drugs, in as timely a manner as possible. However, it must ensure that the best possible price is achieved, as these commitments often represent multimillion-euro investments on an ongoing basis. This can lead to a protracted deliberation process.

The 2013 Health Act does not include provision for a different ruleset when assessing orphan medicines. However, the criteria that apply to the evaluation process allow the HSE to have particular regard for the unique circumstances surrounding orphan drugs, such as small patient populations and unmet clinical need.

In fact, fifteen of the forty-three new medicines approved by the HSE in 2021 (up to 12 November) were orphan medicines. That represents over one third of approvals this year.

The budget allocation of €30m funding for new medicines in Budget 2022 will provide for the reimbursement of both orphan and non-orphan new medicines.

I am prepared to consider any ideas or proposals that might improve on our existing pricing and reimbursement assessment processes, including those with the aim of providing access for Irish patients to orphan medicines.