Written answers

Wednesday, 18 January 2023

Department of Health

Medicinal Products

Photo of Mary Lou McDonaldMary Lou McDonald (Dublin Central, Sinn Fein)
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1689. To ask the Minister for Health if his attention has been drawn to reports that the Health Service Executive is not meeting is obligations as set out in section 18 of the Health (Pricing and Supply of Medical Goods) Act 2013 and that this failure is leading to shortages in supply of commonly-used generic pharmaceutical products; and if he will make a statement on the matter. [2190/23]

Photo of Stephen DonnellyStephen Donnelly (Wicklow, Fianna Fail)
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As this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.

Photo of Mary Lou McDonaldMary Lou McDonald (Dublin Central, Sinn Fein)
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1690. To ask the Minister for Health if he will consider a legislative measure, even on a temporary basis, to reduce the 180-day decision timeframe as set out in section 18 of the Health (Pricing and Supply of Medical Goods) Act 2013 for commonly used generic pharmaceutical products to address the current acute shortage of such drugs; and if he will make a statement on the matter. [2191/23]

Photo of Stephen DonnellyStephen Donnelly (Wicklow, Fianna Fail)
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The HSE has statutory responsibility for medicine pricing and reimbursement decisions, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. The Act specifies the criteria for decisions on the reimbursement of medicines. As Minister for Health, I do not have any statutory power or function in relation to reimbursement of medicines.

Under the 2013 Act, if a company wishes to have a medicine reimbursed through the community drugs schemes, it must submit an application to the HSE to have the medicine added to the Reimbursement List.

As outlined in the 2021 Framework Agreements on the Supply and Pricing of Medicines, and in line with the 2013 Act, the HSE will decide, within 180 days of receiving the application (or a longer period if further information is sought from the company), to add the medicine to the reimbursement list, agree to reimburse it as a hospital medicine or refuse to reimburse it. As part of a pricing and reimbursement application for generic and biosimilar medicines, there are already dedicated reimbursement mechanisms in the 2021 agreements. Reimbursement is automatically approved, provided the pricing is in line with the generic and biosimilar (and hybrid) pricing framework/agreements. The pricing of such medicines is linked to the price of the originator or patented medicine.

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 for the HSE, and makes recommendations on reimbursement to assist HSE decisions. The NCPE uses a decision framework to systematically assess whether a drug is cost-effective as a health intervention.

The HSE strives to reach a decision in as timely a manner as possible. However, because of the significant monies involved, it must ensure that the best price is achieved, as these commitments are often multi-million-euro investments on an ongoing basis. This can lead to a protracted deliberation process.

I am keen to explore ways in which new medicines might be more easily available for public patients in Ireland, but innovative approaches must be compatible with the statutory provisions in place and must also recognise fundamental pricing and funding issues, in the context of finite Exchequer resources.

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