Dáil Éireann Debate, Tuesday - 12 June 2018
597. Deputy Thomas P. Broughan asked the Minister for Health if he will engage with an organisation (details supplied) and the pharmaceutical industry to ensure that all new life-changing medicines are made available to persons with MS in a timely manner; and if he will make a statement on the matter. [24349/18]
View answer689. Deputy Michael McGrath asked the Minister for Health the position on the approval of new medicines for persons with multiple sclerosis; his plans for reforms to address delays in this area; and if he will make a statement on the matter. [24696/18]
View answer765. Deputy Éamon Ó Cuív asked the Minister for Health the medicines not available to persons suffering from multiple sclerosis that are available in other EU member states; the reason for this; the engagement he plans to have with an organisation (details supplied), other EU states and the pharmaceutical industry to ensure that the drugs are available and licensed here and covered by the GMS scheme; and if he will make a statement on the matter. [25040/18]
View answer781. Deputy Jan O'Sullivan asked the Minister for Health the way in which he plans to address the wait time for drugs to be approved for persons with MS; if he will engage with an organisation (details supplied) and the pharmaceutical industry to ensure new medicines are available to persons with the condition; and if he will make a statement on the matter. [25118/18]
View answer814. Deputy Sean Fleming asked the Minister for Health if his Department will engage with an organisation (details supplied) and the pharmaceutical industry to ensure that new medicines are available to persons with multiple sclerosis; and if he will make a statement on the matter. [25231/18]
View answerI propose to take Questions Nos. 597, 689, 765, 781 and 814 together.
The HSE has statutory responsibility for medicine pricing and reimbursement decisions, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. As Minister for Health, I do not have any statutory power or function in relation to the reimbursement of medicines. The Act specifies the criteria for decisions on the reimbursement of medicines.
In line with the 2013 Act, if a company would like a medicine to be reimbursed by the HSE pursuant to the Community Drugs scheme, the company must first submit an application to the HSE to have the new medicine added to the Reimbursement List.
As outlined in the IPHA agreement, 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 either add the medicine to the reimbursement list or agree to reimburse it as a hospital medicine, or refuse to reimburse the 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 (HTAs) 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 on-going basis. This can lead to a protracted deliberation process.
I am keen to engage with Industry and to explore ways in which new medicines might be more easily introduced in Ireland. However, any innovative approaches that may be tabled must be compatible with the statutory provisions which are in place and must also recognise the fundamental pricing/funding issues in the context of finite Exchequer resources.
I have indicated willingness to meet with MS Ireland and my office is in contact with the organisation to arrange a mutually convenient date.
