Seán Fleming (Laois, Fianna Fail)
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626. To ask the Minister for Health the position regarding his engagement with an organisation (details supplied) and the pharmaceutical industry to ensure new medicines are made available to persons with multiple sclerosis, MS; and if he will make a statement on the matter. [35643/18]

Niamh Smyth (Cavan-Monaghan, Fianna Fail)
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643. To ask the Minister for Health if changes to the market access system will be reviewed for new drugs (details supplied); and if he will make a statement on the matter. [35695/18]

Róisín Shortall (Dublin North West, Social Democrats)
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733. To ask the Minister for Health the actions he has taken to improve drug approval times for medicines associated with the treatment of multiple sclerosis; the further actions he will take to reduce the waiting times faced by persons to access new medicines; and if he will make a statement on the matter. [35934/18]

Simon Harris (Wicklow, Fine Gael)
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I propose to take Questions Nos. 626, 643 and 733 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. 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 the reimbursement of medicines.

In line with the 2013 Act, if a company would like a medicine to be reimbursed by the HSE through the community drugs schemes, it must first submit an application to the HSE to have the new medicine added to the reimbursement list.

As outlined in the 2016 Framework Agreement with the Irish Pharmaceutical Healthcare Association (IPHA), 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), whether to add the medicine to the reimbursement list, agree to reimburse it as a hospital medicine, or refuse to reimburse it.

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 context of finite Exchequer resources.

I have indicated a willingness to meet with MS Ireland and my office is in contact with the organisation to arrange a mutually convenient date.