349. Deputy Thomas P. Broughan asked the Minister for Health if he will meet with representatives of an organisation (details supplied) and the pharmaceutical industry regarding access to new and effective medication for multiple sclerosis; and if he will make a statement on the matter. (Question 20039/18 asked on 08 May 2018)

Minister for Health (Deputy Simon Harris): 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 sets out criteria for decisions on reimbursement. 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 through the community drug schemes, it must submit an application to the HSE to have the new item 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 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 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 can be ongoing multi-million euro investments. Pricing issues 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 in place and must also recognise pricing and 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.