Catherine Martin (Dublin Rathdown, Green Party)
Link to this: Individually | In context | Oireachtas source

445. To ask the Minister for Health the actions that have been taken to speed up access to new medicines after their authorisation by the European Commission; and if he will make a statement on the matter. [48099/18]

John Curran (Dublin Mid West, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

475. To ask the Minister for Health the steps he is taking to ensure that patients here have the same access to new medicines as patients throughout Europe; and if he will make a statement on the matter. [48318/18]

Simon Harris (Wicklow, Fine Gael)
Link to this: Individually | In context | Oireachtas source

I propose to take Questions Nos. 445 and 475 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 medicine reimbursement. As Minister for Health, I do not have any statutory power or function in relation to the reimbursement of medicines.

After receiving market authorisation and in line with the 2013 Act, a company which would like a medicine to be reimbursed by the HSE must submit an application for reimbursement approval.

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 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 the context of finite Exchequer resources. 

I am aware that, at the recent bi-annual meeting between my Department and the Irish Healthcare Pharmaceutical Association, this proposed dialogue was discussed. It is envisioned that this will take the form of a structured platform of engagement, building a stronger partnership between the State and industry to create better patient access to new treatments.

The challenge of securing affordable access to innovative medicines is not unique to Ireland. Over the past two years, my officials and I have been engaging with a number of voluntary EU forums in an effort to identify solutions to issues of medicine pricing, sustainability and supply.

On 22 June 2018, I signed the Beneluxa Initiative on Pharmaceutical Policy with Austria, Belgium, the Netherlands and Luxembourg. This Agreement is in line with my objective to work with other European countries to identify workable solutions, in an increasingly challenging environment, to secure timely access for  patients to new medicines in an affordable and sustainable way.

The Beneluxa Initiative will have an important role to play in securing faster access to innovative medicines and will provide important platforms to deliver the shared objective of securing access to high cost, innovative treatments at affordable prices.