I propose to take Questions Nos. 1283 and 1301 together.
The timely and sustainable access to new medicines is a priority for Government. As the Deputy is aware, the Oireachtas put in place a robust legal framework, in the Health (Pricing and Supply of Medical Goods) Act 2013, to give full statutory powers to the HSE to assess and make decisions on reimbursement of medicines, taking account of a range of objective factors and expert opinion as appropriate. These include the clinical and cost effectiveness of the product, the opportunity cost, the potential or actual budget impact, and the impact on resources that are available to the HSE.
By assessing medicines in this manner, we help ensure that the finite resources of our heath service are used most effectively. This process can lead to protracted negotiation processes with pharmaceutical companies but this is necessary to ensure that the HSE can provide access to as many new innovative treatments as possible to patients in Ireland.
The legislative underpinning of the Health Act is backed up by the Framework Agreement on the Supply of Medicines 2016-2020 signed between the State and the Irish Pharmaceutical Healthcare Association (IPHA). It is expected to deliver approximately €600 million in savings from IPHA companies over the four year lifetime of the Agreement and €150 million in savings from non-IPHA companies.
This Agreement contains a number of measures intended to increase sustainable drug access and supply, including setting prices relative to those in over half of EU member states, reviewing prices annually against the reference countries to achieve better value for money over a product’s lifetime and formal health technology assessment of new treatments to inform reimbursement decision making.
The combination of the legislation and the Framework Agreement is in essence the national medicines strategy of the State.
The issue of access and affordability of new medicines is one shared by public health systems across the globe. Over the past number of years, my officials and I have been engaging with a number of voluntary EU forums in an effort to identifying solutions to these key issues.
In June 2018, I signed the Beneluxa Initiative on Pharmaceutical Policy to work 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.
Domestically my Department and the HSE are actively working on making greater efficiencies in medicines usage through a range of initiatives across the health service. This will free up existing resources to invest in new medicines in the future.