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 thoroughly assessing medicines in this manner, we help ensure that the finite resources of our heath service are used in the most effective manner. This process can lead to protracted negotiations with pharmaceutical companies but is necessary to ensure that the HSE can provide access to as many new innovative treatments as possible to patients in Ireland.
My Department and the HSE are working on making greater efficiencies in medicines usage through a range of initiatives both internationally and domestically to ensure the greatest possible access to new treatments for patients in Ireland.
These new measures are expected to complement existing cost control initiatives which are being undertaken by the HSE under the auspices of the Medicines Management Programme. Among the initiatives already being pursued are improvement in practices for the procurement of drugs in hospitals and the designation of preferred products, with a focus on high cost prescribing areas.
The HSE is also strengthening its pharmacy resourcing capacity in order to target particular areas, such as biosimilars. To date substantial progress has been achieved in increasingly biosimilar prescribing rates in acute hospitals. The HSE is working on identifying barriers to the prescribing of biosimilars with a specific focus on education and supports. It is seeking to increase understanding of biosimilars through targeted presentations to clinicians and hospitals.
In spite of significant progress on drug costs achieved from reference pricing and the price reductions under the IPHA Agreement, the Health Service is still facing significant challenges in relation to the affordability of medicines – mainly related to the emergence of increasing numbers of very expensive products, particularly in the high-tech medicines area.
In that regard, I and officials have been engaging over the past number of years, with a number of voluntary EU forums. In June 2018, I signed the Beneluxa Initiative on Pharmaceutical Policy. 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. Members of the Beneluxa Initiative will work closely together to identify pragmatic solutions to the challenges which we all now face with medicine pricing, sustainability and supply.