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.
In line with the 2013 Act and the national framework agreed with industry, if a company would like a medicine to be reimbursed by the HSE, the company must submit an application to the HSE to have the new medicine added to the reimbursement list. Reimbursement is for licenced indications which have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority.
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).
As a country, we invest heavily in medicines, to the tune of almost €2 billion annually. In 2019 to date, the HSE has approved 36 new drugs and newly licensed indications for existing drugs for reimbursement in the public healthcare system.
Notwithstanding the significant progress on drug costs achieved from price reductions under the IPHA Agreement and commercial negotiations conducted by the HSE, the Health Service is still facing very significant challenges in relation to the affordability of medicines. The industry continues to develop very expensive products, particularly in the high-tech medicines area and the costs involved are a challenge for health systems even in countries with much greater resources than Ireland. The Government wants new and innovative medicines to be available to our citizens as quickly as possible but this can only be achieved if medicines are priced by the pharmaceutical industry in a viable and sustainable manner.
My Department and the HSE are working on making greater efficiencies in medicines usage through a range of initiatives both domestically and internationally to ensure the greatest possible access to new treatments for patients in Ireland.
The HSE’s Medicines Management Programme (MMP), incorporating the Preferred Drugs initiative, is overseeing the implementation of a number of actions to bring about greater value for the taxpayer through cost-effective provision of medicines. Among the initiatives being pursed are improvements in practices for the procurement of drugs in hospitals and the designation of preferred products with a focus on high-cost prescribing areas, in particular optimising the use of biosimilars.
Department officials and I have also 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. In June 2019, Ireland became a Founding Member of the International Horizon Scanning Initiative which is being established as part of the work programme of Beneluxa.