John Curran (Dublin Mid West, Fianna Fail)
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436. To ask the Minister for Health the steps he has taken 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. [42113/19]

Simon Harris (Wicklow, Fine Gael)
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Attempts at comparing the speed of reimbursement in Ireland with other countries are often misleading since several countries have quite different and often less rigorous statutory assessment arrangements than Ireland. Furthermore, many of the newer products being licenced are falling well short of cost-effectiveness thresholds, with limited clinical benefits.  

As a country, we invest heavily in medicines, to the tune of almost €2 billion annually. In 2019 to date, the HSE has approved 29 new medicines and 5 new indications for existing medicines for reimbursement in the public healthcare system.    

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.  

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.  

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. 

I and officials 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.  It is a strategic long term project which allows the Beneluxa members to work closely together to identify pragmatic solutions to the challenges which we all now face with regards to medicine pricing, sustainability and supply.

Simon Harris (Wicklow, Fine Gael)
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Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for the administration of the community drug schemes; therefore, the matter has been referred to the HSE for attention and direct reply to the Deputy.