John Lahart (Dublin South West, Fianna Fail)
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279. To ask the Minister for Health the reason persons with multiple sclerosis have access to new medicines within weeks or months in many European countries but patients here can wait over four years for new medicines to be made available (details supplied); the reason for slower approval for new medicines here; the steps he is taking to ensure access is expedited; and the date same will be achieved. [48648/19]

Simon Harris (Wicklow, Fine Gael)
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The HSE has statutory responsibility for medicine pricing and reimbursement decisions, under the Health (Pricing and Supply of Medical Goods) Act 2013. The Act specifies criteria for decisions on the reimbursement of medicines.

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). The NCPE conducts health technology assessments (HTAs) for the HSE and makes recommendations on reimbursement to assist HSE decisions 

As a country, we invest heavily in medicines, to the tune of almost €2 billion annually. As of October 2019, there have been 29 new medicines and 5 new indications for existing medicines approved for reimbursement in the public healthcare system. The approvals to date represent an additional investment by the HSE over five years of approximately €220m in providing access to new and innovative treatment for Irish patients. It is expected that over 3,000 patients will benefit from access to these new medicines over the next 5 years 

Notwithstanding the significant progress on drug costs achieved from price reductions under the pricing framework agreed with industry 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. "League tables" comparing speed of reimbursement in Ireland with that of other countries are often misleading since several countries have quite different and often less rigorous assessment arrangements than Ireland. Furthermore, many of the newer products being licenced are falling well short of cost-effectiveness thresholds, with limited clinical benefits. 

The current process for assessing applications works very well where the new medicines have strong evidence of clinical effectiveness and are priced in a cost-effective manner. Delays in reimbursement decisions for new products do occur in cases where the evidence of clinical effectiveness is weak, and where prices are set well outside of cost effectiveness parameters. 

The HSE strives to reach a decision in as timely a manner as possible. However, because these commitments are often multi-million euro investments on an on-going basis, it must ensure that the best price is achieved. This can lead to a protracted negotiation and deliberation process. 

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. These measures include 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.