Dáil debates

Wednesday, 12 December 2018

Saincheisteanna Tráthúla - Topical Issue Debate (Resumed)

Medicinal Products Availability

5:10 pm

Photo of Pat DeeringPat Deering (Carlow-Kilkenny, Fine Gael)
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I thank the Ceann Comhairle for choosing this topic. The availability of orphan drugs has come to my attention and has been mentioned many times in this House recently. Orphan drugs are drugs specifically designed to diagnose or prevent life-threatening or chronically debilitating rare diseases. An increasingly common issue in Ireland is that drugs fail to secure reimbursement from the HSE. Many of these drugs are available around Europe. In most cases, Ireland is the only country that does not have these drugs available. While not every orphan drug proposed to the State would represent a workable agreement, there are growing discrepancies in availability and barriers to providing the latest medicines available to cure these rare diseases.

While there has been a rare disease plan in place in Ireland since 2014, and the Joint Committee on Health has been dealing with this regularly, there appears to be a breakdown in communications. It is caught between two stools. The HSE has statutory responsibility for the pricing of medicines. However, the HSE is governed by a policy set by the Government through the Health (Pricing and Supply of Medical Goods) Act 2013. The drugs seem to be falling through these two cracks and one does not seem to know how to handle the other. A framework exists whereby the State and industry agree a timeframe but unfortunately we are left with a slow, cumbersome situation. The child who may have a difficult diagnosis or who has a disease who is waiting to be cured could unfortunately have passed away by the time the medicine is made available, which is difficult for the family, especially if it is a child.

Will the Minister of State look at this again and whether the process of making these drugs available could be more streamlined if they are suitable? They should not go through this protracted and drawn-out process whereby the child or person might be diagnosed today and the drug may not be made available for a couple of years. The only way to deal with a particular diagnosis is to give care and attention efficiently and quickly. It is important that we have a fast-track approach to this issue. A number of issues have been debated over a period in this House. Different drugs have become available around Europe but not here in Ireland. That must be addressed. We should be on the same playing field as everybody else. If somebody gets sick in Ireland and the drug has to be available here, that person should not have to go elsewhere to avail of it or to cure the illness he or she may have. Could the system be changed to make it more user-friendly so that the process of this drug being approved and reimbursed by the HSE and Government can be fast-tracked to make sure that the person who requires this medicine can get it when he or she wants it?

Photo of Jim DalyJim Daly (Cork South West, Fine Gael)
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I thank Deputy Deering for raising this issue. I appreciate that a rare disease diagnosis places enormous stress on patients and their families and, as Deputy Deering is aware, access to potentially beneficial medicines for the treatment of rare diseases is extremely important for patients and their families.

I want to assure Deputy Deering that the Minister for Health works tirelessly to address issues around access for patients to new and innovative medicines. The Oireachtas has put in place a robust legal framework in the Health (Pricing and Supply of Medical Goods) Act 2013, which gives statutory powers to the HSE to assess and make decisions on the reimbursement of medicines, taking account of a range of objective factors and expert opinion, as appropriate. The Act specifies the criteria to be applied in the making of reimbursement decisions, to include the clinical and cost effectiveness of the product, the opportunity cost and the impact on resources that are available to the HSE.

While the 2013 Health Act does not include provision for a specific rule set when assessing orphan drugs, the HSE and the NCPE seek to take into account issues such as patient numbers and the nature of the condition to be treated when evaluating these medicines. The criteria that apply to the evaluation process allow sufficient scope for the HSE to take on board the particular circumstances that pertain to orphan drugs. In reaching its decision, the HSE will examine all the relevant evidence and will take into account such expert opinions and recommendations that are appropriate, including from the NCPE.

The Deputy rightly identifies that increasingly drugs are being developed to target rare conditions and that these drugs often come with very high list prices. In that respect, the HSE is required under the Act to have regard to the funding challenges that these drugs represent. It does this by drawing on the criteria contained in the Health Act, including the potential or actual budget impact of the drug in question and the cost effectiveness of meeting health needs by supplying a particular item rather than providing other health services. These are difficult decisions but recognise the core challenges of the availability of finite resources in the face of ever competing demands. Since the signing of the four year framework agreement on the supply and pricing of medicines in 2016, a significant number of orphan drugs have been reimbursed by the State.

Notwithstanding the challenges which orphan drugs present and the fact that the HSE and NCPE are mindful of these issues when assessing orphan medicinal products, a number of changes have been introduced to address those challenges. In June 2018, a technology review committee for rare diseases was established. This committee is now operational and has already completed work in relation to orphan products. As well as examining the methodologies for assessing orphan drugs, it will also consider the views of patients, caregivers and examine the wider issues surrounding health technology assessments. In addition, the composition of the HSE drugs group is being expanded to include two representatives from the National Patients Forum and more clinical expertise in the area of rare disease. Both of these measures are intended to provide greater balance and transparency to the assessment process as a whole.

The challenge of accessing innovative medicines at affordable prices is one shared by most, if not all, developed countries. It is estimated that in the region of 45 new molecules are due to receive market authorisation in Europe each year over the next five years. It is in this high-tech space, including orphan drugs, that the greatest challenges will arise in the years ahead. A significant development in Ireland’s international agenda was joining the BeNeluxA initiative on pharmaceutical policy in June 2018. This collaboration will support the Government's objective of co-operating with other European countries to identify workable solutions in an increasingly challenging environment to secure timely access for patients to new medicines, including orphan medicines, in an affordable and sustainable way.

5:20 pm

Photo of Pat DeeringPat Deering (Carlow-Kilkenny, Fine Gael)
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I thank the Minister of State for his comprehensive reply. I welcome the initiatives commenced this year, in particular the review committee established in June but it is important a timeline is put in place for completion and publication of that review.

It is also important that these drugs are affordable and that the State is not in hock to, or taken advantage of by, the large pharmaceutical companies. Crucially, the people who need these drugs need them now because they may not be around in two years' time when they become available.

As I said, it is important the initiative announced earlier in the year is progressed more quickly such that if a new disease is identified and an adult or child needs drugs that will be of huge benefit to them, they can access them. I ask the Minister of State to ensure that a timeframe is set for completion of that initiative such that the process can be more efficient going forward.

Photo of Jim DalyJim Daly (Cork South West, Fine Gael)
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I will take on the Deputy's challenge of putting in place a timeline for the range of initiatives outlined in my speech. There always will be tension between the State as the purchaser of important drugs and the giant pharmaceutical companies producing and supplying them, often for lottery type amounts of money. The State has to ensure affordability not only in terms of fiscal governance but to ensure they are available to everybody who needs them. If we pay over the odds for any particular drug we would limit the number of people who can avail of them. Notwithstanding those challenges, the Deputy has asked that we be more prescient in our timelines and I will pass on his request to the Minister.