Colm Burke (Cork North Central, Fine Gael) | Oireachtas source

I thank my colleague from Cork North-Central for introducing this Bill, which follows on from the Bill that had been originally published by our former colleague John Brassil. Deputy Pádraig O’Sullivan has outlined the extensive work he has done in this area. It is important we give recognition to that and that we acknowledge the commitment he has made. I also thank the Minister of State for her response.

This whole area has been in the health committee for well over ten years now, since I first served on the committee in 2011. We published a document in 2013, which was on recommendations of the national clinical programme on rare diseases. One of its recommendations was to set up an office to deal with support for parents of children with rare diseases. We must remember there are more than 6,000 rare diseases. I remember coming across one particular rare disease where only 12 children in the entire island of Ireland had it. That is an indicator of how rare some of these diseases are. Therefore, when other countries come to deal with the pharmaceutical companies, they are dealing with far bigger numbers. For instance, Germany starts using the medication immediately after it becomes available and then it negotiates the price of that medication over the following 12 months. Obviously, that is because Germany has larger numbers than Ireland. We might have ten people who have a particular rare disease here in Ireland, whereas Germany might have 1,000. They are, therefore, in a far stronger position to negotiate.

I always wonder about us teaming up with smaller countries to negotiate as a group. Would we have been better-off teaming up with a bigger country in negotiating down the price of drugs? I acknowledge what Deputy Cullinane said about the pharmaceutical companies. A huge amount of research in this area is done in this country, yet when it is completed and the drug is produced, the drug might still not be available to people living in this country four or five years later. We need to look at that. In my own county alone, for instance, we have nine of the ten top pharmaceutical companies in the world. They are based in Cork and are within a 50-mile radius of Cork city. The work and research are being done and the end product is being produced, yet there are parents who have to fight to get access to the drug. We need to look at the timescale.

This even relates to ordinary drugs. I remember being involved in the health committee and dealing with an issue where it took on average 23 months for any drug to be approved by the agency, even though the drug is available at a far earlier stage. Remember that any drug that becomes before the assessment process here in Ireland has already been approved by the European Medicines Agency, EMA. Even though the drug is approved by the European Medicines Agency, we are still taking another two years to come to a decision on whether we will include the drug in the reimbursement system. My colleague has already outlined the situation in Scotland and we need to look other jurisdictions to see how they fast-track the assessment process. We need to engage with them to see if we can replicate what they are doing. This is not about cost in real terms. This is about people’s lives. It is about families whose entire lives are surrounded by taking on the State to try to get access to a drug that they know will be of assistance to a member of their family.

During my short time in the European Parliament, I had to go abroad for medical treatment. One of the things I fought for when I was in the European Parliament was about the right to access medical treatment in another member state if you cannot get it in your own state or if there is undue delay.

We started working on that in 2008. It was eventually signed off on in 2009 and approved by the Commission, the Parliament and the Council in 2011. It was then transposed into Irish law a number of years later. That to which I refer gives people the right to access medical treatment in other member states if they cannot get it in their own state. We should also be making sure there is joined-up thinking across Europe as regards access to medication, especially on orphan drugs. We can come to a far better arrangement from a European point of view by working together with all member states of the European Union on access to a particular drug rather than only working with a number of countries. It is something we need to look at. We have done it with medical treatment so why can we not do it with medication, medical products and orphan drugs?

This Bill is welcome. My former colleague in the House, John Brassil, who was on the health committee, did work on this matter previously. We should not be putting this off when there are families who know there is a drug available and two to three years after coming on the market at European level, they are still not able to get access to it. Families have moved to other countries in order to get access to the drugs they required. We need to look at why it takes, on average, 23 months for drugs to be assessed. That is for all drugs, not just orphan drugs. We need to review this now. We did the review of the clinical programme for rare diseases back in 2013. It is now time to review that clinical programme again. It is nearly ten years on. What part of that programme has been implemented? What needs to be implemented? What needs to be delivered? In fairness to the Department, there are a lot of issues relating to Covid that it has to deal with, and I fully understand that people are under pressure, but we need to look at this as well. We should not say we will come back and look at this in two years. Now is the time to start the review and see what has been implemented, what needs to be implemented and how we can make sure that children or individuals who need a particular treatment can get access to it. I support this Bill and I hope it will go on to the next Stage and that we can progress it. At the same time, we need to bring about improvements in order that people can access the care and treatment they require.

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