Colm Burke (Cork North Central, Fine Gael)
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The Mazars report was commissioned in 2018 and completed and furnished to the Department of Health in January 2020.Three years later, it has not been published. The report arose as a result of the 2018 examination by the health committee, of which I was a member, of the roll-out of orphan drugs and the delaying process that is in place. The health committee's report set out 15 recommendations. The Acting Chair, Deputy Durkan, and I are the only two members of the committee that produced the report in 2018 who are still on the committee. It is disappointing that the Mazars report has still not been published.

We have a problem in Ireland in that it takes, on average, 789 days from the time a drug for a rare disease is approved at European level to the time it is approved here. The average across Europe is 587 days. In Germany, it is 79 days and in Denmark, which is similar in size to Ireland, it is 274 days. We need to publish the Mazars report and make it available. We need to change the whole system to fast-track the roll-out of drugs for children or adults with rare diseases. The process has dragged on for too long. We need to look at other countries. In Scotland, the process for making available the drugs that people require, especially people with rare diseases, works very well. In some cases, there may be only ten, 15 or 20 people in the entire country who require a drug but it is an important part of the care and treatment they require. We seem to be stalling the whole process because although the drug will have been approved at European level, we go through a whole process all over again and the drug is not made available as a result. The 2018 report of the health committee made 15 recommendations, including the following:

The Committee recommends that the Department of Health engage with stakeholders, and in particular with patients during the drafting process of its review. The views of patients are vital to ensuring that the process benefits those in need of orphan drugs... The Committee recommends that the evaluation process for orphan drugs be fit for purpose.

The process is not fit for purpose and it is time it was reviewed and fast-tracked. Why do we have a scenario where a drug is approved at European level and more than 700 days later, that same drug may not be available in this country? This is hugely frustrating, especially for parents of young children who are waiting for long periods without a decision being made. I know there is a bargaining process in relation to price. It is sad that drugs bring produced in this country by manufacturers based here are not available for the people who require them. It is time we published the report and set about reforming the current system.

Joe O'Brien (Dublin Fingal, Green Party)
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I thank Deputy Colm Burke. I am taking this issue on behalf of the Minister for Health, Deputy Stephen Donnelley.

The State spends substantial sums on medicines yearly with the goal of keeping people in Ireland healthy. This expense has grown to more €2.5 billion per year. Considering the financial consequences of funding medicines, it is important we have the best possible system to decide which medicines to fund. The Health (Pricing and Supply of Medical Goods) Act 2013 legislates for the system we use now. For a medicine to be added to the reimbursement list, it must undergo the pricing and reimbursement process. This is a rigorous process that aims to ensure the HSE procures medicines that are safe, effective and the best value for money. Dedicated funding of almost €100 million has seen more than 112 new additions to the reimbursement lists in the past two years, including 34 medicines for people with rare diseases. Budget 2023 has again provided €18 million in funding and the Minister is hopeful the process will make even more medicines available to patients in need. In 2019, the consulting firm Mazars was commissioned to review this process by the then Minister for Health. This report was delivered to the Department in early 2020. Consideration of the report was delayed as resources were diverted to focus on the State's response to the Covid-19 pandemic. The Department has now reviewed the report and the Minister plans to publish it imminently.

Colm Burke (Cork North Central, Fine Gael)
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I thank the Minister of State. I am concerned about the definition of "imminently", the last word he used. Are we talking about today or next week? Rare diseases day is next Tuesday and I wonder whether the report can be published beforehand. It is not just about publishing the report but also about implementing the changes required. Ireland ranks 26th out of 34 countries in Europe on the time taken to roll out new drugs, in particular, new drugs for people with rare diseases. The pharmaceutical industry is a huge employer in this country.

It is five years since this issue came before the health committee. I was involved in drafting the final report and I put a lot of time and effort into working with others to produce that report. I never thought I would have to wait five years to see the report's recommendations being implemented. The review has been done and the Minister of State has said it will be published. The next issue is to have a timeline for implementing the changes required. It is no longer acceptable to wait for 789 days. It is time for change and time to put in place a structure.

I have raised this previously. In Scotland there is a good system. It makes sure the drug is made available in a timely manner. This is about saving lives. It is a money issue in the sense that we have to get value for money but it is also about saving lives. That is the important thing that we need to keep in mind in dealing with this. I ask the Minister of State to ensure the report will be made available and to talk to his colleagues about the implementation and full delivery of the recommendations of that report.

Joe O'Brien (Dublin Fingal, Green Party)
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I do not have an exact publication date but the Minister will publish the Mazars report imminently. The Government is committed to providing access to as many medicines as possible in as timely a fashion as possible from the resources available to it. The Minister and his Department have given careful consideration to the recommendations of the report and will work on the recommendations for the benefit of Irish patients.