Bernard Durkan (Kildare North, Fine Gael)
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10. To ask the Minister for Health the extent to which new modern, effective and safe drugs can become available here once approved by the EU authorities; and if he will make a statement on the matter. [1817/24]

Bernard Durkan (Kildare North, Fine Gael)
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This question seeks to ascertain the extent to which new, effective and safe drugs are made available for use by Irish patients as soon as they become approved at EU level.

Stephen Donnelly (Wicklow, Fianna Fail)
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I thank the Deputy for the question. We spend a lot of money on medicines in this country. Last year the medicines investment was more than €3.2 billion. This is a sizeable amount. The vast majority of the €2.8 billion was spent on the medicines themselves. There was also money spent on administration and payments to pharmacists for dispensing amounting to just over €400 million. Our public spend on medicines is, believe it or not, €1 in every €8 that we spend on healthcare. There is an unprecedented level of investment. Deputy Durkan is aware that over the past three years we have invested almost €100 million in new medicines. It was badly needed. It has led to the provision of almost 150 new medicines or extended new uses for medicines that we have. Spending on these medicines is estimated to have been almost €330 million to the end of 2023. There has been a sizeable investment when we factor in the full year costs of new development funding.

As per the 2013 Act, a company has to submit an application to the HSE to have a new medicine added to the reimbursement list. We sometimes forget that Ireland is a small country and a small market. We are not always prioritised by companies in the first stage. It is something that we are working on, and we have some multilateral agreements in place as well through Beneluxa.

For this year the HSE will have €30 million for new medicine spend. This comprises €20 million that I have allocated from the December additional new development funding and we are targeting a €10 million reduction in the €3.2 billion spend through a rapid switch to generics and biosimilars. This will provide another €30 million this year for new medicines, which is obviously going to be very important. In my next response I will come back to Deputy Durkan on the process he asked about.

Bernard Durkan (Kildare North, Fine Gael)
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I thank the Minister for his reply. What is the extent to which references come from the pharmaceutical sector on the ready availability as soon as these drugs are made available? For instance, what might be the time lag between approval in the European Union and in this country?

I accept that we are a smaller country but we are a member of the European Union. As a member of the Single Market, we have the same rights to new medicines and new drugs and any other service available to the European Union as there is anywhere else, including London as used to be the case once upon a time, Paris or Rome. I heard reference made on a radio programme recently to the theory that as we are a small member state, we should come further down the list. I do not accept this. We must accept that the European regime prevails. If we accept anything less than this we will run ourselves into trouble.

Stephen Donnelly (Wicklow, Fianna Fail)
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I thank the Deputy very much. I agree with him. I do not accept that either. We are a nation whose population deserves rapid access to these medicines. We have to strike a balance. We hear advocacy from the pharmaceutical industry regularly citing lengths of time. It has a particular view. Obviously, it wants Ireland to spend as much money as quickly as possible on its products. When I talk to people working within the service, the view is more nuanced. They say Ireland does quite well in accessing some drugs, and is well ahead of other European countries, but that it is not universal in terms of access to all medicines. To that end, the Deputy will be aware there was a Mazars report done some years ago which looked at the process and it found several ways we could improve it. One is around transparency of the process. I do not believe transparency has been where it needs to be for patients or indeed for the industry, and the other is in the speed with which we can approve the new medicines.

Bernard Durkan (Kildare North, Fine Gael)
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Regarding the urgency in respect of the availability of certain medicines, new medicines in particular, in this country should a safety assessment now be carried out in addition to the general European safety assessment or does the State go along with it?

Stephen Donnelly (Wicklow, Fianna Fail)
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I will ask the Department to revert to the Deputy with a detailed note on the full process involved in the health technology assessments because there are various parts to them. What I can say is that for this coming year there are going to be some important improvements. One is that we are going to have a medicines tracker for the first time. This is something that Rare Diseases Ireland, patient groups and the industry have asked for. They say that at a minimum we need to know where the medicine is in the process. There is going to be more transparency as well around the criteria that are used. For example, when we are considering orphan drugs, there are additional criteria used because they do not fit into the normal cost-benefit criteria that are used for the more mainstream drugs. Second, I have allocated funding for a sizeable increase in the teams working in these areas, which is going to help speed up the process. Third, we must have new medicines funding as well, and that is why that €30 million for new medicines is going to be very valuable for this year.