Róisín Shortall (Dublin North West, Labour) | Oireachtas source

I take the point made by Senator MacSharry that there needs to be transparency around the decision-making in this area. The criteria are set down clearly in Schedule 3. The overriding consideration has to be patient safety. However, we have no option but to consider other criteria as well with cost effectiveness and whether the use of a particular drug will ensure a person does not have to use other health services. These are all set out in the Schedule.

To have some kind of feedback on the process involved where a decision is taken whether to sanction a product or otherwise is a reasonable suggestion. I am happy to examine this before we take the Bill to the Dáil. In the interests of transparency, it would be helpful if there was a determination and people had access to the basis for that determination. I take issue, however, with the Senator’s suggestion of making every drug available and then withdrawing items. The reality is that new medicines are extremely costly. Every action taken in the health service has a reaction because there is a limited budget. We do not even have a fixed budget but a diminishing one.

If a decision is taken to approve a particular drug which is very expensive, it means the money must come from elsewhere in the health service. Often these are the life and death decisions that must be taken within the Department of Health.

A task force to examine patient safety and quality in prescribing has recently been set up under the chairmanship of the chief medical officer in the Department of Health. All of these wider considerations are being examined to ensure we have a system in place that takes decisions based on the best interests of the patient concerned and the wider public as well. These are difficult decisions to take and we need a good deal of data on various aspects of the drugs to feed into them.

This is part and parcel of the situation relating to the overall drugs bill, which, at approximately 16% of total health spending, is not sustainable. I have stated previously that if we are to make room for new and expensive drugs coming on the market and we want to make these available to people as quickly as we can, space must be provided within the drugs spend, which means reducing the cost of existing drugs. That is the reality. There is no easy way out of it and there is no pot of money that we can dip into. There are direct implications in respect of the limited funding available for the health service generally. I take the point and I am happy to consider it before we bring the legislation to the Dáil to determine whether we can have feedback and greater clarity about why the HSE comes to the decisions it does in respect of some of these products. I thank the Senator for the suggestion.