Mr. Stephen Mulvany:

The Deputy may be referring to the fact that the Humira drug is coming off patent. There was some ill-informed media comment on that in recent times. To back up what Mr. Desmond is saying, the HSE conducts a detailed horizon-scanning process in order that we are aware what drugs are in what different stages in the process. There is legislation which covers this, namely, the 2013 Act. We are ready, subject to getting applications - which we have started to get - from bio-similar suppliers, and subject to them having stock, to have those approved from 1 November. We are satisfied nobody would have had stock in the country before 1 November. The HSE processes, which are complex as this is a complex area governed by legislation, have been accelerated to ensure that as soon as stock is available and the appropriate applications in process are made we will give approval for bio-similar drugs, which will bring a substantial cost reduction as and from 1 November. It is unfortunate that the journalist did not seek input from the HSE in advance of writing about this but that is the fact of it.