Seán Fleming (Laois-Offaly, Fianna Fail) | Oireachtas source

I thank the Senator. As I have already mentioned, under the Act, a company that holds a marketing authorisation must apply to the HSE to add its medicine to the reimbursement list. I will follow this up with the Department to ensure there is no undue delay for companies that have applied to have something on the reimbursement list being approved in the meantime. The introduction of the medicine substitution protocol would allow pharmacists to supply a specified medical product without the need to seek authorisation from the prescriber, in other words, going back to ring the original GP and asking can one medicine be changed for another. Substitution will be under the strict direction of the protocol drafted by clinical experts and approved by the Minister. It would only be used when other existing measures are likely to be ineffective and in certain defined serious shortages. The community drugs schemes are designed to address the financial barriers, which the Senator mentioned. The State is committed to enabling safe access to medicines for as many people as possible. This requires the pharmaceutical industry to continue to engage with the public health system, which includes companies applying to the HSE to have their medicines added to the list of reimbursement items.