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

Part 4 of the Bill sets out the statutory procedures relating to the supply of and reimbursement of the cost of medicines and other items to patients under the GMS and the community drug schemes. Section 19 sets out the action to be taken by the executive where it makes a relevant decision under section 18, that is, to either add or refuse to add an item to the reimbursement list.

Section 19(4) provides that in making a relevant decision under section 18, the executive is required to have regard to the criteria set out in Schedule 3 to the Bill. This Schedule sets out three categories of criteria to which the HSE must give consideration in making pricing and reimbursement decisions. The first category includes criteria applicable to medicinal products, the second comprises criteria applicable to medical devices, foodstuffs for particular nutritional uses and dietary foods for special medicinal purposes, and the third sets out the general overarching criteria to which the executive shall have regard in making a relevant decision under section 18. In other words, Schedule 3 already provides criteria covering a broad range of issues which must be taken into account before a decision is made in terms of adding or declining to add an item to the reimbursement list. For example, the general overarching criteria require that the HSE has regard, among other issues, to the health needs of the public, the cost-effectiveness of meeting those needs by supplying the item concerned rather than providing other health services, and the efficacy, effectiveness and added therapeutic benefit of the item as against existing standards of treatment. In these circumstances and given that the Bill is entirely compliant with the transparency directive, as verified by the Office of the Attorney General, I do not propose to accept the amendment.