Marc MacSharry (Fianna Fail) | Oireachtas source

I move amendment No. 4:

In page 24, between lines 25 and 26, to insert the following subsection:

"(3) The Executive shall, within one month of the enactment of this Bill, publish clear and detailed guidelines setting out—

(a) the criteria that shall form the basis for the Executive’s decision to add an item to the Reimbursement List, and
(b) the criteria which shall form the basis for the Executive’s decision to refuse to add an item to the Reimbursement List."

We find ourselves in an unusual situation in that we are supporting the legislation in the interests of ensuring cheaper drugs will become available as quickly as possible. However, we do have a number of concerns about the Bill. In that context, I ask the Minister of State to consider its compliance with the European Council's transparency directive. As I am sure she is aware, the said directive requires the publication of objective and verifiable criteria for deciding whether something should be made available. We are concerned that the legislation is in breach of the directive. The Attorney General has obviously adjudicated on that matter, but the position should be examined further. Perhaps this could be done between now and the introduction of the legislation in the Dáil.

The amendment suggests that within one month of the enactment of the Bill clear and detailed guidelines setting out the criteria that shall form the basis for the executive's decision to add an item to the reimbursement list and the criteria which shall form the basis for its decision to refuse to add an item to the list should be published. The amendment is important and would bring the legislation into line with the directive. In addition, it would ensure people would have confidence in the system and how it worked. I may comment further on this issue when we come to deal with a later section. The amendment is important both in the context of ensuring compliance with the transparency directive and with regard to underpinning the integrity of the legislation.