Billy Kelleher (Cork North Central, Fianna Fail) | Oireachtas source

Section 4 contains the words "as soon as is practicable". No matter what way one reads it, there is no defined period by which the board is required to deal with the issue of the interchangeables. I do not question board members' eminence or ability, but the issue of resources and priorities could come into play. I am also concerned about high-tech drugs and the complexities of that. High-end drugs come on the market and are under patent for a period. When the drugs come out of patent, does the board have the competence, experience and resources to adjudicate on the medicines which become available immediately afterwards? I am concerned that the wording of the section is vague and does not contain specific timelines for adjudication and publication in respect of medicines. Timelines are also lacking to encourage people to apply and to force the board to act promptly where people apply and put their products up for interchangeable use.