Amendments Nos. 2 and 3 essentially seek to put in place an appeals procedure against decisions of the board. I draw attention to the fact that, under the provisions of the Bill, the board cannot refuse any licence unless it has first sought and considered the advice of an appropriate advisory committee, so that the board cannot act unilaterally in refusing to grant a licence. In any event, there is at present a case before the High Court seeking a judicial review regarding a decision to refuse to grant a product authorisation. Among the issues raised in the case before the court was the lack of an appeals mechanism under existing regulations. The judgement of the court is still awaited but is likely to be given during the present term.
Obviously, there is considerable merit in the proposal to seek to provide an appeals procedure. However, I do not believe it is either appropriate or necessary to provide for such a procedure in the Bill. On the contrary, it would be more appropriate for the question of an appeals procedure to be dealt with in the context of the Medicinal Preparations (Licensing, Advertising and Sales) Regulations, 1984, which set out in detail the requirements and procedures for licensing medicines. The regulations will require amending to enable the board to assume the role of licensing authority and the question of providing an appeals procedure will be examined in the context of the amending regulations.
At the same time, regard will be given to the outcome of the case at present before the High Court and any particular issues which the court may identify as requiring attention. I agree that the board should take all possible steps to ensure that applications are processed as speedily as possible but I do not believe that it is necessary to make specific provision in the Bill relating to this. The board will be required by section 20 to carry out an annual examination to ensure it is operating efficiently and economically. At the same time, it will also be required to seek to comply with the requirements of EC Directive 65/65 which stipulates that applications should be processed within 210 days.
The requirements, of course, operate on a "stop the clock" basis. In this context, it is important to note that quite often in the past there were delays where incomplete applications were submitted or where companies took a considerable length of time to deal with the issues raised by the board or its assessors. While I agree that the board should seek to deal with applications as speedily as possible it cannot sacrifice questions of safety or public health considerations which, as I am sure Senators will agree, must at all times be the primary consideration.
Therefore, I do not accept the need for the amendment as proposed, but agree to look at the question of an appeals procedure when amending the regulations.
In relation to amendment No. 4, section 13 is an enabling section whereby the Minister may make regulations for the payment of fees in respect of matters arising out of licensing medicines. It is not appropriate that the section would set out the specific details proposed in the amendment. That is more appropriate to the regulations which will set out the fees and the circumstances in which they will be payable. As Senators are aware, the Minister will be required to lay the regulations before the Houses for approval. At the same time I recognise that the specific proposal in the amendment merits serious and constructive consideration and shall be examined in the drawing up of the regulations.
