Amendment No. 5 was discussed with amendment No. 3.
SECTION 13.
There was to be further clarification on this as the Minister said he might discuss it later. There is a reference to it later in the Bill with regard to fees.
That amendment has already been discussed. There may be a relevant opportunity later to discuss it.
We should discuss it further.
We cannot do so because we discussed it with amendment No. 3.
We did not complete our discussion of it.
It is not in order to discuss it now. I asked at least twice whether we had concluded discussion on amendments Nos. 3, 4 and 5.
Amendment No. 5 was not agreed to.
It was discussed.
On a point of order, none of the members of the committee received a specific notice of this meeting other than the general listing. A briefing session at the beginning of Committee Stage is normally the committee's first step in dealing with a Bill of this kind. As convenor I received no notice other than it being mentioned at our last meeting that this meeting was to take place.
Notices were issued to Deputies on 29 September to their offices and home addresses.
It may not yet have arrived. On occasions I have received notices which have been three or four days late. I have been in the offices of other Deputies who also have not received notices. This is the reason for the sparse attendance. The only notice of the meeting I saw was in the general list of committee meetings. I usually do not operate according to this list. There may have been a postal problem. We have a problem with continuing the meeting because Members have arranged other things and did not know this meeting was to take place.
I have a copy of the notice which was sent to the two addresses of each Member.
Was 29 September a Friday?
Yes.
It has not yet arrived in offices here. I cannot confirm that it has not arrived at Members' homes but it had not arrived at my home last night.
I confirm what Deputy Flaherty said. I also received notice of the meeting only from the overall list. I would have received Tuesday's post before I left home yesterday and the notice had not arrived by then. There obviously was a postal difficulty. We have no doubt that the notices were issued but they had not arrived in our Oireachtas post this afternoon.
I was aware of this meeting for some time because it was arranged between the committee's officials and the Department of Health. It has been listed in my diary for some time. It was stated at the conclusion of our last meeting that we would meet at 2 p.m. today.
I remember that reference but people tend to wait for an agenda to be sent to them. We normally have a briefing session before commencing Committee Stage of a Bill.
We had that at 2 p.m. today.
Unfortunately, notices were not sent. I do not know whether we can proceed. We have a problem, particularly if any votes arise.
I cannot throw any light on what the convenor is saying about a letter which is the normal modus operandi. We are here as a result of the omnibus notice on the activities of all committees of the House, which is a useful document because one does not have to be a Member of this committee to appear here. We are also here as a result of the Order Papers of today and yesterday which clearly set out that the committee was to meet at 2 p.m. today in private session to discuss the matters referred to in them. Each of us receives an Order Paper in the post each morning.
I do not think the Order Paper constitutes an official notice of the meeting in legal terms. We are engaged in a legislative process. Is it technically legal to go ahead without proper notices being issued?
What is the definition of "proper notice"? Notice of the meeting was given in the schedule of the meetings of committees and in the Dáil Order Paper today. It was announced at our last meeting that this meeting was to take place and it is in today's Dáil Order Paper.
The average Member relies on a proper agenda. If we are continuing with Committee Stage there is a more informal arrangement, but that is inadequate notice of the commencement of Committee Stage. There has obviously been a postal problem over the weekend and it is not the first time that this has happened. Notice of an event last Monday arrived with me on Tuesday.
This has not arisen before. I understand there is no specific requirement that an agenda must be received by Members beforehand but there has been notice of the meeting in official documentation. We are here to do the best thing possible in relation to this Bill. We are quite within our legal rights to be here and to do what we are doing. Having said that, however, naturally the purpose of this exercise is to ensure that the Oireachtas and this Committee has every opportunity to process the Bill. If it is felt that this purpose will not be achieved because of confusion about the notification of the meeting, we can adjourn and reconvene on another date if Members so wish.
The sections discussed and dealt with cannot be re-entered. We will recommence where we leave off today. Is it felt that we want to give a wider opportunity to Members to become involved in this Bill?
There is a very real problem with people not knowing that this meeting was on. The only people who knew are those who happened to see it on the general list. Nobody has received an agenda although it is brief enough. In view of the fact that I have missed the briefing session, with regret, I would ask that we might adjourn to another date to be agreed.
Is it the wish of the Committee to adjourn at this stage and to recommence where we left off today?
There is very little left. In reality, the substance has now been dealt with. The remaining amendments concern the substitution of one or two words.
I fully accept what Deputy Flaherty has said.
I am in no position to assess it. As the situation was brought to my attention I wanted to respond. If the Opposition spokesman can assure me of a reasonable approach, and that he is unlikely to be calling cliff-hanger votes, I will be very happy to see it continue.
There are no votes. In fact, the Minister has given us an assurance that on Report Stage he will take on board some of the points we have made. I will be interested to see how he deals with those. There has been substantial agreement and it is only a technical piece of legislation.
Some nine Members have appeared at this meeting, although some have attended only briefly.
The undertakings I gave were in the context of the regulations.
Yes.
If that is the situation, I will be happy to withdraw the objection to continuing.
The point of order raised will be throughly investigated so that, hopefully, we can get an explanation at the next meeting. We are on section 13 of the Bill and had already discussed amendment No. 5 with amendment No. 3 by agreement. Is the amendment withdrawn?
If it will help, I have given an undertaking that in relation to the fees for inspections I will look favourably at the inspections as per large and small plants. I take the thrust of what was said as being fair and equitable, and I am happy to proceed down that road by way of regulation.
Amendment No. 5 not moved.
Amendment No. 6 and amendment No. 10 form a composite proposal and can be discussed together by agreement.
I move amendment No. 6:
In page 12, lines 30 to 33, to delete subsection (4).
The deletion of subsection (4) of section 13 is directly linked to the introduction of amendment No. 10 in a new section 21. Deputies will be aware that the Government decision in 1991 to establish the Irish Medicines Board specifically provided that the board should become self-financing at the earliest possible date. Section 13 (4) was intended to give statutory effect to that decision. However, as originally presented in the Bill, the subsection seemed to require that the income generated by the board solely from fees should be such as to meet the overall running costs of the board.
As I promised on Second Stage, and also following representations from the pharmaceutical industry, I have taken the opportunity to examine the section to ensure that it would properly reflect the intent of the original decision on the financing of the board. I am now satisfied that the subsection as originally presented does not adequately reflect the Government's intention.
In addition to income that will derive to the board from licensing fees, section 14 provides for other forms of income including the possibility of the board charging for certain services. For example, the board would obviously expect to derive some income from activities it may undertake on behalf of the European Medicines Agency.
It was always the intention that the total revenue of the board should form the basis of the board's funding requirements, not merely the income derived from fees. I consequently referred the matter to the parliamentary draftsman, as a result of which I now propose to delete subsection (4) of section 13 and to replace it with a new section 21. I hope Deputies will agree that this meets their concerns and the concerns of the industry as well as reflecting the Government's intention more accurately.
Amendment agreed to.
Amendment No. 7 is out of order.
Amendment No. 7 not moved.
Question proposed: "That section 13, as amended, stand part of the Bill."
Why is amendment No. 7 out of order?
Because it involves a charge on the Revenue. The amendment proposes that the fees which the agency may charge under section 13 shall be limited so as to cover the cost of certain activities of the board only. This limitation could have the effect of requiring an increased State grant under section 15 to cover the cost of the board's other activities. This is a potential charge on the Revenue so it has to be out of order.
The activities of the board are such that it does take on activities that would be pertinent to the Minister for Health in regard to other duties such as blood collection. It has the possibility of going outside its ambit to do other works in different areas. The industry is worried that it will have to carry the can for the board's extra activities. That is the reason it was inserted.
Amendment No. 7 cannot be considered or discussed in detail because it poses a potential charge on the Exchequer.
As amendment No. 6 has been accepted, the subsection to which amendment No. 7 was being made is deleted. Amendment No. 10 to section 21 states:
It shall be the general duty of the Board so to conduct its affairs as to secure, as soon as may be, that, taking one year with another, the revenue of the board shall be at least sufficient to meet the charges properly chargeable to revenue.
This meets the concerns mentioned because it goes beyond fees.
That is a woolly statement. The Minister would need to explain the statement "charges properly chargeable to revenue". There might be a contention about what is properly chargeable.
We are talking about all expenses of the board. That is the standard verbiage from the parliamentary draftsman, but I understand it covers all expenses.
It covers a multitude of expenses, but not specific ones.
The legal interpretation is that it covers all expenditure of the board.
Question put and agreed to.