I would like to announce a correction to the printed list of amendments. The second amendment to section 8 should be numbered 2. Amendments Nos. 2, 3 and 4 are being discussed together.
SECTION 8.
Irish Medicines Board Bill, 1995: Committee Stage (Resumed) and Final Stages.
An Leas-Chathaoirleach
Debate resumed on amendment No. 2:
In page 8, after line 44, to add the following subsection:
"(12) The Board shall ensure that all applications are processed as speedily as possible and shall put in place an independent appeals procedure where applicants can raise matters relating to delays and any refusals of applications.".
—(Senator Finneran.)
Last week we adjourned the debate on this Bill following the tragic news of the death of our colleague, the former Tánaiste, Brian Lenihan.
These amendments relate to applications, an appeals procedure and delays and refusals of applications. I would like to reiterate what I said last week. It is natural justice that there should be an appeals procedure. We are talking about licences for medical products and it would inappropriate if there was no appeals procedure. I believe a case is being dealt with in the courts where the right to appeal is being sought.
My party and I believe the right of appeal should be included in this Bill. I understand the Minister gave certain assurances in the other House. He has spoken about regulations and the commitments he will give. This is fine in theory but in practice it does not always work. We have a responsibility to tease out legislation to ensure all aspects are looked at and that the Minister does not need to return to the Houses of the Oireachtas to amend a Bill.
My party has carefully considered the situation. The Minister should accede to the request for an appeals procedure. Good reasons have been put forward for this. A board appointed by the Minister, which may or may not have a committee to look at this, is not a proper appeals procedure. From my reading of the Bill, an appeal would be dealt with by an advisory committee. It would be in-house and the right hand would ask the left hand what the opinion should be. I do not believe that is appropriate. An independent appeals system should be available to deal with the delay or refusal of an application. It should be part and parcel of the legislation and would protect people in that situation.
The Minister has spoken at length about this in the other House and many contributions have been made in this regard. My party believes there is a need for a safeguard for people who have been refused licences. Delays can also be disastrous for pharmaceutical companies. I believe the Minister said — I do not want to misquote him — that refusals are not usual. However, delays can be as detrimental as refusals. We would be better off if we included a proper appeals procedure for delays and refusals as regards licences.
I agree with Senator Finneran that there should be an appeals procedure; I have no difficulty with that. The difference between us is how that should be done. Senator Finneran seeks acceptance of his amendment. This is an enabling Bill and the type of procedure which is appropriate here should be put in place by way of regulation. I already gave an undertaking in this House to do so. I ask him to bear in mind that the regulations must be placed before the Houses of the Oireachtas, so it comes back to the democratic process at that stage. The board will not be in a position to refuse a licence until it has first sought and considered the advice of the appropriate advisory committee, which is part of the structure of the board.
The appeals committee or the appeals procedure put in place must be independent. The advisory committee of the board will not adjudicate on appeals. This issue which has arisen in the course of debate requires more thought and consultation. We need to put in place a proper appeals procedure which is fair and impartial. I reiterate my commitment to do this.
Senator Finneran referred to speed. The thrust behind this legislation is to speed things up. I explained that the period within which an application for product approval must be processed is 210 days on a stop the clock basis, in other words, if further information is required, the clock is stopped at that stage and it resumes when the information is provided. Throughout the history of the National Drugs Advisory Board there was only one occasion when there was a refusal. That is the case to which the Senator has alluded and which is before the High Court at present.
On a practical level, it is prudent in my view to await the decision of the High Court before finally framing the relevant appeals procedure because I am not presenting this Bill in a confrontational way. I believe that is the way in which the Bill has been accepted in the House. The important issue is to get it right. I put it to the Senator that this type of detail is appropriate to regulation rather than to the legislation itself.
The other issue which Senators raised regards fees charged. I have also given an undertaking here that the size and workforce of particular companies will be taken into consideration when the fees are being put in place. The fees will be put in place by the Minister following consultation with the board and any other relevant necessary consultation. I wish to assure the Senator again: I undertake here to deal with the issues which he raised by way of regulation. Those regulations will come before the House.
The Minister says the clock stops. We had the same situation in local authorities to some extent with regard to seeking further information. This is something which is abused by planning officials in county councils; in fact, I have raised the matter in public on numerous occassions. We have had the unacceptable practice in the last week of the statutory period being almost up. We have had an official write for further information, thereby covering himself and the local authority legally. It is a practice which needs amending but that is for another day and another Minister. I wish to see it amended as soon as possible because, as far as I am concerned, it is malpractice by officials of county councils and local authorities. The sooner it is stamped out the better. It is not applicable in every county but I assure the Minister that it applies to a good extent in my county. I know, being a member of the General Council of County Councils, that it applies in other councils too.
A great deal of regulation is needed on the appeals procedures; in fact regulation will be needed if this amendment is accepted. All this amendment states is that an appeals procedure will be put in place. It does not say anything more than that. The actual mechanics of it will be for regulation and I have no doubt about that. I would leave that totally to the Minister and the Department. I would not interfere with the appeals procedure; those regulations would then be laid before the House.
The principle of appeal should be part of the law. I leave the implementation of the appeals procedure to the regulation of the Minister and his officials. The point of principle is that the Irish Medicines Board Bill should include a proper appeals procedure. All the Minister must do is bring forward the regulations to implement that appeals procedure but the right of appeals should be part of the legislation.
The first point raised by Senator Finneran — the abuse, possible abuse or potential abuse of the stop the clock mechanism — would obviously have to be catered for as part of the appeals regulations. I fully accept that if a person feels his application has been unfairly treated, it would be one ground for appeal. Obviously, it would be a negative decision which would be at issue here.
The other point the Senator made, and I am aware of the context in which it is made, is something which will be catered for by regulation. The regulations will also be law. As this is enabling legislation, regulations which follow from it will, in fact, be law. I am giving a categorical assurance here that the areas which are mentioned in these amendments will be catered for by way of regulation.
Amendment put.
The Committee divided: Tá, 17; Níl, 22.
Tá
- Bohan, Eddie.
- Byrne, Seán.
- Cassidy, Donie.
- Daly, Brendan.
- Farrell, Willie.
- Finneran, Michael.
- Fitzgerald, Tom.
- Kelleher, Billy.
- Lanigan, Mick.
- McGowan, Paddy.
- Mooney, Paschal.
- Mulcahy, Michael.
- Mullooly, Brian.
- O'Brien, Francis.
- Ormonde, Ann.
- Roche, Dick.
- Wright, G.V.
Níl
- Belton, Louis J.
- Burke, Paddy.
- Cashin, Bill.
- Cosgrave, Liam.
- Cotter, Bill.
- D'Arcy, Michael.
- Doyle, Joe.
- Enright, Thomas W.
- Farrelly, John V.
- Howard, Michael.
- Kelly, Mary.
- Lee, Joe.
- Magner, Pat.
- Maloney, Seán.
- Manning, Maurice.
- Neville, Daniel.
- O'Sullivan, Jan.
- O'Toole, Joe.
- Reynolds, Gerry.
- Taylor-Quinn, Madeleine.
- Townsend, Jim.
- Wall, Jack.
Tellers: Tá, Senators Fitzgerald and Ormonde; Níl, Senators Cosgrave and Magner.
Amendment declared lost.
What is the temperature in the Chamber? There is not a breath of air. I do not know how other Members feel but the temperature in the Chamber is disgraceful. It has nothing to do with what people are saying.
I do not know what is causing it but the Senator has another platform on which he can raise this matter.
Somebody should check to see what is the problem.
That is a matter for the Committee on Procedure and Privileges.
Question proposed: "That section 8 stand part of the Bill."
Who will be represented on the advisory committee?
Essentially, there will be committees of experts on the veterinary and on the human medicine sides. The main board, the Irish Medicines Board, will be small, comprising of nine people. The bias will be on management, especially to ensure that the business of the board is streamlined. However, the advisory committees on human and veterinary medicines will be the committees of experts.
Question put and agreed to.
SECTION 9.
An Leas-Chathaoirleach
Amendment No. 3 has already been discussed with amendment No. 2.
I move amendment No. 3:
In page 10, subsection (8), line 13, after "advice." to add "Where the Board refuses to grant a licence, applicants may have recourse to an appeals procedure.".
Amendment put.
The Committee divided: Tá, 21; Níl, 24.
Tá
- Bohan, Eddie.
- Byrne, Seán.
- Cassidy, Donie.
- Daly, Brendan.
- Fahey, Frank.
- Farrell, Willie.
- Finneran, Michael.
- Fitzgerald, Tom.
- Honan, Cathy.
- Kelleher, Billy.
- Kiely, Rory.
- Lanigan, Mick.
- McGennis, Marian.
- McGowan, Paddy.
- Mooney, Paschal.
- Mulcahy, Michael.
- Mullooly, Brian.
- O'Brien, Francis.
- Ormonde, Ann.
- Roche, Dick.
- Wright, G.V.
Níl
- Belton, Louis J.
- Burke, Paddy.
- Cashin, Bill.
- Cosgrave, Liam.
- Cotter, Bill.
- Cregan, Denis (Dino).
- D'Arcy, Michael.
- Doyle, Joe.
- Enright, Thomas W.
- Farrelly, John V.
- Howard, Michael.
- Kelly, Mary.
- Magner, Pat.
- Maloney, Seán.
- Manning, Maurice.
- Neville, Daniel.
- O'Sullivan, Jan.
- O'Toole, Joe.
- Reynolds, Gerry.
- Ross, Shane P.N.
- Sherlock, Joe.
- Taylor-Quinn, Madeleine.
- Townsend, Jim.
- Wall, Jack.
Tellers: Tá, Senators Fitzgerald and Ormonde; Níl, Senators Cosgrave and Magner.
Amendment declared lost.
Question proposed: "That section 9 stand part of the Bill."
With regard to the appointment of the advisory committee, does the Minister envisage a role for the medical associations, the Irish Veterinary Union or other representative organisations or unions of the various professions? Would people from the pharmaceutical companies be on advisory committees?
There is an inherent danger in representation from pharmaceutical companies. Not only must these committees be above board but they must be seen to be so. If there were concerns about conflict of interest or about confidentiality in a particular situation it could take from the perception of these advisory committees as being absolutely above board in all their dealings.
With regard to the composition of the committees, we are talking about experts as distinct from representatives. I dealt with this matter on Second Stage to some extent in the context of the board. Obviously we would better serve the Irish public by getting the best experts we can identify to serve on the committees rather than opting for representation from various bodies. One does not always get the best people through the latter route. The advisory committees will be composed of experts. We would not seek representatives from industry. If the Senator reflects on that he will see the difficulties that could arise from such appointments.
Who will appoint the members of the advisory committee? Will it be the function of the Minister or the board itself? If it is the function of the board, which is appointed by the Minister, would that not be very one sided to some extent? Representative groups nominate members of health boards and so on. Expertise is sometimes a matter of opinion and somebody could be appointed on the basis of their political allegiance. Will the board or the Minister make the appointments to the advisory committee?
The Minister will appoint the advisory committees. We need to take this out of the context of the Minister of the day. I made the point last week that whoever the Minister may be, he or she has the final responsibility for the public health services. In the exercise of that responsibility, politicians should give credit to their colleagues and, in the appointment of a board such as this and advisory committees which play a critical role, the Minister should be able to select whoever he or she believes to be the best people to serve at the various levels. We can put this committee into a political context if we wish but it is a very important committee in terms of public health and safety. I find it difficult to conceive of a Minister who would not make proper and prudent appointments to the Irish Medicines Board and the two advisory committees.
I am not taking from the integrity of any Minister. However, if there was to be a general practitioner representative on the board — although that may not necessarily be the case — would it not be appropriate for the Irish Medical Organisation to nominate that person? Would that body not know best? Would the same not apply to the veterinary organisation and university faculties? Why should the Minister pick and choose?
The Minister, regardless of who he is, is not qualified because he is not directly involved. A Minister may, now and again, come from one of those faculties but that would not often be the case. I know that it will not apply in all circumstances but should it not apply where there are relevant umbrella or representative professional bodies? Does that not seem fairer? The finger could be pointed at the Minister that he made appointments to that committee on the basis of political allegiance or friendship because he has the power to do so, although I am not saying that he will.
It would not be incorrect to compare the advisory committees to a policy making committee as they are committees which will provide technical advice in relation to medicines. There is no reason to have representatives of any particular group. The Senator said the Minister may not have the personal expertise but that expertise is available to the Minister in the Department. These are technical committees which will apply themselves to their task in a scientific way, which is their value. It is prudent and proper for the Minister of the day to have the powers to select the people he or she feels are best, based on the advice available to him or her within the Department. I do not see the difficulty to which the Senator alluded as these are technical, advisory committees.
Question put and agreed to.
SECTION 10.
Question proposed: "That section 10 stand part of the Bill."
This section relates to the chief executive officer, who is the appointee of the Minister. In fact, the Minister appoints the entire board, the chairman and the chief executive officer, who can be removed by the board but only with the Minister's consent. There seems to be some division in regard to financing, litigation and so on. However, the Minister is involved at all times in the appointment of the personnel, board, chairperson and advisory committee. Can the chief executive officer and the chairman of the board be the same person under the terms of the Bill?
The chief executive is appointed by the Minister but on the board's recommendation.
Can the chief executive officer and the chairman of the board be the same person?
No.
There seems to a recent development in the semi-State bodies and elsewhere of having a chief executive officer. Has that been considered by the Minister in regard to this Bill?
It is not provided for in this Bill.
Question put and agreed to.
SECTION 11.
Question proposed: "That section 11 stand part of the Bill."
It has come to my attention that there is a typographical error in section 11. This occurs in subsection (7) at line 40. The second word in that line should read "are" instead of "and" as printed. Thus, the correct phrase would be "are varied by the board" rather than "and varied by the board". Under Standing Order 100, the Clerk may, under your direction, make corrections of a verbal or formal nature at any time during the progress of a Bill. I ask, therefore, that you direct the Clerk to make this correction by replacing the word "and" in line 40 with the word "are".
I have directed the Clerk in accordance with Standing Order 100 to make the appropriate correction.
Question put and agreed to.
Section 12 agreed to.
SECTION 13.
Acting Chairman
Amendment No. 4 has already been discussed with amendment No. 2. Is the amendment being pressed?
I move amendment No. 4:
In page 12, subsection (1), line 21, after "cases." to add "Such regulations shall provide that fees charged for inspections by the Board will be related to the turnover and number of employees of firms. The regulations shall also include an appeals mechanism, with an independent arbitrator to be appointed by the Minister in cases of disputes about fees and charges.".
Amendment put and declared lost.
Question proposed: "That section 13 stand part of the Bill."
Section 13 deals with fees. I proposed an amendment to it. I know the Minister has spoken and to some extent I have accepted what he said on this matter earlier on, but there is a worry on which Senator Henry and myself elaborated during the debate. I speak of it now when we are speaking on the section.
I hope the Minister has taken on board the fears expressed because this matter has not come out of the blue, it was brought to our attention. We do not want a situation where there is no opportunity for arbitration. I hope the Minister will be able to provide safeguards in the regulations. Nobody wants to have legislation that can be used in a heavy handed way where some companies who might not be financially very strong could be the victims. This provision is acceptable when there is plenty of money about and there is provision for the Minister to make a grant towards the board, but if money is scarce — this happens regularly in this country — the only form of income available to this board is that of fees. The Minister can make grants but in times of fiscal rectitude the board might not be top of the priority list. The board may be forced to raise fees to maintain itself and carry out its functions. Therein lies the danger. That is why I put down the amendment here. I hope it will not happen but I see that danger and I would like the Minister to respond.
The fees will be set by the Minister in consultation with the board and whatever other consultation the Minister may feel proper and also in consultation with the Minister for Finance. These regulations have to be laid before both Houses of the Oireachtas, so I stress again that they do come back into the parliamentary democratic process and can be dealt with within that process if people have serious reservations about them. However, I take a more hopeful attitude and that is that the new Irish Medicines Board will get a sufficiency of contracts from the European agency to substantially augment its income. The Government decision going back to 1991 is that the board should be self-financing. In the matter of the Senator's amendment in relation to the level of fee, taking one company as against another and going on its size, workforce, turnover and so on, I gave the undertaking in both Houses that this will be catered for in the regulations and that undertaking will be honoured.
Question put and agreed to.
SECTION 14.
Question proposed: "That section 14 stand part of the Bill."
This section deals with the provision of services. It states in this section that the board may sell anything that it produces. Could the Minister elaborate on that? What is the intention there? What would the board be selling? I know it would be involved in research and so on, but I did not know it would be involved in selling something and charging a fee for it. What is envisaged there?
The board would be selling its services and expertise. I instanced earlier the possibility of contracts with the European agency and, for instance, in the area of adverse reactions, it could well happen that the board would be commissioned to carry out certain works in that regard.
I appreciate that that area was covered. I wish to elaborate further. Payments are mentioned under subsection (1) in respect of "functions performed, services provided, activities carried on or things sold". What is envisaged under that heading of things sold?
Nothing specific is envisaged there but it is a standard provision with this sort of legislation and that is why it is included there. It is not there for any specific reason. It is there to cover contingencies which may arise. It is standard and our advice is that it should be included.
Question put and agreed to.
SECTION 15.
Acting Chairman
Amendment 5 is out of order as it involves a potential charge on the Revenue.
Amendment No. 5 not moved.
Question proposed: "That section 15 stand part of the Bill."
Amendment No. 5 was proposed by Senator Henry and myself. It is a follow on from amendment No. 1. In putting down this amendment we were conscious of a developing situation in this country in regard to litigation which has now become part and parcel of day-to-day living in this country, not just under this legislation. We are in a situation now where people are practically waiting to run against a door that is ajar so they can bring a case against the owner or occupier of the building involved. I see a major difficulty in this situation, whether the Minister does or not, regarding litigation that may take place as a result of somebody feeling that some drug or product damaged either themselves or their property. I instanced that, in the case of a farmer, the property could be his stock.
This board will have to rely a lot on secondment and contract work from experts. I cannot see the board working without the involvement and the introduction at different times of experts on a contract basis. I believe the Minister does not have proper indemnity for that type of situation in this Bill. The board may be at a loss if people are fearful of taking a contract or of being seconded to the board for a certain period because they feel they are not fully indemnified in a situation of litigation. That would be a pity. There should be an inclusion in the Bill to allow for such a situation. Senator Henry and I spoke about this on Second Stage and when we were dealing with section 3. There is a gap in the law there.
People nowadays are far more aware, conscious and worried that anything they do may result in them having to appear in court and having to pay if they do not have full cover. Such cover is on the minds of and weighs heavily on the pockets of the medical profession. I have listened to representatives of the different medical umbrella organisations. The amount of insurance they must have to cover their ordinary everyday activities has gone through the roof. Will the board have protection for its staff, its members and, in particular, for people who will do contract work for it? I see problems arising with regard to the latter. If these people do not have protection I can see a situation where good valuable expertise will be lost to the board because people will be afraid to take up contracts and work on behalf of it. They will feel they do not have proper cover and indemnity against litigation.
I can only reiterate what I stated earlier, which is that the legal advice available to me is that the inclusion of a general statutory indemnity provision is not appropriate and that an administrative solution is the better option. The position until now has been that cases taken against the National Drugs Advisory Board were taken against it as a corporate entity.
I take on board the points made by Senator Finneran and Senator Henry about the hypothetical situation where an individual could be pursued in a particular instance. The National Drugs Advisory Board has looked at this possibility and I will make sure that the Irish Medicines Board will also consider it. I must be guided by the legal advice available to me, which is that an administrative solution appears to be the better road to follow.
Under this section the Minister or the Government will make funds available to the Irish Medicines Board. The intention is possibly good but I see a situation — this arises with every board — where moneys will be scarce and what should be available may not be so. In such situations boards sink or swim and they raise money the only way they can. The only way this board will be able to raise money is to look for new business or charge fees. It will not have any other opportunity to raise funds to maintain itself.
I am told that the National Drugs Advisory Board headquarters is in a poor state of repair and needs massive refurbishment. What type of grant does the Minister envisage being made available to this board on an annual basis? Are we talking about a once off grant to get the building up and running and refurbished or about a set amount? Has the Minister decided the amount of the grant which may be made available on an annual basis?
Essentially, as I stated last week, consultants are at present looking at the operations of the National Drugs Advisory Board with the mandate to come up with recommendations as to how the new board should be resourced and structured and how it can operate most effectively to achieve the objectives we all share. The Senator's question may be slightly previous in the sense that until those recommendations have been fully assessed the financial implication is not fully clear but the commitment is to provide the resources necessary so that the board can operate to its fullest in the interests of public safety and health.
I appreciate that. I expect that the board will be able to raise plenty of money other than by charging fees by tapping into the great deal of expertise which is available. However, I do not think it will be able to do so unless there is a proper infrastructure of buildings and equipment. This is why I ask the Minister not to let the board off on half a leg. It needs a good start up and it is important that it is put on a good solid footing with regard to finance, equipment and its building. It must be allowed develop an understanding and status among our partners in Europe so that it will obtain the work which will provide it with finance. I hope the consultants are looking at the issue on this basis and that the board will not be strapped for cash and that it will be in a position to avail of the great opportunities which exist.
I agree fully that the board must be given every possible assistance, not only to do its work in the best possible way but also to attract extra prestigious work from the European agency which would do a great deal for the image of our country, institutions and professions. I share the Senator's views and it is my intention that what is necessary will be provided.
Question put and agreed to.
SECTION 16.
Question proposed: "That section 16 stand part of the Bill."
This section allows the board to accept gifts but there must not be a conflict of interest. Why should the board accept gifts in any circumstances? I do not see why it should have any authority to do so. Why does it want gifts? Does it want them for the mantelpiece or is there a different reason? Are gifts to be accepted on the basis that they are for research? Gifts may give rise to a conflict of interest and companies who give gifts may feel they have a leg in. In what circumstances may gifts be accepted?
We are talking about a standard provision. Gifts could not be accepted which would compromise the perception of the board's impartiality. A bequest could be made to the board or a benefactor could decide to provide money for a particular project. For example, pictures, etc., could be given as gifts to the board. However, gifts cannot compromise the board or be seen to undermine its independent image.
I appreciate the Minister's point about bequests. What is the situation as regards public knowledge of gifts received by the board? Will the chairman and members of the board be subject to the same guidelines and regulations to which the Minister and Members of this House are subject as regards receiving gifts? Will they have to publish in a journal the details of gifts received? If we want ethics in public office then the Irish Medicines Board should be in the same category as people in public life.
Section 24 deals with conflicts of interest and disclosures. The accounts of the Irish Medicines Board will be audited by the Comptroller and Auditor General. The annual report of the board must be given to the Minister within six months of the end of the previous financial year. This report will then be laid before both Houses of the Oireachtas. Full and sufficient safeguards are provided in this regard.
I appreciate the content of section 24. However, will the details of gifts and bequests be published in a journal? Will the board and its members, who are the Minister's appointees, be subject to the same regulations and guidelines which apply to public representatives in the Ethics in Public Office Bill?
May I deal with section 24 now because it provides the answer to the Senator's query?
We must stay with section 16.
I ask the Senator to bear with me until I am allowed to discuss section 24. We need to make the distinction that this section deals with gifts to the board. Any financial gift must be included in the accounts which is a sufficient public record. The accounts will be audited by the Comptroller and Auditor General.
What about gifts other than financial ones?
Gifts would have a financial value and that must be taken on board in the context of the accounts. If there is no clear procedure in this regard I will look at that in the context of regulations. However, the monetary value of the gift will appear in the accounts.
Question put and agreed to.
SECTION 17.
Question proposed: "That section 17 stand part of the Bill."
Section 17 deals with the ability of the board to borrow money. What amount of money are we talking about? Will the Minister decide on the limit to which the board may borrow and must the Houses of the Oireachtas verify this? Perhaps the Minister could clarify the amount of money the board will be allowed to borrow and the information which will be given to the public in this regard.
We are dealing with a standard provision in this legislation. The section permits the board to borrow money for current or capital purposes, but only with the consent of the Minister for Health and the Minister for Finance. It is an enabling section which is prudent and necessary so that the board can operate to its full potential. I do not know what may arise in the future, but the power exists, subject to the consent of the Minister for Health and the Minister for Finance, for the board to borrow at the appropriate time for current expenditure or capital purposes.
Is there a limit to the amount the board may borrow for current or capital purposes? Is it £2 million or £5 million?
That decision is at the discretion of the Minister for Health and the Minister for Finance.
That is not a good practice. Limits were placed on borrowing in other legislation, including the legislation for the National Roads Authority. It is wrong that a board should be allowed to make proposals to a Minister as regards borrowing. The taxpayer is continuosly bailing out companies, including semi-State companies, such as Irish Steel and Bord na Móna. It is crazy to introduce legislation which does not tie down borrowing.
There should not be a situation where a board can come to a Minister with a good CV, state it needs a certain amount of money and the Minister must decide whether to provide it. If he does not, he must give a grant but because the Department has insufficient funds he allows it to borrow money. This is crazy and this type of legislation, which is bad, will ensure that future generations must pick up the tab. It provides an open cheque book. When the board comes to the Minister looking for funds, at the same time ten Deputies and five Senators will be putting pressure on the Minister to secure particular projects for their county or constituency. The Minister will tell the board to borrow money because he must look after X, Y or Z. This is what will happen. This section is bad.
The Minister should address this aspect, if possible, by regulation. The section is contrary to much of the debate in recent times about accountability. It means no limit must be maintained. No person could meet that requirement so why should public boards, appointed by the Minister, be faced with the position where they can come forward with any type of scheme they wish? I am not suggesting the board will do this but it is bad legislation if it provides such an opportunity.
There is a similar section in most Bills. A board cannot borrow without the consent of the Minister for Finance. He must agree to the board borrowing.
That is no great help in those situations.
This is enabling legislation and similar provisions are regularly contained in other Bills. The following sections are also similar to those contained in most Bills which come before the House.
We must consider this matter in context. The Government decision is that the board should be self-financing. I disagree this section is imprudent. The board must have the wherewithal to seek money from the Ministers for Finance and Health in the first instance if the contingency arises. For example, it could have a short-term shortfall in its cash flow and it might be necessary to negotiate some bridging arrangement with a bank. Another example is that new property or equipment is required and the board deems it prudent that payment should be deferred over a number of years.
I do not envisage that exorbitant or unjustified requests for borrowings will emanate from the board with regard to the section. The taxpayer has the double protection of the Minister for Health, who will be in close contact with the board given the issue of fees, and the Minister for Finance, who is ultimately responsible for the public purse. The section is both prudent and practical. It is required in an operational sense by the board.
I do not doubt the Minister is sincere but we must consider the record of the last number of years. Just a few years ago, eight health boards borrowed £50 million above and beyond the amounts allocated to them by the Department of Health with the sanction of the Minister for Health, although it involved different Ministers. Another example is Bord na Móna, which had debts of over £200 million. Although this has been pulled back to approximately £170 million or £180 million the taxpayer will pick up the tab for £120 million. In the case of Irish Steel, I understand £21 million of taxpayers' money must be spent just to get somebody to buy it.
This situation is open to abuse. The Bill does not contain any provision to ensure that applications for borrowing must come before the House. There will be cases of the board applying to the Minister and the Minister either coming up with a grant or giving the board an opportunity to borrow. This appears to be the bottom line with regard to this section. When money is scarce the Minister will tell the board to borrow because he needs the funds for something else. This is what, unfortunately, will happen. If the Bill contained a provision or there was a regulation that applications for borrowing must come before the House, people would have an opportunity to express their views on whether that is advisable. The matter would be in the public domain and would not be debated after the fact, as happened in many other cases up to now.
There is no amendment before me regarding limiting the borrowing. The alternative is to delete section 17 and this is totally undesirable. It would constrain the board's activities.
Question put and agreed to.
SECTION 18.
Question proposed: "That section 18 stand part of the Bill."
This section deals with accounts and in this context, we are discussing reports of accounts. I am not sure whether this point relates to this section. However, the issue of the accounts is most important. It is also most important that the accounts are available for consideration at an early date. The section contains what I consider is the only safeguard in this area. I presume the accounts will be covered by the issues I mentioned earlier in relation to other aspects.
I apologise to the Senator but I did not catch his last points.
I referred to the board's accounts, which I presume will be made public. Will they be laid before the Houses or will they form part of the report mentioned in section 19? Will this matter be dealt with by another section?
I refer the Senator to subsection (6), which states:
The accounts of the Board for each year shall be prepared in such form and manner as may be specified by the Minister. The accounts shall be submitted as soon as may be but not later than 3 months after the end of the financial year to which they relate by the Board to the Comptroller and Auditor General for audit. A copy of the accounts and the auditor's report thereon shall be presented to the members of the Board and to the Minister as soon as may be and the Minister shall cause a copy of the documents aforesaid to be laid before each House of the Oireachtas.
I understand that. However, at what stage will they be laid before the Houses? Does the Bill contain a provision in this regard? To some extent the next section provides an opportunity to deal with this point in terms of a report. However, what onus is placed on the Minister? Is there any limit on the time available to the Minister to lay those documents before the Houses? Must he lay them before the Houses within one month, two months, three months or six months? What is the position? The Minister receives the accounts from the board and he then lays them before the Oireachtas. However, the Bill does not state how soon they must be laid before the Oireachtas after the Minister receives them. Perhaps the Minister could clarify this aspect, or am I missing something in the Bill?
No particular time limit is placed on the Minister with regard to placing the report he or she receives from the Comptroller and Auditor General before the Houses of the Oireachtas. However, if an undue delay takes place there are parliamentary methods by which that matter may be pursued. If we follow the Senator's line we are attributing bad faith to Ministers by stating that they might delay the publication of these particular documents. The Senator is seeking something which is without precedent. This is the standard approach used in legislation in relation to the publication of documents.
The accounts must be placed before the Comptroller and Auditor General within three months. The speed with which the Comptroller and Auditor General then deals with them is another issue entirely. I do not see a reason why any Minister would delay publication of the accounts. If it appears that an undue delay has taken place, parliamentary devices exist to pursue that particular matter.
I agree that such devices exist. Some Members of the Houses of the Oireachtas are better watchdogs than others. However, the National Drugs Advisory Board has not submitted a report for the past four years. Is it appropriate that this legislation should permit the same type of poor practice to obtain again?
I am not defending the situation described by the Senator. A collective four year report is with the printers at present. I agree that an unacceptable delay took place. However, with the procedure provided for in this section, and the onus placed on the board in section 19 to present its annual report to the Minister within six months and its accounts within three months, I believe that this type of delay will not now arise.
Question put and agreed to.
SECTION 19.
I move amendment No. 6:
In page 14, subsection (1), line 5, after "Oireachtas" to add "within six months of the Board's financial year-end".
There is a good reason for this amendment which follows from the debate on section 18. It appears that the legislation deals with matters in this area but it only goes perhaps 60 to 75 per cent of the way. The legislation does not contain a control mechanism to deal with a delay in publishing the board's report. Only when a delay occurs can individual Members inquire why the report has not been laid before the Houses of the Oireachtas.
The legislation provides that the report be supplied to the Minister within six months. However, there is no provision regarding when the Minister should lay that report before the Houses. Therein lies the difficulty. That is the reason I tabled this amendment. I believe a gap exists in the legislation. It is unbelievable that this Bill has come before the House without a provision that the Minister should place the audited accounts and the report of the board before this House within a particular period. The only provision included is that the Minister must receive the audited accounts from the board within three months and the annual report within six months.
The Bill contains no provision that the Minister must place the audited accounts or annual report before both Houses within a specified period. It is completely incorrect that this legislation should be introduced in this manner when past events are taken into consideration. I repeat that the National Drugs Advisory Board has not issued a report for the past four years. The legislation before the House provides for the establishment of the Irish Medicines Board. However, the legislation contains no provision to oblige the Minister to place that annual report before either House within a specific period. That is a major gap in the legislation.
I have examined the proposed amendment and sought the advice of the parliamentary draftsman in relation to it. I am advised that the section, as proposed in the Bill, is the standard form in relation to State bodies and that the proposed amendment is without precedent. The Bill provides that the board shall furnish the Minister with a report no later than six months after the end of each financial year. There is no reason why the Minister would not lay such reports before the Houses as soon as may be after that. However, as the proposal is without precedent, I am unable to accept the amendment.
Perhaps we should create a precedent. We would receive more respect from the public if we did decide to create some precedents. Dealing with matters in the public domain is an issue of great interest to the public in general at present. In many cases members of the public are not satisfied with the current process in this regard. The public could not be satisfied with the situation where the National Drugs Advisory Board has not brought forward a report during the past four years.
Under this legislation the Irish Medicines Board is obliged to place its report before the Minister, but the Minister is not obliged to lay it before the Houses of the Oireachtas. It is time that we set a precedent. A strict rule should be put in place that the board must produce its accounts and report within a certain period and that the Minister in turn must lay these before the Houses within a specific period of time. I do not care if this creates a precedent. It is about time we created a precedent. That is what should happen. The fact that this may not have been normal procedure in the past is no good reason not to do it now.
If we are to allay public scepticism regarding issues which are supposed to be dealt with in the public domain, the legislation we are enacting should include provisions which lay down strict guidelines. The proper guideline is not laid down in this situation. This legislation places no onus on the Minister to lay the annual report before the Houses of the Oireachtas within a particular period. I believe that is wrong. I intend no disrespect to the Minister, but it would be better if he were obliged under law to bring forward that report. We would be better off with such legislation. The public could then read the annual report and Members analyse and debate its contents. Otherwise things can slip and that should not be the case.
It is an unfortunate omission from the Bill that the Minister is not required to lay the audited accounts and annual report of the Irish Medicines Board before this House within a specific period. The amendment recommends that he should do so within six months of the end of the board's financial year. I believe that this is a reasonable amendment. The Minister should reconsider the situation regardless of precedent. He should set a precedent if necessary. Maybe other situations will follow and it will be all for the better as regards the public perception of what is happening.
The Houses of the Oireachtas, not just the Minister, are entitled to know within a specific period. While the Minister has a job to do, Members of both Houses are entitled to have reports such as the annual report of the Irish Medicines Board presented to them by the Minister within a specified period. My amendment seeks to make that happen "within six months of the Board's financial year-end". It is a reasonable request and one the public expects us to make as public representatives. The Minister should reconsider the situation even though the advice he has received is that there is no precedent for it. That reason is not good enough.
There is an opportunity here to set down a guideline or marker as regards what should happen with annual reports. Too often we are reading history in annual reports and that is not good enough. We have a responsibility to make sure the public gets an opportunity of evaluating and analysing what has happened recently in State boards, not something that happened four or five years later when it is confined to the history books. Debts, for example, usually have to be picked up by the taxpayer.
A lack of public confidence has developed as regards the National Drugs Advisory Board concerning the anti-D and hepatitis C issues. It is a national scandal that a State agency was responsible for that and the same State agency has not produced an annual report for four years. This matter is fundamental to developing genuine openness and accountability by Government and State boards to the public. The Minister should reconsider the situation because the public is demanding that type of approach.
To create precedent just for the sake of it is not good legislation. As I stated earlier in the debate, in any given situation legal reasons may prevent immediate publication of the annual report, or the Minister may require further information or clarification. If you tie the Minister's hands in saying that the report must be published by a certain date, that does not mean that the public at large or the parliamentarians are going to get the best report in the shortest time.
The amendment would place a statutory obligation in this legislation for the production of the annual report within six months. That would make it a legal requirement for the board to provide it. Obviously we cannot pre-empt in legislation the role of any Minister who, for whatever reason, may need further clarification or may have to examine the legal implications of publishing certain information. Those are just some of the difficulties that could arise. If we specify a time we may not be giving the Minister an opportunity to provide the best report.
The Minister said there may be legal constraints, further information may be needed and, although he did not say it, there may be litigation in some situations. I am sure the public and Members of the Oireachtas would fully understand if there were problems, provided the Minister explained to the House the reasons why the report could not be published. Perhaps an interim report could be published inside six months. Regulations could be put in place by the Minister for such an eventuality.
However, the principle of my amendment is that the Minister should bring the report before the Oireachtas within six months from the time he receives it. That does not impinge too much on the Minister's position in evaluating situations or taking further advice.
The general public is sceptical of the attitude of public officials and representatives about reports. One only has to look at certain tribunals and investigations that have taken place. By the time these reports become public they are no longer relevant, they are history books. We must get away from that and into a situation where our public business is relevant and up-to-date. It is an ideal opportunity for the Minister to deal with this, whether it creates precedent or not. The Minister will not create bad law and, in my view, it would be a good precedent.
Amendment put and declared lost.
Section 19 agreed to.
Sections 20 and 21 agreed to.
SECTION 22.
Question proposed: "That section 22 stand part of the Bill."
The situation has developed, not just on this board but in many cases, where Members of the Oireachtas cannot be members of boards nationally. I am not sure whether that is a good thing. It is something that has developed in recent times and I wonder if it is the best situation. What is the conflict in a Member of Seanad Éireann being a member of this or any other board? I do not see that there would be any great conflict. Is it a Government ruling or something that just applies to this board? Is there a ruling on this at a higher level than this Bill?
This provision is contained in other legislation. It goes back a number of years and it is standard nowadays. That is why it is included here.
I do not know if anyone is sure why this prohibition on Oireachtas Members becoming members of State boards was introduced but it has certainly led to debate in this House. Would it be possible before this debate concludes to find out why this provision was made? I accept that this provision was included by previous Governments in other legislation. Senator Finneran made a point about an amendment which he wished to make to the Bill, but he was told it was not acceptable because there was no precedent. Now we are doing things but we cannot remember why we did them in the first instance. We should find out why we are including something in legislation before it is passed.
I will try to get that information. I recall researching this matter in the context of a previous Bill. A Government decision was made some time ago.
I believe it was when the Minister was conducting the An Bord Bia Bill, 1994.
That is correct. I recall that it required much research. I do not want to mislead the House but I believe it was an informal Government decision, although I am not absolutely certain. I will try to get the correct information before we finish or I will convey it to the Senators as soon as I get it.
Question put and agreed to.
Section 23 agreed to.
SECTION 24.
Question proposed: "That section 24 stand part of the Bill."
The Minister indicated that he would provide extra information on this section.
This section places an obligation on the chief executive, members and employees of the board, members of advisory committees and subcommittees or advisers or consultants to the board to disclose any interests they may have which are material to any matter which the board or the committee may have to consider. It creates an offence for failure to do so. That is standard and relates to a conflict of interest. It is well covered in this section.
Are members of the board, the advisory committee and the chairman subject to the Ethics in Public Office Bill as it applies to Members of the Oireachtas?
I understand that Bill will come before the House after this. I am not avoiding the question but it is a matter for that legislation as it concludes its passage.
Acting Chairman
The relevance to the section is questionable.
It involves a conflict of interest and what people would declare.
Acting Chairman
The scope of the Ethics in Public Office Bill does not cover these circumstances.
That was the question I put to the Minister. I appreciate the Bill has not yet been passed and maybe this is hypothetical but is this not something which should be considered as regards this new board and future boards? This should not be confined to Members of Dáil or Seanad Éireann. The Minister said the amount of financial gifts would be contained in the annual report. He also said the value of non-financial gifts would be included. Will all gifts given to the chairman or the board as a corporate body be itemised in the annual report?
The section relating to gifts concerns the body corporate not gifts to individuals. Members of the board may be subject to the provisions of the Ethics in Public Office Bill, but I am not dealing with that legislation at present. Gifts in this legislation relate to those to the body corporate.
Will those gifts be itemised in the annual report?
Gifts with a monetary value will be included in the annual report. I assume — subject to clarification — that the monetary value of other gifts would also be included.
If a pharmaceutical company arranged a round the world trip for five members of the board, would that be logged in the annual report?
That would need to be disclosed under section 24.
I would be more concerned that gifts to individual members of the board would be made known as distinct from gifts to the body corporate. The House of Commons has just dealt with lobbying and gifts. An individual may be induced to make a favourable decision in relation to a product. I believe individual members may be more vulnerable and there is a need to ensure that gifts to individuals are disclosed.
I accept that point.
Question put and agreed to.
Sections 25 to 28, inclusive, agreed to.
SECTION 29.
Question proposed: "That section 29 stand part of the Bill."
Section 29 relates to legal proceedings. The new board will take on the role of the National Drugs Advisory Board. That is of concern to over 1,000 women who are seeking compensation in respect of hepatitis C and anti-D. I understand these people are worried that this matter is not being dealt with in an appropriate manner.
The Minister said that in the event of legal proceedings being taken — and this, to some extent, comes back to what Senator Henry and I queried on Second Stage and, again, on Committee Stage where our amendment was ruled out of order — it would be against the body corporate of the board. Can he elaborate a little under this section? Is there any difference between what the procedure would be for legal proceedings against the National Drugs Advisory Board and those which might be taken against the Irish Medicines Board?
This section deals with pending legal proceedings. This is a standard provision to allow the continuance of any legal proceedings involving the National Drugs Advisory Board, with the substitution of the new board for the National Drugs Advisory Board in any such proceedings. Effectively, it is moving liability from the National Drugs Advisory Board to the new board. That is the basis of this particular section.
Question put and agreed to.
Sections 30 and 31 agreed to.
SECTION 32.
Question proposed: "That section 32 stands part of the Bill."
This section relates to the manufacture, production, preparation, sale, supply and placing on the market of medicinal products. In recent times we had a situation where contraceptives were debated in the public domain as a result of a particular study which was carried out, not in this country but in Canada. I understand those products have not been taken off the market here.
What role has the Irish Medicines Board in that type of scenario? Notice was given in England that there could be problems but we had no such notice here as far as I know. Would we be governed by European clearance on it, or would there be Irish clearance? Does the Minister see the Irish Medicines Board commenting on such a situation as developed with these contraceptives?
Essentially, this board deals with regulations for the Irish market. When the particular information became available in Britain, the National Drugs Advisory Board immediately applied itself to that situation. Indeed, it was referred to the European agency. Subsequently, a statement was issued by the National Drugs Advisory Board. The bottom line was that anyone who had concerns should consult with their medical advisers.
This is the enabling general section for regulations as they apply to the Irish situation. There is the other situation where we can get contracts from the European agency for European licensing.
Will this new board undertake any kind of research? Is there ongoing research and analysis of the safety of products which have been on the market for years, like the contraceptive pills which came in for comment recently? Are we relying specifically on research which is carried out abroad? Do we monitor the products which have been on the market for some time?
Where adverse reactions are reported, yes. This is something which we debated at some length earlier. The board will obviously have to take cognisance of any difficulties which may arise, particularly when they are reported.
Other than referring women to their GPs, is the Irish Medicines Board or the National Drugs Advisory Board undertaking any research into the products which have been described as "potentially" dangerous?
Not to my knowledge. The actual results of the research, which I understand are not fully validated at this point in time, were referred to the European agency. Subsequently, the National Drugs Advisory Board issued a statement to give the correct medical advice to patients as of the present state of knowledge.
They monitor the production of pharmaceuticals in this country, do they not, and assure the standards are kept up? From that point of view, one could, I suppose, say it was their research.
Yes.
I accept what the Minister says. I am a little concerned that we may end up with another crisis. It is unfair to place the onus on GPs until a decision is made, the research is validated or the European agency decides. GPs are being placed in a very dangerous position. It is a kind of "suck it and see" attitude and that sort of responsibility should not be placed on GPs. If it transpires there are side effects from these contraceptives, we could see GPs faced with litigation because the statutory agency has not taken a line on them.
We discussed the liability of members of the board in another section to which Senator Finneran had proposed an amendment. A decision at a governmental level by the drugs advisory agency or any agency to the effect that one should seek advice from one's GP — and I know of women who have gone to their GPs and have been reassured that the product may be safe — is not a responsible enough approach to take to a medication about which there has been some suggestion of side effects.
The evidence is that the risk is very small. Until the evidence is to the contrary, the position is as stated.
Question put and agreed to.
Sections 33 to 38, inclusive, agreed to.
Schedule agreed to.
Title agreed to.
Bill reported without amendment and received for final consideration.
Question proposed: "That the Bill do now pass."
While this piece of legislation has been of a technical nature, it is important. I thank the Minister for the efficient and courteous way in which he steered this Bill through the House.
I join with Senator Doyle in thanking the Minister for the courteous way in which he addressed all the issues raised. While we did not agree on them all and he was not prepared to accept our amendments, his approach to answering questions and giving information to the House is to be commended. I thank him for that. He has always been of that manner in this House and he is an example to the House in his dealings with Bills or statements.
I, too, thank the Minister for understanding our concern about this Bill, which is of extreme importance to the general public, the medical profession and all those involved in hospitals, pharmacies and so forth. I hope that Bill is received in the sanguine way the Minister suggests, particularly in the area of immunity.
I thank the Minister for taking the Bill through the Seanad. Important points were raised by all Members. We cannot be too careful when dealing with medicines. I congratulate the Minister.
I thank Senators for their kind remarks and the constructive and positive way in which the debate was conducted. It was searching at times but that is to be welcomed and the legislation is the better for it. My undertakings about regulations will be honoured. As soon as the Bill is passed we will set about getting the board in place as quickly as possible. I thank all Members for their help and co-operation during the passage of the Bill.
Question put and agreed to.
Acting Chairman
I join with the House in thanking the Minister.
As it is now 6 p.m. by order of the House we will move to item 21. There will not be time to take item 2, the Ethics in Public Office motion.