On Second Stage I indicated that the board would be bound by the EU requirement that applications for product authorisations should be processed within 120 days. This, of course, should have been 210 days. I regret that this inadvertent transposition of figures in the briefing notes supplied to me resulted in me giving incorrect information to the Seanad. As soon as I became aware of the mistake I asked to have the record amended to show the correct period of time. To clarify the situation EU Directive 65/65 requires that member states should take steps to ensure that the procedure for granting an authorisation is completed within 210 days of a valid application and, of course, this operates on a stop the clock basis.
Irish Medicines Board Bill, 1995: Committee Stage.
Question proposed: "That section 1 stand part of the Bill."
Question put and agreed to.
Section 2 agreed to.
SECTION 3.
Amendment No. 1 is out of order as it involves a potential charge on the Revenue.
Amendment No. 1 not moved.
Question proposed: "That section 3 stand part of the Bill."
Senator Lee asked me if it is possible to table amendments which will save money. The Minister can think about this and if, during the course of the debate, I think of anything which will save money we will see if that will be allowed.
I am sorry the amendment is out of order because the indemnification of members of the board and the advisory committees is important. This situation with regard to members of the board has been brought to my attention by people who have already served on various boards. I pointed out the invidious position they could be in and the possibility that this is being considered in other jurisdictions as well, given the hasty action of the committee on the safety of medicines in Great Britain. The Minister said that if such a claim is made against the board he will look at its financial situation at that time. However, that is not satisfactory.
I am not only concerned about individual patients suing the board but also about companies who may sue it. I understand from previous court cases that companies have constitutional rights as well. A pharmaceutical company which believes it has been wronged by the board will also be in a position to sue it. It is possible that a company which has a major interest in a drug that is widely prescribed on the Irish market could take a case against the board and this could tie up the ratification of a licence for a generic and delay its production.
There could be problems as regards the board's immunity from prosecution. I realise it is not possible to confer absolute immunity on the board and that only limited immunity can be conferred on it. Those on the board will be considered to have acted in good faith and the only way they can be considered to have been negligent is if it is wilful negligence or they have acted intentionally in a wrongful manner. However, I doubt if that will happen.
Indemnity was provided in the Clinical Trials Bill. I am worried that the Minister is getting the same advice as was given in 1987 during the debate on the Clinical Trials Bill. An amendment had to be introduced for immunity in the 1990 Bill. I would not like to see that happening in this Bill. This is a serious problem. I have not been able to provide a solution, apart from asking for indemnity for the board and for those on it and advising it.
I accept the Minister's statement that applications for product authorisations should be processed within 210 days instead of 120 days.
As regards this amendment which was tabled by Senator Henry and myself, we referred to this matter on Second Stage. This is an area of major concern which could cause problems at a later stage. Could professional people refuse to make themselves available to the board on a secondment or contract basis to carry out research on behalf of the Irish Medicines Board because indemnity is not provided? Anyone may follow the board or its members if a drug causes problems. Under the existing system such matters were referred back to the Minister and the Department of Health, but the new system seems to have great independence.
What will happen if someone proves that a certain drug has done them damage and compensation has to be paid? Will the members, staff and professionals, like scientists who may carry out certain investigations, involved with the board feel they are in danger of involvement of litigation? The Minister will have to explain that matter further. These drugs might not only damage a person's health. This Bill also covers veterinary medicine and livestock could be damaged. That person could then make a claim against the board or its staff.
Senator Henry and I did not put this amendment down just to hold up proceedings.We are taken aback that the provision could be interpreted in this way. I cannot argue against it because I do not know all the facts. Sometimes I wonder if it is being used so that none of us can challenge it. The concern is there and it has been expressed by many people, including Senator Henry and myself. If what was said on Second Stage in this House and in the Dáil is any evidence to go by, it still remains.
Will the Minister elaborate on this matter further and see if definite information can be given so that the people concerned will not be involved in litigation as a result of this Bill being passed in its present form? We would prefer to have proper safeguards in the Bill to ensure that the likelihood of litigation against the staff of the board will not be possible.
I support Senators Finneran and Henry. This matter was raised during the Second Stage debate. It is hardly acceptable that the Minister should give this kind of responsibility to the new board. Under this legislation, it will become the new licensing authority and that is a huge weight of responsibility to place on any board.
It appears that the board has been given little protection under this section. Senator Finneran asked a number of questions. Usually many people hope to be appointed to State and semi-State boards. However, under the ambiguous content of this section, one will find, as Senator Finneran said — Senator Henry also said it on Second Stage — that able, capable and competent people will not seek appointment to this board and may even refuse an appointment if offered it. Being a member of a licensing authority for any drug is an onerous position. Giving responsibility for veterinary products may be one matter, but to give responsibility for licensing human medication and blood products, which caused great concern recently, to a board without appearing to give it any kind of protection would be its downfall.I cannot see why anybody would seek or accept an appointment to this board unless they were guaranteed some kind of protection.
On Second Stage, I asked who would be liable to be prosecuted if a product is found to have been faulty or caused problems. Would it be the board or the Minister? I know the Minister is no longer the licensing authority but if the board is responsible, the fears raised by Senators Finneran and Henry about this section may be real. If the board is the body that will be sued if a product is at fault, I would not want to be part of it unless I knew I would be indemnified, not for taking wrong decisions, but for taking decisions made in good faith and with the knowledge available to the board at the time. The Minister will have to reassure us that members of the board will be protected.
I am no expert in medicine or law but I support the concerns expressed by the previous speakers and hope they can be resolved in as satisfactory a way as possible.
Members of the board are in the potential firing line if these issues arise. Section 9 (8) states: "The Board shall not refuse to grant a licence in respect of a medicinal product on any ground relating to the safety, quality, or efficacy of a medicinal product unless it has requested the advice of the appropriate committee in relation thereto and considered such advice."
To my layman's mind, this seems to implicate the members of a committee in whatever decision is made. Looking at the phraseology of the section, I am requesting clarification of how far members of committees might be implicated in any legal actions that might arise. I am speaking from a position of ignorance so this is simply a request for information.
Senator Henry referred to immunity in the Clinical Trials Act. The firm legal advice given to me is that this immunity extends to the new board in respect of all its functions on foot of section 34 of the Bill.
I have given careful consideration to the question of providing a statutory indemnification for persons carrying out assessments or other functions for the board. I have also taken legal advice as to whether this would be an appropriate matter for the Bill. I should stress that there have not been any practical difficulties in this area over the years. In any case up to now in the courts it has always been the National Drugs Advisory Board, as a corporate identity, that was cited. However, I accept that there has been some recent concern about the hypothetical possibility that legal action could be taken against the specific individual.I am advised that this is most unlikely as all actions taken by individuals would be done in the name, and on behalf of, the board as a corporate entity. But, we must, nonetheless, accept it as a possibility, however slight.
I am advised that an administrative, rather than a statutory, solution to this possible problem would be more appropriate and I am aware that the National Drugs Advisory Board has been looking at the possible administrative options. It may emerge, for instance, that an insurance based solution is the best option or the board may agree that it will indemnify advisers in respect of furnishing advice to the board. If it was necessary for the Minister to make funds available to the board arising out of such indemnities, this can be done under section 15 of the Bill.
I am certain the new Irish Medicines Board will continue to examine the issue so that the option which emerges as the most suitable can be implemented if it is found that the question of indemnity is proving a genuine obstacle to the board carrying out its functions, although I again stress that it has not been an obstacle up to now.
Given that such an administrative solution is feasible, the legal advice available to me is that the inclusion of a general statutory indemnity provision in the Bill is not appropriate.
I appreciate that section 15, which allows for grants to be made to the board, is there. However, I am not sure if it was ever intended to be used for compensation cases. Maybe that section is a safety valve. I mentioned property because this Bill covers veterinary medicine as well. The Minister did not respond to that point and he might do that.
I am sure section 15 can be used and maybe an administrative solution to this problem is the better one. There is the possibility of a bond being given to the board, but one does not know how much to ask for. The Minister mentioned an insurance based solution, but what insurance company will take on something without knowing the risk involved? I am not an expert on insurance but normally one has to give some notion of the expected risk on which the insurance company will assess the cost. The one trouble with having a bond system to indemnify advisers is that it may encourage litigation and suing is much more open now than it was some years ago. When the Minister says problems have not arisen, it is not strictly true. There was successful litigation in the case of Scotia Pharmaceuticals, against the board. Alarm has not been raised in this jurisdiction about the possibility of members of boards being threatened with litigation but there has been anxiety about it in other jurisdictions and we may be sure that what happens in one place will happen in another. There was a Supreme Court case a few years ago in which the Supreme Court allowed an individual to sue the Department of Post and Telegraphs without having to have the Attorney General's permission.
Any board nowadays is far more open to litigation. Can boards such as An Bord Pleanála who make decisions involving a great deal of money be indemnified or can the Minister be sued? This is an area where we have the problem that individuals or a group can sue if they feel they have been damaged. Later this evening, during Private Members' Business, we will have a debate on this issue and how to resolve it.
As well as that, we have the problem where a company under the Constitution is also in a position to sue. It is all very well to say this has not happened in the past, but our experience of the Control of Clinical Trials Act, 1987, shows that it had to be amended after three years, because of concerns about immunity. Members who have served so ably on the National Drugs Advisory Board are concerned about the possibility of litigation on the new board, within the committees of the board and so forth. An insurance based administrative solution seems vague. I do not know how one gets an insurance firm to quote on the risk of being sued since none of us is in a position to know what that risk is.
Senator Finneran raised a question as to the outcome if property is damaged by a particular medicine and he instanced the case of animals on a veterinary medicine. If a difficulty arises, the person who suffers the damage has to examine where liability may lie. It may lie in a number of different agents at different stages in the process between manufacture, the arrival of the product on the farm and it being administered to the animals. If an individual believes a decision to licence a product has resulted in him suffering serious loss it is open to him to sue. It is then up to courts to judge whether that person has a basis for seeking compensation. It may not be only the proposed Irish medicines board that could be joined in such litigation.
On the various points raised by Senator Henry, it is a commercial decision for an insurance company whether it will insure against a risk or as to what premium it may seek. This system could be a solution and it would be for the board, if it so decided, to seek to have an insurance based indemnity for advisers.
The National Drugs Advisory Board has been looking at this problem with a view to coming up with the best possible solution and that examination will continue during the lifetime of the proposed Irish medicines board. As the Senator conceded, this is not a problem for which there is a ready-made or easy answer. I assure the Senator that I am concerned about it and, when the new board is being set up, I will make it aware of the concerns expressed in the House during the debate on the Bill and ask it to give special attention to continuing the work being done on this by the National Drugs Advisory Board.
The Minister mentioned section 15 as a section which would authorise a Minister to make a payment "after consultation with the Board in relation to its proposed work programme and expenditure for that year". I presume that, strictly speaking, the board will not propose to incur expenditure that would arise from payment for litigation, unless it sets aside a specific amount in anticipation. I do not want to be difficult, but the word "proposed" qualifies both "work programme" and "expenditure" and I wonder if it is a slightly inelegant way of expressing a contingency which we hope does not arise.
I take the point that the way the section is phrased refers to the coming year, but when a difficulty like this arises, it does not arise overnight and it is something that would obviously be taken into consideration in the context of ongoing discussions between the Department of Health and the Department of Finance at a particular time. I take the point but I do not foresee any practical difficulty there.
Question put and agreed to.
SECTION 4.
Question proposed: "That section 4 stand part of the Bill."
I wish to comment on a number of areas in section 4. We must remember why the Bill is before the House and why these matters are being debated — the inability of the previous board to protect the interest of the individual.Paragraph (1) covers this aspect. It states:
to establish and administer a service for the inspection of any service for the collection, screening, processing and quality control facilities and procedures in respect of human blood, blood components, blood products and plasma derivatives for the purpose of ensuring the safety and quality of blood, blood components...
This is the reason behind the Bill. It would not be before the House if the scandal with regard to hepatitis C and anti-D had not occurred recently. The legislation came about as a result of the inability of a State agency to carry out its function in a proper way. The public will be interested to know whether the new board will have better controls and will be in a position to ensure what happened in the past will not recur. I hope the Minister will cover this point in his reply.
Clinical trials worry some people. They feel much goes on about which they do not know. This may be right or wrong but that perception exists. I understand the Bill refers to the Control of Clinical Trials Acts, 1987 and 1990, and safeguards are included in that regard. However, worry exists about this area. There are major chemical and legal drugs industries in this country. There is a major problem with regard to illegal drugs but that relates to a different Department.
The chemical industry involves the development of a range of medicines. I made the point on Second Stage that there is a need for a great level of cooperation between the pharmaceutical companies, the new board and the Department of Health; none can work in isolation. However, we must remember the pharmaceutical companies exist to make money. This is their bottom line but the business of the Department of Health and the Government is to ensure that safe medicines are provided to the citizens of the State. The Bill provides for this responsibility. All necessary protections with regard to clinical trials should be included. In his reply, I hope the Minister will state that definite guidelines and protections exist for individuals in this regard. A death occurred some years ago in a health board area as a result of a clinical trial.
With regard to the connection between the Irish medicines board and the European structure in terms of the investigation of medicines, will the Minister outline the exact position? Will the board accept decisions or conclusions already reached by the European structure regarding the investigation of medicines and those considered safe? Will it be able automatically to take those medicines as sacrosanct, which means it would be unnecessary for it to carry out its own individual investigation, or will the responsibility rest with the board to carry out further investigations and prove to itself that these medicines are safe for the Irish public?
The section covering the functions of the board is most important. Senator Finneran raised the points I wished to cover regarding the control of clinical trials. Paragraphs (f) and (i) will be particularly important if the number of drugs, currently only available on prescription, which may be sold over the counter is to increase. Will the board have to ensure the information given to patients will be readily understood by those who may be buying drugs on an over the counter basis, rather than, as in the past, through their GPs?
Pharmacists carry out splendid work in educating the public about various drugs sold in pharmacies. However, many drugs are sold in supermarkets where people receive no advice from pharmacists, as they pointed out in the past. The board must make clear information available to the public in this area.
Regarding paragraph (g), on Second Stage I mentioned the difficulty with the reporting of adverse reactions. However, given the Minister's reply, I obviously did not make myself clear. In general, pharmaceutical companies are good about reporting adverse reactions but my profession has not been quite as vigilant as it should be in this regard. I hope the new board will try to set in place the simplest possible system of reporting of reactions and adverse reactions.
Kings College in London set up a telephone line where reactions were reported on a confidential basis. There was a greatly increased incidence of reporting of adverse reactions and perhaps this matter could be brought to the Minister's attention. At present one must fill in cards and submit them. There has been an enormous increase in the amount of administrative work and form filling which doctors must carry out and if the reactions do not appear serious they may be pushed to one side. However, in the overall context of assessing problems with drugs, it is most important to encourage as many people as possible to report. I hope this matter will be taken into account. When the Minister replied to the Second Stage debate, he concentrated on the pharmaceutical companies which, in general, are relatively quick to report adverse reactions.
Paragraph (1) deals with establishing and administering a service for the inspection of any service for the collection, screening, processing and quality control facilities and procedures in respect of human blood, blood components, blood products and plasma derivatives for the purpose of ensuring the safety and quality of blood, blood components, blood products and plasma derivatives and to advise the Minister in relation to such general or particular matters arising out of the administration of such a service as the Minister may refer to the board. Will this include assessing premises? There has been some criticism in the recent past about, for example, the storage, not of blood products, but some of the equipment which was to be used for the collection of blood in the Blood Transfusion Service Board.
Will the new board have to advise on premises? It has been suggested that the premises should be upgraded, particularly the national centre which was not purpose built. It is an improvement on the two Georgian houses in Leeson Street but it is not a purpose built centre.Does it have to advise on the premises where collection takes place? Radio broadcasts each morning inform people where the Blood Transfusion Service will operate in their county. This usually takes place at school halls, community halls, swimming pools, etc. Is that covered under this part of the Bill?
We are dealing with this Bill because of one of the central recommendations contained in the report of Dr. Miriam Hederman O'Brien's expert group into the Blood Transfusion Service Board. On Second Stage, I informed the Minister that simply transferring the licensing function to the new board would not overcome the problems experienced by the previous board. It is clearly stated in the report of Dr. Hederman O'Brien's group that the former board suffered greatly from an overload of work. The report also refers to the increased functions undertaken by the board over a period of years.
Section 4 (3) of the Bill states:
The Board shall have all such powers as are necessary or expedient for the performance of its functions.
That is a very vague statement in relation to a service which is so critical. I stated on Second Stage that, unless there is a radical overhaul of the way the new board carries out its work, I fear we will be faced with a crisis similar to the one to which Senator Henry referred. This will be the subject of Fianna Fáil's Private Members' time this evening. I investigated if another reference was made to this in the Bill and section 20 further confirmed my fears. As I understand it, assessment by the board of performance of certain of its functions does not refer in any way to the efficiency of the board in relation to its functions. I believe it refers to the economic and efficient disposal of properties.
The expert group stated that the functions of the chairman and the board should be clearly defined. The Bill does not copperfasten the way in which the board will achieve that efficient means of carrying out its business. Section 4 (3), which I quoted earlier, does not reassure me that the new board will be empowered — by way of resources, staff or whatever is necessary — to overcome the problems created by the National Drugs Advisory Board. These problems occurred as a result of the huge workload and increased functions which were given to the board. While the Bill is worthwhile, I am concerned that it does not address the points raised by the expert group on to the Blood Transfusion Service Board.
I will be quite parasitic on the points raised by those Members more knowledgeable on this subject. The question of dissemination of information, in relation to section 4 (1), was raised during Senator Henry's contribution.Apparently medical products are more widely available for general sale than through prescription. I worked in an institute in America some years ago where one of the subjects under research — which was a long way from my own concerns — was the labelling of products for sale on the open market. The Americans' concern, which I hope will not be as serious an issue here but must exist to some extent, arose from the extraordinary level of illiteracy among a certain category of mothers who could not understand the medical implications of the products they were buying for their children. Is the Minister satisfied that the labelling conventions regarding products of this type, which are now widely available, will ensure as far as is humanly possible against misunderstandings on the part of purchasers?
Senator McGennis raised two questions to which I would like to add small riders. Section 4 (3) states:
The Board shall have all such powers as are necessary or expedient for the performance of its functions.
What is the difference between the terms "necessary" and "expedient"? Why is the term "expedient" included if the terms "necessary" already covers matters? I would like an answer on that issue. Does the term "all such powers" extend to powers to appoint adequate numbers of staff? Can the board invoke this to justify the appointment of staff? How will that battle be fought? What are the ground rules for it in terms of allocation of resources in that direction? I also refer to Senator McGennis's point on section 20, which raises echoes of issues not one million miles from County Cork at present. What is the analytical distinction between "economically" and "efficiently" in the minds of those responsible for drafting the Bill? What criteria may be applied in that context?
I understand and accept a number of the anxieties which have been expressed by Members. I believe the kernel, in relation to the functions of the board, lies in section 4 (1) (l). We do not have a great record in relation to the collection or screening of blood products. Problems occurred in relation to infection with hepatitis C from the anti-D product and a debate took place in this House regarding haemophiliacs and factor 8. Mistakes were made which cost a number of lives in the case of haemophiliacs.The important word in section 4 (1) (l) is "inspection". Can the Minister inform the House as to what type of inspectorate will be set up and its allocation of staff? The kernel of the board's functions lies with its carrying out inspections to ensure that proper screening and collection of blood products takes place.
In relation to adequate staffing, I stated on Second Stage that consultants are considering the functioning of the National Drugs Advisory Board. They will offer recommendations with regard to how the structures of the new board can be set up to provide a streamlined operation which takes safety and public health as its absolute responsibilities. A new chief executive, who will become the chief executive officer of the new board, has been appointed to the National Drugs Advisory Board.
With regard to the words "economically" and "efficiently" to which Senator Lee referred, I would not dare to intrude into the area of legal interpretation of those terms. However, in general terms, economics relates to the use of resources, financial or identifiable ones. Efficiency relates more to systems and how things may operate. I am not able to develop that distinction as well as I would like. It is an interesting question.
The issue of adequate numbers of staff will be dealt with, obviously, in the context of the recommendations of the consultants. In general terms, the Senator mentioned the section in relation to the Minister entering discussions with the board as to its financial needs for the coming year. The bottom line is that the Government decision is that the board would be self-financing.That is an aspiration and an objective. At the end of the day, there must be a marrying of the needs of the board in staffing and carrying out its duties. Obviously, the funding in the initial stages at any rate will come from the Exchequer and the various decisions, regarding fees and so on, will be reflected later in regulations.
It should be taken on board in this discussion on whether a section is broad or comprehensive enough that quite a few regulations, which will emanate from this legislation, will be as binding as legislation. It is proper and appropriate when we are down to specifics, as in fees and so on, and I will be dealing with that in more detail when we get to later amendments, that we use the regulations rather than legislation. The regulations must be placed before both Houses of the Oireachtas and can be rejected by them.
Senator Lee raise a point about labelling and literacy. I will look at this in the context of the regulations as it is worth exploring to see whether the situation can be improved. Literacy is something of which I am aware from my professional background as a teacher. I thank the Senator for raising that issue.
In response to Senator McGennis's point, I stress that the new board will have a bias towards management rather than the professionals, as was the case in the past. The professional advice will be available among the staff of the board. There are advisory committees and a provision for special subcommittees to deal with specific areas later. There is more emphasis on management at board level but I stress that the structures which will be put in place will certainly have public safety and health as a priority.
The Bill arises from a Government decision taken long before the anti-D problem came to light so it is not a response to that problem. However, I concede that the anti-D problem reinforced the need to take action. The Bill is only part of the solution. A radical overhaul of the system, structure and procedures is taking place. A management consultancy has just been completed, its recommendations will be implemented and the necessary resources will be made available. I cannot quantify them now but the professional work is going on in order that they be identified.
Senator Finneran asked about the European agency. Under the EU licensing regulations, a drug may be assessed and licensed at a central level. The European Medicines Evaluation Agency will be responsible for this and the assessment work will be done for it on a contract basis by national agencies, such as the Irish Medicines Board. This is something which we dealt with at some length on Second Stage. The charges which could arise from contract work on behalf of the European agency could be important income for the new board in the context of being self-financing.If a drug gets a European licence, it will automatically be licensed for Ireland. The Irish Medicines Board will then be involved in monitoring the various conditions attached to the licence.
Senator Henry raised the issue of information for patients on products sold in supermarkets. The Medical Preparations (Labelling and Product Information) Regulations, 1993, set out in great detail the information to be included in information leaflets for parents.These reflect requirements laid down by the EU. I refer, again, to Senator Lee's point regarding literacy. That is one which I want to examine to see whether there is some method by which we can bring about improvements there.
Senator Finneran specifically raised the clinical trials role of the new board. The clinical trials Acts provide for the participation of volunteers, the requirement of informed consent and approval of trials by ethics committees. This strikes a balance to facilitate clinical research whilst ensuring protection for individuals. The death to which the Senator referred pre-dated the legislation but the protection of human life and health at all levels must be paramount and I share his concern here. I assure him that the protection provided by the clinical trials Acts will form a part of the new board's work. I am fully committed to pursuing the highest standards.
Senator Henry raised the matter of the inspection of premises. That will be included. She also made an interesting point about a confidential line on adverse reactions. The necessity a confidential line requires further examination.There may be a method whereby we can improve the reporting of adverse reactions. The Senator specifically made the point that where adverse reactions are not startling, it may be they are not reported. Because of its importance I propose to specifically refer that point to the new board when it is set up. The Senator said there had been a great increase in the reporting of adverse reactions because of the confidential line involved. Senator Henry made the distinction between the good record of the pharmaceutical companies and her concerns that adverse reactions were not always reported at practitioner level. I undertake to refer that matter to the new board when it is set up.
Progress reported; Committee to sit again.