I move amendment No. 2:
In page 8, subsection (10), line 36, to delete "chairperson," and substitute "chairperson."
This amendment relates to a meaningless and unnecessary comma which appears in the text which was, unfortunately, overlooked at an earlier proofreading stage.
Amendments Nos. 4 and 5 are related to amendment No. 3 and all may be taken together by agreement. Is that agreed? Agreed.
I move amendment No. 3:
In page 8, after line 44, to insert 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.".
Fianna Fáil is proposing a new subsection to ensure that all applications to the new medicines board are processed speedily and that applicants have an appeals procedure where delays and refusals can be raised. At present, there is a backlog in the NDAB of about 1,200 applications for authorisations for products and about 275 for renewals. Applications for licences sometimes take a number of years to process. There is also the well recorded delay in relation to product authorisation for anti-D and other blood products. These delays cannot continue.
While I accept that the new structures and powers of the medicines board will improve matters, the new board should introduce a code of best practice which sets timescales for processing applications and allows applicants to raise genuine concerns about delays and refusals of applications. This would ensure the agency operates swiftly and efficiently and would allow Irish industry to know, with certainty, how long an application is likely to take. Will the Minister give a commitment in this regard? Fianna Fáil is also proposing an amendment to section 9 to allow applicants who have been refused a licence by the board to have recourse to an appeals procedure.
Section 13 deals with the cost of licences. While those seeking the licence for a product have the potential to make large sums of money, there is a difference with regard to just inspection. There is a case for a scale of fees for inspection based on a firm's turnover and number of employees. The same fee should not apply to a firm employing 200 people and one employing 20. Fianna Fáil is proposing and amendment to that effect. We are also proposing that an independent arbitrator should be appointed by the Minister in cases of disputes of fees and charges.
Fianna Fáil is also proposing an amendment to section 13 (4) to limit the powers in the Bill to levy fees. At present, the new medicines board can ask industry to pay all its fees, irrespective of the purpose of the work. The amendment proposes that the fees levied on industry should apply only to the registration of medicines. At present, about 10 per cent of the work of the NDAB appears to be carried out for the State. While most of the work relates to the registration of medicines, some is in the interest of public health. To ensure the medicines board's fees are competitive with those of other countries, the Exchequer should make some grant available towards this work, if the board's costs are not to rise substantially. The Exchequer should commit itself to providing a grant if there is a shortfall in the board.
The industry is very concerned about the fee provisions in the Bill. Firms fear that because the wording is so loose, at some stage in the future the medicines board might be asked to do major research work for the State and the industry would have to pay. This could result in fees rocketing. In any case, costs seem set to rise with the new Bill as the medicines board will have additional responsibilities and may have to take on at least another ten staff, including professionals.
Will the Minister give details of the current cost of running the NDAB and how this will rise with the new structure over the next five years? Will the board get an annual grant from the Exchequer for accommodation, as its present building requires substantial upgrading? If the Exchequer was to provide some funding it would reduce the dependence of the Irish Medicines Board on industry and might help to copperfasten its independence. The pharmaceutical and animal and human medicines firms are major employers in the State. There is a danger that excessive fees could kill the golden goose. This happened in other countries, especially in New Zealand, where fees were massively increased and some firms and industries decided to move elsewhere. The question then arises as to whether there will be reduced fees for minor use products.
I propose to take amendments Nos. 3 and 4 together. Both essentially seek to put in place an appeals procedure against decisions of the board. I agree in principle with the desirability of having some form of appeals mechanism and I thank the Deputies for raising this for discussion. I had not intended to include a provision in the Bill itself as I consider it more appropriate for detailed regulations, which will be made on foot of the Bill when it is passed.
The Bill already gives the Minister the power, under section 31 (3), to put any necessary provisions into the regulations as he considers expedient. This could include an appeals procedure if considered appropriate. All such regulations must be laid before the Oireachtas and can be annulled by resolution of either House. I would draw attention to the fact that, under the provisions of the Bill, the board cannot refuse any licence unless it has first sought and considered the advice of an appropriate advisory committee. The board, therefore, cannot act unilaterally in refusing to grant a licence.
I agree that the board should take all possible steps to ensure that applications are processed as speedily as possible, but it is not necessary to make specific provision in the Bill relating to this. The board will be required by section 20 to carry out annual examinations to ensure that it is operating efficiently and economically. At the same time it will also be required to seek to comply with the requirements of EU Directive 65\65, which stipulates that applications should be processed within 210 days.
The requirement operates, of course, on a stop the clock the basis and in this context it is important to advise that quite often delays have occurred in the past where incomplete applications were submitted or where companies took considerable lengths of time to deal with issues raised by the board or its assessors. Nevertheless, I agree that the board should seek to deal with applications as speedily as possible, while at the same time seeking to operate as efficiently as possible. The board cannot sacrifice questions of safety or of public health which must at all times be the primary consideration.
Amendment No. 4 states: "... Where the Board refuses to grant a licence, applicants may have recourse to an appeals procedure.". It could happen that a licence may be granted, but a condition or conditions attaching to it may give rise to concerns by the company involved and it may wish to appeal them. I give the assurance that there will be an appeals procedure included in the regulations. They will serve our purposes best if there is time to reflect on them and have them as comprehensive as possible.
With regard to assessment and refusal, the Minister advised that the board cannot refuse any licence unless it has first sought and considered the advice of an appropriate advisory committee. However, this is still an in house procedure.
The board, by itself, cannot decide to refuse to grant a licence. Before it can refuse a licence it must refer to the relevant committee. This provides a safeguard for the applicant.
It does not provide an independent assessment.
I am prepared to take on board all the relevant points made in the debate in the context of the regulations. I am glad this point has been raised. The more effective way of dealing with it is by way of regulation. Deputies will have an opportunity to come back to this issue in a more focused way when the regulations are brought before the Houses, as they can be annulled by resolution of either House.
With regard to the issue of delays, we must take cognisance of our competitors, especially in view of the European situation. We need, therefore, to be fairly specific on this issue, especially if there are undue delays, although I am aware the Minister is not willing to put a specific time frame on this.
Proceeding on the basis of putting time limits within too narrow a framework would not necessarily be in the public interest, nor in the interest of public health and safety. However, we are working within the time limit of 210 days, as per the EU directive. If difficulties arise, for example, if certain side effects are causing concern, it may be necessary to undertake further exploration, which is something we would all wish to do.
The ethos and drive behind the structuring of the board is that there be more efficiency and expediency in terms of reaching the finalising of licences. It is clear that the present system, whereby two agencies are involved, is not the ideal way of getting from point A to point B as quickly as possible.
There might be a mechanism, as the procedure operates, to inform the companies as to what progress is being made, rather than have a situation at the end of the process where a refusal is granted without, for example, companies being advised during the procedure that certain matters were not in order. If companies were given free advice early in the process they might be able to make any necessary corrections and have the process expedited within the period of 120 days, the 210 days or whatever.
I am informed that this is part of the process. It is logical, practical and it makes sense that, if a difficulty arises, the sooner it is signalled to the company the sooner it may respond in whatever way is appropriate. I take the Deputy's point that it is both important and prudent to proceed on this basis.
Certain drugs may need fast tracking in that it may be necessary to have things done expeditiously in the interest of people and of industry. Will the Minister be considering a procedure for fast tracking certain products?
This is something we can look at either in the context of general policy or of regulations. For example, if a cure for an ailment, for which there was no other known remedy, became known we would want to see it available as soon as possible. However, we must always strike the right balance with public health and safety. I do not mention this in any negative context, but ultimately we would all wish to have only the best available on the market.
It can happen that certain drugs may have the potential to do a lot of good in a specific area. The named patient system can be used in the context of these drugs. I see the validity of your point which I will consider.
Some companies are interested in this and there is a fairly large pharmaceutical industry here at present. We should try in any way possible to facilitate it in such procedures. Because we have competitors in this industry, it behoves us to look at these procedures.
I give an undertaking to examine suggestions in relation to regulations from Members, the industry or another reliable source in the context of developing them. I assure you that it is our desire to get this right and functional.
I accept what the Minister said as regards the time factor on reaching decisions. The experience in this country is that where an application must go before a committee and there is no time scale in which a decision must be made, in many cases it goes on and on. A classic example was An Bord Pleanála when originally set up. The process was open ended and we had to wait for one year, 18 months or two years for decisions. It was felt at the time that that was right because it needed time to consider all aspects of the cases that came before it. Then an enlightened Minister decided to cap it at 120 days or four months, which seems to have worked well. I accept we cannot make such a direct comparison here because we are talking about public health.
I agree with the Minister that his priority must be the maintenance of public health. Over the past 20, 30 or 40 years there have been too many examples of drugs which were supposedly put through a particular system — perhaps rushed through — with devastating consequences. We need look no further than thalidomide. I prefer to see the Minister erring on the side of caution. He cannot allow himself to be driven by the industry urgently seeking approvals through this new board. We must also take into account the fact that applicants should have a reasonable expectation of a date by which a decision should be made or that they would have reached a stage where an application would be discussed in detail.
As regards independent appeals, etc., does the Minister have any proposal to allow members of the public who might have a view on an application coming before the board to make representations? From time to time in our work as public representatives we meet individuals whose family members are suffering from a particular ailment and they hear about a drug which has not been approved in Ireland; they look for the drug but cannot get it because it has not been approved. The reverse may also be the case: somebody may have an objection through personal experience. Is there any mechanism for someone to object to the approval of a drug or medicine?
As regards members of the public being concerned about a particular medication, the board of its nature is concerned with scientific medical areas. That is its focus and how it will process licences. The democratic process affords opportunities in as much as it is open to the public to make representations to the Minister for Health who, in his or her wisdom, may take the appropriate action of referring the matter to the board. A Deputy may raise a particular issue in the House by way of a parliamentary question or whatever. I would see that as an appropriate method which already exists and is open to the public.
As I said, where certain medications have not been licensed, they can be made available through the named patient system. As regards the number of days for the processing of an application, we are using the 210 days as set out in EC Directive 65/65. There is also the provision whereby the annual report will be laid before the Houses of the Oireachtas. That affords Deputies the opportunity to comment on, pursue or make representations in relation to how effectively the board is operating. I and the Government are committed to scrutiny by the Oireachtas of how particular services are provided.
We must get the board up and running so that we can put in place the most effective regulations we can at this time. I believe there are sufficient safeguards for ongoing scrutiny of the board's operations. Heightened awareness of this area is a feature of present day Ireland and it will also ensure that Deputies and Senators are tuned in and that they will ensure effective and speedy movement through the licensing process. We must give it a fair chance and it must be subject to a yearly review which will give Deputies access to the report of the organisation.
This is a fairly substantial amendment because it covers appeals and fees. I note the Minister's assurance that he will give consideration to an appeals mechanism. There may be some difficulties because it would appear that we are building one layer on top of another and whether that is possible will test the Minister's ingenuity. We must be conscious of what is happening in every other European country and whether there are appeals mechanisms.
We are now in a single market with the European Medicines Evaluation Agency. Does the Minister believe this agency will play a more important role in the future? Does he believe that Irish based pharmaceutical companies may bypass the Irish Medicines Board and seek authorisation directly from the evaluation agency in London, which would refer the testing of the new product back to the Irish Medicines Board or to another European agency?
If an Irish pharmaceutical company wishes to have a product tested but indicates that its primary market is France where there is a demand for the product, is it possible, if it applies to the evaluation agency in London that the testing of that product would be done in France and not in Ireland? Will the number of applications before the Irish Medicines Board increase or decrease as a result of competition from other evaluation agencies in other countries? Where will this lead in the next five to ten years given that it is possible to get a CE mark? Once a product is passed in one country, authorisation in any other country is not necessary.
For the benefit of Members, does the Minister have any information regarding the approximate average cost or range of costs pharmaceutical companies have faced in the last two or three years in having their products tested and authorisations granted? Are we talking in terms of hundreds or thousands of pounds? The Minister could answer by saying that each case depends on the amount of work involved. However, perhaps he could give a flavour of the range of fees to which they have been subject up to recently.
It is a difficult question. As the Deputy correctly said, there is a range of fees from £160 to £4,000. The running costs of the agency of approximately £2 million may give a ballpark indication in that regard. It would not be productive to go through the information before me because it is highly technical. If the Deputy requires specific information it can be provided.
An important matter was raised regarding a company which says that a certain member state is its main market. The Deputy mentioned a case which might be appropriate to the French market and an evaluation is carried out in the French context. It would then be up to the EMEA to decide how matters would move on from there, in other words, the level of licensing required in this country would be adjudicated at that level. The company always has options. It can go for each country separately or opt for central licensing.
Does the Minister anticipate that pharmaceutical companies in the future will seek a centralised application forum where, if they are sanctioned there, they can penetrate all the European markets without it being necessary to go to each country individually? At present each country had its own bureau to evaluate the propriety of medicines. Now that a centralised bureau exists, how does the Minister see the testing of medicines developing? What impact will the evaluation agency have on the Irish scene vis-�-vis Irish pharmaceutical companies or foreign made medicines which will be marketed in this country?
It will, obviously, have a major impact if a stamp of approval from this agency in effect will allow a pharmaceutical company to launch its products simultaneously in each European country. How does the Minister consider this will impact on commercial activities here? Ireland is a small country and the Irish Medicines Board is a small agency, with, I understand, a staff of approximately 50. I have no doubt it has the same level of sophistication as its European counterparts but I doubt it has the same level of resources. It is a case of making comparisons which I am not in a position to do. However, common sense dictates that countries such as Germany and France must be forces to be reckoned with. How does the Minister see this developing? This is an important point for the pharmaceutical industry.
That is a most important point. The pharmaceutical industry is a very important component because Ireland is a large exporter of pharmaceutical products. Regarding developments in centralised licensing, high technology products will take that road but other products are unlikely to do so because of the cost involved. It will be very expensive to take the centralised European road and it will only be attractive to higher technology products. I do not have major concerns in terms of native Irish industry. However, since we are large exporters, the licensing of our products in the relevant member state is also an important aspect of the industry.
We did not dwell on amendment No. 5——
I will answer that point briefly. The scale of licence fees will be published by way of regulation. This will ensure that a pharmaceutical company which decides to apply for a licence under any particular heading will know in advance the fee which applies. It is unnecessary to have another tier, which would involve an independent arbitrator. The regulations will come before the Dáil and they will be exposed to the democratic process at that point. The situation is adequately covered as matters stand.
Should there not be a differentiation between regulation and inspection of plants?
That is a valid point. The extent of inspection in terms of the size of plant involved is a critical factor. I will deal with that by way of regulation.
We do not want a standardised inspection fee and we ask the Minister to modify this aspect accordingly.
I will respond favourably to that point.
The other aspect we raised is the total fees due to the Irish Medicines Board and the amount of money which will be available.
That matter arises in relation to the next Government amendment I ask the Deputy to bear with me.
