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Seanad Éireann debate -
Wednesday, 10 Dec 2008

Vol. 192 No. 15

Adjournment Matters.

Pharmaceutical Sector.

This matter relates to the registration fee being imposed on the pharmaceutical sector. Three elements in the new regulation cause concern. The first is the extraordinarily high level at which the fee is being set. The second is the bureaucracy and duplication involved, which is wasteful, especially in the registration process itself. The third is the concern about what the Pharmaceutical Society of Ireland intends to do with its enormously increased revenues.

The whole system of registration of pharmacies is a new development that was provided for in the Pharmacy Act 2007 that we passed last year. The case made for it was that the Pharmaceutical Society of Ireland needed to be able to hold pharmacy owners who are not pharmacists, principally the groups of pharmacies owned by large companies, accountable to it. That was reasonable. However, both the PSNI, the Pharmaceutical Society of Northern Ireland and the RPSGB, the Royal Pharmaceutical Society of Great Britain, have been maintaining a register of pharmacy premises for a number of years. I wish to draw some comparisons between them to show how absurdly high and penal is the registration fee.

The fee of €2,500 is excessive and it has not been justified by any demonstrated need to expend this kind of money. It is 15 times the fee charged in Northern Ireland. I wonder sometimes when I see all this stuff about uniting Ireland, yet we magnify the gaps between the two parts of the island in every possible way. I found it ironic during the week that some republican source called for a boycott of Newry. That says a lot for the Thirty-two County republic.

The fee in Britain is three times less at £162 sterling. Let us compare that with €2,500. There is no transparency in how the fee was set. The fee was recommended to the Minister for Health and Children by the council of the Pharmaceutical Society of Ireland, which now has a majority of lay members, all appointed by the Minister. It was inevitable that the Minister would accept the recommendation even though the amount indicated in a submission by the Irish Pharmaceutical Union, which represents the majority of pharmacy owners in the State, was €500 or one fifth of the amount. It is extraordinary that the fee suggested by the professional body representing pharmacists was multiplied by five and the Minister got advice from her own plants to say that is what was necessary. That is just extraordinary behaviour.

We have moved away from professional self-regulation of the pharmacy sector but we seem to have no clear idea of how to replace it, what to replace it with, or how it should be funded. One can ask whether it is appropriate that the new regulator for pharmacies should be funded by those it regulates. Again, it is a question of principle. I raised the issue in regard to the Press Council of Ireland where the newspapers, who are the interested party, pay the fees. As far as I am concerned that corrupts the process. We have a large sum of money but we have no indication of how it will be spent or for what uses it will be appropriated. However, it has been reported that it is to appoint 12 new inspectors to monitor the 1,600 pharmacies in the State so that there will be a ratio of one inspector to every 135 pharmacies. Is this comparable with what happens in neighbouring jurisdictions? The relevant British institution employs 26 inspectors for its 13,000 pharmacies, which is a ratio of 1:500. There is duplication and waste in this country. The HSE is already responsible for ensuring the suitability of pharmacy premises and staff in all 1,600 pharmacies with medical card contracts. Therefore, the expenditure of the money in question is not necessary.

The provision of pharmacy services to the public is covered by the Health Information and Quality Authority. It is a very responsible body and I am extremely impressed by it. It was the authority that produced an audit on the cost efficiency of addressing the issue of human papillomavirus. Tragically, the Minister for Health and Children ignored its advice. This was another missed opportunity.

The bureaucracy is extraordinary. Thank God I do not have to experience this hell. For somebody who hates forms — a fairly human characteristic — to be asked to fill a 25-page form complete with maps, plans of the buildings, solicitors' letters, affidavits and the whole works during the busiest three weeks of the pharmaceutical year is appalling. Evidence of insurance and sworn certificates signed by solicitors are also required, which is dreadful.

Another correspondent of mine stated, "I will have been practising pharmacy for 20 years next year and I have never had a complaint about my professional behaviour." He states from the heart, "I do not need to pay some blood-sucking, jobs-for-the-boys quango €2,500 to regulate and inspect me into alcoholism or an early grave." I understand from where that fellow is coming. How much more unemployment do we want to create? This is a very severe burden given that there are already cutbacks.

The Pharmaceutical Society of Ireland has introduced a fee of €1,500, to be paid by pharmacy graduates for the privilege of completing their pre-registration vocational training. There have been endless problems with this and I raised it a while ago. As a result of a blockage in negotiations, a full annual intake of final-year pharmacy students was to be blocked.

Why is the Pharmaceutical Society of Ireland, a statutory body with some degree of accountability to the Oireachtas, benefiting from a 200% increase in its fee income in an extraordinarily straitened time economically for pharmacists and everybody else? The society currently has an annual fee income of approximately €2 million from pharmacists' membership fees, while the fee of €2,500 per pharmacy will generate an additional €4 million. Why? For what will the money be used and how can it be justified in these difficult times?

I am responding to the Deputy on behalf of my colleague, the Minister for Health and Children, Deputy Harney.

The profession of pharmacy has undergone a dynamic change since the Pharmacy Act 2007 was passed by the Oireachtas in May 2007. The latest stage of this transformation, which began with the commencement of additional sections of the Act on 28 November, includes the new registration regime for retail pharmacy businesses.

Registered pharmacists and pharmacies have a privileged position of responsibility in the sale and supply of medicinal products to the public. However, with this position of responsibility comes an obligation to maintain the trust that the public places in the profession. It is important that the public have confidence in the compliance of the pharmacy sector with the laws governing the provision of medicinal products and the operation of the premises used to provide this service. The registration sections of the Pharmacy Act 2007 set out to achieve this by putting in place a modern and robust regulatory regime for the pharmacists and their retail pharmacy businesses. Under this new regime, the Pharmaceutical Society of Ireland, which will have increased powers of inspection and, where necessary, enforcement, will be in an enhanced position to monitor the application of the laws regarding the storage, sale and supply of medicinal products in retail pharmacy businesses.

The Pharmaceutical Society of Ireland has been, and continues to be, a self-financing body. In arriving at a fee for the provision of the new registration regime for retail pharmacy businesses, the society engaged PricewaterhouseCoopers, PWC, to develop an evidence-based methodology for the determination of registration fees. In engaging in this exercise, the society sought to put in place a viable and sustainable self-financing structure for the provision of the regulatory regime required under the legislation. The process undertaken by PWC included a comparative analysis and benchmarking of the provision of pharmacy business registration services against comparable international pharmacy regulators. The aim was to identify the appropriate costs of the registration process to the society and allow for the allocation of these costs in a proportionate manner.

The PWC study found that regulators in very few other jurisdictions have such a comprehensive scope as the Pharmaceutical Society of Ireland in terms of its statutory obligations and role in public safety. With respect to our closest neighbours, the Royal Pharmaceutical Society of Great Britain, RPSGB, and the Pharmaceutical Society of Northern Ireland, PSNI, are primarily representative bodies, with little statutory responsibility. The arrangements for registration in Northern Ireland and Britain are also substantially different. The primary inspection and enforcement functions of pharmacy and medicine law are carried out by Government agencies such as the Department of Health, Social Services and Public Safety in Northern Ireland. The pharmacy registration fee in England, Scotland and Wales in 2007 was €683, with all statutory inspection and enforcement and the regulation function resting with other statutory agencies. The United Kingdom is currently establishing an independent regulator similar to the Pharmaceutical Society of Ireland. It is likely, therefore, that once this regulator — the general pharmaceutical council — is established in 2010, the position in the United Kingdom in terms of regulation and the funding of such regulation may change.

The Pharmaceutical Society of Ireland undertook the PWC process in order to estimate as accurately as possible the cost of the new services. It has also undertaken to keep the fees for the registration of retail pharmacy businesses under review throughout 2009 and to update the position regarding their appropriateness when preparing its 2010 fee submission. The Minister is satisfied that every effort has been taken to determine a fee for the registration of retail pharmacy businesses that is proportionate to the level of service required by the general public and the pharmacy profession in respect of the supervision of retail pharmacy businesses. The registration fees for individual pharmacists and pharmaceutical assistants have not increased for 2009.

I thank the Minister of State for his reply. There is a clear conflict of evidence between what the Minister of State and I, as advised, put on the record regarding the sums involved in this jurisdiction and in Great Britain. With regard to PricewaterhouseCoopers, it did not exactly help us when we were tumbling into the financial abyss. It is a classic practice to commission reports all over the place. Why would PricewaterhouseCoopers object? It will be paid. However, I am not sure about the validity of the report in question. Will the Minister of State ask the Minister for Health and Children to accept my request, made on behalf of a considerable number of pharmacists, to postpone the deadline of 22 December? It is practically Christmas Eve. It is inhuman and stupid; it is a classic example of idiotic bureaucracy. Will she postpone the date for three months to allow for reconsideration and an examination of what I describe, with a view to removing the awful burden imposed on pharmacists at Christmas? Will the Minister of State pass on this message? I do not want him to seek a commitment to reconsider the deadline but to ensure that it will be postponed.

I will certainly undertake to do so. If there is a conflict of evidence, as the Senator pointed out, I will raise it with the Minister. There would be great criticism of the Pharmaceutical Society of Ireland if it tried to set its own fees. Bearing in mind the society's use of an outside body to produce a report, it is difficult to see how it could have avoided criticism in one way or another. I will certainly undertake to raise the need for postponement of the deadline with the Minister.

There is no great record of people being poisoned and given all kinds of inappropriate drugs and, therefore, I do not know what the hysteria is about. I thank the Minister of State.

Higher Education Grants.

I thank the Minister of State, Deputy Barry Andrews, for taking this issue on the Adjournment tonight. I am raising the proposal to increase fees in the Northern third level institutions and the impact this will have on Border students, particularly in Donegal. I declare my interest by saying that I spent seven years at the University of Ulster, Jordanstown. Students from Donegal tried to go to the colleges nearest to us and I was facilitated by the fact that we had no fees here and there was none there. Subsequent to my finishing college there was a gradual imposition of fees in the North and that has had a considerable impact as regards the availability of those colleges to southern students. While I say "southern students", Donegal is part of the province of Ulster so it is a strange term in that sense.

The Minister of State has recently received a report to the effect that the nine year olds are happy, content and physically active. I would like to believe that at the other end of the spectrum, when they are leaving as opposed to just starting in the school system, we would look at the economic impact. The north west is a region that continually needs high skilled graduates. We believe there is a great workforce there and great opportunities, but like the rest of Ulster, there is no great impetus as regards employment and people being able to stay in the area. If a person attends college in a particular area, he or she tends to stay there on graduating. Ulster, which has nine counties, needs the drive of people educated in the area, with no brain drain from there. People might say that we may have fees here in the next year or two, but the problem is how to deal with the realities of the moment.

The reality is that there are fees in the North, which make it less available to students and they have to leave their own areas to attend college in Dublin, Cork or Galway. The Northern institutions are trying to introduce fees for higher rather than further education whereby southern students, that is, students from the Republic, will be asked to pay fees. That was resisted by me and others as it seemed to be unconstitutional, and it had to be withdrawn.

However, under the Good Friday Agreement some students in Ireland have to pay fees while others do not. There is also the situation whereby when these students go to the colleges, they are not eligible for bursaries. Surely bursaries should be for students, for example, the people gaining the best results or whatever. It should be emphasised that the Minister for Education in the North is not actually in charge of the universities, which come under Sir Reg Empey, MLA, who is Minister for Employment and Learning. That is another difficulty and I know Mr. Mervyn Storey, MLA, chairman of the education committee, recognises that there is no continuity in their system between second and third levels.

The reason I am pushing this is that some of the colleges are within 15 miles of where I live and where my constituents live. For that reason they do not get the full grants. They then apply for a bursary, to be told that because they are from the Republic, they are not eligible. Fees are imposed on them, which, it seems, will increase in the next academic year. The students will then be faced with the choice of whether to stay local to graduate, with the idea that they should remain in the area and be employed there, or take the option of going elsewhere. They can choose to attend college in the Republic. I emphasise that we have an excellent institute of technology in Letterkenny, which is going from strength to strength. It is accredited to grant third level degrees, but not all courses are available. In an all-Ireland post-Good Friday Agreement context, people from the nine counties of Ulster must go to Scotland because there are no fees there. They then tend to stay in Scotland or elsewhere in the UK and do not return to Ireland. The purpose is self-defeating. The Minister, Sir Reg Empey, has launched a review of the hardship some students are facing.

I raise this adjournment motion tonight to ask that we make an input to that review, to put forward the case that there are serious impacts financially for students from Donegal and the rest of the Border counties in going into the North. It is to the detriment of the universities there as well as to the economy of Ulster into the future. While there is an ongoing review, there should not be talk about increasing fees, particularly when the supports for students are not there. The review will consider the hardship for those students. Donegal and other Border county students are being denied bursaries and I ask whether they are welcome in Northern third level institutions, which are responsible for allocating them, as distinct from the various educational departments in the North.

I leave it to the Minister of State to ask whether there is potential for us to make an input into Sir Reg Empey's review and to accept and realise that our students are a valuable addition to the Northern colleges and should not be deterred from attending them, as appears to be happening.

I am taking this adjournment on behalf of my colleague, Deputy Batt O'Keeffe, Minister for Education and Science.

I propose to use this opportunity to outline to this House the formal structures for co-operation in the education sphere between the Department of Education and Science and the Department of Education in Northern Ireland and existing arrangements under the Department's third level student support schemes relating to students from this State who undertake courses in Northern Ireland.

The general context is that the Department's North-South co-operation unit manages the Department of Education and Science's funding and co-ordinates co-operation activities within the education sector with the Department of Education and the Department of Employment and Learning in Northern Ireland. The Department of Education in Northern Ireland has responsibility for all school and youth based education matters in Northern Ireland.

The Department of Education and Science formally engages with this Department at ministerial level on co-operation issues under the auspices of the North-South Ministerial Council in four main areas, special education needs, educational underachievement, teacher mobility and school and youth exchanges.

The Department of Employment and Learning has responsibility for further, vocational and higher education matters as well as employment matters in Northern Ireland. The Minister, Deputy Batt O'Keeffe, wishes to reiterate what he clarified in this House when a similar motion was debated on 21 October 2008, namely, that the Department of Education and Science does not formally engage with the Department of Employment and Learning within the structures of the North-South Ministerial Council. As the Minister has explained, this is due to the provisions of the Belfast and St. Andrews Agreements, which designate the specific sectoral areas for co-operation. During that debate, the Minister also clarified that the Department engages in co-operative activities with the Department of Employment and Learning at official level on a number of issues and gave a number of examples.

Specifically on the issue of student supports for those pursuing university courses, the Minister undertook, within the parameters of existing liaison mechanisms with his Northern Ireland counterparts, to do all he could to make them aware of the concerns raised by the Senator. In that regard, the Minister asked his officials to relay those concerns to the Department of Employment and Learning.

Deputy Batt O'Keeffe also explained on the previous occasion that under the Department's third level free fees initiative the Exchequer meets the tuition fees of eligible students, including those from Northern Ireland and other EU member states, who are attending approved undergraduate courses in the State. The main eligibility conditions of the initiative are that students must be first-time undergraduates, must hold EU nationality or official refugee status and must have been ordinarily resident in an EU member state for at least three of the five years preceding their entry to an approved third level course.

There are no plans to extend the eligibility conditions of the free fees initiative to cover students attending third level institutions in Northern Ireland. With regard to eligibility for financial assistance under the student maintenance grant schemes, which are administered by the local authorities and the VECs on behalf of my Department, the position is that students who are entering approved full-time courses for the first time are eligible for grants where they satisfy the relevant conditions as to residence, means, nationality and previous academic attainment. An approved course for the purpose of the third level maintenance grant schemes means a full-time undergraduate course of not less two years' duration and a full-time postgraduate course of not less than one year's duration pursued in an approved third level institution.

Applications for grant assistance under the student support schemes are submitted to the local authority or the VEC, depending on the type of course in question. Applicants undertaking undergraduate degree and postgraduate courses apply to their local authorities while those pursuing diploma-certificate and PLC courses apply to their relevant VEC. The third level student support schemes extend to undergraduate study in Ireland and the EU and postgraduate study in Ireland, including Northern Ireland. Any extension of the current arrangements to provide for students pursuing postgraduate courses outside the island of Ireland could only be considered in the light of available resources and other competing demands within the education sector. There are no plans to expand the provisions in the grant schemes with regard to study abroad.

Section 473A of the Taxes Consolidation Act 1997 provides tax relief at the standard rate of tax for tuition fees paid in respect of approved courses at approved colleges of higher education, including certain approved undergraduate and postgraduate courses in EU member states and postgraduate courses in most EU countries. Tax relief at undergraduate level extends to approved full and part-time courses in both private and publicly funded third level colleges in the State and any other EU member state and approved full-time or part-time courses operated by colleges in any EU member state providing distance education in the State. Tax relief on tuition fees is claimed directly from the tax office, using an IT 31 form. Details of approved colleges and courses are also available on Revenue's Internet site. Approved undergraduate courses must be of at least two years duration and both the college and the course must satisfy the codes of standards as laid down by the Minister for Education and Science with the consent of the Minister for Finance.

I thank the Senator for allowing me the opportunity to outline the position.

Will the Minister of State bring to the attention of the Minister the fact that the only reason I am raising the issue again within six weeks of having raised it is that the situation is now even more dire? The indications are that the fees will be increased. While I welcome the information on tax relief, some parents of students are not in the tax bracket. Therefore, the problem is that it is the poorest who are being denied easy access to their local third level institutions. I accept there are agreements under the Good Friday Agreement and the St. Andrews Agreement, but in the context of the review taking place under the stewardship of Minister Empey, will the Minister of State engage in formal interaction with him to point out that hardship is being caused and that it is not being alleviated because colleges are choosing not to support students from the Republic of Ireland? This has resulted in the lack of numbers able to access these universities. I urge the Minister of State to convey the message to the Department of Education and Science that I would not have raised this issue if it was not more serious now than it was six weeks ago.

I agree with the Senator. In all contexts, thankfully, mobility across the Border has increased in the past few years. Unfortunately, arguments about issues like this undermine the need for the Border, but it is part of our history and we must accept it. The Senator has identified a serious problem to which we must try to find a solution. I undertake to bring her concerns to the attention of the Minister again.

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