David Norris (Independent)
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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?

Barry Andrews (Dún Laoghaire, Fianna Fail)
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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.

David Norris (Independent)
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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.

Barry Andrews (Dún Laoghaire, Fianna Fail)
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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.

David Norris (Independent)
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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.