It has been the intention of my Department, and the wish of the pharmacy profession, to consolidate and expand existing pharmacy legislation in a new Pharmacy Act for many years. Proposals have, however, continually been overtaken by events and in the interim the practice of pharmacy has evolved significantly. Nevertheless, it is clear that without a comprehensive and robust framework of modern legislation, the profession cannot develop and increase its input into the care of patients.
To this end, I received approval from the Government to prepare pharmacy legislation in two Bills. It is the first of these two Bills which is now before the House. In brief, this is a Bill to allow for fitness to practice regulations for pharmacists and pharmacies, and, as a consequence, the removal of restrictions on pharmacists educated in other EU or EEA countries from owning, managing or supervising a pharmacy in Ireland that is less than three years old. It is also proposed to deal with a number of related issues such as an appropriate statutory basis for the Pharmaceutical Society of Ireland and an updated registration scheme for pharmacists and their premises.
The pharmacy review group was established in 2001, principally to examine findings from the OECD on the Irish retail pharmacy sector and the 1996 community pharmacy contractor agreement. The group consulted widely and submissions were received from a range of sources. The group considered the complex legal and other issues surrounding the OECD's recommendations, as well as contractual and professional issues such as medicines management and greater use of generics. The group recommended the removal, following the introduction of new pharmacy legislation, of the restriction on pharmacists educated in other EU or EEA countries from owning, managing or supervising a pharmacy in Ireland that is less than three years old — the derogation under Article 2.2 of Council Directive 85/433/EEC.
The group's recommendations also included proposals on a number of related issues, for example, a stronger statutory basis for the Pharmaceutical Society of Ireland, including the governance of the PSI, wider non-pharmacist representation on its council, updating regulations with respect to the registration of pharmacists including non-EU and EEA graduates, and some matters concerning the delivery of pharmaceutical services in a community setting, such as linguistic and forensic competence, and experience for supervisory pharmacists.
The second Part of the Bill deals with the setting up of the new pharmaceutical society and the allocation of functions which the society will fulfil in its role as regulator of the pharmacy sector. In particular the role of the society will be to "regulate the profession of pharmacy in the State having regard to the need to protect, maintain and promote the health and safety of the public". As with other regulatory legislation the Government has proposed, the public interest comes first here and it is my desire that this should be the main goal for all health sector regulators. This section also sets out in detail the duties of the society in the area of registration, education and qualifications, and the powers the society shall have to conduct its functions in these areas and other related areas.
The principal change provided for in Part 3 is in the area of representation on the council of the society. Currently the council's membership stands at 21, all of whom are pharmacists and, in line with other recent legislation in this area, I propose to increase representation of non-elected members of the council to a majority. A total of 21 members are to be appointed, of whom nine — who would be members of the society — are to be elected by the membership of the society. One academic will be nominated by the colleges engaged in pharmacy education — he or she would also be a member of the Society — and the remaining 11 will be appointed as follows: one will be nominated by the Irish Medicines Board; one will be nominated by the Health Service Executive; one will be nominated by the Minister as being representative of the area of continuing professional education; five will be nominated by the Minister who are not, nor have ever been, pharmacists in this State or any other state; and, finally, three will be persons who have such qualifications, expertise, interests or experience as would, in the opinion of the Minister, enable them to make a substantial contribution to the performance of the society's functions.
It is my intention that the nominated persons, other than those directly elected by the society and the nominee representing a dean of a pharmacy faculty, will all be non-pharmacists. I will ensure that the Bill is amended to reflect this. This approach of widening the representation on the council to include a majority of non-pharmacists is consistent with the approach being adopted for other regulatory bodies in the health sector, for example, the Medical Practitioners Bill 2007 and the Health and Social Care Professionals Act 2005.
This Part also contains important new provisions relating to the making of rules by the society to enable it to carry out the functions assigned under Part 2. In future the rules of the society, as well as being submitted to the Minister and laid before the Houses of the Oireachtas, must be published and comments invited from interested parties. This is an extremely progressive and new development in the opening up of the activities of regulatory bodies to wider scrutiny and a positive step in injecting transparency into the rule-making process for regulatory bodies. Furthermore, the society will have to submit any code of conduct it proposes to the Competition Authority for their opinion on its likely effect on competition and, if the society decides not to accept the authority's opinion, it will be required to attach this opinion, and its reasons for not accepting it, to the draft code of conduct when submitting it for the approval of the Minister. This is an innovative development which will ground in the pharmacy sector an appreciation of the need for proportionate and focused regulation, with an emphasis on patient safety and being mindful of possible disincentives to competition among pharmacy businesses in the delivery of services.
Parts 4 and 5 deal with the registration of pharmacists and pharmacies, and the conduct of pharmacy businesses. Part 4 contains sections dealing with the establishment and maintenance of registers, covering pharmacists and pharmacies, and what constitutes a pharmacy business. A modern and robust registration system, one which allows for the removal of registrants, if deemed necessary and proper, is considered essential by all bodies that have made representations in this regard. The revised registration system will also allow for updating of the registration process for EU/EEA and overseas pharmacists, which has been requested by the pharmaceutical society for some time.
The provisions on registration recognise the rapidly evolving nature of the pharmacy business in recent years, as well as providing a fair and comprehensive system for assessing the qualifications and training of foreign-trained pharmacists who may wish to work in this country. In particular, the regime proposed in the Bill allows not only for the registration of the individual pharmacist but also, for the first time, the registration of pharmacies. This provision stems from the need to recognise and deal with the increasingly complex ownership structure in the pharmacy sector. The inclusion of a registration system for pharmacies is desirable and necessary as the regulation of the business of pharmacy is the last link in the chain of medicinal product control that has not be legally provided for up to now.
Alongside the registration regime, the provisions relating to the conduct of the business of retail pharmacy will ensure that the pharmacy, or the pharmacy side of any business, will be under the personal and whole-time control of an experienced pharmacist with at least three years' relevant post-qualification experience. This provision, and the requirement that registration be an annual process, are important developments in patient safety and in ensuring that responsibility for the conduct of the retail pharmacy business is conducted in an open and accountable fashion. It is important that those in charge of the pharmacy are easily identifiable to all those availing of its services, and to those supervising the procedures in the sector. I am also making it clear that it is an offence to hold oneself out to be a registered pharmacist, or registered pharmaceutical assistant, or to provide what may be termed "skilled pharmaceutical assistance" or to allow someone to do so, knowing that he or she is not so registered. However, this will not interfere with the provision for registered pharmaceutical assistants to provide cover for registered pharmacists, in their temporary absence.
Under Part 6, pharmacists will be subject, for the first time, to fitness to practise provisions. In keeping with the aim of the Bill to extend regulation to the pharmacy business as well as to the individual practitioner, both will be subject to a complimentary and integrated process.
Broadly, the fitness to practise provisions are based on the general template developed for the Health and Social Care Professionals Act 2005. However, the provisions under that template refer to the practice of the individual only. Both the Pharmaceutical Society of Ireland, PSI, and the Irish Pharmaceutical Union, IPU, have expressed reservations about such a narrow focus for their profession. They consider such a fitness to practise system will be unworkable if the practice of pharmacy, as it refers to the business of pharmacy, is not also regulated or, at the very least, if a licensing and registration system for pharmacies is not also introduced. They argue it is not sufficient to deal with fitness to practise of the pharmacist alone because a problem may arise due to practices within the pharmacy business. The two bodies make the point that a pharmacist is more likely than medicine, nursing or other health care professionals to work in a commercial enterprise and, even if disciplined for a problem related to the carrying out of his or her profession, this may have been the result of the practice of that particular business. Removing or disciplining the individual pharmacist would not therefore deal with the underlying problem and the business could continue to operate as before without penalties or sanctions. Accordingly, given the strength of feeling expressed to the effect that the pharmacy sector is unique in the interaction of corporate ownership and professionals in running pharmacies, I have accepted that the registration process and the fitness to practise regimes need to be linked in order that remedies and sanctions, if judged necessary, can be applied evenly to those responsible for the provision of the service and not just to the individual pharmacist.
Part 7 gives the council of the society, through the appointment of authorised officers, the powers it requires to police and investigate whether any offence under the Act, any breach of a code or any professional misconduct has been committed. This section is based on the similar powers given to authorised officers of the Irish Medicines Board and the proposed powers are wide enough to allow the thorough investigation following a complaint or production of evidence of professional misconduct. The searching of premises and the taking of samples are also provided for if necessary. These provisions will give the Pharmaceutical Society the means to ensure the proper professional practice of pharmacy and the protection and safety of the public.
The remaining sections of the Bill deal with largely technical and procedural matters, such as the staffing, meetings and accounts of the society. These provisions are based on best practice and similar provisions contained in recent legislation in the regulatory area.
In tandem with the introduction of new pharmacy legislation, the restriction on pharmacists educated in other EU or EEA countries from owning, managing or supervising a pharmacy in Ireland that is less than three years old, which is a derogation granted under Article 2.2 of Council Directive 85/433/EEC, will be removed. This was recommended by the pharmacy review group and I am delighted to facilitate it by repealing the Pharmacy Act 1962. Ireland will now have one of the most competitive markets for pharmacy professionals in the EU. This can be only good for the profession and it will ensure that overseas trained Irish graduates and non-Irish EU graduates will find it easier to establish themselves in the Irish pharmacy sector. I am confident their different perspectives and competitive impact will keep the sector vibrant and energised in the future within a modern robust and progressive regulatory regime for the 21st century.
There clearly has been rapid growth in the pharmacy sector in recent times, with many possible interactions arising between prescribers and dispensers. The majority of professionally qualified pharmacists and other medical practitioners adhere to the highest standards in carrying out their professional duties. However, it would be remiss of me not to recognise that unacceptable practices may occasionally arise between professionals. The Government has accepted the view of the pharmacy review group on the issue of conflicts of interest between those who prescribe and those who dispense drugs. Therefore, subject to legal consideration, I intend to introduce an amendment on Committee Stage which will address any possible conflicts in a fair and proportionate manner.
The provisions contained in this Bill are intended to put the regulation of the profession of pharmacy in the State on a firm, modern and robust footing, having regard to the need to protect, maintain and promote the health and safety of the public. The Bill, if enacted, will put the society to the forefront of the processes involved in supervising the pharmacy profession and the retail pharmacy business in Ireland. While the Bill deals mainly with these areas, I would again emphasise that concern for the public and safety are its guiding principles. The proposed repeal of all previous Acts with the enactment of this Bill means that a new coherent and all-encompassing legal regime will now be put in place for the society, pharmacy professionals, pharmacies and the public. I am honoured to be able to bring such comprehensive legislation before this House and I urge a thorough and considered examination of its provisions, with a view to its early enactment.