The existing legislative base for regulation of the profession of Pharmacy dates back to 1875. The Pharmacy Review Group, 2001, 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 preparation of the Pharmacy Act was informed by the recommendations of the PRG, which included proposals on a number of, 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.Purpose of Act:
The Act makes new provision for the regulation of pharmacy, including provision for the dissolution of the Pharmaceutical Society of Ireland and the setting up of a new Pharmaceutical Society of Ireland, for the establishment, constitution and functions of the new Society’s Council, for a new system of registration of qualified pharmacists, druggists and pharmaceutical assistants and of pharmacies and for the setting up of new procedures to ensure that pharmacists, and pharmacy businesses, are, and continue to be, fit to practise; and to provide for related matters.
Part 2 of the 2007 Act deals with the dissolution of the old Pharmaceutical Society of Ireland and the establishment of the new Society. It also outlines the functions of the Society. It provides that the Society must do all things necessary and reasonable for or incidental to the performance of its functions in the public interest. In line with best practice in relation to the governance of regulatory bodies this Part defines the functions of the Society in the context of protecting the public by promoting high standards of professional conduct and professional education, training and competence among pharmacists.
Part 3 outlines the composition of the Council of the Society, its functions and provisions to have the Competition Authority consulted in respect of the competition aspects of any code of conduct drawn up by the Council.
The 2007 Act outlines the composition of a Council to govern the affairs of the Society, including allowing for general public interest representation. Formerly the Council’s membership stands at 21, all pharmacists. In line with current policy dealing with regulatory bodies, the Act will increase to a majority, nonpharmacist representation on the Council.
Part 4 deals with Registration of Pharmacists and Pharmacies and contains sections dealing with the establishment and maintenance of Registers, covering pharmacists and pharmacies. A modern and robust registration system, one which allows for the removal of registrants if deemed necessary and proper, is considered essential.
The revised registration system will also allow for updating of the registration process for EU\EEA and overseas pharmacists. The regime proposed in the Act will allow not just for the registration of the individual pharmacist but also, for the first time, the registration of pharmacies. 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.
Part 5 deals with what constitutes the carrying on of a retail pharmacy business and creates offences for acting other than in accordance with the provisions.
Part 6 — deals with Fitness to Practice provisions for pharmacists and registered retail pharmacy businesses — ranging from disciplinary committees, the grounds for complaints, the procedures for dealing with complaints, the options open to the disciplinary committees, the steps to be taken if sanctions are deemed necessary (and the sanctions available) and an appeals mechanism.
In light of the interaction of the corporate ownership and professionals in running pharmacies, the registration process and the fitness to practice regimes need to be linked so that remedies and sanctions can be applied evenly across those responsible for the provision of the service and not just the individual pharmacist.
Part 7 of the Act gives an authorised officer of the Council of the Pharmaceutical Society the power to investigate, by way of entry, search or seizure, if any offence under this Act, or any breach of a code of conduct or any professional misconduct has been committed. It also outlines the functions of the Council on receipt of the report of an investigation by an authorised officer. Finally, this Part provides for penalties for offences committed under this Act.
Part 8provides that certain powers conferred by the Apothecaries Act 1791 shall cease to be exercisable. Sections 22 to 31 of that Act are repealed. Section 71 provides for amendments to the Poisons Act 1961. Section 73 provides that the Minister shall ensure that a code of conduct drawn up by the Society, and regulations made regarding the registration of pharmacies are laid before each House of the Oireachtas as soon as practicable.
Schedule 1 deals with the Council, its members and the Society’s employees in matters concerning the term of office of the Council, disqualification from office, conditions of office, the President and Vice-President, casual vacancies, meetings and procedures, committees of the Council and other related procedural and staff issues.
Schedule 2 provides for the Council to be the competent authority in the State to demand and receive and to issue diplomas, certificates and other documents concerning education for, qualifications in and the practice of pharmacy.
Schedule 3 is the certificate to be used when reporting on any test, examination or analysis.
The Pharmaceutical Society of Ireland
Dissolution of old and establishment and membership of new Pharmaceutical Society of Ireland.
The 2007 Act provides that the old Pharmaceutical Society of Ireland shall be dissolved and a new body to be known as ‘‘The Pharmaceutical Society of Ireland’’ shall be established. All rights, property and liabilities of the old Society will be transferred to the new Society. The Society will perform the functions and exercise the powers assigned to it by this Act.
Status of the Society.
The 2007 Act provides that the Society is a body corporate with perpetual succession and an official seal.
It provides that the Society must do all things necessary and reasonable for or incidental to the performance of its functions in the public interest. In line with best practice in relation to the governance of regulatory bodies The Act defines the functions of the Society in the context of protecting the public by promoting high standards of professional conduct and professional education, training and competence among pharmacists.
The Minister may confer additional functions on the Society, where necessary or appropriate. The Society shall have the necessary powers to carry out its functions.
The Council of the Society
The 2007 Act outlines the composition of a Council to govern the affairs of the Society, including allowing for general public interest representation. The Council shall consist of 21 persons appointed by the Minister.
Of those 21—
- 11 shall be persons who, in the opinion of the Minister, are representative of the public interest, in the manner as follows:
- 1 person to be nominated by the Irish Medicines Board,
- 1 person to be nominated by the Health Service Executive,
- 1 person to be nominated with an interest in continuing professional development education,
- 5 persons, who have not and never have been, registered pharmacists in the State or another jurisdiction and who are representative of the public interest,
- 3 persons who have such qualifications, expertise, interests and experience as, in the opinion of the Minister, would enable them to make a substantial contribution to the performance of the Council’s functions.
- 9 shall be members of the Society who have been selected by its members, and
- one shall be a member of the Society who has been selected as a representative of third level education establishments carrying out education, training or research in pharmacy, by the deans of the pharmacy faculties of those establishments, and the heads of those establishments.
Schedule 1 applies in relation to the Council and its members and the employees of the Society.
Functions of the Council and their delegation.
The 2007 Act provides for the Council to have the power to make such provision as it thinks fit for facilitating the performance of its functions under the Act, subject to the consent of the Minister.
The Council must submit draft codes of conduct for practitioners to the Competition Authority and take cognisance of the Authority’s opinion.
Pharmaceutical Registration System
The 2007 Act sets out the procedures for the setting up and maintenance of registers for pharmacists, druggists, pharmaceutical assistants and pharmacies. It provides for the registration of persons entitled to practice pharmacy in the appropriate register.
The 2007 Act makes provision for persons registered before the Act was enacted. The 2007 Act sets out the criteria necessary for qualification to practice. The 2007 Act allows for the registration of retail pharmacy businesses..
The 2007 Act allows the Minister, for the purposes of the health, safety and convenience of the public, to make regulations about all or any of a number of matters in respect of retail pharmacy businesses.
The Council, where it considers it appropriate, to have an authorised officer inspect the premises of a retail pharmacy business, at the time of registration or renewal of registration, to ascertain if they comply with any regulations made by the Minister. The authorised office will furnish a written report to the Council and the applicant.
Certificate of registration
Provides for the issuing of a certificate of registration to a pharmacist or pharmacy owner. The period of the certificate to be 12 months.
The 2007 Act sets out the requirement for notification when an application for registration is refused, and the process of appeal by the applicant. It sets out the requirement of the Council to maintain up-to-date registers.It stipulates what constitutes evidence of registration with the Society in any legal proceedings.
The Council may set up and maintain a roll of persons studying pharmacy and that no fee will be chargeable in respect of enrolment. The 2007 Act sets out the definitions of ‘‘3 year minimum postregistration experience’’ and ‘‘representative’’.
There are conditions for the running of a pharmacy business by a natural person, a partnership, a corporate body or a representative of a registered pharmacist. Anyone carrying on a retail pharmacy business otherwise than in accordance with the 2007 Act commits an offence.
A registered pharmaceutical assistant may act on behalf of a registered pharmacist in his/her temporary absence.
The 2020 includes a number of additional Acts which the Council will supervise to ensure compliance by pharmacists and pharmacy owners. There are rules in relation to qualifications from other states and criteria for resuming practice as a registered pharmacist or commencing practice, when not having practised/ obtained qualifications for a period of time.
The 2020 Act deletes the former provision that a person who is an undischarged bankrupt cannot be registered as a pharmacist.
A qualification from a state other than this State which falls within the ground specified in the rules is to be of a standard necessary for practice in this State.
(Declarations by registered pharmacists in relation to certain matters in State or other jurisdictions, etc.)
All pharmacists are to give to the Council annually details of any proceedings in the State or another jurisdiction which might result in the pharmacist being restricted or prohibited from working as a pharmacist or working in one or more kind of health or social care profession, or if the proceedings could result in a conviction. The registrant also needs to provide details within 3 onths of the case concluding.
Declarations by pharmacy owners oblige pharmacy owners to give to the Council annually details of proceedings concerning a contravention of one of the Acts specified or proceedings which may result in a conviction in the State or another jurisdiction.
Council may request certain information concerning registered phar- macists from certain bodies in the State or other jurisdictions
The Council may get information from another health or social care regulatory body in or outside the State in relation to a pharmacist who has been refused registration; has been suspended; has conditions placed on his/her registration; has a conviction; or in relation to the pharmacist’s qualification or registration.
A pharmacy owner includes a reference to a pharmacist who is a director or a shareholder in a retail pharmacy business.
Restriction of Apothecaries Act 1791.
The powers conferred by the Apothecaries Act 1791 shall cease to be exercisable in relation to:
- inspection and direction of chemical and compound preparations and experiments;
- composition of medicines; and
- examination of apprentices and journeymen for the purposes of their learning and transacting the business of apothecaries and to certifying them as qualified for those purposes.
References to pharmaceutical chemists, or dispensing chemists and druggists in prior enactments to be construed as references to registered pharmacists, and that references, in prior enactments, to persons keeping open shop will be construed as referring to retail pharmacy businesses or a representative of registered pharmacist.
Codes, rules and regulations.
The Minister shall ensure that a code of conduct drawn up by the Society, and regulations made regarding the registration of pharmacies are laid before each House of the Oireachtas as soon as practicable. Either House of the Oireachtas may, by resolution passed within 21 sitting days after the day on which the code of conduct or regulations are laid before it, annul the code or, as the case may be, the regulations.
The Council and its members and the society’s employees
Term of office
Members of the Council shall hold office for a term of 4 years from the date of his or her appointment;
6 of the members first appointed and 5 of those first appointed shall hold office for a term of 2 years from the date of appointment;
the members making up these numbers shall be determined by lot to be drawn in the manner fixed by the Minister.
Disqualification from Office
There are circumstances under which a person shall be deemed not to be qualified for office or a member shall cease to be so qualified and shall cease to hold office. It also outlines the circumstances under which the Minister may remove a member from office.
Subject to the other provisions of this Act, a member shall hold office upon such terms and conditions as are determined by the Minister with the consent of the Minister for Finance.
The Council shall elect from among its members a President and a Vice-President, shall each hold office for one year. No person may hold the office of President or VicePresident for more than 2 consecutive years.
The Minister may appoint a person to fill a casual vacancy in the event that a member dies, resigns, or ceases to hold office or is removed from office. The new member shall hold office for the period of office of the former member that remained unexpired at the date of the new member’s appointment and shall be eligible for reappointment on the expiry of that period.
Meetings and Procedure of the Council
The Council shall hold 4 meetings in each period of 12 months and may hold such other meetings as are necessary for the performance of its functions. A meeting shall be chaired by the President, or in his or her absence, the Vice-President, or in both their absences, a member chosen by the members present.
Every question at a meeting shall be determined by a majority of the votes of the members present and voting and, in the case of an equal division of votes, the chair shall have a casting vote.
The quorum for a meeting shall be, unless the Minister otherwise directs, 11 members. Subject to the quorum requirement being met, the Council may act notwithstanding one or more vacancies in its membership.
The Council shall arrange for the recording of the business done at its meetings and those of its committees and, subject to that and the other provisions of this Act, shall regulate its procedure and that of its committees by rules and otherwise as it sees fit.
Committees of the Council
This paragraph provides that in addition to the disciplinary committees which the Council must set up, it may establish committees to advise it in relation to the performance of its functions and may determine their terms of reference. It may also dissolve an advisory committee.
In relation to both the disciplinary committees and advisory committees:
- a committee may include persons who are not members of the Council;
- a member of a committee may be removed from it by the Council;
- the Council shall appoint a member of a committee to chair it;
- the Council shall fix the quorum of a
Membership of either House of the Oireachtas or European Parliament by a Member of the Council or Staff of the Society
Disclosure of certain interests
The 2007 Act provides for disclosure of material interests by members of the Council or its committees and sets out the procedure for those members with material interests in absenting themselves from discussions at meetings where a matter arises in which that member has a material interest.
The 2007 Act provides for disclosure of material interests by employees of the Society and sets out the procedure for those employees with material interests in refraining from dealing with any matter in which those employees have a material interest.
A person who discloses confidential information obtained as a result of involvement with the Society, shall be guilty of an offence.
The Council may appoint a chief officer, to be known as the Registrar of the Pharmaceutical Society of Ireland, to carry on and manage and control generally the administration and business of the Council.
Staff of the Pharmaceutical Society of Ireland
The Council may determine the number, grade and conditions of staff (including conditions relating to remuneration and allowances) subject to the approval of the Minister with the consent of the Minister for Finance.
The Council to establish a superannuation scheme for the payment of superannuation benefits to or in respect of such of its employees (including the registrar) as the Council considers appropriate.
Accounts and Reports
The 2007 Act provides for the maintenance of proper accounts by the Council.
The Council is to submit an annual report on its activities to the Minister and for the Minster to lay copies of the report before each House of the Oireachtas. As soon as practicable after the report has been so submitted, the Council shall have it printed, published and put on sale.
Council’s exercise of Society’s borrowing power
This paragraph lays down the requirements for borrowing of money by the Society.
Acceptance of gifts by the Council
The Council may accept gifts of land, money or other property, but only if any trusts or conditions specified by the donor are consistent with the Society’s functions.
The Society may charge and recover fees.
Failure of Council to perform a function
This paragraph provides for the Minister to direct the Council to perform any of its functions in the event of the Council failing to do so, and if the Council does not comply with the direction, the Minister may remove from office any or all of the Council’s members and perform the function himself.
Recognition of Professional Qualifications in Pharmacy
The Council shall determine an application for registration as soon as possible after receiving all relevant documents, or within 3 months after such receipt.
The Council may require of the competent authorities of the home relevant State, confirmation of the authenticity of diplomas, certificates and other evidence of formal qualifications in pharmacy issued in that State, and confirmation that a person proferring such qualifications has fulfilled minimum training requirements.
The Council is to be the competent authority in the State to demand and receive and to issue diplomas, certificates and other documents concerning education for, qualifications in and the practice of pharmacy.
The Council shall ensure the confidentiality of information received under Article 50.1 of the Professional Qualifications Directive.
There is provision for the giving of information by the Council to relevant States. The Council, when registering a person qualified in a third country, to impose a condition requiring the person to indicate by whom their academic title was conferred or awarded, and for them to do so in a manner specified or otherwise directed by the Council.
The Council may suspend the registration of a person for a specified period or to cancel the registration in the case of a person who does not comply with a condition imposed by the Council.The 2007 Act shall apply in respect of a condition or sanction imposed under this Schedule as they apply in respect of one imposed under Part 6.
The Council, when considering an application for registration for a person qualified in a third country, to take into account any relevant training undergone or experience gained in a third country.
The ‘‘home relevant state‘‘ in relation to a pharmacist, as meaning the relevant State in which the pharmacist acquired his/her diploma, certificate or other qualifications in pharmacy or in which s/he is registered as a pharmacist;