Pharmacy Act 2007

PART 1 Preliminary and General

1. Short title and commencement.

1.— (1) This Act may be cited as the Pharmacy Act 2007.

(2) This Act shall come into operation on such day or days as the Minister may appoint by order or orders either generally or with reference to any particular purpose or provision and different days may be so appointed for different purposes or provisions.

2. Interpretation.

2.— (1) In this Act—

“Company” means a company within the meaning of the Companies Acts 1963 to 2005;

F1["condition" includes a restriction;]

“Council” means the Council established by section 10;

“Directive” means Directive 2001/83/EC of 6 November 2001 on the Community code relating to medicinal products for human use, as amended;

“Enduring power of attorney” means a power of attorney within the meaning of section 2of the Powers of Attorney Act 1996, which is an enduring power construed in accordance with section 5 of that Act;

F1["health or social care", in relation to a person (howsoever described), means the health or social care that the person provides or has provided in his or her capacity or former capacity as a member of a relevant profession;

"inspect" includes search;]

“medicinal product” has the same meaning as in the Directive except that until 30 April 2011 it does not include herbal or homeopathic medicinal products;

“Minister” means the Minister for Health and Children;

F1["partner" shall be construed in accordance with the Partnership Act 1890;]

“pharmaceutical assistant” means a person who before the coming into operation of section 4(1) of this Act was competent, under section 19of the Pharmacy Act, (Ireland) Amendment Act 1890 to transact the business of a pharmacist in his or her temporary absence;

“pharmacy owner” means a person carrying on a retail pharmacy business and, as such, being entitled to the profits and liable to sustain the losses of the business and “pharmacy”, when used with reference to a pharmacy owner, means a retail pharmacy business;

“practice” means the carrying on of practice as a registered pharmacist;

“prescribed” means prescribed by rules made by the Council;

F2[“Professional Qualifications Directive”, has the same meaning as that assigned to“Directive”in the Professional Qualifications Regulations;

“Professional Qualifications Regulations”means the European Union (Recognition of Professional Qualifications) Regulations 2017 (No. 8 of 2017);]

F1["record" includes, in addition to a record in writing—

(a) a disc, tape, sound-track or other device in which information, sounds or signals are embodied so as to be capable (with or without the aid of some other instrument) of being reproduced in legible or audible form,

(b) a film, tape or other device in which visual images are embodied so as to be capable (with or without the aid of some other instrument) of being reproduced in visual form, and

(c) a photograph,

and any reference to a copy of a record includes—

(i) in the case of a record to whichparagraph (a)applies, a transcript of the sounds or signals embodied therein,

(ii) in the case of a record to whichparagraph (b)applies, a still reproduction of the images embodied therein, and

(iii) in the case of a record to whichparagraphs (a)and(b)apply, such a transcript together with such a still reproduction;]

“register” means a register set up and maintained under section 13 and “registered” and connected expressions shall be construed accordingly;

“registered medical practitioner” means a person whose name is entered in the General Register of Medical Practitioners established under the Medical Practitioners Act 1978;

F1["relevant profession" means any of the following professions:

(a) dentist;

(b) a designated profession within the meaning of section 3 of the Health and Social Care Professionals Act 2005;

(c) medical practitioner;

(d) midwife;

(e) nurse;

(f) pharmacist;]

F1["restriction" includes a condition;]

“retail pharmacy business” means a business (not being a professional practice carried on by a registered medical practitioner or a registered dentist) which consists of or includes the sale or supply of medicinal products other than medicinal products on a general sales list (whether or not such products on such a list are also sold or supplied in the course of the business);

“sale” means sale by retail;

“the Society” has the meaning assigned to it by section 5;

“the old Society” has the meaning assigned to it by section 5;

F1["this Act" includes a statutory instrument made under this Act;]

“supply” in relation to a medicinal product, means its supply (other than by way of sale) to a person who receives it for a purpose other than—

(a) selling or supplying it, or

(b) administering it or causing it to be administered to another person,

in the course of a business or profession.

(2) References in this Act to the sale and supply or the sale or supply of a medicinal product include references to the keeping, preparing, compounding or dispensing of the medicinal product.

(3) For the purposes of this Act, two or more premises which are separate and distinct from each other shall each be regarded as separate premises although they are parts of the same building.

(4) Subsection (3) shall not apply to sections 63 and 64.

(5) In the definition of “retail pharmacy business” in subsection (1), “medicinal products on a general sales list” means medicinal products which may be sold under section 32(2)(m)(ii) of the Irish Medicines Board Act 1995.

F1[(6) Unless otherwise specified in this Act, nothing in this Act shall be construed to prejudice the performance by the Council of its functions under the Professional Qualifications Regulations as the competent authority in respect of the regulated professions (within the meaning of Regulation 3 of those Regulations) concerned.]

3. Expenses.

3.— The expenses incurred by the Minister in the administration of this Act shall, to such extent as may be sanctioned by the Minister for Finance, be paid out of money provided by the Oireachtas.

4. Repeals and revocations.

4.— (1) The enactments specified in Schedule 4 are repealed.

(2) The European Communities (Recognition of Qualifications in Pharmacy) Regulations 1987 to 2004 are revoked.

PART 2 The Pharmaceutical Society of Ireland

5. Dissolution of old and establishment and membership of new Pharmaceutical Society of Ireland.

5.— (1) The Pharmaceutical Society of Ireland constituted and incorporated by section 4 of the Pharmacy (Ireland) Act 1875 (in this Act referred to as “the old Society”) is hereby dissolved.

(2) There is hereby established in its place a body to be known as Cumann Cógaiseoirí na hÉireann, or, in the English language, “The Pharmaceutical Society of Ireland” (in this Act referred to as “the Society”).

(3) Every registered pharmacist is a member of the Society.

(4) All rights, property and liabilities of the old Society are transferred to the Society.

(5) The Society becomes the employer of all persons who immediately before the dissolution of the old Society were its employees and shall employ each of them on terms and conditions not less favourable than those then applicable to the employee.

(6) In—

(a) any proceedings in a court or tribunal, and

(b) any contract or other agreement,

to which the old Society is a party, the Society is substituted for the old Society.

(7) References to the old Society which—

(a) occur in any enactment passed or made before this Act is passed, and

(b) relate to anything which becomes the responsibility of the Society by virtue of this Act,

are to be construed as references to the Society.

(8) Anything done by, on behalf of or in respect of the old Society which relates to anything which becomes the responsibility of the Society by virtue of this Act shall be treated as if done by, on behalf of or in respect of the Society.

(9) Enactments are to be construed and applied, so far as it is possible to do so, in a way which achieves continuity between the functions of the old Society and, so far as they correspond, those of the Society.

(10) Stamp duty is not chargeable on an instrument under which any property owned by the old Society is transferred to the Society.

(11) For the purposes of the Capital Gains Tax Acts (within the meaning of section 1 of the Taxes Consolidation Act 1997), any gain accruing to the old Society on a disposal made by virtue of this section shall not be a chargeable gain.

6. Status of the Society.

6.— (1) The Society is a corporate body with perpetual succession and an official seal.

(2) The official seal of the Society shall be authenticated by—

(a) the signature of 2 members of the Council, or

(b) the signature of a member of the Council and an employee of the Society,

authorised by the Council to sign for that purpose.

(3) Judicial notice shall be taken of the official seal of the Society and any document purporting to be an instrument made by and sealed by the Society shall, until the contrary is shown, be received in evidence and be deemed to be such instrument without further proof.

(4) The Society may sue and may be sued in its corporate name.

(5) The Society may acquire, hold and transfer land and other property.

7. Functions of the Society.

7.— (1) The principal functions of the Society shall be—

F3[(a) to regulate the profession of pharmacy in the State, including prescribing by pharmacists, having regard to the need to protect, maintain and promote the health and safety of the public,]

(b) to promote and ensure a high standard of education and training for persons seeking to become pharmacists,

(c) to ensure that those persons and pharmacists obtain appropriate experience,

(d) to ensure that pharmacists F4[and pharmaceutical assistants] undertake appropriate continuing professional development, including F5[in relation to prescribing and] the acquisition of specialisation, and

F6[(e) to—

(i) supervise compliance with this Act, and

(ii) supervise compliance by pharmacists, pharmaceutical assistants and pharmacy owners in their respective capacities as such, with—

(I) the Poisons Acts 1961 and 1977,

(II) the Misuse of Drugs Acts 1977 to 2017,

(III) the Animal Remedies Acts 1993 and 2006,

(IV) the Irish Medicines Boards Acts 1995 and 2006,

(V) the Health (Pricing and Supply of Medical Goods) Act 2013 ,

(VI) any statutory instrument made under any of those Acts, and

(VII) the European Communities (Animal Remedies) (No. 2) Regulations 2007 ( S.I. No. 786 of 2007),

and]

F7[(f) to establish and maintain, in accordance with regulation 19A (inserted by regulation 7 of the Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2015 (S.I. No. 87 of 2015)) of the Medicinal Products (Prescription and Control of Supply) Regulations 2003 (S.I. No. 540 of 2003), the ISS supply list of persons entitled to supply non-prescription medicinal products at a distance to the public by means of information society services.]

(2) Without prejudice to the generality of subsection(1), but subject to the other provisions of this Act—

(a) it is the duty of the Society to—

(i) keep the registers,

(ii) determine and apply the criteria for registration,

(iii) draw up codes of conduct for pharmacists,

(iv) determine, approve and keep under review programmes of education and training suitable to enable persons applying for registration to meet those criteria and pharmacists to comply with those codes,

(v) give the Minister such information and advice about such matters relating to its functions as the Minister may call for,

(vi) act as the competent authority for the purposes of the mutual recognition of pharmacy qualifications obtained in or recognised by Member States and for the purposes of the Professional Qualifications Directive, F8[Commission Implementing Regulation (EU) 2015/983 of 24 June 20154 and the Professional Qualifications Regulations,]

(vii) take suitable action to improve the profession of pharmacy,

(b) the Society shall have power to—

(i) conduct inquiries into the qualifications and fitness of persons to practise,

(ii) impose sanctions on pharmacists whom it finds (whether or not after an inquiry) to be unqualified or unfit to practise,

(iii) impose sanctions on pharmacy owners whom it finds (whether or not after an inquiry) have failed to comply with regulations under section 18,

(iv) to conduct or arrange for the conduct of examinations of persons who are applying or might apply for registration,

(v) give the Minister such advice or information about matters relating to its functions as it thinks fit,

(vi) facilitate the exchange of information between its members collectively or any sector of them and members of the public who use, or might use, their or its services,

(vii) make public statements about any aspect of pharmacy to which its functions relate,

(viii) borrow money,

(ix) authorise persons to exercise the powers of entry and inspection, etc., of drugs and documents, as set out in section 24 of the Misuse of Drugs Act 1977,

(x) appoint persons as authorised officers for the purposes of the Irish Medicines Board Act 1995 and furnish them with warrants, all as set out in section 32B of that Act.

(3) In subsection (2)(a)(ii) and (iv), “registration” includes continued registration.

8. Additional functions.

8.— The Minister may, by order—

(a) confer on the Society such additional functions, connected with those which it has,

(b) make such provision ancillary to the exercise of the power under paragraph (a),

as the Minister thinks fit.

9. Ancillary powers.

9.— (1) The Society shall have all such powers as are necessary or expedient for the performance by it of its functions.

(2) Without prejudice to the generality of subsection (1) or section 7 or 8, the Society may—

(a) carry out or commission research into and evaluation of—

(i) education and training (including the formulation and testing of experimental curricula),

(ii) examination and assessment processes,

(b) keep and publish statistics,

in relation to pharmacy.

PART 3 The Council of the Society

10. The Council of the Society.

10.— (1) The Society shall have a Council.

(2) The Council shall consist of 21 persons appointed by the Minister.

(3) Of those 21—

(a) one shall be nominated by the Irish Medicines Board as representative of the management of the regulation of medicinal products,

(b) one shall be nominated by the Health Services Executive as representative of the management of the public health sector,

(c) one shall be a person appearing to the Minister to be representative of the provision of continuing professional development in relation to pharmacy,

(d) 3 shall be persons with such qualifications, expertise, interests or experience (or such combination of any of them) as would, in the opinion of the Minister, enable them to make a substantial contribution to the performance of the Society’s functions,

(e) 11 (including the persons referred to in paragraphs (a) to (d)) shall be persons who are not and never have been—

(i) registered as pharmacists or (before the coming into operation of Part 4) as pharmaceutical chemists or dispensing chemists and druggists, or

(ii) registered outside the State or otherwise qualified there as pharmacists,

(f) 9 shall be members of the Society who have been selected by its members in accordance with rules made under section 11(2)(b), and

(g) 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—

(i) the deans of the schools of pharmacy of those establishments (including, where there is no such dean, the person whose functions are the same as or most nearly correspond to those which might be carried out by a dean), and

(ii) the heads of those establishments.

(4) In—

(a) making nominations under subsection (3)(a) and (b), the bodies there referred to, and

(b) making appointments in pursuance of subsection (3)(c), (d) and (e), the Minister,

shall have regard to the desirability of ensuring that the persons nominated or, as the case may be, appointed are also representative of the public interest.

(5) In relation to the first Council appointed after the establishment of the Society, the 9 persons referred to in subsection (3)(f) shall be members of the Council of the old Society selected for the purposes of this section by the members of the Council of the old Society before its dissolution.

(6) Schedule 1 shall apply in relation to the Council and its members and the employees of the Society.

(7) The Minister may not refuse to appoint to the Council a person nominated under paragraph (a) or (b) of subsection (3) or selected under paragraph (f) (as read with subsection (5)) or (g) of subsection (3).

11. Functions of the Council and their delegation.

11.— (1) Subject to this Act, the functions of the Society shall be performed on its behalf by the Council.

(2) The Council may make rules for the purposes of—

(a) regulating or prescribing anything that may, in accordance with any provision of this Act, be prescribed,

(b) making such provision as it thinks fit for facilitating the performance of its functions under this Act.

F9[(2A) The Council may make rules in relation to the specification of grounds for the purposes ofsection 16(2)(c)after having regard to—

(a) the standard of education and training required to obtain recognition as a pharmacist in the State referred to in that section for persons seeking to become pharmacists,

(b) the practical experience of such persons, and

(c) the continued professional development for such pharmacists.