Irish Medicines Board (Miscellaneous Provisions) Act 2006

PART 1 Preliminary

1 Short title, collective citation, construction and commencement.

1.— (1) This Act may be cited as the Irish Medicines Board (Miscellaneous Provisions) Act 2006.

(2) The Misuse of Drugs Acts 1977 and 1984 and Part 2 may be cited together as the Misuse of Drugs Acts 1977 to 2006 and shall be construed together as one.

(3) The Irish Medicines Board Act 1995 and Part 3 may be cited together as the Irish Medicines Board Acts 1995 and 2006 and shall be construed together as one.

(4) The Control of Clinical Trials Acts 1987 and 1990 and Part 4 may be cited together as the Control of Clinical Trials Acts 1987 to 2006 and shall be construed together as one.

(5) The Health Acts 1947 to 2005 andPart 5 may be cited together as the Health Acts 1947 to 2006 and shall be construed together as one.

(6) The Animal Remedies Act 1993 and Part 7 may be cited together as the Animal Remedies Acts 1993 and 2006.

(7) This Act (other than Part 7) shall come into operation on such day or days as the Minister for Health and Children 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.— A reference in this Act to any enactment shall be construed as a reference to the enactment as amended, adapted or extended by or under any other enactment including this Act.

PART 2 Amendment of Misuse of Drugs Act 1977

3 Amendment of section 1 of Misuse of Drugs Act 1977 (interpretation).

3.— Section 1(1) of the Misuse of Drugs Act 1977 (as amended by section 2 of the Misuse of Drugs Act 1984) is amended—

(a) by inserting the following before the definition of “cannabis”:

“ ‘ business ’ includes a profession;”,

(b) by inserting the following after the definition of “forged prescription”:

“ ‘ Irish Medicines Board ’ means the Irish Medicines Board established under section 3 of the Irish Medicines Board Act 1995;”,

(c) in the definition of “practitioner”, by substituting “, a registered veterinary surgeon and a registered nurse” for “and a registered veterinary surgeon”, and

(d) by inserting the following after the definition of “registered medical practitioner”:

“ ‘ registered nurse ’ means a person whose name is entered in the register of nurses maintained by An Bord Altranais under section 27 of the Nurses Act 1985;”.

4 Amendment of section 5 of Misuse of Drugs Act 1977 (regulations to prevent misuse of controlled drugs).

4.— Section 5 of the Misuse of Drugs Act 1977 is amended—

(a) in subsection (1), by substituting the following for paragraph (f):

“(f) subject to subsection (1A) of this section, regulating the issue by—

(i) registered medical practitioners, registered dentists or registered veterinary surgeons, or

(ii) registered nurses, or registered nurses belonging to a class of registered nurses,

of prescriptions for controlled drugs and the supply of controlled drugs on prescription,”,

(b) by inserting the following after subsection (1):

“(1A) The Minister shall only exercise the power to make regulations under subsection (1)(f) of this section in the case of registered nurses, or registered nurses belonging to a class of registered nurses, if the Minister, after having had regard to the nature and purpose of the controlled drug concerned (including any deleterious effects which may arise from the misuse thereof), is satisfied that it is reasonably safe to permit the issue by registered nurses, or registered nurses belonging to a class of registered nurses, of prescriptions for that drug.”,

(c) in subsection (2), in paragraph (a), by inserting “(other than a registered nurse)” after “practitioner”, and

(d) by inserting the following after subsection (2):

“(3) Subject to section 13 of this Act, the Minister may exercise the Minister's power to make regulations under this section so as to secure that it is not unlawful under this Act for a practitioner who is a registered nurse, or a practitioner who is a registered nurse belonging to a class of registered nurses, for the purpose of the practitioner's profession as a registered nurse, to prescribe, administer, manufacture, compound or supply a controlled drug if the Minister, after having had regard to the nature and purpose of the controlled drug (including any deleterious effects which may arise from the misuse thereof), is satisfied that it is reasonably safe to permit the practitioner, for the purpose of the practitioner's profession as a registered nurse, to prescribe, administer, manufacture, compound or supply that controlled drug.”.

5 Amendment of section 6 of Misuse of Drugs Act 1977 (directions prohibiting prescribing, supply, etc., of controlled drugs by practitioners or pharmacists, etc., convicted of offences).

5.— Section 6 of the Misuse of Drugs Act 1977 is amended—

(a) by inserting the following after subsection (1):

“(1A) Where a relevant person has after the commencement of this subsection been convicted of—

(a) an offence under this Act, or

(b) an offence against the Customs Acts in relation to the importation or exportation of a controlled drug,

the Minister may give a direction under subsection (2) of this section in respect of that person.”,

(b) in subsection (2)(b), by substituting “or relevant person, be a direction prohibiting the pharmacist or relevant person, as the case may be, from having in the pharmacist’s or relevant person’s, as the case may be,” for “, be a direction prohibiting him from having in his”, and

(c) by inserting the following after subsection (6):

“(7) In this section, ‘relevant person’ means—

(a) a person, not being a pharmacist, keeping open shop for the dispensing or compounding of medical prescriptions in accordance with the provisions of the Pharmacy Acts 1875 to 1977, or

(b) any director, manager, secretary or other official of a person referred to in paragraph (a) of this definition which is a body corporate.”.

6 Amendment of section 8 of Misuse of Drugs Act 1977 (investigation of cases where Minister considers there are grounds for special direction).

6.— Section 8(7) of the Misuse of Drugs Act 1977 (as amended by section 3 of the Misuse of Drugs Act 1984) is amended—

(a) in paragraph (c), by substituting “Council,” for “Council.”, and

(b) by inserting the following after paragraph (c):

“(d) in case the practitioner concerned is a registered nurse, to An Bord Altranais,”.

7 Amendment of section 14 of Misuse of Drugs Act 1977 (licences, etc.).

7.— Section 14 of the Misuse of Drugs Act 1977 is amended—

(a) in subsection (1), by substituting “Irish Medicines Board” for “Minister”, and

(b) by inserting the following after subsection (2):

“(3) A licence, permit or authorisation—

(a) granted or issued by the Minister under subsection (1) (including granted or issued by way of being renewed) at any time before the commencement of this subsection, and

(b) in force immediately before that commencement,

shall, on and after that commencement but subject to the conditions, if any, attached under subsection (1) to it and in force immediately before that commencement, continue in force, unless sooner revoked under subsection (1), for the unexpired portion of the period of validity, if any, which it had left to run immediately before that commencement as if, on that commencement, the Irish Medicines Board had, under subsection (1)—

(c) granted or issued that licence, permit or authorisation, and

(d) attached to that licence, permit or authorisation those conditions, if any,

and the provisions of this Act shall apply to the licence, permit or authorisation accordingly.”.

8 Amendment of section 17 of Misuse of Drugs Act 1977 (prohibition of cultivation of opium poppy or cannabis plant).

8.— Section 17 of the Misuse of Drugs Act 1977 (as amended by section 11(1) of the Misuse of Drugs Act 1984) is amended—

(a) in subsection (1)—

(i) by inserting “for the production of opium” after “poppy”, and

(ii) by substituting “under section 14(1)” for “by the Minister”,

and

(b) in subsection (2), by inserting “for the production of opium” after “poppy”.

9 Amendment of section 24 of Misuse of Drugs Act 1977 (powers to inspect and demand production of drugs, books or documents).

9.— Section 24 of the Misuse of Drugs Act 1977 is amended—

(a) in subsection (1)—

(i) by substituting “writing in that behalf by the Minister or the Irish Medicines Board” for “that behalf by the Minister in writing”,

(ii) in paragraph (a), by adding “or as a practitioner” after “drugs”, and

(iii) in paragraph (c), by inserting “(including any data within the meaning of the Data Protection Acts 1988 and 2003)” after “documents”,

and

(b) by substituting the following for subsection (2):

“(2) For the purposes of enforcing this Act and any statutory instruments made thereunder, and without prejudice to the generality of subsection (1) of this section, a person authorised in writing in that behalf by the Council of the Pharmaceutical Society of Ireland may at all reasonable times—

(a) enter any building or premises in which a person keeps open shop for the dispensing or compounding of medical prescriptions,

(b) require any such person, or any person employed in connection with keeping such open shop for the dispensing or compounding of medical prescriptions, to produce any controlled drugs which are in his possession or under his control,

(c) require any such person, or any person so employed, to produce any books, records or other documents (including any data within the meaning of the Data Protection Acts 1988 and 2003) which relate to transactions concerning controlled drugs and which are in his possession or under his control, and

(d) inspect any controlled drug, book, record or other document produced in pursuance of a requirement under this section.

(3) Where the Minister or the Irish Medicines Board authorises a person under subsection (1) of this section, then the Minister or the Irish Medicines Board, as the case may be, shall furnish the person with a warrant of his authorisation.

(4) Where the Pharmaceutical Society of Ireland authorises a person under subsection (2) of this section, then it shall furnish the person with a warrant of his authorisation.

(5) Where—

(a) a person has been authorised by the Minister under subsection (1) of this section at any time before the commencement of this subsection,

(b) the authorisation is still in force immediately before that commencement, and

(c) either—

(i) the person has, before that commencement, been issued with a certificate of his authorisation, or

(ii) the person has not, before that commencement, been issued with a certificate of his authorisation,

then the Minister shall—

(d) in a case falling within paragraph (c)(i) of this subsection, furnish the person with a warrant of his authorisation upon the surrender of his certificate of authorisation,

(e) in a case falling within paragraph (c)(ii) of this subsection, as soon as reasonably practicable after that commencement, furnish the person with a warrant of his authorisation.

(6) Where a person authorised under subsection (1) or (2) of this section—

(a) claims to exercise a power by virtue of that authorisation, and

(b) is required by a person in relation to whom the power is proposed to be exercised, to produce evidence of that authorisation,

then the person so authorised shall not exercise that power until he has produced the warrant of authorisation furnished under this section to the person in relation to whom the power is proposed to be exercised.

(7) A certificate of authorisation referred to in subsection (5)(c)(i) of this section which has not been surrendered as referred to in subsection (5)(d) of this section shall be deemed to be a warrant of authorisation furnished under this section to the person to whom the certificate of authorisation was furnished, and subsection (6) of this section shall be construed accordingly.”.

PART 3 Amendment of Irish Medicines Board Act 1995

10 Amendment of section 1 of Irish Medicines Board Act 1995 (interpretation).

10.— Section 1(1) of the Irish Medicines Board Act 1995 is amended—

(a) by inserting the following before the definition of “the Board”:

“ ‘ administer ’, in relation to a medicinal product (and whether or not the product has been dissolved or dispersed in, or diluted or mixed with, any other substance), means to administer the product to a natural person—

(a) orally,

(b) by injection or other introduction into the body of the person, or

(c) by external application,

and whether or not by direct contact with the body of the person;”;

(b) by inserting the following after the definition of “cosmetic product”:

“ ‘ drug precursor ’ means a scheduled substance as defined in Article 2 of Council Regulation (EC) No. 111/2005 of 22 December 2004 [^1];”;

(c) by substituting the following for the definition of “medicinal product”:

“ ‘ medical device ’ means a medical device which falls within any of the definitions of ‘medical device’ in—

(a) Article 1 of Council Directive 90/385/EEC of 20 June 1990 [^2],

(b) Article 1 of Council Directive 93/42/EEC of 14 June 1993 [^3], or

(c) Article 1 of Directive 98/79/EC of 27 October 1998 [^4];

‘ medicinal product ’ has the meaning assigned to it by Directive 2001/83/EC of 6 November 2001 [^5], as amended from time to time;”;

(d) by inserting the following after the definition of “the Minister”:

“ ‘ premises ’ includes any aircraft, hovercraft, ship, stall or vehicle;”;

(e) in the definition of “recognised trade unions and staff associations”, by substituting “Board;” for “Board.”; and

(f) by adding the following after the definition of “recognised trade unions and staff associations”:

“ ‘ registered dentist ’ means a person registered in the register established under the Dentists Act 1985;

‘ registered medical practitioner ’ means a person registered in the General Register of Medical Practitioners established under the Medical Practitioners Act 1978;

‘ registered nurse ’ means a person whose name is entered in the register of nurses maintained under section 27 of the Nurses Act 1985;

‘ veterinary medicinal product ’ has the meaning assigned to it by Directive 2001/82/EC of 6 November 2001 [^6], as amended from time to time.”.

11 Amendment of section 4 of Irish Medicines Board Act 1995 (functions of Board).

11.— Section 4 of the Irish Medicines Board Act 1995 is amended—

(a) in subsection (1)—

(i) by substituting “Subject to subsection (4), the” for “The”;

(ii) by substituting the following for paragraphs (b), (c) and (d):

“(b) to exercise the powers conferred on the competent authority by Directive No. 2001/83/EC of 6 November 20015,

(c) to exercise the powers conferred on the supervisory authority by Regulation (EC) No. 726/2004 of 31 March 2004 [^7],

(d) to exercise the powers conferred on the competent authority by Directive No. 2001/82/EC of 6 November 20016,”;

(iii) by substituting the following for paragraph (k):

“(k) to establish and administer a service—

(i) for the receipt of applications from persons proposing to export any description of medicinal products, cosmetic products, veterinary medicinal products or medical devices, and

(ii) for the issue to such persons of certificates containing any statement relating to such description of such products or devices as the Board considers appropriate after having regard to—

(I) the law (whether under any enactment or rule of law or otherwise) in the State which is for the time being applicable to such description of such products or devices, and

(II) the law (whether under any enactment or rule of law or otherwise) in the place to which such description of such products or devices is to be exported which is for the time being applicable to such description of such products or devices,”;

(iv) in paragraph (p), by substituting “1994),” for “1994).”; and

(v) by inserting the following after paragraph (p):

“(q) to exercise, subject to subsection (5), the powers specified in section 14(1) of the Misuse of Drugs Act 1977 (as amended by section 7 of the Irish Medicines Board (Miscellaneous Provisions) Act 2006),

(r) the authorisation of persons under section 24 of the Misuse of Drugs Act 1977 (as amended by section 9 of the Irish Medicines Board (Miscellaneous Provisions) Act 2006),

(s) to exercise the powers conferred on the competent authority by Directive 2001/20/EC of 4 April 2001 [^8],

(t) to exercise the powers conferred on the competent authority by Council Directive 76/768/EEC of 27 July 1976 [^9], as amended, Commission Directive 95/17/EC of 19 June 1995 [^10] and the European Communities (Cosmetic Products) Regulations 2004 (S.I. No. 870 of 2004),

(u) to exercise the powers conferred on the competent authority by Directive 2004/23/EC of 31 March 2004 [^11],

(v) to perform such other functions as are conferred on the Board by this or any other enactment (including any statutory instrument made thereunder).”;

and

(b) by substituting the following for subsections (4) and (5):

“(4) The Board shall exercise the powers conferred on it under a paragraph of subsection (1) as the competent authority or the supervisory authority in accordance with any regulations made by the Minister, or the Minister for Agriculture and Food, for the purposes of giving effect to a Council Directive, Directive, Council Regulation or Commission Directive referred to in the paragraph.

(5) The Board shall, in exercising the powers referred to in subsection (1)(q), comply with any directive or guideline issued by the Minister to the Board in respect of policy in relation to controlled drugs.”.

12 Amendment of section 5 of Irish Medicines Board Act 1995 (conferral of additional functions on Board).

12.— Section 5(1)(a) of the Irish Medicines Board Act 1995 is amended by inserting “, veterinary medicinal products, cosmetic products, drug precursors or medical devices” after “products”.

13 Amendment of section 7 of Irish Medicines Board Act 1995 (members of Board).