I move amendment No. 104:
In page 25, subsection (1), to delete " and to whom " from line 44.
SECTION 33.
I move amendment No. 103 :
In page 25, subsection (1), to delete lines 6 to 36 and insert the following:
"(b) section 14 (3) is hereby amended by——
(i) the substitution of the following paragraph for paragraph (j):
‘(j) provide for the enforcement and execution of the provisions of the regulations——
(i) by officers of the Minister,
(ii) with the consent of the Minister for Agriculture and Fisheries, by officers of that Minister,
(iii) by the Pharmaceutical Society of Ireland and its officers, and
(iv) by health boards, and their officers,',
and
(ii) the insertion of the following paragraph after paragraph (j):
'(jj) enable any such officer (with, in the case of an officer of the Minister or the Minister for Agriculture and Fisheries, a written authorisation of whichever of those Ministers is appropriate, in the case of an officer of the Pharmaceutical Society of Ireland, a written authorisation of that Society, and in the case of an officer of a health board, a written authorisation of the board) at all reasonable times, for the purpose of ascertaining whether or not there is or has been a contravention of the regulations, to enter premises of a class or description specified in the regulations and to inspect any substance or article which is so specified and require the production of and inspect, and if he thinks fit take copies of any entry in, any book, record or other document which is of a prescribed class or description,'".
Amendment agreed to.
Amendment agreed to.
I move amendment No. 105 :
In page 25, lines 52 to 63, and in page 26, lines 1 to 13, subsection (1), to delete paragraph (d).
Amendment agreed to.
Section, as amended, agreed to.
NEW SECTION
I move amendment No. 106 :
In page 26, between lines 28 and 29, to insert the following new section before section 34 :
" 34. — Section 2 of the Pharmacy Act, 1962, is hereby amended by the substitution of the following subsection for subsection (4):
‘(4) It shall not be a contravention of subsection (2) of this section for a person to keep open shop for the sale of a substance which is declared to be a poison for the purposes of regulations made under section 14 of the Poisons Act, 1961, if the person is a person, or a member of a class of persons, by whom pursuant to such regulations the substance may be sold or offered or kept for sale.'".
Amendment No. 113a is consequential and therefore must be taken with No. 106.
This is a drafting amendment for the Pharmacy Act of 1962. It is purely a question of improving the construction of section 2 (4) of the Pharmacy Act so as to make its intention more clear and to remove possible ambiguity. It makes it clear that those granted powers to handle poisons by the Poisons Regulations will not be in breach of the Pharmacy Acts.
Amendment agreed to.
NEW SECTION
Amendments Nos. 110 and 114 are consequential on 107 and must be taken together.
I move amendment No. 107:
In page 26, between lines 28 and 29, to insert the following new section before section 34 :
" 35. —(1) The Pharmacopoeia Act, 1931, is hereby amended as follows :
(a) section 2 (1) shall be construed and have effect as if the reference therein to the Council were a reference to the Minister for Health;
(b) the following subsection shall be substituted for subsection (2) of section 2 :
‘ (2) The Minister for Health may by regulations make such modifications (by way of deletion, addition or amendment) in the British Pharmacopoeia for the time being in force in Great Britain as he thinks fit.';
(c) the following subsection shall be substituted for subsection (2) of section 3 :
‘ (2) A certificate endorsed on a book purporting to be a copy of the British Pharmacopoeia and purporting to be signed by an officer of the Minister for Health that such book is a copy of the British Pharmacopoeia in force in Great Britain on a specified day or days, or during a specified period, shall in any legal proceedings until the contrary is shown be admitted as evidence of the facts so certified, and in such proceedings it shall not be necessary to prove the signature of the person purporting to sign the certificate or that the person was an officer of the said Minister,'; and
(d) the following new section shall be inserted after section 4 :
' Regulations. 4.A— Every regulation made under this Act shall be laid before each House of the Oireachtas as soon as may be after it is made and, if a resolution annulling the regulation is passed by either such House within the next twenty-one days on which that House has sat after the regulation is laid before it, the regulation shall be annulled accordingly, but without prejudice to anything previously done thereunder.'.
(2) As on and from the specified day section 4 of the Pharmacopoeia Act, 1931, shall be construed and have effect as if——
(a) ‘or the European Pharmacopoeia ' were inserted after ' Saorstát Éireann Pharmacopoeia ' in subsection (1), and
(b) the following subsection were added to the section:
‘ (3) In this section " the European Pharmacopoeia " means the Pharmacopoeia elaborated under the auspices of the Council of Europe in pursuance of the Convention in that behalf done at Strasbourg on the 22nd day of July, 1964.'.
(3) In this section ‘the specified day‘ means the day specified for the purposes of this section in a notice published by the Minister in the Iris Oifigiúil.”.
I move amendment No. 1 to amendment No. 107:
To add the following new subsection after subsection (3):
" (4) The Minister shall have power (including the appointment of an advisory Committee) to investigate the feasibility of formulating an Irish Drug Formulary".
Will the Deputy withdraw his amendment to the Minister's amendment and submit it for Report Stage?
I see no reason why the Committee should not accept it. It simply gives the Minister power to investigate the feasibility of formulating an Irish Drug Formulary and to include the appointment of an advisory committee.
I am informed that I have this power already.
Amendment to amendment, by leave, withdrawn.
Amendment No. 107 agreed to.
NEW SECTION.
I move amendment No. 108:
In page 26, between lines 28 and 29 to insert the following new section before section 34:—
36. —Section 65 of the Health Act, 1947, as amended by section 39 of the Health Act, 1953, and section 6 of the Health Act, 1970, is hereby amended by—
(a) the substitution of the following paragraphs for paragraph (j) of subsection (3):
'(j) the enforcement and execution of the regulations——
(i) by officers of the Minister,
(ii) by health boards and their officers,
(iii) with the consent of the Minister for Finance, by officers of Customs and Excise,
(iv) with the consent of the Minister for Industry and Commerce, by officers of that Minister,
(v) by the Pharmaceutical Society of Ireland and its officers;
(k) the enabling for the purpose of ascertaining whether or not there is or has been a contravention of the regulations, of any such officer (with, in the case of an officer of the Minister or the Minister for Industry and Commerce or an officer of Customs and Excise, a written authorisation of whichever of those Ministers or the Minister for Finance is appropriate, in the case of an officer of a health board, a written authorisation of the board and in the case of an officer of the Pharmaceutical Society of Ireland, a written authorisation of that Society), at all reasonable times to enter any premises which are of a class or description specified in the regulations and to inspect or examine any substance or article which is of a class or description so specified and require the production of and inspect, and if he thinks fit, to take copies of any entry in, any book, record or other document which is of a prescribed class or description;
(l) the taking (without payment) by such officers, with such authorisation, of samples of such substances or articles for test, examination or analysis;
(m) the prescribing of the certificate or other evidence to be given of the result of any such test, examination or analysis and the classes of person by whom such certificate or evidence is to be given; and
(n) providing that any certificate or other evidence specified under paragraph (m) of this subsection and given in respect of the test, examination or analysis of a sample shall with regard to that sample be evidence for all purposes of the result.', and
(b) the substitution of the following subsection for subsection (5):
‘(5) An offence under this section may be prosecuted by the Minister, the Pharmaceutical Society of Ireland or by the health board in whose functional area the offence is committed,'".
Amendment No. 115, in the name of the Minister, is directly consequential and must be taken with amendment No. 108.
Will the Minister assure us that the amendment is strictly necessary and in the best interest of the health of the Irish people?
Yes.
Amendment agreed to.
Question: "That section 34 stand part of the Bill."
On this section I am giving notice that on Report Stage I wish to table an amendment in relation to paragraph (a) of section 34. This paragraph states: "by delivering it to him" and I wish to have inserted "by personally delivering it to him".
Question put and agreed to.