S.I. No. 163/1966 - The National Drugs Advisory Board (Establishment) Order, 1966.

S.I. No. 163 of 1966.

THE NATIONAL DRUGS ADVISORY BOARD (ESTABLISHMENT) ORDER, 1966.

The Minister for Health in exercise of the powers conferred on him by sections 3 to 6 of the Health (Corporate Bodies) Act, 1961 (No. 27 of 1961), hereby orders as follows :—

1. This Order may be cited as the National Drugs Advisory Board (Establishment) Order, 1966.

2. A body to be known as An Bord Comhairleach Náisiúnta Druganna or, in the English language, the National Drugs Advisory Board, is hereby established.

3. In this Order—

" the Board " means the National Drugs Advisory Board established by this Order ;

" the Chairman " means the Chairman for the time being of the Board ;

" the Minister " means the Minister for Health ;

" Drug " means any prophylactic, diagnostic or therapeutic substance or mixture of substances which may be used for the prevention, diagnosis or treatment of human disease or defect or for the modification of physiological function in man.

4. The functions of the Board are as follows :—

(a) to organise and administer a service for obtaining and assessing information as regards the safety of new and reformulated drugs and, in particular, their toxicity and other adverse effects,

(b) to organise and administer a service for obtaining and assessing reports on the adverse effects of drugs in use in the State,

(c) to advise the Minister and others concerned as to the precautions or restrictions, if any, subject to which drugs may be marketed or continued in use in the State,

(d) if requested by the Minister, to consider and report to him on the arrangements to be made for the quality control of drugs, for the registration and inspection of the premises of drug manufacturers, importers and wholesalers, and for the sampling and testing of drugs,

(e) if requested by the Minister, to advise on the certification for export purposes of drugs manufactured or processed in the State,

(f) if requested by the Minister and subject to such conditions as he may approve, to arrange for the collection and dissemination of information in respect of drugs, their pharmacological classification and therapeutic efficacy and in respect of economies in prescribing,

(g) if requested by the Minister, to make recommendations regarding standards for the composition, purity and strength of drugs and for the methods of testing drugs,

(h) to consider and report to the Minister on such general or particular matters in regard to drugs as he may refer to the Board for advice.

5. The Board shall consist of twelve members appointed by the Minister.

6. The term of office of a member of the Board shall be such period not exceeding four years as may be specified by the Minister when appointing him and he shall hold office for the period for which he is appointed unless he sooner dies, resigns by letter addressed to the Minister or ceases to be a member in accordance with article 7 of this Order.

7. A member shall cease to be a member of the Board on his being requested by the Minister to resign.

8. The Minister shall appoint from amongst the members of the Board a Chairman who shall hold office until he ceases to be a member of the Board or until the Minister appoints another person to be Chairman.

9. The quorum of the Board shall be four.

10. The Board shall hold such and so many meetings as may be necessary for the performance of its functions.

11. The proceedings of the Board shall not be invalidated by any vacancy or vacancies among its members or by any defect in the appointment of the Board or any member thereof.

12. (1) The Chairman may, at any time, call a meeting of the Board.

(2) If the Chairman refuses to call a meeting of the Board after a requisition for that purpose, signed by three members of the Board, has been presented to him, any three members of the Board, may forthwith, on that refusal, call a meeting of the Board, and, if the Chairman (without so refusing) does not, within seven days after the presentation of the requisition, call a meeting of the Board, any three members of the Board may, on the expiration of these seven days, call a meeting of the Board.

13. At a meeting of the Board—

(a) the Chairman shall, if he is present, be chairman of the meeting,

(b) if and so long as the Chairman is not present, the members of the Board who are present shall choose one of their number to be chairman of the meeting.

14. Minutes of the proceedings of each meeting of the Board shall be entered in a book kept for that purpose and shall be signed by the Chairman of the meeting or of the next ensuing meeting.

15. (1) The names of the members present at a meeting of the Board shall be recorded in the minutes of the proceedings of the Board.

(2) The names of the members voting on any question arising at a meeting of the Board shall be recorded in the minutes of the proceedings of the meeting and the record shall show which members vote for and which against the question.

16. (1) A person shall not receive any remuneration for acting as a member of the Board.

(2) Members of the Board may be paid travelling and subsistence allowances in accordance with such scale as may from time to time be approved by the Minister.

17. (1) All acts of the Board and all questions coming or arising before the Board may be done and decided by the majority of such members of the Board as are present and vote at a meeting of the Board.

(2) In case of equality of votes on any question arising at a meeting of the Board, the chairman of the meeting shall have a second or casting vote.

18. (1) In order to facilitate the discharge of the functions of the Board, the Board may establish committees.

(2) The Board may appoint to any committee such members of the Board as are willing to act on the committee and, if the Board so think fit, other persons who have special knowledge and experience related to the purpose of the committee.

(3) The Board shall notify the Minister of the establishment of any committee, of the purpose of the committee and of the names of the members thereof.

(4) If considered appropriate by the Minister, he may appoint additional persons to be members of any committee.

19. The seal of the Board shall be authenticated by the signature of the Chairman or some other member of the Board duly authorised by the Board to act in that behalf and the signature of an officer of the Board duly authorised by the Board to act in that behalf.

20. (1) The Board shall cause to be kept proper accounts of all income and expenditure of the Board, and of the sources of such income and the subject matter of such expenditure, and of the property, credits and liabilities of the Board.

(2) The financial year of the Board shall be the period of twelve months ending on the 31st day of December in any year and for the purposes of this provision the period commencing on the date of this Order and ending on the 31st December, 1966, shall be deemed to be a financial year.

(3) A statement of accounts of the Board for each financial year shall, as soon as may be after the end of such financial year, be prepared and after such preparation be audited by and be subject to a report by an auditor appointed for the purpose by the Minister after consultation with the Board.

(4) The expenses generally of such audit shall be paid by the Board as soon as may be after each audit.

(5) A copy of the accounts and the auditor's certificate and report thereon shall be presented to the members of the Board and to the Minister.

(6) The Board and the officers thereof shall, whenever so requested by the Minister, permit any person appointed by him to examine the books and accounts of the Board in respect of any financial year or other period and shall pay such fee therefor as may be fixed by the Minister.

21. (1) The Board shall in each year, not later than such day as the Minister shall direct, make a report to the Minister of its activities during the preceding year.

(2) The Board shall submit to the Minister such information regarding the performance of its functions as the Minister may from time to time require.

22. (1) The Board may appoint such and so many officers and employ such and so many servants as the Board may, from time to time, think proper and in appointing any officer or employing any servant the Board shall comply with any directions given by the Minister relating to the procedure to be followed.

(2) Every officer of the Board holding office in a permanent capacity shall cease to hold his office on attaining the age of sixty-five years.

(3) The Board shall determine the remuneration and conditions of service of each officer and each servant.

(4) The Board shall, from time to time, assign such duties as they consider appropriate to each officer and servant of the Board and each such officer and servant shall perform the duties so assigned to him.

(5) The Minister may, whenever and so often as he thinks fit, declare that any of the powers conferred on the Board by this article shall be exercisable only with the consent of the Minister, and whenever any such declaration is in force, the said powers may, in relation to any office or employment to which the declaration applies, be exercised only with such consent.

23. A person who for the time being holds any office under or is in the employment of the Board shall be disqualified from being a member of the Board.

24. The Local Government (Superannuation) Act, 1956 (No. 10 of 1956) shall apply to the Board as if it were a local authority.

25. (1) For the purpose of the performance of its functions, the Board may, with the consent of the Minister, borrow money and purchase or take on lease any land.

(2) The Board may, with the consent of the Minister, sell, exchange, let or otherwise dispose of any land vested in it.

26. (1) The Board may accept gifts of money, land and other property upon such trusts and conditions, if any, as may be specified by the donor.

(2) The Board may not accept a gift if the conditions attached by the donor to its acceptance are not consistent with the functions of the Board.

GIVEN under the Official Seal of the Minister for Health this twelfth day of July, 1966.

DONOGH O'MALLEY,

Minister for Health.

EXPLANATORY NOTE.

The effect of this Order is to establish under the Health (Corporate Bodies) Act, 1961 , a body, to be known as the National Drugs Advisory Board, which will organise and administer a service for obtaining, assessing and disseminating information as regards the safety of new and reformulated drugs and of drugs already in use, and will advise the Minister for Health on matters relating to the safety and quality of drugs.