The HPSMAB is currently operating under a draft statutory instrument as follows:
HAEMOPHILIA PRODUCT SELECTION and MONITORING ADVISORY BOARD (ESTABLISHMENT) ORDER, 2007
I, Mary Harney, Minister for Health and Children, (herein referred to as the Minister) in exercise of the powers conferred on me by Section 3 of the Health (Corporate Bodies) Act, 1961 (No. 27 of 1961) as amended by Section 22 of the Health (Amendment) (No. 3) Act, 1996 (No. 32 of 1996) and adapted by the Health (Alteration of Name of Department and Title of Minister) Order 1997 (S.I. No. 308 of 1997) hereby order as follows:
1. This Order may be cited as the Haemophilia Product Selection and Monitoring Advisory Board (Establishment) Order 2007.
2. In this Order:
“Board” means the Haemophilia Product Selection and Monitoring Advisory Board established by this Order;
Chairperson means the Chairperson for the time being of the Board;
Contract Holder” means the Irish Blood Transfusion Service, which is the body established by The Blood Transfusion Service Board (Establishment) Order, 1965 (S.I. No. 78 of 1965), or such other body as the Minister may establish or authorise;
“Haemophilia” means the following disorders: inhibitors to factors VIII and IX, inherited deficiencies of factors I, II, V, VII, VIII, IX, X, XI, XIII and von Willebrand\’s Disease;
“Health Services” means health services provided under the Health Acts 1947 to 2004 and the Mental Treatment Acts 1945 to 2001;
“Health Service Executive” means the body established under Section 6 of the Health Act 2004;
Minister means the Minister for Health and Children;
“Officer” means an employee of the Board, unless the context otherwise requires;
“Product” means any clotting factor concentrate or concentrates used in the treatment of haemophilia.
THE BOARD
3. (1) A body to be known as the Haemophilia Product Selection and Monitoring Advisory Board is hereby established to perform the functions conferred upon it by this Order.
(2) The Board shall be a body corporate with perpetual succession and a seal and with power to sue and be sued in its corporate name and to hold land.
4. (1) The principal function of the Board shall be to advise the Minister, the Contract Holder and the Health Service Executive on any matter relating to products, on its own initiative or at the request of the Minister, the Contract Holder or the Health Service Executive.
(2) Without prejudice to (1) the Board may:
(a) advise the Contract Holder on national product requirements and on the products available to meet those requirements;
(b) advise the Contract Holder on the selection and monitoring of products, including advice on product delivery and distribution taking account of national and EU procurement, product regulatory and licensing laws;
(c) advise and make recommendations to the Contract Holder on the evaluation criteria to be used for the tender process for products;
(d) advise on the tenders received according to the recommended criteria;
(e) recommend to the Contract Holder the products to be purchased;
(f) request reports from the Contract Holder on product delivery;
(g) request information from pharmaceutical companies in relation to product developments;
(h) advise the Contract Holder on emergency procedures in relation to product safety, supply and availability;
(i) advise the Contract Holder on national and international trends in respect of product safety, including reported incidents of adverse reactions, efficacy, quality and supply;
(l) advise the Minister, the Contract Holder and the Health Service Executive on the risk of infection from viral or other sources associated with products within its remit and on appropriate action to minimise risks;
(m) advise the Contract Holder on the process of product tracing and recall.
(3) Nothing in (2) shall impede the Contract Holder in discharging its responsibilities in law, including its responsibilities relating to product safety, public procurement and licencing.
(4) In the event of a disagreement between the Board and the Contract Holder in relation to a recommendation on product selection, both parties will present the reasons for their conclusions to a meeting of both parties. If this does not result in agreement, the matter will be referred by the Contract Holder to the Minister for Health and Children.
(5) The Board may promote its functions through the publication of documents and organisation of conferences.
(6) The Board may request advice from any person in relation to the performance of its functions.
(7) The Board shall, not later than 30th June of each year, present an annual report to the Minister in relation to the performance of its functions during the preceding year and for the purposes of this provision the period commencing on the date of this Order and ending on 31st December, 2007, shall be deemed to be a calendar year.
(8) The Board shall submit to the Minister such information regarding the performance of its functions as the Minister may from time to time request, other than commercially sensitive information.
MEMBERSHIP OF THE BOARD
5. (1)The Board shall consist of not more than 13 members appointed by the Minister, of whom-
(a) two shall be nominated by the Irish Haemophilia Society;
(b) one shall be the National Haemophilia Director;
(c) one shall be a consultant haematologist with an interest in paediatric haemophilia;
(d) one shall be a consultant haematologist who treats persons with haemophilia;
(e) one shall be nominated by the Contract Holder;
(f) one shall be a transfusion medicine expert, nominated by the Irish Blood Transfusion Service Board;
(g) one shall be an officer nominated by the Irish Medicines Board;
(h) one shall be a person working in a management capacity within the health services, nominated by the Health Service Executive;
(i) one shall be a virologist with expertise in bloodborne diseases;
(j) one shall be the external reviewer of the National Centre for Hereditary Coagulation Disorders;
(k) up to two other members may be appointed by the Minister.
6. The Minister shall appoint one of the members of the Board to be the Chairperson of the Board. The Chairperson shall hold office until he or she ceases to be a member of the Board or until the Minister appoints another person to be Chairperson.
7. (1)The Irish Haemophilia Society may nominate an external expert advisor to attend and participate in all meetings of the Board on an ex-officio basis;
(2) The Board may invite other expert advisors to attend and participate in meetings of the Board on an ex-officio basis as and when required;
(3) Paragraphs (1) and (2) shall not be construed as conferring on the ex-officio advisors the right to vote in relation to any matter falling to be decided by the Board.
TERM OF OFFICE
8. The term of office of each member of the Board shall be 5 years from the date of appointment. Members may be appointed for more than one term of office.
9. A member of the Board may at any time resign his or her membership by letter addressed to the Minister and the resignation shall take effect from the date specified therein or upon receipt of the letter by the Minister, whichever is the latter.
10. A member of the Board may at any time be removed from membership of the Board by the Minister if, in the Minister\’s opinion, the member has become incapable through ill-health of performing his or her functions, or has committed stated misbehaviour, or his or her removal appears to the Minister to be necessary for the effective performance by the Board of its functions, or if the Minister is satisfied that the member has failed to comply with the provisions of paragraph (1) of Article 20.
11. In the event of a casual vacancy arising on the Board, the vacancy shall be filled by appointment by the Minister and where the vacancy arises from a member who was appointed on the nomination of a body referred to in Article 5 the appointment shall be made on the nomination of that body. The person appointed to fill a casual vacancy shall hold office as a member of the Board for the unexpired period of the term of office of the said member.
MEETINGS OF THE BOARD
12. (1) The Board shall hold such and so many meetings as may be necessary for the performance of its functions and shall meet not less than 3 times per annum.
(2) The quorum for a meeting of the Board shall be 5, which shall include at least one member who was appointed by the Minister on the nomination of the Irish Haemophilia Society and a member who is a consultant haematologist.
(3) The Board may regulate by Standing Orders or otherwise, its procedures and business.
(4) 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.
13. (1) The Chairperson may, at any time, call a meeting of the Board.
(2) If the Chairperson refuses to call a meeting of the Board after a requisition for that purpose, signed by not less than five members of the Board, has been presented to the Chairperson, any five members of the Board may call a meeting of the Board.
(3) If the Chairperson, without so refusing, does not, within seven days of the presentation of a requisition for that purpose signed by not less than five members of the Board, call a meeting of the Board, any five members of the Board may call a meeting of the Board.
(4) For each meeting of the Board:
(a) the Chairperson shall, if present, chair the meeting;
(b) in the absence of the Chairperson, the members of the Board who are present shall choose one of their number by simple majority, to be Chairperson of the meeting;
(c) minutes of each meeting of the Board shall be kept by a person designated by the Chairperson and shall be agreed at the following meeting;
(d) the names of the members present at a meeting of the Board shall be recorded in the minutes of the meeting.
14. (1) All acts of the Board and all questions coming or arising before the Board in relation to product procurement may be done and decided by a two-thirds majority of such members of the Board as are present and vote at a meeting of the Board. All other acts and questions may be done and decided by a simple majority of such members of the Board as are present and vote at a meeting of the Board.
(2) In the case of equality of votes on any question requiring a simple majority arising at a meeting of the Board, the person chairing the meeting shall have a second, or casting vote.
(3) A memorandum signed by all the members of the Board shall be effective for all purposes as if it was a resolution of the Board passed at a meeting duly convened, held and constituted.
REMUNERATION
15. (1) A person shall not receive any remuneration for acting as a member of the Board, or as a member of a Committee established by the Board under Article 16, but may be paid travelling and subsistence allowances in accordance with such scales as may from time to time be approved by the Minister, with the consent of the Minister for Finance.
COMMITTEES
16. (1) In order to facilitate the discharge of its functions, the Board may establish committees whose functions shall be to assist and advise the Board in relation to the performance of its functions.
(2) Membership of a committee established by the Board may include persons who are not members of the Board.
(3) Any committee so appointed shall act subject to such directions as may be given by the Board, and any expenditure of moneys by such committee shall be subject to the approval of the Board.
(4) A member of a committee established under this Article may be removed from membership by the Board, and the Board may appoint new members to a committee.
(5) The Board may dissolve a committee appointed under this Article.
(6) The acts of a committee established under this Article shall be subject to confirmation by the Board.
FINANCE
17. (1) The Board shall submit estimates of income and expenditure to the Minister in such form, in respect of such periods, and at such times as may be required by the Minister, and shall furnish to the Minister any information which the Minister may require in relation to such estimates.
(2) The Minister may pay to the Board, in each year out of moneys provided by the Oireachtas, a grant or grants, of such amount or amounts as the Minister may decide.
(3) The Board shall keep all proper and usual accounts of all moneys received or expended by the Board, including an income and expenditure account and balance sheet and, in particular, shall keep all such special accounts as the Minister may from time to time direct.
(4) The financial year of the Board shall be the period of twelve months ending on 31st day of December in any year.
(5) If the Board is paid money by the Minister, a statement of accounts of the Board for each financial year shall be prepared and after such preparation be subject to audit by the Comptroller and Auditor General under Section (5) (First Schedule) of the Comptroller and Auditor General (Amendment) Act 1993.
MEMBERS OF STAFF AND CONSULTANT ADVISORS
18. (1) The Minister may, with the consent of the Minister for Finance, appoint such and so many officers as the Minister considers necessary to assist the Board in the performance of its functions
(2) The Minister may, with the consent of the Minister for Finance, determine the remuneration and conditions of service (including superannuation) of such officers.
(3) An appointed officer shall not be a member of the Board but may be entitled to attend all Board meetings unless the Board otherwise decides.
(4) The Board shall assign such duties as it considers appropriate to each officer and each such officer shall perform the duties so assigned.
(5) The Board may from time to time engage such consultants or advisors as it may consider necessary for the performance of its functions, and any fees due to a consultant or advisor engaged under this Article shall be paid by the Board out of moneys at its disposal.
SEAL
19. (1) The Board shall, as soon as may be after the establishment day, provide itself with a seal.
(2) The seal of the Board shall be authenticated by the signature of –
1. the Chairperson of the Board, or some other member of the Board authorised by the Board to act in that behalf, or
2. an officer of the Board authorised by the Board to act in that behalf.
(3) All courts shall take notice of the seal of the Board, and every document purporting to be an instrument made by the Board and to be sealed with the seal (purporting to be authenticated in accordance with paragraph (2) of this Article) of the Board, shall be received in evidence and be deemed to be such instrument without proof, unless the contrary is shown.
DISCLOSURE OF INTEREST
20. (1) Where the Chairperson, any other member of the Board, or officer of the Board, a consultant, advisor or other person engaged by the Board, has a direct or indirect beneficial interest in, or material to, any matter which falls to be considered by the Board, including any company or concern with which the Contract Holder proposes to engage in a tender process or in contract for products.