Health and Social Care Act 2008

Functions of Health Protection Agency in relation to biological substances

159 Functions of Health Protection Agency in relation to biological substances

(1) The National Biological Standards Board is abolished (and, accordingly, the Biological Standards Act 1975 (c. 4) ceases to have effect).

(2) The Health Protection Agency Act 2004 (c. 17) is amended as follows.

(3) After section 2 insert—

“2A Functions in relation to biological substances

(1) The Agency has such functions in relation to a matter specified in subsection (2) as the relevant authority directs.

(2) Those matters are—

(a) the establishment of standards for biological substances;

(b) the preparation, approval and provision of standard preparations of biological substances;

(c) the testing of biological substances.

(3) The relevant authority shall be deemed to have directed under subsection (1) that the Agency is to have the functions specified in paragraphs (a) to (f) of Article 2 of the 1976 Order (the pre-abolition functions of the National Biological Standards Board).

(4) The direction under subsection (3)—

(a) shall be deemed to have been given on the commencement of that subsection;

(b) may be varied in the same way as any other direction under subsection (1);

(c) is not affected by the repeal of the Biological Standards Act 1975 or by the 1976 Order ceasing to have effect as a result of that repeal.

(5) In this section—

• “biological substance” means a substance whose purity or potency cannot, in the opinion of the Secretary of State, be adequately tested by chemical means;

• “the relevant authority” means—

  (a)

  the Secretary of State, and

  (b)

  the Department of Health, Social Services and Public Safety in Northern Ireland,

  acting jointly;

• “the 1976 Order” means the National Biological Standards Board (Functions) Order 1976.

(6) The generality of section 2(1) is to be taken not to be prejudiced by this section; and the generality of subsections (1) to (4) is to be taken not to be prejudiced by section 2.”

(4) In section 6 (meaning of “appropriate authority”), after subsection (5) insert—

“(6) Subsections (2) to (5) do not apply in relation to biological-substances functions.

(7) In relation to any biological-substances function, the appropriate authority is—

(a) the Secretary of State, and

(b) the Department of Health, Social Services and Public Safety in Northern Ireland,

acting jointly.

(8) In subsections (6) and (7) “biological-substances function” means—

(a) a function of the Agency under section 2A, or

(b) a function of the Agency under section 2(1), (2)(a) or (b), (3), (4) or (10) that is a function in relation to a matter specified in section 2A(2).”

(5) In section 8 (power to make transfer schemes)—

(a) after subsection (4) insert—

“(4A) The Secretary of State and the Department of Health, Social Services and Public Safety in Northern Ireland, acting jointly, may make a scheme for the transfer of property, rights and liabilities of the National Biological Standards Board to the Agency.”, and

(b) in subsection (7), after “section 2” insert “, 2A”.

(6) In section 9 (directions)—

(a) in subsection (2) (certain directions to be given in regulations made by statutory instrument), after “section 2(2), (3) or (4)” insert “or 2A(1),”; and

(b) in subsection (3) (certain statutory instruments making regulations giving directions to be subject to annulment), after “section 2(2)(a) or (3)” insert “or 2A(1)”.