Part 5Miscellaneous

Functions of Health Protection Agency in relation to biological substances

159Functions 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—

2AFunctions 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—

    1. a

      the Secretary of State, and

    2. 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.

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) ”.