The Blood Safety and Quality (Fees Amendment) Regulations 2009

Statutory Instruments

2009 No. 372

Fees And Charges

Health And Safety

The Blood Safety and Quality (Fees Amendment) Regulations 2009

Made

23rd February 2009

Laid before Parliament

3rd March 2009

Coming into force

1st April 2009

The Secretary of State makes these Regulations in exercise of the powers conferred by section 2(2) of the European Communities Act 1972(1) and section 56(1) and (2) of the Finance Act 1973(2).

The Secretary of State has been designated for the purposes of section 2(2) of the European Communities Act 1972 in relation to health protection measures regulating the use of material of human origin(3).

The Treasury has consented to the making of these Regulations as required by section 56(1) of the Finance Act 1973.

Citation, commencement and interpretation

1.—(1) These Regulations may be cited as the Blood Safety and Quality (Fees Amendment) Regulations 2009 and shall come into force on 1st April 2009.

(2) In these Regulations “the principal Regulations” means the Blood Safety and Quality Regulations 2005(4).

Amendment of regulation 22 of the principal Regulations

2.—(1) Regulation 22 of the principal Regulations (fees) is amended as follows.

(2) In paragraph (2)—

(a) in sub-paragraph (a), for “£2,927” substitute “£3,044”;

(b) in sub-paragraph (b), for “£493” substitute “£513”; and

(c) in sub-paragraph (c), for “£440” substitute “£458”.

(3) In paragraph (2A), in sub-paragraph (b) for “£468” substitute “£487”.

(4) In paragraph (3)—

(a) in sub-paragraph (a), for “£2,452” substitute “£2,557”; and

(b) in sub-paragraph (b), for “£1,226” substitute “£1,279”.

(5) In paragraph (3A), for “£650” substitute “£676”.

(6) In paragraph (3C)(c), for “£468” substitute “£487”.

(7) In paragraph (5)—

(a) in sub-paragraph (a), for “£2,452” substitute “£2,557”; and

(b) in sub-paragraph (b), for “£1,226” substitute “£1,279”.

(8) In paragraph (5B)—

(a) in sub-paragraph (a), for “£2,452” substitute “£2,557”; and

(b) in sub-paragraph (b), for “£1,226” substitute “£1,279”.

(9) In paragraph (5C)—

(a) in sub-paragraph (a), for “£2,452” substitute “£2,557”; and

(b) in sub-paragraph (b), for “£1,226” substitute “£1,279”.

Signed by authority of the Secretary of State for Health.

Dawn Primarolo

Minister of State,

Department of Health

9th February 2009

We consent

Tony Cunningham

Dave Watts

Two of the Lords Commissioners of Her Majesty’s Treasury

23rd February 2009

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations amend the Blood Safety and Quality Regulations 2005 (S.I.2005/50) (“the principal Regulations”), which implement Directive 2002/98/EC of the European Parliament and of the Council setting out the standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components(5) and related Commission Directives(6).

Regulation 2 amends regulation 22 of the principal Regulations to increase the fees payable by blood establishments and hospital blood banks or facilities in relation to authorisation, operation, and haemovigilance. The overall average fee increase is around 4%.

An impact assessment of the effect that this instrument will have on the costs of the business is available from the Medicines and Healthcare products Regulatory Agency, Market Towers, 1 Nine Elms Lane, London SW8 5NQ.

(1)

1972 c.68. Under section 57(1) of the Scotland Act 1998 (c.46), despite the transfer to Scottish Ministers of functions in relation to implementing obligations under Community law in relation to devolved matters, the functions of the Secretary of State in relation to implementing these obligations continues to be exercisable by the Secretary of State as regards Scotland.

(2)

1973 c.51.

(3)

S.I. 2004/3037.

(4)

S.I. 2005/50, as amended by S.I. 2005/1098, 2532 and 2898, 2006/2013, 2007/604 and 2008/525 and 941.

(5)

OJ No. L33, 8.2.2003, p.30.

(6)

Commission Directive 2004/33/EC (OJ No. L91, 30.3.2004, p.25), Commission Directive 2005/61/EC (OJ No. L256, 1.10.2005, p.32) and Commission Directive 2005/62/EC (OJ No. L256, 1.10.2005, p.41).