Regulations, 2010

L.N. 27 of 2010

HUMAN BLOOD AND TRANSPLANTS ACT

(CAP. 483)

Blood Supply (Temporary Derogations to Eligibility Criteria)

Regulations, 2010

IN exercise of the powers conferred by article 16 of the

Human Blood and Transplants Act, the Minister for Social Policy,

after consultation with the Licensing Authority, has made the

following regulations:-

The title of these regulations is the Blood Supply

(Temporary Derogations to Eligibility Criteria) Regulations, 2010.

The scope of these regulations is to transpose the

Commission Directive 2009/135/EC of 3 November 2009 allowing

temporary derogations to certain eligibility criteria for whole blood

and blood components donors laid down in Annex III to Directive

2004/33/EC in the context of a risk of shortage caused by the

Influenza A(H1N1) pandemic.

(1) When confronted with a serious risk of shortage

or actual shortage in the supply of blood and blood components

directly due to the A (H1N1) pandemic the blood establishment

may temporarily by way of derogation

(a) from point 1.2 of Annex III to Directive 2004/33/

EC, reduce the minimum haemoglobin levels in donors’ blood

to no less than 120 g/l for females and 130 g/l for males;

(b) from point 2.2.1 of Annex III to Directive 2004/33/

EC, apply a deferral period of no less than 7 days after

cessation of symptoms of a flu-like illness.

(2) The implementation of the aforementioned

derogations shall apply only

(a) when and after the Licensing Authority declares

a state of serious risk of shortage or an actual shortage of

blood and blood components directly related to the A(H1N1)

pandemic; and

(b) up to the 30th June, 2010.

B

(3) Any reference, in any other legislation, to the

articles in Annex III of Directive 2004/33/EC, shall be construed in

the light of the provisions of these regulations.

€0.19