The Blood Safety and Quality (Modification) Regulations 2009

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations modify the Blood Safety and Quality Regulations 2005 (“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(1) and related Commission Directives.

Regulations 1 and 2 modify the principal Regulations to implement Commission Directive 2009/135/EC(2) (“the Directive”) allowing temporary derogations to certain eligibility criteria for donors of whole blood and blood components in the context of any shortage in the supply caused by the influenza A(H1N1) pandemic. In particular these modifications provide that—

• when certain conditions are satisfied, a blood donation may be accepted from persons with slightly lowered blood haemoglobin levels and also from donors giving blood one week after symptoms of flu-like illness had ended;

• the conditions are that the levels of GP consultations for flu-like illness and incidence of flu-like illness in the UK population are above threshold level and the Secretary of State is satisfied that there are risks to the supply of blood and blood components due to the A(H1N1) influenza pandemic and has subsequently advised the blood establishment that the eligibility criteria for donors may be modified as described above;

• any modification of the eligibility criteria under these Regulations shall only apply for the period beginning from the date that the conditions are satisfied to the date after the date on which the blood establishment notifies the Secretary of State that levels of blood or blood components are equal to or exceed 5 days supply;

• in accordance with the Directive these Regulations shall cease to apply after 30th June 2010.

An Impact Assessment has not been prepared in respect of this instrument as it has negligible impact on the private and voluntary sectors. A Transposition Note in relation to the implementation of the Directive has been placed in the libraries of both Houses of Parliament and copies may be obtained from the Medicines and Healthcare products Regulatory Agency, Room 16-111 Market Towers, 1 Nine Elms Lane, London SW8 5NQ.