§ Sandra GidleyTo ask the Secretary of State for Health (1) what plans he has to submit all blood and blood derivative products available in the United Kingdom to the Medicines Control Agency; [75003]
257W(2) what plans he has for all plasma products to be evaluated by NICE. [75005]
§ Ms BlearsThere are no plans to submit blood and blood components to the Medicines Control Agency for licensing. We do not believe that doing so would confer any additional public health benefit. The Medicines Control Agency already ensures that the United Kingdom blood services meet European good manufacturing practice standards. In addition, the new European Blood Directive will, when adopted, require the accreditation of all blood establishments to ensure common standards of safety and quality in blood and blood components across all Members States. We have no plans to refer the use of all plasma products to NICE for evaluation. Safety issues relating to plasma products fall within the remit of the United Kingdom expert advisory committee on the microbiological safety of blood and tissues for transplantation (MSBT). MSBT seeks specialist advice where necessary or includes the relevant specialists among its members.
§ Sandra GidleyTo ask the Secretary of State for Health what assessment he has made of the safety of fresh frozen plasma and methylene blue treated plasma; and if he will make a statement. [75004]
§ Ms BlearsThe Government's advisory committee on the microbiological safety of blood and tissues for transplantation (MSBT) is continuing to consider the relative efficacy and risks of the different types of fresh frozen plasma (FFP) available. United Kingdom FFP is already a very safe product. To minimise the risk from viruses, it is made only from previously tested blood donors. The current high levels of safety are achieved by screening out potential high risk donors and then further testing every unit of donated blood for the presence of infections such as HIV, hepatitis B and hepatitis C. FFP produced by the national blood service (NBS), using UK donors, has also been leucodepleted to remove white cells, which evidence suggests may carry the greatest risk of transmitting vOD. Over 300,000 units of FFP are issued annually and it is only given in life-threatening situations to prevent or stop haemorrhage associated with abnormal blood clotting. MSBT has recommended importing single unit FFP from the United States. On 15 August 2002 the Government announced that imported FFP will be used for new-born babies and young children born after 1 January 1996, as an added precaution against the theoretical risk of vCJD transmission. On the advice of MSBT, US sourced FFP will be virally inactivated using methylene blue (MB) treatment. MB has been administered in medical practice since 1900, and in much larger doses (many thousand-fold) than the NBS will be using. NBS will be removing more than 90 per cent, of MB before the FFP is issued to National Health Service hospitals. MB is a registered medical device under the Medical Devices Directive and has a European safety (CE) marking.