§ Mr. MaplesTo ask the Secretary of State for Health what estimate he has made of the likely effect of the decision to source manufactured blood products from non-United Kingdom plasma on the number of blood donors in the United Kingdom. [42863]
§ Mr. BoatengThe decision to source blood products from non-United Kingdom plasma related to manufactured blood products only and has no impact on the blood used in transfusions. The decision does not mean that we need less blood—on the contrary, we need more than ever in order to support increasing hospital activity.
We hope and expect that blood donors will understand that their gift remains vital to the work of the National Health Service, and that they will continue to support the NHS and help to save lives as they have done in the past.
§ Mr. MaplesTo ask the Secretary of State for Health (1) if he(a) sought and (b) received the advice of the National Blood Authority before taking the decision to source manufactured blood products from non-United Kingdom plasma; [42861]
(2) what steps he will take to ensure that imported plasma is safe; and what estimate he has made of the risk that it is not; [42858]
(3) what estimate the National Blood Authority has made of the probability of death resulting from (a) hepatitis and (b) HIV/Aids as a result of sourcing blood products from non-United Kingdom plasma; [42856]
(4) if he will publish the full text of the report of the Committee on the Safety of Medicines on which his decision to source manufactured blood products from non-United Kingdom plasma was based; [42859]
(5) what is the Committee on the Safety of Medicines estimate of the probability of contracting new variant CJD from blood products; [42857]
354W(6) if he will make a statement on the role of the National Blood Authority in his decision to source blood products from non-United Kingdom plasma. [42860]
§ Mr. BoatengThe decision to source blood products from non-United Kingdom plasma follows the advice of the Committee on Safety of Medicines (CSM), which the Department, acting with the Scottish, Welsh and Northern Ireland Offices, has accepted.
The CSM, in consultation with its expert group on new variant Creutzfeldt-Jakob Disease, undertook a risk assessment of individual plasma derived medicinal products. This assessment took into account the therapeutic benefit of the products, details of the manufacturing process, the theoretical risk of transmission, the quality and availability of alternative supplies and the blood product supply situation. In the course of that assessment, the CSM took evidence from the two UK blood product manufacturers, the Bio Products Laboratory (which is part of the National Blood Service) and the Protein Fractionation Centre (its Scottish equivalent).
The CSM's advice was that, although there is no evidence to indicate that nvCJD can be transmitted via blood products and the risk therefore remains hypothetical, it cannot be fully discounted. Therefore, as a purely precautionary measure, blood products should not be sourced from UK plasma for the time being. The full text of their advice is appended to the Department's press release of 13 May, copies of which are in the Library.
We would not accept non-UK plasma which was considered unsafe. The imported plasma will come only from centres approved by the UK Medicines Control Agency. Only when the inspectors are assured that the stringent safety standards applied to the new sources of plasma are equivalent to those currently available in the UK will plasma be imported.
Clinicians currently do not have to use Bio Products Laboratory or Protein Fractionation Centre products, but can use the licensed product of their choice. As a result, many of the licensed blood products already on the UK market are made from non-UK plasma and they have a high quality and safety record.