HL Deb 24 September 2002 vol 638 cc228-30WA
Lord Clement-Jones

asked Her Majesty's Government:

In the light of the Hepatitis C liability case A & others v. National Blood Authority & others, Burton J, 26th March 2001

  1. (a) whether they have full confidence in the safety of transfusion plasma that is currently being provided by the National Blood Service; and whether they will provide reassurance that as per Council of Europe guidelines all patients requiring transfusion plasma in the National Health Service will receive only virus inactivated products; and
  2. (b) whether they will submit all blood and blood derivative products available in the United Kingdom to the Medicines Control Agency for licensing to ensure patient safety; whether legislative changes are needed to allow this, and whether they intend to make these changes; and [HL5669]

Given that fresh frozen plasma and methylene blue-treated fresh frozen plasma supplied by the National Blood Service are exempted from licensing by the Medicines Act and therefore also from control and regulation by the Medicines Control Agency, whether they will apply the obligatory safety monitoring and other patient safeguards, which are standard for licensed pharmaceutical products, to fresh frozen plasma and methylene blue-treated fresh frozen plasma. [HL5704]

Lord Hunt of Kings Heath

The safety of blood and blood components used in the National Health Service is of paramount importance. Every reasonable step has therefore been taken to minimise any risk associated with fresh frozen plasma. However, it is not possible to guarantee that blood and blood components are 100 per cent safe.

We do not believe that the continued use of non-virally inactivated fresh frozen plasma is contrary to Council of Europe guidelines. Indeed, a number of other countries in Europe continue to provide this product to their patients.

There 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 UK 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 Member States.

Serious adverse reactions and events associated with fresh Frozen plasma, and all other blood components, are already monitored by the Serious Hazards of Transfusion (SHOT) enquiry. SHOT is a voluntary scheme. However, 92 per cent of hospitals in the United Kingdom already participate in SHOT and recent guidance to the National Health Service on the appropriate use of blood asks all hospitals to do so. SHOT publishes an annual report, and a copy of the most recent (for 2000–01) has been placed in the Library.

Lord Clement-Jones

asked Her Majesty's Government:

In the light of the fact that many other governments in Europe have either banned or removed fresh frozen plasma and methylene blue-treated plasma from their markets, whether they believe that all transfusion plasma products available in England and Wales should be evaluated by the National Institute for Clinical Excellence (NICE); and [HL5700]

Given that the licence for methylene blue-treated fresh frozen plasma was not renewed by the Paul Ehrlich Institute in Germany due to safety concerns, and that it has also been banned or removed from the market in a number of other European countries, why methylene blue-treated fresh frozen plasma is advocated for use in children and others by the National Blood Service. [HL5701]

Lord Hunt of Kings Heath

We have no plans to refer the use of transfusion plasma to the National Institute of Clinical Excellence for evaluation. This issue falls 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.

The methylene blue photoinactivation system for fresh frozen plasma is a registered medical device under the Medical Devices Directive and has a European safety (CE) marking. Methylene blue has been administered in medical practice since 1900, and in much larger doses (many thousand-fold) than the National Blood Service (NBS) will be using. The NBS will be removing more than 90 per cent of the methylene blue before the fresh frozen plasma is issued to National Health Service hospitals.