This item was published during the term of a previous administration that ended in April 2007
Listen
Changes in blood processing activities
26/06/2006
Plans for the future supply of blood plasma products were accepted today by Health Minister Andy Kerr.
These plans followed a strategic review - which examined the Protein Fractionation Centre (PFC), the Edinburgh based manufacturing arm of the Scottish National Blood Transfusion Service (SNBTS) - aimed at ensuring a safe and reliable source of high quality products for patients which also provides value for money for the taxpayer.
This concludes that the PFC is no longer viable because of the need to purchase plasma from other countries as a result of vCJD risks and the move away from the use of blood clotting factors for haemophiliacs, and that options should be explored for selling the plant or developing its activities in the private sector. This means that in future plasma products will be bought in from outside Scotland.
Mr Kerr said:
"The PFC has had a successful track record in developing innovative products, but the market and the regulatory landscape have altered significantly in recent years.
"Two main changes have occurred. Firstly, the need to implement vCJD risk reduction measures since 1998 meant plasma could no longer be used from voluntary blood donations in Scotland and had to be purchased elsewhere, principally from the US and Germany. This has fundamentally undermined the finances of plasma processing at the plant.
"Secondly, many commercial products are more advanced, offering greater benefits for patients and clinicians. Since the suspension of manufacturing at the PFC earlier this year because of weaknesses in quality assurance, many are already being bought in from either the NHS Bio Products Laboratory in England or from commercial sources. It would be unacceptable to return to older products and would take years to develop new products to the point of licensing.
"Production costs at the PFC are now higher than the value of its products and, even with substantial extra investment of around £20 million to meet modern regulatory standards, it is unlikely that such a small-scale operation could be economic in the long term. I have therefore asked SNBTS to explore whether the plant, where staff have significant skills and knowledge, can be sold or whether some of its activities can be developed in the private sector where it may be able to develop niche products for international distribution.
"I would hope we could find a buyer who could retain as many of the 145 jobs as possible. If a buyer cannot be found by SNBTS, we will aim to ensure that staff are redeployed elsewhere in the NHS in Scotland. I fully appreciate the uncertainty and anxiety this decision will create - I have already met with Amicus and will continue to engage with them throughout this process and I know that SNBTS will work closely with unions and staff.
"I want to stress that decisions about the future of the PFC have nothing to do with the mainstream blood donor and collection activities of the Blood Transfusion Service. It is vitally important that people continue to give blood to save lives and allow important operations to go ahead for people who need them."
Ian Franklin, Medical Director of SNBTS, said:
"PFC has a long and proud record of serving the NHS in Scotland. Scotland was the first country in the world to have safe plasma products available to meet the needs of all Scottish patients.
"However, the plasma industry worldwide has consolidated and, along with the issue of vCJD, this means that this chapter in PFC's existence now comes to a close and a new one opens with the potential to become a modern, international biopharmaceutical endeavour.
"Patients in Scotland will now benefit from access to an increased range of state of the art products."
Richard Herriot, Consultant Clinical Immunologist and Member of the Medical Advisory Panel of the Primary Immunodeficiency Association, said:
"Now that the move towards more advanced commercial products for patients with Primary Immune Deficiency has been made, clinical immunologists in Scotland believe that further product changes for anything other than clinical reasons would be a retrograde step and should be avoided, in the best interests of patient care. Patients are also now benefiting from the fact that they have access to liquid immunoglobulin products, which are easier to administer, particularly for those on home therapy."
The Protein Fractionation Centre is based at Liberton, Edinburgh and started operations in 1975. It is part of the Scottish National Blood Transfusion Service, and recommendations on its future were made by NHS National Services Scotland (NSS).
Mr Kerr answered a Parliamentary Question from Janis Hughes MSP today on the future of blood processing activities at SNBTS.
The main products which were made at PFC prior to the suspension of processing in January were intravenous immunoglobulin, albumin, and a number of specialist immunoglobulin products. These are used in a variety of clinical settings, for example to combat deficiencies in patients' immune systems which may be primary - present and requiring treatment from birth - or may develop as a consequence of other illnesses. In the past blood clotting factors were also produced for haemophiliacs. These have now been replaced by artificial recombinant products.
Production at PFC was voluntarily suspended in January following an inspection by the Medicines and Healthcare products Regulatory Agency (MHRA) which identified weaknesses in quality assurance processes. The plant is now operating again but is not currently making products for patient use. Since January the NHS in Scotland has been purchasing the products required from elsewhere.
The review also looked at Alba Bioscience, a manufacturer of monoclonal and red cell blood grouping reagents within SNBTS. These products allow healthcare professionals to perform key blood matching and associated tests, ensuring that patients receive the correct blood products. It is a supplier to the NHS in Scotland, and also makes significant sales to the commercial sector. Alba Bioscience is potentially a successful business, with the opportunity for growth. SNBTS have been asked to develop and prepare Alba Bioscience for sale at an appropriate time.