Medicines Inspectorate reports on BPL: more investment is needed; there should be no increase in production until essential steps are taken to improved safety.

Since 1980, it is clear that BPL is not capable of meeting the requirements of the Medicines Act 1968 and is actually relying on Crown Immunity to stay in operation.

The Medicines Inspectorate visit BPL Elstree and discover that BPL does not conform to acceptable industry standards. The investigation discovers that:

• There is mould growing on a glycol line that serves one of the vessels.
• The cold freezer does not have any kind of temperature recording apparatus.
• There is water dripping from overhead metal panels and again mould growth is noticeable.
• There is plaster cracking in many parts of the building, resulting in bits of plaster breaking off.
• The autoclaves in the autoclave area have not been validated. The necessary commissioning using a multi channel recorder has not been done.
• In Room 13, paper is taped to improve the wooden benches where Factor 8 initial phase processing chromatographic work is carried out, and there are still openable windows present in what should be an aseptic area used for sterilising solutions.

Following visits in 1979 and 1980 by Her Majesties Inspectors, a damming report declares BPL to be unfit for the good pharmaceutical manufacturing practice under the provisions of the Medicines Act 1968. As a result of failure in Duty of Care and breach of statutory duties, there was a significant delay in the introduction of a system to pasteurise Factor VIII by heat treatment, thus directly leading to many haemophiliacs becoming infected with Hepatitis C.

Following the highly critical report of Her Majesty’s Inspectors, plans are drawn up that specifically include a heat-treatment operation for the inactivation of Non-A Non-B hepatitis.

The Government is slow to implement these plans.

BPL is still not covered by the licensing requirements of the Medicines Act because of Crown Immunity.

However, some of its products and facilities are already so licensed and it will be seeking licences for other products, including high purity Factor VIII, under the arrangements leading to the removal of Crown Immunity. For many years the BPL has been inspected by the Medicines Inspectorate and its products have been tested by the National Institute of Biological Standards and Control, as are similar licensed pharmaceutical products.

The Department of Health releases a report into Self Sufficiency in Blood Products in England and Wales, A Chronology from 1973 to 1991.

The report came out of the opinion held by Ministers that the infection of haemophiliacs could have been avoided had the United Kingdom achieved self-sufficiency in blood products; a policy Government initiated in 1975.

Note:
The review conveniently omits important correspondence between Government bodies in the timeframe 1973-79, and instead concentrates more on efforts to address the failings highlighted in the Medicines Inspectorate report of BPL Elstree, which, if they had been any normal business, would certainly have been closed down. However, due to Crown Immunity, the Government avoided the closure of BPL and they continued to process blood products in a condemned facility. The question must therefore be asked as to why this facility was allowed to fall into such disrepair?

The Department of Health publishes a report into how patients were infected with Hepatitis C and HIV through contaminated blood in the 1970s and early 1980s.

The press release presents conclusions as fact rather than opinions, whereas the Department of Health report itself concludes that “The information gathered during this review has been at times contradictory and incomplete, but the following conclusions can be “inferred”.”

Note: The report is a review which focuses upon "surviving" documents from 1973 (when a decision was made to pursue self-sufficiency for England and Wales) to 1991 (when a validated screening test for HCV was introduced in the UK).

The Haemophilia Society condemns the report by the Department of Health into self-sufficiency in blood products as "an attempt to gloss over the details of a medical disaster that left a generation of people with haemophilia infected with life-threatening viruses."

The following shortcomings are mentioned:

• The report does not have a named author
• There is no mention of what information was given to patients regarding the safety of products to enable them to give informed consent
• The report fails to mention the use of UK prison blood in clotting factors
• The report fails to explain why the phased redevelopment of the Government facility for producing blood products took a year to implement and why the laboratory was allowed to continue manufacturing whilst having been declared 'unfit' under the Medicines Act 1968.

Haemophilia Society Press Release Feb 06