The taintedblood Timeline  -  what really happened...

According to correspondence between J Walker SHHD and Health Board Secretaries:

"In England and Wales the view is taken that in law the activities of health authorities attract Crown Exemption so that the provisions of the Medicines Act are not binding on them. Arrangements are being made whereby health authorities will be brought within the licensing provisions of the Act in a manner analogous to that which applies to commercial pharmaceutical manufacture."

Medicines Inspectorate inspection report published on plasma fractionation facilities at BPL recommending a set of actions that should take place immediately, and others that should be implemented in the long term.

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.

Sometime in January 1981, Sir George Young, Under Secretary of State in the Department of Health, gives a warning of the "possible risks of hepatitis" from imported products, particularly from those made from plasma supplied by paid donors.

Sir George Young's warning was reported the following month in the Sunday Telegraph (on 01.02.81) in an article entitled: "10 Sick After Factor 8 Doses". The article goes on to say:

"Imports worth an estimated £10 million of Factor 8, the missing factor in a haemophiliac's blood, come from America, Germany and Austria in powdered form to supplement the limited amount made in Britain."

Dr Charles Rizza: "There might be a greater degree of risk from commercial products."

"The National Institute for Biological Standards and Control, [NIBSC] which tests all foreign blood products imported by Britain, rejects a "small amount," believed to be about 5%, of the millions of bottles of Factor 8 brought in each year."

Note: The Under Secretary of State's warning came just one month after the damning Medicines Inspectorate report of the laboratories of BPL Elstree on 9th December 1980 which gives insight into the state of domestic production. This warning over the risks of imported products from paid donors was either ignored or came too late for 10 of the haemophiliac boys attending the Lord Mayor Treloar School in Alton as by the beginning of February, they contract hepatitis from commercial Factor VIII.

They were only children, aged between 9 and 14.

UK Health ministers are warned about the dangers of importing contaminated blood products from the United States:

In February 1981, 10 children at the Treloar specialist school in Alton, Hampshire are infected with hepatitis from contaminated Factor VIII in what we believe to be a second outbreak of hepatitis B. There then follows a warning regarding infected Factor VIII supplies being imported from the USA.

The Department of Health admitted at the time that they knew there was a risk of infection and the then Health Minister, Dr Gerard Vaughan, claimed that the £1.29m being invested in the BPL Elstree would resolve the problem.

Note: We have to wonder if this second outbreak of hepatitis was as a direct consequence of an approach made by the Public Health Laboratory Service (PHLS) two years earlier on 14th May 1979? We can determine from documentation that there was the intention from the PHLS of transfusing mild haemophiliacs with a Factor VIII 'material' which would have caused mild haemophiliac children to go on to develop hepatitis.

In a reply letter of May 1979 to the PHLS from Dr A. Aronstam of the Lord Mayor Treloar Hospital, we read that Dr Aronstam totally disagreed with the PHLS' suggested concept and he adamantly stated that he did not wish any of his mild haemophiliacs to develop hepatitis in any form.

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.

Crown Immunity is soon to be removed from NHS establishments.

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.

Crown Immunity comes to an end as of 1 April 1991. The products of BPL are now within the scope of formal licensing arrangements of the Medicines Act.

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 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