The taintedblood Timeline - what really happened...
"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."
Find related entries
"The issue of manufacturing licences for the Blood Transfusion Centres in Scotland when similar licences were not issued in England and Wales resulted, as you know, from differing legal advice in each case. Scottish law officers held that Crown Privilege did not apply and that licences were required; legal advice for England and Wales held that Crown Privilege did apply and that licences were not necessary. Licences were therefore issued for BTS Centres in Scotland but not for BTS Centres in England and Wales.
We were advised in 1979 (Mr Sutherland wrote to Mr Firstbrook) that the Scottish law officers had reviewed their original opinion and decided that Crown Privilege did apply to the CSA and Health Boards in Scotland, and that formal licensing of the Blood Transfusion Service in Scotland was no longer required. In other words from that time the BTS in Scotland was on the same footing vis-a-vis the Medicines Act as the BTS in England and Wales."
Note: The differences of opinion do seem to eventually settle on the view that Crown Immunity did apply to Scotland.
"Dr Thomas referred to the excess of Factor 8 now on the market saying that non-heat treated Factor 8 was no longer available commercially. He believed the Committee on the Safety of Medicines was licensing standard Factor 8 when heat-treated without trial. He pointed out that BPL had no product license and thought that a license was necessary, despite Crown privilege. Dr Lane stressed the desirability of producing this new safer product (Factor 8Y) as early as possible."
Note: These minutes also mention a meeting with Kenneth Clarke.
Type: Penrose Evidence File
Find related entries
"...I have discussed the situation with Christopher Ludlam concerning the use of patients for half-life and recovery studies and he still has some reservations."
"I know that Crown Immunity has been removed from BPL and I assume (although I have not heard specifically) that the same applies to PFC. Christopher is concerned about the situation as far as indemnity to patients who suffer as a result of being infused with the trial material. I have a strong feeling that he will be unwilling to agree to such trials unless there is a specific commitment by the SHHD that any patients who suffer adverse effects as a result of the infusion will be given appropriate compensation."
Note: We would have to disagree that Crown Immunity was removed from BPL or PFC in 1986. At most, this is about the right point in time when these laboratories were becoming aware of the coming changes in legislation, such as Product Liability under CPA in 1988. Despite the Medicines Act being in force from 1968, the products of BPL failed to come within the scope of the licensing arrangements required under the Act and it was not until 1st April 1991 that Crown Immunity came to an end.
"The Government have therefore agreed in principle to meet the Steering Committee's proposals."
"...the proposed settlement will require the formal approval of all individual plaintiffs, and in the case of minors, of the court,..."
It is interesting to note that the Health Minister is surprisingly confident concerning Department of Health liability in relation to Crown Immunity, especially considering that he had only been Minister for just over 1 month.
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.
A statement from the Department of Health said:
"The National Institute for Biological Standards & Control have batch-tested all blood products released for use in this country including those from IMMUNO. No HIV contamination has been found in any products authorised for release by the NIBSC."
NOTE: If no HIV contamination was found in the products authorised for release by NIBSC ~ which from the mention of Immuno clearly included imported products ~ how was it possible that 1,200+ UK haemophiliacs became HIV positive which led to the deaths of over 900 of them?
If no HIV contamination was found in the products authorised for release by NIBSC ~ which from the mention of Immuno clearly included imported products ~ how was it possible that 1,200+ UK haemophiliacs became HIV positive which led to the deaths of over 900 of them?
Legal Note: Should the batch release certificates ever be disclosed by NIBSC to our solicitors, we dare say that NIBSC could be held liable for releasing contaminated products which were batch-tested and deemed safe. We believe Crown Immunity will be of little use as a defence since the products being tested included imported commercial concentrates. The very fact that these were not manufactured in the UK from 'altruistically' donated blood weakens the aegis of Crown Exemption that applied to all NHS bodies and premises until 1st April 1991. NIBSC may well find that the provisions of the Medicines Act are, in fact, binding on them in this case.
Type: Press Article. The Scotsman. Assurance After AIDS Contamination Scare. 6th November 1993
Find related entries
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.
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?
Lord Morris of Manchester: "The other issue to which I must finally refer is that of Crown immunity, on which the Archer report raises in commenting on behaviour of the Blood Products Laboratory (BPL). The report says:In July 1979, the Medicines Inspectorate visited BPL. They reported that the buildings were never designed for the scale of production envisaged. They commented: "If this were a commercial operation we would have no hesitation in recommending that manufacture should cease until the facility was upgraded to a minimum acceptable level.".
"...The report then says: "BPL was rescued by Crown Immunity", and goes on to say that, "the existing plant continued production, relying on Crown Immunity to dispense with all the requirements of the Medicines Act, but was able to meet only about 40 per cent of the national requirements".
Lord Morris of Manchester: "Surely, words have lost their meaning if this does not mean that by the use of Crown immunity, a relic of feudal England, the lives of countless haemophilia patients were blatantly and gravely put at risk."
"...There could be no clearer text for describing the enormity of the use by the BPL of Crown immunity to dispense with all the requirements of that renowned and vital statute. I beg to move."
Type: Lords Hansard
Find related entries
"Unless otherwise provided, the Crown and its agencies are exempt from regulation. The Medicines Act provided that no exemption in the Act should be construed as derogating from Crown Immunity. This was interpreted as meaning that parts of the NHS such as health boards and the blood transfusion services did not have to comply with the licensing regulations, so long as the Act remained unqualified. The facilities at BPL (Elstree), PFL (Oxford) and PFC (Edinburgh) were part of the National Health Service and therefore were considered to have immunity from the Medicines Act 1968. On 1 April 1991 Crown Immunity was removed from the NHS by the National Health Service Community Care Act 1990."
"It should be noted that although SNBTS operated under Crown Immunity this operation was inspected by the UK Medicines Inspectorate and was found to be suitable and was eventually licensed when Crown Immunity was withdrawn in 1991."
All rights reserved