The taintedblood Timeline  -  what really happened...

The NHS is created and Crown Immunity is applied to all NHS bodies and premises.

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."

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.

In a letter dated 14th February 1983, from B. K. Chambers (DHSS) to Mr Murray (SHHD), there appears to be some considerable confusion as to whether Crown Immunity applied to Scotland.

"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.

In the 17th meeting of the CBLA held at BPL on 1st Feb 1985, the fact that BPL had no product licence was discussed:

"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.

On 5th December, 1986, Dr F. E. Boulton (Deputy Director of the Edinburgh and South-East Scotland Regional Blood Transfusion Service) writes to Dr John Cash, National Medical Director, SNBTS:

"...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 EEC's strict Directive on Product Liability is introduced in the UK, along with a possible future Directive to remove Crown Immunity from NHS establishments.

Crown Immunity is soon to be removed from NHS establishments.

Mr Waldegrave: "We believe that our case is legally strong and that the plaintiffs would not succeed in proving negligence on the part of the Department of Health. None the less the Government have always recognised the very special and tragic circumstances of the haemophiliacs infected by HIV and of their families."

"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,..."

Note:
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.

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 Crown immunity that was applied to all NHS bodies from the date of the creation of the NHS in 1948 is to be removed by means of the NHS and Community Care Act 1990 which comes into force on 1 April 1991.

On Saturday, 6 November 1993, an article in The Scotsman entitled "Assurance After AIDS Contamination Scare" reveals a surprising statement that NIBSC batch-tested all blood products released for use in the UK, yet found no contamination with HIV...

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?

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.

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?

On Tuesday 17th March 2009, Lord Morris of Manchester made important reference to Crown Immunity and BPL (raised in the Archer report) during the Committee Stage debate of Amendment 133 of the Health Bill:

CROWN IMMUNITY:

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."

The Preliminary Report of the Penrose Inquiry, discusses the situation with respect to Crown Privilege and immunity from the licensing requirements of the Medicines Act:

"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."

On 24th February 2011, a letter was sent from Thompsons Solicitors to Douglas Tullis, Solicitor for Penrose, stating:

"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."