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.

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.