30 March 2022: Snape - D

The end begins with Dr Snape's recognition of the contribution of Richard Lane. In his view, without Prof Lane, the new BPL (Building 27) facility would never have happened, resulting in England and Wales still being dependent on some element of commercial products.

Questions from Recognised Legal Representatives included:

* Clarification of the "economic" leg of the milking stool analogy. It was a focus on the value of the freely donated blood.

* Reviewing the problems raised by Dr Maycock in relation to the supply of plasma. Fixing the problems would require "shoe-horning" into existing processes in a very unsatisfactory way. Reverting to cryo dependency would have been very problematic.

* Dr Snape said he was not aware of any nationality coordinated strategic meeting to consider the possibility of reverting to cryo if that had appeared to be necessary.

* The pros and cons of using larger pool sizes was reviewed. The need to remove from each batch a certain quantity of end product for monitoring and other required purposes would use up more plasma than for larger pools.

* The changes in processes, such as Blomberg to Johnson, was not undertaken lightly due to the significant changes of the production facilities and processes.

* PFC small volume mixing processes were not part of Dr Snape's knowledge or work. Dr Perry would be likely to explain any benefits, for example on relation to larger molecules such as immunoglobulin.

* The views of Haemophilia patients were mainly received by Dr Snape through the Haemophilia clinicians. So the views about apparent patient preferences, for example, for factor over cryo, was an indirect impression from a (not-independent) third party.

* A question about the pool size being printed on the label for the benefit of patients was taken by Sir Brian for his consideration.

* The balance of risk of greater pool size against greater risk of infection was not seen by Dr Snape as making much difference.

* The statement on the label about not assuming the product free from infection was considered weak and should have stated the likelihood of infection. Dr Snape said he did not receive any criticism of the wording and it was not dissimilar from other types of statements.

* When asked who had responsibility to respond to Dr Lane's warnings, that was assumed to be DHSS.

* The lack of promotion of BPL and PFC could be seen as a criticism. Dr Snape thought that the non-financial nature of its supply did not match commercial marketing.

* The notion of "plasma compromise" needed explanation. It involved a system of traceability in case a product needed to be recalled or otherwise checked.

* The reason why the international plasma packs were so late in coming to BPL was explored. It related to the capacity of individual transfusion centres having the means to change or not to a standard gathering method.

* A question was raised about the qualifications of staff. Limiting factors for attracting people from the private sector included the constraints of pay scales and the poor quality work setting.

* The significant pool size shift from 10,000 to 25,000 was primarily justified by the expected capacity and processes of the new building, and the need for securing self-sufficiency in relation to factor concentrates that were virally inactivated.

* On there being a "tipping point" for non-A-non-B related to pool size, Dr Snape said he was not qualified to say.

* Dr Snape did have discussions with haemophilia clinicians about the emerging AIDS issue, including Dr Rizza.

* The card system for monitoring hepatitis would have come from the Haemophilia Centres anonymously. It was not an automatic or systematic process. It was only if there was thought to be something to report.

* What patients were being told about the use of their information was not known to Dr Snape.

* Similarly, Dr Snape did not know what Zuckerman and Craske were doing with the data.

* The four flag condition for highlighting suspect batches was not based on any pre-existing methodology.

* BPL did not check it's own processing systems to see if it had contributed to the infectivity of the HL3186 batch.

* Yield was inconsistent, especially for cryo and that was even more the case for single donor cryo. The checking process couldn't be done on single donor cryo, it required to be part of an extracted batch.

* The different yield figures for Scotland and England was explained in part by the one or two stage assays used. It was also linked to an exaggeration of yield claims by certain individuals.

* (Sir Brian) A question about international standards being applied to get consistency, that was seemingly compromised in reliability by the variations of local working yield units and not measuring the same thing.

* "Batch size" versus "pool size". Batch size is what goes into the tank. The pool size is dependent on the supply from individual centres.

* (Note: the above core participant question summaries are likely to contain errors or missing detail due to the rapid-fire nature of how they were asked.)

Sir Brian concluded with his questions. The "pressure" to achieve amounts of product production was in part down to a matter of patient need, or clinician demand. There was pressure in relation to what plasma was available and the needs arising from the Medicines Inspectorate report. The availability of plasma (amount) was one aspect, and a further matter was the capacity of the production process to maximise what could be obtained from that which was supplied.

The Chair returned to the witnesses repeated topic of the limitations of the poor facilities. This was an important issue for Dr Snape. He believes it took too long to decide it was not possible to renovate, and instead the need was to build a new facility. A 1967 plea for improvements should have been heeded. It put both output and patients at risk. It created a situation where importing product was the only option, with all that entailed.

Was there a reason to use commercial product if local product was available. "No". The F9 case was illustrative of what could have been for F8 if facilities allowed.

Shift work was operated at BPL, but the unusual circumstances of things like cold rooms to work in meant it could not be like a regular shift system. It may or may not be significant that Dr Snape has adopted greater gesticulation in providing his answers towards the end of his evidence session.

In relation to identifying a "rogue" batch, from the video it was seen that a barcode reading system operated to check in newly received boxes, but the end product logging was seen as being entered in a hand-written ledger. Individual vials were not then barcoded, but the numbers on the vials could be matched back to the original barcoded delivery box. Within the delivery boxes, each donation it contained was also individually barcoded. The German Blood Law required vein to vein tracing. That was not the situation in the UK.

Those more severe haemophiliacs were often supplied with different products. This would complicate things if look-back was required. Then, adverse events would be hard to trace back to the origin. The reporting of an adverse event was dependent on the patient's clinician reporting the matter timeously. Too often there was no report, or it came in late and might have resulted in various other adverse events.

Dr Snape appeared to use the phrase "our cauldron". Surely this cannot be the actual terminology they used.

Dr Snape's final comments included an admission of being moved to tears by watching the testimonies of those infected and affected. He summarised that the efforts of the organisations he was associated with could be summed up as "too little, too late". Dr Snape finished with a "sincere apology" for what was suffered by patients.