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QUESTION: Yes. We will see how this -- how it plays out in the documents that follow, I won't take you to a ll of them, is that the DHSS arrange the central contract. They do so to try to take advantage of economies of scale, and that is a contract with the providers of Hemofil and Kryobulin. However, that is...
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QUESTION: I think, at least I read this as what would later be described as high purity, intermediate pur ity and -- ANSWER: It might, however, mean extra concentrated.
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QUESTION: It -- ANSWER: Just as one buys a bottle -- to use a home-spun analogy -- a bottle of squash and then you can get a smaller bottle, which is supposed to be three times as concentrated.
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QUESTION: It could mean that, sir. My -- I can't take you to any document which shows this, but my sense is t hat it is probably referring to what later becomes term ed "purity". But I cannot be sure about that. ANSWER: Yes. I mean, if there's no other document that helps, well, that's just a mystery an d...
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QUESTION: We can look into it and see if we can find anything. The terminology in this period is a litt le looser than it becomes later. 75 ANSWER: Well, they knew what they meant.
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QUESTION: They knew what they meant, yes. Certainly, the sense is that there should be two forms of product, one which will be for general use, as it were, and one which is for a more specialised use. ANSWER: Yes.
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QUESTION: The next meeting of note is on 20 July 1973. I won't take you to the document, but it was a meet ing of the Regional Transfusion Directors, which discus sed the issue of domestic production, and considered a paper, which is referred to in the written presentation at paragraph 60. At that meeting, it w...
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QUESTION: Well, again, the terminology isn't absolutely clear. And it could mean -- sometimes BPL is used as a term to cover both Elstree and Liberton. From th e previous documents, the discussion was very much th at you would need -- to provide self-sufficiency acros s the UK, you need both. Both plants. A...
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QUESTION: Yes. ANSWER: Is there any description anywhere as to how quality was to be assessed?
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QUESTION: There isn't a single document, I think, that sets that out. There is discussion in some of the other meetings which really echoes what is said the re: that the domestically made product is as good to us e as the commercial products. Now, I have inferred f rom that discussion that that is a reference...
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QUESTION: -- "the Meeting supported and wholeheartedly endorsed the Appendix B Document [that is the MRC report]. Again it was stressed that the estimates in Appendix B are just for present but in five years' time there may be a need for more material. "ACTION . The Chairman agreed to write to the DHSS saying...
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QUESTION: Yes, and that is an argument which is made repeatedly in the papers by various people, includi ng Dr Waiter. ANSWER: But, as you say, it cuts against the principle of regional payment.
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QUESTION: It does, sir. What we will see in the papers that follow is that, in order to expand plasma supp ly requires significant upfront capital costs and, indeed, revenue costs that occur. Those will be incurred upfront, and you won't get your plasma -- increased plasma supply until sometime afterwards bec...
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QUESTION: Just to pick up on three things from this morning, sir. First, SAMO stands for Senior Administrative Medical Officer. Apologies. There' s so many acronyms. Sometimes they slip through the net. 7 ANSWER: Well, I'm sorry couldn't hel...
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QUESTION: The second point, this question of potency and purity. If we could have on screen, please, WITN3431001, page 32. This is the witness statemen t of Dr Snape from whom we will hear at the tail end of this block of hearings. We'll have paragraph 90 wh en it comes up. Page 32, paragraph 90. The contex...
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QUESTION: -- which, in Dr Snape's usage, will therefore be 98 a reference to the concentration in units of Factor VIII per millilitre. ANSWER: It's the degree of concentration. It's the -- my example of the concentrated squash o r the concentrated washing up liquid.
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QUESTION: Exactly, sir. Exactly so. The wider context of that discussion is that 90 per cent of what may be referred to as standard Factor VIII was required an d 10 per cent of the higher potency -- ANSWER: He makes the point here that the two might be linked, possibly, in this sense: that if y ou are usi...
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QUESTION: Yes. ANSWER: -- which may (unclear) , by the way, but they're there. So it is also going to be more equivalent to higher purity although -- because it's -- high purity refers to the amount of excess protein that you get, doesn't it?
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QUESTION: That is my understanding, that the two will be closely related. A higher potency Factor VIII prod uct may be an increasingly pure Factor VIII product. ANSWER: Yes, on the other scale.
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QUESTION: Dr Snape I hope will be able to take us through 99 this -- ANSWER: Well, he can tell us if that's right, but thank you for that. It looks as though there was a proper distinction to be made.
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QUESTION: Yes. ANSWER: Thank you.
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QUESTION: Finally, a measure that I didn't introduce earlier but will introduce now. We looked at the M RC paper, Dr Biggs' paper that was later enthusiastica lly endorsed by various meetings and was recommended as the basis for planning. That expressed the amount of blood donations required as the measure for...
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QUESTION: It's PRSE0002350. Electronic page 18, internal page 17. Perhaps, actually, we will bring it up, Paul. PRSE0002350. Electronic page 18. We can see at the top there the figure that we discussed earlier, 547,540 to 750,000 blood donations per annum. If w e go down a few lines, it says: "Expressed a...
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QUESTION: We will see increasingly, as the '70s goes on, the measure of blood donations is dropped in favour of weight or volume for the amount of plasma and international units for the amount of Factor VIII t hat is produced. This is a translation between the two presented by Dr Biggs. There are various ways...
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QUESTION: The conversion that I have found, and I stress this is a layman essentially looking online to try to find the conversion, I think it's in the region of 1.024 kilograms. ANSWER: Thank you.
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QUESTION: But there will be others who are far better placed to be able to make that conversion. ANSWER: So it's very close to a kilogram being equivalent to a litre.
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QUESTION: You will see in appendix 1 and appendix 2 when the Inquiry legal team have had to do that calculat ion in order to be able to compare data points, the conversion used is 1:1. ANSWER: Yes.
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QUESTION: But it is stressed that that is a rough approximation. And as we will hear when we come on to look at those figures, they come with a lot of caveats, the core of which is that they are helpful in showing a general trend but they shouldn't be relie d upon to be absolutely precise at all points as to...
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QUESTION: Yes. There are so many variables, it is never going to be possible to say this figure is exactly this figure in equivalence. ANSWER: You'd expect the donations to approximate if there are enough of them in a pool, to a hundred per cent activity, that being the average , but you don't know.
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QUESTION: Exactly, sir. ANSWER: I see.
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QUESTION: Returning, then, sir, to the chronology. The tension that we were exploring before the break was between the DHSS and the Regional Health Authoritie s about who was going to fund the expansion of plasma supply. There was also a tension that was growing between clinicians and the DHSS, and no doubt wit...
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QUESTION: From memory, and I stress it is from memory, I think it was Factorate, Armour's Factorate, which came on to the market third. ANSWER: Factorate. Because Profilate came later?
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QUESTION: Yes, I will check on that. ANSWER: Because I thought the date of that was after '74 but, plainly, that's a mis-memory on my part.
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QUESTION: Well, the licence, I think, was after '74 but it was provided off licence on a named-patient basis. ANSWER: Well, that would be so of any product. 13
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QUESTION: Yes, yes. My recollection, I will check it over the break or overnight, is that Factorate is the th ird product that enters the market, and rapidly -- ANSWER: But it may not be the third she was referring to, if she was talking about named-patien t basis.
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QUESTION: It may not be. But, again, my recollection from last autumn is that Factorate pretty quickly establishes a very strong market position, partly because it's cheaper. So it may well be that Factorate is the one that she is referring to. Dr Owen, in his reply there doesn't seek to rebuff the central c...
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QUESTION: I can look back, sir. I will look at the letter and see if there is anything else that can tell us which product she is referring to. ANSWER: Thank you.
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QUESTION: Dr Owen, in his response then, not seeking to deny the central charges that Dr Biggs had made in her letter, and seeming to accept that the question of how 114 great a number of concentrates can be provided, is tied heavily with how much domestic supply can be increased, and that is the question for ...
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QUESTION: That is my understanding as well. ANSWER: So this is not setting up something which is a contradiction.
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QUESTION: No. ANSWER: It's basically saying we need more plasma because it will serve these various differen t needs.
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QUESTION: That's right, and we will see later under a group called the Working Party on Trends, they're 17 trying to work out how much plasma is needed to be fractionated. The measure that they take is the amount needed for albumin, and they say, "...
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QUESTION: That's right. And, indeed, for other blood components as well. And you may remember Dr Walfor d, when she was discussing the arguments about reverti ng to cryoprecipitate, drew attention to Dr Lane's statement, something that we will look at in due course, where he said: if you are going to revert t...
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QUESTION: Returning to the document at point (c), and this is the third of Dr Maycock's factors that are causi ng 118 difficulties for the NBTS, he says, and I quote: "The need to depend, at least temporarily, upon supplies of AHG concentrate and possibly PPF [that' s protein plasma fraction] from commercial s...
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QUESTION: Sir, before turning to how the £500,000 was spent, just a couple of points that we have checked over the break. The first refers to the point that you raised from Dr Biggs' letter to The Lancet, where she said that three commercial companies are now licensed to sell good quality human Factor VIII in thi...
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QUESTION: Yes, sir. ANSWER: And it's a shame she's not available to us to explain.
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QUESTION: Yes. What I would say is from the documents 144 that we looked at in November, when Dr Walford come s in the early '80s to try to tot up who was providin g which products, those are the products that she ref ers to. There is no other licensed product within the United Kingdom that she is referring ...
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QUESTION: I'm afraid I can't assist more than that at the moment. ANSWER: There will be perhaps some indication given if we looked at the UKHCDO returns and saw what was on their list, if they had a list at that stage, for the different sorts of concentrates because they did have pretty early on a list, didn'...
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QUESTION: I believe so. There is ongoing work trying to put together all of the returns and interrogate the m in order to provide some useful data for you. We w ill feed this question into that. ANSWER: It doesn't -- this particular little point, it's intriguing, but it doesn't actually aff ect your presen...
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QUESTION: No, it doesn't. No. A second point concerns Hansard references. The Inquiry legal team, as I said, had identified the question that was posed of Dr Owen following Dr Big gs' 45 letter as the first Hansard extract that we had fou nd tha...
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QUESTION: It could do, sir. I'm afraid I cannot go any further beyond that Hansard answer. ANSWER: Yes, but at least there is an answer, and there is something about that, so I'm grateful to Collins for having pointed that out.
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QUESTION: Turning, then, to the £500,000. Appendix 3 to the main presentation is a detailed analysis prepar ed by the Inquiry legal team on how that money was spe nt. And it is a centre-by-centre analysis at points. I'm not going to take you to all of the documents in that, or indeed take you to the substanti...
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QUESTION: He's answering purely for England and Wales because that is his departmental responsible for th e DHSS. What is slightly unclear is whether or not these answers cover Northern Ireland as well, but I 'm afraid I can't assist on that. The amount allocated to PFL and BPL in England in 1978 to 1979 was ...
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QUESTION: Then between 1994 and 1996, you were a research 2registrar at the Public Health Laboratory Service, which I'm going to call the PHLS, Communicable Dise ase Surveillance Centre. Broadly, what did that organisation do? ANSWER: Well, we were a public health protection service fo r England, and I was wo...
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QUESTION: And in 1996 you received an MSc from the London Sch ool of Hygiene and Tropical Medicine and took up a post as senior registrar still at the PHLS. ANSWER: Yes. They have a training programme.
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QUESTION: In 1999 you became a faculty of public health, becoming a fellow in 2008. Is that the organisatio n that sets the standards for training, examination a nd specialist practice? ANSWER: That's our professional body. 3
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QUESTION: Professional body for public health specialists. Then in 1999 you were seconded from the PHLS to take up a role at the Department of Health as Senio r Medical Officer for the environmental transmission of infection unit; is that right? ANSWER: Yes. So I think I was coming to the end of my training, an...
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QUESTION: By November 2000 you had become the Senior Medical Officer at the CJD policy unit at the Department of Health, again seconded from the PHLS. ANSWER: That's correct.
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QUESTION: What was your role as Senior Medical Officer in the CJD policy unit? ANSWER: Supporting the team there involved in running vario us committees that they ran and giving advice. To be honest, I found it quite hard to remember exactly w hat my role was now. It's about 20 years ago. But looking at the do...
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QUESTION: So it looks again from the documentation as though you were a member during that period. So November 2000 to February 2002, you were a member of the Department of 4Health Medical Research Council Research Advisory Group on TSEs? ANSWER: It's more likely that I was being an official rathe r than a me...
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QUESTION: And an official -- what's the status of an official ? ANSWER: Attending meetings, writing minutes, making notes, communicating the decisions to other members of the policy team.
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QUESTION: Then you are noted as being an observer on the Advisory Committee on Dangerous Pathogens Working Group on TSEs. Is that a similar role to an offici al? ANSWER: Yes.
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QUESTION: And you are again recorded in minutes as being a technical adviser to SEAC. Is that a different role? ANSWER: Yes -- well, I'm just trying to think. I mean, aga in, it's hard without seeing the paperwork to remember exactly what I was doing, but it might have been things like helping prepare papers fo...
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QUESTION: And then you are also described as an official in minutes of the Chief Medical Officer's SEAC epidemiology subgroup? ANSWER: Yes. I mean, it's all the same kind of supportive role.
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QUESTION: Supportive role. So not in a decision-making role but in a supportive role. So either the secretariat or to the groups themselves. ANSWER: Yes.
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QUESTION: Then in March 2002 you took up your role as head of the CJD team, presumably first at the PHLS, and the n in 2003 when the HPA was formed -- the HPA being th e Health Protection Agency -- you continued in that r ole as head of the CJD team at the Health Protection Agency. ANSWER: That's correct.
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QUESTION: And you were, at that stage, a consultant epidemiologist. ANSWER: That's correct.
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QUESTION: And you remained in that role until May 2012. ANSWER: Yes.
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QUESTION: So just pausing there in your CV to ask you some questions about the Health Protection Agency. You've told us that it then became Public Health England, and then Public Health England has now bec ome the UK Health Security Agency. So you have referre d to those as PHE and UKHSANSWER:
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QUESTION: So that's what that stands for, is it? ANSWER: Yes.
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QUESTION: Was the -- geographically, in terms of the four nations, what was the remit of the Health Protectio n Agency? ANSWER: England.
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QUESTION: And what were the equivalent organisations in Scotland? ANSWER: We worked -- it was then -- we worked with SCIEH, Scottish -- I can't remember exactly what it stands for. But, again, infectious, epidemiology, health. I can't remember what the actual acronym stood for. Now it's, I think, Health Protection ...
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QUESTION: So they were equivalent to agencies in those -- ANSWER: I was just trying to think whether our remit covere d Wales at any time. I think we were always working with Wales. It's hard for me to remember exact rem its of the different organisations.
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QUESTION: And the purpose of the Health Protection Agency? ANSWER: I'm trying to think how it changed. At which point we -- I think it was still pretty much the same, an d I think it was when we became PHE that it became a much broader remit, including non-infectious 7diseases.
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QUESTION: So the description you gave us in relation to PHLS applies equally to the Health Protection Agency. ANSWER: From our perspective, yes.
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QUESTION: And I understand that the Health Protection Agency was what's called a non-departmental public body. So i s this right: it wasn't actually part of the Departme nt of Health, but it was funded by the Department of Health? ANSWER: I don't want to give you incorrect information, so it would have to be in...
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QUESTION: And so is it right to understand that you received instructions from the Department of Health to carry out some task? For example, a notification exercis e. ANSWER: Okay, so I think that you're talking about -- is th e relationship between also the CJD Incidents Panel a nd the Department of Health becau...
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QUESTION: So that would come through the Chief Medical Office r or the Department of Health through -- accepting th e recommendation or advice of the Panel. And then wh o would instruct the Health Protection Agency? The Panel or the Department of Health or if you don't know -- ANSWER: I think it may have been...
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QUESTION: It may become clearer as we look through some of th e documents; it may not. Returning then to look at what your team were doing, the CJD team. What was the remit of your te am? ANSWER: Okay, there were different pieces of work going on, so part of it, what I was doing, was we were providing ...
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QUESTION: We will come and we will be looking later this morn ing at some of the documentation that relates to, for example, following up those that were at risk in th e community from CJD. In terms of the prevalence work, is it right that the Health Protection Agency set up the tonsil lar and appendix tissue na...
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QUESTION: Was that headed up by your colleague Professor Gill ? ANSWER: Yes, so Noel Gill, and I think Kate Soldan was also involved with those, as well as more junior members of the team.
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QUESTION: Can you give us an idea of the size of the team. ANSWER: Okay. So I think it might be a bit more confusing than otherwise, just because I kept having -- it wa s at the stage when I was doing maternity leave and child care stuff, so people were covering for me, b ut in essence there was myself and there...
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QUESTION: Then in May 2012 you took up a post as a consultant epidemiologist at the HIV and STI (sexually transmitted infection) division of the HPA? ANSWER: Well, yes, it's actually -- I had the same post. S o 11 I took the -- got the consultant post in CJD, and I just moved responsibility. So the CJD team was...
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QUESTION: And that's a post you hold -- ANSWER: That's the same post I'm in.
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QUESTION: -- today. So, I'm going to ask you some questions now about the notification exercise, and we heard quite a lot of evidence about that yesterday. I just wan t to understand the division of responsibility, insof ar as you understand it, between the Panel, the Health Protection Agency and the Department o...
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QUESTION: Then it was for the Department of Health to accept or not accept that advice? ANSWER: Yes.
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QUESTION: We know that they did accept that advice? ANSWER: Yes.
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QUESTION: Then it was for the Health Protection Agency to put 12 into effect that decision, that notification, to effectively coordinate it and deliver it? ANSWER: Yes.
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QUESTION: And in terms of authoring documentation, working ou t how the process is actually going to work, the nuts and bolts of it, was that led by the Health Protect ion Agency or led by the Panel, can you recall? ANSWER: I think we would be -- we generally -- so are you talking specifically about the haemophili...
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QUESTION: I'm talking generally now. ANSWER: Okay. We would have been the people coordinating w hat should -- how to do it, but we would work very clos ely with members of the Panel. So, I mean, I can comme nt on yesterday if you -- if that helps, I don't know? I mean, so, for example, in creating some of the ...
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QUESTION: Equally, you didn't have the -- you weren't sitting in the full Panel, CJDIP meetings going through, line by line, the toolkits, but you were going off and doing -- getting advice and help from people outsid e the Panel meetings and so on -- ANSWER: I can't remember whether we sent drafts to the Pane ...
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QUESTION: Just in terms of trying to understand the time fram es in which everything was taking place, we heard from Professor Ironside that there was a period of consultation in October 2001, and we know from the papers, which we can go to if necessary, that the framework document was provided to the Chief Medica...
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QUESTION: October -- ANSWER: So the secretariat was still within the Department of Health at that stage or had it moved over?
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QUESTION: I don't know the answer to that actually. ANSWER: Given that the CMO set up the Panel, maybe that was an expectation, that the Government would approve i t. In a way you could -- I was thinking that in some w ays it is a bit like the Covid response you can see now , that here is a recommendation to take...
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QUESTION: And we -- again, we can go to the documents if necessary but the Inquiry -- I know you have looked at some of the CJDIP annual reports which set out that the four CMOs responded to the proposals in the framework document in June 2003. Does that ring a bell with you? ANSWER: I'm sure if it is in the a...
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QUESTION: Then, the framework document was published. And I suggested to Professor Ironside that it was in December 2003 but, having looked again at the annua l reports from the Panel, it looks like it was March 2004. Again, does that period of -- does tha t sound right to you? ANSWER: I'm in the same boat as ...
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QUESTION: Yes. And certainly with Professor Ironside we look ed at a version that was dated December 2003, but -- ANSWER: Mm.