J how will that be improved by this claim coming to an end and another one starts. They say they'll be giving you disclosure later AS that presupposes there has been co-operation in the pre-action protocol process. We were not given the minutes of the research ethics committee
meetings J yes that's a disclosure application and we can determine that later. What I don't understand is why the stay and then... surely the target is moving atmo and on D's proposal - the target will come to a standstill in 8 weeks time and you can shoot at it
J you'll know what the target is, you'll know what the claim is and then we can see what expert evidence is admissible etc and if there is an issue about disclosure, then we can work that into the timetable. AS there are two concerns
AS one is disclosure - the ability to take shots without a blindfold on and that 2) no one will be recruited by the trial until this is sorted. Mr Sharland stands up to say "determined by the High Court" - we don't want to get into what the Court of Appeal might say
[all parties seem agreed that no recruitment will take place for the PB trial until this claim has been determined in the High Court - so if the JR fails at the High Court and C's appeal - the govt is not agreeing not to recruit for the PB if this JR goes to CoA]
[AS makes more complaints about disclosure] J it's unusual in JR to have a disclosure app before AS producing summary grounds J well certainly detailed grounds. if you want a disclosure application determined maybe we can incorporate that into the timetable.
J and there's the issue of expert evidence being admissible AS there is a fundamental issue on what constitutes a duty of candour and when it is triggered.
[lots of discussion about lack of disclosure - sounds very familiar]
J your worry is that you want enough material to plead a proper case AS exactly J so you're saying when they give you the further decision - you don't just want a one-page letter saying this is the decision you want the underlying reason for it
AS yes J I see Mr Milford [SS] nodding - it may be that you get the reason and some of the underlying documents AS yes J it's in D's interests to give you that as they want to know what your case is about this decision
AS that's the history of this matter which underlies this concern. My lord it is significant to take into account the context. This is a C which involves performing a clinical trial on a highly vulnerable group of people- not just.
because they're children - the court should apply "anxious scrutiny... and that has an impact on the duty of candour" and what was and wasn't considered is very important when it comes to the decision-making process
[reckon the stay will be granted with a disclosure application and possible hearing about admissibility of expert evidence built into the timetable. let's see]
AS our resistance to the stay - 1st is addressed in no recruitment for PB trial untill matters over. 2nd is in relation to disclosure - and there are still issues there
J in this case if there is a timetable and D have to disclose something at a later stage, they might as well disclose it early AS 3rd objection - moving target - if the court can live with a moving target then I think my clients can
J your view is that nothing should be done to this cohort which you describe as vulnerable on the other hand as both interested parties have pointed out there's a need
. to get on with it as D are saying that the trial may well be of benefit to these vulnerable people and the risks faced by these people in the interim.
J you want the matter determined AS we want the matter determined fairly J yes and the disclosure application should do that AS we can debate which way is more efficient - we could have a redetermination on an accelerated timetable, but I'm not pushing back on that aspect
J but you are still opposing AS some of my concerns have been met today J but you are opposing it in principle on the basis we should get on with it [Sharland on his feet]
[says recruitment to the trial will definitely not happen until end July. Can't make any guarantees beyond that] J timetable has been set to get a judgment at end of july but it is a matter for the judge. J okay since your oppo to the stay remains I'll need to give a judgment
[J is doing it in real time] J the C is brought by three C's to challenge regulatory approval in respect of the clinical trial for PB drugs for u18s. The C was filed at begin Feb though there was a slight delay in issuance. Since C has been filed the 2nd defendant - the Sec of
State for Health - but acting through the MHRA sent a letter to the operators of the trial - the interested parties - outlining a number of concerns with the trial. In the light of that letter there are discussions between the interested parties and MHRA
with a view to seeing if these concerns can be met. AM for the claimants says that even if the decision was taken not to make such amendments they can challenge that and it follows there will be a fresh decision in this case. He says the effect of the letter from Prof J in the
MHRA (though he no longer involved) states there were "very serious failings" in the process by which reg approval was given for the trial. He says it is inevitable that a further decision will be made
The Interested Parties are at one in supporting D's application for stay, following discussions over the next 8 weeks will give C the ability to amend their claim. Then a hearing to decide if C's can rely on expert evidence. Then various submissions ending in a 2 day trial
in week commencing 6 July or 3 to 4 days if expert evidence is allowed. I am granting the stay. It is true there is bound to be. a fresh decision. The contours of the litigation are likely to change or at least a strong possibility. There is no point in proceeding with a process