The Secretary of State for Health & Anor v Servier Laboratories Limited & Ors

Perindopril was licensed for use in the UK to treat hypertension, heart failure and major adverse cardiac events (or “MACE”) and also after a stroke or transient ischaemic attack (a “mini-stroke” or “TIA”). A number of other ACEIs were also licensed for hypertension and heart failure (captopril, enalapril, lisinopril and ramipril) and generic versions of these came to be available. As the Judge noted in paragraph 89 of the Judgment, “[g]eneric enalapril became available around December 1999; generic lisinopril in about December 2002; and generic ramipril was introduced in the UK in about January 2004”.

Servier’s case on issues (a) and (b) was that ACEIs exercised a class effect and were clinically substitutable with another (and should have been regarded as such by prescribers throughout the period relevant to the claims). Every patient who was prescribed perindopril could, Servier maintained, have been prescribed an alternative ACEI that was available in generic form.

The Judge addressed preliminary issues (a) and (b) in paragraphs 169-232 of the Judgment. In paragraph 230, he concluded that there was “no simple or binary answer to the questions posed by preliminary issues (a) and (b)”. He continued:

“The answer varies according to the condition for which the ACEI is being prescribed, the time period concerned and whether the question relates to a prescription initiating a patient for treatment with an ACEI or switching a patient already stable in treatment with perindopril, in which case the circumstances of the patient are also relevant. In my judgment, these preliminary issues are to be answered as follows: -

i)

For ‘straight’ or uncomplicated hypertension:

a)

for patients initiated on an ACEI prior to late March 2005, it would have been reasonable or appropriate to prescribe lisinopril instead of perindopril if the appropriate daily dosage of lisinopril was 20 mg; however, if 40 mg lisinopril was the appropriate dose, it was not reasonable or appropriate to prefer lisinopril as against perindopril (or any other ACEI) since there was no cost advantage.

b)

for patients initiated on an ACEI from April 2005 onwards, it was reasonable or appropriate to prescribe lisinopril or ramipril instead of perindopril, except where the appropriate target dose was 40 mg lisinopril or 10 mg ramipril and the GP considered that the need for titration would be a burden on the patient or their practice.

ii)

Subject to the qualifications as to timing in (i), it would have been reasonable or appropriate at the patient’s next review at the GP surgery to switch a patient being treated with perindopril for uncomplicated hypertension to lisinopril or ramipril except where the patient was elderly or frail or vulnerable because of co-morbidities being treated with other drugs or had previously been switched to perindopril because of an adverse experience with either of those alternative ACEIs.

iii)

For patients being initiated on an ACEI for heart failure or MACE, there was no reason to choose another suitable ACEI instead of perindopril prior to late March 2005 as this brought no cost advantage for the equivalent dosage. For patients initiated from April 2005 onwards, if the clinician followed the respectable body of opinion that one could have greater confidence in the benefit of perindopril for these conditions since it was better supported by evidence, then, to adopt the formulation in Servier’s skeleton argument, it would not ‘have been reasonable [or appropriate] for that doctor to prescribe an ACEI other than perindopril.’ For those clinicians who took a different view, it would have been reasonable or appropriate to prescribe lisinopril or ramipril for heart failure instead of perindopril (unless the patient suffered left ventricular heart failure and administration of ramipril would involve twice daily doses) and to prescribe ramipril for MACE, unless the clinician was concerned about the burden on the patient or the GP practice of more frequent attendance for titration.

iv)

For patients being initiated on an ACEI post-stroke or a TIA, a clinician could reasonably regard the evidence supporting treatment with perindopril as significantly stronger than the evidence for ramipril. For those who took that view, it would have been unreasonable or inappropriate to prescribe ramipril instead of perindopril, and no other ACEI would have been appropriate. In any event, there was no reason to prefer ramipril to perindopril prior to April 2005 since there was no cost advantage.

v)

For patients initiated on perindopril by a consultant in secondary care for heart failure, MACE or post-stroke, it was unreasonable or inappropriate for the GP to switch the patient to another ACEI prior to March 2005 as that brought no cost advantage; after March 2005, it would have been unreasonable or inappropriate for the GP to make that switch if the GP considered that the consultant had selected perindopril based on his or her more specialised experience and expertise.”

The Judge added in paragraph 231 of the Judgment:

“I observe that this shows, in my view, that in many cases the prescribing decision to choose among the class of ACEIs was not a formulaic exercise but a more evaluative judgment involving varied considerations.”

The Judge addressed preliminary issue (c) in paragraphs 233-391 of the Judgment.

The Judge considered in turn various ways in which Servier had alleged that the claimants should have taken steps either at national level or more locally to encourage use of alternatives to perindopril. In paragraphs 270-306 of the Judgment, he rejected Servier’s criticisms of what was done in terms of national guidance. He then turned on to, among other matters, arguments which Servier had advanced in relation to local formularies, the “Qualities and Outcomes Framework” (“the QOF”) and a software programme called “ScriptSwitch”.

By the end of the period relevant to the claims, “virtually all PCTs and many of the Health Boards in Wales and Scotland had produced formularies listing the drugs recommended for prescribing by GPs and most hospital trusts (or groups of hospitals in an area) maintained their own formularies”: paragraph 309 of the Judgment. It was Servier’s case that the formularies could have been used to limit the use of perindopril. However, the Judge observed in paragraph 312 that “there is no basis on the expert evidence for finding that perindopril should have been removed from the formulary at the start of the Relevant Period” and that Ms Kerr’s evidence did not provide support, either, for the contention that it was unreasonable to leave perindopril on the formulary. Servier put forward “an alternative and lesser contention that local formularies should have contained an indication that one or more ACEIs which were available generically (and therefore not perindopril) were the preferred option or ‘first line’ ACEIs” (paragraph 314), but the Judge rejected that, too. In that connection, he said that “the use of formularies was in the process of development”; that “in some areas the introduction of a formulary that was seen as too prescriptive would have encountered considerable resistance”; that “for a PCT/Health Board issuing a formulary to go further than selecting the recommended drugs so as to set a preference between them imposed a significant additional burden, especially as such an approach could not normally be confined to ACEIs”; that “before lisinopril and ramipril came off patent it would not have been reasonable to indicate that generically available ACEIs should be the preferred choice or first line”; that the October 2004 edition of a publication called “Prescribing Outlook” (incorrectly) indicated that the patent for perindopril had expired; that in July 2007, after Patent 947 had been held to be invalid, “it was clear that the price of perindopril would come down”; that “where local consultant(s) supported the inclusion or retention of perindopril as a first line drug, … the PCT/Health Board was not acting unreasonably if it followed the advice of the hospital consultants specialised in the particular field and not the pharmaceutical adviser”; and that Servier “was very alert to a threat to remove or ‘demote’ perindopril from local formularies and developed a strategy to mobilise support from local cardiologists to counter this threat”: see paragraph 315. With regard to the last of these points, the Judge said in paragraph 315:

“Of course, Servier’s efforts were not necessarily successful. But I do not accept the submission made for Servier that what it did at the time is irrelevant to the question before the Court. In my judgment, in the context of this case, such a strategy on Servier’s part is very material to the determination of whether a PCT or Health Board was acting unreasonably in failing to mitigate its loss recoverable from Servier because it did not decide to mark perindopril as a second line or less preferable choice of ACEI on its formulary.”

GPs generally provided their services through “General Medical Services” contracts. With effect from 1 April 2004, a new “General Medical Services” contract was introduced which included the QOF. This “sought to resource and reward GPs on the basis of how well they cared for patients rather than simply paying them for the number of patients that they treated”: paragraph 49 of the Judgment.

Servier contended that the QOF should have been used to encourage the prescription of cheaper alternatives to perindopril. The Judge, however, said that it was common ground between Ms Kerr and Professor Chapman that the claimants “had multiple competing priorities in relation to safety, therapeutic quality, and cost-effectiveness of prescribing in relation to a variety of medicines”, that “[t]he point about competing priorities was a theme of virtually all the factual evidence from those who worked in medicines management or as pharmaceutical advisers”, that “[t]he initiative to move all GPs to generic prescribing … applied across all drugs”, that “while some PCTs and Health Boards may have chosen to include the level of perindopril prescribing as a priority from about 2004, when ramipril became available generically, … it was eminently reasonable for others to decide that not only statins but also [proton pump inhibitors] and [angiotensin receptor blockers] were greater priorities”, that “[m]edicines management was a relatively recent development which was evolving”, that “in England the reduction of the 303 PCTs to 152 PCTs with wider jurisdiction in 2006 caused particular disruption” and that “realistically, the view of local consultants would be a significant factor in determining what initiatives could effectively be pursued”: see paragraphs 328-347 of the Judgment.

With regard more specifically to whether targets relating to ACEIs should have been set, the Judge noted in paragraph 349 of the Judgment that the QOF “envisaged setting a very limited number of targets” and added that “that was doubtless for good reason, in order to maximise effectiveness”. In paragraph 351, he said:

“there were other priorities in prescribing on which pharmaceutical advisers could reasonably have chosen to concentrate in their limited meetings with GPs and the setting of targets under the QOF. Accordingly, I do not think that it was in any way unreasonable if they chose not to make ACEI prescribing a priority.”

Turning to whether GPs should have been incentivised to switch to ACEIs other than perindopril, the Judge concluded in paragraph 356 of the Judgment that “it was not unreasonable if, either at national or more local level, the Claimants did not include within [an incentive] scheme the prescribing of ACEIs that were available in generic form”. Likewise, the Judge thought that it was not unreasonable if a PCT or Health Board did not introduce a switching programme to discourage perindopril prescribing: see paragraph 361. In that connection, the Judge said:

“362.

My conclusion is reinforced in the context of this case by the fact that Servier was active in seeking to dissuade PCTs/Health Boards from introducing such schemes for perindopril. In June 2006, it produced an internal document with the objective: ‘To set in place a pro-active call strategy for negating PCTs that are focussing on a switch from Coversyl to Lisinopril/Ramipril usage.’ The 12 page document set out a comprehensive strategy, both proactive and reactive, involving contact with GPs, with PCTs and the use of [‘key opinion leaders’] to engage with pharmaceutical advisers. The document summarises relevant clinical arguments (with charts, graphs and footnote references to academic studies), practical arguments in terms of titration and dosages, ‘deflection strategies’ (pointing out the significantly greater savings from switching among statins or away from ARBs) and further that emphasis can be placed on the GP workload which such a switching programme imposes. Further, in September 2006, when several PCTs in the London area appeared ready to implement a policy of seeking to switch patients on perindopril to one of the ACEIs available in generic form, Servier’s strategic response highlighted the fact that the first generic perindopril had just appeared on the UK market – a reference to the short period of supply by Apotex – and that ‘it is expected that there will be increased generic availability within the UK in the near future’.

363.

I do not suggest that a PCT or Health Board should necessarily have been influenced by such efforts on the part of Servier. But, in my judgment, when assessing what the Claimants should have done to mitigate the damages which they can claim from Servier as the result of Servier’s anti-competitive conduct, the Claimants were not reasonably required to do precisely what Servier made sustained and calculated efforts to dissuade them from doing.”

ScriptSwitch could be purchased by a PCT, downloaded onto the computers of GP practices and programmed with the prescribing messages that the PCT wished to convey to GPs at the time they wrote particular prescriptions. Servier argued that, “where a GP practice had ScriptSwitch, it was unreasonable for the PCT not to use it to encourage prescriptions of less expensive ACEIs available in generic form instead of perindopril, at least for all new patients”: see paragraphs 364-367 of the Judgment. The Judge “fully accept[ed] that when a GP was about to initiate a patient with uncomplicated hypertension on perindopril, ScriptSwitch could be a useful tool in encouraging the GP to prescribe an alternative”: paragraph 369. He continued, however:

“But whether it was unreasonable not to use it for that purpose comes down again to a matter of priorities, given the need to avoid alert fatigue, the fact that Ms Kerr considered that the real value would come as regards new patients, and that there was a range of conditions for which it may not have been reasonable or appropriate to select another ACEI. Taking all this into account, I do not consider that it was unreasonable if the medicines management team chose not to include alerts for perindopril on ScriptSwitch.”

In paragraph 370 of the Judgment, the Judge said:

“I have addressed in turn all the various steps identified by Servier as each needs separate consideration. However, there are many common themes to the analysis and to some extent the steps have to be considered together as several were mutually supportive and it would be realistic to use them in conjunction with one another. For example, if a PCT had an incentive scheme, that could be featured in a newsletter and also be the basis for inserting an alert on ScriptSwitch, and the pharmaceutical advisers in their meetings with GPs would discuss the evidence base and savings that underpinned those steps so that the GPs would appreciate and support the objective. I found persuasive the evidence … that to change GPs’ prescribing practice was complex and did not involve just one kind of approach. This was appreciated by the medicines management teams who gave considerable thought to selecting and developing their strategies. Some PCTs and Health Boards considered it appropriate and important to take steps to encourage or reward prescribing of other ACEIs instead of perindopril at certain times during the Relevant Period, but choices had to be made and others saw their priorities elsewhere, possibly because of the influence of local consultants or a belief that the entry of generic perindopril was not far off. That reasoning applies also to those PCTs/Health Boards with higher than average levels of perindopril prescribing. As Prof Chapman put it during cross-examination:

‘… you may recognise there is an area of particularly aberrant prescribing, but you may not choose to direct your resources to that because there are greater gains elsewhere.’

In my judgment, that was entirely reasonable.”

The Judge summarised his conclusions on preliminary issue (c) in these terms:

“386.

The answer to issue (c) is of course affected by my conclusions on issues (a)-(b). Taking account of those conclusions, for all the reasons set out above I do not consider that the Claimants from any of the four nations failed unreasonably at national level to take steps to encourage clinicians to prescribe other ACEIs instead of perindopril.

387.

By the end of the trial, Servier’s approach to mitigation measures at the local level had considerably shifted. It submitted that the Claimants should have taken steps to ensure that new patients were initiated on a generically available ACEI in all cases (except where the patient was allergic to or could not tolerate alternatives to perindopril), but that a programme to switch existing patients on perindopril to an alternative ACEI should have been undertaken only by PCTs/Health Boards with a high level of perindopril prescribing. Servier did not suggest that all the pleaded steps should reasonably have been taken in every local health area. But it contended that: ‘at least some of these steps should have been taken by each PCT/HB in the UK.’ For the reasons I have fully set out, I reject that contention.

388.

However, Servier developed an alternative contention that even if not all PCTs and Health Boards should reasonably have taken some steps, those with ‘higher’ rates of perindopril prescribing should have done so. Servier accepted that the standard of the required reasonable conduct which the Court has to apply is a general one across all PCTs and Health Boards, but submitted that what constituted reasonable conduct that complied with this standard varied as between different PCTs and Health Boards according to their individual circumstances.

389.

This allegation was not pleaded in Servier’s Amended Defence. Servier did not put forward any clear criterion according to which ‘higher’ perindopril prescribing PCTs/Health Boards would be distinguished – whether it would be any that were above the national average, or only those exceeding the national average by some unspecified margin. Nor did Servier say whether for this purpose it was sufficient for that higher level to apply in one year or whether it had to be for two or more consecutive years, given that most of the measures Servier argued should have been adopted took several months to prepare. If this allegation had been pleaded, I expect such matters might have been the subject of a CPR Part 18 Request. But as I understood it, the argument was that the third preliminary issue should be resolved in such a way as to allow the prescribing argument to proceed to trial, at least for ‘higher’ perindopril prescribing PCTs and Health Boards, so that they (or the various successor bodies to which their documents have passed) would provide disclosure to reveal what steps each of them took regarding ACEI prescribing, their individual assessment of their other priorities at the time, the resources and experience of their then medicines management teams, the extent of any opposition from local consultants to any proposal to discourage perindopril prescribing and any other reasons why they did not take various other steps which it is alleged they should have taken. Indeed, Servier’s closing submissions assert: ‘Without giving proper disclosure, [the Claimants] cannot prove that every PCT and Health Board that had high levels of perindopril prescribing did so because of local factors that could not be overcome by modest and obviously sensible steps.’

390.

However, the burden of showing a failure to mitigate (or contributory negligence) rests on Servier. I observed at the outset that this trial was not a general inquiry into the operation of medicines management in the NHS in the four nations over the Relevant Period. The question is, to adopt the language of Lord Nicholls in [Kuwait Airways Corpn v Iraqi Airways Co (Nos 4 and 5) [2002] UKHL 19, [2002] 2 AC 883], what is the extent of the loss for which Servier ought fairly or reasonably or justly to be held liable, given the reasons why the law has recognised a cause of action for anti-competitive conduct in the form of agreements between a patent-holder and generic suppliers whereby the generics stayed out of the market and the high patent price of a drug was maintained. Servier’s rights to raise mitigation and contributory negligence defences must be observed. But as Green LJ recently observed in the Court of Appeal as regards a mitigation defence to a competition damages claim:

‘… where a claimant has a justiciable right the procedural and evidential rules governing the enforcement of that right must not be allowed to become so onerous that they undermine or weaken the very right itself by making it too hard to vindicate.’

NTN Corp v Stellantis NV [2022] EWCA Civ 16 at [26].

391.

Unless Servier can show that the Claimants, at least to some extent, failed unreasonably to observe clear standards in the provision of medicines management which applied at the time, then given Servier’s efforts not only to persuade clinicians to prescribe perindopril but to forestall any initiatives by PCTs and Health Boards to dissuade them from prescribing perindopril, I consider that it would not be fair or reasonable or just to reduce by reason of Servier’s prescribing argument the amount which the Claimants would otherwise recover for purchasing perindopril at the higher prices which resulted from Servier’s actions to delay generic entry. Far from finding that there was such a failure to do what was reasonably required, I found that the evidence from all four nations demonstrated a considered and thoughtful effort to apply the evolving approach of medicines management to promote more cost-effective prescribing, within the limits of their resources and taking account of national and local considerations and priorities. And I do not consider it either proportionate, necessary or just to postpone an answer to the third issue to allow for detailed disclosure from individual PCTs and Health Boards. Accordingly, my answer to the question in the third preliminary issue is: No.”

Servier asked Roth J to grant permission to appeal on, among others, the ground that he had been “wrong to reject Servier’s case in its entirety on issue (c)” and “should have found that some PCTs/Health Boards should have taken some of the steps set out in Servier’s Amended Defence under the prescribing argument”. Declining to grant permission to appeal, the Judge said in a written ruling dated 5 April 2022 (“the PTA Decision”):

“10.

As regards issue (c), the fact that PCTs and Health Boards could take steps to encourage more cost-effective prescribing was never in dispute. The Claimants’ witnesses gave abundant evidence of the various steps that could be taken, and in most cases were taken as regards other drugs. The question before the Court was a very different one: it was whether it was unreasonable for the Claimants or their predecessor organisations not to take such steps as regards the prescribing of perindopril. The Judgment held that it was not unreasonable having regard to a host of considerations and addressing each of the different steps on which Servier sought to rely. Those considerations included the priority that could reasonably be given for cost-effective prescribing in other areas. They included also the sustained and calculated efforts made by Servier at the time to prevent some of those steps from being taken: see Judgment e.g at [315(vi)]; [362]-[363]. Servier’s grounds of appeal do not seek to assert that this was an irrelevant consideration.

11.

Secondly, the thrust of this ground of appeal appears to be that it was wrong to reject Servier’s alternative contention advanced only at trial that some PCTs/Health Boards should have taken at least some of those steps, given the acknowledged variation between the circumstances in individual PCTs and Health Boards: Judgment at [388]-[391]. As Servier acknowledges in its submissions under Ground 1, its pleaded case was framed in absolute terms:

‘Servier’s pleaded case was that all PCTs and HBs should have taken all of the steps set out in Servier’s Amended Defence.’

12.

Servier accepted at trial that for the purpose of preliminary issue (c) it had to establish a general standard that could be applied across all PCTs and Health Boards: Judgment at [388]. The Court did not reject Servier’s alternative case because Servier did not ‘identify at trial which PCTs/HBs should have taken additional steps and failed to do so’ as its submissions under Ground 1 suggest. The alternative case was rejected because Servier did not advance any clear criteria that could be used for the purpose of such identification: see the Judgment at [389]. This is not a technical pleading point. If Servier’s case had been that steps should have been taken by any PCT/Health Board where more than, say, 40% of ACE prescribing was of perindopril for at least two consecutive years, then that would have put forward a general standard. It could have been addressed by the expert and factual witnesses and they could have been questioned to determine whether this was a reasonable or practicable standard. But Servier’s case on this, raised only at trial, remained entirely vague.

13.

As for the contention that Servier should be permitted to maintain its mitigation defence as regards issue (c) because if that defence had been raised in a case involving only a single PCT then full disclosure and exploration of all the individual circumstances would have been permitted, that is wholly misconceived. Irrespective of how such a hypothetical case might have been conducted, it cannot be equated with the present claims, which in England alone involve 303 PCTs for the earlier years and 152 PCTs for the later years. The decision to order preliminary issues to establish general standards was taken as a means of proportionate case-management, whereas the course advocated by Servier would fly in the face of the overriding objective. See also the observations of Green LJ in NTN Corp v Stellantis NV, quoted in the Judgment at [390].”

Servier’s main ground of appeal is to the effect that the Judge could not properly dismiss the entirety of its defence on preliminary issue (c) at this stage, without fuller disclosure having been given by the claimants. Mr Nicholas Saunders KC, appearing for Servier, explained that it did not challenge the Judge’s findings of fact. He argued, however, that Servier’s pleaded case was not limited to an allegation that all PCTs/Health Boards should have taken certain steps but encompassed an allegation that some PCTs/Health Boards should have taken some of the steps identified in Servier’s defences. The Judge nonetheless rejected Servier’s case altogether, rather than examining what had been done by (say) individual PCTs, on the basis that Servier had not advanced a case expressed in formulaic terms (i.e. any PCT/Health Board in clearly defined circumstances X needed to carry out defined step Y). That was not a permissible approach. To suggest that Servier should have proceeded in that way in the absence of more extensive disclosure was unfair: how could Servier have framed detailed particulars of this type without knowing what steps PCTs/Health Boards with particular levels of ACEI prescribing had taken? The trial showed that what should have happened at the local level depended on local circumstances. The Judge was not, in the circumstances, entitled to conclude that no PCT/Health Board should reasonably have done more and so ought not simply to have given judgment for the claimants on the defences Servier was advancing. Servier, Mr Saunders said, should have an opportunity to examine whether particular PCTs/Health Boards which prescribed perindopril in larger quantities should have done more than they did. The exercise need not be all that onerous since sampling and/or other case management techniques can be used to limit what is involved.

During his reply submissions, Mr Saunders focused on use of ScriptSwitch by way of illustration. Echoing evidence given by Ms Kerr, he initially suggested that, where a GP practice already had ScriptSwitch, it was unreasonable for the relevant PCT not to use it to encourage the use of an ACEI other than perindopril. Reference having been made to Ms Kerr’s recognition of the risk of “alert fatigue”, Mr Saunders spoke of the need to install an appropriate prompt where a GP practice already had ScriptSwitch and the PCT was one with high perindopril spending.

One difficulty with these submissions is that the Judge stated in unqualified terms, in paragraph 369 of the Judgment, “I do not consider that it was unreasonable if the medicines management team chose not to include alerts for perindopril on ScriptSwitch”. The Judge did not therefore find merely that it was not unreasonable for all PCTs with ScriptSwitch not to include perindopril alerts. As I read the Judgment, it also involved the conclusion that no PCT was reasonably required to have such an alert.

Aside, however, from points such as that, there are more fundamental objections to Servier’s appeal.

In Fage UK Ltd v Chobani UK Ltd [2014] EWCA Civ 5, [2014] FSR 29, at paragraph 114(ii), Lewison LJ observed in a much-quoted passage that a trial is “not a dress rehearsal” but “the first and last night of the show”. That was as true of the trial of preliminary issues in these proceedings as it is of a full trial. The Judge noted in paragraph 389 of the Judgment that Servier’s “alternative contention” involved preliminary issue (c) being “resolved in such a way as to allow the prescribing argument to proceed to trial, at least for ‘higher’ perindopril prescribing PCTs and Health Boards, so that they (or the various successor bodies to which their documents have passed) would provide disclosure to reveal what steps each of them took regarding ACEI prescribing, their individual assessment of their other priorities at the time, the resources and experience of their then medicines management teams, the extent of any opposition from local consultants to any proposal to discourage perindopril prescribing and any other reasons why they did not take various other steps which it is alleged they should have taken”. On the face of it, however, the time to determine preliminary issue (c) was at the trial that had been ordered in respect of it, not at a future date after additional disclosure.

Of course, Servier was not in a position to conduct a PCT-by-PCT critique of the steps taken to discourage prescribing of perindopril at the trial. The Judge had expressly stated in the judgment he gave at the PTR on 4 May 2021 that the preliminary issues were “looking at the conduct of the claimants across the board” and were “not concerned with the conduct of particular PCTs, even if evidence from PCTs has been served as illustrative”. Even, however, if the Judge had been willing to allow Servier to examine PCTs individually, Servier would not have been in a position to do so. Disclosure had been given in respect of only 11 of the numerous PCTs.

That this was the position should not, however, have come as any surprise to Servier. To the contrary, it reflected decisions made earlier in the litigation. In fact, the preliminary issues were directed with a view to obviating the need for disclosure as regards all the PCTs and SHAs. Thus, it can be seen from the transcript of the CMC on 22-23 January 2018 that the Judge was ordering the preliminary issues to be tried on the basis that they would not require extensive additional disclosure and, consistently with that, the order of 31 January 2018 provided for Servier’s application for further disclosure to be adjourned pending the outcome of the trial of the preliminary issues. It was already evident at that stage, therefore, that the preliminary issues were to be tried without more disclosure and, hence, that the issues would not be assessed PCT by PCT. Servier nonetheless made no attempt to appeal the Judge’s decision.

A year later, at the CMC on 18 January 2019, Servier argued against the trial of the preliminary issues proceeding. In doing so, moreover, it suggested that the Judge might “conclude that some or all of the PCTs needed to take at least some steps to satisfy the duty to mitigate” and that he might find himself having to say, “We will need evidence from each PCT to even say what was reasonable”. The Judge, however, declined to vacate the trial and clearly indicated that he considered that, if the claimants were successful on the preliminary issues, “the mitigation defence would fall away” and “massive and expensive disclosure by a whole series of public authorities” would be rendered unnecessary.

On this occasion, Servier asked the Judge for permission to appeal but, he having refused it, Servier did not renew its application before the Court of Appeal. The Judge’s decision thus stood and, accordingly, it was apparent that the trial of the preliminary issues was to be undertaken without either disclosure from other PCTs or an examination of what was done PCT by PCT.

When, therefore, the Judge said in his judgment of 4 May 2021 that the “whole point” of the preliminary issues was “to avoid disclosure at the local level”, he was saying no more than ought to have been obvious to Servier from previous decisions. It should also have been evident to Servier already that the trial would look at the conduct of the claimants “across the board”, not at “the conduct of particular PCTs”.

By this point, the trial was only about six weeks away. Even so, Servier could have tried to challenge by way of appeal the approach which the Judge had explained that he would be taking at the trial. It is by no means inconceivable that the Court of Appeal would, if necessary, have heard an appeal before the date fixed for the beginning of the trial. Be that as it may, however, the simple fact is that, come the trial, there was no question of Servier being entitled to require the Judge to assess what was done by individual PCTs or to defer the determination of any of the preliminary issues pending disclosure from more PCTs. Those boats had sailed. The Judge was in the circumstances amply entitled to consider that it was not “either proportionate, necessary or just to postpone an answer to the third issue to allow for detailed disclosure from individual PCTs and Health Boards” (to quote from paragraph 391 of the Judgment). As the Judge said in paragraph 13 of the PTA Decision, preliminary issues were ordered “as a means of proportionate case-management, whereas the course advocated by Servier would fly in the face of the overriding objective”.

The fact that the preliminary issues were to be determined without more disclosure will not, as it seems to me, have prevented Servier from seeking to persuade the Judge that, if certain conditions were satisfied, a PCT ought reasonably to have taken a particular step. To revert to ScriptSwitch, for example, Servier might have proposed that a PCT where perindopril was prescribed to a specified value in a particular period should reasonably have used ScriptSwitch to encourage switching to another ACEI where GPs practices had it. Had the Judge accepted such standards, it would have been possible to apply them to relevant PCTs after the trial.

Paragraph 12 of the PTA Decision is relevant here. The Judge explained there that Servier’s “alternative case” had been rejected because “Servier did not advance any clear criteria that could be used for the purpose of such identification”. The Judge went on:

“If Servier’s case had been that steps should have been taken by any PCT/Health Board where more than, say, 40% of ACE prescribing was of perindopril for at least two consecutive years, then that would have put forward a general standard. It could have been addressed by the expert and factual witnesses and they could have been questioned to determine whether this was a reasonable or practicable standard. But Servier’s case on this, raised only at trial, remained entirely vague.”

Mr Saunders submitted that Servier was not in a position to frame such standards. I do not see, however, why this should have been the case. I should have thought that Servier ought to have been able to formulate standards that, on its case, the PCTs and Health Boards should have met without knowing what the PCTs and Health Boards had in fact done. Even, however, if that is wrong, the fact remains that the Judge’s various pre-trial decisions, none of which was even the subject of an appeal, meant that Servier had to conduct the trial of the preliminary issues, and to prepare for it, on the basis that no further disclosure would be ordered.

In the circumstances, if it wished to contend that some PCTs/Health Boards should have taken some steps, it should have put forward standards by which their conduct could have been judged. Had it done so in good time, it would, as the Judge said, have been possible for expert and other evidence to be adduced in relation to them. In the event, however, not only did Servier not advance any such standards in sufficient time for evidence bearing on them to be prepared, it never did so. That being so, it cannot complain that the Judge did not rule on such standards.

In short, I do not consider that the Judge can fairly be criticised either for deciding preliminary issue (c) without awaiting further disclosure or for failing to rule on whether some PCTs/Health Boards should have taken some of the steps specified in Servier’s defences. Not only had it been clear well in advance of the trial that the preliminary issues were to be determined without any more disclosure, but they were ordered in order to avoid such disclosure. Servier’s contentions on this appeal thus run entirely counter to the basis on which the trial was directed and maintained. Moreover, although the Judge had made it plain that the preliminary issues would be addressed on a general basis rather than PCT by PCT, Servier did not put forward any standards by which the conduct of individual PCTs could subsequently have been assessed.

I would, accordingly, reject the main ground of appeal.

Servier advanced two further grounds of appeal, relating to particular aspects of the Judge’s conclusions on preliminary issues (a) and (b). It recognised, however, that these could not affect the outcome of the proceedings unless it also succeeded on its main ground of appeal. Since I have concluded that the main ground of appeal fails, I do not need to address the other grounds of appeal.

I would dismiss the appeal.