2022-02-25 16:25:51
In Secretary of State for Health v Servier Laboratories and others [2022] EWHC 369 (Ch), The Secretary of State and various health bodies across the UK are claiming damages from Servier Laboratories for breaches of UK and EU competition law that resulted in the NHS paying more for perindopril than if those breaches had not been committed.
The breaches involved Servier making substantial payments to generic companies in return for their agreement not to challenge Servier’s perindopril patents, thereby avoiding the risk of generic entry into the market and a substantial fall in price. The purpose of the applicable competition rules is to prevent such agreements which sought to ensure that prices for perindopril remained high.
Appeals are currently pending against an EU Commission decision. Pending the outcome of those appeals, the High Court was asked to determine preliminary issues in proceedings brought by UK health bodies. In particular, and perhaps somewhat ironically, Servier argued that any losses the UK health bodies could provide to have suffered because of breaches of competition law should be reduced because those health bodies had failed to mitigate their losses.
Servier argued that perindopril should not have been prescribed in the UK to the extent that it was and that the various NHS bodies should reasonably have encouraged the prescribing of alternative ACEIs to perindopril
Mr Justice Roth had to determine whether the public health authorities who paid high prices for perindopril acted unreasonably in not making greater efforts to persuade prescribers to select an alternative drug. Much of the argument centred on whether guidance should have been given to GPs and other prescribers. Here are some extracts from the judgment that members may find of interest:
“In my judgment, if in certain circumstances a prescriber could reasonably consider, in the light of the knowledge and understanding at the time, that perindopril offered a real advantage for her or his patients compared to other ACEIs, then it would not have been reasonable or appropriate for them to prescribe another ACEI. By ‘advantage’ I include the possibility that the clinical benefit of perindopril was better established than for the alternatives such that the prescriber could, objectively viewed, be more confident of its likely effectiveness; and I also include non-clinical benefits such as convenience.”
In relation to the possibility of switching existing perindopril patients to alternative, cheaper medication that might require additional visits by patients to their GP:
“I think that having to get the patient to attend the GP surgery several times, even if seen only by a practice nurse not the GP, would reasonably be seen by GPs as an inconvenience and cost. Where a patient was frail or elderly, this could be a burden on the patient which I consider the GP could legitimately take into account.”
In relation to an allegation that the Secretary of State should have told, or requested, NICE to include guidance on prescribing alternatives to perindopril:
“ministers never sought…to influence [NICE’s] findings or recommendations or to give it directions to give guidance on the use or non-use of specific licensed drugs. I regard that position as entirely reasonable and, in my judgment, it cannot be said that the ‘duty’ to mitigate required ministers to depart from this policy and, exceptionally, to have “directed” NICE to include a recommendation on the lines suggested”
On whether local pharmaceutical advisers should have given prescribing guidance on perindopril:
“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.
As for the QOF and incentive schemes, there was also the issue of timing and, above all, of priorities. For all the reasons set out above, I think it was not unreasonable if a PCT or Health Board did not introduce a switching programme to discourage perindopril prescribing”
The irony referred to above (or is it chutzpah?) is encapsulated in this passage from the judgment:
“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.”
There is a lot going on in the NHS and resources are finite, as the judge acknowledged here:
“It is well-known that the NHS in all four nations is under constant financial pressure. To the extent that priorities, and the expected effectiveness of potential measures which therefore fed into the setting of priorities, were affected by limitation on financial resources, the allocation of more resources to one area meant a corresponding reduction in the resources available for another.
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.”
The role of NHS bodies in promoting medicines management was acknowledged here:
“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 [NHS bodies] 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.”