Clinical trials – examining legal duties

07/08/2015

R (on the application of Richmond Pharmacology Ltd) v Health Research Authority [2015] EWHC 2238 (Admin), [2015] All ER (D) 288 (Jul)

The claimant contended that the defendant Health Research Authority (HRA) had wrongly asserted that it was under legal duties to register its clinical trials on a publicly available website and to publish data about their outcome. The Administrative Court held that, although the HRA had not expressly stated that there was a legal obligation and that was not clearly inferred, the HRA’s public utterances failed the public law test of certainty and transparency.

What was the issue at the heart of this dispute? 

The issue changed during the course of the dispute. At the outset, the case had a broad compass, seeking to challenge the manner in which the HRA went about regulating human clinical trials generally. At its culmination, the claimant’s complaint had narrowed its focus to some of the explanatory wording aimed at clinical trial researchers on the HRA’s website. The judge held that in the case of some wording highlighted by the claimant, any confusion amounted to no more than ‘textual infelicities’, whereas other wording was so ambiguous in relation to the duties of those who run clinical trials and their sponsors as to be unlawful–in that it was not sufficiently certain and transparent.

What does this case tell us about the requirements to register clinical trials? 

The court was asked to examine only one type of clinical trial, namely adult phase one clinical trials. The claimant was concerned that the HRA was purporting to regulate, or at least appearing to wish to regulate, a legal duty to register publicly adult phase one clinical trials, when in fact no such legal duty exists. It was accepted that in the case of all other clinical trials, including phase one trials with any paediatric element, the regulatory and legal landscape is such as to require public registration.

The judge distinguished between ethical duties on the one hand and strict legal duties on the other:

“An ethical obligation (in this context, being an obligation falling short of amounting to good clinical practice) flows from the application of standards which have national or international backing, including standards which are imposed by the regulator [the HRA]. Furthermore, the regulator would be entitled to set out the consequences of breach of an ethical obligation, although in the present case it has not done so. It is trite law that the entity being regulated is entitled to a clear statement of what those consequences may be.” (para [71])

How did the court frame the functions of the HRA? 

As is apparent from the sentence in the above passage from the judgment, the court (as had the claimant) accepted that the HRA is empowered to regulate those who sponsor and run clinical trials against national and international ethical standards–provided that such regulation is conducted with sufficient clarity and certainty. As also noted by the court, the HRA has not (yet) chosen to seek to regulate trial companies in this manner. In fact, the HRA has so far been adopting a more persuasive approach.

What is the significance of this decision? 

The substantive decision itself is not particularly significant. The finding in relation to one or two of the words on the HRA’s website is relatively trivial–the only substantive issue remaining in dispute by the end of the case. Furthermore, the court reached a view as to the legal position in relation to the public registration of adult phase one clinical trials that was the same as that propounded by both the claimant and defendant–namely that there is no strict legal duty to publicly register such trials. It was only the interested party that had sought, somewhat ambitiously, to persuade the court that such a residual, albeit heavily qualified, legal duty could be said to exist.

There is, however, some significance in the court’s approach to the issue of how to distinguish between legal and ethical norms, and why and when such a distinction is important. It was the HRA’s failure to ‘keep these normative streams clear and separate’ in its published materials which had incurred liability in this case.

What should lawyers take from this case? 

Where public bodies make statements concerning legal rights and obligations, those statements need to be clear and correct. If, as was found in some instances in this case, such statements are ‘so ambiguous…as to mislead’ readers, the public body is probably in breach of its obligation to express the scope of such rights and obligations with certainty and accuracy

Jonathan Price was interviewed by Anne Bruce.

This article was first published on Lexis®PSL on 7 August 2015

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