Rules, Recommendations and clear distinctions - R (Richmond Pharmacology Ltd) v Health Research Authority

17 September 2015


Shortly before the summer recess, the High Court gave judgment in R (Richmond Pharmacology Ltd) v Health Research Authority. The court held that the Health Research Authority (HRA) had acted unlawfully by including statements on its website which, in its description of the regulatory regime, failed the public law test of certainty and transparency.

Background

The claimant was a leading clinical research company, carrying out a range of trials including "phase 1 trials". Phase 1 trials test the safety, but not the efficacy, of medicinal products. It sought to challenge the HRA's requirements and various public statements made by the HRA relating to such trials.

The main functions of the HRA relate to the coordination and standardisation of practice relating to the regulation of health and social care research and to research ethics committees (RECs). A clinical trial must not be started without a REC giving its approval and, among other things, the HRA is empowered to require RECs to impose conditions on the giving of their approval.

In addition, the HRA has a statutory duty to publish guidance on principles of good practice relating to health and social care research and to publish guidance on the requirements to which persons conducting such research are subject.

On 30 September 2013, the HRA introduced a requirement for RECs to make it a condition of approval from that date that the Phase 1 clinical trial for which approval was requested must be registered on and have details of the trial published on publically available websites. The declaration which sponsors of declarations were required to make included a commitment to abide by the publication requirements. It was not in question that this was within the HRA's power.

In October 2014, the HRA proposed an amendment to the declaration, which in effect required the sponsor to declare that any clinical trial (which had reached a specified recruitment stage) had been registered, including those which were given REC approval before September 2013. The accompanying materials made clear that the giving of the declaration was a condition of REC approval. The amendment was implemented in April 2015.

The claimant brought judicial review proceedings, challenging the HRA's decision to amend the declaration, in particular on the basis that the HRA was (unlawfully) making an application for approval for a clinical trial conditional on changing the terms under which other trials were being conducted.

The HRA's position was that it had not intended to make REC approval conditional on the registration of other trials. However, to avoid the costs of full proceedings, it amended the declaration to resolve the issue. It did not change the other various statements on its website (beyond minor changes).

While the claimant did not object to the amended wording, it continued its claim on an amended ground; that by the various statements on its website, the HRA was asserting that sponsors were under a legal duty to register trials on a publically accessible website, beyond where the sponsor has committed to do so or where it was a condition of REC approval. It claimed that the HRA was seeking to regulate against this supposed legal duty.

The claimant acknowledged that the HRA had a duty to publish guidance, but argued that it was conflating its duty to publish guidance on good practice, with its duty to publish guidance on legal requirements. In the alternative, the claimant submitted that the HRA's public statements were ambiguous and therefore offended the principle of legality and the principles of legal certainty and transparency.

The HRA defended the challenge, arguing that it had not stated that sponsors were under a legal duty to register trials (beyond the agreed circumstances where there was such a duty) and that its public statements made sufficiently clear the nature of the relevant obligations.

The decision

As a preliminary point, it should be noted that Sense about Science (intervening as an interested party) argued that, on a proper interpretation of EU law, sponsors are subject to a legal duty to register and publish the results of all phase 1 trials. These arguments were not accepted by Jay J, who held that there is no such overarching obligation.

Jay J agreed that it was correct for the HRA to withdraw the amended sponsor declaration. It did not say in terms that there was a legal requirement in relation to trials approved before 30 September 2013 but a sponsor could not give the declaration without warranting that such trials were registered. In practice, this made an application contingent on the registration of pre-September 2013 trials.

On the HRA's published materials, Jay J's starting point was that the readership of the HRA's website was both knowledgeable and sophisticated and could reasonably be expected to have access to legal advice. Having determined that sponsors had no overriding legal requirement to register pre- September 2013 trials, the question was whether the nature of the actual obligations had been clearly, fairly and accurately communicated to those informed readers.

He noted that the vice of muddying the waters between legal and ethical obligations is that the entity being regulated will not know exactly where it stands in relation to the consequences of any breach.

He agreed with the HRA that nowhere had it stated in unequivocal terms that sponsors were under overarching legal duties to publish and register phase 1 trials. However, he then carried out a forensic analysis of the various passages in the HRA's published materials, including webpages on further information, key messages and questions and answers.

Jay J identified a number of passages which were misleading, confusing and unclear. Some of these related to how terms such as 'existing responsibility' and 'HRA requirement' had been used in the context of particular passages. He considered whether anything on the relevant materials cancelled out the defective nature of these passages. It did not, because: (i) too many passages were defective; (ii) the informed reader would be entitled to read the passages and be left in a state of confusion; and (iii) in addition to the passages which were defective, there were others which were not unlawful but which were far from ideal and this weighed against the HRA.

Jay J made clear that his finding was not that the HRA had expressly stated that a legal obligation existed where one did not, but that the HRA's public utterances describing the regulatory regime failed the public law test of certainty and transparency, being 'so ambiguous as to the expression of [their] scope as to mislead' the informed reader.

Commentary

The court's finding that the material published on the HRA's website was sufficiently unclear as to be unlawful is a finding that any regulator should take note of.

The internet has changed the way regulators communicate with those that they regulate and allowed materials explaining regulatory regimes to be accessible and easy to update. Many such materials are carefully crafted to convey to the intended audience how a particular (and often complex) regime operates. Other materials are not so carefully crafted.

Communicating clearly whether a regulated entity is merely recommended to take, or refrain from taking, specified action, or is under a legal obligation to do so, is also an important issue for any regulator to bear in mind. In this case, whether or not the HRA had made this clear turned on fine textual analysis of the wording used on the various webpages. That fine textual analysis was ultimately used to determine whether the HRA had complied with a fundamental constitutional principle, the principle of legality (encompassing the principles of certainty and transparency).

The case is aligned with the growing trend of courts carrying out a forensic review of the documents of a public authority which are relevant to a judicial review claim, rather than reviewing the documents at a higher level. A similar approach is now being taken in cases involving an allegation of unlawful consultation, where the court is willing to scrutinise consultation materials very closely (see Moseley v Haringey LBC, R (Robson) v Salford CC and other recent cases).

It should be remembered that the HRA has the promotion of transparency in research as one of its statutory objectives and its approach in this case was surely intended to further that objective. However, while any regulator should aim to meet its statutory objectives, the point was not relevant to the issue of whether or not the published materials were clear.

Jay J noted that he would now expect the HRA, as a responsible public body, to cast a self-critical eye over the whole of its website material in this domain. It must also surely be the case that any regulator (or other public body) which has a website explaining a regulatory regime must cast such a self-critical eye over that material when published and over time, or risk potential censure by the courts.


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