Dowson v The General Medical Council [2015] EWHC 3379 (Admin)
The High Court’s recent judgment of an appeal of the GMC’s Medical Practitioners Tribunal Service’s (“MPTS”) findings of fact against the appellant doctor provided notable commentary on dishonesty and relatively rare High Court consideration of the ethical issues affecting practitioners conducting clinical trials.
The appellant doctor had been employed in 2004 by a sponsoring company as the Chief Investigator and the Site Investigator (amongst other roles) of the clinical trial (known as the “MIST trial”) of a device purported to resolve migraines of patients suffering from a congenital heart defect. The MPTS Fitness to Practise panel found several allegations against the appellant proven. These related predominantly to the appellant’s failure to disclose and make known to relevant parties the fact of an earlier GMC investigation and adverse decision against him by the GMC’s fitness to practise panel in 2006[1] arising from a separate clinical trial involving Botox, and of failing to inform the MIST trial’s research ethics committee that the Botox trial’s research ethics committee had required him to stand down as Chief Investigator of the Botox trial. The panel found that the appellant had been dishonest in two such respects. The panel also found proven charges relating to the appellant’s disclosure of payments from the sponsoring company and to the reporting of the MIST trial’s results but did not consider that these constituted dishonesty. The appellant was suspended for four months by the panel.
The High Court rejected the appellant’s appeal of the panel’s findings of dishonesty, as outlined above. It upheld only one of his further five grounds of appeal concerning the reporting of the MIST trial results. It appears that the Court will decide upon the appellant’s suspension at a later date.
Dishonesty
The judgment is notable for Mr Justice Edis’ commentary on the “proper approach to the dishonesty issue” notwithstanding that the appellant did not dispute the MPTS panel’s application of the Twinsectra/ Ghosh test. This has been the subject of significant wider judicial scrutiny in regulatory and disciplinary proceedings in the past two years[2], although the MPTS hearing[3] in the present case pre-dated the most significant recent examples of this.
The Court cited Kirschner v General Dental Council[4], which recognised that the two-limbGhosh test still applies to disciplinary proceedings (despite Mostyn J’s criticism of this inKirschner). The Court noted Longmore LJ’s comments in Hussain[5] and the purported adaptation of Ghosh so that the relevant standard in the first limb of the test should properly be that of “reasonable and honest doctors” and not lay people. However, the Court did not consider that it was necessary to “resolve the precise terms” of the Ghoshtest in this context – apparently as to whether a different ethical standard applies to doctors than the wider population – as no evidence had been adduced to this effect. Mr Justice Edis stated, however, that it was reasonable to assume that doctors are “at least as scrupulous” about professional integrity as the population at large, and if this was correct then Longmore LJ’s test might in fact impose an elevated ethical standard, in respect of the Ghosh test, on the medical profession. Notwithstanding this observation, the Court did not see it necessary to modify the gloss Hussain places on Ghosh in relation to “reasonable and honest doctors”.
Clinical trials
The Court recognised that doctors’ conduct of clinical trials on behalf of pharmaceutical or other commercial treatment providers involves “very significant ethical questions”, often relating to either participants’ consent or potential conflicts of interest between patients’ wellbeing and the sponsors’ commercial interests.
As well as expert evidence relied upon by both parties, of note are the sources of published ethical standards relied upon by the GMC before the MPTS panel, namely: itsGood Medical Practice (“GMP”), a now withdrawn GMC guidance note to doctors regarding their role in research[6], and the World Medical Association Declaration of Helsinki’s guidance on ethical principles[7]. The Court also noted the application of the EU Directive for clinical trials[8].
The Court stated that the ethical judgments which the MPTS panel was required to make could not be reached by “simply applying GMP or Helsinki because there is no code which covers every factual situation”; rather, its assessment of the appropriate ethical standards affecting the appellant depended upon the particular circumstances of the case. The Court noted that in combination these sources stipulated that a doctor researcher is under a positive obligation to proactively volunteer significant material and information to a research ethics committee[9]. Underlying the more specific requirements was GMP’s requirement that a practitioner act with “honesty and integrity”.
In this case, the Court considered that it was reasonable for the panel to find that the appellant should have informed the MIST trial’s research ethics committee of his dismissal as Chief Investigator of the Botox trial by its respective research ethics committee, given that this was relevant to his suitability for that role in the MIST trial, and that this was dishonest.
Notwithstanding the significantly differing views presented by (expert) witnesses as to the appellant’s duties of disclosure, the Court considered that the MPTS panel was entitled to come to the findings it did.
The case provides a brief but interesting discussion of the test for dishonesty in disciplinary proceedings (particularly in respect of the application of Hussain in cases before the MPTS). Recent High Court judgments, particularly Mostyn J’s thorough if critical survey in Kirschner, have consistently applied the Ghosh test with the Hussainadaptation[10]. Although judicial consolidation of the test for dishonesty in disciplinary proceedings as between the tests in Ghosh/ Hussain and Barlow Clowes remains elusive, “as things stand” (to borrow Mostyn J’s phrase), a panel should determine whether on the balance of probabilities a defendant acted dishonestly by the standards of ordinary and honest members of that profession and, if it finds they did so, determine whether it is more likely than not that the defendant realised that what they were doing was dishonest by those standards.
Further, it is relatively rare for the MPTS, still less the Court, to consider a practitioner’s conduct in the course of a clinical trial. Whilst the Court’s findings and the MPTS’ decision in this case are unlikely to be controversial, the divergence between expert witnesses’ opinions before the MPTS panel was considerable, and it is interesting that the Court expressed surprise that the MPTS panel heard several days’ worth of expert evidence concerning what it considered were “the more simple ethical aspects of a complex clinical trial”. This suggests that the issue of ethical standards in clinical trials has the potential to be both fiercely fought and, as a result, (perhaps unnecessarily) complex.
[1] The appellant was not found to have acted dishonesty in the Botox trial, however.
[2] Please see our earlier blog posts on dishonesty: 1, 2, 3
[3] October 2014 – February 2015
[4] [2015] EWHC 1377
[5] Hussain v The General Medical Council [2014] EWCA Civ 2246
[6] Similar provisions appear in the current “Good practice in research and Consent to research” guidance document
[7] WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects, an updated version of which can be found here
[8] Directive 2001/20/EC on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
[9] Another notable requirement was that must a researcher must declare to the relevant research ethics committee all financial interests that they stand to be paid for the research undertaken and only accept payments which have been approved by the committee.
[10] See also Okafor v Nursing and Midwifery Council [2015] EWHC 1872 (Admin)