On 19 May 2016, Mr Justice Green handed down his judgment in the English High Court case of R. (on the application of British American Tobacco UK Ltd & Others) v Secretary of State for Health [2016] EWHC 1169 (Admin) in which the claimant tobacco companies challenged the legality of the Standardised Packaging of Tobacco Products Regulations 2015.

This decision is significant as Mr Justice Green discusses the way in which the Court, in the context of a judicial review, should evaluate expert evidence in the form of research.

One of the arguments advanced by the claimant tobacco companies was that, in the process of consulting and drafting the Regulations, the Health Secretary placed only limited weight on the expert evidence (in the form of research) submitted by them.

As stated by Mr Justice Green (at [281]):

The present litigation has thrown into sharp relief all of these controversies and the issue for this Court is how they translate into practical rules of evidence which can be applied to the facts of this case. The legal framework for this ground takes as one point of reference Article 5(3) FCTC and the WHO guidance. But it also engages (i) with ordinary common law principles of evidence and how a Court, in the context of a judicial review, should evaluate expert and other evidence; and (ii) with the effect of CPR 35 on expert evidence [emphasis added]
Mr Justice Green held that:
  • the expert evidence (in the form of research) submitted by the claimant tobacco companies fell significantly below internationally accepted best practices;
  • the use of such research standards is very important and valuable for any court seeking to assess and weigh competing evidence of this sort;
  • on the facts of this case, the Secretary of State for Health was correct to attach limited weight to the expert evidence submitted by the claimant tobacco companies.


Best practices for research methodology endorsed by the Court

Mr Justice Green analysed and discussed the best practices for research methodology from [282] to [404] of his judgment.

Independence & bias / conflict of interest

Mr Justice Green stated (at [284]):

Independence is not an absolute requirement; in normal litigation where expert evidence is required experts are instructed by parties and they may be very well paid to present an opinion to the Court. The quality of that evidence cannot be automatically discounted simply because it is advanced on behalf of those who are parti pris. The same will apply to evidence submitted in the course of a consultative process.


The problems associated with a lack of independence can be overcome. Where there is full disclosure of the facts giving rise to the actual or perceived lack of independence those who subsequently come to read or rely upon the research output can evaluate the research through the optic of possible bias and predisposition … Sometimes the expert evidence might concern a subject matter which is of great complexity and which is, thereby, exceedingly difficult for a Court or decision maker to unravel so that the mere fact that the author has declared an interest does not equip a reader with the tools needed to determine whether in actual fact the research output is affected or distorted by that declared interest … Whilst independence is a relevant factor it is not necessarily the determinative factor and adherence to other quality control practices such as peer review and/or benchmarking against internal documents can play an important and possibly crucial role in providing the guarantee that the research output is of the highest quality.

Mr Justice Green further stated (at [372]):
the fact that an expert is instructed and paid for by one side of an argument does not mean that the expert is, thereby, necessarily biased or compromised or has a conflict of interest. However, the fact that an expert is instructed by a body with a clear partisan interest highlights the real importance of that expert adhering to recognised and applicable best standards and to rules of procedures and evidence, such as those laid down in CPR 35. [emphasis added]
Peer review
Mr Justice Green stated (at [288]): “[The claimants] submit that the fact that their evidence is exposed in litigation and subject to judicial review is a superior process to peer review. I fundamentally disagree.”
Transparency and openness
Mr Justice Green made the following remarks (at [314] – [315], [318]):
Professor McKeganey conducts a review of some of the main pieces of research literature in a report dated 5th August 2014. I was prepared on behalf of BAT for the purposes of the consultation process … Professor McKeganey adopted the position that at times researchers who generated results in favour of tobacco control were biased and that this was a real obstacle to providing a clear assessment of the evidence results they generated … The upshot of this was that, in substance, a Court should discount the evidence in favour of tobacco control; it was unreliable and biased … Professor McKeganey then goes on to review various pieces of research literature and he concludes with an overarching and central proposition that decisions to start smoking during adolescence are related to factors other than those related to packaging and design of tobacco products.


Yet, and once again I repeat the criticism that I make of so many of the Claimants’ experts, his conclusions contradict a very great deal of research by independent peer reviewed researchers, and also the internal research of the tobacco industry, and his conclusions contradict the findings of Judge Kessler who, after a comprehensive nine month trial, found the opposite, and he ignores the adverse conclusions of WHO upon analysis of the tobacco companies’ internal documentation. What I find unacceptable is the preparation of a report which by its total refusal to engage with any of this contra-material simply conveys the impression that it does not exist and that the best way to refute it is to ignore it. Yet, at the same time and inconsistently, Professor McKeganey accepts that the principles of transparency and openness are “foundational tablets of the scientific enterprise“. Had Professor McKeganey confronted head-on the contrary evidence, including that from the tobacco companies, then it is hard to see how he could have advanced the opinions that he did; at the very least he would have been compelled to provide a further rationale for why his opinion could be sustained in the light of this inconsistent evidence.


This point is important in the overall context of this case because to succeed on evidential grounds the Claimants must not only establish that their own, new, post-Australian implementation quantitative evidence is powerfully probative, but also refute or oust or at the very least massively discount the probative value of pre-Australian qualitative evidence which is against them. And that substantial task will not be achieved by reports from experts, howsoever distinguished, which simply fail to address the contrary evidence base (which must include internal assessments) and the adverse conclusions on that evidence base by researchers, Courts and international organisations such as the WHO. One is left in the case of Professor McKeganey with an expert report that is prima facie inadmissible because it fails to adhere to domestic civil procedure rules but that, even when fully considered, appears slanted and partial.


Uniquely in this case there is an international consensus from within the WHO and across the world that tobacco companies are set on subverting national health policies antithetical to their financial interests. This is, in part, due to experiences in the US courts and the sharp conflict between public utterances and private analysis. There is in such circumstances a real premium upon full observance with the principles laid down in the CPR and (in so far as there is day light) with best and transparent research and publication practices generally. It is in this way that the tobacco companies can persuade a systematically sceptical world that their research is valid and worthy of the great probative weight they claim for it. [emphasis added]


Mr Justice Green clarified (at [370]) that “the application of each of the best practice principles will be context specific. They do not apply in any absolute manner but must be applied flexibly to take account of the circumstances of the particular case. Adherence to best practice is, however, at a premium in a case such as this where the Claimants have already been found wanting at the level of international governmental opinion and in proceedings before the US courts.”

Overall, Mr Justice Green held (at [374] that “on the basis of my own review of the methodologies adopted by the Claimants’ experts in the light of the Secretary of State’s evidence on this issue I conclude that that body of expert evidence does not accord with internationally recognised best practice. This is most striking in the context of the evidence submitted during the consultation; but it also applies to a considerable portion of the evidence placed before the Court in relation to other grounds of challenge”. Mr Justice Green then concludes (at [375]) that “the four most significant ways in which evidence submitted during the consultation generally fell below best practice are (i) the fact that it was not peer reviewed or based upon peer reviewed material; (ii) the fact that it was not benchmarked against internal documents; (iii) the fact that the underlying worldwide literature base was largely ignored; and (iv) the fact that it was not verifiable”.

Official transcript of the judgment (Judiciary of England and Wales website)

Summary of the judgment (Judiciary of England and Wales website)