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Wednesday, June 27, 2007

Trials Data - Part II: Defences, etc under the MHU Regulations 2004

Trials Data - Part II: Defences, etc under the MHU Regulations 2004


Part I can be read here

By Matthew Holford

Matthew writes exclusively for Seroxat Sufferers


Now, if I may remind the gentle reader, Part I involved a brief analysis of the offences created by the the Medicines for Human Use (Clinical Trials) Regulations 2004 (as amended by the Medicines for Human Use (Clinical Trials) Amendment Regulations 2006). In this piece, I will be discussing the concept of "reasonability", as it applies to the wider law. The reason for this will become clear, once one takes a look at the list of defences available to a defendant charged with an offence under the Regulations.

Defences

Regulation 51(1) and (2) - The essence of this Regulation is that a defendant will avoid liability for any conduct, which would otherwise amount to an offence under the Regulations, if he/she/it is able to demonstrate that he/she/it took all reasonable precautions and exercized due diligence in order to avoid committing that offence. The court (or jury) is required to assume that the requirements for the defence is met, unless the prosecution is able to demonstrate that it is not. Presumably, this requires evidence of an intention to commit the offence.

This is a concept that is in operation in the financial services industry, in essence. The Financial Services Authority (the "FSA") has a bunch of overarching principles, which inform the rules that it creates and enforces. However, given the multiplicity of forms that its members take, a rule governing any aspect of Financial Services Law/regulation will not apply equally to all. Or will not apply in the same way. So, for example, a consultancy will not have to concern itself unduly with issues raised with respect to the holding client funds, because it doesn't hold any - the only cash it receives would be for services rendered, against invoices properly raised. As such, the provisions that it puts in place, in order to comply with the rules concerning client funds will not be the same as that of a bank, for example, which clearly does hold client funds. In point of fact, a consultancy might only need to evidence that fact that it had considered the issue, and had regarded it as irrelevant to its business.

The upshot of this is that the FSA's (note: it shouldn't really be called this, because the FSA is the Food Standards Agency!) guidance to members is that rules should be applied proportionately. That is, if something goes down, did the member do what would normally be considered appropriate, in terms of its business model, to avoid what happened, such that what happened was anomalous, or extraordinary? Now, the FSA is streets ahead of the MHRA, in my view, as to its understanding of the issues surrounding compliance. The FSA understands (and acknowledges) that any commerical enterprise is driven by profit. As such, most decisions are taken in accordance with whether they will cost the firm money, and whether there will be a reward for that outlay. This is not necessarily a good thing, if one is trying to encourage a compliance culture, because firms may have a tendency to turn a blind eye to the activities of clients, simply because they do not wish to lose the custom (largely because most firms think that there is another firm, much like themselves, perfectly happy to take on any client that they reject - and they're probably right). This is particularly true where a company is run at a senior level by a dominant few who are marketing oriented.

Now, in the context of this analysis, it becomes quite difficult for me to provide any insight into the specifics of pharmaceutical companies' operations, because I've never worked in that industry. That issue becomes further muddied by the fact that what might be regarded as reasonable, (eg, the withholding of raw data, tacitly approved as it is by the MHRA), actually undermines the efficient operation of the system, as a whole. The MHRA, then, apparently regards this type of behaviour as "reasonable", and I imagine that the greater part of the industry would agree. Indeed, the standard test of reasonability in operation within the law of negligence is such that what is reasonable is that which the reasonable pharmaceutical company would regard as reasonable (perhaps it might be worth establishing definitively what the reasonable pharmaceutical company thinks, in this regard), and not what the reasonable person (patient?) believes to be reasonable. In any event, we've seen the issues that this gives rise to, and so I would argue that it is not reasonable to withhold raw data.

And there, my friends, in a nutshell, we have the issue that would face any court considering a case brought under the Regulations, in my view. Now, if I were to argue this point further, I would point out, as is my wont, that sailing with the bow doors open was standard industry practice, at the time that the Herald of Free Enterprise sank in Zeebrugge harbour. That is, the very fact that something is standard practice does not point to the reasonability of that activity, necessarily. The difference is, that the car ferry industry learnt from the error: bow doors have to be closed, prior to sailing, nowadays.

And yet, despite the issues that have been noted with respect to regulatory assessments made pursuant to the issue of marketing authorizations on the basis of a summary of data provided by the applicant, there appears to be no great determination to avoid similar issues, in the future, by changing that facet of the system. "Why is that?" I hear you ask. I don't know: why is that?

The MHRA is four years old.

Matthew Holford (c) 2007

Related links:

Glaxo SmithKline
MHRA
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