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Thursday, June 28, 2007

Trials Data - Part III: Penalties and Miscellaneous under the MHU 2004

Part III of the Trials Data by Matthew Holford. Parts 1 & 2 can be seen here and here.

Matthew writes exclusively for Seroxat Sufferers.

Welcome back, gentle reader! Today, I will be tying up a few loose ends, in terms of our whistlestop tour of the Medicines for Human Use (Clinical Trials) Regulations 2004 (as amended by the Medicines for Human Use (Clinical Trials) Amendment Regulations 2006). This will involve a brief outline of the penalties for transgression of the Regulations, and a quick look at the role of the Ethics Committee, in the process.

Regulation 52(a) and (b) - A prosecution may be brought summarily (before a Magistrates' Court), or on indictment (before a jury in a Crown Court). Magistrates' Courts tend to deal with less serious offences, which explains the lower penalties in para (a). On summary conviction, then, a defendant will be liable to a fine not exceeding the statutory maximum, which if my memory serves me is currently £50,000 and/or a prison sentence of 3 months. Before a Crown Court, the fine will be unlimited, and the defendant may also be liable to a two year prison sentence.

This is, then, not regarded as the most serious of offences. However, it should be borne in mind that presumably the punishment will be multiplied according to the number of offences for which the defendant is found guilty.

The Ethics Committee
What a mysterious thing "the" Ethics Committee is! Given the prominence given it in the MHU, the uninitiated might be given to think that this was a permanent body established to oversee the probity of such activities as it was assigned, from time to time. But one would be wrong.

The Ethics Committee is any committee that is recognized as such by the United Kingdom Ethics Committee Authority, (the "UKEA"), any member of which may act jointly or severally, by agreement. You didn't know that we had such a thing as the UKEA? Well, we do, and it is a body consisting of the Secretary of State for Health, the National Assembly of Wales, the Scottish Ministers and the Department of Health, etc for Northern Ireland. So says Regulation 5, anyway.

Now, aside from acting jointly and severally, the UKEA may appoint such person(s) as it sees fit to discharge its functions, in accordance with Regulation 5(4). Furthermore, in accordance with Regulation 5(5), the UKEA may make arrangements with any government department, local or public authority or holder of public office to discharge its duties for it. In theory, then, I imagine the UKEA could instruct the MHRA to act for it. Under Regulation 5(6) it says that the UKEA retains responsibility for any fuck-ups, though, which is just as well, because the words "piss-up" and "brewery" spring to mind in relation to anything that the MHRA has dealings with.

Under Regulation 6, the UKEA may appoint and abolish (under Regulation 8) ethics committees as it sees fit, as far as I can make out. It can broaden the remit, or the geographical jurisdiction of a committee, and so on. It can establish ethics committees to act with respect to certain classes and descriptions of clinical trials. Now, I find this interesting. I would quite like to know who was on the current version of the SSRI clinical trials Ethics Committee (if there is such a thing), wouldn't you? Do you imagine the DoH or the MHRA would tell us, at all?

Regulation 7 deals with recognition of Ethics Committees, and provides for the procedure by which an application to be recognized as an Ethics Committee operates. Schedule 2 of the Regulations deals with a bunch of administrative stuff, which impacts on the selection of members of the Committee, appointment of Chair and Vice Chair, reimbursement of expenses, creation of sub-committees, meetings, annual reports, I've lost interest. Finally, under Regulation 10, the UKEA is required to monitor ethics committees, in order to ensure that they are doing their job adequately, and may give such advice and assistance as is necessary to assist the ethics committees in their operation.

Any clearer? No, me neither. However, what I understand this to amount to is that there may be any number of ethics committees, across the UK, governing any number of different geographic locales, and any number of industries. Within the pharmaceutical industry, there may be any number of ethics committees, overseeing the conduct of trials of different types of drugs, for example. Nice work, if you can get it, I imagine.

Now, very briefly, you will remember from Part I that the Ethics Committee is responsible for providing opinion on a range of matters, including the granting of trials licences and any amendment to such licence. Unless a favourable opinion has been granted, a trial may not proceed.

To be honest, I'm losing interest in this subject, simply because the operation of the relevant ethics committee is of greater interest to me than the broad brushstrokes of the Regulations. However, Regulation 14 deals with the procedural niceities of an application for an opinion and Regulation 15 covers a whole bunch of issues that the ethics committee should consider, when forming its opinion, which I'm not going to go into, other than suggest that the gentle reader takes a look for him/herself. Finally, Regulation 16 deals with appeals against an ethics committee's opinion.

Please stay tuned and alert, gentle readers: in Part IV, I may be asking questions!

Matthew Holford (c) 2007

Related links:
UK Department of Health