Legislative Review or Window Dressing?

One of the biggest news stories this month has been the latest announcement of an independent review of the regulation and governance of UK clinical research. This was announced by Health Secretary Andy Burnham on March 25^th, and will be conducted by the Academy of Medical Sciences, which called for such a review in its January 2010 report “Reaping the rewards: a vision for UK medical science”. In announcing the review, Mr Burnham said “It is becoming increasingly clear that medical research is getting tied up in red tape. For research to flourish and provide the huge benefit it can give to the health and wealth of the country, it needs freedom from unnecessary bureaucracy and interference.”

This sounds rather familiar, having been the rallying cry behind reviews, reports and reorganisations going back at least as far as PICTf nearly a decade ago. This was followed by the UKCRC set of initiatives (now mostly under the banner of the NIHR) and more recently the Office for Life Sciences, which published its own report on “Delivering the Blueprint” only a few months ago. All of these have overlapped, in goals and activities, and all have provided incremental solutions to specific problems. It is hardly surprising that problems still remain to be solved, but people criticising the current systems should remember the ‘bad old days’ that preceded them.

So, is the AMS review going to provide that ‘Eureka!’ moment, delivering transformative recommendations that none of the previous review panels were able to come up with? Or is it the latest window dressing on the long-running series of evolutionary reforms that have fought against the gradual ‘decline’ of UK clinical research competitiveness, as medicine development has globalised, throwing the UK’s inbuilt demographic disadvantage into sharp relief? Of course, editorial hyperbole aside, the truth of the matter will be somewhere in between. However, well-meant as it is, there are some pretty fundamental problems with this particular review…

For a start, there is the long history of reviews in this area, including the ones described above, plus internal reviews conducted by the MHRA, Department of Health etc. over the past few years (and that continue to be ‘works in progress’). Is it really plausible that the ACM panel could spot a flaw or propose a solution that had been previously missed? Indeed, the overarching issue seems to be not so much with identifying specific problems as with translating them into generalisable solutions that can be applied usefully across commercial and non-commercial research, balancing provision for public confidence with available resources, and taken up in a homogenous way by a very heterogeneous set of organisations (and combinations of organisations).

Information about the review is still pretty sparse, but it has been described as “rapid”. However, the UK is a matter of weeks away from a General Election. Even if the AMS can produce its report before the election, it will surely be buried under the media froth on other campaign issues from the economy, crime and foreign policy to the environment, UK military operations overseas and MPs expenses! With the election widely expected to result in a change of government, there is no guarantee that the incoming politicians will choose to implement any of the AMS’ recommendations, and might even decide to commission yet another review on taking office…

Finally, a similar debate has been taking place on a pan-European level, with the European Commission already being more than 12 months into a discussion on the impacts of the Clinical Trials Directive, with broad consensus that something must and will be changed, and increasing acceptance that the text of the Directive itself might be part of that change. There is surely much wrangling to be done at this level over the next few years, but when this is complete, the UK legislation will have to change all over again as a result, regardless of any improvements brought about by the AMS.

So, although its aims are laudable, there is little practical value in commissioning this review now: it duplicates reviews that are already in progress, it’s unlikely to be able to solve the multi-level problems it’s designed to address, and the broader legislative environment is likely to change soon anyway! Sometime, somehow, further reform of UK clinical research regulation and governance is certain to take place, but the timing and context of this review appear certain to undermine any value that it could add.

Ask Louise Wood

In a few weeks time, I will be interviewing Louise Wood, Head of Industry/R&D Relations at the UK Department of Health. I expect our conversation to traverse the recent updates in the UK clinical R&D environment, the UKCRC, UKCRN etc.

But what do you want to know? Please send me any questions you’d like me to ask Louise, and I’ll try to ask her.

The interview is scheduled to be published in the July issue of CRfocus, with  an extended audio interview available from the website (www.crfocus.org).