They may be well-meaning, but sometimes the EU’s decisions can have harmful effects, as is the case with its much criticized clinical trials directive.
The furore over European Union rules created by the UK’s Royal College of Surgeons is another fine example of the workings of the law of unintended consequences. The surgeons say that the EU’s imposition of a maximum 48-hour working week is lengthening waiting lists and lowering standards.
By putting an end to the standard UK practice of long hours for junior doctors, the EU has inadvertently limited the experience that novice surgeons acquire during their training, and reduced the number of operations that can be carried out in any given period.
It isn’t what the EU intended when it forced the limit through last year, against UK opposition. The aim was to improve the lot of the working man everywhere in the EU. And in many cases it has achieved its objective. But not, in the UK at least, in the health service.
An organization as big as the EU, with so many diverse national practices across its 27 member states, and with so many different predilections among its half-a-billion citizens, is bound to run into trouble of this sort from time to time. The ‘one-size-fits-all’ approach cannot always be the ideal instrument for legislation or administration in such mixed territory.
Sometimes, the EU tries to row back, to modify where it has got it wrong. Right now it is trying to correct some of the problems created by its equally well-meaning — but equally damaging — bid to harmonize the rules for clinical trials of medicines across the EU. Since 2004, clinical trials have been regulated in the EU by a 2001 directive — but the EU itself recently admitted that this is “arguably the most criticized piece of legislation” in the entire body of its legislation on medicines.
To make amends, it is planning revisions of the rules, to meet at least three of the major criticisms the directive faces — divergent application across the member states, undue administrative burdens, and failure to reflect the global scale of today’s trials.
The EU has now completed an extensive public consultation exercise, and is currently refining the approach it will take — which could vary from a wholesale recasting of the rules, so as to force member states to align their practice on clinical trials controls, to publishing just a few more guidelines.
Before making its decisions (and many will be disappointed if it opts for only minimal action), it is going to gather additional data and information from experts in the clinical trials community. And — in a genuflection to the sort of problems that have arisen with the unintended consequences of the working time directive — it is going to focus on “the impact of clinical research on human health, ie, a quantified assessment of the benefit of clinical research.” This more holistic approach may help avert a short-sighted amendment that would create more problems than it solves.
However, there is, as ever, a downside. Clinical trials professionals have been crying out for modifications of the rules ever since it came into effect. But according to the latest EU planning, the “expected date” for a decision is October 2011 — and that will be only the start of a process that could last another two or three years before principle becomes practice.
Inadvertently again, by spending such a long time on consultation and design of modifications to a bad rule, the EU is jeopardizing its goal of boosting European clinical trials. Which is another example of the law of unintended consequences.