What is a regulator's role?

In the UK, there is a debate about the regulator's role in the financial industry. Could they have prevented a global crash? probably not ... but if they'd kept their eyes on the big picture, says our chancellor, rather than get involved with details, they might have seen the worst coming.

I've been thinking about regulators in the industry we deal with most - medicines and healthcare. Of late, they have been intervening at an ever more detailed level in the process and craft of information design and leaflet editing. Well, that's OK in itself: it's an important part of medicines, and it's bound by law.

But too many interventions are uninformed, and go against the research evidence. One example: a friend working in mainland Europe was told that hand-made mock-ups of booklets were not acceptable - machine-finished specimens had to be used for patient testing. I am not aware of any evidence to support this insistence, which will slow user tests down by weeks, and cost much, much more, even if print factories will take it on.

I do know of evidence (and I've told the regulators about it) that the quality of the mock-up barely matters, versus the design and wording. Here, different standards seem to apply. Various European regulatory assessors are happy to change wording that has arisen from user testing, because they disagree with it – even though the law says that leaflets must reflect the results of such testing. So (arguably) they're acting outside the law – to which their reply is, effectively, "we're the regulator, so what we say goes".

Now I've come across some research (not yet published: I'll link to it when it is) analysing the content of 40-odd patient leaflets. Five altogether fail to give important warnings, and the leaflets vary wildly in their references to important side effects typical of the drugs. Patients getting different versions of the same medicine (eg generics) will get very inconsistent advice. Isn't this the sort of big picture that the regulators should be concentrating on?