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ADAM COHEN: So, we think about the idea of regulatory science now, and we never did.
So, that in itself is important.
I personally wouldn't call it regulatory science,
because science tends to be a way of finding new concepts
that simplify a complicated biological or scientific process.
But it's more a regulatory audit
and organisational research into how it has worked.
So, it's important that this is being done.
Well, the MEB has started a very laudable programme
in doing this sort of audit in the Escher programme,
and Chairman Leufkens, of course, has been instrumental in doing that.
They do differentiate themselves from the other regulatory authorities,
who do less, I think, but of course they have to operate in the European space
to be able to do that properly, and I think they do.
I think it's very important if it leads to changes.
Now, this is where I have a certain amount of criticism, and this may be too early.
It's possible that we're going to experience this later,
but we have to be honest that a clinical trial,
which used to cost about a million dollars when I started,
now costs close to a billion.
So, whatever we've done in regulation, that hasn't made it a lot easier to do this work.
And I'm not sure it has become safer or more reliable
in proportion to the amount of money it actually costs to do it.
So, the value of it, the value should be that it becomes easier to develop good drugs
and that you find the bad ones quicker.
I'm not sure that's happened.
So, there is lots of work to be done. That's quite important.
As a citizen, I would say,
they have to focus really on judging the data that were produced
and actually making sure that we get safe drugs that are, at least,
drugs where the safety outweighs the risks.
As a scientist, I think that the most important function they could have
is to make public as much of the data as they have.
Both for science, or audit or whichever way you'd like to call it,
but more importantly even, for education.
If you think about the openness of the files of a regulatory authority,
then the immediate response would be, from everyone:
this is secret, and it belongs to the companies that have delivered it to them,
so it should remain a secret. That's how it is at the moment.
But if you think about the value of it for future drug development and for education,
it's enormous, and it shouldn't remain in the archives.
And even files that are ten years old
would be of immense value to train future drug regulators
or to train future drug developers.
And so, I think they should be as open as possible,
and I'm sure it's possible, if you think about it.
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