At 12:35 03/03/2012 +0000, Galbraith, Jane wrote:
>Thanks, Kate, for the explanation. Does anyone know whether NICE (National
>Institute for Health and Clinical Practice) has any connection or
>influence on MHRA (medicines and healthcare products regulatory authority)?
>I have the impression that NICE does a reasonable (but not perfect) job in
>judging efficacy, safety and cost but doesn't look at devices.
NICE does look at devices (and diagnostics, and anything else to do with
clinical care) as well as medicines. However, it's really working at a
different 'level', and serves a different purpose, from the MHRA (and/or
the EU equivalent, the EMA), and is totally separate from the MHRA/EMA.
The MHRA (or EMA) is concerned about the quality, safety and efficacy (and
that, in effect, means 'some proven efficacy') of approved products
(medicines, devices or whatever). They give marketing authorisations
('licences') to products and have the ability to modify, restrict or revoke
those approvals in the light of emerging information. However, they cannot
generally withhold or revoke a 'license' on the basis of their being a
superior product available, and certainly not on the basis of cost or
cost-effectiveness.
NICE essentially does 'what it says on the tin'. It provides advice on
optimum clinical strategies, including optimum usage of products (medicines
or devices) _which are available_, which generally means products that the
MHRA/EMA have approved (although they have been known to talk about the use
on unlicensed products). In so doing, they assume that any approved
product is satisfactory in terms or quality and safety, and that it has at
least some proven efficacy - if they had doubts about any of that, they
would presumably report their concerns to the MHRA and not get involved
themselves - but that is no different from what any healthcare professional
or, indeed, member of the public, could do. What they do is compare the
available products, and strategies for using those products (and for
clinical treatment in general), in relation to efficacy, tolerability (i.e.
even if deemed safe, one product may produce more side effects than
another) and cost-effectiveness / resource-effectiveness.
In as much as their activities are generally 'downstream' of the MHRA's
involvement with approving a product, and that their terms of reference are
essentially different, I can't see that there is really much scope for them
to 'influence' the MHRA.
Kind Regards,
John
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