APPENDIX 52
Letter to the Clerk of the Committee from
Dr Richard Tiner, Medical Director, the Association of the British
Pharmaceutical Industry
Many thanks for your letter of 4 May requesting
clarification of two points in our written and oral evidence to
the Science and Technology Committee.
On the issue of cost structures of research
in the UK and other countries, we did provide to the Committee
part of the information obtained from DataEdge LLC.[24]
However, for completeness I enclose a copy of the full results
of the 1996 data and the 1998 data.[25]
This data does confirm that the costs of clinical research in
the United Kingdom have increased in comparison with the rest
of Europe and United States.
The second issue relates to our comments on
the differences between the ICH GCP guidelines and MRC GCP guidelines.
The MRC GCP guidelines are the standard for MRC clinical trials
and have been adopted also by the NHS R&D Directorate for
NHS clinical trials. The major difference between the two sets
of guidelines is around auditing of clinical trials where the
requirements under ICH GCP are more stringent than those under
the MRC GCP guidelines. The ICH guidelines have been developed
through negotiation between the regulatory authorities of America,
Europe and Japan and the pharmaceutical industry representatives
in America, Europe and Japan. Although the ICH guidelines are
guidelines they have, in essence, become regulatory requirements
for clinical trials involved in marketing authorisation applications
or extensions to marketing authorisations. For medicine in trials
done under guidelines not to ICH standard it is quite possible
that the regulatory authorities will refuse to recognise them
for licensing purposes and therefore such trials may not be acceptable
and therefore might lead to a licence not being granted, This
is a considerable area of concern for the pharmaceutical industry
and discussions have taken place, in particular, between the ABPI
and the NHS R&D Directorate about the differences between
the two guidelines. It is hoped that these concerns will be sorted
out in the near future so that where a trial involving a medicine
that might lead to a licensing application is being done, it will
be done under ICH GCP guidelines including the auditing requirements.
The industry recognises that the auditing requirements do make
the clinical trial more expensive. The MRC guidelines, as they
stand at present, are a potential disincentive to collaborative
studies and the ABPI is keen to develop an agreement between itself,
the MRC and the NHS R&D Directorate that collaborative studies
involving the pharmaceutical industry should be done to ICH GCP
guidelines where the study is likely to lead to the licensing
of a medicine or the extension of a current licence. These discussions
are taking place and it is to be hoped that a satisfactory solution
will be reached.
I hope this clarifies the position and if I
can be of further help, please do not hesitate to contact me.
15 May 2000
24 See HC 332-iii, pp. 50-57. Back
25
Annex (except data printed with HC 332-iii). Back
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