Written evidence from the Faculty of Pharmaceutical
Medicine (REV 36)|
1. The Faculty of Pharmaceutical Medicine (FPM)
is a registered charity with approximately 1,400 members who are
practising or retired pharmaceutical physicians or those with
a professional interest in the specialty.
2. The FPM's mission is to advance the science
and practice of pharmaceutical medicine by working to develop
and maintain competence, ethics and integrity and the highest
professional standards in the specialty for the benefit of the
3. As the standard setting body for pharmaceutical
physicians and a Faculty of the Royal Colleges of Physicians of
the UK, the FPM has been actively involved in developing the framework
and machinery required for revalidation, both through the Academy
of Medical Royal Colleges (AoMRC) and directly with the GMC and
4. Physicians working in the specialty of pharmaceutical
medicine are concerned with the discovery, development, evaluation,
licensing and monitoring of medicines and the medical aspects
of their marketing. Most of their work is undertaken outside the
NHS - predominantly in private pharmaceutical companies, the regulatory
agencies or as private contractors.
5. The majority of pharmaceutical physicians'
work does not involve direct patient contact however their work
does have an impact on the health of populations of patients and
the public. The FPM has recommended that all pharmaceutical physicians
in active practice maintain a Licence to Practise.
6. The process of revalidation for pharmaceutical
physicians will need to take a different course to that of clinical
doctors in certain aspects and this has required us to take a
different approach when proposing appropriate mechanisms for revalidation.
We are particularly keen to see that the revalidation of pharmaceutical
physicians is carried out in a manner which is as objective, transparent
and robust as possible, so as to avoid all possible conflicts
of interest, and we will ensure this.
7. Doctors normally spend a number of years working
in the NHS before joining the pharmaceutical industry or related
organisation and they take this expertise with them. It is important
that the revalidation process enables the movement of doctors
between industry, the NHS and academia. This occurs in different
directions and often a number of times during an individual's
8. The Faculty is committed to ensuring that
there is a process for revalidation for pharmaceutical physicians
wherever their place of work, whatever their role and we are making
good progress with developing proposed processes for this. It
is intended that these processes will be available to all pharmaceutical
physicians, whether they are members of the FPM or not (as many
practicing pharmaceutical physicians are not currently members
of the FPM). We have also been consulting with our members and
others to refine our thinking as the strategy for revalidation
9. We have prepared detailed proposals as to
how the various proposed components of revalidation could operate
in pharmaceutical medicine. For example, the Faculty is proposing
to provide an appraisal service for pharmaceutical physicians
who are either self-employed or who are employed in settings that
are too small to facilitate medical appraisal.
10. The Faculty has been designated within the
Responsible Officer (RO) legislation as having a duty to provide
RO functions for those of its members that are not able to relate
to a local RO. This will apply to those who are self-employed
or those who are employed in settings that are not appropriate
for designation due to their small size. We are aware that larger
pharmaceutical companies have not yet been designated within legislation
and would recommend that this is addressed at the earliest opportunity.
The FPM is also concerned that there remains insufficient clarity
on the role of RO's in the independent sector.
11. The FPM is not directly involved in the initial
raft of ten "Pathfinder" pilot schemes run by the NHS
Revalidation Support Team to test the strengths and frailties
of proposed systems for revalidation. The Faculty of Public Health
and the Faculty of Occupational Medicine are in a similar position
to the FPM, in that their members either work outside the NHS
or do not have direct patient contact. In light of this the FPM
has been working in partnership on a "tri-faculty" project
to set up a pilot revalidation project to mirror those that are
taking place within the NHS. The tri-faculty steering group is
aiming to have its pilots up and running by February 2011, with
appraisals taking place over a period of 6 months. Participants
will be drawn from the spectrum of pharmaceutical medical practice.
A detailed analysis of the outcomes of the pilot will be carried
out and the findings will be reported to the Academy of Medical
Royal Colleges (AoMRC), who awarded the funding for the pilots,
and the NHS Revalidation Support Team.
FPM RESPONSE TO
THE GMC CONSULTATION
Revalidation: The Way Ahead
12. Earlier this year, the FPM independently
submitted a response to the GMC's consultation Revalidation:
The Way Ahead. We stated that although we are generally satisfied
with the manner in which the GMC is handling the revalidation
process to date, there are several issues that we felt needed
further attention and compelled the GMC to ensure that the revalidation
process remains "pragmatic, rather than bureaucratic".
The FPM is seriously concerned that the process could become
far too complex and time-consuming.
13. The GMC recently released a document outlining
their reaction to the responses received from all parties. We
feel that the GMC has in general responded positively to the comments
which we ourselves made. However, there are still several areas
where we feel the GMC response has not fully addressed our concerns.
We would like to draw your attention to the following
points which are of particular relevance to the specialty of pharmaceutical
medicine. The questions quoted below were posed by the GMC as
part of its consultation and are included here for reference purposes.
14. (Q5) What role should Colleges and Faculties
have in the revalidation process?
The FPM is not yet sure if Colleges and Faculties
should have responsibility for audit and quality assurance of
the recommendation process. We feel that this would present a
potential conflict of interest for Colleges and Faculties that
are designated bodies within the RO legislation. The FPM is therefore
pleased to note that the GMC are now intending to review this
and develop different options relating to quality assurance and
a possible GMC programme of sampling and audit.
15. (Q7) Do you agree with our proposals for
the revalidation of doctors with no medical practice of any kind?
The FPM would encourage the GMC's commitment to ensure
that the revalidation process is applicable for doctors in non-mainstream
roles and its continued dialogue with relevant organisations such
as the FPM.
16 (Q8) Do you agree that the List of Registered
Medical Practitioners should indicate the field of practice on
the basis of which a doctor has secured revalidation?
The FPM is pleased to see that the GMC has planned
to develop more detailed proposals around this issue and is supportive
of the concept. The level of detail which would be given within
the GMC register would require consideration and is of particular
interest to the FPM.
17. (Q14) Do you agree with our approach to
patient and public involvement in revalidation?
Although the FPM approved of all three of the patient
and public feedback options, we expressed concerns that lay involvement,
especially within pharmaceutical medicine, in RO involvement and
GMC decision making must be unbiased and preferably have some
understanding of the specialty. The GMC has clearly taken on board
our comments and will further consider whether there is a role
for patients and public in the GMC decision making process. The
GMC are also to commission a literature review to examine the
evidence base for patient and public engagement.