Safety, Quality, Efficacy: Regulating Medicines in the UK
Safety, Quality, Efficacy: Regulating Medicines in the UK
Safety, Quality, Efficacy: Regulating Medicines in the UK
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SAFETY, QUALITY, EFFICACY: REGULATING MEDICINES IN THE <strong>UK</strong><br />
Appendix 11<br />
NAO Management report to<br />
<strong>the</strong> Agency<br />
We prepared a management report for <strong>the</strong> Agency to provide<br />
more detailed conclusions on a number of areas. The executive<br />
summary of <strong>the</strong> management report is reproduced here.<br />
F<strong>in</strong>d<strong>in</strong>gs<br />
1 The Agency has developed performance <strong>in</strong>dicators<br />
related to its fee-based outputs and has also attempted<br />
to demonstrate <strong>the</strong> quality of its public health protection<br />
work <strong>in</strong> a "balanced scorecard" style performance<br />
statement. The performance <strong>in</strong>dicators and targets<br />
<strong>in</strong>cluded have been agreed with M<strong>in</strong>isters. However, <strong>the</strong><br />
performance measurement arrangements are not yet<br />
provid<strong>in</strong>g <strong>the</strong> sort of focused, balanced and appropriate<br />
<strong>in</strong>formation required by all stakeholders, and have not<br />
been well <strong>in</strong>tegrated with bus<strong>in</strong>ess plann<strong>in</strong>g.<br />
2 The Agency has been at pa<strong>in</strong>s to develop performance<br />
measures and targets which are capable of accurate<br />
measurements and are attributable to <strong>the</strong> work of <strong>the</strong><br />
Agency. However, <strong>the</strong>re is scope to improve <strong>the</strong><br />
relevance of <strong>the</strong> <strong>in</strong>formation <strong>the</strong>y provide to give <strong>the</strong><br />
reader more <strong>in</strong>formation about <strong>the</strong> Agency's success<br />
aga<strong>in</strong>st its objectives, even if this <strong>in</strong>volves shar<strong>in</strong>g some<br />
outcome measures with o<strong>the</strong>r parts of <strong>the</strong> Department.<br />
There is also scope to draw on best practice guidance <strong>in</strong><br />
construct<strong>in</strong>g measures which are reliable and avoid<br />
creat<strong>in</strong>g perverse <strong>in</strong>centives.<br />
3 One of <strong>the</strong> early Executive Agencies, <strong>the</strong> <strong>Medic<strong>in</strong>es</strong><br />
Control Agency has also operated as a self-sufficient<br />
Trad<strong>in</strong>g Fund for n<strong>in</strong>e years. A recent Cab<strong>in</strong>et<br />
Office/Treasury review found that a number of agencies<br />
have tended to become detached from <strong>the</strong>ir parent<br />
Departments and need to reconnect at a strategic level.<br />
By follow<strong>in</strong>g <strong>the</strong> recommendations of this review, <strong>the</strong><br />
new merged Agency could contribute to improved<br />
policy-mak<strong>in</strong>g and delivery through streng<strong>the</strong>ned<br />
relationships with <strong>the</strong> Department.<br />
5 After identify<strong>in</strong>g <strong>the</strong> need for a major upgrade of its IT<br />
provision, <strong>the</strong> Agency managed a complex procurement<br />
project effectively. They sought professional advice and<br />
put <strong>in</strong> place new arrangements for manag<strong>in</strong>g risks. After<br />
a procurement exercise, <strong>the</strong> Agency have now signed a<br />
contract with Accenture to design, build and operate <strong>the</strong><br />
new systems, on which work beg<strong>in</strong>s <strong>in</strong> January 2003.<br />
As <strong>the</strong> Agency moves to implementation, cont<strong>in</strong>uity <strong>in</strong><br />
strong risk management arrangements will be needed to<br />
ensure a successful outcome.<br />
Action po<strong>in</strong>ts for <strong>the</strong> Agency and<br />
Department of Health<br />
! The Agency could look to published best practice<br />
when develop<strong>in</strong>g performance measurement<br />
systems as part of <strong>the</strong> merged Agency. They should<br />
aim to put <strong>in</strong> place as soon as possible systems that<br />
meet <strong>the</strong> needs of stakeholders as well as help<strong>in</strong>g<br />
drive improvements <strong>in</strong> performance.<br />
! The Agency should consider seek<strong>in</strong>g <strong>in</strong>dependent<br />
validation of its performance <strong>in</strong>formation, which<br />
could be provided by <strong>the</strong> Department's <strong>in</strong>ternal<br />
auditors or ano<strong>the</strong>r <strong>in</strong>dependent body.<br />
! The Agency and Department should take <strong>in</strong>to<br />
account <strong>the</strong> recommendations of <strong>the</strong> jo<strong>in</strong>t Cab<strong>in</strong>et<br />
Office/Treasury review of agencies when putt<strong>in</strong>g <strong>in</strong><br />
place arrangements for <strong>the</strong> governance of <strong>the</strong><br />
merged Agency.<br />
! The Agency and Department should cont<strong>in</strong>ue to focus<br />
on manag<strong>in</strong>g uncerta<strong>in</strong>ty and communicat<strong>in</strong>g a vision<br />
of <strong>the</strong> future agency to staff to help address current and<br />
future problems of staff recruitment and retention.<br />
! The Agency and Department should cont<strong>in</strong>ue to<br />
ensure risk management arrangements for <strong>the</strong><br />
Information Management Strategy rema<strong>in</strong> a priority<br />
<strong>in</strong> <strong>the</strong> merged Agency.<br />
appendix eleven<br />
4 The Agency has taken important steps to improve all<br />
aspects of its Human Resources management function,<br />
which was previously weak. At a time of change and<br />
external threats to <strong>the</strong> Agency, a clear focus on people<br />
management is a key priority.<br />
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