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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 />

52

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