Safety, Quality, Efficacy: Regulating Medicines in the UK

SAFETY, QUALITY, EFFICACY: REGULATING MEDICINES IN THE UK
Appendix 3
Additional detailed
recommendations
On managing its own resources
and performance
! The Agency should ensure that on its merger it
maintains the skills and resources needed to manage
effectively the risks to delivering its IT strategy.
On protecting the public
The Agency should:
! carry out an assessment of what level of Medicines
Testing Scheme sampling is required to protect
public health, whether above or below the current
level, and what resources are required to achieve it;
! implement the national rules scheme for
homoeopathics, drawing on lessons learned from
the existing homoeopathic schemes and on
experiences overseas;
! carry out an assessment of the risks to public health
from the absence of fully effective arrangements for
distributing safety alerts for medicines on general
sale to the public, and work with industry and
retailers to manage these risks;
! make optimum use of the General Practice Research
Database and other methods to measure routinely
the effectiveness of its regulatory actions and publish
the results;
! identify areas where outsourcing of certain research
to academia could supplement or enhance its own
pharmacovigilance activities, and develop links to
facilitate this.
The Department should:
On protecting the public by
communicating information
about medicines
The Agency should:
! maintain, for example on the internet, a comprehensive
public list of medicines that are licensed,
including herbal and homoeopathic products;
! publish the responses to external consultations and
indicate how it has responded to the points raised;
! consult with health professionals about the best way
of presenting medicines information and tailoring it
to their needs, and build this into their information
strategy;
! continue to work closely with the National Patient
Safety Agency to ensure that their respective adverse
event reporting systems complement each other
effectively and avoid any confusion for health
professionals. Information sharing arrangements
should be formalised as soon as possible.
The Department and the Agency should:
! ensure that the Agency Board and Medicines Act
bodies reflect the interests of the public, through
properly resourced lay representation.
On providing a service to industry
! The Agency should consider international benchmarking
(both qualitative and quantitative) of its
activities to learn from best practice overseas and
demonstrate its competitiveness to industry.
! keep under review the areas of medicines
development and production which are not
currently regulated and develop strategies as
necessary to manage any risks to public health.
appendix three
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