Business Plan for 2004-05
The full version of this plan is on the Agency’s website:
Making an Effective Contribution to Public Health
Working with The Agency is part of the Department of Health and serves its Ministers in their aim of
Ministers and protecting public health. Many of their priorities are also ours. We will maintain strong
the Department contact with the Department and continue to advise Ministers on all issues of concern
and on communication with Parliament and the public.
Choice for More medicines and medical devices available over the counter supports the
Patients Government’s aim of choice for patients. But there are safety implications for devices,
some of which may not be suitable for lay use. We need systems for public warnings
about unsafe devices and adequate safeguards in instructions for users. We expect to
expand the range of medicines that can safely be made available without prescription;
our new reclassification process has resulted in interest from many potential applicants.
Medication Another of Department’s priorities, set out in Improving Medication Safety, has
Safety implications for both parts of the Agency. We have already produced guidance on the
labelling and packaging of medicines and more work will follow. We will also help
develop an education programme on the safe use of infusion systems delivering
Paediatric The licensing of medicines suitable for children is a third priority. We will work along-
Medicines side the Department and in support of Ministers to promote the development of such
products. We will encourage pharmaceutical companies to put in paediatric plans for
existing products and invite them to submit applications to allow their use in children.
Other One of the developing areas for medicines is biotechnology products, for which we are
Medicinal one of the leading rapporteurs in Europe. Two much older areas are also developing.
Products We will consult on proposals for licensing homeopathic medicines and, in collaboration
with industry, will prepare a traditional use registration scheme for herbal products.
Clinical Trials The regulation of clinical trials for medicines will change as a result of a European
Directive. There are new requirements for authorisation of Phase I volunteer studies and
for licensing manufacturers of investigational medicinal products.
Variations and We will build on opportunities arising from the new Variations regulations in dealing
Renewals with the increasing volumes and complexity of variations. Following the 2001 Review
of pharmaceutical legislation, a single five year renewal will be retained with the option
of a further term where there are safety concerns. We will also develop a targeted
approach to pro-active risk assessments for established medicines.
Unlicensed New TSE Regulations minimise the risk of transmitting spongiform encephalopathy
Medicines agents, but some unlicensed herbal remedies and traditional medicines are excluded
from their scope; we will assess the risks.
GPRD We will promote broader research applications of the General Practice Research
Database and investigate, with the trade associations, the possible use of the data to
support device development.
Yellow Cards We will extend the Yellow Card Scheme to allow patients to report adverse drug
reactions and promote Internet-based reporting amongst health professionals. We will
monitor industry’s compliance with requirements for reporting adverse drug reactions
and remind them of their responsibilities under the new statutory pharmacovigilance
Device Reports of adverse incidents involving devices have levelled off but may increase again
Incidents now pharmacists are handing leaflets about our role to purchasers. Other specific groups
of users will be reminded of the Agency’s role and encouraged to make reports, and we
will ensure we exchange relevant information with the NPSA.
Notified Bodies As before, all active UK Notified Bodies will be audited at least once a year to ensure
for Devices that they operate at an acceptable level of performance in the CE-marking of devices.
The recent In-Vitro Diagnostic (IVD) Medical Devices Directive is likely to increase
work in connection with Notified Bodies, as will a new Directive introducing additional
controls on medical devices manufactured with tissues of animal origin.
Good Practice There will be new statutory Good Manufacturing Practice inspections for
Inspections Investigational Medicinal Products, with additional work in issuing associated licences.
Additional inspectors will support new mandatory Good Clinical Practice inspections
and a new team has been established specifically to undertake Pharmacovigilance
Manufacturing inspections. The Good Distribution Practice team aims to achieve a
three-year inspection cycle for wholesaling sites handling Prescription Only Medicines
and Pharmacy lines.
Enforcement Increased enforcement activity for medicines will focus on illegal sale and supply
through the Internet and unlicensed alternative medicines. Our new Intelligence Section
will gather intelligence and seek innovative ways of dealing with Internet activity,
supported by new powers to access communications data. We are proposing extensions
of enforcement powers to deal with false or misleading information in licensing
applications. For devices we will have one of the largest compliance programme in
Europe, with several hundred investigations a year. While urging manufacturers to
correct non-compliances, we will take formal enforcement action if need be.
Advisory The Committee on Safety of Medicines (CSM) will continue to support the Agency in
Committees providing safe and effective medicines, though, subject to external consultation, a single
advisory body would replace the CSM and the Medicines Commission at the beginning
of 2005. We are keen to encourage lay and patient representation on such bodies. The
Committee on the Safety of Devices will continue to support the Agency in delivering
advice to the health service about the safety of devices. An ad-hoc group of its members
will continue to audit our assessments of clinical trial notifications. and we will
communicate the audit findings to industry.
Quality of our One of our key targets for this year is to develop better measures and procedures for
Decisions assessing the quality of the decisions we make in protecting public health
Providing authoritative and accessible information
Our Profile The Agency needs to raise its profile, promote its role and communicate more
effectively with its various audiences. That will include establishing a separate media
relations capability for the Agency. A communications strategy will be agreed early in
2004-05. One key component will be the development of our website as a shop window
for the Agency providing a full range of information and services.
Labelling and To reduce opportunities for medication errors we will promote our Best Practice
Advertising guidance for the labelling and packaging of medicines. The Agency will vet
advertisements for medicines while maintaining the prohibition on advertising
prescription only medicines. We are working with the industry to ensure safe use where
restrictions on advertising are removed.
Guidance for A checklist for patients discharged from hospital with medical devices will ensure they
Patients have all the necessary information to use them safely. We will work with patient groups
to ensure that all our guidance for patients is relevant, intelligible and correctly targeted.
Guidance for We will work with the Royal Colleges to incorporate safety aspects of medicines and
Professionals devices into professional training. We aim to expand our range of publications
addressing concerns for devices user in acute settings and will find new ways of
educating and informing staff in community settings. We also need to reinforce the
message that equipment designated for single use only should not be reused.
Device Liaison Medical device liaison officers in Trusts and Social Services Departments play a crucial
Officers role in reporting incidents and ensuring the distribution of Medical Device Alerts. We
will explore whether their role can also embrace drug safety.
Evaluating The Device Evaluation Service will support several Government priorities, including for
Devices example help to the National Cancer Screening Programme with evaluations of devices
for imaging and pathology screening. It will also evaluate over-the-counter products
such as blood pressure monitors and blood glucose monitors.
Communication As one of several agencies engaged with the Department in protecting public health, we
Within need to ensure that messages to the NHS and other stakeholders complement each other.
Government We will strengthen our links with such bodies and with other Government Departments.
When Ministers look to us for advice, we will give it quickly and effectively.
Influencing International Regulation
Medicines New European medicines legislation following the 2001 Review must be transposed
Legislation into UK law by late 2005, with much preparatory work during 2004-05. We will
complete preparations for implementing the Directive regulating herbal products and
contribute to the development of several other EU regulations or guidelines, including
for paediatric medicines, the conduct of clinical trials, and xenotransplantation, and will
press for consistency of inspection standards across Europe.
IVD Devices With the new IVD Directive now in force, we expect to clarify requirements for
Directive controlling IVD devices manufactured within the health service. We will help all
companies making IVDs understand their responsibilities under the Directive but we
can still expect an increase in the number of alleged breaches of the regulations.
Operation of We will press for improvements across Europe in the operation of the medical devices
Device Directives in regard of Notified Bodies and Market Surveillance activities, and for more
Directives transparency in the way the Directives operate. We expect new regulations to develop
during the year for more stringent regulatory control of certain long term implants.
Emerging Expecting proposals from the European Commission on tissue engineered products, we
Technologies will invite relevant parties to help develop our negotiating position. Separately, we will
discuss within Europe how developments in technologies such as nanotechnology,
micro-electronics and biomaterial science might best be handled, and consider whether
any changes are needed in European regulation for drug/device combination products.
Expansion of The expansion of the EU presents challenges in ensuring that medicines and devices
Europe licensed or CE-marked in Accession Countries are as safe as those regulated in the
existing Union. There will be further opportunities to influence those countries.
Supporting industry and innovation
Targets We aim to regulate industry without a bureaucratic burden that would inhibit innovation
or delay the benefits of new products for patients. Both former Agencies had high level
targets for providing a speedy service. Some of them continue into 2004-05 but they
may not be the best measures of our service. We therefore have a new key target to
develop better or additional measures, informed by the views of industry.
Advice We expect to increase the volume of advice offered to companies during the
development of medicinal products and to widen its range to include for example
advertising, labelling and packaging. With our European partners we will explore
mechanisms for dialogues with device companies during product development.
Help from IT Developments in information technology will provide better channels for industry to
communicate with us. We hope to establish an electronic system for pharmacovigilance
reports and will introduce electronic submission of applications for authorising Phase I
studies for clinical trials, which should shorten our response times, as an early part of a
programme to allow all applications from industry to be submitted electronically.
Discussion Many forums for discussions with trade associations have developed over the years.
Forums With likely scope for rationalisation, we will discuss appropriate channels of
communication with them. We will remain heavily involved in the Healthcare Industries
Task Force, where Government and industry are seeking ways to stimulate the growth
and performance of the UK healthcare industry and maximise its benefit to patients.
Operating a Successful Business
Completing the Though the new Agency was formed in April 2003, much remains to be done to
merger integrate its two former parts. The first stage is to establish a top management team and
the organisational structure beneath them, including merged support functions such as
Finance and HR. During 2004 we expect to bring the two main parts of the workforce
together in the same building. Then a common culture can develop, supported by better
internal communication as we integrate two different IT systems.
Human With two workforces coming together, we will harmonise our HR policies and
Resource practices, in discussion with the Trades Unions, so as to manage and reward staff
effectively. Leadership and other skills will be developed so that the Agency can meet
its business objectives and we will support the continuing professional development of
all our staff. Our physicians will be able to revalidate through an internal process.
Information New IT systems to be implemented by the end of the year as part of the Sentinel
Technology programme include support for clinical trials, product licences and certificates.
Developments for the devices sector will include a system for interchanging safety
information with Europe.
Efficiency and We keep our operations under review. The medicines sector is planning for IT-led
Effectiveness improvements in the efficiency of much resource-intensive work. The Agency’s
Inspection and Enforcement Division will extend the coverage of its Quality Systems
accreditation. And a strategic review of the Device Evaluation Service will report early
in 2004-05. We will take a more systematic look at value for money during the year.
Income The Agency will continue to develop additional income-generating services in respect
Generation of medicines, building on established links with new Member States of the EU and the
successes of its Conference and Education function, while the devices sector will recruit
a specialist to help market its services.
Finance The budget for 2004-05 is summarised in an annex to the full version of the plan. It is
written to achieve a surplus before interest and dividends of £0.5m, in line with a
requirement to earn a return of 3.5% on capital employed.
Annex: Key Targets for 2004-05
All these targets are for completion by 31 March 2005 unless earlier dates are quoted.
1 Ensure that all fatal and serious adverse drug reactions received through the Yellow Card Scheme are
captured and rapidly made available for the detection and analysis of possible drug safety hazards.
100% within 3 working days 100% within 7 working days
90% within 1 working day 95% within 3 working days
2 Develop better or additional measures and procedures for assuring and assessing the quality and
effectiveness of the Agency’s decision making.
3 Agree by the end of June an outline communications strategy for 2004-05 and the actions and
resources that are needed to implement that strategy, including the establishment of a dedicated
communications function. Implement agreed actions during the year.
4 Issue timely Drug Alerts and Medical Device Alerts which identify clear and appropriate action which
recipients can achieve within realistic timescales, and review the effectiveness of these alerts.
5 Provide draft replies to 90% of correspondence received by Ministers within 20 days.
6 Continue to lead the European Risk Management Strategy to ensure effective co-ordination of
pharmacovigilance within Europe and support for the development of risk management plans.
7 Contribute to the creation of an effective regulatory regime for tissue engineered products by
effectively representing all relevant UK interests during negotiations following the Commission’s
8 Review the Agency’s contacts with and forums for discussion with industry, and establish, with
industry, effective and transparent structures and lines of communication.
9 For introduction in 2005-06 as part of a longer programme of continuous improvement, develop better
or additional measures and procedures for assessing the quality and effectiveness of the Agency’s
services to its customers.
10 Develop and implement by the end of July an organisational structure and decision making forums to
suit the needs of the merged Agency.
11 Subject to approval of the business case, co-locate all London-based staff in a single building and
achieve this with the minimum of disruption to services and staff (an average of no more than three
days loss of productive working time for staff whose locations change, excluding those supervising the
12 Ensure that the Agency achieves its agreed budgeted surplus.
Other high level targets for the year are listed in an annex to the full version of the plan.