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| (a) identify resources and work with others to fully implement and deliver its excellence in pharmacovigilance strategy, which is designed to make safety monitoring less reactive
| The MHRA Pharmacovigilance Strategy has been accepted as the basis for the development of a collaborative European Risk Management Strategy capable of achieving high standards of protection of public health in relation to all medicines regardless of route of authorisation. UK is playing a leading role in co-ordinating the roll-out of the strategy designed to make best use of the Community resource for pharmacovigilance.
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| The Department and the Agency should: |
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| (b) ensure transparency in the arrangements for preventing conflicts of interest in the Medicines Act bodies that advise Ministers
| A revised policy on interests has been developed which will apply to the chairmen and members of the restructured advisory bodies when they are appointed in the autumn 2005. We are currently undertaking a public consultation on our proposed policy (MLX316) but we expect that that in the future the chairmen and members of the new Commission and the committees that advise on homoeopathic products and herbal products will not be permitted to hold current financial interests in the industry producing products on which that committee advises. All other interests, including those of immediate family, will have to be declared and will be published annually.
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| (c) continue to work to identify what improvements to medicines labelling and information leaflets can be made in the UK within existing legislation, building new guidelines for industry and involving the public
| Following the publication of the NAO Report, the CSM made recommendations on how medicines labeling might be improved within the current regulatory framework. Guidance was published by the MHRA in March 2003. [Best Practice Guidance on the Labeling and Packaging of Medicines (BPGLPM) available at www.mhra.gov.uk]. Improvements to medicines labeling are already becoming apparent in the market place as medicines manufacturers embrace the principles of best practice.
Since then, the MHRA and CSM have set up an Expert Working Group, under lay chairmanship, to advise on steps to improve the quality of PILs supplied with medicines. It includes members from a range of backgrounds, including patient groups. The work-plan includes the production of guidance on risk communication and addressing issues of access. The Group has also considered specific patient information leaflets, including the results of a focus group hosted by the MHRA for a particular product.
Importantly, the UK has implemented early changes to UK law on the requirement for user testing of patient information resulting from the review of European law designed to accelerate improvement of the quality of information.
The MHRA is also committed to delivering pilots of patient reporting of suspected adverse drug reactions which also offers the potential for improvements to patient information though a clear understanding of the patient perspective.
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| (d) build on actions already taken to ensure that the Drug Alert distribution system for recall of defective medicines across the UK reaches all appropriate health professionals, especially in the light of widened prescribing powers
| The drug alert system involves distribution of alerts by fax-press to a list of NHS and other contacts that is updated on a regular basis. In order to validate the system contact is made at random with recipients of drug alert letters to confirm receipt and clarity. A formal system of six-monthly checks on all recipients is to be introduced by end 2004-05 as part of the continual review of the quality management system.
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| (e) continue to inform the public giving higher profile to the risks of purchasing Prescription-only medicines on the internet and publicise its work in this area, subject to the need to avoid jeopardising the Agency's covert investigation activities
| Enforcement and Intelligence staff continue to be proactive in communicating the risks of purchasing prescription-only medicines via the Internet and to take part in national and international forums where these issues are discussed. A strategy to inform the public more widely will be further developed with the Director of Communication when he is in post. The forthcoming creation for a separate Group to manage the Enforcement and Intelligence work of the Agency will give this work a higher profile.
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| (f) consider whether its public profile is sufficient to enable it to fulfil effectively that part of its mission involving the provision of information that contributes to the safe and effective use of medicines and consider in what ways this profile can be strengthened
| The management of the newly created MHRA were aware of the changing context of their work and the need to ensure that public health messages were received by stakeholders. Accordingly, in December 2003, the Agency commissioned a major study of its external profile involving 27 external stakeholder interviews, an online survey of health and social campaigners and an internal consultation programme.
The Review has been a key part of the MHRA's strategy to increase its profile. The MHRA's communication aims, as defined in the report are both to ensure that day to day messages get through and are heard by those who need to hear them, and that in the long term, patients and carers become more aware of the risk benefit balance in medicines and devices.
The communications strategy will be spearheaded by a new Director of Communications who takes up post shortly.
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| (g) build on its existing regional networks, and work with others, such as hospital and community pharmacists and consultants, to disseminate key information on medicines safety more effectively to health professionals including GPs
| Following the Independent Review of Access to the Yellow Card Scheme the MHRA is currently considering how to optimise local networks to enhance communication of drug safety issues—in both directions. The Agency has made strenuous efforts to increase the effectiveness on its communications of drug safety issues, including by using the Public Health Link quickly to convey safety information to all health care professionals and by ensuring patient focussed information is available on the MHRA website and through NHS Direct and NHS Direct online.
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| The Department and the Agency should: |
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| (h) work with Royal Colleges and other professional organisations to integrate a greater knowledge of medicines regulation and surveillance into health professionals' training
| This recommendation is closely connected to the work of the (yet to be formed) Communications Division and, while there is no formal programme in place, this issue is being actively discussed with the Academy of Royal Colleges. Three issues have been raised with them: how the work of the Agency in regulation of medicines and devices can be better appreciated by undergraduate and postgraduate medical staff; whether the roles and responsibilities of the Agency could be incorporated into the teaching curricula; how the importance of adverse reaction reporting can be reinforced within the medical culture. Agency staff lecture to pharmaceutical physicians at their Diploma course, and are involved in setting questions for examinations and marking them.
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| (i) continue its client survey work across all services to industry and publish details of how it has responded to feedback
| Client survey work continues to be done mainly by the Trade Associations representing the industry we regulate. The results of this survey work has been disseminated within each trade body but not, for example, published on our website.
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| The Department and the Agency should: |
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| (j) ensure where necessary that the Department's and the Agency's objectives are better integrated
| The NAO report drew attention in its paragraph 1.11 to the report's Figure 5 which displayed objectives in the Department's NHS Plan set against corresponding Agency work which was underway at the time but not represented in the Agency's objectives. Paragraph 1.11 highlighted four themes—overlapping those of Figure 5—not represented in Agency objectives. All four of those themes subsequently had objectives published in the current MHRA Business Plan for 2004-05 (referenced as H12; K6, K7, H18, H22 and H24; H10; H20). The first two items in Figure 5 also have objectives for 2004-05 (H3; H18). The Agency continues to be mindful of the Department's objectives when proposing its own to Ministers.
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| (k) identify clearly for stakeholders and managers the Agency's key performance objectives, ensuring that they reflect the full breadth of its functions
| The 2004-05 Business Plan, published for all stakeholders and Agency staff to see, contains 46 objectives, 12 of them key targets. With the diversity of work within the Agency, it is not possible for 12 key targets to reflect the full breadth of function. But the 46 objectives reflect most of the breadth.
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| (l) examine the scope to adopt performance indicators which measure progress towards outcomes, rather than simply outputs
| As the NAO report conceded (paragraph 1.13), this is difficult. An output is something produced by the Agency usually completely within its control. The Agency understands an outcome to be something desirable that usually happens in the world outside the Agency, subject to the Agency's influence but also subject to countervailing influences from other parties, for example other Member States of the EU. It is inappropriate to publish targets for such outcomes, for the Agency could not be fully accountable for their fulfilment.
There were several discussions within the Agency during 2004 which identified desirable outcomes for pieces of the Agency's work, and studies of the relationships between activities, outputs and outcomes. That has led to clearer thinking about the Agency's role and its activities in support of its aims, but not yet to any systematic set of performance indicators measuring progress towards outcomes. There are nevertheless some such indicators. Several of the Agency's targets for
2004-05 have them, though none are quantitative. Key target 3, for example, has an indicator in the development and agreement of a communications strategy, to fulfil the desirable outcome of a better-informed public. The concept of outcomes in now embedded in the Agency's thinking and discussions on how to extend that concept will continue.
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| (m) ensure, when setting objectives for the new Agency that, in achieving the dual objectives of protecting the public and providing a service to industry, potential conflicts of interest are minimised and effectively managed
| The 46 targets for 2004-05 are set out in the MHRA Business Plan under five corporate objectives. One corporate objective relates to public health protection and another to supporting industry and innovation. The Agency sees these objectives as reflecting distinct, though complementary, roles. There are more targets under the first of these objectives than under the second. One of the prospective targets for 2005-06 is currently worded, "Develop and implement proposals for a new Medicines advisory body structure, and introduce revised codes of practice on interests in the pharmaceutical industry for committee members and staff by October."
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| (n) review the strategic plan to ensure that the Agency can continue effectively to protect UK public health within the changing European regulatory environment
| This encompasses legislative change, maintaining standards of scientific quality and representing national interests. The changes to the EU regulatory system proposed by the European Commission and the new herbals directive have been negotiated and we are currently transposing the provisions into UK law to come into force end of October 2005. The Agency's strategic approach is to ensure that it continues to play a leading role in the revised EU regulatory system by ensuring it has access to high quality scientific resources. This ensures that MHRA makes appropriate decisions to protect UK public health. The UK is seen as a leading Member State in the EU medicines regulatory system and our experts make a significant contribution to the EU regulatory system. Industry continues to be attracted to using MHRA rather than some other regulatory authorities where they have a choice because of the high quality of our assessments. The Agency's overall objective is to ensure that wherever possible UK experts are appointed to EU scientific committees and make a key contribution in support of public health protection.
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| (o) implement a permanent cost and time recording system to allow continuous review of its costs against income streams
| This has been implemented as part of the Agency's Information Management Strategy, a major programme to develop new ways of working supported by a new, integrated, IT structure. All members of staff with access to the Sentinel (the MHRA's new system) participate in the process.
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