Terms of reference
These are the published terms of reference for the Medicines and Healthcare products Regulatory Agency.
The Board is primarily responsible for advising on the strategic development of the Agency and ensuring that targets set out in our business plan and endorsed by ministers are met.
The Board will consist of not more than 12 individuals and will be chaired by the Agency chairman. Non-Executive members will be appointed by the Secretary of State following open competition and do not represent any specific customer, sectoral or stakeholder interests.
Since 18 September 2015, when the Board adopted a unitary structure, the Chief Executive and the Chief Operating Officer now serve as executive members of the Board. Other executive directors may attend all Board meetings as observers.
A member of the Department of Health’s Legal Services usually attends to inform the Board on the Agency’s business.
Non-Executive members of the Board should have terms of appointment clearly setting out what is required of them, how their performance will be appraised and the duration of their appointments.
Members should pro-actively declare any potential conflicts of interest arising either from business on the agenda or from changes in their personal circumstances. The Chair should determine an appropriate course of action, from exclusion for a particular item of business to cessation of membership. Where the Chair has a conflict of interest, the other members present should determine the appropriate course of action. Members of the Board are subject to the Agency’s Conflicts of Interest policy and the Cabinet Office’s Code of Conduct for Board Members of Public Bodies.
The Board is primarily responsible for advising on the strategic development of the Agency, holding the executive to account and ensuring that targets set out in our business plan and endorsed by Ministers, are met.
The responsibilities of the Board are set out in the DH and MHRA framework agreement.
The Board is responsible for monitoring the implementation of ministers’ objectives for the strategic direction of the Agency, taking into account the perspective(s) of its stakeholders, and advising Ministers and the Agency accordingly.
In particular this includes the content of the Agency’s annual report including:
- corporate governance and financial management
- business strategy and corporate objectives
- five-year corporate plan (link needed) and annual business plan (link needed)
- key financial and performance targets
- culture and values
- internal and external communications management and quality
The Board monitors the effective, efficient and economic delivery of the Agency’s objectives and ensures that the Agency fulfils its core objectives and complies with all statutory and administrative requirements for the use of Agency funds and the maintenance of the highest standards of corporate governance and public accountability.
The Board, as a whole, does not exercise any line management or executive functions, nor does it have a legal or constitutional role or any liability in respect of decisions of the executive. It does not determine the details of regulatory policy, nor does it have any involvement in any regulatory decisions affecting medicines or medical devices. These are the responsibility of the Chief Executive, working through Corporate Executive Team (CET) directors and their staff, and of the expert advisory committees.
The Board use their experience and expertise and meet these responsibilities by:
- meeting on a regular basis
- attending sub-committees, e.g. Audit and Risk Assurance Committee
- considering strategy papers from the CET and other Agency staff as necessary
- attending occasional Agency events including all-staff meetings, Agency annual lectures and informal briefing meeting with executive staff where necessary.
Meetings will be held up to nine times per financial year, together with two Board/ Corporate Executive Team strategic away days, which usually take place every six months. The Board does not meet in August.
All meetings will be chaired by the Chairman or, in his/her absence, the Deputy Chairman.
Ad hoc meetings where necessary may also be called either by the Chairman or Deputy Chairman.
In exceptional circumstances, should members of the Board be are unable to join a Board meeting in person, they may join by telephone or video link.
Officials from the Department of Health (England) and the three Devolved Administrations (Northern Ireland, Scotland, Wales), may attend as observers.
Since February 2016, the Agency has opened part of its programme of Board meetings to staff observers and members of the public. Up to fifteen staff observers and up to fifteen members of the public may attend the meetings of the Board in public session, which are usually held every quarter.
A quorum for meetings will consist of 6 members, one of whom must be an executive member of the Board.
The Board Secretariat will be responsible for:
- preparing the agenda in consultation with the Chair.
- commissioning Board papers.
- circulating Board papers to members and invitees, normally five working days before each meeting.
- producing and circulating draft minutes of the Board meetings to members, normally within ten working days after the meeting.
- maintaining an action log.
Directorate (Office of the Chairman and Chief Executive) will provide the secretariat for the Board. Minutes of the Board meetings will be provided to the CET for information and consideration. The minutes of Board will be made available to staff to Agency’s intranet, INsite, and more widely on the Agency’s page on GOV.UK.
Corporate executive team
The corporate executive team (CET) is the highest executive decision-making body of the agency.
The CET’s primary responsibilities are to ensure that:
- the strategic direction of the agency is developed in co-ordination with the agency board
- the strategic direction, as set out in the 5-year corporate plan, is implemented and delivered through the business plan
- the agency’s performance targets are met the agency follows the principles of good governance, including:
- risk management and assurance
- financial management and assurance
- information management and assurance
- health and safety assurance
- management of corporate ethics and conflicts of interest; and
- quality management and assurance
- oversight of the activities of the 3 centres within the agency
The CET will meet these responsibilities by:
- developing the 5-year corporate plan, setting out the strategic focus for the agency in the next period, for annual review and agreement by the AB
- agreeing, and overseeing the implementation of, the key strategies that cascade from the corporate plan, including on:
- workforce planning
- information technology
- regulatory and standards
- EU and international
- Clinical Practice Research Datalink (CPRD)
- agreeing, and overseeing the implementation of, an annual business plan, aligned with the 5-year corporate plan
- monitoring of performance against the principles of good governance (as above)
- monitoring the performance and activities of the regulatory, National Institute for Biological Standards and Control (NIBSC) and CPRD centres by way of quarterly governance reports, which will include an assessment against key performance indicators – agreed by CET - for the NIBSC and CPRD centres
- providing a corporate view on specific issues that are brought to CET by directors
- agreeing all papers that are submitted by the executive to the AB
- monitoring of, and reporting to the agency board on, performance against the corporate plan, business plan and operations of the agency
The CET will devolve certain areas of its business to sub-groups, each chaired by a designated director. The CET may also initiate time-limited programmes of work, each led by a designated director. Each of these groups will have their own terms of reference, agreed by the CET.
Frequency of meetings
The CET will meet informally on a weekly basis to share intelligence on emerging issues and to highlight key events in the week ahead. These meetings do not formally consider strategy or governance matters.
The formal responsibilities of the CET will be carried out through a single monthly meeting.
The CET will also meet once per month for a CET mini away day to explore emerging strategic issues. Full away days will also be held.
CET reporting arrangements
Minutes of formal CET meetings will be provided to the agency board.
Quarterly governance reports from the following will be provided to the CET by:
- NIBSC senior management team, CPRD executive committee and the MHRA regulatory group (RG), covering the activities and performance of each of the 3 centres
- CET sub-groups and time-limited programmes of work
Minutes of the MHRA RG will be submitted to the CET for information together with the current issues register.
The directors of NIBSC and CPRD will make monthly reports to the CET on the activities of the senior management team and executive committee respectively.
The CET is chaired by the chief executive and has as members the directors of the corporate divisions, operating divisions and NIBSC and CPRD centres. A representative from the Department of Health Legal Services shall also attend the CET.
The membership is:
- the chief executive as chair
- the directors of: devices division, communications division, information management division, policy division, finance and procurement, human resources, licensing division, inspection, standards and enforcement, vigilance and risk management of medicines, the NIBSC and CPRD
Alternates will be required where full members are unavailable.
Conflicts of interest
Members and alternates will comply with established procedures for .
The agency’s guiding principle is full transparency unless non-disclosure is justified on the basis of established freedom of information exemptions. Final agreed minutes of CET meetings will be published each month following any necessary redactions.