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Non Executive Directorships

Member of the British Pharmacopoeia Commission

Location: London

Date Posted: 09/09/2019

Closing Date: 04/10/2019

Vacancy Description

Ministers are seeking to make 6 appointments to the board of British Pharmacopoeia Commission.

Role and Responsibilities of a Member

The British Pharmacopoeia Commission (BPC) was established under Section 4 of the Medicines Act 1968 (superseded by the Human Medicines Regulations 2012). It is responsible for preparing new editions of the British Pharmacopoeia and British Pharmacopoeia (Veterinary) and for keeping them up to date. It also provides advice to the United Kingdom delegation to the European Pharmacopoeia Commission, of which the United Kingdom is a member. The BPC is also responsible for selecting and devising British Approved Names.

The British Pharmacopoeia contributes to the overall control of the quality of medicinal products by providing an authoritative statement of the quality that a product is expected to meet at any time during its period of use. The publicly available and legally enforceable pharmacopoeial standards are designed to complement and assist the licensing and inspection processes and are part of the system for safeguarding purchasers and users of medicinal products.

The BPC is an Advisory Non-Departmental Public Body and is part of the Medicines and Healthcare products Regulatory Agency.

Terms of Reference

Under the terms of the Human Medicines Regulations 2012, the duties of the BPC are to:

  • Prepare new editions of the British Pharmacopoeia and related publications (The British Pharmacopoeia (Veterinary) and British Approved Names);
  • Prepare a list of names to be used as the title of monographs in the British Pharmacopoeia and related publications;
  • Prepare amendments to the British Pharmacopoeia and related publications.

In addition, the duties of the BPC are to:

  • Frame clear and unequivocal technical advice to discharge the Commission’s responsibilities both for the British Pharmacopoeia, the British Pharmacopoeia (Veterinary) and British Approved Names and as the national pharmacopoeial authority with respect to the European Pharmacopoeia;
  • Provide clear advice to support the development of clear policies for the preparation and publication of the British Pharmacopoeia and its related publications;
  • Act as Chair, Vice-Chair or member of one or more Expert Advisory Groups or Panels of Experts of the BPC;
  • Approve new and revised monographs and supporting material for inclusion in new editions of the British Pharmacopoeia, the British Pharmacopoeia (Veterinary) and British Approved Names.

 

Person Specification

To be considered, you must be able to demonstrate that you have the qualities, skills and experience to meet all the essential criteria for appointment.

For all the roles, you must:

  • Be able and prepared to contribute actively to the work of the BPC
  • Be able to assimilate complex information at pace
  • Be a skilled communicator

 You must also:

  • Have a general understanding of the purpose and function of a pharmacopoeia and its place in the overall regulatory system (UK and Europe)
  • Have significant experience in the pharmaceutical industry, academia or the hospital service, including in one or more of the following areas:
    • Quality control of medicinal products (three posts)
    • Analysis of biological and biotechnology products, ideally with expertise in the area of advanced therapy medicinal products and/or biotechnologically produced proteins (one post)
    • Unlicensed medicines (one post)
    • Veterinary medicine (one post)

Be recognised by their peers as an eminent member of their profession, with wide and recent experience in at least one of the following areas:

    • The practice of pharmacy
    • Analytical chemistry
    • Biology
    • Standardisation and specifications for human medicines
    • Standardisation and specifications for veterinary medicines
    • Standardisation and specifications for biological medicines.

 Desirable criteria

You may demonstrate first-hand experience of the work of one or more of the BPC Expert Advisory Groups or Panels of Experts.

 

Additional Information

British Pharmacopoeia Commission role and responsibilities

The British Pharmacopoeia Commission was established in 1970 under Section 4 of the Medicines Act 1968 (superseded by the Human Medicines Regulations 2012). It is an Advisory Non-Departmental Public Body, sponsored by the Department of Health and Social Care. As such, it has no staff but is supported by a Secretariat from the Medicines and Healthcare product Regulatory Agency. A triennial review was carried out in 2014, which confirmed that the BPC performs necessary functions and should continue to operate as an ANDPB.

The key role of the BPC is the preparation of the annual editions of the British Pharmacopoeia (BP), which is widely recognised as one of the leading global pharmacopoeias. The publicly available and legally enforceable pharmacopoeial standards are designed to complement and assist the licensing and inspection processes and are part of the system for safeguarding purchasers and users of medicinal products.

The BPC has responded to the changing pharmaceutical environment, to changes in priority for the European Pharmacopoeia Commission and to the changes taking place within the MHRA to ensure that the agency is fit for the future. This includes supporting innovation and ensuring the safe production and supply of medicines. Current strategic priorities for the BPC include the development of appropriate standards for biological medicines, the development and application of a revised policy on dissolution testing and the potential application of Analytical Quality by Design principles to the development of national monographs. The BPC plays a significant role in the work of the European Pharmacopoeia, contributing to the development of policies and monographs for that pharmacopoeia, and works closely with other national and international pharmacopoeias. It has strong links with the pharmaceutical industry, with academia and with the National Institute of Biological Standards and Control.

Members of the BPC also serve on the Expert Advisory Groups and Panels of Experts responsible for developing national monographs, thereby ensuring that the strategic priorities of the BP Commission are implemented within these groups.

An annual report, highlighting the work of the BPC, is published each year (https://www.gov.uk/government/publications/human-medicines-regulations-2012-advisory-bodies-annual-report-2018).

For further information, see the BP website (https://www.pharmacopoeia.com/the-bp-Commission.

All members must comply with the British Pharmacopoeia Commission Code of Practice on Declaring Interests in the Pharmaceutical Industry (https://www.pharmacopoeia.com/file/BPC-Code-of-Practice.pdf) and must complete an annual declaration of interests form. All members will be subject to an annual appraisal.

Message from Prof Kevin Taylor, Chair, British Pharmacopoeia Commission.

“The British Pharmacopoeia, which produces legally enforceable quality standards for medicinal products, plays a vital role in the regulatory framework that ensures medicines supplied and used in the UK are safe and efficacious.

As Chair it is a real pleasure and privilege to work with members of the BP Commission and its expert groups, the BP Secretariat and laboratory staff, and external stakeholders including industry, to develop meaningful documentary standards which have a direct impact on public health.

With more than 150 years of history, the BP has a strong international presence and an enviable reputation for accessibility, excellence and engagement with external stakeholders. I am very keen that the BP maintains its international pre-eminence whilst continuing to develop and innovate, embracing the latest science, and where appropriate exploring alternative approaches to analytical methods and standards to support innovation and to ensure the quality of all medicines, including biological products.”

 

How to Apply

To make an application please email your CV, a supporting letter and completed monitoring forms to:

appointments.team@dhsc.gov.uk – please quote VAC-1671 in the subject field.

If you are unable to apply by email you may send your application by post to:

Daniel Clemence Department of Health and Social Care, Room 1N09, Quarry House, Quarry Hill, Leeds, LS2 7UE

Applications must be received by midday on Friday 04 October 2019.

In making an application please note the following:

Supporting letter

The supporting letter is your opportunity to demonstrate how you meet each of the criteria set out in the person specification. It will benefit the Advisory Assessment Panel if you can be clear which specific evidence you provide relates to which criteria. Providing separate paragraphs in relation to each criterion is common practice. Please write all acronyms in full first.

Please ensure your full name, the role to which you are applying and the corresponding reference number for the post are clearly noted at the top of your letter.

Please limit your letter to two pages, and type or write clearly in black ink.

Conflicts of interest

If you have any business or personal interests that might be relevant to the work of the BPC, and which could lead to a real or perceived conflict of interest if you were to be appointed, please provide details in your Supporting letter.

If appointed, you will also be required to declare these interests on appointment and they will be entered on a register which is available to the public.

Standards in public life and ensuring public confidence

Given the nature of public appointments, it is important that those appointed as members of public bodies maintain the confidence of the public and Government. If there are any issues in your personal or professional history (including any convictions or bankruptcy) that could, if you were appointed, be misconstrued, cause embarrassment to Ministers or the BPC or cause public confidence in the appointment to be jeopardised, it is important that you bring them to the attention of the Assessment Panel and provide details of the issue/s in your Supporting letter. In considering whether you wish to declare any issues, you should also reflect on any public statements you have made, including through social media and blogs. Due Diligence may be carried out on any publicly available information and shared with the Advisory Assessment Panel.

The panel may explore any issues you declare with you before they make a recommendation on the appointment.

Failure to disclose such information could result in an appointment being terminated, as those who hold public appointments are expected to demonstrate the highest standards of corporate and personal conduct and are required to subscribe to the Code of Conduct for Board Members of Public Bodies, as part of agreeing to the terms and conditions of appointment. You can access this document at:

https://www.gov.uk/government/publications/board-members-of-public-bodies-code-of-conduct

There are also circumstances in which individuals may not be considered for appointment, due to them not meeting certain eligibility criteria for appointment. For further information, please refer to Section 2.3: Eligibility Criteria

If you wish to discuss any queries on conflicts, please see the contacts section.

CV

Please ensure your CV includes:

  • Your full name, title, home address, personal contact telephone numbers (land line and mobile), personal email address and details of any twitter accounts and LinkedIn accounts including your twitter handle/username.
  • Similar contact details for two referees who will support your application. One referee should be the person to whom you are/were accountable in your current/most recent appointment or position of employment. Please indicate the relationship of each referee to you. References will be requested for short-listed candidates prior to interview
  • Brief details of your current or most recent post and the dates you occupied this role. Please identify any past or present Ministerial appointments.

Monitoring form

Please complete the monitoring form. Diversity monitoring information will not be seen by the Advisory Assessment Panel assessing your application.

Political activity information is primarily for monitoring purposes only, however if you are shortlisted for interview, this information will be shared with the selection panel. The reason for this is that it is appreciated that such activities may have given you relevant skills, including experience gained from committee work, collective decision-making, resolving conflict and public speaking. If you have had such experience and you consider it relevant to your application for this post, you should also take the opportunity to include it separately in your supporting statement. If possible, you should not, however, identify the relevant political party in your statement.

If you are appointed to this role, please note that any political activity you declare will be published in accordance with the Governance Code on Public Appointments.

Guaranteed Interview Scheme

The Department of Health and Social Care operates a Guaranteed Interview Scheme (GIS) for disabled people. The Equality Act 2010 defines a person as disabled if they have a physical or mental impairment and the impairment has a substantial and long-term adverse effect on their ability to carry out normal day to day activities. Under the GIS a disabled candidate will be selected for interview if they meet the essential criteria for the post.

If you wish to apply under the GIS please complete the GIS form and return it with your application.

All applications will be acknowledged by email after the closing date.

Contacts

For further information regarding the selection process, please contact

Daniel Clemence

Appointments Team

Tel: 0113 2545335

Email: Daniel.Clemence@dhsc.gov.uk

For further information regarding the role of the BPC and the role of a Member please contact:

Name: Mr James Pound

Tel: 020 3080 6430

Email: james.pound@mhra.gov.uk

or

Name: Dr Fiona Swanson,

Tel: 020 3080 6567,

Email: fiona.swanson@mhra.gov.uk.

Please quote reference VAC-1671 on all correspondence.

If you choose to apply, we would like to thank you in advance for your time and effort in making an application.

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