Veterinary Products Committee Appointment of Five Members Information pack for applicants The closing date for the receipt of applications for these roles is: Friday, 09 October 2015 at Noon Ref: PAPPT 007/15 #752926 Information packs are available in other formats such as larger font and Braille. If you need a different format please contact us. Email: publicappts@defra.gsi.gov.uk Diversity To ensure our public bodies better represent the communities we serve, we positively welcome applicants from all walks of life. All public appointments are made on merit following a fair and open competition as regulated by the Office of the Commissioner for Public Appointments. Equal opportunities UK government has a policy of equality of opportunity. We aim to promote equal opportunity policies whereby no one suffers unfair discrimination either directly or indirectly, or harassment, on grounds such as race, colour, ethnic or national origin, sex, gender identity, marital status, disability, sexual orientation, religious beliefs or age. Disability Defra will be operating an interview access scheme for disabled people (as defined by the Equalities Act 2010) who meet the minimum criteria for this appointment as published in these notes. If you wish to apply for consideration under this scheme, please notify the Department when you return your application. In addition, if you require any special arrangements at interview stage, please give details in a covering letter to enable us to make the appropriate arrangements if necessary. Furthermore, adjustments will be made in the event of a successful application. Contents The Veterinary Products Committee (VPC)..................................................................... 4 Introduction 4 What is the Veterinary Products Committee 4 Further information 4 The Role.......................................................................................................................... 4 Description of the roles available 4 Essential criteria 5 Essential criteria (1 to 3) for all roles 5 Role-specific essential criteria 5 Terms of appointment 5 Period of appointment 5 Remuneration and allowances 6 Annual Appraisal 6 Conflicts of Interest 6 Applying for a role ........................................................................................................... 7 The Commissioner for Public Appointments 7 How to respond 7 Selection Process 7 Short listing 7 Interviews & Selection Panel 8 How we will handle your application 8 Data protection 8 Annex A........................................................................................................................... 9 The Seven Principles of Public Life 9 Annex B......................................................................................................................... 10 VPC terms of reference 10 Annex C ........................................................................................................................ 10 Current Membership 10 Annex D ........................................................................................................................ 12 A code of practice for members of the Veterinary Products Committee 12 Different Types of Interest ............................................................................................. 12 Declaration of interests during the meeting and implications 14 VPC member's declaration of interests in the pharmaceutical industry 15 3 The Veterinary Products Committee (VPC) Introduction The Veterinary Products Committee was originally established in 1970. The current provision providing for its continued existence is regulation 28 of the Veterinary Medicines Regulations 2013 (SI 2013/2033). Members of the VPC are appointed by the Department for Environment Food and Rural Affairs (Defra). We need to appoint five new members for terms of office ending on 31 December 2019. Members are required to abide by the Nolan principles of public service, (Annex A). The appointments are not for full-time employment. What is the Veterinary Products Committee The VPC is a scientific advisory committee consulted by the Veterinary Medicines Directorate (VMD) when it requires advice on specific scientific issues relating to the authorisation of veterinary medicines and it considers reports of suspected adverse events relating to veterinary medicines. The VPC also considers appeals when the VMD intends to suspend a Marketing Authorisation (MA) on the grounds of safety, quality or efficacy, or to refuse to grant a MA or an Animal Test Certificate, grant one that is different from that which was applied for, vary it other than on the application of the holder, refuse to grant a variation applied for by the holder, or revoke it. The VPC’s terms of reference are given at Annex B. Members of the VPC are independent experts in their particular specialisms who contribute by their individual expertise and judgement to the advice given by the VPC to the VMD. A list of current members is given at Annex C. The majority of documents for VPC meetings are distributed electronically two weeks before a meeting with a second distribution one week before the meeting. Documents are also made available on the VPC members’ website forum. It is expected that Members will have access to the internet and will use their laptops at meeting to access documents. Further information For further information on the work of the VPC either contact Lea Stott, VPC Secretariat, Veterinary Medicines Directorate, Woodham Lane, New Haw, Addlestone Surrey KT15 3LS (email: l.stott@vmd.defra.gsi.gov.uk or tel: 01932 338490) or go to GOV.UK. The Role Description of the roles available Members of the VPC are independent experts in their particular specialisms. As a member of the VPC you will contribute by your individual expertise and judgement to the advice given by the VPC to the VMD. 4 Essential criteria Essential criteria (1 to 3) for all roles Essential 1: An ability to communicate effectively with a range of stakeholders. Essential 2: A strong record of achievement in applying your specialist knowledge to influence decision making. Essential 3: Experience in successfully arriving at sound, balanced, and timely decisions independently and with others (e.g. in committee). Role-specific essential criteria VPC Role 8: Clinical Toxicologist Essential 4: You will be medically qualified and have current or recent experience in clinical toxicology. VPC Role 9: Toxicologist Essential 4: You will be knowledgeable in the application of toxicology to the development of new medicines and/or pesticides. Essential 5: You will have current experience in the investigation of adverse events and in the assessment of safety to animals and humans. VPC Role 10: Working Farmer Essential 4: You will have first-hand knowledge of the on-farm use of veterinary medicines in a range of farm animals. Essential 5: You will be familiar with UK agricultural practices. VPC Role 11: Veterinary surgeon (large animal) Essential 4: You will be a practising veterinary surgeon and have an interest or specialism in large animal medicine. VPC Role 12: Environmental Scientist Essential 4: You will be an environmental scientist knowledgeable about the fate and effects of pharmacological active substances in the environment, and how to assess the overall risk to the environment from exposure to chemicals and risk management options. For further information on these roles please contact Lea Stott, VPC Secretariat, Veterinary Medicines Directorate, Woodham Lane, New Haw, Addlestone Surrey KT15 3LS (email: l.stott@vmd.defra.gsi.gov.uk or tel: 01932 338490). Terms of appointment Period of appointment These appointments are for terms of office beginning on 1 January 2016 and are normally for four years. Members may resign at any time by notice in writing to the Minister. The Minister may terminate the appointment under certain conditions, which will be notified to the successful candidate on appointment. 5 Remuneration and allowances The Committee holds regular meetings, usually in January, May and September, at the offices of the VMD, Woodham Lane, New Haw, Addlestone, Surrey KT15 3LS and it may, occasionally, be necessary to hold ad hoc meetings. Meetings begin at 09:45 and generally finish mid-afternoon. Members are expected to make every attempt to attend meetings. Where appropriate, the VPC secretariat will arrange overnight accommodation at a local hotel for those members who find it more convenient to travel the day before a meeting and will arrange for taxis to meet members at local railway stations or Heathrow/Gatwick. In addition to attendance at meetings, members need to allow sufficient time to prepare for the meeting by familiarising themselves with the agenda and supporting documents, which, in most cases, should take no longer than a day and, quite often, much less. However, if a member is asked to lead the discussion on, for example, an application for a marketing authorisation, the amount of data to consider could be quite substantial, although the specific issues to be addressed will be made clear in an accompanying paper. The VPC also holds an open meeting, usually in the autumn, which provides an opportunity for interested parties to discuss with the Committee the advice it has given to the VMD over the preceding year. Members may be asked to make presentations on different aspects of the Committee’s work. Members receive £148 for each meeting attended and an additional £76 for preparation time spent reading the papers prior to the meeting. The role is not pensionable. Members will be reimbursed the full cost of travel as a consequence of attendance at committee meetings but are asked to use the most economical method of transport available. Claims must always be supported by original tickets or receipts (not photocopies or travel agents’ invoices). Members will also be reimbursed for any legitimate costs, not covered by other allowances, which are incurred as a consequence of attending VPC meetings. These may include, amongst other things, the cost of a locum, additional childcare etc. Original receipts/invoices that clearly outline the nature of the cost incurred must support these claims. Gratuities to porters, stewards, taxi drivers etc. cannot be reimbursed from public funds. Further advice on claiming expenses will be provided by the committee's secretariat. Annual Appraisal The VPC Chair will carry out an annual evaluation of each VPC member. The VMD's directors will carry out an annual evaluation of the VPC Chair. Conflicts of Interest Members of the VPC are required to follow a code of conduct on relations with the pharmaceutical industry and, upon appointment, you will be required to complete the declaration shown at Annex D. It is also a requirement for members to make a declaration of their interests at each meeting and to withdraw from discussions on any 6 items where these may be deemed to influence their contribution. All the interests of members are recorded in the VPC annual report, published on GOV.UK. Members must not engage in specific political activities on matters directly affecting the work of the VPC or its sub-committees. Applying for a role The Commissioner for Public Appointments This appointment is regulated by the Commissioner for Public Appointments, to ensure that it is made on merit after fair and open competition. More information about the role of the Commissioner and their Code of Practice is available from http://publicappointmentscommissioner.independent.gov.uk/wpcontent/uploads/2012/02/Code-of-Practice-20121.pdf For full details of the complaints process for public appointments, please click on the following link which will take you to the Commissioner for Public Appointments website http://publicappointmentscommissioner.independent.gov.uk/contact-us/ Alternatively please contact the Commissioner’s office on 0207 271 0831 for a printed copy. How to respond All candidates are required to complete the following forms: Political Activity Questionnaire Diversity Monitoring Questionnaire Conflicts of interest Questionnaire Advertising Questionnaire Candidates should submit their CV with education, professional qualifications and employment history and the names and contact details for two referees, together with their statement of suitability. The statement of suitability should give evidence of strength and depth of your ability to meet essential criteria for this role. Please provide specific examples to demonstrate how you meet each of the criteria (max two pages please). Your CV and statement should be returned to the following address by the closing date: Noon. Email to publicappts@defra.gsi.gov.uk quoting reference PAPPT 007/15. Selection Process Short listing This appointment is being made in accordance with the guidance laid down by the Office of the Commissioner for Public Appointments (OCPA). The candidates who demonstrate that they meet all of the essential criteria will be invited to interview. It is therefore essential for your statement to give full but concise information relevant to the appointment. The short listing Panel will comprise Paul Green (VMD Director of Operations) and will include the VPC Chair, Professor Bill Reilly, and Julia Drown (Non-executive Director, VMD). 7 Interviews & Selection Panel Interviews will take place between 16, 17 and 25 November at the VMD, Woodham Lane, New Haw, Addlestone, Surrey, KT15 3LS. The selection panel for all roles will be chaired by Paul Green (VMD Director of Operations) and will include the VPC Chair, Professor Bill Reilly, and Julia Drown (Non-executive Director, VMD). If you are invited for interview you will receive a local map with directions to the VMD from the M25. If you are travelling by train to West Byfleet station and advise Lea Stott, VMD (01932 338490 or email l.stott@vmd.defra.gsi.gov.uk) of your estimated time of arrival she can arrange for a taxi to meet you. She can also make a similar arrangement if you are coming via Heathrow or Gatwick airports. The interview will last about 45 minutes and candidates will be asked questions to assess whether they can demonstrate that they meet the essential criteria. All interviewees will be advised in writing of the outcome of the interview. Candidates will be able to claim reasonable expenses incurred travelling to and from the interview (please note you may be asked to justify travelling costs if the Department consider the claims unnecessarily excessive). Please let Lea Stott know beforehand if you are likely to claim and costs if known. For queries about your application or the recruitment process, please email the Public Appointment Team publicappts@defra.gsi.gov.uk. How we will handle your application Defra will acknowledge receipt of CVs and your statement. Candidates will be contacted again after the closing date and once the panel have considered all the applications. Data protection Defra is committed to protect your privacy and to process your personal information in a manner which meets the requirements of the Data Protection Act 1998. 8 Annex A The Seven Principles of Public Life Selflessness Holders of public office should act solely in terms of the public interest. Integrity Holders of public office must avoid placing themselves under any obligation to people or organisations that might try inappropriately to influence them in their work. They should not act or take decisions in order to gain financial or other material benefits for themselves, their family, or their friends. They must declare and resolve any interests and relationships. Objectivity Holders of public office must act and take decisions impartially, fairly and on merit, using the best evidence and without discrimination or bias. Accountability Holders of public office are accountable to the public for their decisions and actions and must submit themselves to the scrutiny necessary to ensure this. Openness Holders of public office should act and take decisions in an open and transparent manner. Information should not be withheld from the public unless there are clear and lawful reasons for so doing. Honesty Holders of public office should be truthful. Leadership Holders of public office should exhibit these principles in their own behaviour. They should actively promote and robustly support the principles and be willing to challenge poor behaviour wherever it occurs. 9 Annex B VPC terms of reference The VPC’s terms of reference are to: (i) provide the Secretary of State with scientific1 advice on any aspect of veterinary medicinal products and specified feed additives; (ii) hear representations on decisions relating to the granting, refusal, variation, suspension or revocation of a marketing authorisation for a veterinary medicinal product or an animal test certificate; (iii) promote the collection of information relating to suspected adverse reactions for the purpose of enabling the advice at i) above to be given. Each year the Veterinary Products Committee will publish a report of its activities and those of its sub-committees. ¹Scientific advice means all aspects, including risk/benefit analysis, of the safety, quality and efficacy of a veterinary medicinal product apart from regulatory issues. Annex C Current Membership Professor Bill Reilly Chairman Mrs Margaret Chambers Lay member Mrs Nicola Ackerman Veterinary nursing Dr Chris Collins Food safety/risk assessment Mr Rory Bell Veterinary surgeon (small animal) Ms Sally Harmer Suitably Qualified Person (large animal) Professor Malcolm Bennett Virology/infectious diseases Dr Robert Jefferson Clinical toxicology Dr Tanya Bleiker Dermatology Dr Elizabeth Kubiak Medical microbiology Professor Clare Bryant Pharmacology Mr Stephen Lister Veterinary surgeon (poultry) Professor Francis Burke Hand surgery Dr Tim Marrs OBE Toxicology Professor David Cavanagh Molecular biology/genetics Professor Jacqui Matthews Parasitology 10 Mr Robert Morris Pharmacy Mr Peter Scott Veterinary surgeon (fish) Mr Declan O’Rourke Risk analysis Mr John Sherington Statistics Professor Andrew Peters Veterinary immunology Mr Keith Siddorn Working farmer Mr Andrew Praill Veterinary surgeon (large animal) Vacancy Environmental science Professor Colin Robertson Physician (A & E) Vacancy Veterinary surgeon (public health) 11 Annex D A code of practice for members of the Veterinary Products Committee Conflicts of interest The Veterinary Products Committee's advice concerns matters which are connected with the pharmaceuticals industry and it is therefore desirable that members should have a good understanding of the work of the industry. It is also desirable that some members should have practical experience of the scientific problems of product development. The pharmaceuticals industry relies heavily on the advice of doctors, veterinarians and pharmacists outside the industry in, for example, the universities. To avoid any public concern that commercial interests might affect the Committee's advice, ministers have decided that the arrangements which govern relationships between members and the pharmaceuticals industry and information on significant and relevant interests should be on public record. You will therefore comply with the following Code of Practice which describes the circumstances in which you should declare an interest in the pharmaceuticals industry. In this Code of Practice ‘pharmaceuticals industry’ means: companies, partnerships or individuals who are involved with the manufacture, sale or supply of veterinary medicinal products (including veterinary homoeopathic products) trade associations representing companies involved with such products companies, partnerships or individuals who are directly concerned with research, development or marketing of a veterinary medicinal product (including a veterinary homoeopathic product) which is being considered by the Committee. References to 'the pharmaceuticals industry' include cases involving a single company. In this Code of Practice ‘the secretariat’ means the secretariat of the Veterinary Products Committee. Different Types of Interest The following is intended as a guide to the kinds of interests which should be declared. If you are uncertain whether an interest should be declared you should consult the secretariat or, if it concerns a particular product which is to be considered at a meeting, the Chairman at that meeting. If you have an interest not specified in these notes but which you believe could be regarded as influencing your advice you should declare it. However, you do not need to search out links between one company and another, for example where a company with which you are connected has an interest in a pharmaceutical company of which you are not aware and could not reasonably be expected to be aware. 12 Personal Interests A personal interest involves payment to you personally. The main examples are: any consultancy, directorship, position in or work for the pharmaceutical industry, which attracts regular or occasional payments in cash or kind any work commissioned by the pharmaceutical industry for which you are paid in cash or kind any shareholding in or other beneficial interest in shares of the pharmaceutical industry but excluding shareholdings through unit trusts or similar arrangements where you have no influence on financial management. Non-personal Interests A non-personal interest involves payment which benefits a department for which you are responsible, but you do not receive personally. The main examples are: the holding of a fellowship endowed by the pharmaceutical industry any payment, other support or sponsorship by the pharmaceutical industry which does not convey any pecuniary or material benefit to you personally but which does benefit your position or department e.g. a grant from a company for the running of a unit or department for which you are responsible a grant or fellowship or other payment to sponsor a post or a member of staff in the unit for which you are responsible but excluding financial assistance for students the commissioning of research or other work by, or advice from, staff who work in a unit for which you are responsible. You are under no obligation to seek out knowledge of work done for, or on behalf of, the pharmaceutical industry in departments for which you are responsible if you would not normally expect to be informed. 13 Declaration of interests during the meeting and implications NATURE OF INTEREST You have at any time worked on the product under consideration and have personally received payment for that work from the industry. INVOLVEMENT IN DISCUSSION You should take no part in the proceedings as they relate to that product and would normally be asked to leave the room for the duration of the discussion. Lapsed Personal Specific As above but the interest is no longer current. You can take part in proceedings. Personal non-specific Current personal interest in the pharmaceutical company concerned which does not relate specifically to the product under discussion. You should take no part in the proceedings as they relate to that product, except at the Chairman's discretion to answer questions from other members. Current Personal Either in the pharmaceutical company concerned which does not relate specifically to the product under discussion or in a company marketing a rival product. You should take no part in the proceedings as they relate to that product, except at the Chairman's discretion to answer questions from other members. Non-Personal Specific You are aware that the department for which you are responsible has at any time worked on the product under discussion. You may take part in the proceedings unless you have personal knowledge of the product through your own work or the supervision of others in which case, you should take no part in the proceedings as they relate to that product, except at the Chairman's discretion to answer questions from other members. Non-Personal, NonSpecific You are aware that the department for which you are responsible is currently receiving payment from the company which does not relate to the product under discussion. You may take part in the proceedings unless the Chairman rules otherwise. Personal Specific DESCRIPTION 14 VPC member's declaration of interests in the pharmaceutical industry Name: ................................................................................................................... Under the Guidance of the Code of Practice on Declarations of Interest, I wish to declare to the Veterinary Medicines Directorate that I have no interests in the pharmaceutical industry: Please go to Section 3. . my interests1 in the pharmaceutical industry are declared below: Please complete sections 1 – 3 as necessary and Section 4. . Section 1 Current personal interests Name of company 1 Nature of interest (e.g. Shares, fees, consultancy, salary, grants etc.) Please state if your interest is limited to a particular product or group of products 15 Section 2 Non-personal interests Name of company Nature of interest 16 Whether current Yes or no Section 3 Additional information: Please include here any information which, whilst not strictly a personal or nonpersonal interest within the definitions of the Code, may nevertheless cause a conflict of interest. (For example a partner or close member of your family has an influential post in a pharmaceutical company.) If none, please state 'None'. Then go to Section 4. Section 4 I will advise the Veterinary Medicines Directorate of any changes to this information. Date: ....................................... Signature: ......................................................................... Please return this document to the VPC Secretary at the Veterinary Medicines Directorate, Woodham Lane, New Haw, Addlestone, Surrey, KT15 3LS. 17