Clause 9 Training

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Clause 9
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9.1

(16.1) All relevant personnel, including representatives, and members of staff, and others retained by way of contract, concerned in any way with the preparation or approval of material or activities covered by the Code must be fully conversant with the Code and the relevant laws and regulations.

  • Clause 9.1 (16.1) Training

    Extensive in-house training on the Code is carried out by companies and by the PMCPA. In addition, the PMCPA runs seminars on the Code which are open to all companies and personnel from advertising agencies, public relations agencies and the like which act for the pharmaceutical industry. Details of these seminars can be obtained from the PMCPA.

most recent cases See all Applicable Code year
Applicable Code year

Please check the date of the Code that applies to the Case that you are looking at. The date of the complaint may vary from the activity/material alleged to have been in breach.
AUTH/3747/2/23 - Anonymous complainant v Otsuka UK Breach: 3.1, 5.1, 6.1, 9.1, 14.4 Applicable Code: 2021 Received: 28 February 2023 Completed: 04 June 2024 AUTH/3779/6/23 and AUTH/3780/6/23 - Ex-employee v Boehringer Ingelheim/Eli Lilly No breach: 5.1, 9.1 Applicable Code: 2021 Received: 19 June 2023 Completed: 21 August 2024 AUTH/3775/6/23 - Complainant v AstraZeneca Breach: 5.1, 5.2, 26.1 No breach: 2, 9.1 Applicable Code: 2021 Received: 07 June 2023 Completed: 14 August 2024 AUTH/3697/10/22 - Complainant v AstraZeneca No breach: 6.1, 6.6, 8.1, 9.1 Applicable Code: 2021 Received: 14 October 2022 Completed: 28 September 2023 AUTH/3634/4/22 - Complainant v Daiichi Sankyo No breach: 2, 6.1, 6.2, 9.1 Applicable Code: 2021 Received: 15 April 2022 Completed: 03 April 2023 AUTH/3617/3/22 - Complainant v GlaxoSmithKline No breach: 2, 9.1, 12.1, 26.1 Applicable Code: 2021 Received: 09 March 2022 Completed: 10 March 2023 AUTH/3579/11/21 - Health professional v Novartis Breach: 5.1, 6.2, 6.1, 14.4, 26.1, 26.2 No breach: 2, 5.2, 5.5, 9.1, 9.3, 14.1, 14.2, 18.1 Applicable Code: 2021 Received: 08 November 2021 Completed: 09 November 2022 AUTH/3573/10/21 - Complainant v GlaxoSmithKline Breach: 5.1, 26.1, 26.2 No breach: 2, 5.1, 8.1, 9.1, 11.1, 12.1, 12.9 Applicable Code: 2021 Received: 27 October 2021 Completed: 07 September 2022

9.2

(16.2) All personnel (and others retained by way of contract) must be fully conversant with pharmacovigilance requirements relevant to their work, and this must be documented.

9.3

(15.1) Representatives must be given adequate training and have sufficient scientific knowledge to enable them to provide full and accurate information about the medicines which they promote.

most recent cases See all Applicable Code year
Applicable Code year

Please check the date of the Code that applies to the Case that you are looking at. The date of the complaint may vary from the activity/material alleged to have been in breach.
AUTH/3579/11/21 - Health professional v Novartis Breach: 5.1, 6.2, 6.1, 14.4, 26.1, 26.2 No breach: 2, 5.2, 5.5, 9.1, 9.3, 14.1, 14.2, 18.1 Applicable Code: 2021 Received: 08 November 2021 Completed: 09 November 2022

9.4

Representatives must take an appropriate examination within their first year of employment as a representative and must pass it within two years of starting such employment. To be acceptable, an appropriate examination must have been accredited to at least Level 3 or its equivalent by an external awarding body recognised by Ofqual.

An appropriate examination for medical representatives is one that requires a broad understanding of body systems, diseases and treatments, the development of new medicines and the structure and function of the NHS and of the pharmaceutical industry. Such an examination must be at the level of a Diploma (equivalent to at least 480 hours Total Qualification Time).

An appropriate examination for generic sales representatives is one that requires a broad understanding of body systems and the structure and function of the NHS and of the pharmaceutical industry. Such an examination must be at the level of a Certificate (equivalent to at least 330 hours Total Qualification Time).

An appropriate examination can be either the relevant ABPI examination (advanced or intermediate programme for industry personnel) or an examination of at least the same standard which covers similar content and learning material as the corresponding ABPI examination.

  • Clause 9.4 Representatives Examinations

    The ABPI offers two examinations, and further details can be obtained from the ABPI.

    Examinations may also be offered by other providers. A company using an examination provider other than the ABPI must be able to demonstrate that its examinations are at least equivalent to those offered by the ABPI. The syllabus studied should be mapped to and meet the requirements in the published ABPI standards. The assessment must be under invigilated examination conditions.

    The ABPI Advanced Programme for Industry Personnel (previously called ABPI Medical Representatives Examination) is appropriate for representatives whose duties comprise or include one or both of:

    • calling upon doctors and/or dentists and/or other prescribers

    • the promotion of medicines on the basis of, among other things, their particular therapeutic properties.

    The ABPI Intermediate Programme for Industry Personnel (previously called ABPI Generic Sales Representatives Examination) is appropriate for representatives who promote medicines primarily on the basis of price, quality and availability to non-prescribers.

    Persons who have passed the ABPI Advanced Programme for Industry Personnel or similar whose duties change to those specified for generic sales representatives do not need to take another examination. However, persons who have passed the ABPI Intermediate Programme for Industry Personnel or similar whose duties change to those specified for medical representatives must take an appropriate examination within one year of their change of duties and pass it within two years.

  • Clause 9.4 Accredited Examinations

    Representatives commencing such employment on or after 1 October 2014 must take an accredited examination. The unaccredited examination ceased on 31 December 2015.

    A candidate who has taken part of an ABPI examination who wishes to transfer to a new provider will have to take the whole of the new provider’s examination. Similarly, a candidate who has taken part of an alternative provider’s examination who wishes to transfer to an ABPI examination will have to take the whole of that examination. This will not apply if it can be demonstrated that the units already passed are equivalent to those of the new provider.

  • Clause 9.4 Information from Examination Provider

    A company must ensure that its examination provider would respond to requests for information from the PMCPA.

  • Clause 9.4 Time Allowed to Pass an Examination

    Prior to passing an appropriate examination, representatives may be engaged in such employment for no more than two years, whether continuous or otherwise and irrespective of whether with one company or with more than one company. A representative cannot, for example, work eighteen months with one company and eighteen months with another and so on, thus avoiding an examination. Maternity or paternity leave does not count towards the specified time periods.

    In the event of extenuating circumstances, such as prolonged illness or no or inadequate opportunity to take an appropriate examination, the Director of the PMCPA may agree to the continued employment of a person as a representative past the end of the two year period, subject to the representative passing an appropriate examination within a reasonable time.

    Similarly, in the event of failure to take an appropriate examination within the first year, the Chief Executive may agree to an extension, subject to the representative taking an examination within a reasonable time.

    An application for an extension should be made on a form available from the PMCPA. It should preferably be made by the company rather than the representative.

    Service as a representative prior to 1 January 2006 by persons who were exempt from taking the appropriate examination by virtue of Clause 16.4 of the 2003 edition of the Code does not count towards the two year limit on employment as a representative prior to passing the appropriate examination.

  • Clause 9.4 Extensions to the Time Allowed to Pass an Examination as a Result of the COVID-19 Pandemic

    Arrangements for extensions to the time allowed to pass an examination as a result of the COVID-19 pandemic are set out in the supplementary information to Clause 9.4 of the 2021 Code.

    Arrangements were put in place in the 2021 Code as the ABPI examination was not available between 13 March 2020 and 30 September 2020 due to the impact of the COVID-19 pandemic.

9.5

Details of the numbers of representatives who have passed an examination, together with the examination status of others, must be provided to the PMCPA on request.