What Joint Working material requires certification?

  • Clause 8.1 (14.1) Certification

    An acceptable way to comply with Clause 8.1 is for the final proof to be certified, but this is not obligatory provided that that which is certified is in its final form to which no subsequent amendments will be made. Companies may use validated electronic signatures for certifying material. Paper or electronic copies of certificates and the final form of material etc must be preserved in order to comply with Clause 8.6.

    All promotional material must be certified in this way, including audio and audiovisual material, promotional material on databases, interactive data systems and the internet and relevant representatives’ briefing materials. Promotional aids must also be certified – although not strictly promotional material, they are used for a promotional purpose.

    Companies should be aware that if they use a non-promotional item for a promotional purpose, it would need to be certified.

    When certifying material where the final form is to be printed, companies can certify the final electronic version of the item to which no subsequent amendments will be made. When such material is printed, the company must ensure that the printed material cannot be used until the item has been examined and signed in its final form to ensure it accurately reflects the content and presentation certified electronically. In such circumstances, the material will have a certificate and a declaration approving the final form and both must be preserved as they form the certification of the item. The examination of the printed form can be carried out by a signatory, an appropriately qualified person signatory (AQP signatory) or an appropriately qualified person (AQP).

    In certifying audio and audiovisual material and promotional material on databases, interactive systems and the internet, companies must ensure that a written transcript of the material is available, including reproductions of any graphs, tables and the like that appear in it. In the event of a complaint, a copy of the written material will be requested. Alternatively, companies may certify material on interactive systems by means of producing an electronic copy, for example, on a CD-ROM or data stick, if the electronic copy is write protected and unable to be changed.

    See also the supplementary information to Clause 11 regarding the certification of promotional material to be used at international conferences.

  • Clause 8.1 (14.1) Certifying Dynamic Content

    When certifying dynamic content such as websites etc care must be taken to ensure the dynamic content meets the requirements of the Code as a standalone item. As the final form is not static, consideration needs to be given to the context in which it appears but each possible combination does not need to be certified.

  • Clause 8.1 (14.1) Qualifications for Signatories

    In deciding whether a person can be a nominated signatory, account should be taken of product knowledge, relevant experience both within and outside the industry, length of service and seniority. In addition, signatories must have an up-to-date, detailed knowledge of the Code. The registered medical practitioner should be capable of being registered in the UK without the need for additional tests of medical/clinical knowledge.

  • Clause 8.1 (14.1) Joint Ventures and Co-Promotion

    In a joint venture in which a third party provides a service on behalf of a number of pharmaceutical companies, the pharmaceutical companies involved are responsible for any activity carried out by that third party on their behalf.

    It follows, therefore, that the pharmaceutical companies involved should be aware of all aspects of the service carried out on their behalf and take this into account when certifying the material or activity involved. Similarly, if two or more pharmaceutical companies organise a joint event/meeting, each company should ensure that the arrangements for the event/meeting are acceptable.

    Under co-promotion arrangements or other arrangements where companies work together, such as collaborative working projects, the companies concerned can agree to have only one final signatory to certify on behalf of all the companies. This must all be agreed beforehand and the MHRA and the PMCPA must be informed in advance who the signatory will be. In the event of a complaint about material certified in this way, each company involved in the project/activity would be responsible under the Code.

  • Clauses 8.1 and 8.2 Appropriately Qualified Persons

    It is possible for a company to have different individuals who would act as an AQP for examination depending on their skill sets and the material and activities etc being examined. For example, an individual with proof reading skills could examine and sign the final form of printed material which has been certified electronically as set out in the supplementary information to Clause 8.1. It is unlikely that this AQP would also have the necessary skills to examine market research material to ensure it does not contravene the Code as set out under the supplementary information to Clause 8.3.

  • Clause 8.2 (14.2) Events/Meetings Involving Travel Outside the UK

    UK companies have responsibilities under the Code for events/meetings which they organise and when UK delegates are supported and/or UK speakers are contracted to go to events/meetings outside the UK. Clauses 24, 28, 29, 30 and 31 in relation to disclosure of transfers of value will also need to be followed.

    When certifying arrangements for events/meetings which involve travel outside the UK, all the relevant documents and arrangements must be considered, including the programme, the venue, the reasons for using that venue, the intended audience, the anticipated cost and the nature of the hospitality and the like.

    If the company’s only involvement is to support a speaker to present at the event/meeting and there is no pharmaceutical company involvement with the event/meeting at all, for example, a learned society event/meeting, then neither certification nor examination is required.

  • Clause 8.2 (14.2) Presentations by UK Speakers at Events/Meetings Held Outside the UK

    When a pharmaceutical company based outside the UK arranges via a UK company for a UK speaker to present at an event/meeting to be held outside the UK, then that speaker’s presentation materials do not need to be certified or examined by the UK, provided there are no UK delegates and the UK company has no role whatsoever in relation to the event/meeting or the presentation. In such circumstances, the event/meeting arrangements, in as much as they apply to the UK speaker, will not have to be certified or examined.

  • Clause 8.2 (14.2) Qualifications for those who Certify Events/Meetings Involving Travel Outside the UK

    In deciding whether someone other than a registered medical practitioner or a pharmacist registered in the UK is appropriately qualified to certify events/meetings involving travel outside the UK (AQP signatory), account should be taken of relevant experience both within and outside the industry, length of service and seniority. In addition, such a person must have an up-to-date and detailed knowledge of the Code.

  • Clauses 8.1 and 8.2 Appropriately Qualified Persons

    It is possible for a company to have different individuals who would act as an AQP for examination depending on their skill sets and the material and activities etc being examined. For example, an individual with proof reading skills could examine and sign the final form of printed material which has been certified electronically as set out in the supplementary information to Clause 8.1. It is unlikely that this AQP would also have the necessary skills to examine market research material to ensure it does not contravene the Code as set out under the supplementary information to Clause 8.3.

  • Clause 8.3 (14.3) Examination of Other Material

    Material issued by companies which is not required to be certified under the Code should be examined by a signatory or an AQP, who needs not be a signatory, to ensure that it does not contravene the Code or the relevant statutory requirements. Such material might include corporate advertising, press releases, market research material, financial information to inform shareholders, the Stock Exchange and the like, and written responses from medical information departments or similar to unsolicited enquiries from the public etc.

  • Clause 8.4 (14.4) Notification of Signatories

    The names and qualifications of signatories and changes to them should be notified to the MHRA by email to signatories.advertising@mhra.gov.uk. The PMCPA can be notified by completing the nominated signatory form which can be found at www.pmcpa.org.uk. The names and qualifications to be sent to the MHRA and PMCPA are those of the registered medical practitioner or the pharmacist registered in the UK or, if the product is for dental use only, a UK registered dentist as set out in Clause 8.1 and the AQP signatory as set out in Clause 8.2.

  • Clause 8.6 (14.6) Retention of Documentation

    The MHRA is entitled to request details of an advertisement, including particulars as to the content and form of the advertisement, the method of dissemination and the date of first dissemination, and such a request is not subject to any time limit. This does not apply to the certificates themselves in respect of which the three year limit in Clause 8.6 is applicable. There is further information in the MHRA Blue Guide.

  • Clause 20 Medical and Educational Goods and Services which Comply with Clause 19 of the 2019 ABPI Code, Including their Transition under the 2021 ABPI Code.

    Medical and educational goods and services (MEGS) provided under Clause 19 of the 2019 Code are likely to fall under donations in Clause 23 or collaborative working in Clause 20 of the 2021 Code. Companies wishing to continue with ongoing MEGS from 1 July 2021 can do so until 31 December 2021 under the 2021 Code without the need for them to be reclassified as either a donation or collaborative working and comply with any new requirements as a result of this change. Thus there is a six month transition period for MEGS.

    If the collaborative working involves services, then the supplementary information to Clause 23 Donations and Grants should be considered.

  • Clause 20 Collaborative Working with Organisations

    Collaborative working between the pharmaceutical industry, healthcare organisations and others must be conducted in an open and transparent manner and must either enhance patient care or be for the benefit of patients or, alternatively, benefit the NHS and, as a minimum, maintain patient care. It is expected that the arrangements will also benefit the NHS and the pharmaceutical company or companies involved. Treatments, when mentioned, must be in line with nationally accepted clinical guidance where such exists. Collaborative working differs from the situation where pharmaceutical companies provide funds in the form of a grant for a specific event or programme.

    Collaborative working between the pharmaceutical industry, healthcare organisations and others may, in addition, involve working with a patient organisation. In such circumstances, the arrangements for the patient organisation involvement must comply with Clause 27 and is likely to be a contracted service, as set out in Clause 27.5.

    Collaborative working is acceptable in principle provided that it is carried out in a manner compatible with the Code. Collaborative working must not constitute an inducement to health professionals or other relevant decision makers to prescribe, supply, recommend, buy or sell any medicine. It must, therefore, always be ensured that none of the benefits of any collaborative working project go to these individuals or their practices. If the collaborative working is a joint working project and there are benefits which are due to the NHS, these must go to an NHS or similar organisation.

    The use of a particular medicine of a company party to a collaborative working agreement is not prohibited provided all parties are satisfied that the use of the medicine is appropriate and that the requirements for collaborative working are met.

    Resources provided by the company to deliver the collaborative working project must be relevant and the agreement as a whole must be fair and reasonable. Any resources provided by the company must themselves contribute to either patient care or healthcare.

    The written agreement should cover the following points:

    • the name of the collaborative working project, the parties to the agreement, the date and the term of the agreement

    • the expected benefits for patients, the population or user groups, the NHS, pharmaceutical company and other organisation(s) as applicable; benefits should always be stated first, and outcomes should be measured

    • an outline of the financial arrangements

    • the roles and responsibilities of the NHS, the pharmaceutical company and other organisations and how the success of the project will be measured, when and by whom; all aspects of input should be included

    • the planned publication of any data or outcomes

    • if a pharmaceutical company enters into a collaborative working agreement on the basis that its product is already included in an appropriate place on the local formulary, a clear reference to this should be included in the collaborative working agreement so that all the parties are clear as to what has been agreed

    • contingency arrangements to cover possible unforeseen circumstances such as changes to summaries of product characteristics and updated clinical guidance; agreements should include a dispute resolution clause and disengagement/exit criteria, including an acknowledgement by the parties that the project might need to be amended or stopped if a breach of the Code is ruled

    • publication by the company of a summary of the collaborative working agreement, for example, on a clearly defined website or section of a website, such as on the company’s or companies’ websites; the healthcare organisation(s) and other parties involved in the collaboration should also be encouraged to publish this

    • outcomes should be published by all parties as soon as possible and usually within six months of the project’s completion, so that other NHS organisations and others can learn from and potentially replicate the initiative. Companies should publish the outcomes on their websites.

    Collaborative working should be distinguished from straightforward sales where medicines are simply sold and there are no accompanying goods and services etc and from package deals and outcome or risk sharing agreements as defined in the supplementary information to Clause 19.1.

  • Clause 20.4 (20) Joint Working as a Form of Collaborative Working

    Joint working as defined by the Department of Health and first introduced in the Code in 2008 is a form of collaborative working as set out in Clause 20.

    The Department of Health defines joint working between the NHS and the pharmaceutical industry as situations where, for the benefit of patients, one or more pharmaceutical companies and the NHS pool skills, experience and/or resources for the joint development and implementation of patient centred projects and share a commitment for successful delivery. Each party must make a significant contribution and the outcomes must be measured. Treatments, when mentioned, must be in line with nationally accepted clinical guidance where such exists.

    In addition to the certification requirements set out in Clause 20.3, the joint working project initiation document must also be certified.

    The Department of Health has issued best practice guidance on joint working between the NHS and pharmaceutical industry and other relevant commercial organisations. The ABPI has produced guidance notes on joint working between pharmaceutical companies and the NHS and others for the benefit of patients with separate guidance for England, Scotland and Wales. When considering joint working, companies should take account of the applicable guidance.

    Collaborative working which relies on benefiting the NHS and maintaining patient care will not meet the requirements for a joint working project.

  • Clause 20.5 (24.2) Disclosure

    The information required by Clause 20.5 as to transfers of value must be publicly disclosed annually, giving in each case the financial amount or value and the name of the recipient.

    Companies must ensure that the amount spent on collaborative working projects is made public irrespective of whether the value is transferred to a healthcare organisation etc or some other funding model is used. Disclosure must be carried out in accordance with Clause 28.

Joint working is a form of collaborative working and the requirements for each collaborative working project, including the certification requirements are set out in Clauses 20.1, 20.2 and 20.3. Clause 20.4 and its supplementary information set out additional requirements for material which requires certification for Joint Working.