Disclosure - Methodological Notes points for consideration

  • 1

    Clause 1 - Scope of the Code and Definition of Certain Terms

    1.1 This Code applies to the promotion of medicines to members of the United Kingdom health professions and to other relevant decision makers.

    The Code also applies to a number of areas which are non-promotional, including information made available to the public about prescription only medicines.

    It does not apply to the promotion of over-the-counter medicines to members of the health professions when the object of that promotion is to encourage their purchase by members of the public.

    For the purposes of the application of the Code, the United Kingdom includes the Channel Islands and the Isle of Man.

    The Code applies to the promotion of medicines to members of the health professions and to other relevant decision makers as specified in Clause 1.1. This includes promotion at meetings for UK residents held outside the UK. It also applies to promotion to UK health professionals and other relevant decision makers at international meetings held outside the UK, except that the promotional material distributed at such meetings will need to comply with local requirements.

    Some of the requirements of the Code are not necessarily related to promotion. Examples include declarations of sponsorship in Clause 9.10, clinical trials and non interventional studies in Clause 13, certain aspects of the provision of medicines and samples in Clause 17, donations, grants and fees for services in Clauses 19.2 and 21, the use of consultants in Clause 23, the provision of information to the public in Clause 26 and relations with patient organisations in Clause 27.

    The Code does not apply to the promotion of over-the-counter medicines to members of the health professions when the object of that promotion is to encourage their purchase by members of the public as specified in Clause 1.1. Thus, for example, an advertisement to doctors for an over-the-counter medicine does not come within the scope of the Code if its purpose is to encourage doctors to recommend the purchase of the medicine by patients. Where the advertisement is designed to encourage doctors to prescribe the medicine, then it comes within the scope of the Code.

    Advertisements for over-the-counter medicines to pharmacists are outside the scope of the Code. Advertisements to pharmacists for other medicines come within the scope of the Code.

    • Clause 1.1 Market Extension
    • Clause 1.1 Joint Working
    • Clause 1.1 Journals with an International Distribution
    • Clause 1.1 Advertising to the Public and Advertising Over-the-Counter Medicines to Health Professionals
    • Clause 1.1 Promotion to Other Relevant Decision Makers

    1.2 The term promotion means any activity undertaken by a pharmaceutical company or with its authority which promotes the administration, consumption, prescription, purchase, recommendation, sale, supply or use of its medicines. It includes:

    • journal and direct mail advertising
    • the activities of representatives including any electronic or printed material used by them
    • the supply of samples
    • the provision of inducements to prescribe, supply, administer, recommend, buy or sell medicines by the gift, offer or promise of any benefit or bonus, whether in money or in kind
    • the provision of hospitality for promotional purposes
    • the sponsorship of promotional meetings
    • the sponsorship of scientific meetings including payment of travelling and accommodation expenses in connection therewith
    • all other sales promotion in whatever form.

    It does not include:

    • replies made in response to individual enquiries from members of the health professions or other relevant decision makers or in response to specific communications from them whether of enquiry or comment, including letters published in professional journals, but only if they relate solely to the subject matter of the letter or enquiry, are accurate and do not mislead and are not promotional in nature
    • factual, accurate, informative announcements and reference material concerning licensed medicines and relating, for example, to pack changes, adverse reaction warnings, trade catalogues and price lists, provided they include no product claims
    • price lists relating to unlicensed medicines, provided they include no product claims and they make clear that the products are unlicensed
    • information supplied by pharmaceutical companies to national public organisations, such as the National Institute for Health and Care Excellence (NICE), the All Wales Medicines Strategy Group (AWMSG) and the Scottish Medicines Consortium (SMC) is exempt from the Code provided the information is factual, accurate and not misleading
    • measures or trade practices relating to prices, margins or discounts which were in regular use by a significant proportion of the pharmaceutical industry on 1 January 1993
    • summaries of product characteristics
    • European public assessment reports
    • Risk minimisation material
    • UK public assessment reports
    • the labelling on medicines and accompanying package leaflets insofar as they are not promotional for the medicines concerned; the contents of labels and package leaflets are covered by regulations
    • information relating to human health or diseases provided there is no reference, either direct or indirect, to specific medicines.
    • Supplementary information
    • Advice
    • Clause 1.2 Replies Intended for Use in Response to Individual Enquiries
    • Clause 1.2 Price Lists for Unlicensed Medicines
    • Clause 1.2 Risk Minimisation Plans and Material
    • Do risk minimisation materials need prescribing information?
    • Do the requirements of the Code apply to third parties working on behalf of a pharmaceutical company?
    • If a representative gained agreement to deliver approved risk minimisation materials to a health professional and then used this as an opportunity to promote medicines to the health professional would this be acceptable?
    • What are examples of forms of sales promotion?
    • What is promotion?

    1.3 The term ‘medicine’ means any branded or unbranded medicine intended for use in humans which requires a marketing authorization.

    1.4 The term ‘health professional’ includes members of the medical, dental, pharmacy and nursing professions and any other persons who in the course of their professional activities may administer, prescribe, purchase, recommend or supply a medicine.

    1.5 The term ‘other relevant decision makers’ particularly includes those with an NHS role who could influence in any way the administration, consumption, prescription, purchase, recommendation, sale, supply or use of any medicine but who are not health professionals.

    1.6 The term ‘over-the-counter medicine’ means those medicines or particular packs of medicines which are primarily advertised to the public for use in self medication.

    1.7 The term ‘representative’ means a representative calling on members of the health professions and other relevant decision makers in relation to the promotion of medicines.

    1.8 The term ‘promotional aid’ means a non-monetary gift made for a promotional purpose.

    1.9 The term ‘healthcare organisation’ means either a healthcare, medical or scientific association or organisation such as a hospital, clinic, foundation, university or other teaching institution or learned society whose business address, place of incorporation or primary place of operation is in Europe or an organisation through which one or more health professionals or other relevant decision makers provide services.

    1.10 The term ‘transfer of value’ means a direct or indirect transfer of value, whether in cash, in kind or otherwise, made, whether for promotional purposes or otherwise, in connection with the development or sale of medicines. A direct transfer of value is one made directly by a company for the benefit of a recipient. An indirect transfer of value is one made on behalf of a company for the benefit of a recipient or through an intermediate and where the company knows or can identify the recipent that will benefit from the transfer of value.

    1.11 Pharmaceutical companies must comply with all applicable codes, laws and regulations to which they are subject.

    1.12 Each company must appoint a senior employee to be responsible for ensuring that the company meets the requirements of the Code.

     

  • 19

    Clause 19 - Medical and Educational Goods and Services

    19.1 Medical and educational goods and services which enhance patient care, or benefit the NHS and maintain patient care, can be provided subject to the provisions of Clause 18.1. They must not be provided to individuals for their personal benefit. Medical and educational goods and services must not bear the name of any medicine but may bear the name of the company providing them.

    Clauses 18.1 and 19.1 do not prevent the provision of medical and educational goods and services. In order to comply with the Code such goods and services must be in the interests of patients or benefit the NHS whilst maintaining patient care. They must not be provided to individuals for their personal benefit.

    The requirement in Clause 19.1 that medical and educational goods must not bear the name of any medicine does not apply where the goods involved consist of independently produced textbooks or journals which include as part of their texts the names of medicines.

    Medical and educational goods and services may bear a corporate name. The involvement of a pharmaceutical company in such activities must be made clear to relevant health professionals and/or other relevant decision makers receiving the service. In addition the involvement of a pharmaceutical company in therapy review services should be made clear to patients. However, if there are no materials for patients this would be a matter for the relevant health professional. If there are materials for patients the requirements for declaration of sponsorship set out in Clause 9.10 would apply.

    The following guidance is intended to assist companies in relation to medical and educational goods and services.

    1(i) The role of medical/generic representatives in relation to the provision of goods and services supplied in accordance with Clauses 18.1 and 19.1 needs to be in accordance with the principles set out below. In this context companies should consider using staff other than medical/generic representatives.

    (ii) If medical/generic representatives provide, deliver or demonstrate medical and educational goods and services then this must not be linked in any way to the promotion of products.

    In order to comply with this stipulation the representative must not carry out both activities at the same visit. Representatives may introduce a service by means of a brief description and/or delivering materials but may not instigate a detailed discussion about the service at the same time as a call at which products are promoted.

    If, during a promotional visit by a representative, a change in medication to one of the company’s products is agreed, the representative may not then offer a therapy review service to facilitate the change as this would be seen as a way for the company to ensure that the agreed change would in fact be made.

    (iii) The acceptability of the role of medical/generic representatives will depend on the nature of the goods and services provided and the method of provision.

    (iv) The nature of the service provider, the person associated with the provision of medical and educational goods and services, is important ie is the service provider a medical/generic representative or is the service provider some other appropriately qualified person, such as a sponsored registered nurse? If the goods and services require patient contact, for example either directly or by identification of patients from patient records and the like, then medical/generic representatives must not be involved. Only an appropriately qualified person, for example a sponsored registered nurse, not employed as a medical/generic representative, may undertake activities relating to patient contact and/or patient identification. Medical/generic representatives could provide administrative support in relation to the provision of a screening service, but must not be present during the actual screening and must not discuss or help interpret individual clinical findings.

    (v) Neither the company nor its medical/generic representatives may be given access to data/records that could identify, or could be linked to, particular patients.

    (vi) Sponsored health professionals should not be involved in the promotion of specific products. Registered nurses, midwives and health visitors are required to comply with the Nursing & Midwifery Council Code - Standards of conduct, performance and ethics for nurses and midwives.

    2 The remuneration of those not employed as medical/generic representatives but who are sponsored or employed as service providers in relation to the provision of medical and educational goods and services must not be linked to sales in any particular territory or place or to sales of a specific product or products and, in particular, may not include a bonus scheme linked to such sales. Bonus schemes linked to a company’s overall national performance, or to the level of service provided, may be acceptable.

    3 Companies must ensure that patient confidentiality is maintained at all times and that data protection legislation is complied with.

    4 Service providers must operate to detailed written instructions provided by the company. These should be similar to the briefing material for representatives as referred to in Clause 15.9. The written instructions should set out the role of the service provider and should cover patient confidentiality issues. Instructions on how the recipients are to be informed etc should be included. The written instructions must not advocate, either directly or indirectly, any course of action which would be likely to lead to a breach of the Code.

    5 Service providers must abide by the principle set out in Clause 15.5 that in an interview, or when seeking an appointment, reasonable steps must be taken to ensure that they do not mislead as to their identity or that of the company they represent.

    6 A recipient of a service must be provided with a written protocol to avoid misunderstandings as to what the recipient has agreed. The identity of the sponsoring pharmaceutical company must be given. For example, a general practitioner allowing a sponsored registered nurse access to patient records should be informed in writing of any data to be extracted and the use to which those data will be put.

    7 Any material designed for use in relation to the provision of medical and educational goods and services must be non- promotional. It is not acceptable for such materials to promote the prescription, supply, sale or administration of the sponsoring company’s medicines. Nor is it acceptable for materials to criticise competitor products as this might be seen as promotional. All materials must identify the sponsoring pharmaceutical company.

    8 Material relating to the provision of medical and educational goods and services, such as internal instructions, external instructions, the written protocol for recipients and other material, including material relating to therapy reviews, etc, must be certified by the Code of Practice signatories within companies to ensure that the requirements of the Code are met as required by Clause 14.3.

    A copy of the materials must be made available to the Prescription Medicines Code of Practice Authority on request.

    9 Companies are recommended to inform relevant NHS or other organisations of their activities where appropriate. This is particularly recommended where companies are proposing to provide medical and educational goods and services which would have budgetary implications for the parties involved. For example the provision of a screening service for a limited period might mean that funds would have to be found in the future when company sponsorship stopped. Another example might be the provision of diagnostic or laboratory services and the like, which the relevant organisation would normally be expected to provide.

    • Clause 19.1 Switch and Therapy Review Programmes
    • Clause 19.1 Disclosure

    MOST RECENT CASES See all Applicable Code year

    19.2 The provision of medical and educational goods and services in the form of donations, grants and benefits in kind to institutions, organisations or associations that are comprised of health professionals and/or that provide healthcare or conduct research are only allowed if:

    • they comply with Clause 19.1 or are made for the purpose of supporting research
    • they are documented and kept on record by the company
    • they do not constitute an inducement to prescribe, supply, administer, recommend, buy or sell any medicine
    • details are publicly disclosed as donations, grants or benefits in kind or as research and development transfers of value.

    Supplementary information

    Cases

     

  • 20

    Joint working between one or more pharmaceutical companies and the NHS and others is acceptable provided that this is carried out in a manner compatible with the Code. Joint working must always benefit patients.

    A formal written agreement must be in place and an executive summary of the joint working agreement must be made publicly available before arrangements are implemented.

    Transfers of value made by companies in connection with joint working must be publicly disclosed.

    Supplementary information

  • 21

    Clause 21 Relationships and Contracts with Certain Organisations

    Contracts between companies and institutions, organisations or associations of health professionals under which such institutions, organisations or associations provide any type of services on behalf of companies (or any other type of funding by the company
    not otherwise covered by the Code) are only allowed if such services (or other funding):

    • comply with Clause 19.1 or are provided for the purpose of supporting research
    • do not constitute an inducement to prescribe, supply, administer, recommend, buy or sell any medicine.

    Pharmaceutical companies must publicly disclose details of transfers of value made to such institutions, organisations or associations.

    Clause 21 Supplementary Information Clause 21 Disclosure

    The information required by Clause 21 must be publicly disclosed in relation to transfers of value made in 2015 and each calendar year thereafter, giving in each case the financial amount or value and the name of the recipient institution, organisation or association.

    Fees and agreed expenses should be disclosed separately.

    Disclosure must be carried out in accordance with Clause 24.

  • 23

    Clause 23 - The Use of Consultants

    ​23.1 Health professionals and other relevant decision makers may be used as consultants and advisors, whether in groups or individually, for services such as speaking at and chairing meetings, involvement in medical/scientific studies, clinical trials or training services, participation at advisory board meetings, and participation in market research where such participation involves remuneration and/or travel. The arrangements which cover these genuine consultancy or other services must, to the extent relevant to the particular arrangement, fulfil all the following criteria:

    • a written contract or agreement must be agreed in advance of the commencement of the services which specifies the nature of the services to be provided and the basis for payment of those services
    • a legitimate need for the services must be clearly identified in advance of requesting the services and entering into arrangements with the prospective consultants
    • the criteria for selecting consultants must be directly related to the identified need and the persons responsible for selecting the consultants must have the expertise necessary to evaluate whether the particular consultants meet those criteria
    • the number of consultants retained must not be greater than the number reasonably necessary to achieve the identified need
    • the contracting company must maintain records concerning, and make appropriate use of, the services provided by consultants
    • the hiring of the consultant to provide the relevant service must not be an inducement to prescribe, supply, administer, recommend, buy or sell any medicine
    • the compensation for the services must be reasonable and reflect the fair market value of the services provided. In this regard, token consultancy arrangements must not be used to justify compensating health professionals and other relevant decision makers
    • in their written contracts or agreements with consultants, companies must include provisions regarding the obligation of the consultant to declare that he/she is a consultant to the company whenever he/she writes or speaks in public about a matter that is the subject of the agreement or any other issue relating to that company. Similarly, companies that employ, on a part-time basis, health professionals that are still practising their profession must ensure that such persons are obliged to declare their employment arrangement with the company whenever they write or speak in public about a matter that is the subject of the employment or any other issue relating to that company.
    • Clause 23.1 The Use of Consultants Supplementary information
    • Guidance
    • 23 Use of Consultants

    The term ‘consultant’ in Clause 23 covers any health professional or other relevant decision maker consulted for the purposes described in Clause 23 regardless of their normal roles.

    Other relevant decision makers covered by Clause 23 are those who could influence in any way the prescription, supply, administration, recommendation, purchase or sale of any medicine.

    • Clause 23 Patient Organisations

    23.2 Pharmaceutical companies must publicly disclose details of the fees paid to consultants in the UK, or to their employers on their behalf, for certain services rendered by them such as chairing and speaking at meetings, assistance with training and participation in advisory boards etc. It includes payments to consultants in relation to research and development work, including the conduct of clinical trials.

    23.3 In addition to the information required to be made public by Clause 23.2, companies must publicly disclose details of payments made to consultants in relation to market research (unless the company concerned is not aware of the identities of those participating in the market research).

    23.4 Fees, expenses and the like due to consultants in relation to Clauses 23.2 and 23.3 must be disclosed whether paid directly to them or to their employers or to healthcare organisations or to companies or charities etc.

     

  • 24

    Clause 24 - Transfers of Value to Health Professionals and Healthcare Organisations

    24.1 Companies must document and publicly disclose certain transfers of value made directly or indirectly to health professionals and healthcare organisations located in Europe.

    The term ‘transfer of value’ is defined in Clause 1.10. The term ‘Europe’ comprises those countries that are within the EU and other countries with a trade association that is a member of EFPIA. 

    The term ‘health professional’ in relation to disclosure of transfers of value also includes any employee of a pharmaceutical company whose primary occupation is that of a practising health professional as defined in Clause 1.4.

    Disclosure is required even if the payments etc are made by overseas affiliates, head offices in the UK or overseas and UK based offices.

    24.2 The transfers of value covered by Clause 24.1 are

    • joint working in accordance with Clause 20
    • donations, grants and benefits in kind provided to institutions, organisations and associations in accordance with Clauses 19.1 and 19.2
    • contracts between companies and institutions, organisations and associations in accordance with Clause 21
    • sponsorship of attendance by health professionals and other relevant decision makers at meetings in accordance with Clause 22.5
    • fees and expenses paid to health professionals and other relevant decision makers, or to their employers on their behalf, in accordance with Clauses 23.2, 23.3 and 23.4
    • contributions towards the costs of meetings paid to healthcare organisations or to third parties managing events on their behalf, which may include sponsorship of health professionals by way of registration fees and accommodation and travel.

    Supplementary information Clause 24.2 Further Information

    24.3  Clause 24.1 does not apply to transfers of value to patient organisations. These transfers of value are covered by Clauses 27.7 and 27.8.

    24.4 Disclosures must be made annually in respect of each calendar year. Disclosure must be in the first six months after the end of the calendar year in which the transfers of value were made.

    24.5 The information disclosed must remain in the public domain for at least three years from the time of disclosure.

    24.6 Companies must document all disclosures and retain the records for at least five years after the end of the calendar year to which they relate.

    24.7 Different categories of transfers of value to individual health professionals can be aggregated on a category by category basis, provided that itemised disclosure would be made available upon request to the relevant recipient or the relevant authorities.

    Payments to healthcare organisations are required to be disclosed on a per activity basis.

    24.8 Where a transfer of value is made to a health professional indirectly via a healthcare organisation such a transfer should be disclosed once only, preferably as being a transfer to the health professional.

    24.9 Where recipients of transfers of value cannot be identified for legal reasons, the amount attributable to such transfers must be disclosed on an aggregate basis. The number of recipients involved must be stated together with the percentage of all recipients that they represent and the aggregate amount attributable to transfers of value to such recipients.

    24.10 Each company providing transfers of value must publish a note summarising the methodologies used by it in preparing the disclosures and identifying each category of transfer of value. The note, including a general summary and/or country specific considerations, must describe the recognition methodologies applied and should include the treatment of multi-year contracts, VAT and other tax aspects, currency aspects and other issues relating to the timing and amount of transfers of value for the purposes of this Code.

     

  • 24.10

    24.10 Each company providing transfers of value must publish a note summarising the methodologies used by it in preparing the disclosures and identifying each category of transfer of value. The note, including a general summary and/or country specific considerations, must describe the recognition methodologies applied and should include the treatment of multi-year contracts, VAT and other tax aspects, currency aspects and other issues relating to the timing and amount of transfers of value for the purposes of this Code.

Introduction

In recent years there has been growing public interest in the pharmaceutical industry’s relationships with health professionals (HCPs), other relevant decision makers (ORDMs) and healthcare organisations (HCOs).  Members of the public want to be confident that such relationships are appropriate and that they can trust their health professional to provide high quality care based on clinical evidence and experience.  There are already detailed requirements in the ABPI Code of Practice for the Pharmaceutical Industry setting out the basis of these relationships.  Since 2012 certain transfers of value have been required to be collected and disclosed in aggregate the following year.  Current requirements mean that data identifying individuals who have received certain transfers of value are published on a publicly available central platform, Disclosure UK.  This was launched in June 2016 when 2015 data was published.  Disclosure UK lists data for three calendar years.  The 2018 data was published in June 2019 and the 2015 data will be removed. Transfers of value to healthcare organisations are  also disclosed on the Disclosure UK on a per activity basis. 

By creating greater transparency around the pharmaceutical industry’s collaborations and partnerships with HCPs, ORDMs and HCOs, the ABPI Code requirements for disclosure of certain transfers of value aim to improve understanding and increase the public’s confidence in these relationships.

The ABPI Code disclosure requirements are predominantly set out in Clause 24, however information can also be found in Clauses 1, 19, 20, 21, 22 and 23. 

Methodological Note

As part of the requirements of the EFPIA Code on Disclosure of Transfers of Value from Pharmaceutical Companies to Healthcare Professionals and Healthcare Organisations, which has been transposed in the ABPI Code, each company is required, at the same time as it discloses the data, to publish a methodological note.  This is accessible via Disclosure UK and gives important additional information about, and context to, the disclosed data.  Clause 24.10 of the ABPI Code states:

‘Each company providing transfers of value must publish a note summarising the methodologies used by it in preparing the disclosures and identifying each category of transfer of value.  The note, including a general summary and/or country specific considerations, must describe the recognition methodologies applied and should include the treatment of multi-year contracts, VAT and other tax aspects, currency aspects and other issues relating to the timing and amount of transfers of value for the purposes of this Code.’

Companies are likely to take different approaches in developing their methodological note; some might develop a document to cover the whole of Europe whilst others might decide on a separate methodological note for each country.  The length and content of a methodological note will differ from company to company; much will depend on the size of the company and the range and complexity of its relationships with HCPs, ORDMs and HCOs.  It is important that it is written in such a way as to help a member of the public easily understand the data disclosed.

The form of the methodological note is for each company to determine.  However for 2018 data onwards the methodological note must make clear the number of individuals who have agreed to some transfers of value being disclosed individually and some in aggregate (as set out on the disclosure template for 2018 data.  In addition the following points may be helpful when preparing methodological notes.

How has the company treated:

  • Tax considerations?
  • VAT (included or not)?
  • Currency aspects (including conversion rates)?
  • Cross border payments?
  • Multi-year contracts?
  • Over-the-counter transfers of value? Are they/some included?
  • Medical device transfers of value? Are they/some included?

Other aspects for consideration:

  • Do the disclosures go beyond what is required by the Code? If so, is this made clear?
  • How has the company defined ‘Donation’, ‘Grant’, ‘Sponsorship’ and has this been made clear?
  • Are the appropriate arrangements in place to lawfully disclose the information and are recipients aware of the process?
  • How have non-monetary transfers of value been quantified?
  • Is it clear whether the disclosures cover subsidiaries, affiliates etc?
  • If the company has changed name or merged etc how is this explained?. Can relevant disclosures be easily tracked? 
  • When working with other pharmaceutical companies, how are disclosures handled? How are transfers of value divided amongst the parties (eg  joint working projects etc)?
  • Are the necessary links included and active eg for joint working project executive summaries?

January 2019

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