Are patient case studies promotional?

  • 1.2

    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.
  • 27

    Clause 27 - Relationships with Patient Organisations

    27.1 Pharmaceutical companies can interact with patient organisations or any user organisation such as disability organisations, carer or relative organisations and consumer organisations to support their work, including assistance in the provision of appropriate information to the public, patients and carers.

    Companies must respect the independence of patient organisations.

    There are other codes and guidelines which cover patient groups, including Charity Commission requirements.

    27.2 When working with patient organisations, companies must ensure that the involvement of the company is made clear and that all of the arrangements comply with the Code. This includes the need to declare sponsorship (Clause 27.9) and the prohibition on advertising prescription only medicines to the public (Clause 26.1). The requirements of Clause 22, which covers meetings for health professionals and other relevant decision makers, also apply to pharmaceutical companies supporting patient organisation meetings.

    27.3 Companies working with patient organisations must have in place a written agreement setting out exactly what has been agreed, including funding, in relation to every significant activity or ongoing relationship.

    27.4 No company may require that it be the sole funder of a patient organisation or any of its programmes.

    27.5 A company must not make public use of a patient organisation’s logo or proprietary material without the organisation’s written agreement. In seeking such permission, the specific purpose and the way in which the logo or material will be used must be clearly stated.

    27.6 A company must not seek to influence the text of patient organisation material in a manner favourable to its own commercial interests. This does not preclude a company from correcting factual inaccuracies.

    27.7 Each company must make publicly available, at a national or European level, a list of patient organisations to which it provides financial support and/or significant indirect/non-financial support, which must include a description of the nature of the support that is sufficiently complete to enable the average reader to form an understanding of the significance of the support. The list of organisations being given support must be disclosed 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.

    The published information must include the monetary value of financial support and of invoiced costs. For significant non-financial support that cannot be assigned a meaningful monetary value, the published information must describe clearly the non-monetary value that the organisation receives.

    27.8 Contracts between companies and patient organisations under which they provide any type of services to companies are only allowed if such services are provided for the purpose of supporting healthcare or research.

    Patient organisations may be engaged as experts and advisors for services such as participation at advisory board meetings and speaker services. The arrangements that cover 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 and documented in advance of requesting the services and entering into the arrangements
    • the criteria for selecting services must be directly related to the identified need and the persons responsible for selecting the service must have the expertise necessary to evaluate whether the particular experts and advisors meet those criteria
    • the extent of the service must not be greater than is reasonably necessary to achieve the identified need
    • the contracting company must maintain records concerning, and make appropriate use of, the services
    • the engaging of patient organisations must not be an inducement to recommend a particular medicine
    • the compensation for the services must be reasonable and not exceed the fair market value of the services provided. In this regard, token consultancy arrangements must not be used to justify compensating patient organisations
    • in their written contracts with patient organisations, companies are strongly encouraged to include provisions regarding an obligation of the patient organisation to declare that they have provided paid services to the company whenever those concerned write or speak in public about a matter that is the subject of the agreement or any other issue relating to that company
    • each company must make publicly available, at a national or European level, a list of patient organisations that it has engaged to provide significant contracted services, which must include a description of the nature of the services provided that is sufficiently complete to enable the average reader to form an understanding of the arrangement without the necessity to divulge confidential information. Companies must also make publicly available the total amount paid per patient organisation over the reporting period. The list of organisations engaged must be updated at least once a year.

    Supplementary information Clauses 27.7 and 27.8 Transfers of Value to Patient Organisations  Clause 27.8 Consultancy Services Provided by Patient Organisations

    27.9 Companies must ensure that their sponsorship is always clearly acknowledged from the outset. The wording of the declaration of sponsorship must accurately reflect the nature of the company’s involvement.


The term patient case study is broadly used to describe material about the treatment of a particular patient with a certain disease, including outcomes.

As with any material, item or activity developed by a pharmaceutical company (or third party on their behalf), much will depend on the content, how it is used, who uses the case study, the intended audience, method of dissemination etc. Patient case studies are likely to be viewed as promotional. Each use of a patient case study should be considered and categorised accordingly. See Clause 1.2.