Index

• amendments to Code and Constitution and Procedure
• all-embracing claims
• administrative charges
  • appeals against number of
    • determination of charges
      • in cases
      • in co-promotion
      • levels of
      • in relation to admissions
    • payment of in relation to rulings
      • by Appeal Board
      • by Panel
    • failure to pay
• ABPI (the Association of the British Pharmaceutical Industry) Board of Management
  • examinations
    16.3
• appeals against Panel rulings
  • appearance before Appeal Board
  • appeals by respondent companies
  • withdrawal of appeals
  • appeals by complainants
• adverse reactions
  • claims about
    7.9
  • need to consult SPC
    4.2

    5.4
  • reporting mechanisms
    4.10

    5.6
  • references to in prescribing information
    4.2
• audio, audio-visual material and interactive data systems etc
  • abbreviated advertisements not permitted
    5.2
  • prescribing information requirements
    4.4

    4.5

    4.6
  • certification
    14.1
• artwork, illustrations, graphs and tables
  • references to sources when taken from published studies
    7.8

    7.2
  • general
    7.8
  • abbreviated advertisements
    5.5

    5.6

    5.7

    5.8

    5.9

    5.4
  • use of statistical information
• amount of advertising in journals
  Clause 6
• advice on Code
• audit of company’s procedures
  • charges for
• absolute risk, reference to
  7.2
• approval of promotional material – see certification
• animal data, use of
  7.2
• advertising to the public
  1.1

  26.1
• administrative staff, promotion to
  1.1
• abbreviated advertisements
  Clause 5
• automated calling systems
  9.9
• admissions by pharmaceutical companies
• advance notification of new products
  3.1

• black triangle symbol
  4.11

  4.1
  • in abbreviated advertisements
    5.7
  • in material intended for patients
    26.3
• bonus stock – see samples
• benefits
  18.1

  19.1

  19.2
• benefit/risk profile
  7.10
• briefing material for representatives
  15.9
• Bribery Act
• British Medical Association
  • Medical Ethics Today
  • consultation with
    • on Code
    • on appointment of Appeal Board independent registered medical practitioners
  • case reports
• brand names, use of other companies’
  7.3
• Blue Guide
  28.1

  28.4

  28.5

  1.1

• conferences – see meetings
• Code of Practice Appeal Board
  • power to publicly reprimand
  • Constitution and Procedure
  • power to require a corrective statement
  • power to require pre-vetting
  • independent members to be in a majority
  • membership
  • rulings
  • reports from Code of Practice Panel
  • reports to ABPI Board
  • power to require audit
  • reports to, consideration of
  • power to require recovery of items
• Code of Practice Panel
  • membership
  • Constitution and Procedure
  • reports to Appeal Board
  • power to suspend material or activities in certain circumstances pending an appeal
  • rulings
  • power to suspend advertising on complaints from Medicines and Healthcare products Regulatory Agency
• complaints procedure
  • making complaints general – see introduction to Constitution and Procedure
    • general – see introduction to Constitution and Procedure
    • by pharmaceutical companies
  • complaints from Medicines and Healthcare products Regulatory Agency
  • confidentiality of complainants – see introduction to Constitution and Procedure
  • withdrawal of complaints
  • dealing with complaints
• case reports
• contracts with institutions etc
• comparisons
  • disparaging references, prohibition on
    8.1
  • general
    7.2

    7.3
  • hanging comparisons
    7.2
  • price/cost comparisons
    7.2
• current views of authors
• certification
  • audio and audio-visual material etc
    14.1
  • promotional material
    14.1
  • joint working material
    14.3
  • general
    Clause 14
  • content of certificate
    14.5
  • Internet
    14.1
  • notification of signatories
    14.4
  • patient organisation material
    14.3
  • non-promotional material relating to the provision of medical and educational goods and services
    14.3
  • qualifications and experience of signatories
    14.1
  • educational material relating to diseases or medicines
    14.3
  • meetings held outside UK
    14.2
  • patient support programme material
    14.3
  • preservation of certificates
    14.6
  • promotional aids
    14.1
  • promotional material at international conferences in UK
• conciliation between companies
• consultants
  • from patient organisations
  • disclosure of payments to
  • use of
• criticism in media
• clinical and scientific opinion
  • emerging opinion
    7.2
  • current views of authors
    10.4
  • disparaging clinical and scientific opinion
    8.2
• Code of Practice levy
• clinical assessments
• continuing professional development meetings and courses
• clinical trial data, use of
  7.5
• corporate advertising, examination of
• children in advertisements
  12.2

  7.8
• Competition and Markets Authority consultation with on Code
• Commission on Human Medicines, Medicines and Healthcare Products Regulatory Agency and licensing authority, references to
  9.5
• cost comparisons
• confidence in the industry
• case preparation manager
• competitions & quizzes
• co-promotion
• carers, hospitality to
  27.2
• clinical trials, disclosure of details
  13.1
• Codes of Practice for Advertising Over-the-Counter Medicines of the PAGB

• donations
  • see also prohibition on financial inducements
  • to institutions etc
  • to charities
  • in lieu of hospitality
• disparaging references, prohibition on
• disguised promotion
• discredit to the industry
• dynamic content for websites
• delivery of items by representatives
• date of promotional material
• distribution of promotional material
• date of prescribing information
• discounts – see trade practices
• Disease Awareness Campaigns Guidelines
• disease awareness campaigns
• doctors, use of names and photographs
• DVDs for health professessionals
• data on file, provision of

• examinations for representatives
• exhibitions and exhibition panels, prescribing information requirements
• Europe – definition of term
• emoticons, use of
• experience programmes
• employees, current and prospective, information for
• employee responsible for ensuring compliance with Code
• economic evaluation of medicines
• educational goods and services, provision of
• EFPIA Code on Disclosure of Transfers of Value by Pharmaceutical Companies to Healthcare Professionals and Healthcare Organisations
• EFPIA Code of Practice on Relationships between the Pharmaceutical Industry and Patient Organisations
• EFPIA Code on the Promotion of Prescription – Only Medicines to, and Interactions with, Healthcare Professionals
• European Directive
• exaggerated or all-embracing claims
• electronic data communications
• email, use of
• extremes of format, size & cost of promotional material

• financial inducements, prohibition of
• free goods – see samples
• facsimile, use of
• frequency
  • of mailings
  • of calls by representatives
  • of mailings for new medicines
• films – see audio-visual material and interactive data systems etc

• graphs – see artwork, illustrations, graphs and tables
• General Pharmaceutical Council
• gifts
• grants to institutions etc
• General Medical Council
• guidelines on company procedures relating to the Code of Practice

• hospitality
  • limit on cost of meal
• health professions, criticism of
• healthcare organisation – definition of term
• Human Medicines Regulations
• health professionals, use of names and photographs
• healthy volunteer studies, use of data from
• high standards, maintenance of
• hanging comparisons

• international journals, advertising in
• interactive data systems
  • see audio, audio-visual material and interactive data systems etc
• illustrations
  • see artwork, illustrations, graphs and tables
• in-vitro data, use of
• Internet
  • prescribing information requirements
  • general
  • certification
  • abbreviated advertisements not permitted
  • access to promotional material by public
  • journals
• inserts in journals
  • cannot be abbreviated advertisements
  • size of
  • see also si to
• inducements
• international conferences, symposia and meetings
  • see meetings
• items delivered by representatives
• information to the public
• IFPMA Code of Practice

• journal advertising
  • specific requirements
  • advertising in international journals
  • see also abbreviated advertisements in professional publications
• joint ventures & co-promotion
• joint working with the NHS

• knocking copy

• links to prescribing information
• loans,long term or permanent
• labelling
  • labelling of medicines
  • labelling of samples
• licensing authority, references to
• levy
  • level of
  • failure to pay
• legislation
• limitations on journal advertising

• meetings general
  • certification of meetings held outside the UK
  • venue, suitability of
  • prohibition on inducements and payments for interviews
  • sponsorship of meetings, disclosure of
  • organised by affiliates
  • payment of room rental
  • reports on meetings
  • certification of
  • involving travel outside the UK
  • subsistence, provision of
  • promotion at international meetings
  • attendance by administrative staff
  • sponsorship of attendance at meetings, disclosure of
  • held outside the UK
  • exhibitions and exhibition panels, prescribing information requirements
  • certification of
  • continuing professional development (CPD) meetings and courses
  • payment of travelling and accommodation expenses
  • hospitality, provision of
• memory sticks for health professionals
• MHRA Drug Safety Update
• medicines
  • posted
  • handled by representatives
  • distributed in hospitals
• market research
  • guidelines – The Legal & Ethical Guidelines for Healthcare Market Research
  • disclosure of payments
  • general
• membership
  • of Code of Practice Appeal Board
  • of Code of Practice Panel
• Medicines and Healthcare Products Regulatory Agency
  • consultation with
    • on Code
    • on appointment of Appeal Board independent members
  • submission of briefing material
  • references to
  • submission of names of signatories for promotional material
  • MHRA Drug Safety Update
  • case reports
  • Disease Awareness Campaigns Guidelines
  • complaints from
  • The Blue Guide Advertising and Promotion of Medicines in the UK
  • submission of certificates
• mailings
  • mailing lists
  • frequency and number of
  • mailed medicines
• media
  • relations with
  • complaints arising from
• marketing authorization
• market extension
• margins – see trade practices
• market share claims
• meals – limit on cost
• medical and educational goods and services, provision of

• naked or partially naked people, use of in advertising
• non - interventional studies of marketed medicines
  • general
  • disclosure of
  • approval and supervision of
• new medicines
  • advance notification of new products
  • use of the word ‘new’
  • introduction of a new medicine
  • avoidance of extremes of format, size or cost
  • limitations on mailings
• National Health Service, joint working with
• Nursing & Midwifery Council – Standards of conduct, performance and ethics for nurses and midwives
• non-proprietary name, size and position

• over-the-counter medicines
  • definition of term
  • scope of the Code
• outcome agreements
• offence, causing
• other relevant decision makers – definition of term
• official documents, reproduction of

• post-marketing surveillance studies
• public assessment reports (European & UK)
  • outside scope of the Code
    • provision of
      • to the public
      • on the Internet
• postcards, use of
• public health campaigns
  • responsibility for
• Prescription Medicines Code of Practice Authority annual report
  • material to be supplied to Authority
    • examination status of representatives
    • names of signatories
    • medical representatives briefing material
    • authority of Director to require material
    • material required for scrutiny
    • copies of certificates
  • structure and responsibilities
  • scrutiny
• patients, items given to
• pre-printed private prescription forms
• private prescription forms, preprinted
• pre-vetting
  • power of Appeal Board to require
  • cost of
• prescribing information
  • size of non-proprietary name
  • provision on
    • exhibitions and exhibition panels
    • Internet
    • multi-page advertisements other than journal advertisements
    • journal advertisements
    • audio-visual etc
  • typesize
  • requisite information
  • date of
  • legibility
  • exemptions
  • general
• pharmacovigilance – personnel’s knowledge of
• patient organisations
  • relationships with
  • disclosure of support
  • services provided by
• price lists
• prices – see trade practices
• package leaflets
  • on the Internet
  • provision to the public
• prizes
• public, relations with
  • provision of samples to not allowed
  • disease awareness campaigns
  • Internet
  • advertising to
  • provision of information to
  • public health campaigns
  • exposed mailings
  • enquiries from
• prescription forms
  • pre-printed private prescription forms
  • reproduction of official documents
• promotional aids
• press conferences and press announcements
• posted medicines
• package deals
• patient carers, hospitality to
• post - authorization studies
• patient access schemes
• patient information leaflets
  • provision by doctors to patients
• price comparisons
• professional publications
• payments for interviews
• potency per weight claims
• patient support items

• quotations
• quizzes

• representatives
  • contract representatives
  • hospitality and payments for meetings
  • delivering items
  • examinations
  • definition of term
  • items delivered by representatives
  • frequency & manner of calls on doctors
  • briefing material
  • identifying themselves
  • provision of summary of product
  • prohibition on payments for interviews
  • general
• Royal Pharmaceutical Society
  • on Code
  • case reports
  • on appointment of Appeal Board independent registered pharmacist
  • consultation with
• rulings
  • by Appeal Board
  • by Panel
• risk, relative and absolute
• replies to individual enquiries
• Royal College of Nursing
  • case reports
  • on Code
  • consultation with on appointment of Appeal Board
  • independent registered nurse prescriber
• representatives, by
• reply paid cards
  • reply paid cards offering items to be delivered
• references
  • prohibition in abbreviated advertisements
  • references to published studies
• relative risk, reference to
• representatives, characteristics by
  • training, general
• reprints of articles, distribution of
• risk/benefit profile
• room rental, payment
• remote detailing
• referee, independent
• reproduction of official documents
• risk sharing agreement

• sanctions
  • corrective statements
  • pre-vetting
  • suspension/expulsion from ABPI
  • audit of company’s procedures
  • special provision for non ABPI companies
  • reprimand and publication
  • publication in medical, pharmaceutical and nursing press
  • case reports
  • reports to Appeal Board and ABPI Board
  • recovery of items
  • undertakings from companies ruled in breach
• sponsorship of meeting attendance, disclosure of
• summaries of product characteristics
  • provision of
    • with samples
    • by representatives
    • to the public
    • on the Internet
    • summary in prescribing information
    • with press releases and press packs
  • need to consult
  • outside scope of the Code
• scientific service in charge of information
  • reports on adverse reactions by representatives
  • general
• scope of the Code
• samples
  • use as inducement
  • titration packs
  • system of control and accountability
  • use for patient treatment
  • labelling
  • which medicines can be sampled?
  • distribution
    • in hospitals
    • to the public not allowed
  • maximum number of
  • request forms and their retention
  • identification samples
  • general
  • posted
  • definition of
  • size
  • starter packs
• statistical information, use of
• starter packs
• subsistence, provision of
• scientific service in charge of non-interventional studies of marketed medicines
• safe, use of the word
• size of promotional material
  • journal advertisements, size of
  • abbreviated advertisements, size of
• sexual imagery, use of
• scrutiny
• substantiation of information, claims and comparisons
• suspension of advertising on complaints from Medicines and Healthcare Products Regulatory Agency
• Serious Fraud Office consultation with on Code
• sponsorship of material and meetings, disclosure of
• superlatives
• symposia – see meetings
• suitability and taste
• switch and therapy review programmes
• side-effects – see adverse reactions
• suspension of material or activities pending appeal when required by Panel

• teaser advertising
• travelling expenses
• timing under complaints procedure
  • responding to complaint
  • payment of administrative charge
  • general
  • extensions
  • providing an undertaking on rulings by
    • Appeal Board
    • Panel
  • appeals
  • suspension pending appeal when required by Panel
  • commenting on appeal by complainant
  • commenting on appeal by respondent
• training
  • training on Code
  • training of representatives
• telemessages, use of
• terms of trade – see trade practices
• tables – see artwork, illustrations, graphs and tables
• taste in advertising
• telephone and text messages, use of
• text messages, use of
• transfers of value
  • definition of term
  • central platform for disclosure
• therapy review programmes
• trade practices, prices, discounts, margins, etc
• the, use of the word
• textbooks, provision of
• titration pack – see samples

• unlicensed medicines, price lists of
• undertakings, breach of
• undertakings by companies ruled in breach
• unique, use of the word
• unauthorized medicines and unauthorized indications

• volume of promotional material
• voluntary admissions by pharmaceutical companies

• withdrawal of complaints and appeals
• wraparounds, on journals
• WHO Ethical criteria for medicinal drug promotion

• yellow cards