CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY - Edition 8.5 - Effective 01st Mar 2021

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CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY - Edition 8.5 - Effective 01st Mar 2021
IPHA CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY, V8.5

CODE OF
PRACTICE FOR
THE PHARMACEUTICAL
INDUSTRY

                    Edition 8.5 –
                    Effective 01st Mar 2021

                                                   #InnovateForLife1
© Irish Pharmaceutical Healthcare Association
7 Clanwilliam Terrace, Grand Canal Quay, D02 CC64
      Tel: +353 (1) 6610018 Fax:+353 (1) 6610164
                               E-mail: info@ipha.ie
                            Websites: www.ipha.ie,
                           www.transferofvalue.ie,
                                 www.medicines.ie
IPHA CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY, V8.5

We partner for better health
through innovative medicines,
vaccines and technologies.
IPHA CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY, V8.5

    INTRODUCTION

    The Code has been prepared by the Irish Pharmaceutical Healthcare
    Association (IPHA) with a view to securing the universal acceptance and
    adoption of high standards of conduct in the interactions with healthcare
    professionals, healthcare organisations and patient organisations, and
    the marketing of medicine to healthcare professionals, whether intended
    for use under medical supervision or otherwise.

    The advertising of medicine for human
    use in European Union Member States is
                                                              GENERAL
    governed by Council Directive 2001/83/EC of               The provisions of the Code fully reflect the
    6 November 2001, as amended. This Code                    standards of the July 2019 edition of the
    of Practice fits into the general framework               European Federation of Pharmaceutical
    established by Article 97 Paragraph 5 of                  Industries and Associations (EFPIA) Code. IPHA
    Directive 2001/83/EC as amended, which                    is a member of EFPIA and compliance with
    recognises the role of the voluntary control              the European Code is a requirement of all
    of advertising of medicine by self-regulatory             member associations of EFPIA.
    bodies and recourse to such bodies.
                                                              This IPHA Code of Practice incorporates
    The Code emphasises the importance of                     the provisions of the Medicine (Control of
    providing healthcare professionals with                   Advertising) Regulations 2007 (S.I. 541 of
    accurate, fair and objective information about            2007) for the purposes of providing practical
    medicine so that rational decisions can be                guidance in implementing the Regulations.
    made as to their use. Moreover, the Code
    accepts the principle that such information               The Minister for Health, as provided for under
    must be presented in a form and by ways                   Regulation 26 of the medicinal products
    and means which conform not only to                       (Control of Advertising) Regulations 2007
    legal requirements but also to professional               [the ‘Regulations’], endorses the parts of the
    standards of ethics and good taste.                       IPHA Code of Practice for the Pharmaceutical
                                                              Industry, that are directly derived (verbatim)
    Acceptance and observance of the provisions               from the aforementioned Regulations.
    of the Code and its annexes are a condition
    of membership of the IPHA. Companies                      This Code has been provided to help in
    observing the Code also acknowledge that its              implementing the requirements of the
    provisions are to be applied in spirit, as well as        Regulations. It is designed to be used in
    in the letter.

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IPHA CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY, V8.5

conjunction with the Regulations and is, by    3. We act with RESPECT, therefore we:
no means, a substitute for the Regulations.
                                                •	Are conscious of the importance of
                                                   providing accurate, fair and objective
ETHICAL PRINCIPLES                                 information about medicines so that
                                                   rational decisions can be made about
1. We keep PATIENTS AT THE HEART OF                their appropriate use
   WHAT WE DO, therefore we:                    •	Support the independence of the
 •	Continue to improve existing treatments        prescribing decisions of HCPs
    and deliver innovative new medicines        •	Assure mutual respect and
 •	Support the common objective of timely         independence, in terms of political
    access to medicines                            judgment, policies and activities, in all
                                                   partnerships with Patient Organisations
 •	Maintain a dialogue to better
    understand the needs of patients            •	Promote an attitude and environment
                                                   of mutual regard for other stakeholders,
 •	Work with stakeholders including               taking into account differences such as
    research communities to tackle                 cultures, views and ways of working
    healthcare challenges
 •	Continue appropriate collaboration with
    HCPs and others to support their role in   4. We are TRANSPARENT about our
    treating patients                             actions, therefore we:

                                                •	Share clinical trial data in a responsible
2. We act with INTEGRITY, therefore we:            way
                                                •	Publish details of the Transfers of Value
 •	Engage with HCPs, HCOs and Patient             made to HCPs and HCOs on www.
    Organisations only when there is a             transferofvalue.ie
    legitimate need
                                                •	Publish details of financial support and
 •	Take into consideration the role and           significant non-financial support to
    responsibility of stakeholders with            Patient Organisations
    whom we interact to avoid conflicts of
    interest or improper influence              •	Clearly indicate pharmaceutical
                                                   company sponsorship of any material
 •	Consider the values, standards and             relating to medicines and their uses
    decision-making processes of other
    stakeholders
 •	Support evidence-based decision
    making
 •	Facilitate access to medical education
    and help rapid dissemination of
    scientific information.

                                                                                                         5
IPHA CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY, V8.5

    CONTENTS

    1.       Scope and Definition of Terms........................................................................................................ 8
    2.       Activities of Member Companies................................................................................................... 9
    3.       Marketing Authorisation..................................................................................................................10
    4.       Nature and Availability of Information......................................................................................10
    5.       Claims and Comparisons................................................................................................................12
    6.       Disparaging References...................................................................................................................13
    7.       Textual and Audio-Visual Promotional Material....................................................................13
    8.	References to the Health Products Regulatory Authority
        and Related Organisations.............................................................................................................15
    9.       References to the Primary Care Reimbursement Service...................................................15
    10. Distribution of Promotional Material.........................................................................................16
    11. Reprints, Abstracts and Quotations............................................................................................16
    12. Company Employees (Direct and Contracted)........................................................................17
    13. Samples.................................................................................................................................................19
    14. Gifts.........................................................................................................................................................20
    15. Grants, Healthcare Support Services and Other Forms of Support.................................20
    16. Hospitality, Sponsorship and Meetings.....................................................................................23
    17. Medical Education.............................................................................................................................23

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IPHA CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY, V8.5

18. Use of Consultants.............................................................................................................................23
19. Market Research, Post Marketing Surveillance
    and Related Activities.......................................................................................................................24
20. Non-Interventional Studies............................................................................................................25
21. Relations with the General Public
    and Lay Communication Media....................................................................................................26
22. Company Procedures for Code Compliance.............................................................................28

ANNEXES
Annex I: Administration of the Code and Complaints Procedure..............................................29
Annex II: N
           ursing Services Provided by Companies........................................................................43
Annex III: Working with Patient Organisations.................................................................................46
Annex IV: Digital Communication in the Pharmaceutical Sector..............................................54
Annex V: Disclosure of Transfers of Value from Companies to Healthcare Professionals
          and Healthcare Organisations..............................................................................................61
Annex VI: Organisation and Conduct of Advisory Boards.............................................................72

                                                                                                                                                        7
IPHA CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY, V8.5

    PROVISIONS
    OF THE CODE
                                                              (iv) Registered nurses
    1. S
        COPE & DEFINITION
       OF TERMS                                               1.4	The term ‘’medicinal product’’ or
                                                                   medicine means means:
    1.1	The Code covers interactions with
         healthcare professionals, healthcare                  (i) Any substance or combination of
         organisations and patient organisations,                  substances presented as having properties
         and the promotion to healthcare                           for treating or preventing disease in
         professionals of prescription-only                        human beings.
         medicine.                                             (ii) Any substance or combination of
                                                                    substances which may be used in or
    1.2	The term “promotion” means those                           administered to human beings either
         marketing and informational activities                     with a view to restoring, correcting
         coming under the control or authority                      or modifying physiological functions
         of the company, the purpose of which is                    by exerting a pharmacological,
         to induce the prescribing, supply, sale or                 immunological or metabolic action, or to
         consumption of the company’s medicine.                     making a medical diagnosis.
    	Promotion includes, for example, the                    1.5	The term ‘Healthcare Organisation
      activities of medical representatives;                       (HCO)’ means any healthcare, medical or
      various aspects of sales promotion such                      scientific association or organisation such
      as journal and direct mail advertising,                      as a hospital, clinic, foundation, university
      the use of mail (including hardcopy,                         or other teaching institution or learned
      telephone, email, and other electronic                       society (except for a Patient Organisation
      means), the use of the internet, the use                     (PO) within the scope of Annex III of this
      of audio-visual materials such as films,                     Code) whose business address, place
      video recording, data storage services                       of incorporation or primary place of
      and the like, informational systems and                      operation is in Europe or an organisation
      exhibitions; and the provision of samples,                   through which one or more HCPs or other
      gifts or hospitality.                                        relevant decision makers provide services.
    1.3	The term “healthcare professional” means                  In addition to the specific provisions set
         a person of any of the following classes:                 out in the Code the following general
                                                                   conditions apply when working with a
    (i) Registered medical practitioners                           HCO:
    (ii) Registered dentists                                   •	The public use of an HCO logo and/
    (iii) Registered pharmacists

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IPHA CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY, V8.5

    or proprietary material by a Member         1.9 The Code does not cover:
    Company requires written permission
    from that HCO. In seeking such               –	the labelling of medicine and the
    permission, the specific purpose and the        accompanying package leaflets, which
    way in which the logo and/or proprietary        are subject to the provisions of the
    material will be used must be clearly           Medicine (Control of Placing on the
    stated.                                         Market) Regulations 2007 (S.I. 540 of
                                                    2007) as amended;
 •	Member Companies must ensure that
    their sponsorship is always clearly          –	correspondence, possibly accompanied
    acknowledged and apparent from the              by material of a non-promotional nature,
    outset. This can be achieved by clearly         needed to answer a specific question
    documenting or acknowledging the                about a particular medicine. Non-
    sponsors on relevant materials related to       promotional, general information about
    the activity.                                   companies (such as information directed
                                                    to investors or to current/prospective
 •	In addition, no member company
                                                    employees), including financial data,
    may require that it is the sole funder
                                                    descriptions of research and development
    or sponsor of an HCO or any of its
                                                    programmes, and discussion of regulatory
    programmes. Member Companies
                                                    developments affecting the company and
    welcome broad funding and sponsorship
                                                    its medicine.
    of HCOs from multiple sources.
                                                 –	factual, informative announcements
1.6	The term “marketing (or product)               and reference material relating, for
     authorisation” refers to a medicine            example, to pack changes, adverse-
     licence granted or renewed by the Health       reaction warnings as part of general drug
     Products Regulatory Authority or the           precautions, trade catalogues and price
     European Commission.                           lists, provided they include no product
                                                    claims;
1.7	The Code is not intended to inhibit the
                                                 –	books, journals, periodicals and other
     exchange of medical and scientific
                                                    publications that are imported into the
     information during the development of
                                                    State and which contain advertising
     a product.
                                                    which is not intended for, or directed at,
	The term ‘’promotional aid’’ means: a             persons resident in the State;
  non-monetary gift, that is inexpensive,        –	information relating to human health or
  relevant to the practice of medicine              diseases provided there is no reference,
  or pharmacy, and is made for a                    even indirect, to medicine.
  promotional purpose by a commercially
  interested party.                                ACTIVITIES OF
                                                2.	
1.8	The term ‘medical education’ includes         MEMBER COMPANIES
     education related to human health and
                                                2.1	The activities of member companies
     diseases and specific non-promotional
                                                     that fall within the scope of this Code
     training related to medicines. Medical
                                                     must never be such as to bring discredit
     education may include materials and
                                                     upon or reduce confidence in the
     activities.
                                                     pharmaceutical industry.
                                                                                                          9
IPHA CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY, V8.5

                                                              Promotional material for medicine which
        MARKETING
     3.	                                                     are not authorised in any EEA country at the
        AUTHORISATION                                         time of the congress or symposium, may not
                                                              be displayed or distributed to participants.
     3.1	A medicine must not be promoted prior               Scientific papers on such medicine may,
          to receipt of the marketing authorisation           however, be provided in accordance with
          permitting its sale or supply.                      Clause 1.6 of the Code.
     3.2	The promotion of a medicine must be
          consistent with the terms of the marketing          4. NATURE AND
          authorisation. All promotion must                       AVAILABILITY OF
          encourage the rational use of the medicine
          by presenting it objectively and not
                                                                  INFORMATION
          exaggerating its properties.                        4.1	Upon reasonable request, a company
                                                                   must promptly provide healthcare
     3.3	At independent international congresses
                                                                   professionals with accurate and relevant
          or symposia held in Ireland, promotional
                                                                   information about the medicine which it
          material which appears on exhibition
                                                                   markets.
          stands or is distributed to participants
          may refer to a medicine or indication for           4.2	Information about medicine must be up-
          a medicine which is not the subject of an                to-date, verifiable and accurately reflect
          authorisation in Ireland (but which is so                current knowledge or responsible opinion.
          authorised in at least one Member State
          of the European Economic Area [EEA])                4.3	Information about medicine must be
          provided that the following conditions                   accurate, balanced, fair, objective and
          are observed:                                            must not mislead either directly or by
                                                                   implication.
     (i)	The meeting must be a truly
            international, scientific event with a            4.4	Information about medicines must
            significant proportion of the speakers and             be capable of substantiation. Such
            delegates from other countries;                        substantiation need not be provided
     (ii)	To ensure that the promotional material                 however in relation to the validity of
            does not promote the prescription,                     indications approved in the marketing
            supply, sale or consumption of the                     authorisation.
            medicine in Ireland, a clearly visible and
                                                              4.5	Substantiation that is requested pursuant to
            legible statement must be included
                                                                   Clause 4.4 must be provided without delay
            to the effect that the medicine is
                                                                   at the request of members of the medical
            not authorised in Ireland or that it is
                                                                   and pharmacy professions including the
            authorised for different indications in this
                                                                   members of those professions employed in
            country;
                                                                   the pharmaceutical industry.
     (iii)	Promotional material which refers to
            the prescribing information (indications,         4.6	When promotional material refers to
            warnings etc.) authorised in other                     published studies, clear references must
            countries must include an explanatory                  be given.
            statement indicating that licensing
            conditions differ internationally.                4.7	In accordance with an agreement reached

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IPHA CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY, V8.5

     between the IPHA and the Department                and demonstrated on those stands and
     of Health, the summaries of product                requests for them accepted for later
     characteristics (SmPCs) relating to                delivery. Patient support items may be
     individual medicine are included in www.           provided to HCPs by those representing
     medicines.ie which is made available free          the company during the course of a visit
     of charge in Ireland. The contents of the          or when requested by a HCP.
     SmPCs in that electronic compendium
     are determined by the relevant marketing       	In limited circumstances patient support
     authorisations.                                  items may be made available for the use
                                                      of HCPs even though they are not to be
4.8	The provision of informational or                passed on to patients for them to keep.
     educational materials is permitted               This is where their purpose is to allow
     provided that the materials are: (i)             patients to gain experience in using their
     inexpensive; (ii) directly relevant to the       medicines whilst under the supervision
     practice of medicine or pharmacy; and            of a HCP. Examples include inhalation
     (iii) directly beneficial to patient care.       devices (with no active ingredient) and
     Such items may be company branded.               devices intended to assist patients to
                                                      learn how to self-inject.
	Materials provided for informational
  or educational reasons may include:               4.10	Items of medical utility aimed directly at
  scientific articles and items used to provide            the education of healthcare professionals
  information about medicine (such as detail               and patient care may be provided if
  aids); patient education materials given to              they are inexpensive and do not offset
  healthcare professionals for use with their              the routine business practice costs of
  patients, etc.                                           the HCP. Such items may be company
                                                           branded, only if the brand name is
	Companies may provide pens or paper                      essential for the correct use of the
  exclusively during company-organised                     medicine.
  meetings, as long as they are inexpensive
  and not product branded.                          5. CLAIMS AND
	Companies shall not distribute pens or                COMPARISONS
  paper at medical exhibition stands. Pens
  or paper included in conference bags              5.1	Claims for the usefulness of a medicinal
  shall not be branded (neither product nor              product must be based on an up-to-
  company branded).                                      date evaluation of all the evidence and
                                                         must reflect this evidence accurately
4.9	HCPs may be provided with items which               and clearly. Such claims must have prior
     are to be passed on to patients which               medical review and approval.
     may bear the name of a medicine and/or
     information about medicines only if such       5.2	Exaggerated claims must not be made
     detail is relevant to the appropriate use of        and all-embracing claims must be
     the medicine by patients who have been              avoided. Claims must not imply that a
     prescribed that medicine. Additionally,             medicine, or an active ingredient, has
     although items which are to be passed               some special merit, quality or property
     on to patients may not be issued at HCP             unless this can be substantiated.
     exhibition stands, they may be exhibited
                                                    5.3	The word “safe” must not be used
                                                                                                             11
IPHA CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY, V8.5

          without qualification and it must not be
          stated categorically that a medicine has
                                                              7. T
                                                                  EXTUAL AND AUDIO
          no side-effects, toxic hazards or risk of              VISUAL PROMOTIONAL
          addiction (see also Clause 7.2).                       MATERIAL
     5.4	The word “new” must not be used to                  7.1	All promotional material issued by a
          describe any medicine which has been                     marketing authorisation holder or with
          generally available, or therapeutic                      his authority, must be consistent with the
          indication which has been generally                      requirements of this Code.
          promoted, in Ireland for more than 12
          months.                                             7.2	Where the purpose of promotional
                                                                   material is to provide persons qualified
     5.5	Comparisons of medicine must be                          to prescribe or supply with sufficient
          factual, fair and capable of substantiation.             information upon which to reach a
          In presenting a comparison, care must be                 decision for prescribing or for use, then
          taken to ensure that it does not mislead                 the following minimum information,
          by distortion, by undue emphasis, by                     which must be compatible with the
          omission or in any other way.                            SmPC, must be given clearly and legibly
                                                                   and must be an integral part of the
     5.6	The brand names of other companies’
                                                                   advertisement:
          medicine must not be used in
          comparison unless the prior consent                 (i)	The relevant marketing authorisation
          of the companies concerned has been                        number and the name and address of
          obtained.                                                  the holder of the authorisation or the
                                                                     business name and address of the part of
     6. DISPARAGING                                                 the business responsible for placing the
         REFERENCES                                                  medicinal product on the market;
                                                              (ii)	The name of the product, and a list of the
     6.1	Other companies, their medicine, services                  active ingredients, using the common
          or promotions must not be disparaged                       name, placed immediately adjacent to
          either directly or by implication.                         the most prominent display of the name
                                                                     of the product;
     6.2	The clinical and/or scientific opinions of
          members of the healthcare professions               (iii)	One or more of the indications for the use
          must not be disparaged either directly or                  of the product compatible with the terms
          by implication.                                            of the marketing authorisation;
                                                              (iv)	Recommended dosage, method of use
                                                                     and, where not obvious, method of
                                                                     administration;
                                                              (v)	The classification for the sale or supply of
                                                                     the product;
                                                              (vi)	Adverse reactions, warnings and
                                                                     precautions for use and relevant
                                                                     contraindications of the product;
                                                              (vii) A statement that additional information is
                                                                    available on request;

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IPHA CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY, V8.5

(viii) T he date on which the above particulars         appropriate, irrespective of the editorial
       were generated or last updated.                   control of the material published.

7.3	Where the purpose of the promotional            7.6	Promotional material must conform, both
     material is to remind persons qualified to           in text and illustration, to canons of good
     prescribe or supply of the availability and          taste and must be expressed so as to
     of the indication(s) of a medicine (i.e. a           recognise the professional standing of the
     “reminder advertisement”), the following             HCPs and not be likely to cause offence.
     information, which must be compatible with
     the SmPC, must be included:                     7.7	The names or photographs of healthcare
                                                          professionals must not be used in
(i)	  The name of the medicine, or the                   promotional material without their
       international non-proprietary name,                permission nor in any way that is contrary
       where such exists, or the trademark;               to the ethical code of the appropriate
(ii)	 A statement which clearly indicates that           profession.
       further information is available upon
                                                     7.8	Promotional material must not imitate
       request or in the SmPC;
                                                          the devices, copy, slogans or general
(iii)	The name and address of the holder                 layout adopted by other companies in a
       of the marketing authorisation or the              way that is likely to mislead or confuse.
       business name and address of the part of
       the business responsible for placing the      7.9	Where appropriate (for example, in
       medicine on the market;                            technical and other informative material),
(iv)	The classification for sale or supply of the        the date of printing or of the last review
       medicine.                                          must be stated.

The indication(s) for the medicine may also be       7.10 Extremes of format, size or cost of
included in a reminder advertisement.                     promotional material must be avoided.

All promotional material not falling within the      7.11 Postcards, other exposed mailings,
category of “reminder advertisements” must                envelopes or wrappers must not carry
comply with Clause 7.2.                                   matter which might be regarded as
                                                          advertising to the lay public or which could
7.4	Promotional material such as mailings                be considered unsuitable for public view.
     and journal advertisements must not be
     designed to disguise their real nature.         7.12 Audio-visual material must be
     Where a company pays for or otherwise                accompanied by all appropriate printed
     secures or arranges the publication of               material so that all relevant requirements
     promotional material in journals, such               of the Code are complied with.
     promotional material must not resemble
                                                     7.13 Material relating to medicines and their
     editorial matter.
                                                          uses, whether promotional in nature or
7.5	All promotional material appearing in                not, which is sponsored by a company
     journals, the publication of which is paid           must clearly indicate that it has been
     for, secured or arranged by a company                sponsored by that company and if that
     and referring by brand name to any                   company had any input into the content
     product of that company, must comply                 of the material.
     with Clause 7.2 or 7.3 of this Code as
                                                                                                              13
IPHA CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY, V8.5

                                                                  announcements, advertisements and
        REFERENCES TO THE
     8.	                                                         other communications to this effect
        HEALTH PRODUCTS                                           may include in the body of prescribing
        REGULATORY                                                information, a statement that the product
                                                                  is “PCRS reimbursable” (or similar)
        AUTHORITY                                                 provided that the print size of such
        AND RELATED                                               statements is no larger than the rest of
        ORGANISATIONS                                             the text. Such a statement may be carried
                                                                  for no longer than twelve months from
     8.1	Unless specific requirements with regard                the date of the adding or restoring of the
          to distribution or use have been imposed,               product to the PCRS list.
          companies must not include in any
          promotional material, a statement that              9.4	Reproductions of official documents,
          the marketing of the medicine has been                   such as prescription forms, must not be
          approved or recommended by the Health                    used for promotional purposes unless
          Products Regulatory Authority or related                 the agreement of the appropriate State
          organisations such as the European                       Organisation has been received.
          Medicines Agency (EMA), the European
          Commission or the Committee for                     10.DISTRIBUTION OF
          Medicine for Human Use (CHMP).                          PROMOTIONAL
                                                                  MATERIAL
     9. REFERENCES TO
         THE PRIMARY CARE                                     10.1	Promotional material must only be sent
                                                                  or distributed to those categories of
         REIMBURSEMENT                                            persons whose need for, or interest in, the
         SERVICE                                                  particular information can be reasonably
                                                                  assumed.
     9.1	References to the Primary Care
          Reimbursement Service (PCRS) (or                    	Promotional material must be tailored to
          the GMS as it was previously known)                   the audience to whom it is directed. For
          in promotional material must be                       example, promotional material devised
          confined to including the relevant code               for general practitioners may not be
          number (the print size and typeface of                appropriate for hospital doctors.
          which must be the same as that of the
          marketing authorisation number) and /               10.2	Any information designed to encourage
          or price.                                               the use of medicine in clinics, industrial
                                                                  concerns, clubs or schools must be
     9.2	Where reference is made to the                          addressed to the appropriate healthcare
          prescribing of a product under the PCRS,                professional.
          the phrase “freely prescribable” or similar
          phrases suggesting a lack of restriction or         10.3 Restraint must be exercised on the
          restraint must not be used.                              frequency of distribution and on the
                                                                   volume of promotional material
     9.3	Where a product has been added                           distributed.
          or restored to the PCRS list,
                                                              	The style of mailings is relevant to their

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IPHA CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY, V8.5

     acceptability to healthcare professionals           from personal communications received
     and criticism of their frequency is most            from healthcare professionals, must
     likely to arise where their informational           accurately reflect the meaning of the
     content is limited or where they appear             author and the significance of the study.
     to be elaborate and expensive.
                                                    12.	COMPANY EMPLOYEES
10.4 Mailing lists must be kept up-to-date.
     Requests from healthcare professionals              (DIRECT AND
     to be removed from mailing lists must               CONTRACTED)
     be complied with promptly and no
     name should be restored except at the          12.1 The term “medical representatives”
     healthcare professional’s request or with           includes medical sales representatives,
     his/her permission.                                 including personnel retained by way of
                                                         contract with third parties, and any other
10.5 The use of faxes, e-mails, automated               company representatives who call on
     calling systems, text messages and other            healthcare professionals, pharmacies,
     electronic data communications for                  hospitals or other healthcare facilities
     promotion is prohibited except with the             in connection with the promotion of
     prior permission, or upon the request, of           medicine.
     the HCP.
                                                    12.2 Medical representatives must be
11.REPRINTS, ABSTRACTS                                  provided with thorough training by the
                                                         company which employs them and
    AND QUOTATIONS                                       possess sufficient scientific knowledge
(Such use is, of course, subject to the                  to present information on the company’s
Law of Copyright)                                        medicine in an accurate, complete and
                                                         responsible manner. The contribution
11.1	All reprints of articles supplied to               of the Medical Representatives Institute
    individual healthcare professionals in the           of Ireland in this respect (for example
    course of promotion must comply with                 by the inclusion of the IPHA Code of
    the provisions of Clause 7.2 or 7.3 16 as            Practice in its examination syllabus) is
    appropriate.                                         acknowledged.

11.2 It is permissible to include in               12.3 During each visit medical representatives
     promotional material, reasonably brief              must give the person visited or have
     abstracts of, or quotations from, articles,         available for them, the most up-to-date
     or accurately reproduced tables or                  version of the SmPC for each medicinal
     other illustrative matter taken from the            product they promote. Where the SmPCs
     scientific literature and to include in such        are published in a compendium such as
     material references to authors’ names               www.medicines.ie and this fact is drawn
     in a bibliography of published works. In            to the attention of the persons visited, this
     no case however, should authors’ names              requirement is deemed to be satisfied.
     be used in a prominent manner in
     promotional material.                          12.4 All company employees must transmit
                                                         to the Scientific Services established
11.3 Quotations from medical literature, or             in their companies any information on
                                                         adverse reactions reported to them by

                                                                                                             15
IPHA CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY, V8.5

          the persons they visit.                                 endeavour to treat healthcare
                                                                  professionals’ time with respect and if for
     12.5 Medical representatives must at all times              any reason an appointment cannot be
          maintain a high standard of ethical                     kept by the representative, the longest
          conduct in the discharge of their duties.               possible notice must be given.
          They must comply with all relevant
          requirements of the Code.                           12.8 Medical representatives must take
                                                                   adequate precautions to ensure the
     	Medical Sales Representatives must,                         security of medicine in their possession.
       from the outset, take reasonable steps
       to ensure that they do not mislead as                  12.9 Medical representatives must not use the
       to their identity or that of the Member                     telephone or similar electronic means
       Company they represent.                                     to promote medicine to healthcare
                                                                   professionals unless prior arrangement
     12.6 Medical representatives must not employ                 has been made with the individuals
          any inducement or subterfuge to gain                     concerned.
          an interview. They must not pay, under
          any guise, for access to a healthcare               12.10	Companies are responsible for the
          professional.                                             activities of all their employees and
                                                                    must ensure that employees who are
     	This clause does not preclude                                concerned in any way with the drafting
       the occasional provision of light                            or approval of promotional material
       refreshments/modest meals at a meeting                       (including employees of third parties
       organised by a medical representative.                       contracted on behalf of the company)
       Such hospitality may only be provided                        are fully conversant and compliant with
       to healthcare professionals and occur                        the requirements of the Code.
       in a manner and venue conducive to
       information exchange and/or scientific                 		Other third parties working for or
       education.                                                on behalf of companies, (including
                                                                 advertising company executives,
     	Payments to healthcare professionals to                   business consultants and market
       cover the cost of such hospitality are not                research companies), and those that
       allowed.                                                  do not act on behalf of companies
                                                                 (such as joint ventures and licensees)
     12.7 Medical representatives must ensure
                                                                 commissioned to engage in activities
          that the frequency, timing and duration
                                                                 covered by the Code must also be fully
          of calls on healthcare professionals, or
                                                                 conversant and compliant with
          on hospitals, together with the manner
                                                                 the Code.
          in which they are made, are acceptable
          to the healthcare professionals and                 12.11	The provision of nursing services by
          hospitals as appropriate and are not such                 a company must be undertaken in
          as to cause inconvenience. The wishes                     accordance with the guideline on
          of an individual healthcare professional,                 the provision of nursing services by
          or the arrangements in force at any                       companies published in Annex II.
          particular establishment, must be
          observed by representatives.                        12.12	Companies must ensure that all
                                                                    regulatory obligations are met. In
     	Medical representatives must always
16
IPHA CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY, V8.5

      particular their pharmacovigilance                  authorisation application or following an
      departments must be notified of all                 extension application for new strengths/
      market research activities, Patient                 dosage forms that include a new
      Support Programmes etc.                             indication. Extensions of the marketing
                                                          authorisation to additional strengths/
13.	SAMPLES                                              dosage forms for existing indications or
                                                          pack sizes (number of units in the pack)
13.1	Free samples of medicine shall not                  cannot be considered as new medicines.
    be supplied to any person who is not           (iii)	Any supply of such samples must be in
    qualified to prescribe such product.                  response to a signed and dated request
	The supply of a sample means the supply                 from the HCP;
  of a medicine made otherwise than in             (iv)	An adequate system of control and
  connection with a clinical trial.                       accountability must be maintained in
                                                          respect of the supply of such samples.
13.2	Where samples of medicine are                       This system shall also clearly establish,
    distributed by a medical representative,              for each person supplied, the number of
    the sample must be handed directly                    samples provided in application of the
    to a person qualified to prescribe such               provision in Clause 13.3(ii);
    product or to a person authorised to           (v)	Each sample shall be no larger than the
    receive the sample on their behalf.                   smallest presentation on the market;
	Medical samples must not be provided             (vi)	Each sample shall be marked “free
  as an inducement to recommend and/                      medical sample – not for sale” or bear
  or prescribe, purchase, supply, sell or                 another legend of analogous meaning;
  administer specific medicines, and must          (vii)	Each sample shall be accompanied by
  not be given for the sole purpose of                    a copy of the most up-to-date version
  treating patients.                                      of the SmPC relating to that product in
                                                          accordance with the requirements set out
13.3	The following conditions shall be observed          in Clause 12.3.
     in the provision of samples to a person
     qualified to prescribe such product:          13.4	A person shall not supply a sample
                                                       of a medicine which is a controlled
(i)	Such samples are provided on an                   drug under Section 2 of the Misuse of
      exceptional basis only (see (ii) to (vii)        Drugs Act, as amended, or which is an
      below) and for the purpose of acquiring          anti-depressant, hypnotic, sedative or
      experience in dealing with such a                tranquilliser.
      product;
(ii)	Such samples in respect of a medicinal       13.5	Samples sent by post must be packed so
      product shall not exceed four in number          as to be reasonably secure against the
      per year and sampling shall not extend           package being opened by children.
      beyond the two years after he/she first
      requested samples of each particular new     13.6	Distribution of samples in hospitals must
      medicine. In this context, a new medicine        also comply with individual hospital
      is a product for which a new marketing           regulations, if any.
      authorisation has been granted,
      either following an initial marketing

                                                                                                            17
IPHA CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY, V8.5

                                                                      for positions that are predominantly
     14.GIFTS                                                        research based and for a defined period
     14.1	No gifts, pecuniary advantages or benefits                 of time. Any request for funding should
          in kind may be supplied, offered or                         clearly outline the focus of the research,
          promised to persons qualified to prescribe                  the output of the research work and the
          or supply by a company in relation to                       full cost of employment for the period in
          the promotion/ marketing of prescription                    question.
          medicines. This does not preclude any               (iv)	Any such support must not be linked
          regulations for the time being in force                     in any way with product promotion. No
          relating to prices, margins and discounts.                  commitment must be sought or given in
                                                                      relation to the prescribing, supply or use
     15.GRANTS, HEALTHCARE                                           of the company’s medicine;
         SUPPORT SERVICES                                     (v)	Any such support must be reasonable,
                                                                      modest and in proportion to the scale
         AND OTHER FORMS                                              and scope of the HCP institution
         OF SUPPORT                                                   and must be likely to appear so to
                                                                      independent third parties.
     15.1	Clause 14 shall not preclude a company
                                                              (vi)	Companies must make public details of all
         from providing support in the form of
                                                                      Transfers of Value as outlined in Annex V.
         educational, research or employment
         grants, donation or sponsorship of                   (vii)	Companies should actively check that
         equipment for the betterment of patients,                    their support has been spent as intended.
         provided that the following conditions are                   In particular, the written agreement
         complied with.                                               must require that the HCP provides
                                                                      confirmation that the support has been
     (i)	The company must be in receipt of                           spent as agreed.
            a written request from a healthcare               (viii)	The funding confirmation ‘Agreement’
            professional or institution (for example,                 must specify the name of the HCO that the
            a practice, medical centre, clinic or                     ToV payment can be disclosed against on
            hospital) for the specific type of support                the IPHA Transfer of Value website.
            provided. Sufficient information must
                                                              (ix)	Companies must obtain written
            be obtained to establish that there
                                                                      confirmation of the authorised account
            is a genuine need for such support
                                                                      for ToV payments from the CEO, Finance
            and that it does not offset the routine
                                                                      Director or other comparable role of
            business practice costs of the HCP. A
                                                                      the HCO.
            written agreement, including details of
            the duration and nature of the support            15.2	A Healthcare Support Service (HSS) is
            must be signed in advance of the                      defined as a process enhancement
            commencement of the support.                          initiative or medical service support (e.g.
     (ii)	Support must be paid directly to an                    patient compliance initiative, sharps bin
            institution rather than to an individual              service, disease identification, screening
            healthcare professional;                              or genetic marker test, review of patient
     (iii)	Employment grants provided directly                   management/ treatment quality review
            or indirectly to HCOs are only permitted              etc.) provided by a pharmaceutical
                                                                  company that ultimately improves
                                                                  patient care and welfare. Further
18
IPHA CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY, V8.5

    guidance regarding Nursing Services            the service, the requirements for safety
    provided by companies are detailed             reporting, adherence to data privacy
    separately in Annex II.                        requirements etc.

	A HSS must have the objectives of            	Information collected in the course of
  monitoring disease activity, achieving         the provision of a HSS may not be used
  better healthcare outcomes and                 for promotional purposes or to plan
  enhancing patient care. HSSs must be           promotional activity. Furthermore, it
  non-promotional, must not be designed          may not be used for clinical research
  as an inducement to prescribe and              purposes without the appropriate prior
  must not be designed or operated in a          written consent of the HCP and the
  promotional manner. Decisions regarding        patient. In general, a HSS should only
  provision of the HSS must be based upon        collect the minimum amount of personal
  objective criteria linked to the defined       information needed to ensure the HSS’s
  purpose and not linked to past or future       management.
  prescription, supply, sale or consumption
  of a company’s medicine. Proposals to        	All HSS material used in the services
  provide a HSS must be reviewed, and            must be non-promotional. Materials
  the details approved in advance, by the        may be company branded. However,
  appropriate non-promotional function           they may only include the brand name
  within the company (e.g. Scientific            of the medicine, to support the safe use
  Services, medical, legal etc.). The HSS        of the medicine, after the prescribing
  must be provided under the supervision         decision has been made. Companies
  of this function. When company staff           must ensure that they have a process in
  are involved in the provision of the HSS       place to ensure that all HSS materials are
  they must report to the aforementioned         developed, reviewed, approved, released
  function within in the company and their       and removed from use, appropriately.
  compensation must not relate to sales of
                                               	Companies must ensure that they have
  the company’s medicine.
                                                 the resources to manage and monitor
	A written agreement (or referral)              the HSS. The records relating to the
  between the company and the patient’s          HSSs must be retained according to the
  HCP, including the nature of the               legislation and be made available for
  support, project scope, timelines and          review by regulators and auditors.
  HSS objective must be signed before
                                               	Sales representatives may inform the
  commencement of the HSS. All patients
                                                 relevant healthcare professional(s) about
  involved in the HSS must be advised
                                                 the availability of a HSS, but may not
  of the company’s involvement and
                                                 provide, deliver, demonstrate or have
  the patient’s consent obtained, when
                                                 other involvement in a HSS.
  required. The operation of the HSS
  must be monitored with reference to its
  objectives.

	A HSS may be provided directly or
  indirectly (through a service provider) to
  patients. Contractual arrangements with
  service providers should clearly outline
                                                                                                        19
IPHA CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY, V8.5

                                                                   be approved in advance by a non-
     16.HOSPITALITY,                                              promotional function of the company.
         SPONSORSHIP                                               Consideration and priority should be given
         AND MEETINGS                                              to HCPs who are experts in their respective
                                                                   fields (e.g. are associated with university
     16.1	The pharmaceutical industry has                         teaching hospitals, participate in training
          a special obligation to ensure that                      schemes or have academic and research
          healthcare professionals are kept in touch               interests in a relevant field). The decision
          with continuing developments in the                      to fund must be based on the potential of
          pharmaceutical field. With this in mind,                 the attendee to acquire useful knowledge
          the practice has arisen of meetings and                  at the event, congress or symposium and
          events being organised between the                       ultimately improve patient management
          industry and the professions for the further             and patient outcomes.
          exchange of ideas and information. In
          addition, the custom has grown of the               16.3 (i) Companies shall not provide or offer
          industry supporting independent meetings                 any meals to healthcare professionals,
          of healthcare professionals intended                     unless, in each case (i.e. per meal and
          to update and expand the continuing                      per HCP), the value of such meals
          education of the relevant healthcare                     (food and beverages) does not exceed
          professionals.                                           €80 (including VAT and excluding any
                                                                   gratuity). This threshold is in addition to
     	Many of these meetings could not take                       the existing restrictions on hospitality
       place without the support and assistance                    (reasonable, secondary to the main
       of the pharmaceutical industry. Companies                   purpose etc) and only applies to events
       may legitimately provide assistance that is                 in Ireland.
       directly related to the bona fide continuing
       education of the healthcare professionals              (ii)	In the case of any virtual meeting
       and which genuinely facilitates attendance                   (sponsored or other), hospitality cannot
       of the healthcare professional for the                       be provided to an individual HCP
       duration of the educational aspect of                        attending a virtual meeting. In the case
       the event. Such support and assistance                       of a group of HCPs attending a virtual
       must however, always be such as to leave                     meeting together, the provisions of clause
       healthcare professionals’ independence of                    16.3(i) apply.
       judgement manifestly unimpaired.
                                                              16.4	It should be the programme that attracts
     16.2	Where appropriate and depending on the                 delegates and not the associated venue
          time, location and length of the meeting,               or hospitality.
          support to healthcare professionals may
                                                              	Companies must not organise or sponsor
          cover actual travel expenses, meals,
                                                                meetings to coincide with sporting,
          refreshments, accommodation and
                                                                entertainment or other leisure events or
          registration fees.
                                                                activities.
     	In this respect, if companies support HCPs
                                                                    ll Events must be held in appropriate
                                                                   A
       to attend company-organised or third
                                                                   locations and venues that are conducive
       party international medical education
                                                                   to the main purpose of the Event.
       events, congresses and symposia then
       the criteria for HCP selection must
20
IPHA CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY, V8.5

	Venues that are renowned for their                     purpose of the event. Clause 16.4 also
  entertainment or leisure facilities or are             applies to all such meetings.
  extravagant must not be used for such
  meetings.                                         16.8	A company may not organise or sponsor
                                                        an event or a participant’s attendance at
16.5	In addition to the requirements of clause         an event that takes place outside Ireland
    16.3 any hospitality offered to healthcare          unless there is a valid reason to do so.
    professionals must:                                 All the previous relevant provisions must
                                                        be applied together with the following
(i)	Be reasonable in level and be likely to            additional principles:
       appear to be reasonable to independent
       third parties;                               (i)	Most of the invitees are from outside
(ii)	Be secondary and strictly limited to the             Ireland and, given the countries of origin
       main purpose of the event at which it is            of most of the invitees, it makes greater
       offered;                                            logistical sense to hold the event in
                                                           another country or;
(iii)	Not exceed the level that HCPs would
       normally be prepared to pay for              (ii)	Given the location of the relevant
       themselves;                                         resource or expertise that is the object
                                                           or subject matter of the event, it makes
(iv)	Not be extended to spouses or other
                                                           greater logistical sense to hold the event
       accompanying persons, unless they are
                                                           in another country;
       healthcare professionals who qualify as
       participants in their own right. Travel      (iii)	As with meetings held in Ireland,
       expenses may not be paid for spouses or             consideration must be given to the
       other accompanying persons, unless they             educational programme, overall cost,
       are healthcare professionals who qualify            facilities offered by the venue, nature of
       as participants in their own right;                 the audience and the hospitality to be
                                                           provided, which must be secondary to the
(v)	Not include sponsoring, securing,
                                                           meeting and not out of proportion to the
       organising directly or indirectly any
                                                           occasion;
       entertainment, sporting or leisure events.
                                                    (iv)	In addition to the requirements of Clause
16.6	Funding of healthcare professionals to               16.5 any hospitality offered to healthcare
    compensate them for the time spent in                  professionals at international meetings
    attending the event is not permitted.                  must ensure that:
                                                    		 (a) it is the programme that attracts
16.7	All promotional, scientific or professional
                                                               delegates and not the associated
    meetings, congresses, conferences,
                                                               venue or hospitality;
    symposia, and other similar events
    (including, for example, advisory               		 (b) To avoid any confusion as to the
    board meetings, visits to research or                      primary purpose of the event,
    manufacturing facilities, and planning,                    international events should not
    training or investigator meetings for                      coincide with a major event of a
    clinical trials and non-interventional                     sporting or social nature in a locality.
    studies) (each, an “event”) organised or        (v)	For flights that have a scheduled duration
    sponsored by or on behalf of a company                 of five or less hours, only economy flights
    must be held at an appropriate location                may be sponsored by companies for HCP
    and venue that is conducive to the main                attendance at conferences.

                                                                                                             21
IPHA CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY, V8.5

     16.9	The following additional requirements                  product range. This form of exhibition by
         shall apply in relation to the sponsorship               companies is acceptable.
         of meetings convened by the healthcare
         professions:                                         	As far as possible, for reasons of security,
                                                                medicine must not be brought to such
     	
      No one company may undertake the                          meetings. In no circumstances should
      sponsorship of any meeting or series                      medicine be handed over to visitors to
      of meetings to the exclusion of other                     the stand or exhibition.
      available and willing sponsors. No
      payment must be made by a company                       	Other support for such meetings must
      to be included on a shortlist of possible                 not extend beyond a contribution to
      sponsors.                                                 the general expenses of the meeting.
                                                                An acknowledgement of this support,
     (i)   Smaller meetings                                     by way of a list of sponsors on the
                                                                programme (if any) and/or by way of a
     	The sponsorship of local clinical meetings,              similar list displayed on a notice board, is
       initiated by an organising body of the                   acceptable.
       healthcare professions, is frequently
       sought from companies. In such instances,              16.10 Corporate Hospitality
       companies must respond only to formal
       written requests for support from the                  	Aside from meetings and events as
       organising committee. Any request                        referred to in the preceding paragraphs,
       for support should indicate the exact                    it is recognised that, on occasion,
       anticipated items of expenditure for which               companies may provide what may be
       the support is sought.                                   considered as “corporate hospitality” (e.g.
                                                                opening a new office).
           Support must not extend beyond:
                                                              	Corporate hospitality involving sporting,
       • cost of room hire                                      entertainment or social events or
       • cost of equipment hire                                 activities must not be extended to
                                                                healthcare professionals.
       •	actual travel expenses of speaker(s)
       •	honorarium to speaker(s) if appropriate             	The following principles shall apply to
       •	modest meals and/or light refreshments                corporate hospitality:

     	Promotional input from companies at an                 (i)	There must be no element of product
       appropriate stage of the meeting must                       promotion at the event, either direct or
       be with the agreement of the Chair or                       implied;
       through a printed acknowledgement on
                                                              (ii)	Companies should appreciate the need
       the programme (if any).
                                                                    for moderation.
     (ii) Larger meetings
                                                              	Corporate hospitality must never be such
     	For larger meetings initiated by the                     that, on a reasonable view, it might give
       healthcare professions, such as annual                   rise to the inference that the scale and
       association meetings, support usually                    costs of such hospitality could adversely
       involves the rental of a stand or space for              affect the cost of medicines to the patient
       the purposes of exhibiting the company’s                 or taxpayer;

22
IPHA CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY, V8.5

(iii)	Corporate hospitality should be
       reasonable in level and likely to appear
                                                  18.	USE OF CONSULTANTS
       so to independent third parties. It        Healthcare professionals can be used as
       should not exceed the level that HCPs      consultants and advisors, whether in groups or
       would normally be prepared to pay for      individually, for:
       themselves.
                                                   •	Services (e.g. chairing or speaking at
17.	 MEDICAL EDUCATION                               meetings, being involved in medical/
                                                      scientific studies or in clinical trials)
Medical education is aimed at increasing the       •	Training
scientific knowledge and competence of HCPs
to enhance medical practice and improve            •	Participating in advisory board meetings
patient outcomes.                                     (see Annex VI)
                                                   •	Participating in market research where
17.1	Medical education activities / materials       such participation involves remuneration
       must not constitute promotion.                 and/or travel
17.2The level and type of a company’s
      involvement must be clearly                 With the exception of one-off phone
      acknowledged and apparent from the          interviews or mail/email/internet
      outset. It must not mislead the HCP         questionnaires, the arrangements that cover
                                                  these genuine consultancy or other services
17.3Companies are responsible for the           must fulfil all of the following criteria:
      content of medical education activities
      / materials, if the arrangements            (i)	A legitimate need must be clearly
      are such that the companies have                 identified before the request for such
      influenced or provided input into                services, and the arrangements with the
      what is communicated during those                prospective consultants, are made;
      activities. Such influence may include
      but is not limited to: the selection of     (ii)	A written contract or agreement,
      topics, speakers and co-authorship of             including details regarding the nature of
      content.                                          the services to be provided and the basis
17.4The content of medical education                  for payment of those services, must be
      materials or activities must be fair,             signed in advance of the commencement
      balanced and objective, and designed to           of the services;
      allow the expression of diverse theories    (iii)	Criteria directly related to the identified
      and recognised opinions.                           need must drive the selection and
17.5The provisions of Clause 16 regarding              evaluation of consultants;
      hospitality and arrangements for
      meetings must be applied for all medical    (iv)	No greater number of healthcare
      education events. Such requirements               professionals can be retained than
      apply regardless of whether such                  is reasonably necessary to fulfil the
      activities are led, or supported by,              identified need;
      the company.
                                                  (v)	Records concerning the services provided
                                                       by consultants must be maintained by
                                                       the contracting company;

                                                                                                           23
IPHA CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY, V8.5

     (vi)	The hiring of the healthcare professional
           to provide the relevant services must not
                                                              19.	MARKET RESEARCH,
           be an inducement to prescribe, supply,                  POST MARKETING
           sell or consume a particular medicinal                  SURVEILLANCE AND
           product;
                                                                   RELATED ACTIVITIES
     (vii)	The compensation for the services must
            be reasonable and reflect the fair market         19.1	Methods used for market research must
            value of the services provided. In this               never be such as to bring discredit
            regard, token consultancy arrangements                upon, or reduce confidence in, the
            must not be used to justify compensating              pharmaceutical industry. The following
            healthcare professionals.                             provisions set out in this clause apply
                                                                  whether the research is carried out
     Consultants who have entered contractual                     directly by the company or by an
     arrangements with companies or are employed                  organisation acting on its behalf.
     on a part-time basis while still practising their
     profession, must be strongly encouraged to               19.2	Access to respondents must not be
     declare their arrangements with the company,                 gained by subterfuge. Any incentives
     whenever they write or speak in public about                 given must be kept to a minimum and be
     a matter that is the subject of the agreement                commensurate with the work involved.
     or any other issue relating to that company.             19.3	Questions intended to solicit disparaging
     Additionally, companies are required to make                 references to competing medicine or
     public details of all Transfers of Value as per              companies must be avoided.
     Annex V of this Code.
                                                              19.4	Market research must not be used as a
     If a healthcare professional attends an event                form of disguised sales promotion.
     (an international event or otherwise) in a
     consultant or advisory capacity the provisions           19.5	Post-marketing surveillance studies,
     of Clause 16 covering hospitality shall apply.               pharmacoeconomic studies, non-
                                                                  interventional trials, clinical audit
     Contracts between member companies,                          programmes and the like (including
     HCPs and HCOs under which they provide                       those that are retrospective in nature)
     any type of services to member companies,                    commissioned, undertaken or provided
     not otherwise covered by the Code, are only                  by companies must never be promotional
     allowed if                                                   in nature and must be conducted
     (i)	such services are provided for the                      primarily with a scientific or educational
          purpose of supporting healthcare,                       purpose. This clause does not preclude
          research or education; and                              the use of the data generated from such
                                                                  studies to support claims in promotion.
     (ii)	do not constitute an inducement to
           recommend and/or prescribe, purchase,              20.NON-INTERVENTIONAL
           supply, sell or administer specific                    STUDIES
           medicines.
                                                              20. 1 A “non-interventional study” (NIS) must
                                                                    not be disguised promotion and is
                                                                    defined as:

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