CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY - Edition 8.5 - Effective 01st Mar 2021
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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.ieIPHA 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.
4IPHA 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.
5IPHA 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
6IPHA 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
7IPHA 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
8IPHA 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.
9IPHA 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
10IPHA 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
11IPHA 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;
12IPHA 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
13IPHA 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
14IPHA 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
15IPHA 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
16IPHA 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
17IPHA 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
18IPHA 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
19IPHA 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
20IPHA 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.
21IPHA 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;
22IPHA 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;
23IPHA 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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