CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY - EDITION 8.3 1 FEBRUARY 2018 - IPHA
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CODE OF
PRACTICE
FOR THE PHARMACEUTICAL INDUSTRY
EDITION 8.3 1 FEBRUARY 2018
IPHA Code of Practice for the Pharmaceutical Industry Edition 8.3 – 1st February 2018 © Irish Pharmaceutical Healthcare Association Wilton Park House, Wilton Place, Dublin 2 Tel: +353 (1) 6610018 Fax:+353 (1) 6610164 E-mail: info@ipha.ie Website: www.ipha.ie
IPHA CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY
THE IRISH PHARMACEUTICAL
HEALTHCARE ASSOCIATION (IPHA)
REPRESENTS THE INTERNATIONAL
RESEARCH-BASED PHARMACEUTICAL
INDUSTRY IN IRELAND. ITS MEMBER
COMPANIES INCLUDE BOTH
MANUFACTURERS OF PRESCRIPTION
MEDICINES AND NON-PRESCRIPTION
OR CONSUMER HEALTHCARE
MEDICINES.
3
IPHA CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY
1. 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
associations, and the marketing of medicinal products
to healthcare professionals, whether intended for use
under medical supervision or otherwise.
The advertising of medicinal products for conform not only to legal requirements
human use in European Union Member but also to professional standards of
States is governed by Council Directive ethics and good taste.
2001/83/EC of 6 November 2001, as
amended. This Code of Practice fits Acceptance and observance of the
into the general framework established provisions of the Code and its annexes
by Article 97 Paragraph 5 of Directive are a condition of membership of the
2001/83/EC as amended, which IPHA. Companies observing the Code
recognises the role of the voluntary also acknowledge that its provisions are
control of advertising of medicinal to be applied in spirit, as well as in the
products by self-regulatory bodies and letter.
recourse to such bodies.
The provisions of the Code fully reflect
The Code emphasises the importance of the standards of the July 2014 edition
providing healthcare professionals with of the “EFPIA Code on the Promotion
accurate, fair and objective information of Prescription-only Medicines to,
about medicinal products so that rational and Interactions with, Healthcare
decisions can be made as to their use. Professionals”, June 2011 edition of the
Moreover, the Code accepts the principle “EFPIA Code of Practice on Relationships
that such information must be presented between the Pharmaceutical Industry and
in a form and by ways and means which Patient Organisations” and July 2014
4
IPHA CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY
edition of the “EFPIA Code on Disclosure
of Transfers of Value from companies
to Healthcare Professionals and
Healthcare Organisations” which are
published by the European Federation
of Pharmaceutical Industries and
Associations (EFPIA). IPHA is a member
of EFPIA. Compliance with the European
Code is a requirement of all member
associations of EFPIA.
This IPHA Code of Practice incorporates
the provisions of the Medicinal Products
(Control of Advertising) Regulations
2007 (S.I. 541 of 2007) for the purposes
of providing practical guidance in
implementing the Regulations.
The Minister for Health, as provided for
under Regulation 26 of the Medicinal
Products (Control of Advertising)
Regulations 2007 [the ‘Regulations’],
endorses the parts of the IPHA Code of
Practice for the Pharmaceutical Industry,
that are directly derived (verbatim) from
the aforementioned Regulations.
This Code has been provided to help in
implementing the requirements of the
Regulations. It is designed to be used in
conjunction with the Regulations and
is, by no means, a substitute for the
Regulations.
5
IPHA CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY
CONTENTS
1. Scope & Definition of Terms................................................................... 8
2. Methods of Promotion......................................................................... 10
3. Marketing Authorisation...................................................................... 10
4. Nature and Availability of Information............................................... 11
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.................... 16
10. Distribution of Promotional Material.................................................. 16
11. Reprints, Abstracts and Quotations..................................................... 17
12. Company Employees (Direct and Contracted)..................................... 17
13. Samples.................................................................................................. 19
14. Gifts........................................................................................................ 21
15. Grants & Other Forms of Support........................................................ 21
16. Hospitality, Sponsorship and Meetings................................................ 23
17. Use of Consultants................................................................................ 27
6IPHA CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY
18. Market Research, Post Marketing Surveillance
and Related Activities........................................................................... 29
15. Grants & Other Forms of Support..........................................................X
19. Non-Interventional Studies................................................................... 29
16. Hospitality, Sponsorship & Meetings......................................................X
20. Relations with the General Public
17. and LayConsultants..................................................................................X
Use of Communication Media............................................................ 31
21. Company Procedures for Code Compliance........................................ 32
18. Market Research, Post Marketing Surveillance & Related Activities....X
19. Non-Interventional Studies.....................................................................X
ANNEXES
20. Relations with the General Public & Lay Communication Media.........X
Annex I: Administration of the Code and Complaints Procedure............. 33
21. Company
Annex Procedures
II: Guideline for Code
on Nursing Compliance...........................................X
Services Provided
by Companies............................................................................................... 50
ANNEXES
Annex III: Guideline for Companies on Working
Annex I: Administration
with Patient Associations.of the Code & Complaints Procedure..................X
............................................................................ 53
II: Guideline
Annex IV: Guidelineon onNursing Services Provided by companies................X
Digital Communication
in the Pharmaceutical Sector....................................................................... 62
Annex III: Guideline for companies on Working with Patient
Annex V: IPHA Code on Disclosure of Transfers of Value
Associations....................................................................................................X
from Companies to Healthcare Professionals and
Annex IV: Guideline
Healthcare on Digital Communication in the Pharmaceutical 69
Organisations............................................................................
Sector..............................................................................................................X
Annex V: IPHA Code on Disclosure of Transfers of Value from companies
to Healthcare Professionals and Healthcare Organisations........................X
7IPHA CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY
PROVISIONS
OF THE CODE
SCOPE & DEFINITION
1. 1.3 The term “healthcare professional”
means a person of any of the
OF TERMS following classes:
1.1 The Code covers interactions (i) Registered medical practitioners
with healthcare professionals,
healthcare organisations and patient (ii) Registered dentists
associations, and the promotion (iii) Registered pharmacists
to healthcare professionals of (iv) Registered nurses
prescription-only medicinal products.
1.4 The term “medicinal product”
1.2 The term “promotion” means means:
those marketing and informational
activities coming under the control (i) Any substance or combination
or authority of the company, the of substances presented as
purpose of which is to induce having properties for treating
the prescribing, supply, sale or or preventing disease in human
consumption of the company’s beings.
products.
(ii) Any substance or combination of
Promotion includes, for example, substances which may be used
the activities of medical in or administered to human
representatives; various aspects of beings either with a view to
sales promotion such as journal restoring, correcting or modifying
and direct mail advertising, the use physiological functions Code of
of mail (including post, telephone, Practice for the Pharmaceutical
email, and other electronic means Industry by exerting a
of communication), the use of the pharmacological, immunological
internet, the use of audio-visual or metabolic action, or to making
materials such as films, video a medical diagnosis.
recordings, data storage services
and the like, informational systems 1.5 The term “marketing (or product)
and exhibitions; press releases and authorisation” refers to a medicinal
the provision of samples, gifts or product licence granted or renewed
hospitality. by the Health Products Regulatory
8IPHA CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY
Authority or the European pack changes, adverse-reaction
Commission. warnings as part of general drug
precautions, trade catalogues and
1.6 The Code is not intended to inhibit price lists, provided they include
the exchange of medical and no product claims;
scientific information during the
development of a product. – books, journals, periodicals
and other publications that are
1.7 The Code does not cover: imported into the State and
which contain advertising which
– the labelling of medicinal products
is not intended for, or directed at,
and the accompanying package
persons resident in the State;
leaflets, which are subject to
the provisions of the Medicinal – information relating to human
Products (Control of Placing on health or diseases provided there
the Market) Regulations 2007 (S.I. is no reference, even indirect, to
540 of 2007) as amended; medicinal products.
– correspondence, possibly
accompanied by material of a
nonpromotional nature, needed to
answer a specific question about
a particular medicinal product.
Non-promotional, general
information about companies
(such as information directed to
investors or to current/prospective
employees), including financial
data, descriptions of research
and development programmes,
and discussion of regulatory
developments affecting the
company and its products.
– factual, informative
announcements and reference
material relating, for example, to
9IPHA CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY
METHODS OF
2. (i) The meeting must be a truly
international, scientific event
PROMOTION with a significant proportion of
2.1 Methods of promotion must the speakers and delegates from
never be such as to bring discredit other countries;
upon or reduce confidence in the (ii) To ensure that the promotional
pharmaceutical industry. material does not promote the
prescription, supply, sale or
consumption of the medicinal
product in Ireland, a clearly
MARKETING
3. visible and legible statement
AUTHORISATION must be included to the effect
that the medicinal product is
3.1 A medicinal product must not be not authorised in Ireland or that
promoted prior to receipt of the it is authorised for different
marketing authorisation permitting indications in this country;
its sale or supply.
(iii) Promotional material which
3.2 The promotion of a medicinal refers to the prescribing
product must be consistent information (indications,
with the terms of the marketing warnings etc.) authorised in
authorisation. All promotion must other countries must include an
encourage the rational use of the explanatory statement indicating
medicinal product by presenting it that licensing conditions differ
objectively and not exaggerating its internationally.
properties.
Promotional material for medicinal
3.3 At independent international products which are not authorised in any
congresses or symposia held in EEA country at the time of the congress
Ireland, promotional material which or symposium, may not be displayed
appears on exhibition stands or is or distributed to participants. Scientific
distributed to participants may refer papers on such products may, however,
to a medicinal product or indication be provided in accordance with Clause
for a medicinal product which is not 1.6 of the Code.
the subject of an authorisation in
Ireland (but which is so authorised
in at least one Member State of
the European Economic Area
[EEA]) provided that the following
conditions are observed:
10IPHA CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY
NATURE AND
4. 4.6 When promotional material refers to
published studies, clear references
AVAILABILITY OF must be given.
INFORMATION
4.7 In accordance with an agreement
4.1 Upon reasonable request, a reached between the IPHA and
company must promptly provide the Department of Health, the
healthcare professionals with summaries of product characteristics
accurate and relevant information (SmPCs) relating to individual
about the medicinal products which medicinal products are included
it markets. in www.medicines.ie which is
made available free of charge in
4.2 Information about medicinal Ireland. The contents of the SmPCs
products must be up-to-date, in that electronic compendium
verifiable and accurately reflect are determined by the relevant
current knowledge or responsible marketing authorisations.
opinion.
4.8 The provision of informational or
4.3 Information about medicinal educational materials is permitted
products must be accurate, provided the materials are: (i)
balanced, fair, objective and must inexpensive; (ii) directly relevant
not mislead either directly or by to the practice of medicine or
implication. pharmacy; and (iii) directly beneficial
to patient care. Such items may be
4.4 Information must be capable of
company branded.
substantiation. Such substantiation
need not be provided however in Materials provided for informational
relation to the validity of indications or educational reasons may include:
approved in the marketing scientific articles and items used to
authorisation. provide information about medicinal
products (such as detail aids);
4.5 Substantiation that is requested
patient education materials given to
pursuant to Clause 4.4 must be
healthcare professionals for use with
provided without delay at the
their patients, etc.
request of members of the medical
and pharmacy professions including Companies may provide pens or
the members of those professions paper exclusively during company-
employed in the pharmaceutical organised meetings, as long as they
industry. are inexpensive and not product
branded.
11IPHA CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY
Companies shall not distribute pens 4.10 Items of medical utility aimed
or paper at exhibition stands. Pens directly at the education of
or paper included in conference healthcare professionals and patient
bags shall not be branded (neither care may be provided if they are
product nor company branded). inexpensive and do not offset the
routine business practice costs of
4.9 HCPs may be provided with items the recipient. Such items may be
which are to be passed on to company branded. In addition, it
patients which may bear the name might also be acceptable to use the
of a medicine and/or information product branding, when the item
about medicines only if such detail is used with that medicine, within
is relevant to the appropriate use the limits permitted by laws and
of the medicine by patients who regulations.
have been prescribed that medicine.
Additionally, although items which
are to be passed on to patients may
not be issued at HCP exhibition CLAIMS AND
5.
stands, they may be exhibited and COMPARISONS
demonstrated on those stands
and requests for them accepted 5.1 Claims for the usefulness of a
for later delivery. Patient support medicinal product must be based
items may be provided to HCPs by on an up-to-date evaluation of all
those representing the company the evidence and must reflect this
during the course of a visit or when evidence accurately and clearly.
requested by a HCP. Such claims must have prior medical
review and approval.
In limited circumstances patient
support items may be made 5.2 Exaggerated claims must not be
available for the use of HCPs even made and all-embracing claims must
though they are not to be passed be avoided. Claims must not imply
on to patients for them to keep. that a medicinal product, or an
This is where their purpose is to active ingredient, has some special
allow patients to gain experience in merit, quality or property unless this
using their medicines whilst under can be substantiated.
the supervision of a HCP. Examples
5.3 The word “safe” must not be used
include inhalation devices (with
without qualification and it must
no active ingredient) and devices
not be stated categorically that a
intended to assist patients to learn
medicine has no side-effects, toxic
how to self-inject.
hazards or risk of addiction (see also
Clause 7.2).
12IPHA CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY
5.4 The word “new” must not be used TEXTUAL AND
7.
to describe any medicinal product
which has been generally available, AUDIO-VISUAL
or therapeutic indication which has PROMOTIONAL
been generally promoted, in Ireland MATERIAL
for more than 12 months.
7.1 All promotional material issued by
5.5 Comparisons of medicinal products a marketing authorisation holder
must be factual, fair and capable or with his authority, must be
of substantiation. In presenting a consistent with the requirements of
comparison, care must be taken to this Code.
ensure that it does not mislead by
distortion, by undue emphasis, by 7.2 Where the purpose of promotional
omission or in any other way. material is to provide persons
qualified to prescribe or supply with
5.6 The brand names of other sufficient information upon which
companies’ products must not to reach a decision for prescribing
be used in comparison unless the or for use, then the following
prior consent of the companies minimum information, which must
concerned has been obtained. be compatible with the SmPC,
must be given clearly and legibly
and must be an integral part of the
advertisement:
DISPARAGING
6.
REFERENCES (i) The relevant marketing
authorisation number and
6.1 Other companies, their products, the name and address of the
services or promotions must not holder of the authorisation or
be disparaged either directly or by the business name and address
implication. of the part of the business
responsible for placing the
6.2 The clinical and/or scientific opinions
medicinal product on the
of members of the healthcare
market;
professions must not be disparaged
either directly or by implication. (ii) The name of the product, and
a list of the active ingredients,
using the common name,
placed immediately adjacent to
the most prominent display of
the name of the product;
13IPHA CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY
(iii) One or more of the indications is available on request or in the
for the use of the product SmPC;
compatible with the terms of
the marketing authorisation; (iii) The name and address of
the holder of the marketing
(iv) Recommended dosage, method authorisation or the business
of use and, where not obvious, name and address of the part
method of administration; of the business responsible for
placing medicinal product on
(v) The classification for the sale or the market;
supply of the product;
(iv) The classification for sale or
(vi) Adverse reactions, warnings and supply of the product.
precautions for use and relevant
contraindications of the product; All promotional material not falling
within the category of “reminder
(vii) A statement that additional advertisements” must comply with
information is available on Clause 7.2.
request;
7.4 Promotional material such as
(viii) The date on which the above mailings and journal advertisements
particulars were generated or must not be designed to disguise
last updated. their real nature. Where a company
pays for or otherwise secures
7.3 Where the purpose of the
or arranges the publication of
promotional material is to remind
promotional material in journals,
persons qualified to prescribe or
such promotional material must not
supply of the availability and of the
resemble editorial matter.
indication(s) of a medicinal product
(i.e. a “reminder advertisement”), 7.5 All promotional material appearing
the following information, which in journals, the publication of which
must be compatible with the SmPC, is paid for, secured or arranged
must be included: by a company and referring by
brand name to any product of
(i) The name of the medicinal
that company, must comply with
product, or the international non-
Clause 7.2 or 7.3 of this Code as
proprietary name, where such
appropriate, irrespective of the
exists, or the trademark;
editorial control of the material
(ii) A
statement which clearly published.
indicates that further information
14IPHA CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY
7.6 Promotional material must conform, 7.13 M
aterial relating to medicines and
both in text and illustration, to their uses, whether promotional in
canons of good taste and must nature or not, which is sponsored
be expressed so as to recognise by a company must clearly indicate
the professional standing of the that it has been sponsored by that
recipients and not be likely to cause company and if that company had
offence. any input into the content of the
material.
7.7 The names or photographs of
healthcare professionals must not
be used in promotional material
without their permission nor in any REFERENCES TO THE
8.
way that is contrary to the ethical
code of the appropriate profession.
HEALTH PRODUCTS
REGULATORY
7.8 Promotional material must not
imitate the devices, copy, slogans
AUTHORITY
or general layout adopted by other AND RELATED
companies in a way that is likely to ORGANISATIONS
mislead or confuse.
8.1 Unless specific requirements with
7.9 Where appropriate (for example, regard to distribution or use have
in technical and other informative been imposed, companies must not
material), the date of printing or of include in any announcement or
the last review must be stated. promotional material, a statement
that the marketing of the product
7.10 Extremes of format, size or cost
has been approved or recommended
of promotional material must be
by the Health Products Regulatory
avoided.
Authority or related organisations
7.11 Postcards, other exposed mailings, such as the European Medicines
envelopes or wrappers must not Agency (EMA), the European
carry matter which might be Commission or the Committee for
regarded as advertising to the lay Medicinal Products for Human Use
public or which could be considered (CHMP).
unsuitable for public view.
7.12 Audio-visual material must be
accompanied by all appropriate
printed material so that all relevant
requirements of the Code are
complied with.
15IPHA CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY
REFERENCES TO
9. 9.4 Reproductions of official documents,
such as prescription forms, must not
THE PRIMARY CARE be used for promotional purposes
REIMBURSEMENT unless the agreement of the
SERVICE appropriate State Organisation has
been received.
9.1 References to the Primary Care
Reimbursement Service (PCRS)
(or the GMS as it was previously
known) in promotional material 10. DISTRIBUTION OF
must be confined to including the PROMOTIONAL
relevant code number (the print
size and typeface of which must be
MATERIAL
the same as that of the marketing 10.1 Promotional material must only
authorisation number) and /or price. be sent or distributed to those
categories of persons whose need
9.2 Where reference is made to the
for, or interest in, the particular
prescribing of a product under
information can be reasonably
the PCRS, the phrase “freely
assumed.
prescribable” or similar phrases
suggesting a lack of restriction or Promotional material must be
restraint must not be used. tailored to the audience to
whom it is directed. For example,
9.3 Where a product has been added
promotional material devised for
or restored to the PCRS list,
general practitioners may not be
announcements, advertisements
appropriate for hospital doctors.
and other communications to
this effect may include in the 10.2 Any information designed to
body of prescribing information, encourage the use of medicinal
a statement that the product is products in clinics, industrial
“PCRS reimbursable” (or similar) concerns, clubs or schools must
provided that the print size of such be addressed to the appropriate
statements is no larger than the rest healthcare professional.
of the text. Such a statement may
be carried for no longer than twelve 10.3 Restraint must be exercised on the
months from the date of the adding frequency of distribution and on
or restoring of the product to the the volume of promotional material
PCRS list. distributed.
16IPHA CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY
The style of mailings is relevant to 11.2 It is permissible to include in
their acceptability to healthcare promotional material, reasonably
professionals and criticism of their brief abstracts of, or quotations
frequency is most likely to arise from, articles, or accurately
where their informational content is reproduced tables or other
limited or where they appear to be illustrative matter taken from the
elaborate and expensive. scientific literature and to include
in such material references to
10.4 Mailing lists must be kept up-to- authors’ names in a bibliography
date. Requests from healthcare of published works. In no case
professionals to be removed from however, should authors’ names
mailing lists must be complied with be used in a prominent manner in
promptly and no name should be promotional material.
restored except at the healthcare
professional’s request or with his/ 11.3 Quotations from medical literature,
her permission. or from personal communications
received from healthcare
10.5 The use of faxes, e-mails, professionals, must accurately
automated calling systems, text reflect the meaning of the author
messages and other electronic data and the significance of the study.
communications for promotion is
prohibited except with the prior
permission, or upon the request, of
the recipient. 12. COMPANY
EMPLOYEES (DIRECT
AND CONTRACTED)
REPRINTS,
11.
12.1 The term “medical representatives”
ABSTRACTS AND includes medical sales
QUOTATIONS representatives, including personnel
(Such use is, of course, subject to retained by way of contract
the Law of Copyright) with third parties, and any other
company representatives who
11.1 All reprints of articles supplied to call on healthcare professionals,
individual healthcare professionals pharmacies, hospitals or other
in the course of promotion must healthcare facilities in connection
comply with the provisions of Clause with the promotion of medicinal
7.2 or 7.3 16 as appropriate. products.
17IPHA CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY
12.2 Medical representatives must be 12.6 M
edical representatives must
provided with thorough training by not employ any inducement or
the company which employs them subterfuge to gain an interview.
and possess sufficient scientific They must not pay, under any
knowledge to present information guise, for access to a healthcare
on the company’s products in an professional.
accurate, complete and responsible
manner. The contribution of the This clause does not preclude
Medical Representatives Institute of the occasional provision of light
Ireland in this respect (for example refreshments/modest meals at a
by the inclusion of the IPHA Code meeting organised by a medical
of Practice in its examination representative. Such hospitality
syllabus) is acknowledged. may only be provided to healthcare
professionals and occur in a manner
12.3 During each visit medical and venue conducive to information
representatives must give the exchange and/or scientific
person visited or have available education.
for them, the most up-to-date
version of the SmPC for each Payments to healthcare professionals
medicinal product they promote. to cover the cost of such hospitality
Where the SmPCs are published are not allowed.
in a compendium such as www.
12.7 M
edical representatives must
medicines.ie and this fact is drawn
ensure that the frequency, timing
to the attention of the persons
and duration of calls on healthcare
visited, this requirement is deemed
professionals, or on hospitals,
to be satisfied.
together with the manner in which
12.4 All company employees must they are made, are acceptable to
transmit to the Scientific Services the healthcare professionals and
established in their companies any hospitals as appropriate and are not
information on adverse reactions such as to cause inconvenience. The
reported to them by the persons wishes of an individual healthcare
they visit. professional, or the arrangements
in force at any particular
12.5 Medical representatives must at all establishment, must be observed by
times maintain a high standard of representatives.
ethical conduct in the discharge of
their duties. They must comply with Medical representatives must
all relevant requirements of the always endeavour to treat
Code. healthcare professionals’ time with
respect and if for any reason an
18IPHA CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY
appointment cannot be kept by the 12.11 The provision of nursing services
representative, the longest possible by a company must be undertaken
notice must be given. in accordance with the guideline
on the provision of nursing
12.8 Medical representatives must take services by companies published in
adequate precautions to ensure the Annex II.
security of medicinal products in
their possession. 12.12 Companies must ensure that all
regulatory obligations are met. In
12.9 Medical representatives must particular their pharmacovigilance
not use the telephone or similar departments must be notified
electronic means to promote of all market research activities,
medicinal products to healthcare Patient Support Programmes etc.
professionals unless prior
arrangement has been made with
the individuals 18 concerned.
13. SAMPLES
12.10 Companies are responsible for the
activities of all their employees 13.1 Free samples of medicinal products
and must ensure that employees shall not be supplied to any person
who are concerned in any way who is not qualified to prescribe
with the drafting or approval of such product.
promotional material (including
employees of third parties The supply of a sample means the
contracted on behalf of the supply of a medicinal product made
company) are fully conversant and otherwise than in connection with
compliant with the requirements a clinical trial.
of the Code.
13.2 Where samples of products
Other third parties working for or are distributed by a medical
on behalf of companies, (including representative, the sample must
advertising company executives, be handed directly to a person
business consultants and market qualified to prescribe such product
research companies), and those or to a person authorised to receive
that do not act on behalf of the sample on their behalf.
companies (such as joint ventures
and licensees) commissioned 13.3 The following conditions shall
to engage in activities covered be observed in the provision of
by the Code must also be fully samples to a person qualified to
conversant and compliant with prescribe such product:
the Code. (i) Such samples are provided on
19IPHA CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY
an exceptional basis only (see samples provided in applicatio
(ii) to (vii) below) and for the of the provision in Clause
purpose of acquiring experience 13.3(ii);
in dealing with such a product;
(v) Each sample shall be no larger
(ii) S uch samples in respect of a than the smallest presentation
medicinal product shall not on the market;
exceed four in number per
year and sampling shall not (vi) Each sample shall be marked
extend beyond the two years “free medical sample – not for
after he/she first requested sale” or bear another legend of
samples of each particular new analogous meaning;
medicine. In this context, a new
(vii) Each sample shall be
medicine is a product for which
accompanied by a copy of
a new marketing authorisation
the most up-to-date version
has been granted, either
of the SmPC relating to that
following an initial marketing
product in accordance with the
authorisation application
requirements set out in Clause
or following an extension
12.3.
application for new strengths/
dosage forms that include a 13.4 A person shall not supply a sample
new indication. Extensions of of a medicinal product which is
the marketing authorisation a controlled drug under Section
to additional strengths/dosage 2 of the Misuse of Drugs Act, as
forms for existing indications or amended, or which is an anti-
pack sizes (number of units in depressant, hypnotic, sedative or
the pack) cannot be considered tranquilliser.
as new medicines.
13.5 Samples sent by post must be
(iii) Any supply of such samples packed so as to be reasonably
must be in response to a signed secure against the package being
and dated request from the opened by children.
recipient;
13.6 Distribution of samples in hospitals
(iv) A
n adequate system of control must also comply with individual
and accountability must be hospital regulations, if any.
maintained in respect of
the supply of such samples.
This system shall also clearly
establish, for each person
supplied, the number of
20IPHA CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY
14. GIFTS business practice costs of the
recipient. A written agreement,
14.1 No gifts, pecuniary advantages including details of the duration
or benefits in kind may be and nature of the support must
supplied, offered or promised to be signed in advance of the
persons qualified to prescribe or commencement of the support.
supply by a company in relation Additionally, the company
to the promotion/ marketing of must ensure notification to
prescription medicines. This does senior management of the
not preclude any regulations for relevant recipient Healthcare
the time being in force relating to Organisation which will appear
prices, margins and discounts. on the IPHA Transfer of Value
website.
(ii) Support must be paid directly
15. GRANTS AND OTHER to an institution rather than
to an individual healthcare
FORMS OF SUPPORT professional;
15.1 Clause 14 shall not preclude a
(iii) Employment grants provided
company from providing support
directly or indirectly to HCOs
in the form of Healthcare Support
are only permitted for positions
Services (HSSs), educational,
that are predominantly research
research or employment grants,
based and for a defined period
donation or sponsorship of
of time. Any request for
equipment for the betterment
funding should clearly outline
of patients, provided that the
the focus of the research, the
following conditions are complied
output of the research work
with.
and the full cost of employment
(i) The company must be in for the period in question.
receipt of a written request
(iv) Any such support must not be
from a healthcare professional
linked in any way with product
or institution (for example, a
promotion. No commitment
practice, medical centre, clinic
must be sought or given in
or hospital) for the specific type
relation to the prescribing,
of support provided. Sufficient
supply or use of the company’s
information must be obtained to
products;
establish that there is a genuine
need for such support and that
it does not offset the routine
21IPHA CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY
(v) Any such support must be promotional, must not be designed
reasonable, modest and in as an inducement to prescribe and
proportion to the scale and must not be designed or operated
scope of the recipient institution in a promotional manner. Decisions
and must be likely to appear so regarding provision of the HSS
to independent third parties. must be based upon objective
criteria linked to the defined
(vi) Companies must make public purpose and not linked to past or
details of all Transfers of Value future prescription, supply, sale
as outlined in Annex V. or consumption of a company’s
products. Proposals to provide a
(vii) Companies should actively
HSS must be reviewed, and the
check that their support has
details approved in advance, by
been spent as intended.
the appropriate non-promotional
In particular, the written
function within the company
agreement must require
(e.g. Scientific Services, medical,
that the recipient provides
legal etc.). The HSS must be
confirmation that the support
provided under the supervision
has been spent as agreed.
of this function. When company
15.2 A Healthcare Support Service staff are involved in the provision
(HSS) is defined as a process of the HSS they must report to
enhancement initiative or medical the aforementioned function
service support (e.g. patient within in the company and their
compliance initiative, sharps bin compensation must not relate to
service, disease identification, sales of the company’s products.
screening or genetic marker test,
A written agreement (or referral)
review of patient management/
between the company and the
treatment quality review etc.)
patient’s HCP, including the nature
provided by a pharmaceutical
of the support, project scope,
company that ultimately improves
timelines and HSS objective must
patient care and welfare. Further
be signed before commencement
guidance regarding Nursing
of the HSS. All patients involved
Services provided by companies are
in the HSS must be advised of the
detailed separately in Annex II.
company’s involvement and the
A HSS must have the objectives patient’s consent obtained, when
of monitoring disease activity, required. The operation of the HSS
achieving better healthcare must be monitored with reference
outcomes and enhancing to its objectives.
patient care. HSSs must be non-
22IPHA CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY
A HSS may be provided directly must be retained according to the
or indirectly (through a service legislation and be made available
provider) to patients. Contractual for review by regulators and
arrangements with service auditors.
providers should clearly outline
the service, the requirements for Sales representatives may
safety reporting, adherence to data inform the relevant healthcare
privacy requirements etc. professional(s) about the availability
of a HSS, but may not provide,
Information collected in the course deliver, demonstrate or have other
of the provision of a HSS may not involvement in a HSS.
be used for promotional purposes
or to plan promotional activity.
Furthermore, it may not be used
for clinical research purposes 16. HOSPITALITY,
without the appropriate prior SPONSORSHIP
written consent of the HCP and the
patient. In general, a HSS should AND MEETINGS
only collect the minimum amount 16.1 The pharmaceutical industry has
of personal information needed to a special obligation to ensure
ensure the HSS’s management. that healthcare professionals
All HSS material used in the are kept in touch with
services must be non-promotional. continuing developments in
Materials may be company the pharmaceutical field. With
branded. However, they may only this in mind, the practice has
include the brand name of the arisen of meetings and events
medicine, to support the safe being organised between the
use of the medicine, after the industry and the professions for
prescribing decision has been the further exchange of ideas
made. Companies must ensure and information. In addition, the
that they have a process in place custom has grown of the industry
to ensure that all HSS materials are supporting independent meetings
developed, reviewed, approved, of healthcare professionals
released and removed from use, intended to update and expand
appropriately. the continuing education of the
relevant healthcare professionals.
Companies must ensure that
they have the resources to Many of these meetings could not
manage and monitor the HSS. take place without the support and
The records relating to the HSSs assistance of the pharmaceutical
23IPHA CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY
industry. Companies may Companies must not organise or
legitimately provide assistance sponsor meetings to coincide with
that is directly related to the bona sporting, entertainment or other
fide continuing education of the leisure events or activities.
healthcare professionals and which
genuinely facilitates attendance of Venues that are renowned for their
the healthcare professional for the entertainment or leisure facilities or
duration of the educational aspect are extravagant must not be used
of the event. Such support and for such meetings.
assistance must however, always
16.5 In addition to the requirements of
be such as to leave healthcare
clause 16.3 any hospitality offered
professionals’ independence of
to healthcare professionals must:
judgement manifestly unimpaired.
(i) Be reasonable in level and be
16.2 Where appropriate and depending
likely to appear to be reasonable
on the time, location and length
to independent third parties;
of the meeting, support to
healthcare professionals may cover (ii) Be secondary and strictly limited
actual travel expenses, meals, to the main purpose of the
refreshments, accommodation and event at which it is offered;
registration fees.
(iii) Not exceed the level that
16.3 Companies shall not provide or recipients would normally be
offer any meals to healthcare prepared to pay for themselves;
professionals, unless, in each case
(i.e. per meal and per recipient), (iv) Not be extended to spouses or
the value of such meals (food other accompanying persons,
and beverages) does not exceed unless they are healthcare
E80 (including VAT and excluding professionals who qualify
any gratuity). This threshold is in as participants in their own
addition to the existing restrictions right. Travel expenses may
on hospitality (reasonable, not be paid for spouses or
secondary to the main purpose other accompanying persons,
etc) and only applies to events in unless they are healthcare
Ireland. professionals who qualify as
participants in their own right;
16.4 It should be the programme that
attracts delegates and not the (v) Not include sponsoring,
associated venue or hospitality. securing, organising directly or
indirectly any entertainment,
sporting or leisure events.
24IPHA CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY
16.6 Funding of healthcare professionals that is the object or subject
to compensate them for the time matter of the event, it makes
spent in attending the event is not greater logistical sense to hold
permitted. the event in another country;
16.7 All promotional, scientific or (iii) As with meetings held in
professional meetings, congresses, Ireland, consideration must
conferences, symposia, and other be given to the educational
similar events (including, for programme, overall cost,
example, advisory board meetings, facilities offered by the venue,
visits to research or manufacturing nature of the audience and
facilities, and planning, training or the hospitality to be provided,
investigator meetings for clinical which must be secondary to
trials and non-interventional the meeting and not out of
studies) (each, an “event”) proportion to the occasion;
organised or sponsored by or on
behalf of a company must be held (iv) In addition to the requirements
at an appropriate venue that is of Clause 16.5 any hospitality
conducive to the main purpose of offered to healthcare
the event. Clause 16.4 also applies professionals at international
to all such meetings. meetings must ensure that:
16.8 A company may not organise or (a) it is the programme that
sponsor an event or a participant attracts delegates and not
at an event that takes place outside the associated venue or
Ireland (an “international event”) hospitality;
unless there is a valid reason to
(b) To avoid any confusion as to
do so. All the previous relevant
the primary purpose of the
provisions must be applied together
event, international events
with the following additional
should not coincide with a
principles:
major event of a sporting or
(i) M
ost of the invitees are from social nature in a locality.
outside Ireland and, given the
(v) For flights that have a scheduled
countries of origin of most of
duration of five or less hours,
the invitees, it makes greater
only economy flights may be
logistical sense to hold the event
sponsored by companies for
in another country or;
HCP attendance at conferences.
(ii) Given the location of the
relevant resource or expertise
25IPHA CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY
16.9 The following additional In any series of such meetings,
requirements shall apply in relation as for example during the winter
to the sponsorship of meetings season, no one company should
convened by the healthcare undertake the sponsorship of
professions: such a series of meetings to the
exclusion of other available and
(i) Smaller meetings willing sponsors. No payment must
be made by a company in order
The sponsorship of local clinical
to be included on a shortlist of
meetings, initiated by an
possible sponsors.
organising body of the healthcare
professions, is frequently sought (ii) Larger meetings
from companies. In such instances,
companies must respond only to For larger meetings initiated by
formal written requests for support the healthcare professions, such
from the organising committee. as annual association meetings,
Any request for support should support usually involves the
indicate the exact anticipated rental of a stand or space for
items of expenditure for which the the purposes of exhibiting the
support is sought. company’s product range. This
form of exhibition by companies is
Support must not extend beyond: acceptable.
• cost of room hire As far as possible, for reasons of
• cost of equipment hire security, medicinal products must
• actual travel expenses of not be brought to such meetings.
speaker(s) In no circumstances should
medicinal products be handed
• honorarium to speaker(s) if
over to visitors to the stand or
appropriate
exhibition.
• modest meals and/or light
refreshments Other support for such meetings
must not extend beyond a
Promotional input from contribution to the general
companies at an appropriate expenses of the meeting. An
stage of the meeting must acknowledgement of this support,
be with the agreement of the by way of a list of sponsors on
Chairman or through a printed the programme (if any) and/or by
acknowledgement on the way of a similar list displayed on a
programme (if any). notice board, is acceptable.
26IPHA CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY
Sponsorship of major annual or bi- adversely affect the cost of
annual meetings of any discipline medicines to the patient or
within the healthcare professions taxpayer;
should not be undertaken by any
one company to the exclusion (iii) Corporate hospitality should be
of other available and willing reasonable in level and likely to
sponsors. No payment must be appear so to independent third
made by a company in order to be parties. It should not exceed
included on a shortlist of possible the level that recipients would
sponsors. normally be prepared to pay for
themselves.
16.10 Corporate Hospitality
Aside from meetings and events
as referred to in the preceding USE OF
17.
paragraphs, it is recognised that,
on occasion, companies may
CONSULTANTS
provide what may be considered Healthcare professionals can be used
as “corporate hospitality” (e.g. as consultants and advisors, whether in
opening a new office). groups or individually, for:
Corporate hospitality involving • Services (e.g. chairing or speaking
sporting, entertainment or at meetings, being involved in
social events or activities must medical/scientific studies or in
not be extended to healthcare clinical trials)
professionals.
• Training
The following principles shall apply
• Participating in advisory board
to corporate hospitality:
meetings
(i) T here must be no element of • Participating in market research
product promotion at the event, where such participation involves
either direct or implied; remuneration and/or travel
(ii) Companies should appreciate With the exception of one-off phone
the need for moderation. interviews or mail/email/internet
questionnaires, the arrangements that
Corporate hospitality must never
cover these genuine consultancy or other
be such that, on a reasonable
services must fulfil all of the following
view, it might give rise to the
criteria:
inference that the scale and
costs of such hospitality could
27IPHA CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY
(i) A
legitimate need must be and reflect the fair market value
clearly identified before the of the services provided. In
request for such services, and this regard, token consultancy
the arrangements with the arrangements must not be
prospective consultants, are used to justify compensating
made; healthcare professionals.
(ii) A written contract or Consultants who have entered
agreement, including details contractual arrangements with
regarding the nature of the companies or are employed on a
services to be provided and part-time basis while still practising
the basis for payment of those their profession, should be strongly
services, must be signed in encouraged to declare their
advance of the commencement arrangements with the company,
of the services; whenever they write or speak in public
about a matter that is the subject of the
(iii) Criteria directly related to the agreement or any other issue relating to
identified need must drive the that company. Additionally, companies
selection and evaluation of are required to make public details of all
consultants; Transfers of Value as per Annex V of this
Code.
(iv) N
o greater number of
healthcare professionals can If a healthcare professional attends
be retained than is reasonably an event (an international event or
necessary to fulfil the identified otherwise) in a consultant or advisory
need; capacity the provisions of Clause 16
covering hospitality shall apply.
(v) Records concerning the services
provided by consultants must be
maintained by the contracting
company; 18. MARKET RESEARCH,
(vi) The hiring of the healthcare POST MARKETING
professional to provide the SURVEILLANCE AND
relevant services must not be
an inducement to prescribe, RELATED ACTIVITIES
supply, sell or consume a
18.1 Methods used for market
particular medicinal product;
research must never be such as
(vii)The compensation for the to bring discredit upon, or reduce
services must be reasonable confidence in, the pharmaceutical
industry. The following provisions
28IPHA CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY
set out in this clause apply 19. NON-
whether the research is carried out
directly by the company or by an INTERVENTIONAL
organisation acting on its behalf. STUDIES
18.2 Access to respondents must not 19. 1 A “non-interventional study” is
be gained by subterfuge. Any defined as:
incentives given must be kept to a
minimum and be commensurate (i) A study of one or more
with the work involved. medicinal products which have a
marketing authorisation where
18.3 Questions intended to solicit the products are prescribed in
disparaging references to the usual manner in accordance
competing products or companies with the terms of that
must be avoided. authorisation and where;
18.4 Market research must not be (ii) The assignment of the patient to
used as a form of disguised sales a particular therapeutic strategy
promotion. is not decided in advance by
18.5 Post-marketing surveillance studies, a trial protocol but falls within
pharmacoeconomic studies, non- current practice and where;
interventional trials, clinical audit (iii) The prescription of the medicine
programmes and the like (including is clearly separated from the
those that are retrospective in decision to include the patient
nature) commissioned, undertaken in the study and where;
or provided by companies must
never be promotional in nature and (iv) No diagnostic or monitoring
must be conducted primarily with procedures are applied to the
a scientific or educational purpose. patients included in the study,
This clause does not preclude the other than those which are
use of the data generated from ordinarily applied in the course
such studies to support claims in of the particular therapeutic
promotion. strategy in question and where
epidemiological methods shall
be used for the analysis of data
arising from the study.
19.2 Non-interventional studies that
are prospective in nature and that
involve the collection of patient
data specifically for the study
from or on behalf of individual, or
29IPHA CODE OF PRACTICE FOR THE PHARMACEUTICAL INDUSTRY
groups of, healthcare professionals conduct of non-interventional
must comply with all of the studies;
following criteria:
(ix) The study results must be
(i) The study must be conducted analysed by or on behalf of
with a scientific purpose; the contracting company
and summaries thereof must
(ii) T here must be a written study
be made available within a
plan;
reasonable period of time to
(iii) The healthcare professionals the company’s Scientific Service.
and/or the site at which the This Scientific Service shall
study will take place, on the maintain records of such reports
one hand, and the company for a reasonable period of time.
sponsoring the study, on the The company should send the
other hand, must sign written summary report to all healthcare
contracts which specify the professionals that participated
nature of the services to be in the study and should make
provided and the basis for the summary report available
payment of those services; to industry self-regulatory
bodies and/or committees that
(iv) Any remuneration provided
are in charge of supervising
must be reasonable and reflect
or enforcing applicable Codes
the fair market value of the
upon their request. If the study
work performed;
shows results that are important
(v) If applicable, the study protocol for the assessment of benefit-
must be submitted to the Ethics risk, the summary report should
Committee for review; be immediately forwarded
to the relevant competent
(vi) Laws, rules and regulations
authority;
on personal data privacy
(including the collection and (x) Medical sales representatives
use of personal data) must be may only be involved in an
respected; administrative capacity and
such involvement must be
(vii) The study must not constitute
under the sole supervision of
inducement to prescribe,
the company’s Scientific Service
supply, sell or consume a
that will also ensure that the
particular medicinal product;
representatives are adequately
(viii) The company’s Scientific trained. Such involvement must
Service must approve the study not be linked to the promotion
protocol and supervise the of any medicinal product.
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