CODE OF CONDUCTFARMINDUSTRIA

5th April 2022

1

TABLE OF CONTENTS

1.

GENERAL PRINCIPLES

2.

DIRECT PROVISION OF SCIENTIFIC INFORMATION
−
−
−
−
−
−
−

3.

General principles;verbal information imparted to physicians;
informational material;
promotional material;
professional updating and scientific cooperation;
advertising in newspapers and magazines;
free samples.

CONFERENCEEVENTS,VISITSLABORATORIES,REFRESHERINVESTIGATOR MEETINGSTOCOMPANYCOURSES
AND

−
−
−
−
−
−
−
−
−
−
−
−
−

General principles;
conference venues;
regional events and scientific meetings at a local level;inter-regional events;
international and national meetings;
promotional materials used at congresses;
online refresher courses and training;refresher courses;
satellite symposia;
visits to company laboratories;
investigator meetings;
the initiatives of professional relations;interactions with other non-prescribers involved in theadministration of therapies;− information to the public;− interactions other than medicine promotion

4.

RELATIONS BETWEEN THE INDUSTRY, SCIENTIFIC &HEALTHCARE SECTORS AND PATIENT ASSOCIATION− scientific consultancy;− scholarships;− relations with scientific companies;2

− clinical trials and drug-related studies;− internet sites;− relations between Pharmaceutical Companies, Patient Associations
and Expert Patients;− Patient Support Program.

5.

TRANSPARANCY OF TRASFERS OF VALUE FROM
PHARAMCEUTICAL COMPANIES TO HEALTHCAREPROFESSIONALS AND HEALTHCARE ORGANISATIONS
−
−
−
−
−
−
−
−
−

Obligations of transparency;
method of application;
applicability of national codes;
disclosure of data on an individual and aggregate basis;
duplication;
research and development expenses;
methodology;
attachment 1: data disclosure model;
attachment 2: definitions.

REGULATORY
BODIESAND
IMPLEMETATIONPROCEDURES OF THE CODE OF PROFESSIONAL CONDUCT
−
−
−
−
−
−
−

The Supervisory Committee: composition and functions;
the Single-Judge Tribunal: composition and functions;
the Jury: composition and functions;
the Secretariat, head-office and meetings;
sanctions;amendments and supplements to the Code of Professional Conduct;
stipulating the undertaking to abide by the Code of Professional
Conduct.

3

THE FARMINDUSTRIA CODE OF PROFESSIONALCONDUCT
1.

GENERAL PRINCIPLES

1.1

In order to comply with the provisions of statute law and the rules laid
down by the Codes of Conduct of European and international
federations of the pharmaceutical industry (EFPIA and IFPMA),
Farmindustria has drawn up a Code of Professional Conduct in theform of a voluntary agreement underwritten by the pharmaceuticalcompanies belonging to Farmindustria. The Code sets out to regulate
relations not only between companies but also their relations with thescientific and healthcare sectors.
All member companies of Farmindustria shall accept and comply withthe provisions of the Code of Professional Conduct.
The following are excluded from the scope of this Code:− Activities aimed at releasing non-promotional information, general
information about companies (such as direct information toinvestors or the press), including financial data and descriptions ofresearch and development, provided that Healthcare Professionals
are not present in significant numbers.
− Institutional events organized by pharmaceutical companies on
issues that go beyond promotional information, which are ofinterest to a variety of individuals from all areas potentially affected,
which are held in right locations and in which healthcare
professionals are present in amounts not prevalent.
On these occasions, however, cannot be provided for healthcare
professionals present any form of hospitality or travel unlessexceptional initiatives that shall be approved in advance by theSupervisory Committee.

1.2.

The Code represents the commitment of the industry not only to abideby specific laws in force but also to operate on the basis of transparent
standards of conduct that regulate the various circumstances in which
corporate activities take place.
The regulations constituting the subject matter of the Code of4Professional Conduct have been drawn up in the general interest andto safeguard the prestige and honour of the pharmaceutical industry
towards the state, public opinion, the medical profession andhealthcare professionals in general.

1.3

The text of the code of professional behaviour shall be issued to all
relevant public institutions, entrepreneurial organisations,professional associations and professional associations of healthcare
professionals.

1.4

Observance of the code by the member companies of Farmindustria
entails:- compliance with the resolutions of the governing bodies passed inconformity to the Farmindustria’s byelaws, the principles of faircompetition and democratic principles and abstaining frominitiatives in contrast with such resolutions;− observance of fair competition between companies and in the
management of all corporate operations, in all their various aspects,
in such a way as not to harm the legitimate interests of others;− the contribution of each company towards the defence of the goodname of the pharmaceutical industry towards the public at large.

1.5

In performing its activities the companies shall not damage the imageof competing companies or their products. The companies shall also
be ethically and professionally responsible for the behaviour of theirpersonnel and shall, therefore, issue them with appropriate internal
directives to regulate their conduct when engaged on corporate
business.

1.6

The jurisdiction and activities of the Supervisory Committee and theJury are exclusively designed to secure compliance with the Code ofProfessional Conduct.

1.7

Companies operating in Italy that belong to multinational groups shallbe held responsible for the behaviour of their parent companies andassociate companies for invitations issued to Italian physicians toattend events held either inside or outside Italy whenever such
behaviour infringes the provisions of the Code of Professional

5

Conduct.

1.8

Promotional initiatives taking place in Italy, sponsored or organized bycompanies with head offices in Europe, are subject to the applicationof the Code of Professional Conduct of the country in which thepharmaceutical companies that sponsor these initiatives are based,
and to the application of the Farmindustria’s Code of Professional
Conduct. Promotional initiatives taking place in Italy, sponsored ororganized by industries that are based on non-European territory are
subject to the EFPIA Code and to the Farmindustria’s Code.
In case of conflict between the provisions of the various Codes, theprovision will be more narrowly.

1.9

Unless stated otherwise, the Code refers to relations between each of
the member companies and healthcare professionals. The latter shallbe understood to refer to the various types of physicians, pharmacists,and healthcare directors as also technical and administrative
personnel employed in public and private healthcare structures.

1.10

For purposes of the application of the provisions of this Code ofProfessional Conduct the term "general practitioner" shall refer to a
generalist physician who provides general medical services on behalfof the National Health Service, independently of any specialist
qualifications that he or she may possess.

1.11

The provisions of this Code that apply to the general practitioner shallalso apply to hospital pharmacists.

1.12

Pharmaceutical companies shall not, either directly or indirectly
sponsor (by hiring rooms, equipment, etc.) organisations with nonational or international scientific standing or whose mission is
unknown. This prohibition especially applies to medical practices run
by partnerships among physicians.

1.13

By February 28th of each year member companies shall acquire andsubmit to the President of Farmindustria a certificate attesting to theobservance of procedures governing marketing and scientificinformation activities in the preceding year. The attestation shall be
issued by entities recognised by ACCREDIA (Italian Body Of
Accreditation) and may provide, exclusively for companies belonging

6

to the National Committee of the Small Industry the use of a simplified
procedure according to the instructions of the respective Certification
Bodies.

1.14

The provisions contained in this Code shall have no retroactive effect.

1.15

All the data where storage in hard copy is required by this Code,alternatively, it may be stored in electronic format as well. The
provisions of the Chapter 5 of this Code stand unmodified.

2. DIRECT PROVISION OF SCIENTIFIC INFORMATION
General principles

2.1.

Companies are responsible for the information and promotional
actions conducted on their products even if arranged and/or
performed by third persons (consultants, agents, agencies, etc.).

2.2

The information contents shall always be documented anddocumentable. Exaggerated statements, universal and exaggerated
claims and indemonstrable comparisons without any objective basis
are inadmissible.

2.3

The use of email, automated calling systems and other electronic
communication means to divulge promotional material regularly
approved by AIFA fax is prohibited, unless the company holds a priorwritten and documented consent of the physician to whom thematerial is addressed.

Verbal information imparted to physicians
2.4

When presenting information on medicinal products to healthcare
professionals, medical sales representatives shall always qualify
themselves and state the capacity in which they are acting.

7

2.5

Medical sales representatives shall not be engaged in healthcare orpara-healthcare activities, or activities in any way connected to the useof drugs, neither on a gratuitous basis nor in any form of continuous
gainful employment synonymous with that of a salaried worker.

2.6

Companies are responsible for training of medical sales
representatives to provide information on the properties andcharacteristics of their drugs to healthcare professionals in a mannersuch as to allow them to be used for therapeutically correct purposes.

2.7

Companies will also be responsible for training of medical sales
representatives to collect feedback on their drugs, as this is a means toensure the fullest information on the products being marketed.

2.8

Medical sales representatives directed to provide scientific information
on drugs shall also verify the presence of their products in pharmacies
or in other point of sale and use their best efforts to ensure theirtraceability.

Information material
2.9

Where the scientific information is carried out using media computing
facilities, mail or telephone, including through third persons, shall befully respected the same regulatory provisions identified by theapplicable law and the present Code on scientific information.

2.10

Apart from ministerial authorisations no omnicomprehensive
statements are admissible such as "the preferred drug", "absolutely
innocuous", "fully tolerated" or similar and no categorical assertions
shall be made stating that a product has no collateral effects or toxicity
risk.

2.11

Scientific citations shall accurately portray the meaning intended by
the author(s).

2.12

The texts, tables and other illustrations taken from medical reviews or8

scientific works shall be reproduced faithfully and in full, and with anexact indication of the source. No citations are admissible that appear
partial and/ or contradictory with respect to the author's intentions
when separated from the context in which they originally appeared.

The promotional material

2.13

As part of the information and presentation of medicines carried out
by doctors or pharmacists, it is forbidden to grant, offer or promise
prizes, pecuniary or in-kind advantages.
The promotional material concerning drugs and their use, sponsoredby a pharmaceutical company, must have a negligible perceived
value, in line with current national and regional legislation, be nonfungible and in any case linked to the activity carried out by thedoctor and pharmacist.
In any case, the offer of economic incentives aimed at compensating
for the time taken away by health professionals from their normal
professional activity and dedicated to participation in congress
events is prohibited.
It must also be ensured that all promotional material intended for
doctors and pharmacists is purchased directly from the company
centrally.

Professional updating and scientific cooperation
2.14

Free information material for scientific or professional consultation
not specifically connected to medicinal products may only be
distributed to public healthcare structures unless the material inquestion has a perceivably negligible value, namely a value of less than
25 euros. Companies shall procure such material directly throughcentralised functions.

Loans for use and donations
2.15 With regard to donations, loans for use and acts of liberality relating to
instruments strictly related to the medical profession, these can only bemade in favour of University Institutes, Hospitals, Nursing Homes andPublic Health Organizations operating in the area (UCCP, Case health /MGI / PTA or similar) in compliance with the administrative procedures of9the Body and the regulatory framework that governs them. Outside thescope of clinical trials, donations or loan for use relating to fungible
instruments - with different or alternative methods of use with respect tothe diagnostic or therapeutic purpose - such as smartphones, smartwatches,
tablets are not permitted to the aforementioned structures. or similar, to be
assigned to doctors for personal use outside the facilities or to be given topatients.
Advertising in newspapers and magazines
2.16

In the ambit of newspaper and magazine advertising, companies shallcomply with the rule of transparency and thereby accept, as an
essential criterion, the net separation between information andadvertising and hence guaranteeing the reader to be immediately able
to recognise a promotional message, whatever its editorial or columnar
layout.

Samples

2.17

Medical samples can only be supplied in response to a written requestfrom physicians qualified to prescribe that particular medicine.
Written request shall be signed, stamped and dated by physicians.
Medical Representatives cannot supply more than 2 medical samples
per physicians/visit of each form or dosage up to a maximum of 8
samples of each for or dosage for 18 months starting from the date offirst marketing. Medical Representatives can also supply not morethan 4 samples per physicians/visit up to a maximum of 10 samples
per year of products chosen among those in company’s products listthat have been on the market for more than 18 months.
Without prejudice to the provisions of article 125 of the Legislative
Decree 219/2006.

10

3.

CONFERENCE EVENTS, COMPANY LABORATORYVISITS, TRAINING COURSES AND INVESTIGATORMEETINGS

General principles

3.1

Without prejudice to the statutory provisions in force on this question,
the subject matter of these provisions shall be conventions, congresses
and scientific meetings held to discuss themes, related in a variety ofways to the use of medicinal products, that provide an occasion for anindustrial enterprise to meet healthcare professionals and entail
addressing a number of participants.
The subject matter shall not include the so-called group interviews thatshall, instead, be conducted, free-of-charge, directly on the premises ofhealthcare institutions or in medical surgeries where healthcare
professionals perform their professional duties. No other circumstanceis admitted. No form of hospitality can be offered within theframework of such initiatives (e.g. coffee-breaks, lunches, dinners).

3.1.bisPursuant to Article 113 of Legislative Decree lgs.219 / 2006
companies can provide ‘the patronage of scientific congresses where
persons authorized to prescribe or supply medicines participate’.
As part of the sponsorship of ECM congress events, it is forbidden forcompanies to identify and appoint directly or indirectly the lecturers
and moderators, as well as to interfere with the scientific contents ofthe same congress event, in accordance with the regulations
applicable to these types of events.
In any case, companies must implement a system of internal
procedures that provide suitable mechanisms for verifying the
economic adequacy of the sponsorship costs incurred by thecompany in support of congress events. The authorization of thesponsorship of congress events is left to the scientific director of thecompany.
Limited to the case of invitation to ECM congress events by medical
specialists employed by public bodies or private affiliated structures,the invitation, even if managed by the sponsoring company, must be
non-nominative and sent by the company to the public body / private
structure with an appropriate agreement at least 60 days before thestarting date of the ECM congress event. The invitation can be
nominative only in cases where the indication of the healthcare
worker is required by the public body / private facility under which
the healthcare worker provides their activities and for which the bodyprovides express authorization. The invitation must specify the11hospitality costs incurred by the company (by way of example only:
registration fee, travel, accommodation) and attach the scientificprogram of the event. In case of non-response from the public
body/private facility within the 30 days prior to the holding of theECM congress event, the company will be tacitly authorized to invite
the healthcare worker identified by the same, without prejudice to
any more restrictive provisions adopted by the public body / private
structure under agreement under which the healthcare operator
provides its activities (by way of example: provisions that require
express authorization from the public body / private structure underagreement).
3.2

With reference to the statutory provisions on the subject of thesafeguarding of persons and other subjects in relation to the handlingof personally-identifiable information (the law on privacy), a
pharmaceutical company that intends to invite physicians tocongresses, conferences, scientific meetings, refresher course andcompany laboratory visits shall, together with the professionals’
acceptance, also acquire express consent to use their names and, where
necessary, disclose these names to the Supervisory Committee,
together with their date of birth and the indication of any
specialisations acquired as well as proof of their compliance with thegeneral and regional laws on the obligation to inform their reference
healthcare structures of their participation in such sponsored visits toconference events. These requirements are exclusively for purposes of
ensuring conformity to the Code of Professional Conduct and arelimited to a specific conference or congress or the visit to a company
laboratory. This provision is applicable only to company laboratory
visits, not CME conferences, and CME refresher courses andconferences limited to cases of direct recruitment of doctors bypharmaceutical companies.
Failure to produce the documents indicated in the foregoing
subsection by a company when requested by the Supervisory
Committee of the Code of Professional Practice will automaticallyentail the referring the case to the Jury for the application of a possible
sanction.
The forms used by healthcare professionals to express their consent to
the handling of personally identifiable information shall be kept by thecompanies for a period of three years and may be used by thesupervisory bodies specified in the Code of Professional Conduct andalso for the purpose of verifying companies’ compliance with theannual quantitative limits fixed under points 3.3, regarding thenumber of invitations permitted for each physician, as well as thepercentages of actual participation by physicians under 40 years of age,in line with the requirements stated under the following point 3.11.

12

3.3

Participation in conference events by the companies shall be related to
the role performed by the industries in the field of research,development and scientific information and shall be inspired by
ethical, scientific and cost-effective criteria.
In this context the pharmaceutical companies may only offer economyclass air travel to Italian healthcare professionals invited to Italian
conference events in Italy or abroad while the category of hotel
accommodation shall not exceed four stars. In the case of rail transport
is allowed all travel classes except for class Executive.
On the occasion of international conferences involving
intercontinental flights longer than 6 consecutive hours of flight will
be possible to offer the travel business class only for speakers andmoderators included in the official program of the conference with the
exception of those involved with the presentation of Posters.
In addition, companies may not invite a healthcare Professional tocongresses, conferences, scientific meetings, refresher course andcompany laboratory visits more than twice a year. However, thisrestriction does not apply to speakers or moderators and the provision
is applicable only to company laboratory visits, not CME conferences,
and CME refresher courses and conferences limited to cases of direct
recruitment of doctors by pharmaceutical companies.
Similarly, the limit shall not apply in the case of educational or training
events concerned with specific pathologies, and taking place inconcomitance with a public pronouncement by the World HealthOrganisation of potential healthcare crises higher than the IV alertlevel. In this case derogation from the limit can only refer to initiatives:-

exclusively designed to update physicians on the pathology;
organised by public organisations;
held on the premises of the foregoing public organisations;that have acquired ECM credits;that do not make provision for any kind of hospitality;
for which prior information was sent to Farmindustria.

3.4

No meetings or congresses may be directly or indirectly organised by acompany outside Italy if it is to be mainly attended by Italianphysicians.

3.5

As concerns the choice of venue for meetings organised directly by acompany, the latter shall provide the Supervisory Committee, in the13

course of an investigation, good scientific, organisational and logistic
reasons for the choice of the locality.
In no event may scientific initiatives be organised that also serve
tourist purposes. And 'forbidden organization or sponsorship ofcongresses that are held or which provide the hospitality of theparticipants in structures that, by the type of services offered, are in
conflict with the principles of the Code of Conduct as may occur, forexample, for: Resorts, Ships, Castles that are outside the urban
context, Masseria Farms, Agritourisms, Farms, Golf Clubs, Museums,
Stadiums, Aquariums, Health Spas or facilities that have as a main
activity services dedicated to Wellness or Spa.

3.6

Invitations issued to physicians by pharmaceutical companies toattend conferences and congresses are subject to the condition that thetheme of the congressional meeting shall be pertinent to thespecialisation of the physicians who will attend.

3.7

The primary objective of the participation in or organisation ofinternational, national and regional conferences and congresses shallbe to promote scientific cooperation between physicians.

3.7 bisEvents carried out in hybrid mode or in which participation is expectedboth face-to-face and via the web will be governed by the following
principles:
1. Participation in presence - please refer to the provisions envisaged
for the realization of ‘physical’ events in relation to hospitality,
locations, duration, etc.
2. Participation via web - please refer to Article 3.18 of this code.
This rule applies to both speakers and learners and is valid for all
events (ECM and otherwise).

The Conference venue
3.8

Events organised directly or indirectly by pharmaceutical companies
shall be held in places and venues chosen for logistic, scientific andorganisational reasons, which shall exclude venues in catering or
restaurant facilities and they shall be characterised by a scientificprogramme that qualifies the event as an expert meeting. The
participants invited to meetings shall be chosen on an international,
national, interregional, regional or local basis. Places with tourist

14

vocation are rigorously prohibited in the periods June 1st - September
30th, as concerns seaside resorts and from 1 December 1 st- March 31st
and July 1st - August 31st , as concerns mountain resorts.
The Italian places that are on the sea and which are Regional Capitals
or Province, headquarters also Universities and major Hospitals, areexempt from this prohibition. This, provided that the congress and thehospitality of the participants are concentrated in the urban context ofthe capital with the exclusion, however, of structures that are close to
sea-equipped and accessible for bathing.

Regional events and scientific meetings at the local level
3.9

Regional events and scientific meetings at the local level arecharacterized by a geographical area of origin of the participants at theprovincial level or the individual region. The events will have acquired
CME credits and on this occasion may not be offered or hospitality
except for the coffee break. For events that include a number oftraining hours than 6 may be offered a "light lunch" in the interval
between the morning session and the afternoon session in theconference structure where the event takes place. Such events shall beheld in locations such as hospitals, universities, foundations ofscientific and conference rooms that ensure scientific dignity.

The interregional events
3.10

The interregional events are characterized by a 'balanced
representation of physicians from at least three regions and may not
require more than an overnight stay. These initiatives follow the same
rules laid down in this Code for national events.

International and national meetings
3.11

The Pharmaceutical companies, with regard to non-CME conferencesin Italy or abroad organised by scientific societies or public or private
institutions and entities as well as conferences in Italy directly
organised by companies, shall endeavour to ensure that at least 10% of
the physicians chosen by them to attend the meetings will be under 40
years of age. In any event the companies shall guarantee that, on a
yearly basis, 10% of the physicians participating in such events will be
under 40 years of age.

3.12

The involvement of companies in the hospitality offered to participantsin congressional events cannot exceed a 12-hour time period prior to15and immediately after the congress and such hospitality may not havecharacteristics such as to overshadow the technical-scientificcharacteristics of the event.
3.13

Any costs to be borne by the hospitality pharmaceutical companies
may cover General practitioners, hospital pharmacists, pharmacists ofthe territory and, where applicable nurses, only in relation to CME
events that are held in Italy.

3.14

In the context of conference meetings in or outside Italy it is forbidden
to arrange or sponsor autonomous initiatives with social, cultural or
tourist purposes, including gala dinners. Social dinners organised by
the conference for the participants as a whole are allowed and shall be
included in the inscription fees for the conference.
No hospitality of any kind or form can be offered to companions of thepersons invited.

3.15

Non-CME Conference events organised at a national level bypharmaceutical companies may not, in terms of their proceedings, lastless than six hours per day. The provision of this paragraph shall not
apply to events organized directly by national and international
scientific Societies.

3.16

Hospitality offered by pharmaceutical companies on occasion ofcongress events shall be limited to travel, accommodation andpayment of the registration fees to the congress. During the days of thecongress the hospitality offered may also include meals and drinks up
to a threshold of 60 Euro per each Professional per meal for all events
in Italy. As for events held abroad, referral shall be made to theamounts and thresholds mentioned in the relative country’s Code ofProfessional Conduct, where applicable. In any other case, the limit
remains fixed at 60 Euro also for events held abroad. The respect ofthe principle of sobriety shall, however, be guaranteed and the meal
shall be offered preferably in the same hotel where the guests arestaying or in contiguous structures.

Promotional materials used at the conference
3.17

During the conference events will be distributed gadget of negligible
value and relevant to the profession of the doctor or the pharmacist
with the exception of objects that recall graphically packaging of
medicinal products. On gadgets will be written the name of medicinal
products and / or the name of the active ingredient and / 0 the namepharmaceutical company

16

Updating and web-based training
3.18

The training and updating medical science made through theelectronic instrument such as web meetings, e-meetings and similar
events or FAD, cannot provide any form of hospitality and are notsubject to any restriction in terms of the duration of the work.

Refresher courses
3.19

For medical - scientific refresher courses at any territorial level thesame rules shall apply as those mentioned above for scientificcongresses, conferences and meetings.

3.20

Companies are prohibited from organising or sponsoring theparticipation of professionals in refresher courses that do not have a
medical or scientific character, such as foreign language, IT, or tax
courses or similar initiatives. It’s 'instead allowed the sponsorship ofinitiatives directed at healthcare professionals update identified in
section 1.9 of this Code and relating to matters directly related to thehealthcare management directly related to the drugs, provided thatthey are take in Italy, are organized by qualified entities, to take placein venues hospital or university or at least capable of ensuring scientificdignity and be completed within the course of a day with a forecast of
at least 6 hours of actual work. In these cases, companies will not beable to bear any burden of hospitality except for a light lunch. It 's also
allowed the sponsorship of initiatives whose duration is more than justa day in the case of national level events organized by companies
qualified in relation to the subject matter. In this case pharmaceuticalcompanies may also support the costs of travel and hospitality to theparticipants
withamaximumofonenight.
These initiatives are subject to the provisions of this Code relating tonational events.

The satellite symposia
3.21

If pharmaceutical companies shall ensure the organization of satellite
symposia in conjunction with conference events in Italy or abroad,shall be complied with current regulations and ethical rules on
Conferences and Meetings and, where applicable, the rules ofContinuing Education in Medicine. These initiatives will be
implemented or in the main event, or in half a day before the start orfollowing the end of it. If it starts in the afternoon the satellite

17

symposium will be held in the morning of the same day or in theafternoon of the last day in the event that the main event will end at
mid-day.
Visits to company laboratories
3.22

Healthcare Professionals may visit company laboratories on condition
that appropriate time is dedicated to information-training within theframework of the visit, that the duration of the visit does not exceed
the period of one day, that the hospitality offered is limited to a periodof time not in excess of twelve hours prior to and immediately
successive to the conclusion of the initiative and that its charactershall not be such as to compromise the technical purposes of the visit.
For such visits, pharmaceutical companies may only provide economy
air travel and accommodation in hotels of no more than four stars.
Moreover, no hospitality of any kind can be offered, in any
circumstance, to any accompanying persons. The organisation of any
type of social, cultural or tourist initiative, including gala dinners, isprohibited.

The Investigator meetings
3.23

The term Investigator Meetings shall refer to study meetings called byinvestigators for the purpose of pre-clinical, clinical or observational
studies.
In the event that a company takes steps to organise specificInvestigator meetings, such meetings shall comprise a number ofparticipants proportionate to the number of centres involved in the
study, address the formulation of a protocol to be filed at the local
Ethical Committee or be attested to by the existence of a specificprotocol filed with the local Ethical Committee, and have no
promotional implications.
The duration of the initiative shall comply with a programme of workthat excludes elements of tourism or recreation as well as hospitality
for accompanying persons of any type.
The choice of the venue shall be made in compliance with the criteria
fixed for the choice of conferences and congresses as well as theidentification of the limits of hospitality. Do not allow the organizationor sponsorship of initiatives that take place abroad where they concern
studies involving mostly Italian centers or if you participate mainly

18

Italian doctors.
Where to get the seat Investigator meetings are necessaryintercontinental flights longer than 6 consecutive hours of flight will
be possible to provide for participants traveling in business class. Thispossibility is not applicable to Investigator Meetings related toobservational studies.

The initiatives of Professional Relations

3.24

PR initiatives with Healthcare Operators (such as business lunches anddinners) may be carried out by pharmaceutical companies only if thefollowing conditions are met:
• a modest number of Operators generally no more than 6;• company directors, possibly accompanied by an Area Manager orsimilar, with the absolute exclusion of operational territorial roles.
Such initiatives must, moreover, be inspired by the principles of sobriety
and shall not be of a repetitive nature.

Interactions with otheradministration of therapies
3.25

non-prescribers

involved

intheThe companies, also through their local operational staff, will be able
to carry out training and information activities in favour of nonprescribing subjects involved in the administration of the therapies,
provided that these activities have no promotional purpose and theinformation processed is connected to the role of these subjects in thepatient management process, in clinical research and in the correctand safe administration of therapy.
The use of the package insert, and of the materials made for the
purpose of minimizing the risk of the use of medicines, is permitted
so long as these are used in the format and, where applicable, in themanner authorized by the regulatory authorities.
Any form of advertising as defined pursuant to Legislative Decree219/2006.
Participation in events, courses and congresses is permitted, incompliance with the legal limits only for initiatives having issues not
related to medicines pursuant to art. 124, paragraph 9, Legislative

19

Decree. 219/2006. Any hospitality offered to other non-prescribing
subjects by the companies may not exceed the value limits provided
for by the Presidential Decree 62/2013, equal to 150 euros per year,
and must be carried out in compliance with the regulations adopted
by the relative bodies to which it belongs.
Information to the public
3.26

Pharmaceutical companies can reactively provide, through personnel
not belonging to commercial or marketing areas, information to the
public relating to products and pathologies of their therapeutic areasof competence provided that such information is not of a commercial
nature and derives solely from the package insert or frominstitutional sites or from registers managed by Public
Bodies/Institutions.
In any case, it is forbidden to provide therapeutic consultations ortreatment recommendations.
It is possible to insert information including the brand name and thefull and literal reproduction of the package leaflet as well as thefaithful reproduction of the medicine packaging on the company's
publicly accessible websites provided that such information has notbeen subject to a selection or reworking and is contained in a specificpart of the site accessible, exclusively, through an active search action
by the user who wants to obtain them.

Interactions other than medicine promotion
3.27

In order to respond to changes in the context and the informationneeds of the various stakeholders (such as institutions, healthcare
professionals,
non-healthcare
workersandhealthcareorganizations), companies adapt their organizational structures andprocesses by putting in place a plurality of interactions that do not
fall in the context of medicine promotion.
As a general rule, such non-promotional interactions must be carriedout in compliance with the law and applicable regulations,guaranteeing the prohibition of carrying out any form of advertisingof the medicine as defined pursuant to Legislative Decree 219/2006.
Further detailed requirements applicablepromotional interactions are provided below.

tospecificnon-20

Access and institutional affairs
During the life cycle of the medicine, it is possible to carry out
institutional activities, access or further non-promotional
interactions with institutions and health professionals with the aimof ensuring the accessibility of medicines to treatment.
The use of materials with pharmaco-economic contents or related to
the value of the product is allowed, understood in its meaning of
economic advantage and savings for the health system, as well as interms of health policies, pathology and patient journeys provided
that these are differentiated by form and content from those used for
promotional activities and do not contain promotional elements.
Account management
It is possible to carry out activities aimed at ensuring the applicationof commercial policies through interactions with public or private
counterparties involved in medicine procurement processes.
The use of price lists as materials is allowed as long as they do notcontain promotional elements.

Scientific Exchange
Through the medical affairs staff, it is possible to carry out activities
aimed at mutual sharing of data and non-promotional information
on issues related to the healthcare context and its dynamics towards
healthcare professionals.
In particular, the proactive sharing of data and insights connected toclinical practice as well as factual and non-promotional information
relating to the company pipeline or connected to the access activitiesof new products such as, by way of simplification, the information
contained in institutional sites or registers is allowed. managed bypublic bodies / institutions, indexed independent publications or
non-promotional congressional acts relating to national orinternational events.
Other types of information relating to company products may beprovided to healthcare professionals only on a reactive basis andupon specific unsolicited request, companies adopt tools aimed at
guaranteeing the traceability of requests.

21

4.

RELATIONS BETWEEN THE INDUSTRY AND THE
SCIENTIFIC AND HEALTHCARE WORLDS

Scientific consultancy
4.1

Pharmaceutical companies may avail themselves of the cooperation ofphysicians as consultants for services such as rapporteurs andmoderators at conferences or invite them to participate inobservational studies or training and education services. Such formsof cooperation entail that the following criteria be fully complied with:- A written contract shall be stipulated between the physician and thepharmaceutical company specifying the nature of the service
offered. The need for the service in question shall be clearly
identified and stated.
- The contract shall also stipulate that the consultant undertakes todisclose his or her relationship with the pharmaceutical company
whenever he or she writes or speaks in public on the subject matter
to which the cooperative relationship refers. The same obligation
also applies in the event that the pharmaceutical company employs
physicians on a part-time basis who are also practising medical
professionals.
- The company is required to keep the documentation on the services
offered by consultants for a period of at least 3 years.
- The consideration paid by pharmaceutical companies for theservices provided shall meet cost-performance criteria and reflect
the market value of such services. The initiative shall guarantee
coherence and appropriateness in respect of the objectives pursued
and shall be capable of being fully documented.
- The decision on such initiatives shall be reserved to the executive
top management.
- Whenever journeys or any form of hospitality are provided, theprovisions set forth under subsection 3 of this Code, concerning
conferences and congresses, shall apply.

Scholarships
4.2

The collaboration between pharmaceutical companies and scientificworld can also be activated through scholarships. In this case, the bags

22

shall be designed to a project of considerable scientific interest withspecific and measurable goals, and shall be subject to priorconclusion of a specific agreement with the facility where thebeneficiary is active, in which are indicated all applicablerequirements; shall have unique character and not normal not being
able to repeat with the same structure with the same hospital or
operating unit / Department before 3 years.
This time limit does not apply, therefore, in the case of different
Operating Units / Departments, even if they belong to the same
Hospital Structure. The decision-making aspect related to the grantingof scholarships must be reserved for the company's top management.
Finally, pharmaceutical companies must publish, through theirwebsites, by June 30th of each year, the list of scholarships awarded
for each single centre, in the previous calendar year, together with theeconomic value of each individual loans.
Relations with scientific societies
4.3

Pharmaceutical companies may establish relations of cooperation with
scientific societies and medical associations on condition that they
serve the exclusive purpose of divulging scientific knowledge andimproving professional knowledge and are undertaken with entities ofproven reliability and national standing, and whose mission is wellknown.

Clinical trials and drug-related studies

4.4

In the phase following the release of the marketing authorization of
the medicinal products, only clinical trials authorized in accordancewith the current legislation governing the matter are permitted.
It must be ensured that clinical studies, ‘post marketing’ and postmarketing surveillance investigations are conducted exclusively for
scientific purposes.
The implementation by pharmaceutical companies of noninterventional (observational) clinical studies is subject tocompliance with the provisions of the circular of the Ministry of
Health 2 September 2002, n. 6, and the AIFA Determination of 20
March 2008 containing the Guidelines for the classification andconduct of observational studies on drugs.
The following criteria must also be respected:− a written contract must be drawn up in advance between thesponsoring company and the bodies involved in the study in which
the characteristics of the study itself and the nature of the services

23

−

−

−
−

offered by the body and / or participating doctors must be
specified in detail;the Study Protocol must be approved by the Corporate Scientific
Service or by the Medical Management who must also monitor the
conduct of the Study in compliance with the privacy legislation;
any remuneration recognized for participation in the Firm mustbe identified according to economic criteria and reflect the market
value of the work performed;
the Study must not contain elements of induction or
recommendation to prescribe or purchase a particular medicine;the scientific representatives may be involved in the observational
studies exclusively from the logistical point of view, with theexclusion of any aspect of an economic-financial nature. Any
involvement must, in any case, take place under the supervision of
the Corporate Scientific or Medical Management Departments
and subject to adequate training.

It is understood that the company remains responsible for all
activities related to these studies even if carried out with the supportof third parties.
In the event that for the purposes of the study, carried out directly or
indirectly by companies, it is necessary to use electromedical
instruments aimed exclusively at the study itself (such as Holter,electrocardiographs and other telemedicine tools), the distribution to
doctors of these instruments must be carried out through the Entity
or Entities involved in the study (ASL, University, Hospital Entities
and IRCCS) and its use must be regulated under a specific Agreement
between the company and said Entities. In any case, the use of theequipment must be fixed-term, exclusively for the duration of thestudy. In the event that the experimentation or study consists ofseveral phases or the company should conduct, at the same
institution, several studies, in close sequence with each other (inwhich between the end of one study and the beginning of the next no
more than 6 months elapsed), the Entity may send a formal request
to the company to retain the asset, identifying the duration of thefurther (or further phase of) experimentation or study and the
purposes of using the well, provided that it is stated that the centre
cannot use the instrument for other purposes during the interval
between one trial and the next. Companies will be able to accept thisrequest with a formal response. The maximum duration of theconcession to use the asset must not, however, exceed the overall
duration of the trial or study. Also, the suitability of use of the asset
must be guaranteed for the entire duration of the concession of useof the same. At the end of the study, the withdrawal of the asset must
be expressly documented and made available by the pharmaceutical

24

companies concerned upon any request of the Control Committee inthe context of investigative investigations.
Also in the context of these studies, the use of computer supports(both hardware and software) is not permitted unless such supports
are absolutely essential for the conduct of the study and there isfunctional incompatibility between said supports and those in use by
the bodies where the study in question is carried out, or there is a riskof mixing between the data functional to the conduct of the study - orin any case obtained during the same - with those already present in
the instrumentation in use by these bodies. In any case, this computermaterial will be usable only for the purposes of the specific study forwhich it is intended.
As for instrumental equipment, also in this case, the distribution to
doctors of such hardware and software supports must be carried out
through the Body or Bodies involved in the study (ASL, University,
Hospital Bodies and IRCCS) and its use must be regulated under aspecific Convention between the company and said Bodies.
The aforementioned material must, in any case, be returned to theSponsor / Promoter at the end of the study with tracking of the
return. The Ethics Committee may carry out specific checks to verify
the timely compliance with the provisions referred to in thisparagraph.
Internet sites
4.5

Every internet site opened by an Italian company or a company
operating in Italy that is addressed to the general public and Italian
professionals, in addition to complying with the requisites laid down
under the regulations and the pertinent laws in force, shall also
guarantee that the sponsor, the source of all information set forth in thesite, the designated recipients of such information and the objectives ofthe site are all clearly identified and/or specified. In all cases it shall be
guaranteed that access to sections containing promotional informationon the company's products shall be exclusively reserved to pharmacists
and physicians.

Relations between Pharmaceutical Companies, Patient Associations
and Expert Patients
4.6

Any form of direct or indirect financial support from a pharmaceuticalcompany towards a patient association must be in compliance with thefollowing criteria:25

- a specific agreement must be signed in advance to regulate theamount of the loan and the purpose for which it is disbursed. To thisend, each pharmaceutical company will have to develop a standard
internal approval process for this category of agreements;- the public use by a pharmaceutical company of the logo or material
owned by a Patient Association must be authorized in advance by that
Association. In order to acquire the authorization, the purposes andmethods of using the logo must be clearly defined;- any form of sponsorship by pharmaceutical companies towards
patient associations must be transparent and free from promotional
purposes;- no company may request a patient association to be the sole lender;- in all cases where travel or any form of hospitality is envisaged, theprovisions referred to in point 3 of this Code regarding conventions
and congresses are applied;- Pharmaceutical companies must make public through their website,
for a period of at least 3 months coinciding with the first quarter of
each year, the list of patient associations supported by them in theprevious year, together with the purposes underlying this support
and the economic value of the loans disbursed to each Association.
For the sole purpose of supporting public health or research, contracts
may be stipulated between pharmaceutical companies and patientassociations aimed at providing the companies with specific services;
these activities must not have promotional purposes.
The involvement of representatives of patient associations is also
allowed and, subject to the application of a specific segregated approval
process, of ‘expert patients’, such as consultants for services such as
participation in advisory boards and speakers; the reasons underlying
the activation of consultancy assignments with expert patients must be
well defined, documentable and non-promotional and have the purposeof collecting or disseminating information and insights aimed atunderstanding the needs of patients and their point of view. The
activation of these tasks is delegated to non-commercial functions.
Patients are considered ‘expert patients’ who, in addition to having
direct knowledge of the disease, have specific skills and experience inaspects related to medicine research and development, regulatory26

activities or advocacy activities understood as the ability to promote andsupport the causes and needs of a plurality of patients; these skills must
be effective and documentable and may be accompanied bycertifications or certificates issued following participation in courses
and training programs carried out by qualified and independent third
parties.
When assigning tasks to expert patients, the possession of the integrity
requirements and the absence of conflicts of interest must also beverified; this verification can also be carried out by means of a specificself-declaration.
In the event of assignment of assignments to individual members ofPatient Associations and ‘expert patients’, companies will be able tosupport or reimburse, where documented, any travel and hospitality
costs necessary for carrying out the assignment in compliance with theprovisions applied to travel and hospitality provided for in point 3 of thisCode of Ethics.
In the event of assignment of assignments to ‘expert patients’, a suitableform of remuneration may also be provided, as long as it is reasonable,
appropriate and strictly proportionate to the nature and duration of theassignment.
For the management of the services, an agreement or a preventive
contract must be signed which specifies the nature, the methods ofcarrying out the assignment and, where applicable, the criteria for thepayment of the services themselves. As part of the contract, the need touse these services must be clearly identified and documented.
The contract with expert patients must also include the obligation forthe consultant to declare the relationship in place with thepharmaceutical company on all occasions in which he writes or speaks
in public on the subject of the consultation.
Pharmaceutical companies will each year have to publicize the list ofpatient associations for which service contracts have been stipulated.
Finally, for expert patients, pharmaceutical companies will have to makepublic in an aggregate form the total amount of transfers of value madeas well as, subject to the acquisition of specific consent, the list of
individual names involved.

27

Patient Support Program
4.7

Patient Support Program (PSP) is defined as an initiative that has as its
purpose the provision, by the pharmaceutical company, of additional
services and not substitutes to those of the institution or the NHS for the
direct benefit of the patient being treated with a specific medicine
already authorized for placing on the market.
The pharmaceutical company will be able to finance a provider toorganize a PSP. In this case, the provider may send its specialized,
qualified and previously trained personnel to the patient's home or to
public or private health facilities, provided that the relationship between
the company and the supplier falls within the form of a service contract,
therefore without any form attributable to the administration of labouror posting. The company is, in any case, responsible for the services
provided by the external provider in charge.
The program and the material used must not, in any case, be a
promotional tool, but only functional to the communication of
information necessary for the appropriate use of the medicine.
The duration of the services offered by the PSP must be previously
defined and congruous with respect to the identified need and therelative desired benefit for the patient. The corporate function that has
the decision-making responsibility of the PSP must not be commercial
and operates under the supervision of the company's compliancefunction. The PSP must guarantee the management ofpharmacovigilance, the management of privacy, the responsibility forthe management of materials, the responsibility for compliance.
The pharmaceutical company must remain extraneous to the processingof personal data of patients involved in the PSP. The company will only
be able to view aggregated data for statistical purposes on the use of theservice.

5.

THE TRANSPARENCY OF TRANSFERS OF VALUE AMONGSTPHARMACEUTICALCOMPANIES,HEALTHCAREPROFESSIONALS AND HEALTHCARE ORGANISATIONS

Obligation of transparency
5.1

On an annual basis, each pharmaceutical company shall document andrender public, by using the template that constitutes part of this code28

(att. 1) , all transfers of value carried out directly or indirectly to
Healthcare Professionals and Organisations, as identified in the
Definitions Attachment (att. 2). The disclosure of this data shall comeabout on an individual basis and any eventual disclosure in aggregate
form, as per the following point 5.5, shall represent an exceptional
circumstance.
Data shall be published on the company’s website. Companies are
required to keep, alternatively also in electronic format, the appropriate
documentation for at least 3 years where it states that consensus has
been requested from the Healthcare Professional on the disclosure ofdata. The verification on the existence of a policy aimed at the systematic
acquisition of the above mentioned consensus’ will be carried out
annually and this is included in the activities of Certification as laid
down in point 1.13 of the general principles of the Code of Professional
Conduct.
5.2

The exclusion of the obligation to disclosure is on transfers of value
connected to OTC medicines and those related to promotional materials
referred to in point 2.13 of this Code, to meals and drinks and to medical
samples.

Method of application
5.3

The disclosure of the information connected to the transfers of value
shall be carried out on an annual basis starting from 2016 with reference
to economic data regarding 2015.
Pharmaceutical companies may indicate the transfers of value
exclusively by choosing exclusively cash-based or accruals-based
criteria. These criteria must be followed for a period of no less than 3
years.
The pharmaceutical companies shall disclose the transfers of value
carried out during each year, within the first six months of the following
year. The information shall remain public domain for a period of at least
3 years from the moment of disclosure. The companies shall, moreover,conserve, alternatively also in electronic format, the documentation to
support the data disclosed for a period of at least 5 years and make itavailable also in detailed form to any requests from the Healthcare
Professionals involved.

Applicability of the national Codes
5.4

The data regarding the transfers of value shall be disclosed in the state
where the recipient has their own domicile and will be governed by the29rules laid down in the Code of Professional Conduct of that state. Whena company does not have a subsidiary or affiliate in the country where
the recipient has their own domicile, the providing company shall,
however, disclose the data regarding the transfers of value to that person
according to the rules and regulations of the Code where the recipient isdomiciled.

Disclosure of data on an individual and aggregate basis

5.5

Each pharmaceutical company shall disclose, on an individual basis forevery recipient, the amount of the transfers of value carried out during
the previous year with reference to:a) expenses for the participation at conferences and congresses
regarding registration fees, travel and accommodation (excluding
meals and drinks);b) expenses for consultancy and professional activities not otherwise
covered in letter a), resulting from a specific contract between thecompany and individual Healthcare Professionals where the type ofservice is stated.
To this end, pharmaceutical companies shall do the utmost possible toobtain consensus from the Healthcare Professionals. If the Healthcare
Professional does not give their consensus on data privacy, the company
shall disclose the data on an aggregate basis.
If this is this case, for each of the categories listed in the previous lettersa) and b), the following data shall be identifiable:- the number of recipients on an absolute basis and as a percentage ofthe total recipients;- the aggregate data attributable to those Healthcare Professionals;- the percentage of the transfers of value as an aggregate of the totaltransfers.

5.6

Each company shall disclose the amount of the transfers of value carriedout for each Healthcare Organisation, as laid down in the definitions inattachment 2 to this Code, during the previous year with reference to:a) donations and grants (including free-of-charge leases) both in cash
and benefits in kind;30b) direct or indirect contribution to congress events carried out throughhealthcare structures or third parties, including the sponsorship ofdoctors to conferences and congresses with the payment of theregistration fees and the expenses of travel and accommodation;c) economic transactions related to consultancy and professional
activities resulting from a written contract between the company andthe Institute/Organisation or Association that provide any type ofservice not covered in a) or b).
Duplication
5.7

In the case a transfer of value has been made to an individual Healthcare
Professional indirectly via a Healthcare structure or third party, this data
shall be disclosed on an individual basis where possible, and only once.

Research & Development expenses
5.8

The annual expenses that pharmaceutical companies incur for activities
shall be disclosed in aggregate form. These include those related toplanning and actuation of:a) non-clinical studies, as defined in the Good Laboratory Practices;b) clinical studies, as defined in the Directive 2001/20/CE;c) observational prospective studies, according to point 4.4 of this Code,that involve the gathering of data on patients by individuals or groupsof doctors.

5.9

Expenses related to Investigator Meetings, Advisory Boards or
hospitality where they are connected to the activities according to point
5.8 above shall be disclosed on an aggregate basis.

Methodology
5.10

Each pharmaceutical company shall disclose a note summarising themethodology used to lay down data with reference to information
regarding VAT, currency or possible fiscal aspects connected to thetransfers of value in individual or aggregate form.

31

ATTACHMENT 1
Full
Name

(Art.
1.01)

HCPs: City of
Principal Practice
HCOs: city whereregistered(Art. 3)

Country of
Principal
Practice(Schedule 1)

Principal
Practice
Address

Unique country local
identifyer OPTIONAL(Art. 3)Contribution to costs of Events (Art. 3.01.1.b & 3.01.2.a)Donations andGrants to HCOs
(Art. 3.01.1.a)(Art. 3)Sponsorship agreementswith HCOs / third parties
appointed by HCOs tomanage an Event

Registration
Fees

Travel &Accomodation

Fee for service and consultancy (Art.
3.01.1.c & 3.01.2.c)

Fees

Related expenses
agreed in the fee forservice or consultancy
contract

Transfers of Value re
Research &Development as
defined (Art. 3.04)

TOTAL
OPTIONAL

INDIVIDUAL NAMED DISCLOSURE - one line per HCP (i.e. all transfers of value during a year for an individual HCP will be summed up: itemization should be available for the individual Recipient or public authorities' consultation only, as appropriate)
YearlyYearlyYearly amountamountamountYearlyYearlyDr B
N/A
N/A
Yearly amountamountamountYearlyYearlyetc.
N/A
N/A
Yearly amountamountamountOTHER, NOT INCLUDED ABOVE - where information cannot be disclosed on an individual basis for legal reasonsAggregate
Aggregate
Aggregate
Aggregate amount attributable to transfers of value to such Recipients - Art. 3.2
N/A
N/A
HCPs
HCPs
HCPs

INDIVIDUAL

HCPs

Dr A

N/A

N/A

Yearly amount

N/A

Yearly amount

N/A

Yearly amount

N/A

Aggregate HCPs

N/A

Optional

Number of Recipients (named list, where appropriate) - Art. 3.2

N/A

N/A

numbernumbernumbernumberN/A

Optional% of total transfers of value to individual HCPs - Art. 3.2

N/A

N/A

%

%

%

%

N/A

N/A

% on total of Recipients - Art. 3.2

N/A

N/A

%

%

%

%

N/A

N/A

HCOs

INDIVIDUAL NAMED DISCLOSURE - one line per HCO (i.e. all transfers of value during a year for an individual HCO will be summed up: itemization should be available for the individual Recipient or public authorities' consultation only, as appropriate)

HCO
1

Yearly amount

Yearly amountHCO
2

Yearly amount

Yearly amountetc.

Yearly amount

Yearly amount

YearlyamountYearlyamountYearlyamountYearly amount

Yearly amount
Yearly amount

YearlyamountYearlyamountYearlyamountYearly amount

N/A

Optional

Yearly amount

N/A

Optional

Yearly amount

N/A

Optional

OTHER, NOT INCLUDED ABOVE - where information cannot be disclosed on an individual basis for legal reasonsAggregate amount attributable to transfers of value to such
Recipients - Art. 3.2

Aggregate HCOs

Aggregate HCOs

Aggregate
HCOs

Aggregate
HCOs

Aggregate
HCOs

Aggregate HCOs

N/A

Optional

Number of Recipients (named list, where appropriate) - Art. 3.2

numbernumbernumbernumbernumbernumberN/A

Optional

%

%

%

%

%

%

N/A

N/A

OPTIONAL

OPTIONAL

OPTIONAL

OPTIONAL

TOTAL AMOUNTOPTIONAL

AGGREGATE% of total transfers of value to individual HCOs - Art. 3.2

AGGREGATE DISCLOSURE

N/A

N/A

N/A

N/A

N/A

OPTIONAL

OPTIONALATTACHMENT 2

DEFINITIONS RELATING TO POINT 5 OF
TRANSPARANCY OF THE TRANSFERS OF VALUE

THE

CODE

ON

Recipient
Any Healthcare Professional or Organisation that carries out a profession or principle
activity or that has the main domicile or legal head office in Europe.

Donations and Grants
By donations and grants (including free-of-charge leases) these must include all the
supplies, in cash or kind, destined either directly or indirectly to the Healthcare
Organisations as defined hereafter.

EventsAll the events of a promotional nature whether scientific or professional such as
congresses, conferences, symposiums and other similar initiatives (including as
examples Advisory Boards, visits to company plants, Investigator Meetings finalised
towards clinical studies and not interventional) organised or sponsored bypharmaceutical companies.

Healthcare Professionals
Any person who carries out their activity in the medical sector, dentistry, public, private
or hospital pharmacies, any nurses, Administrators or staff of Local Health Authorities,
any technical or administrative personnel of public or private healthcare structures andany other person within the scope of their professional activity can prescribe, dispense,
purchase or administer a medicinal speciality and that has their activity mainly inEurope. Intermediary pharmaceutical distributors are however excluded.

Healthcare structures
Any structure whether it is an association or medical, scientific, healthcare or researchorganisation, (independently from its legal form) such as Hospitals, Clinics,
Foundations, Universities, specialisation and training schools (except for patientassociations) that have their legal headquarters or main office or activity in Europe, or
through which a Doctor may practice.

33

Research and Development
The transfers of value connected to the research and development include those
activities planned or carried out with the aim of developing non-clinical studies as
defined in the Good Laboratory Practices, clinical studies, as governed by Directive
2001/20/CE, and non-intervention studies that are prospective in their nature and thatinvolve the gathering of information on patients by doctors for the study itself.

Subjects that must respect the obligations of transparency
The pharmaceutical companies associated to Farmindustria and all their subsidiaries
and affiliates are bound to respect the obligations laid down in point 5 of theProfessional Code of Conduct. The pharmaceutical entities that are legally separate butpart of the same group are also bound to respect the Code.

Transfers of value
Economic transfers whether direct or indirect, both in cash or kind, carried out foreither promotional aims or for the development and commercialisation ofpharmaceuticals for human use subject to medical prescription. The direct transfers arethose carried out directly between the company for the benefit of the recipient. The
indirect transfers are those carried out on behalf of the company by a third party.

34

REGULATORY
BODIESAND
PROCEDURES
FORIMPLEMENTING THE CODE OF PROFESSIONAL CONDUCTArticle 1
The Bodies
The bodies set up to supervise and execute procedures for the code of selfregulation are the Supervisory Committee, the Single-Judge Tribunal and the
Jury.

Article 2
Supervisory Committee
The Supervisory Committee is made up of 17 members, including thePresident. The President of the Committee is appointed by the President of
the Supreme Court of Cassation and chosen from among the retired
Magistrates of the most representative districts on the national territory who
have exercised higher managerial functions. He remains in office for 3 years
and can be reconfirmed only once. The 16 members are nominated by theFarmindustria Council and chosen from among the legal representatives of
the associated companies (or their permanent delegates, whether they are
members of the Management or the Board of Directors of the Company) in aratio of eight representing the Italian-owned companies and eight
representing companies predominantly foreign-owned. The members of theCommittee remain in office for two years and can be reconfirmed. The legal
representative of the associated company who has not received, during the last
12 months, specific sanctions by the presiding Single Judge Tribunal or Juryor who has no specific pending investigation by the presiding Single Judge
Tribunal or Jury. For the exercise of its functions, the Committee may makeuse of consultants chosen according to the needs of the case. Any member who
does not participate in three meetings during the year is replaced.

35Article 3
Single-Judge Tribunal
The Single-Judge Tribunal is constituted by a member of the Jury as stated in
the following article 4, chosen by the Jury itself from among its members. Heor she may avail him/herself of a consultant appointed by the National
Federation of Medical Associations from independent physicians of recognised
standing who no longer perform professional work and a consultant chosenfrom representatives of the pharmaceutical sector who hold no positions ofcorporate responsibility. The consultants do not have voting rights.
The judge is chosen, hearing-by-hearing, in rotation, from the members of theJury on the basis of age, commencing from the youngest and he or she shall notparticipate in any appeal hearings before the Jury to discuss the decisions thathe or she took.
The judge shall consider the sanctions proposed to him or her by theSupervisory Committee and deliver his/her decisions concerning the sanctions
in conformity to the following article 14.
Article 4
The Jury
The Jury is made up of the Chairman and three members.
The Chairman of the Jury is appointed by the Presiding Judge of the Court ofCassation and is chosen among retired judges in the most representative
districts within the national territory who have had important management
responsibilities. Two members are appointed by the Presiding Judge of the
Court of Milan and chosen from retired judges. One member is appointed by
the National Council of the Bar and chosen from qualified and retired lawyers.
The Jury shall also avail itself of the services of a consultant appointed by the
National Federation of Medical Associations to be chosen from independent
physicians of recognised standing and who no longer perform professional
work, and an industrial consultant chosen from representatives of thepharmaceutical sector who no longer hold positions of corporate
responsibility. The consultants do not have voting rights. The President,
members of the jury and Advisors hold office for 3 years and can bereconfirmed once. During the initial application of this provision after 3 years
after its entry into force will proceed to the renewal of half of the members of
the Jury and half of consultants. The Chairman of the Jury shall adopt
measures at his/her own discretion to decide organisational and management
matters referring to the Jury and the Single-Judge Tribunal.

36

He/she is responsible for relations with the Supervisory Committee, the SingleJudge Tribunal and the Presidency of the Association.
The members of the Jury and the Chairman of the Supervisory Committee,
upon acceptance of the office, shall expressly declare that they have no current
professional relations or interests with the member companies and undertake
not to establish such relations during the tenure of their office.
In agreement with the secretariat, the Jury fixes the dates of its hearings andthose of the Single-Judge Tribunal and draws up the internal regulations
governing the working of the Jury and the Single-Judge Tribunal.
At the request of associate bodies, the Jury provides opinions on the Code ofProfessional Conduct and where necessary can convene the Supervisory
Committee and the Jury in a joint sitting.
The Jury decides appeals on the basis of all the elements collected by theSupervisory Committee and the Single-Judge Tribunal.
Article 5
The investigative, proactive and consultative functions of theSupervisory Committee
The Supervisory Committee shall:−draw up internal regulations to protect the confidentiality of the work
conducted by the committee;−

order - upon receipt of a circumstantial report received from a recognised
source - investigations into cases related to presumed infringements of the
code;

−

submit to the Single-Judge Tribunal proposals in order to sanction alleged
infringements of the code, which, in its opinion, have been proven.

−

express non-binding opinions at the request of members or the Chairmanof the Jury.

37

Article 6
Fact-finding function of the Supervisory Committee
The Supervisory Committee can carry out, within the framework of theascertainment to be made in the investigative phase, fact-finding activities on
the premises of the companies, for the sole purpose of the investigation in hand,by means of an auditing company to be specifically appointed on a case-by-casebasis. Furthermore, the Supervisory Committee, for its fact-finding mission
regarding alleged violations of the Code of Professional Conduct, may appointa specialised company of proven integrity, to carry out specific investigations
on congressional events and promotional activities conducted within the
territory, with exclusive reference to the field of application of the Association's
Code of Professional Conduct and the specific laws in force regulating theprovision of scientific information on drugs.
Article 7
Guideline-setting function of the Supervisory Committee
The Supervisory Committee performs a preventive advisory function withregard to cases that while not representing blatant infringements of the code do
not appear to comply with the general principles of the code and members'
ethical standards.
In such circumstances it shall inform all members - while guaranteeing theanonymity of the companies involved – that the behaviour in question does notcomply with the principles indicated in this subsection and, whenevernecessary, shall submit adjustments and supplements to the Code ofProfessional Conduct that regulate such cases to the Governing Council for
approval in line with the provisions of the following article 17.

Article 8
Secretariat
A Secretariat for the Supervisory Committee and the Jury is instituted. The
secretariat is made up of a secretary chosen from the functionaries of the
Association. The secretariat's functions are as follows:- to receive and prepare the documentation on the reports received;38

−

to prepare an explanatory report for the Supervisory Committee, the SingleJudge Tribunal and the Jury;−to provide assistance to the collective bodies in their operations byappropriately storing the documentation and filing the relative acts.

Article 9
Headquarters and Meetings
The Supervisory Committee, the Single-Judge Tribunal, the Jury and theoffices of the Secretariat are based at Farmindustria.
The Supervisory Committee, the Single-Judge Tribunal, the Jury meetwhenever the need arises, upon convocation of the respective Presidents, tobe communicated at least three days prior to the date set by them.
This term may not be observed in cases of particular urgency. The meetings of
the Supervisory Committee, the Single-Judge Tribunal and the Jury are notpublic. The Supervisory Committee and the Jury are validly constituted withthe presence of the majority of the members in office.
The Suprvisory Committee and the Jury deliberate with the vote of the
majority of the members in office; in the event of a tie, the vote of the chairman
prevails.
For changes to the Code of Ethics or the Regulations, the Committee must
express itself by a qualified majority (2/3 of the members).
The Supervisory Committee, the Single Judge and the Jury are assisted by the
Secretariat which is bound by official secrecy.

Article 10
Applications to the Supervisory Committee
The Supervisory Committee examines the reports and information written in
non-anonymous form or in any case the specific facts that emerged during an
investigation.
Written reports must be addressed to the President of the Supervisory
Committee, by registered mail with acknowledgment of receipt, to theheadquarters of Farmindustria in Rome, or by certified e-mail. The receipt will
be recorded in a specific internal protocol.
Only reports referring to events occurring in the 12 months preceding the dateof receipt of the same will be considered valid.
In relation to the communication, if it does not appear manifestly without

39

foundation, the Committee initiates an investigation and for the execution ofwhich it may make use of technical consultants chosen according to the needof the case. In particular cases, in which a more detailed investigation isrequired, the Chairman may entrust this investigation to one or more speciallychosen representatives of the Committee.
The Supervisory Committee, at the time of the first examination of discovering
a possible ethical violation, then informs the company concerned, through theSecretariat, inviting it to provide written clarifications and to appear for a
specific hearing on the matter. This hearing is reserved exclusively for the legal
representative of the company concerned who can be accompanied, if
necessary, by a company official or his consultant. The prior hearing of thecompany concerned is mandatory, except in the case of immediate archiving.
Together with the request for clarification, the company is in any case invited
to provide all the useful documentation in their possession that is believed tocontribute significantly to the formation of the Committee's opinion.
During the eventual hearing, the Supervisory Committee will also inform thecompany about all the evidence it was in possession of.
The investigation may involve the filing of the case or the adoption of a specificsanction proposal. Minutes are drawn up of the meetings of the Supervisory
Committee which, in compliance with the information rules for Members,
guarantee the anonymity of the companies involved in the proceedings.
Specific information is provided to the whistle-blower on the conclusions of
the investigation.
Article 11
Decisions Proposed by the Supervisory Committee
If the Supervisory Committee, upon concluding the investigation procedure,
establishes that a specific infringement of the code has taken place, it will decideto propose a specific sanction and notify the company concerned.

40

In the event that the company recognises its own responsibility andsimultaneously and formally undertakes to change its conduct the Supervisory
Committee will inform the Single-Judge Tribunal of these undertakings andmay make a reasoned proposal for a less severe sanction than that originallyproposed.

Article 12
Proceedings before the single judge tribunal
The single Judge tribunal, having received formal communication from theSupervisory Committee containing the sanction proposal formulated against
the company concerned, orders the communication of the procedure to thecompany itself, assigning it a term of no less than eight, and no more thanfifteen days, for the submission of any deductions. Upon communication, thecompany concerned, in through its legal representative, may intervene in thediscussion before the presiding judge. The legal representative of the company
may be accompanied, if necessary, by a trusted collaborator. It is possible forthe company involved to present to the single Judge tribunal even new
documentation that justifiably could not be provided to the Supervisory
Committee before formulating its judgment. Such late documentation must,in any case, be provided in advance to the Committee. A specially delegatedrepresentative of the Supervisory Committee participates in the discussion,
who will be heard by the presiding Judge to answer his questions about theprocedure already carried out without the Committee ever assuming theposition of a party in the proceedings.
Once the discussion is over, the presiding Judge reaches their decision andnotifies the company concerned. After 30 days from this communication, if
the company does not appeal to the Jury, the decision taken is also notified to
the Farmindustria Board. In this case, the decision is immediately enforceable- except in the case referred to in the following art. 14, letter d) - and specificinformation is given to all associated companies.
The sanctioned company must communicate the final sanction received to its
certifying body, referred to in point 1.13 of this Code.
At any time during the proceedings, the presiding judge may request opinionsfrom the Supervisory Committee.

41Article 13
Appeal procedure
Within 30 days from the date of communication of the decisions of the SingleJudge Tribunal, the company can lodge an appeal before the Jury together withany additional documentation. In that regard, the jury will consider only those
appeals that are properly motivated.
Having received the appeal, the Jury makes provision to notify the company
concerned of the date of the appeal meeting, which shall be fixed within 30 days
from the date on which the appeal was filed.
Subject to the receipt of this communication, the company, in the person of its
legal representative, may participate in discussions before the Jury.
The Jury may request new documentation or arrange for a supplementary
investigation through the Supervisory Committee.
A specially appointed representative of the Supervisory Committee, who may
also file written briefs, will participate in the discussions.
When the discussions are terminated, the Jury will make a ruling andcommunicate it to the company concerned and to the Governing Council ofFarmindustria. All member companies will be apprised of the decision by aspecific circular.
Article 14
Sanctions
The sanctions that may be applied by the Single-Judge Tribunal in the event ofproven infringements of the provisions of the Association's Code ofProfessional Conduct are as follows:a ) warning with a request to cease any behavior, if still in use, and ban itcompletely if necessary;b) written reprimand;c ) temporary suspension;d) expulsion.
In addition to the sanctions stated under the foregoing letters b), c) and d) a
graduated pecuniary sanction may also be applied, whose amount will depend
upon the seriousness of the violation as well as the damage to the image andreputation of the sector, the number and nature of previous and, wheneverquantifiable, the expenditure borne by the company for the carrying out theinitiative forming the subject matter of the judgement.

42

The sanction may not, in any case, exceed the sum of €200,000.00 (twohundred thousand). In the event that a company accept the decision of thesingle-judge and thereby expressly waive its right of appeal to the jury, it will beaccorded a reduction of one quarter of the pecuniary sanction.
In the event of a violation committed within a 12-month period successive toany violation for which a company had already been required to pay the full
pecuniary sanction, the foregoing €200,000.00 (two hundred thousand), will
not apply.
The application of the sanction referred to under d) shall be formally approvedby the Governing Council.
If the Single-Judge Tribunal were to decide to apply a sanction different fromthe warning with a request to cease any behavior and / or with disqualificationof the same or a written censure without pecuniary sanctions, twice against thesame company for infringements committed in the space of 24 months, it will,through the offices of the Association, disclose the decision on a newspaper withnational circulation along with the name of the offending company. In the eventthat the date of the infringement could not be ascertained, reference will bemade to the date of the violation's report in order to determine whether theforegoing 24-month period has elapsed.
Article 15
Loss of office of a member of the Supervisory Committee
The member of the Supervisory Committee whose company is formallysanctioned by the Jury or by Single Judge will automatically forfeit office assoon as the decision is notified to him.
Article 16
Procedural costs for the ruling
All the costs sustained by the Association shall be for the account of thecompany in question.

43

Article 17
Amendments and supplements to the Code of Professional Conduct
Amendments and supplements to the Code of Professional Conduct that
represent an integral part of the byelaws of the Association shall be approved by
the Governing Council at the proposal of the Supervisory Committee.

Article 18
Stipulating and undertaking to abide by the Code of Professional
Conduct

When the Code of Professional Conduct is issued each member company
belonging to Farmindustria in the person of its legal representative shall, as
an essential condition for their membership of the Association, be required tomake a specific undertaking that it accepts the code and will not impede thework of the bodies set up to monitor and enforce it.

44