CODE OF ETHICS FOR PHARMACEUTICAL

COMMUNICATION

Table of Contents

CHAPTER 1 - Legislative background …………………………………… 2

CHAPTER 2 - Enforcement of the Code………………………………....... 3

CHAPTER 3 - Scope of the Code…………………………………………...3

CHAPTER 4 - Provisions of the Code…………………………………….. 4

Article 1. Marketing authorization ……………………………. …………......... 4
Article 2. Information to be presented to healthcare professionals …………….. 5
Article 3. Promotional information and its substantiation ….…………………... 5
Article 4. Use of quotations in promotion ………………………………………. 7
Article 5. Acceptability of promotion …………………………………………... 7
Article 6. Recipients of promotion ........................................................................7
Article 7. Transparency of promotion ................................................................... 8
Article 8. Advertisements directed at the general public .………………………. 8
Article 9. Events and hospitality ........................................................................... 9
Article 10. Gifts and inducements ......................................................................... 9
Article 11. Sponsorship of healthcare professionals……………........................ 10
Article 12. Medicine samples ............................................................................. 10
Article 13. Pharmaceutical company staff………….. ........................................ 11
Article 14. Collection and evaluation of data of therapies and treatment
programs involving medicines available on the market .………….. 12
Article 15. Procedural rules…………... .............................................................. 12
Article 16. Bylaws of the Communication Ethics Committee……….. .............. 13
Article 17. Rules facilitating enforcement of this Code,
closing provisions ..……...........……..................................................17
CODE OF ETHICS FOR PHARMACEUTICAL
MARKETING COMMUNICATION
CHAPTER 1 – Legislative background
The member companies of the Hungarian Pharmaceutical Manufacturers Association
(hereinafter: MAGYOSZ) and the Association of Innovative Pharmaceutical
Manufacturers - Hungary (hereinafter: AIPM) are the representation of interests of the
pharmaceutical companies operating in Hungary.
Their members acknowledge their responsibility and obligation in the formulation and
implementation of an ethical pharmaceutical marketing communication, which ensures
the provision of adequately wide ranging information and reflects the role of the
pharmaceutical industry and trade in the system of healthcare in the interest of public
health.

In Hungary the advertising of prescription medicines is regulated by

Article 9 of Act LVIII of 1997 on Business Advertising Activity, and the existing decree
of the Minister of Health, Social and Family Affairs No. 64/2003 (X.31.) governing
advertising and presentation of medicinal products and preparations with therapeutic
effect not qualified as medicines.

Advertising of medicines dispensed by pharmacies without prescription is regulated by

Article 10 of Act LVIII of 1997 on Business Advertising Activity, the existing decree of
the Minister of Health, Social and Family Affairs No. 64/2003 (X.31.) governing
advertising and presentation of medicinal products and preparations with therapeutic
effect not qualified as medicines.

The present Code fits into the general legal framework established by Act LVII of 1996
on the prohibition of unfair and restrictive market practices together with Act XXV of
1998 governing medicinal products for human use and amendments thereto.

After the accession of Hungary to the European Union on May 1, 2004 the above laws
and directives have been harmonized with directive 2001/83 EC. The present Code
complies with the minimal requirements of the European Federation of Pharmaceutical
Industry Associations (EFPIA) European Code of Practice and responds to the special
Hungarian challenges.

The present Code of Communications was approved by the General Assembly of

MAGYOSZ and AIPM, respectively. Only the General Assemblies shall have the right to
amend this Code, and the General Assemblies shall authorize the Board of MAGYOSZ
and the Executive Committee of AIPM to amend and align this Code in their own
discretion, as may be needed, the with applicable legal regulations in effect at that time.

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This Code shall become effective on April 1, 2005 following its approval by the General
Assemblies of MAGYOSZ and AIPM respectively.

The original text of this Code of Ethics for Pharmaceutical Marketing Communications
was approved by:
• the General Assembly of MAGYOSZ on April 10, 1995
• the General Assembly of AIPM on May 9, 1995
.
The current modified text of the Code was approved by
• the General Assembly of MAGYOSZ on 22 March, 2005 and
• the General Assembly of AIPM on 30 March, 2005.

The member companies of the above organizations undertake to strictly adhere to the
provisions and the spirit of this Code and recommend signing of, compliance with and
application of this Code for companies operating in Hungary which are neither
MAGYOSZ nor AIPM members, and for each and every natural and legal entities that
are active in the field of pharmaceutical manufacturing, trade and communication.

CHAPTER 2 - Enforcement of the CODE

MAGYOSZ and AIPM, in an attempt to determine cases of breach of the present Code,
laws and decrees comprising its legal framework, to define the rules of procedures to deal
with such cases and to publish statements supporting enforcement of the Code decided to
establish the MAGYOSZ-AIPM Communication Ethics Committee (hereinafter: KEB)
and define its bylaws with that the complaints and disputes of ethical nature shall be
judged on the basis of the KEB bylaws pursuant to the provisions of this Code (see
Article 16). KEB shall make public its decisions. MAGYOSZ and AIPM shall ensure
appropriate information to their member companies on the positions issued by KEB.

CHAPTER 3 - Scope of the CODE

The scope of this Code shall extend to all marketing and information activities
(promotion) undertaken by pharmaceutical manufacturing and distributor companies -
being signatories to this Code - operating in the territory of the Republic of Hungary, in
particular employees and agents of MAGYOSZ and AIPM member companies, in respect
of substances or mixture of substances qualified as medicinal products (prescription and
non prescription) officially registered and having marketing authorization, with the aim
to promote prescription, sale and consumption of a specific medicinal product. These
activities shall include pharmaceutical presentation, advertisement and promotion
directed at consumers/patients. The scope of this Code shall moreover extend to
promotional activities aimed at persons active in healthcare and qualified to prescribe and
supply medicinal products.

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The scope of this Code shall apply to all activities relating to medicinal products
regulated in Act XXV of 1998 governing medicinal products for human use but shall not
apply to preparations having medicinal effect but not qualified as medicines, to nutrients
and to veterinary preparations.

The scope of this Code shall extend but not be limited to advertisements and promotional
activities performed by means of communication as hereunder, irrespective of whether or
not they are addressed to consumers/patients or healthcare professionals (pharmaceutical
presentation):

Word of mouth;
Printed materials;
Advertisements:

in the printed press,

in the electronic media,

in public places,

in printed materials for professionals,
Audio-visual advertising tools;
Conferences and congresses;
Medicine samples, gifts;
Internet;
Telecommunication.

The provisions of this Code shall not apply to:

- the labeling of medicinal products and the accompanying package leaflets;

- correspondence needed to answer a specific question about a particular medicinal
product;
- factual, informative announcements relating, for example, to pack changes,
adverse-reaction warnings as part of general drug precautions, trade catalogues
and price lists, provided they include no product claims;
- statements relating to human health or diseases, provided there is no reference,
even indirect, to medicinal products.

CHAPTER 4 - Provisions of the CODE

Article 1. - Marketing authorization

1.1. A medicinal product must not be promoted prior to the grant of marketing
authorization.

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 1.2. Advertisement/promotion must be consistent with the particulars listed in
the summary of product characteristics of the given medicinal product and can
relate to approved indications only.
1.3. Scientific information and offprints related to drug development may be
distributed at scientific conferences. During regular promotions these materials
can only be distributed if satisfying the criteria in 1.2. and if the printed material
clearly states which are those particulars that are not part of the documentation
as approved by the registration authority.

Article 2. - Information to be presented to healthcare professionals

2.1. In the interest of giving detailed and balanced information to healthcare

professionals all promotional materials presented to them must include the
following information clearly and legibly:

a) Essential information consistent with the summary of product

characteristics (specifying the date on which such essential information
was generated or last revised) with special regard to the conditions of safe
use (counter indications);
b) the supply classification of the product; and
c) its selling price or the conditions and extent of reimbursement by the
social insurance.

2.2. When the advertisement includes no more but the name of the medicinal
product (its proprietary name or international non-proprietary name) the above
information need not be presented. The promotional material must call for
detailed study of the summary of products characteristic of the given medicinal
product and state from where further information regarding the use of the product
may be obtained.

Article 3. - Promotional information and its substantiation

3.1. Promotion must be accurate, balanced, fair, objective and sufficiently

complete to enable the recipient to form his or her own opinion of the therapeutic
value of the medicinal product concerned. It should be based on an up-to-date
evaluation of all relevant evidence and reflect that evidence clearly. It must not
mislead by distortion, exaggeration, undue emphasis, omission or in any other
way.

3.2. Information to be used to substantiate a promotion including relevant

details of one’s own database must, on request, be provided promptly to
healthcare professionals or the competent authority, but not later than 10 working
days. Information relating to side effects should also be duly substantiated.

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Substantiation need not be provided, however, in relation to the validity of
elements approved in the marketing authorization.

3.3. Promotion must encourage the rational use of medicinal products by

presenting them objectively and without exaggerating their properties. Claims
must not imply that a medicinal product, or an active ingredient, has some special
merit, quality or property unless this can be substantiated. Attributes such as
“unparalleled”, “outstanding” can only be used if they can clearly be proven.

3.4. When promotion refers to published studies clear references should be

given.

3.5. In comparative advertisement all claims relating to the medicinal products

to be compared must also be objective. Any comparison made between different
medicinal products must be based on the relevant and comparable aspects of the
products. Comparative advertising
- must not be misleading or disparaging
- must not discredit the competitor’s product
- must not be used for generating unfair gains via the reputation of the
competitor’s product or trademark
- Promotional materials of other companies (manufacturers, distributors)
must not be presented, not even in servile copy, and/or must not be
published as own work.
3.6. All artwork, including graphs, illustrations, photographs and tables taken
from published studies included in promotional material should

- clearly indicate the precise source(s) of the artwork

- be faithfully reproduced; except where adaptation or modification is

required in order to comply with any applicable laws or ethical norms, in
which case it must be clearly stated that the artwork has been adapted
and/or modified.

- Particular care must be taken to ensure that the artwork included in the
promotional material does not mislead about the nature of a medicine (for
example whether it is appropriate for use in children) or mislead about a
claim or comparison, for example by using incomplete or statistically
irrelevant information or unusual scales.

3.7. The word “safe” must never be used to describe a medicinal product without
proper qualification. Proper qualification (e.g. for kidney patient, etc.) must
always be provided. The use of the term” proven safety” is not acceptable.

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 3.8. The word “new” must not be used to describe any medicinal product or
presentation which has been generally available on the market for more than
one year.

3.9. It must not be stated that a product has no side-effects, toxic hazards or
risks of addiction or dependency.

3.10. Data gleaned from in vitro and animal experiments and/or from healthy
volunteers must be presented so that it properly projects the importance of
such findings. Clinical conclusions from such data should not be drawn unless
these data verify their relevance and significance.

3.11. No such claims are allowed that tend to exaggerate or generalize, and the
use of superlatives is prohibited except if used to describe an unambiguous
fact in connection with the product (for example: it is the first of its kind).

3.12. The advertisement (promotion), in particular the one directed at the

general public should not contain any comparison claim, reference or
expression, which

 implies that a medical diagnosis, treatment or surgical intervention is

unnecessary or dispensable,
 suggests that the application of the medicinal product results in
guaranteed recovery or that the medicinal product has no side effects,
 presents a medicinal product as a cosmetic or food,
 attributes the efficacy and safe use of the medicinal product to its
natural origin,
 by description or detailed presentation of a case history may result in
inaccurate self-diagnosis,
 presents any alteration caused by a disease or an injury or the effect of
a medicinal product in the human body or in any of its parts in a
frightening or untrue manner,
 contains the recommendation of scientists, health professionals or other
known personalities,
 implies that without the application of the medicinal product human
health would be impaired, and
 refers to the marketing authorization of the medicinal product.

Article 4. - Use of quotations in promotions

4.1. Quotations from medical and scientific literature or from personal

communications must be faithfully reproduced and its precise source identified.
If adaptation or modification is required in order to comply with any applicable
laws or ethical norms it must be clearly stated that the quotation has been adapted
and/or modified.

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Article 5. - Acceptability of promotion

5.1. Companies must maintain the highest ethical standards at all times.
Promotion must:
a) never be such as to bring discredit upon the pharmaceutical industry or
reduce confidence in the pharmaceutical manufacturers,
b) be of a nature which recognizes the special nature of medicinal
products and the professional standing of the recipient(s);
c) The text of advertisements and presentations must be succinct and
must comply with the grammatical rules and orthography of the
Hungarian or any other language, and be in accordance with the rules
of correct style;
d) Advertisements and promotions targeting consumers / patients must be
such that the general public easily understands;
e) In all advertising activities, reasonable self-control and moderation
should be observed and such activities must not be likely to cause
offence.

Article 6. - Recipients of promotion

6.1. Promotion should only be directed at those persons whose need for, or
interest in, the particular information can reasonably be assumed.

6.2. Mailing lists must be kept up-to-date. Requests by healthcare professionals

to be removed from promotional mailing lists must be respected.

6.3. The use of faxes, e-mails, automated calling systems, text messages for
promotional purposes is prohibited except with the prior permission, or upon the
request, of the recipient.

Article 7. - Transparency of promotion

7.1. Promotion must not disguise its real nature. Advertisements must be
published with their advertising character made clear and in isolation from their
environment. Any advertisement published in the form of information pretending
to be neutral (disguised advertisement) shall be prohibited. The advertisement
(promotion) should make it clear that it is a pharmaceutical advertisement.
7.2. Clinical assessments, post-marketing surveillance and experience
programs and post-authorization studies must not be disguised promotion. Such
assessments, programs and studies must be conducted with scientific or
educational purpose under the strict conditions referred to hereafter (in Article
14.).

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 7.3. Where a company pays for or otherwise secures or arranges the
publication of promotional materials in journals, such promotional material must
not resemble independent editorial matter.
7.4. Material relating to medicinal products and their uses, whether
promotional in nature or not, which is sponsored by a company, must clearly
indicate that it has been sponsored by that company.
7.5. Printed materials supporting physicians’ work (e.g. referrals,
recommendations) must not contain the name of any prescription medicine.

Article 8. - Advertisements directed at the general public

8.1. The following medicinal products shall not be allowed to be advertised for
the general public:
a.) prescription medicines;
b.) medicinal products which contain substances defined as psychotropic or
narcotic by international conventions;
c.) other drugs whose use is restricted by law;
This restriction does not apply to vaccination campaigns organized by the
pharmaceutical industry and authorized by the competent authorities.
8.2. In the case of requests from individual members of the general public for
advice on personal medical matters, the enquirer should be advised to consult a
healthcare professional.
8.3. Patient information leaflet containing particulars of a prescription
medicine can only be given to patients that had the medicine prescribed by their
physician. The information can not be promotional in nature, its content should
be in closest harmony with the official patient information leaflet and should aim
at transferring knowledge about the medicine in question and giving advices on
the use of that medicine.

Article 9. - Events and hospitality

9.1. All promotional, scientific or professional meetings, congresses,

conferences, symposia, and other similar events (hereinafter: “event”) organized
or sponsored by a company must be held in an appropriate venue that is
conducive to the main purpose of the event and may offer hospitality only when
such hospitality is appropriate and otherwise complies with the provisions of any
applicable pieces of legislation.

9.2. As regards conferences of promotional or scientific nature the provisions

of Ministry of Health, Social and Family Affairs decree No. 64/2003 (X.31)
shall be governing. No company or representation office may organize or

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 sponsor any event that takes place outside its home country (“international
event”) unless part of the invitees are from abroad and it makes greater sense to
hold the event in another country. In all other cases a position from KEB must be
sought prior to the event.
9.3. Hospitality extended in connection with promotional, professional or
scientific events shall be limited to travel, meals, accommodation and genuine
registration fees. (If the event in a foreign country lasts for more than one day
one extra day each can be provided for traveling there and back.)
9.4. Hospitality may only be extended to persons who qualify as participants in
their own right, i.e. to healthcare professionals but not to their spouses and other
guests.
9.5. All forms of hospitality offered to healthcare professionals shall be
reasonable in level and strictly limited to the main purpose of the event. As a
general rule, the hospitality provided must not exceed what healthcare
professionals would normally be prepared to pay for themselves.
9.6. Hospitality shall not include sponsoring or organizing entertainment (e.g.,
sports or leisure) events. Companies should avoid using venues that are
renowned for their entertainment facilities.
9.7. Companies must comply with guidance in existing decrees concerning the
meaning of the term “reasonable” and “moderation”.

Article 10. - Gifts and inducements

10.1. No gift, pecuniary advantage or benefit in kind may be supplied, offered

or promised to a healthcare professional as an inducement to prescribe, supply,
sell or administer a medicinal product.

10.2. Where medicinal products are being promoted to healthcare professionals,

gifts, pecuniary advantages or benefits in kind may be supplied, offered or
promised to such persons only if they are inexpensive and relevant to the practice
of medicine or pharmacy.

10.3. Except where they carry all the information stipulated in 2.1, gifts may
bear no more than the name and the logo of the company and the name of the
medicinal product or its international non-proprietary name. Gifts for the
personal benefit of healthcare professionals (such as tickets to entertainment
events) should not be offered or provided.

10.4. Companies must comply with guidance in existing decrees concerning the
meaning of the term “inexpensive”.

10.5. When buying non prescription, non reimbursed medicines patients or

consumers should not directly or indirecty be offered gifts.

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 10.6. Prizes offered at prize draws at events or elsewhere must also belong to
the inexpensive category.

Article 11. - Sponsorship of healthcare professionals

11.1. Companies must comply with the criteria governing selection and
sponsorship of healthcare professionals to attend events as provided in, or in
connection with, any applicable decrees in order to avoid the impression of
applying unfair influences. Funding must not be offered to compensate merely
for the time spent by healthcare professionals in attending events. People
directly interested in sale must not be allowed to decide about awarding grants
of considerable value. The way of winning support is through open application.
Support that equally benefits all participants must be preferred.

Article 12. - Medicine samples

12.1. Medicine samples are regulated by the provisions of the Promotional

Decree and/or the relevant rules of GMP.

12.2. Companies must have adequate systems of control and accountability for
samples of medicinal products handled by their medical sales representatives.

Article 13. - Pharmaceutical company staff

Personal conditions relating to pharmaceutical presentation are regulated by the

provisions of the Promotional Decree.

13.1.

a) Each pharmaceutical company shall ensure that its sales representatives,

including personnel retained by way of contract with third parties and any
other company representatives who call on healthcare professionals,
pharmacies, hospitals or other healthcare facilities in connection with the
promotion of medicinal products (hereinafter: “medical sales
representatives”)
- are familiar with the applicable laws and regulations and the relevant
requirements of this Code and are adequately trained and have
sufficient scientific knowledge to be able to provide precise and
complete information about the medicinal products they promote.

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 - comply with the applicable laws and regulations and the relevant
requirements of this Code.

- approach their duties responsibly and ethically; and

b) Medical sales representatives must refrain from:

- subordinating truth to other criteria;
- disseminating information that is unfounded and based on non-
verifiable facts;
- participating in such undertaking or transaction which conflicts with
legal regulations and/or is unethical;
- employing any manipulative method or technique the purpose of
which is to create an unconscious motivation which is beyond the
control of the person concerned and which results in that such person
cannot be held responsible for any action taken under such influence.

c) Medical sales representatives shall abstain from giving unfounded, false or

misleading information about companies present on the Hungarian
pharmaceutical market, or impairing the reputation of such companies in any
other way.

d) Medical sales representatives must not use any inducement or subterfuge to

gain an interview with healthcare professionals. In an interview, or when
seeking an appointment for an interview, medical sales representatives must,
from the outset, take reasonable steps to ensure that they do not mislead as to
their identity or that of the company they represent.

13.2.
a) Every company must establish a scientific service in charge of information
about its medicinal products. This scientific service must include a doctor or,
where appropriate, a pharmacist who will be responsible for approving any
promotional material before release. Such person must certify that he or she
has examined the final form of the promotional material and that in his or her
belief it is in accordance with the requirements of the applicable legislation
and any applicable advertising laws and regulations, is consistent with the
summary of product characteristics and is a fair and truthful presentation of
the facts about the medicinal product.

b) Each company must appoint at least one senior employee who shall be
responsible for supervising the company and its subsidiaries to ensure that the
various requirements of the applicable legislation are complied with.

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 Article 14. - Collection and evaluation of data of therapies and treatment
programs involving medicines available on the market

Any therapy observation, commissioned by pharmaceutical manufacturers or

distributors, involving registered indications of medicinal products available on the
market and falling under the scope of this Code, i.e. recording, collection and
evaluation of data thereof (hereinafter "Non invasive procedures") may be pursued
provided that the following requirements are met:

a) Observation studies may only be carried out with scientific or educational

purpose.

b) Medical sales representatives directly involved in sale – in order to avoid

the impression of applying unfair influence – are not allowed to take part in
the organization, arrangement and evaluation of observation studies,
especially as regards the selection of the participants. Logistic chores such as
distribution and collection of data sheets may be an exemption;

c) Therapy observations may only be performed on the basis of a document,

prepared prior to the commencement of therapy and which must contain the
name and workplace of the manager responsible for the observation of therapy
and those responsible for monitoring;

d) A written agreement with the physicians and/or institutes performing

therapy observation must be concluded prior to the commencement of the
activity, in which the objective of therapy observation, the special criteria
thereof and the method of remuneration must be specified.;

e) All expenses related to therapy observation may only be paid in the form of
a bank transfer;

f) During therapy observation increased attention must be paid to compliance

with Act XLVII of 1997 on the management and protection of health and
related personal data and the decree implementing this Act.;

g) On completion of a therapy observation a written summary must be

prepared on its evaluation, irrespective of whether or not the results are going
to be published in a professional paper or in any other way;

h) Clients must preserve the therapy observation documentation and the

summary containing the evaluation for a period of five (5) years;

i) By handing it over the documentation the registration authority should be

notified of the therapy observation prior to its commencement and must be
kept posted on all severe, undesirable events that occurred during the therapy
observation.

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Article 15. - Procedural rules

MAGYOSZ and AIPM, in an attempt to determine cases of breach of the present

Code, laws and decrees comprising its legal framework, to define the rules of
procedures to deal with such cases and to publish statements promoting enforcement
of the Code decided to establish the MAGYOSZ-AIPM Communication Ethics
Committee (hereinafter: KEB) and define its bylaws with that the complaints and
disputes of ethical nature shall be judged on the basis of the KEB bylaws pursuant to
the provisions of this Code. KEB shall make public its decisions. MAGYOSZ and
AIPM shall ensure appropriate information to their member companies on the
positions issued by KEB.

If a conduct violates the provisions of Act LVIII of 1997 on business advertising

activity as amended by Act I. of 2001, Act LVII of 1996 on unfair and restrictive
market practices and Act XXV of 1998 governing medicinal products for human use
as well as the decree of the Minister of Health, Social and Family Affairs No. 64/2003
(X.31.) governing advertising and presentation of medicinal products and
preparations with therapeutic effect not qualified as medicines, any action initiated or
conducted under this Code shall not impair or limit the institution of a proceeding
before the advertising control authority, competition control authority or at a court of
law.

Article 16. - Bylaws of the Communication Ethics Committee

16.1. Composition of KEB and election of its members

KEB shall have eight (8) members; MAGYOSZ and AIPM shall delegate four (4)
members each.

Members delegated to KEB shall be elected at the respective annual meetings of

MAGYOSZ and AIPM.
The President of the Board of MAGYOSZ and the Chairperson of the Executive
Committee of AIPM shall send the list of elected members to each other in
writing, within eight (8) days of their election at the latest. MAGYOSZ and AIPM
shall have the right to recall their elected members in accordance with their
respective procedural rules, however, a new member must be immediately
delegated to replace the recalled member. This rule shall apply to cases of
termination of membership in KEB for any other reason.

The term of membership in KEB shall be for one (1) calendar year from the date

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of election. The General Assembly of MAGYOSZ and AIPM respectively may
extend the term of some members for an additional period of one (1) more year.
The mandate of a KEB member can be extended four times.
At the inaugurating meeting the KEB members shall elect a Chairman from
among themselves. The person of chairman shall alternate yearly between
MAGYOSZ and AIPM delegates.
The Chairman shall

convene and chair the meetings of KEB,

put the resolutions of KEB in writing, and send them to the interested
parties,

oversee the implementation of the resolutions and

represent KEB.
An assigned official of either MAGYOSZ or AIPM, depending on the Chairman’s
affiliation, shall assist the Chairman in the operation of KEB and the related
administrative duties, including the provision of an independent legal expert if
needed.
A KEB member employed by a party interested in a case heard by KEB - be it the
complainant or the one complained againt - may not participate in the settlement
of the given case. The concerned member can not be present when the case is
being heard. Hearing shall mean participation in the proceeding, decision-making
and appeal. In the event the Chairman is an employee of a party having an
interest in the given matter, the KEB members shall elect an acting chairman
from among themselves to conduct the case.

16.2. Meetings and procedures of KEB

KEB shall initiate a proceeding upon request – notice - or may initiate a

proceeding ex officio regarding issues that it had come to know of on its own.
A notice may be submitted by any natural or legal person noticing a conduct that
violates the provisions of this Code.
If any signatory to this Ethical Code wishes to submit a notice, the Parties shall
first have to attempt to resolve their dispute amicably. If a mutually acceptable
solution cannot be reached within ten (10) days, a formal notice may be lodged
with KEB.
KEB shall pay increased attention to whether the parties attempted to resolve their
disputes between themselves, and in doing so shall investigate ex officio, before
the outset of the proceeding, if such reconciliation took place. If not, it shall call
the parties to resort to such a reconciliation.
KEB shall send the notice it received, irrespective of whether or not the
complainant had done so, to the demurred party calling it to present its views on

15
the matter within ten (10) days. KEB may only set to discuss the case after the
deadline has expired.
If the concerned parties mutually declare in writing to KEB that they had failed to
come to terms with each other KEB may dispense with sending the notice.
If KEB, on noticing breach of this Code, initiates a proceeding ex officio, it shall
notify the party (parties) of the illegal conduct. From this point the ex officio
proceeding shall take the same course as the proceeding started on notice.
KEB shall be entitled to decide, in its discretion, whether to initiate a proceeding
on the merits of the notice received. If KEB decides not to initiate a proceeding, it
shall inform the applicant in writing within thirty (30) days from the date of
submission of the notice.
A resolution rejecting initiation of a proceeding may be appealed within fifteen
(15) days from the date of receipt of the resolution at the Board of of MAGYOSZ
or the Executive Committee of AIPM.
In the event when the Board of MAGYOSZ or the Executive Committee of AIPM
finds that the appeal was well founded, it shall inform KEB thereof and advise it
to initiate a proceeding within fifteen (15) days from the date of receipt of notice
to this effect.
No appeal may be lodged against KEB’s refusal to start an action in those cases
when KEB transfered the matter, on suspicion of violation of existing legal
regulations, for investigation by a supervisory authority as specified in legislation.

Applications submitted to KEB must contain all data and evidence necessary for
the evaluation of the case. If an application does not contain sufficient
information, KEB shall return it to the applicant once to have the missing
information furnished by the deadline given in the letter. In such case, deadline
shall count from the date of receipt of the missing information.
No action may be initiated if one (1) year has elapsed from the date when the
violation of this Code was committed.
The Chairman shall convene the KEB meetings in writing. The meetings can only
discuss those matters for which the relevant documentation has been sent to the
members at least ten (10) workdays before the meeting.
Information relating to KEB actions and documents generated during meetings
must be treated confidential until final decision is made.
A meeting of KEB is a quorum if at least three (3) MAGYOSZ delegates and
three (3) AIPM delegates are present. The KEB meetings are closed and should
only be atttended by the members as well as the invited persons and independent
experts. KEB shall pass its resolutions with a simple majority of votes. In the
event of a tie vote, the vote of the Chairman shall be decisive.
If a properly convened KEB meeting is not a quorum for poor attendance the
Chairman shall convene a new meeting within five (5) days. Such a repeated KEB

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meeting shall be a quorum if at least four (4) KEB members (including two (2)
MAGYOSZ and two (2) AIPM delegates) are present.
KEB shall enter its resolutions within sixty (60) days from the date of receipt of a
notice. This deadline may be extended once by the chairman for another thirty
(30) days.
During its proceedings, KEB shall hear the interested parties and the independent
experts, examine the documents and other materials necessary for deciding the
case and, if needed, make copies and extracts from the relevant documents. Since
KEB is an arbitration body acting in the interest of self regulation it may only be
in touch with the representative of the given member company involved in the
case in question. KEB shall refrain from using the services of legal attorneys in
the proceedings and shall advise the same to the affected parties. Failure of the
parties to appear on hearings shall not impede KEB’s ability in reaching a
decision.
The parties shall have the right to reach a compromise in the given case at any
time prior to the resolution of KEB and to ask the chairman to stop the proceeding
by sending him a copy of the written deal. In such case the given matter will not
be published in the half yearly KEB report.

16.3. Resolutions of KEB

KEB shall pass its resolution after the examination of all relevant circumstances
of the case and will send the resolution to the parties involved within fiften (15)
days from the date of adoption thereof, via registered mail with return receipt
requested, or by hand delivery.

In its written resolution KEB:

establishes that no ethical violation has occurred

establishes that ethical violation has occurred

At the same time:

a) it shall urge the party committing the breach to cease the illegal conduct and
shall seek a written report from it that the contents of the resolution have been
implemented;

b) as well as the application of paragraph a) it shall warn the committer of the

breach in writing.

c) in addition to applying paragraphs a) and b) it shall inform - half yearly - the

official journals of the Hungarian Chamber of Doctors and the Hungarian
Chamber of Pharmacists requesting publication of the text issued by KEB;

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d) in case of grave ethical violation committed by members of MAGYOSZ or
AIPM KEB may propose the general assembly through the Board of
MAGYOSZ or the executive Committee of AIPM, to
- suspend membership with temporary nature (for 1-3 year ); or
- terminate membership by expulsion.
Even when applying the sanctions as set forth in point d) KEB shall have the right
to advise the professional press.

16.4. Appeal against the resolutions of KEB

A review of a KEB resolution may be initiated within fifteen (15) days from the
date of receipt of the resolution by an application submittted both to the Board of
MAGYOSZ and the Executive Committee of AIPM. The Board of MAGYOSZ
and the Executive Committee of AIPM shall confer on the matter and issue a joint
decision on the review application within thirty (30) days from the date of receipt
thereof. The resolution containing the decision shall be sent to the interested
parties via registered mail with return receipt requested, or by hand delivery. The
resolution passed by the Board of MAGYOSZ and the Executive Committee of
AIPM shall be final. The resolution may be published in the professional press.
A member whose membership has been terminated may file a case against the
final resolution of KEB with the competent court within thirty (30) days from the
date of receipt of the final resolution.

16.4. Positions issued by KEB

Issuance of a position from KEB may be initiated by:

at least two members of KEB;

the chairman of KEB;

The Board of MAGYOSZ and /or the Executive Committee of AIPM
A position may be issued and its entire text approved if two-third of the KEB
members taking part at the meeting vote in favor of it.
The Chairman of KEB shall make sure that the text of such positions is published
in the official journal of the Hungarian Chamber of Doctors and the Hungarian
Chamber of Pharmacists respectively.

In matters initiated after 30 days from the date of publication of a position the
KEB shall take into account the contents of the position.

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Article 17. - Rules facilitating enforcement of this Code, closing provisions

17.1. Rules facilitating enforcement

Control over the observance of the provisions of this Code shall be the
responsibility of the Board of MAGYOSZ, the Executive Committee of AIPM
and the KEB. Members of MAGYOSZ or AIPM that breach the provisions of
this Code can be sanctioned according to the rules set forth herein.

Those that violate the provisions of this Code will be required to enforce the
resolutions passed by KEB whereby they will have to immediately discontinue the
illegal conduct and possibly destroy, at their own expense, all materials that relate
to the violation and send a notice to KEB thereof, and undergo the sanctions as
imposed by KEB.

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