CODE OF CONDUCT OFPHARMACEUTICAL PRACTICES

IN INDONESIA

Ratifedin the Munas XII / 2003 in Bali

on 30 May 2003

CODE OF CONDUCT OF PHARMACEUTICALMARKETING PRACTICES OF ETHICAL

PRODUCTS IN INDONESIA

CENTRAL BOARDINDONESIAN PHARMACEUTICAL ASSOCIATION(GP. FARMASI - INDONESIA)

Jakarta, 17 August 2003No : 0USK/MPKE/GPFI12003Re : Code of Ethics

To:- Management of Pharmaceutical Industry- Management of PBF- Management of Apotek- Management of Toko Obat

Dear Sirs,

As we are all aware of, the Revision of Code ofPharmaceutical Marketing Practices in Indonesia, whichis an improvement version of the previous Code of Ethics,has been ratified the Munas XII/2003 in Bali on 30 May2003. The decision to improve the Code is a long awaitedone and this Code is expected to boost the performanceand improve the image of the pharmaceutical industry inIndonesia.

In implementing the Code, it will certainly need some timeto go through the stages of technical preparation and itssocialization. This will also give the members enough timeto carefully study and thus achieve a better understandingof the Code. Therefore, the Ethics Council and the CentralBoard of GP Farmasi Indonesi4 after careful considerations,have decided and hereby announce that this new Codewill become effective as of Janu ary 1,2004.

Thanking you for your

Yours sincerely,GP Farmasi IndonesiaCentral Board

kind attention, we remain.

Code of Ethics Council

Anthony Ch Sunarjo, MBAChairman

wDorodjatun Sanusi

Chairman

CODE OF CONDUCTOF PHARMACEUTICAL MARKETING

PRACTICES IN INDONESIA

TABLE OF CONTENTS

Preamble ............... 1

Chapter I THE OBIECTIVE ................ 1

Chapter II THE CODE OF CONDUCT ..............2

Article I Implementation of the Code .............2

Article 2 Information and Claims .....................3

Article 3 Medical Representatives .................. L0

Article 4 Symposia, Congresses and

Continuous Medical Education ...... L1

Article 5 Prize and Donation to Healtcare

Professionals ....... .............. 14

Article 6 Printed Promotional or

Advertising Materials ....................... 15

Article 7 Audio-visual and Electronics

Promotional Material ........................ 18

Article 8 Samples ............. 18

Article 9 Market Research ............... L8

Article 1,0 Communication with the Publicand Mass Media ............... 19

Chapter III STANDARD PROCEDURES FOR

SUBMISSION OF COMPLAINTS

RELATED TO CODE OF ETHICS ... 19

Chater IV CLOSING .........25

CODE OF CONDUCT OF PHARMACEUTICALMARKETING PRACTICES OF ETHICAL

PRODUCTS IN INDONESIA

PREAMBLEIt is with the blessing and mercy of the one and theonly God that having a good health is one of thebasic rights of each person. Realizing that protectingand imprroving public health is one of the essentialelements of the framework of the developmentprogram. By due observance that the pharmaceuticalindustry next to its main dtty as an enterprise carriesout a social function relevant to the interest of thebroad community and plays a great role in trying toachieve the development objectives, especially in thehealth sector, and motivated by a great and sincereintention, the Code of Pharmaceutical MarketingPractices of Indonesia was composed. This Code isone of the important elements in the endeavors oftrying to regulate, guide and develop a sound andresponsible pharmaceutical business, in line with thegreat tradition in the healthcare sector and thephilosophy of the Indonesian people, which isPancasila.

CHAPTER ITHE OBIECTIVE

The objective of this Code is to define the highstandards that must be abode by the industry in itsmarketing activities as well as to establish the processof self-discipline that best serves the public intereststoward an improved health level of the society andpromotes the rational use of drugs.

CHAPTER IITHE CODE OF CONDUCT

Article L

IMPLEMENTATION OF THE CODE

L. ScopeThe scope of this Code covers the marketingof pharmaceutical or biological productsintended for use in the diagnosis, treatmentor prevention of human diseases or influencingthe function and structure of the human body,which are used on the advice of or under thesupervision of a healthcare professional.

Promotional activities related with distribution(e.g. price lists, trade catalogues) and thepromotion of OTC (Green or Blue Dot)products, Infant Nutritional, In-VitroDiagnostic Tests, Surgical and Medical Devicesare not subject to this Code.

2. Application and ExecutionIn all matters related to the application,interpretation and execution of any p.art ofthis Code, it is to be understood that adherenceto the prevailing laws and regulations shouldcome first.

3. ResponsibilityFull adherence to this Code is a pre-requisitefor a membership in the GP Farmasi Indonesia.The President Director and other Boardmembers are responsible for the bestcompliance with this Code. Companies withlicensing or agency agreements in Indonesiashould require their licensees or agents toadhere to this Code.

Article 2INFORMATION AND CTAIMS

General CriteriaInformation and claims on pharmaceuticalproducts should be honest, objective, accutate

and should present a balance of the proofs.Information and claims should also be

presented meeting highly ethical standard,in conformity with the product informationlatest approved by Badan POM and in such a

way as not to be misleading or ambiguous-

Scientific EvidenceInformation provided should be based on the

latest evaluation data which are suPPorted byscientifically valid evidence, accurate, clear

and presented in a way that is not misleading.The scientific data should be referenced and

traceable. In-vitro and animal test data shouldbe clearly marked as such, in order not to givean incorrect or misleading impression.Thesecriteria are applicable for the product(s) being

promoted as well as for other products beingquoted for reference or comparative PurPoses'

Requests for InformationCompanies should handle requests forinformation from healthcare professionals withobjectivity and good intention by providingaccurate and relevant data. Responses torequests for data to support promotional claims

should be completed within a maximum of 3months from the date of the request.

1

2.

3.

4. Safety Data4.7 Information on the product safety, as well

as contraindications, warnings and sideeffects should conform with thoseapproved by Badan POM.

4.2 The word "safe" should not be usedwithout qualification or explanatorynotes.

4.3 All companies are obliged to report toBadan POM and/or related institutionson any unexpected and serious adversedrug reactions associated with theirproducts in accordance with theprevailing regulations.

5. Incorrect or Misleading Claims/DataInformatiory promotional claims, supportingdata, graphic or other visual presentations ofa product shall not be directly or indirectlymisleading by omission of certain parts ordistortion of evidence or expert opinion.Information should be based on scientificallyvalid evidence and in conformity with productinformation as approved by Badan POM.Some examples of what is not permissible andtherefore considered as violations of this Code:5.1 Quoting vague inferences from clinical

evidence or experience that can not bevalidated. Therefore, it is recommendedto quote resuits of specific, publishedstudies.

5.2 Using or quoting data from a study,which is not relevant to the claim(s) beingmade. Presenting data to support a claimwithout a reference to a published study.

Claims based on data that are no longer

applicable, e.g. data that have been

proven invalid or replaced by the results

of more recent research.

Dosage recommendations or claims for

an indication that do not conform withthe Badan POM aPProved Productinformation.Using In-Vitro data or data from animal

studies which are not clearly identifiedas such or which is presented in a way

that is misleading or implying that it isIn-Vivo and/or human data.

Presentations or layouts that lead to an

incorrect or misleaditg interpretation e.g.

important and relevant data but actually

not supporting the promotional claims,

relegated to fine print; manipulatingscales on graphs/charts etc to distortcomparisons with competitor's product.

Negative statements concernlngcompetitive products bearing no scientific

basis or are refutable based on current

evidence or having no relevance to the

product being promoted.Claims implying a product's efficacy for

a certain indication but ignoring the

warning or caution applicable to its use

in such circumstances.

5.3

5.4

5.6

5.5

5.7

5.8

6.

5.9 Claims utilizing evidences orquotations :

- Which are selectively presented tomisleadingly highlight advantages

- Which are presented or quotedbeyond or out of context

- Which are quoted or presented insuch away as to distort the meaningor objective of the author.

5.10 Non-medical or non-scientific claimswith no evidence.

5.11 Unqualified superlative claims orhanging comparatives - (see Paragraph6 below)

5.72 Comparisons with competitive productsthat are not based on scientifically validevidence or which distort the evidenceor which are not objective and reasonable(see Paragraph 7 below).

Unqualified Superlative and HangingComparative Claim

6.7 Making unqualified superlative claimsare not allowed, e.g.- "Product X is the best treatment for

condition Y"- "Product X is the fastest treatment

for condition Y|'- "Product X is the strongest/most

powerful treatment for condition Y"- "Ptoduct X is the safest treatment

for condition Y"

If these or other superlatives are to be

used, then the claims must be provablesupported by scientifically valid evidence.

6.2 Hanging comparative claims should notbe made, e.g. "Product X is better/stronger/ faster/safer for condition y" Acomparative claim must include a

statement that indicates against what the

product is better/stronger/ faster/saferetc and that this superiority is supportedby current scientifically valid evidence(for more explanations see point Tbelow).

Comparisons7.7 Comparisons between products should

be honest, based on facts proven bY

scientific evidence. In presenting theresults there should be no attempt todeceive by distortion, unreasonableemphasis or other means. Comparisonsin bad taste or insulting to thecompetitors' or their Products should be

avoided.7.2 Comparisons on efficacy and safety

should not be based on data that does

not reflect the current published literatureor that come from different database notcomparing the same thing.

7.3 Comparisons on efficacy and safetyshould consider all aspects of efficacyand safety. trf a comparison is made based

on one parameter only, then this shouldbe clearly stated.

8.

9.

7.4 Dataused to support comparative claimsshould satisfy the requirements ofstatistical significance. If the data do notmeet these conditions, then they shouldbe clearly marked as such and shouldnot be used to generalize or to supportclaims indicating equality or superiorityagainst another product. The statisticalsignificance indicator (i.e. the "P" value)should accompany the cclmparative data.

Imitating or Copying Other Companies'Materials

A company should not deliberately imitate orcopy other company's marketing/promotional/advertising materials, which might lead tomisleading or confusion.

Healthcare Professionals in PromotionalMaterials

Names or photographs of healthcareprofessionals or institutions should not beused in the promotional/advertising materialsin a way that violates the medical code ofethics. It is, however, acceptable to use thenames and photographs in proceedings ofscientific meetings (e.g. where a healthcareprofessional makes a presentation) but it isnot allowed to do so inpromotionalbrochures,journal advertisements and the like.

Hidden Promotion/Advertising10.1 Promotional materials such as

mailings and medical journaladvertisements should be clearlymarked as such so that its real nafure isnot disguised e.g. advertisement injournal which is part of theeditorial should be marked"PROMOTIONAL ADVERTISEMENT'or "ADVERTORIAL " in capitalletters of the largest

pitch used in the bodY text of theadvertisement.

10.2 All Clinical Trials should beconducted in accordance with theGood Clinical Practice (GCP) guidelines.Post-Marketing studies should not be

conducted merely as a means to promotea product or to influence healthcareprofessionals with little or no scientificbasis.

Pre-Registration CommunicationsA product shall not be promoted until theprerequisite license to market has beengranted by Badan POM.

This provision, however, is not meant tolimit the rights of the scientific communityand the general public to gain completeinformation on advances in the scientific andmedical fields, provided that the results ofthe research have been acknowledgedinternationally. It is also not meant to limitthe full and proper exchange of scientificinformation on a product, including thedissemination of research findings in thescientific or general communications mediaor through scientific congresses. Likewise,this provision should also not limitdisclosure to the shareholders and otherparties related with the product as may be

required by law or regulation. In the eventan intemational or regional conference is beingheld in Indonesia, research findingson a product not yet aPProved for theIndonesian market by BPOM are allowed tobe communicated therein provided that thisis conducted in a ProPer and responsiblemanner and in accordance with Article 2 ofthis Code. It should also be clearly stated

lt.

L0

that the product is not yet registered byBadan POM in Indonesia.

1,2. Company ProceduresI2.I All promotional communications should

undergo a medical clearance process(i.e. approved by u medically qualifiedperson) or, where appropriate, approvedby the person-in-charge before beingreleased.

I2.2 Companies should establish and maintainappropriate procedures to ensure fullcompliance with this Code and to reviewand monitor all existing promotionalactivities and materials.

Article 3

MEDICAL REPRE SENTATIVES

1. The company is fully responsible for the qualityand conduct of their medical representatives.

2. Medical representatives must have appropriateeducational background and the company isresponsible for providing the required technicaltraining concerning their obligations. MedicalRepresentative should preferably be accredited,the system of accreditation might be ruled by GPFarmasi in cooperation with other professionalor ganrzalion and related govemment instifu tion.

3. Medical representatives should be able to givetechnical explanations on their company'sproducts in a balanced, accurate and in an ethicalmanner to the members of the healthcareprofessionals' or ganization.

4. Medical representatives should be prohibited togive or offer rewards to the members of healthcareprofessions other than as specified in the point5 below.

5. Medical representatives in doing their dutiesshould show good conducts when visiting themembers of healthcare professions.

6. The ruling on Medical rePresentative should be

adjusted from time to time in order to be incompliance with the prevailing regulations/lawsissued by the relevant government institutiongoverning the manufacturers and distributors(PBF) as well or other similar companies.

Article 4SYMPOSIA, CONGRESSES & CONTINUOUS

MEDICAL EDUCATION

1" Understandings and ObjectivesSymposia, congresses, Continuous MedicalEducation (CME) and the like are essential forthe dissemination of science and experience.Scientific objectives should be the prime focusin arranging such meetings.

2. Symposia & Congresses2.7 The participation of a company or an

association in a symPosium, congressor the like should be declared clearlyduring the meeting and in any printedproceedings f rom the meeting.Printed, audio-visual or electronicmaterials from the meeting shouldaccurately reflect the presentationsand discussions of the event.

2.2 If the meeting Program is accreditedfor post graduate education bY a

medical association or otherhealthcare professional or ganrzation,the responsibility for the program

content remains with that organization.A^y support from the pharmaceuticalindustry should be sufficiently stated ordisclosed.

2.3 Companies are prohibited from offeringany kind of induction, giftlappreciation,incentive, donatiory financial reward andother form whatsoever to the medicalprofession.

3. Sponsoring Healthcare Professionals3.1 Any support provided to an individual

healthcare professional to attend a

scientific meeting should not be madeconditional upon any obligation topromote or Prescribe certain product.

3.2 Companies shall keep individualsponsorship within reasonable level e.g.

payment for the registration fee,accommodation and meals,transportation to and from the event.

3.3 It is not allowed for companies to pay forany expenses of accomPanying person/s,

be it the spouse or family member of theinvited medical particiPant.

3.4 It is prohibited to give honorarium orcompensation to a healthcareprofessional for attending a scientificmeeting. (Honorarium is howeverpermitted for speakers/moderators ata meeting - see Article 3.5 below).

3.5 Speaker/Moderator HonorariumPayment for reasonable honorariumand out-of-Pocket exPenses,

including travel exPenses for speaker/moderator are customary and proPer.The amount of the honorarium for local

speaker/moderator at a local meetingshould not be more than USD 300 or IDRequivalent. The honorarium for localspeaker at overseas meeting should be

adjusted to conform with the normalpractice in the country where the meeting

is held. The honorarium for foreignspeaker at local meeting should be fixedat the usual rate of the speaket's homecountry.

Exhibition & Hospitality Stalls/Counters4.I Exhibition booth, hospitality room, and

the like should be secondary to and notdetract from - the scientific objectives ofthe event.

4.2 Exhibitions are to be organized solely forthe benefit of medical profession. The

name of the comPany/exhibitor shouldbe clearly visible and the exhibition itselfshould meet the terms as set bY theorganizing committee.Distribution of product samples shouldrefer to the applicable regulation as

stipulated by Badan POM.Other activities such as games, raffles,and the like should not be held at times

when the scientific sessions are inprogress so as to avoid disturbing ordistracting participants from the primeobjectives of the meeting.

4.

4.3

4.4

5. Miscellaneous Pro grams5.1 Companies should not hold hospitalir.

programs such as tours, social eventscontests, sports, games or the like irsuch a manner that will disturb ordistract participants from the officia.program of the event.

5.2 Companies are permitted to invitehealthcare professionals to dining orcocktail events. Such events should bereasonable and modest rather thanlavish.

5.3 Companies should not deliberatell'interfere or attempt to undermine a

single company sponsored scientificevent (e.9. a meeting which is not apartof national, regional or internationalcongress).

Article 5

PRIZE AND DONATION TOHEATTHCARE PROFE S SIONALS

General PrinciplesNo gifts/rewards, incentives, donations,financial, and the like shall be offered tohealthcare professionals in return forprescriptions or recommendations for thecornpany's medicine(s)/product(s).

Gifts2.1, Cifts are permissible only if granted t<t

institution, and are strictly prohibited tobe given directly to healthcareprofessional.

l l The gifts should entail a benefit for the

patients and/or the work or education ofthe healthcare professionals in thatinstitution.

1.3 No gifts shall be given in return forproducts purchased or inclusion in theproducts standard rzatrort, prescriptionsor use of a company's product(s) at thatinstitution.

Donations3.1 Donations are permissible only if granted

to institutioru and are strictly prohibitedto be given directlY to healthcareprofessional.

3.2 The donations should entail a benefit forthe patients and/or the work or educationof the healthcare professionals in thatinstitution.

3.3 No donations shall be given in retum forproducts purchased or inclusion in theproducts standard rzafion, prescriptionsor use of a company's product(s) at thatinstitution.

Article 6PRINTED PROMOTIONAL ORADVERTISING MATERIALS

GeneralThis section takes care of printed promotionalor advertising material of each ethical productintended for the healthcare professional.Printed promotional or advertising materialshould be presented in a legible manner. The

scientific basis and presentation of theinformation on a product should con{orm withthe principles as described in Article 2 of thisCode and should conform with the productinformation as approved by Badan POM.

1.

1.

2.

2. Full/Complete Printed Promotional Material orAdvertisements

Since the objective is to provide the healthcareprofessionals with adequate information tomake a rational decision on the prescriptionor use of a product, the information providedmust include, clearly and concisely, thefollowing:- Product name (Brand/Trade Name)- Ceneric name of active ingredient(s) or

INN (hrternational Non-proprietary Name)- Name and address of the marketing

company- Approved indications foruse of the product

(Minimum of 1 indication)- Dosage, method of use/recommended

application- A brief statement on side effects, clinically

important cautions and warnings, contra-indications and major interactions at therecommended dosage.

- A statement that further information isavailable upon request.

Brief ("Remin der" I Promotion/AdvertisementIn short promotional materials andadvertisements which provide only a simplestatement on the indications to denote therelevant therapeutic category and why theproduct is recommended for that indicatiorythe following minimum information shouldbe stated:- Product name (Brand/Trade Name)- Ceneric name of active ingredient(s) or

INN (Intemational Non-proprietary Name)- Name and address of the marketing

company.

Brand Reminders/'Gimmicks'Promotional give-away items/gimmicks

distributed to healthcare professionals shouldbe related to their work and should be ofreasonable value (maximum USD20 or IDRequivalent). On small items with little spacefor printing and where no promotionalmessage or scientific information is presented,it is acceptable for just the Brand or Companyname/logo to appear.

References5.1 Promotional materials containing

information from published studiesshould include clear and traceablereferences to those sfudies.

5.2 The use of reprints, abstracts andquotations should be compliant with thecopyright conditions of such material.

5.3 Quotations or opinions from medicalliterature or from personalcommunications must not be modifiedor distorted so as to mislead or confuseor alter the intended meaning of theauthor.

Mailings6.1 Promotional materials should only be

sent to appropriate individualsconsidered to have a professional interestin the information being supplied.

6.2 The frequency and volume ofpromotional mailings to healthcareprofessionals should be reasonable.Requests from healthcare professionalsto be removed from the mailing lists forpromotional materials must be respected.However, companies must maintain a

complete list for other importantinformation such as contra-indications,adverse reactions, warnings etc.

6.3.

Article 7AUDIO,VISUAL AND ELECTRONIC

PROMOTIONAL MATERIAL

Promotional information for the healthcareprofessionals using these media should comply withthe requirements relevant to printed materials as

described in Article 6.

Product information may be omitted provided thefull product information is available on request frominterested parties.

Article 8SAMPLES

In accordance with Ministry of Hea.lth Decree No.437/MEN.KES/SK lVll7g87 of 11th ;.r.r"].987,providing free samples of pharmaceutical productsto the medical profession is prohibited. Flence,companies are not allowed to send samples to thehealthcare professionals, except in the case ofspecifically approved by the respective authority.

Article 9

MARKET RESEARCH

Market research should not employ methods that inany way might discredit, or reduce public trust inthe pharmaceutical industry. This requirement isapplicable in any case, whether the research is beingconducted by the marketing company or otherorganization acting on its behalf.

Devious or coercive methods to influence respondentsare prohibited. Fees for research respondent shouldbe lowest possible and in proportion with the workinvolved. (maximum USD 50 or IDR equivalent perrespondent per project)

Article L0

COMMUNICATION WITH THE PUBLICAND MASS MEDIA

Unless stipulated otherwise by BPOM or relatedinstitution, ethical products may only be promotedand advertised to the healthcare professionals andshall not be advertised to the general public.Companies should not place articles or advertorialsin the mass media to promote a prescriptionmedicine or for the purpose of encouraging thegeneral public to request a certain product throughtheir physician.

CHAPTER IIISTANDARD PROCEDURES FOR

SUBMISSION OF COMPLAINTS RELATEDTO CODE OF ETHICS

1. Complaints1.1. The Council of Code of Ethics ('Ethics

Committee') receives and investigates an

official complaint against a person andJor a

legal body/pharmaceutical company, whichis alleged to be in breach of the Code of Ethics

of Marketing.I.2. On its own initiative, the Ethics Committee

may conduct activities to gather informationand/or facts and then to discuss it in the Ethics

Committee meeting in the case of a strongindication of violation of the Code by one

pharmaceutical company or in cooperationwith other partylies. After further investigation

and due deliberation, the Committee has to

decide whether there is a breach of the

Code or not.

)

3.

1.3. Complaints may be submiffed by:1.3.1. Pharmaceutical companies being

members of GP Farmasi Indonesia

L3.2. Official of Badan POM or relatedinstitutions

1.3.3. Board of Advisory, Chairman and

Head of Divisions of GP FarmasiIndonesia

1.3.4. Central Board of Medical Profession

Organization1"3.5. Foundation of Consumers Protection

Indonesia.

InvestigationThe investigation on any submitted complaint willbe conducted by the Ethics Commiffee.

Standard Procedures for Submission of Complaints3.1 The complainant should file an official

complaint in writing stating the identify ofthe company or the represented institution,addressing it to the Ethics Committee and

also providing copies of all necessarydocuments for the consideration of the Ethics

Committee. The letter of complaint shouldbe addressed as follows:

The Chairman of Code of Ethics Councilc/o Secretariat of GP Farmasi IndonesiaJl. Angkasa No. 20A Kemayoran JakartaPusat, 10620 INDONESIA Telp (021)4203040,Fax (021) 4203047 I 48.

The letter of complaint should include the

tbllowing points for the members of the

committee to review:

a. Effort for SettlementF{as there been any atternpt for a

direct settlement prior to referral toGP Farrnasi hrdonesia. Any effort toapproach the company, whichallegedly is in breach of the Codeand the outcome of these efforts,have to be stated in the tretter ofcompiaint.

b. The violating companyFor each compiaint case, the identifvof the possibiy offending company/and the narne of each prodtlct(s) imarketing activities specificallvreXated to the case should be

rnentioned.c. Reference Material

The original sampie coPy being thesubject of the grievance (the"violated article of the Code").

d. Date and Place of the cnse

The exact date and venue wherefromthe actual offending item wasretrieved as evidence, for exampie:Poster in the waiting room ofClinic A.

e. Presentation of Alleged Breach ofCodeA summ ary of how and why theCode was violated, with a sPecificreference to the chapter, article andother relevant information.

Upon receipt of the compiaint, theSecretariat of GP Farmasi shall checkwhether or not the complaint containsthe required data and relevantdocumentation as mentioned above forthe Ethics Committee to act upon.

@

If the submission is incomplete, thecomplaining party will be informedaccordingly to make a resubmission withthe necessary documentation. The casewill only be processed by the Code ofEthics Council of GP Farmasi Indonesiaafter completion of the requireddocuments. Submitted complaints whichare complete and proper will beimmediately distributed underconfidential cover to all Ethics Comrnitteemembers for their review. To expediteprompt handling of the complaints, theSecretariat of GP Farmasi Indonesia willconcurrently write thereof to thecompany/industry, which allegedly is inbreach of the Code. A photocopy of theletter of complaint with the identity ofthe complainant's name and companybeing concealed/deleted will be extendedto the offending company. The violatingcompany will be given a period of 10(ten)working days to respond in writing tothe allegations.

If necessary, this can be extended up tomax. 3 times. If requested, the violatingcompany must provide the relevantscientific documentation to substantiateits scientific claims. The response fromthe offending company with sufficientcopies of the corresponding supportingdocuments will then be distributed bythe Secretariat of GP Farmasi Indonesiato all members of the Code of EthicsCouncil for evaluation. If a summon isnot respected, the Ethics Committee

{nay proreed tq.r process this issue furtherwithout any hearing w'ith ihe offeradingcCImpanv. fufeanwhitre, the HthicsL-crmnnittee shall ta-ble the compXaint ina meeting ai the eariiest p<lssibtie claLe.

{r"u that n"reeting, the Cornrn:i.ttee sha{lreviemr anc{ <iecicie -whether furfherinvestigation is warranted, or whetherfurther re{erences are required to tacilitatebetter rnter:pretaLion of the case. .[{ furtheropinion frocn rnedieal/l,egal experts is

regarCed. necessary anct paymertt isreq.u.ired for su.ch serviees, theeoneplainant witri be asnceetr for theiroeriiiingrress fo bear these costs and-**hether cr t"rot the Con-rmittee shoulctr

continue the case " Whenevernecessarv, the offerecXing corxlpanv shallbe obliged by the Comr:nittee tr-r giverebuttai to the aliegations. Aftersuffi.eienttrv investigating anCevaluating the facts as presenterJ tryboih sieles, the Cornmittee wili cast as;ecret ballot to rlecide if there is indeeda breach of the Code.

When after due consideration, theCornmittee concludes that there hasbeen a breach of the Code, theoffendin;i companv shall be requesteciio give an agreement in writing to stop-rrith irnmediate effect the activitvwhich is in breach of the Code, not tocommit a similar offence in the future,as well as to instifute corrective action.

The respective company shall respondto the decision of the Committee within14 (fourteen) days. In the event theoffending company is unwilling to givesuch an agreement, and/or the breach ofthe Code is perpetuated, the Committeemay decide to give sanctions such as toterminate the company from themembership or any other actions, suchas to file a notification to Badan POM orother authorities, an announcement tothe organizations of healthcareprofessionals for its further action, tonotify the offender's parent company orheadquarter, or to publish the issue inthe GP Farmasi Indonesia bulletin, ORtake all actions of the above mentioned.

In the case that it is established that therehas been no breach of the Code,a notification to this effect shall be madeby the Ethics Committee to such relevantparties as the Ethics Committee maydecide.

The Chairman of the Ethics Committeewill submit a report to the Chairman ofthe Central Board of GP FarmasiIndonesia on all cases finalized by theEthics Cornmittee. Such report whetherin writing or in verbal form will bedelivered with all details including thenames of the companies involved at asubsequent Board Meeting following thefinalization of a case. However, theminutes of the Board Meeting shall notreveal any confidential information northe names of the companies to ensurecomplete confidentiality.

4. ExceptionThe Ethics Committee will automaticallydiscontinue or be requested to discontinue allactivities in connection with acomplaintprocedure of a certain case, as soon as theBadan POM and Balai Besar/ Balai POM hasstarted conducting an investigation and/orexamination of the same case in accordancewith the Decreeof the Head of Badan POMNo. HK.00.05.3.02706 of 2002, conceming DrugPromotion or other related regulationsgoverning the above subject.

CHAPTER IVCLOSING

All members of GPFarmasi Indonesia should be wellversed in this Code of Conduct and all Board levelsof GPFI are instructed to pass this on to themanagement of all pharmaceutical companies undertheir jurisdiction.

As ratified in DenpasarDated 30 May 2003

Chairman(Presidium)

Tirto KusnadiChairman

(Pengda DKI Jaya)

Note

A.TiahionoVice Chairman

(Pengda Jawa Tengah)

t///r7-thru-M.Soleh Depati

Member(Pengda Sumsel)

Liansvah LokmansvahSecretary

(Pengda Kalsel)

Tb.Dede Sutardi BioelMember

(Pengda Banten)