review open access ethical pharmaceutical …...it analyzes legislative, regulatory, and code-based...

Francer et al Philosophy Ethics and Humanities in Medicine 2014 97httpwwwpeh-medcomcontent917

REVIEW Open Access

Ethical pharmaceutical promotion andcommunications worldwide codes and regulationsJeffrey Francer1 Jose Zamarriego Izquierdo2 Tamara Music3 Kirti Narsai4 Chrisoula Nikidis5 Heather Simmonds6

and Paul Woods7

Abstract

The international pharmaceutical industry has made significant efforts towards ensuring compliant and ethicalcommunication and interaction with physicians and patients This article presents the current status of theworldwide governance of communication practices by pharmaceutical companies concentrating onprescription-only medicines It analyzes legislative regulatory and code-based compliance control mechanismsand highlights significant developments including the 2006 and 2012 revisions of the International Federationof Pharmaceutical Manufacturers and Associations (IFPMA) Code of PracticeDevelopments in international controls largely built upon long-established rules relating to the quality of advertisingmaterial have contributed to clarifying the scope of acceptable company interactions with healthcare professionalsThis article aims to provide policy makers particularly in developing countries with an overview of the evolution ofmechanisms governing the communication practices such as the distribution of promotional or scientific material andinteractions with healthcare stakeholders relating to prescription-only medicines

Keywords Pharmaceutical industry Self-regulation Code compliance Promotion of medicines

IntroductionRational prescribing decisions should be enhanced bythe quality of interactions between healthcare providersand the companies that research and develop medicinesThe medicines that research-based companies produceand the scientific information they provide to physiciansare important components of quality healthcare for pa-tients With the ever increasing number of treatment op-tions available to patients healthcare providers need tobe kept up to date with the scientific advancements ofnew medicines Likewise providing patients with infor-mation relating to medicines may encourage healthcareproviders to explore various treatment options in orderto best match patient needs It is important thereforethat the information provided by companies is scientific-ally accurate and fair Interactions between pharmaceut-ical companies and healthcare professionals should alwaysbe appropriate and support good patient care With theaim of further supporting these important goals the globalpharmaceutical industry has made significant changes in

Correspondence pwcompliancebtinternetcom7Paul Woods Compliance Ltd Macclesfield UKFull list of author information is available at the end of the article

copy 2014 Francer et al licensee BioMed CentralCommons Attribution License (httpcreativecreproduction in any medium provided the or

recent years in the worldwide controls on companiesrsquointeractions with healthcare professionals This reviewexplores the mechanisms for ensuring the quality ofmaterial supplied by international pharmaceutical man-ufacturers including product advertising and educa-tional communicationsInformation is often categorized as ldquopromotionalrdquo ldquonon-

promotionalrdquo or ldquoscientificrdquo although the distinction be-tween what is ldquopromotionalrdquo and ldquonon-promotionalrdquo maynot always be clear Promotional information as someregulators and codes have defined encompasses advertis-ing and sales material related to particular products andmay be distributed to patients through advertising cam-paigns or to healthcare professionals by pharmaceuticalrepresentatives Non-promotional material usually focuseson the current state of understanding of certain diseasesand is not related to specific products Scientific informa-tion broadly includes the contributions of research anddevelopment (RampD) firms to the exchange of scientificinformation For example scientists from pharmaceuticalcompanies may present research data at scientific confer-ences or publish works in trade- and peer-reviewed jour-nals It is important to emphasize however that the

Ltd This is an Open Access article distributed under the terms of the Creativeommonsorglicensesby20) which permits unrestricted use distribution andiginal work is properly credited

Francer et al Philosophy Ethics and Humanities in Medicine 2014 97 Page 2 of 17httpwwwpeh-medcomcontent917

distinctions between and among these categories arguablymatters less to patient welfare than the truthfulness anddescription of the scientific basis of conclusions aboutmedicines It should also be noted that prescribers receiveinformation about medical products from a wide varietyof sources including clinical trial summaries posted bycompanies on government registries as well as the medicaland scientific literatureA range of quality control mechanisms are employed by

governments pharmaceutical companies and industry as-sociations to evaluate the acceptability of companiesrsquo pro-motional communications and interactions with healthprofessionals (Figure 1) There are systems to take actionwhen concerns are raised and various interest groups alsomonitor and comment publicly on companiesrsquo promo-tional activities [1]Over the past decade pharmaceutical advertising prac-

tices have changed significantly [2] Laws and regulationshave also increased during this period but in manycountries the research-based pharmaceutical industryhas implemented various mechanisms to self-regulatecommunication and promotional activities which en-compass but go beyond statutory legal requirements Forexample many pharmaceutical companies have substan-tially expanded compliance functions to ensure that inter-actions and communications with healthcare professionalsand patients are appropriate Many compliance depart-ments issue internal standards and operating proceduresthat guide employeesrsquo communications activity and em-ployees are trained on these internal requirements on a

Figure 1 Summary of different code and regulatory mechanisms app

regular basis The goal is to supply healthcare providerswith the threshold amount of information needed for in-formed treatment decisionsCompaniesrsquo standards and operating procedures relat-

ing to communications often go beyond the require-ments imposed by laws and regulations However nocompliance documentation can cover all possible situa-tions Corporate culture is a key aspect of successfulself-regulation When employees understand that com-munication activities are for the benefit and welfare ofpatients the rules governing these activities are put incontext Compliance departments can thus play a criticalrole in educating and shaping a companyrsquos values andcultureAnalyzing communication activities requires proper

identification of the parties involved Commentary oftenattributes isolated activities to the whole pharmaceuticalindustry It is critical to distinguish not only betweenresearch-based and generic-based companies but alsobetween different types of product (ie diagnostic kitsmedicines or medical devices) This paper focuses ex-clusively on the communication activities of research-based pharmaceutical companies in relation to medi-cines that are prescribed National and regional differ-ences in medical business and cultural attitudes shouldalso be acknowledgedCurrent mechanisms governing pharmaceutical com-

munications comprise industry codes of practice in-ternal company procedures laws and regulations andcountries have put in place different combinations of

lying to international pharmaceutical companies


governing mechanisms to reflect national circumstancesDepending on the domestic circumstances countriesmay adopt policies to address legislative gaps andorpromote self-regulatory mechanisms The mechanismsshould encompass all sectors of the pharmaceutical in-dustry including domestic manufacturers and genericsproducersThis paper will focus on the international code frame-

work and describe the cascade of code provisions intodetailed national codes in developed countries Severalnations with emerging markets (China India SouthAfrica etc) are developing control frameworks that re-flect and build on experience in Europe and elsewhereWe also highlight good practice models We hope thatthis comprehensive review of current codes and regula-tory controls will fill a gap in the literature in an areathat often generates debate and controversy We hopethat our review will inform the debate as well as provid-ing a sound basis for future legal and code developmentsworldwide

Analysis of the current situationControl systemsFour general categories of control systems govern thecommunications of pharmaceutical companies relatingto prescription products industry codes of practice in-ternal company standards laws and regulations (Table 1)The aim of each mechanism is to enable high standardswithout compromising effective communication frompharmaceutical companies which benefits healthcareproviders and their patients The effectiveness of a singlemechanism should not be determined in isolation Forinstance when industry stakeholders create and adhereto robust codes of practice regulatory frameworks maybe less prominent However in most instances strikinga balance among these four mechanisms is necessary toensure good quality communicationsEffective control mechanisms should apply to all inter-

acting parties pharmaceutical companies healthcareprofessionals government officials patient groups andothers Applying codes of practice laws and regulationsto all the parties involved provides additional safeguardsto discourage wrongdoing For example in Europe if aninappropriate payment or gift is given or offered by acompany or requested or accepted by a healthcare pro-fessional both parties could be penalized [3] Similarlaws exist in the United States [4]A significant high-level development occurred early in

2014 when the international bodies representing doctorspharmacists nurses patients and the pharmaceuticalindustry issued a lsquoConsensus Frameworkrsquo for ethicalcollaboration [5] Under the mantra lsquoput patients firstrsquo itsets out common elements for interactions between in-dustry and healthcare professionals Importantly it does

not supersede the partner organisationsrsquo tailored indi-vidual codes or guidelines but rather identifies sharedprinciples

Laws and regulationsLaws and regulations that apply to communications re-lating to prescription medicines operate at national andstate levels For instance European Union memberstates are required to apply a baseline set of laws but in-dividual countries may promulgate additional laws relat-ing to pharmaceutical communications [6] In additiongeneral business practice laws apply to pharmaceuticalcompanies as they do to all business sectors In recentyears anti-bribery and anti-corruption laws have signifi-cantly impacted pharmaceutical companiesrsquo interactionswith healthcare professionals For example the US For-eign Corrupt Practices Act [7] or the UK Bribery Act [8]can affect firmsrsquo activities beyond their respective do-mestic markets holding companies subject to such lawsaccountable for wrongdoings abroadMost countries have laws and regulations specific to

the advertising of medicines The European Union hasa comprehensive set of legal requirements coveringthe advertising of medicines [3] which are imple-mented on a national basis In the US labeling and ad-vertising of medicines is regulated under statute bythe US Food and Drug Administration [9] Similarlyin countries such as Canada [10] and Australia [11]specific regulations govern pharmaceutical advertis-ing However such regulations are found less consist-ently in emerging marketsThe practical goal of these laws and regulations is to

deter improper activities through enforcement measuresGenerally judicial enforcement can expose companies tosubstantial financial penalties or settlements acting as adeterrent to similar future activities However court ac-tion is often lengthy and expensive Depending on the cir-cumstances litigants may opt to settle disputes outside ofcourt thereby forgoing costs associated with litigationFurthermore limited data are available to compare the ef-fectiveness of judicial enforcement with self-regulatedadjudicationsLaws and regulations may also be enforced by govern-

ment regulatory bodies Some countries including the US[12] and UK [13] have dedicated regulatory enforcementunits These units can investigate possible violations andinitiate enforcement proceedings Some regulatory adjudi-cation can also be sought by third parties Often the regu-latory enforcement process is faster than judicial actionreducing costs associated with protracted court actionsEven so any enforcement mechanism requires significantinvestment and this may be one reason why regulatorybodies are often not as robust in developing countries asin developed jurisdictions

Table 1 Control systems for prescription medicine advertising

IFPMA affiliated industry codesof practice

Independent localindustry codes ofpractice

Professional bodiesrsquo codes ofpractice

Regulatory authorityactivities

Legal actions Company standards

Description National codes incorporate andexpand on the IFPMA Code

National codesdevelopedindependently

International or national medicalpharmacy and nursing bodieshave professional behaviorcodes Employers may also havecodes of conduct

Regulatory authorityinterprets and applies lawand regulations Caninclude pre-approval andpost-hoc enforcement

Possible breaches of laws andregulation pursued throughcourt action

Companies have codesof conduct andinternal complianceand auditorganizations toenforce them

Applicability International pharmaceuticalmember companies wherever theyoperate Includes local companiesin a few countries

Local companies thatbelong to thesponsoring tradeassociation or haveagreed to comply withthe Code

Applied nationally by theprofessional body

All sectors within thescope of the legislationApplied nationally

All sectors within the scope ofthe legislation Appliednationally

All countries where thecompany doesbusiness

Comment National codes are often detailedand are subject to national lawsand regulations Some countriesembrace code based actions morereadily than others

Variable in scope andapplication

Professional codes may includerequirements concerninginteractions with commercialorganizations

Some regulatoryauthorities are more activethan others

Actions may be brought bygovernment bodies orcompetitor companies Somecountries resort to legal actionmore readily than others

Internal standards areusually broader inscope than externalcodes and legislation

Franceret

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Medicine

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The consequences for violating laws or regulationsgoverning pharmaceutical product communications canvary greatly by country Some regulatory bodies haveadopted proactive measures such as mandatory pre-launch reviews [14] to facilitate compliant communica-tions of certain communications such as those on newlyapproved medicines In the event that regulatory investi-gation leads to adjudication settlements may sometimesbe reachedRelying solely on laws and regulations is a reactive ap-

proach to guiding proper communication activitiesNevertheless robust legal and regulatory mechanismsmay be especially useful in countries that do not haveother control mechanisms (ie codes of practice) Atthe same time it is important to point out that pharma-ceutical companies that are members of the Inter-national Federation of Pharmaceutical Manufacturersand Associations (IFPMA) apply national associationcodes of practice and the IFPMA Code of Practice [15]worldwide in every market in which they operate evenin the absence of legal or regulatory controls Thismeans that in some countries international pharmaceut-ical companies will be subject to codes and legislationwith cross-border reach whereas local companies maynot be routinely subject to any robust controls on theiradvertising and related activities

Industry codes of practiceA system of integrated international and national codesof practice on advertising prescription medicines appliesto many multinational companies (Table 2) Nationalcodes of practice usually operated by local industrytrade associations have been put in place in developedcountries and in many developing countries [14]Various pharmaceutical industry codes have existed forseveral decades however beginning in 2002 weobserved a shift in industry attitudes towards communi-cations activity prompting regular revisions to inter-national codes with all dependent national codes beingupdated and expanded at least as frequentlyIn 2002 the Pharmaceutical Research and Manufacturers

of America (PhRMA) substantially updated its nationalCode That revision required PhRMA member companiesto follow threshold guidelines relating to communicationactivities between pharmaceutical companies and health-care professionals in the United States [16] In order tosynchronize national efforts IFPMA revised its own codein 2006 [17] The IFPMA Code of Practice which was up-dated again in 2012 binds its members to adopt baselinecommunications standardsThe practical effect of the 2006 revisions to the

IFPMA Code was the creation of a multi-tiered self-regulatory scheme IFPMA members consisting of com-panies and national trade associations are required to

adopt the IFPMA Code Its reach is wide companiesthat are not direct IFPMA members may be bound tothe same threshold requirements because of their rela-tionship with IFPMA national associations Importantlythe IFPMA Code outlines minimum requirementsMembers are allowed and encouraged to promulgatenational or company codes that reflect IFPMA Code re-quirements national laws and regulations healthcare sys-tem needs and local corporate cultures In this mannerindividual companies may be subject to various communi-cation requirements through different sets of obligationsIndustry codes of practice are tiered National codes

must be consistent with the international IFPMA Codeof Practice In Europe national associations that aremembers of the European Federation of PharmaceuticalIndustries and Associations (EFPIA) must ensure thattheir codes are consistent with EFPIA Codes [18]National association codes in turn require membercompanies to follow complementary baseline standardsand procedures Because each level sets minimum re-quirements national codes are generally more detailedthan international codes Company standards are evenmore detailed often reflecting corporate cultures as wellas incorporating international and national codesTogether the different levels of codes and company

procedures with few exceptions include complaint-handling mechanisms whereby information may be sub-mitted to companies or associations to resolve allegedcode violations Since laws and regulations are mirroredin codes of practice a concern in some countries hasbeen that full transparency of code of practice rulingsmight lead to ldquodouble jeopardyrdquo (ie a second case con-cerning the same matter) which in turn might inhibitthe utility of the code adjudication process The effectiveoperation of codes of practice requires investment ofconsiderable financial and human resources by nationalassociations This typically involves the employment offull-time staff to administer the code and its implemen-tation In addition independent and industry personnelwho make up the adjudication panels devote largeamounts of time to adjudicate consistently on cases thatcan be highly complexIFPMA member companies and their agents must

comply directly with the IFPMA Code and applicablenational codes of member associations where such codesexist However the global network of IFPMA-affiliatedcodes of practice that apply to international pharmaceut-ical companies does not necessarily extend to other par-ticipants and organizations in the healthcare systemsuch as physicians domestic manufacturers and sup-pliers of generics and medical devices Pharmaceuticalcompanies are only covered by the same codes of prac-tice and standards if they are members of the localIFPMA-affiliated national association and thereby agree to

Table 2 Codes of practice governing pharmaceutical companies

Country(ies) IFPMA-affiliated responsible organization IFPMA-linked national codes (further information atwwwifpmaorg) Additional laws regulations codes andguidelines usually apply in each country In some casesthese codes also apply to companies andor sectors notaffiliated to IFPMA

Global

All countries (Applies to internationalpharmaceutical companiesrsquo activities incountries not listed below)

International Federation of PharmaceuticalManufacturers and Associations

IFPMA Code of Practice

Regional

Europe European Federation of PharmaceuticalIndustries and Associations

EFPIA Code on the Promotion of Prescription OnlyMedicines to and Interactions with Healthcare Professionals

EFPIA Code of Practice on Relationships between thePharmaceutical Industry and Patient Organizations

EFPIA Code on Disclosure of Transfers of Value fromPharmaceutical Companies to Healthcare Professionalsand Healthcare Organisations

Central America Federacioacuten Centroamericana de LaboratoriosFarmaceacuteuticos (FEDEFARMA)

Code of Good Practices for the Promotion of Medicines

National

Argentina Caacutemara Argentina de EspecialidadesMedicinales (CAEMe)

Coacutedigo de Eacutetica CAEMe

Australia Medicines Australia Medicines Australia Code of Conduct

Austria Association of the Austrian Pharmig code of conduct and code of procedure of theCOC committees of experts of the 1st and 2nd instance

Pharmaceutical Industry (PHARMIG)

Belarus AIPM AIPM Code of Marketing Practice in the Republic ofBelarus

Association of International PharmaceuticalManufacturers

Belgium Pharmabe Code of Deontology

Brazil Interfarma Coacutedigo de Conduta

Canada RxampD Code of Ethical Practices

Chile Caacutemara de la Industria Farmaceacuteutica de Chile(CIF)

Coacutedigo FIIM de buenas praacutecticas para la promocioacutende losmedicamentos

China RampD-based Pharmaceutical Association inChina (RDPAC)

Code of Pharmaceutical Marketing Practices

Colombia Asociacioacuten de Laboratorios Farmaceacuteuticos deInvestigacioacuten y Desarrollo (AFIDRO)

Coacutedigo de eacutetica

Czech Republic Asociace inovativniacuteho farmaceutickeacutehoprůmyslu (International Association ofPharmaceutical Industries)

Etickyacute Kodex

Denmark Laumlgemiddelindustriforeningen (LIF) Lifrsquos ethical rules for dialogue and negotiations withdecision-makers

Ecuador Industria Farmaceacuteutica de Investigacioacuten eInnovacioacuten (IFI)

Coacutedigo de Eacutetica IFI

Finland Pharma Industry Finland (PIF) PIF Code of Ethics

France Les entreprises du meacutedicament (LEEM) Dispositions Deacuteontologiques Professionnelles

Germany Verband Forschender Arzneimittelhersteller eV(VFA) (German Association of Research-BasedPharmaceutical Companies)

FSA Code of Conduct on the Collaboration withHealthcare Professionals

FSA Code of Conduct on the Collaboration with PatientOrganizations

Guatemala Fedefarma La Federacioacuten Centroamericana deLaboratorios Farmaceacuteuticos


Hungary MAGYOSZ Hungarian PharmaceuticalManufacturers Association

Code of Ethics for Pharmaceutical Communication


Table 2 Codes of practice governing pharmaceutical companies (Continued)

India Organisation of Pharmaceutical Producers ofIndia (OPPI)

OPPI Code of Pharmaceutical Marketing Practices

Hong Kong Hong Kong Association of the PharmaceuticalIndustry (HKAPI)

Code of pharmaceutical marketing practices

Indonesia International Pharmaceutical ManufacturerGroup (IPMG)

IPMG code of Pharmaceutical Marketing Practices

Ireland Irish Pharmaceutical Healthcare Association(IPHA)

Code of Marketing Practice for the PharmaceuticalIndustry

Italy FARMINDUSTRIA Associazione delle Impresedel Farmaco

Codice deontologico Farmindustria (code of professionalconduct)

Japan Japan Pharmaceutical ManufacturersAssociation (JPMA)

JPMA Promotion Code for Prescription Drugs

Korea Korean Research-based Pharmaceutical Indus-try Association (KRPIA)

KRPIA Fair Competition Code and its working guideline

Malaysia Pharmaceutical Association of Malaysia(PhAMA)

PhAMA Code of Conduct

Netherlands NEFARMA vereiniging innovatievegeneesmiddelen Nederland

Code of conduct for pharmaceutical advertising

Norway Legemiddelindustriforeningen (LMI) Rules for marketing of medicinal productsRecommended guidelines between the NorwegianFederation of Organizations of Disabled people (FFO) andthe Norwegian association of pharmaceuticalmanufacturers (LMI) for contact and cooperationbetween patient organizations and the pharmaceuticalindustry

Peru ALAFARPE Asociacioacuten Nacional de LaboratoriosFarmaceacuteuticos

Coacutedigo IFPMA de praacutecticas de marketing farmaceacuteutico

Philippines Pharmaceutical and Healthcare Association ofthe Philippines (PHAP)

PHAP Code of Pharmaceutical Marketing Practices

Portugal Associaccedilatildeo Portuguesa da InduacutestriaFarmacecircutica (APIFARMA)

Coacutedigo Deontoloacutegico para as Praacuteticas Promocionais daInduacutestria Farmacecircutica e para as Interacccedilotildees com osProfissionais de Sauacutede

Coacutedigo de Conduta para as Relaccedilotildees entre a InduacutestriaFarmacecircutica e as Associaccedilotildees de Doentes

Russia Association of International PharmaceuticalsManufacturers (AIPM)

Code of Marketing Practices of the Association ofInternational Pharmaceutical Manufacturers (AIPM)

Singapore Singapore Association of PharmaceuticalIndustries (SAPI)

SAPI Code of Marketing Practices

South Africa Marketing Code Authority Code of Marketing Practice for the Marketing andpromotion of medicines medical devices and in vitrodiagnostics

Spain FARMAINDUSTRIA The National Association ofthe Pharmaceutical Industry in Spain

Spanish Code of Good Practices for the Promotion ofMedicines and Interaction with Healthcare Professionals

Spanish Code of Practice on Relationships between thePharmaceutical Industry and Patient Organizations

Sweden Laumlkemedelsindustrifoumlreningen (LIF ) Ethical rules for the pharmaceutical industry in Sweden

Switzerland Interpharma Code of Conduct of the Pharmaceutical Industry inSwitzerland (Pharma Code)

Scienceindustries Switzerland BusinessAssociation Chemistry Pharma Biotech

Taiwan International Research-Based PharmaceuticalManufacturers Association (IRPMA)

IRPMA Code of Practices

Thailand Pharmaceutical Research and ManufacturersAssociation (PReMA)

PREMA Code of Sales and Marketing Practices

Turkey Association of Research-Based PharmaceuticalCompanies (AIFD)

Code on Good Promotion Practices for MedicinalProducts to and Interactions with HealthcareProfessionals



United Kingdom Association of the British PharmaceuticalIndustry (ABPI)

Code of Practice for the Pharmaceutical Industry

United States Pharmaceutical Research and Manufacturers ofAmerica (PhRMA)

Code on Interactions with Healthcare Professionals

Principles on Conduct of Clinical Trials andCommunication of Clinical Trial Results

PhRMA Guiding Principles on Direct to ConsumerAdvertisements About Prescription Medicines

PhRMA Principles on Interactions with PatientOrganizations


abide by the applicable code (as is the case with inter-national pharmaceutical companies) Healthcare profes-sionals may have their own professional codes of practicewhich focus on high quality patient care However they areoften not focused on relationships with commercial enter-prises and include far less guidance on healthcare profes-sional ndash industry relationships than is contained in theindustry codes Domestic companies may belong to otherassociations with local codes and control mechanisms andthere are separate codes covering the advertising of medicaldevices Although all sectors will be subject to applicablelaws and regulations these may not be detailed or diligentlyapplied and may not exist at all in some countries

Scope of activities covered by codes of practiceThe codes of practice laws and regulations governingthe advertising and selling of prescription medicinescover both what companies can claim about their prod-ucts and the interactions their employees can have withhealthcare professionals medical institutions patientgroups and other key stakeholdersThe main areas of coverage of international and na-

tional codes are listed below Note that in some coun-tries certain requirements are covered by legislationrather than codes

Fundamental requirements for ethical andprofessional behavior putting patients firstcompliance with regulations etc

Standards for interactions between companies andhealthcare professionals

Sponsorship or support for healthcare professionalsrsquoattendance at meetings and continuing medicaleducation

Acceptability of venues and locations for meetings Fees for service for engagement of healthcare

professionals Providing promotional aids samples etc Hospitality limitations Standards for promotional information ndash accuracy

balance substantiation etc Essential information for advertisements

(eg prescribing information)

Prohibition of promotion of unlicensed productsand uses

Electronic communications Interactions with patient organizations Clinical research and transparency Company procedures and responsibilities including

approval and certification arrangements stafftraining

Complaints handling and enforcement arrangements

Additional coverage of these areas is provided in allEuropean and some other national codes

Expanded requirements of the above areas Prohibition of direct to consumer advertising for

prescription-only medicines Specific requirements for representatives Requirements for public listings of support andor

engagement of healthcare professionals andorpatient groups

Donations and grants Non-interventional studies Aspects of market research activities Providing educational and support services eg

therapy review and nurse services

Additional coverage of these areas occurs in one ormore individual codes

Expanded requirements of the above areas Standards for non-promotional medical information

to healthcare professionals andor patients Non-promotional information for patients and the

public disease awareness activities Interactions with the media press releases etc Specific requirements for websites social media etc

At a national level the requirements of codes and legis-lation usually overlap extensively A promotional claim oran activity that is illegal will also generally breach the localcode of practice In many countries the code require-ments are broader than those in legislation andor providemore detail on exactly what is and is not acceptable In


other countries notably the US competition or antitrustlaw may limit the ability of companies or national associa-tions to dictate joint marketing rules [19] Accordingly insuch markets marketing codes may not include formaladjudication procedures Rather rules on the advertisingof pharmaceuticals are covered extensively in US laws andregulations In addition to the basic requirements such asthe essential information that must be included in adver-tisements (prescribing information etc) rules cover thetwo main areas of product claims (eg concerning effect-iveness and tolerability) and interactions with healthcareprofessionals (eg sponsorship and benefits) [20]

Product claimsThe same basic rules regarding the veracity of promo-tional claims are enshrined in most national legislationwhere it is in place in the IFPMA Code and in nationalcodes These have been fundamental requirements sincethe first codes (which preceded legislation) were put inplace The first industry code governing prescribed med-icines (ie those available on prescription from a quali-fied health professional) was initiated in the UK in 1958[21] Refinements have occurred since then but the re-quirement persists that promotional claims must be ofhigh quality and consistent with the prescribing informa-tion approved by regulatory authorities This latter as-pect has prompted a high proportion of code complaintcases often from competing companiesGenerally speaking the IFPMA Code of Practice and

national codes require that product claims relating toprescription medicines be accurate balanced and up todate Material must be truthful and not misleading in-cluding misleading by omission and half-truths For ex-ample claims must strike a balance of the availableevidence and cannot provide only ldquohalf the picturerdquo Ifchallenged a company is obliged to provide data to sub-stantiate its claims The IFPMA Code includes the con-cept that material must be ldquosufficiently complete toenable the recipient to form his or her own opinion ofthe therapeutic valuerdquo of the product Materials shouldalso ldquoencourage appropriate userdquo of medicines by pre-senting information objectively and without exagger-ation These and other specific requirements set a veryhigh standard for claims in advertisements for prescrip-tion medicines including comparative claimsDirect to consumer advertising (DTCA) is prohibited

in most countries that regulate prescription medicinesalthough the United States and New Zealand are majorexceptions Although the IFPMA Code of Practice setsglobal standards it remains silent on DTCA because thecode cannot preempt national laws and regulations At anational level codes of practice reflect the local legalsituation and usually detail the rules and standards fornon-promotional communications concerning prescription

medicines that companies can make direct to the public orpatients PhRMA in the US has promulgated a set of vol-untary standards regarding DTCA including appropriaterisk communication and timing of certain advertising [20]A universal and important prohibition relates to adver-

tising a medicine or a new use of an existing medicinebefore regulatory marketing authorization is receivedLegislation and codes share similar wording on thispoint however distinguishing promotional and non-promotional information remains complicated More-over at least one appeal court in the United States hasrecognized the right of companies to provide truthfuland non-misleading information about unapproveduses of approved drugs this decision was based on thecompaniesrsquo First Amendment right of expression [22]However different authorities have different perspec-tives on the dividing line between ldquopromotionalrdquo andldquonon-promotionalrdquo information Even within one coun-try regulatory bodies may make different decisions asin a UK case in which the code decision [23] was stric-ter than that of the government regulatory body [24]with respect to the responsibility of a company for ma-terial it sponsored Furthermore new communicationmechanisms have blurred the line between promotionaland non-promotional material because interactions areno longer necessarily face to face Nonetheless the ex-change of accurate and data-driven scientific informa-tion between pharmaceutical companies and medicalpractitioners and researchers should bring importantbenefits to patient care

Pharmaceutical industry interactions with healthcareprofessionalsInteractions and communication between companies thatresearch and manufacturer medicines and the healthcareprofessionals that prescribe them are important in contrib-uting to the appropriate and effective use of prescriptionmedicines These relationships are covered by pharmaceut-ical advertising codes and legislation Additionally nationalbribery and corruption legislation such as the US ForeignCorrupt Practices Act (FCPA) and the UK Bribery Actcould have potential application to activities in anycountry for many companies Ensuring compliance withthe IFPMA Code and the affiliated national codes islikely to help ensure compatibility with relevant sec-tions of anti-bribery legislation Essentially the code re-quirements are designed to prohibit inappropriate personalbenefit being offered to healthcare professionals and oftengo beyond the requirements of anti-bribery legislationOne issue covered by most national codes is whether

companies are able to support healthcare professionalattendance at medical conferences While codes in manycountries deem it acceptable to sponsor attendance ofhealthcare professionals at scientific meetings and cover

Francer et al Philosophy Ethics and Humanities in Medicine 2014 97 0 of 17httpwwwpeh-medcomcontent917

associated costs such as reasonable travel accommoda-tion and meals they also include a number of caveats Inparticular the main purpose of the meeting must be scien-tific and professional in nature and any refreshments pro-vided must be incidental to that purpose The venue mustbe conducive to the scientific or educational purpose andinternational travel must be justified by the internationalnature of the meeting or other logistical or security reasonsCompany sponsorship of healthcare professionals to at-

tend meetings nevertheless remains a topic of debateSome countries (eg the United States and Norway) donot permit direct sponsorship of attendance at scientificmeetings (except for medical students in the US) whileothers (eg France) require review of the arrangements byan independent body Some countries have put other mea-sures in place such as co-payment of expenses Inter-national companies may also impose on themselvespolicies relating to sponsorship of healthcare professionalsthat go beyond external rules [2] This highlights sensitiv-ity over the perception of companies funding attendanceat international educational meetings However ceasingsponsorship could deny healthcare professionals withoutaccess to sufficient funding the opportunity to hear andinteract with world leaders in their chosen field unless al-ternative funding arrangements are developed or digitally-based specialist educational services are expanded and arefeasible in their country This is particularly important forhealthcare professionals from developing counties wherealternative sources of funding may not be availableProviding low-value branded promotional aids (pens

pads tongue depressors antiseptic wipes etc) has longbeen a tradition of pharmaceutical and other advertis-ing International rules still permit inexpensive promo-tional aids provided they are relevant to the practice of

Table 3 Summary of code of practice sanctions and provision

Sanction or requirement Comments

Requirement to cease non-compliant activity A universal requirement Ocompliant or similar activitoffending material Repetit

Publication of the outcome or public reprimand Undertaken if local legal cosummaries Offending compublicised in the medical p

Monetary penalties The amount is usually gradgenerally from thousands

Additional pre-screening requirements In countries where pre-scre

Requirement for a formal audit of companyprocedures

This is particularly useful ifrepeated shortcoming

Suspension or expulsion from membership ofthe local trade association

Expulsion may mean thatlegal and regulatory controcompany is still required to

Issue a corrective communication This provision is particularlthe expense of the compa

aIn most countries regulatory bodies and legal court proceedings provide additionabNot all sanctions are applied in all countries

the healthcare professional However there is a trend toban promotional aids altogether and within the past fiveyears the US [16] and UK [25] amongst others haveprohibited branded promotional aids At least one globalcompany has ceased their distribution worldwide [2]The rationale for a ban is not that such promotional aidsrepresent a gift that will affect a healthcare professionalrsquosprescribing or purchasing decisions but rather that suchitems are not conducive to a new relationship built onmutual professional respect In addition industry leadersseek to base relationships with healthcare professionalson sharing educational information rather than onprovision of items that could be perceived as giftsIn most parts of the world it is permissible to provide

samples of medicines to healthcare professionals andsuch samples may improve patient care However thesituation varies considerably between countries accord-ing to local factors In a number of countries samplesare not permitted at all while several countriesrsquo industrycodes restrict their number frequency and the periodafter launch during which they can be provided [1826]

Code of practice sanctionsCodes of practice operate on a fundamentally differentbasis to legislation They do not rely merely on the threatof punitive fines for their effectiveness Rather they repre-sent a collective commitment of member companies tobehave in a responsible manner Deviations from the coderequirements are dealt with in a variety of ways that mustalways be consistent with local laws including anti-trustand anti-competition provisions (Table 3)In many countries fines or administrative fees may be

levied and there are requirements to cease the activitythat caused the breach However the effectiveness of

sab [14]

ften associated with a written undertaking not to repeat the non-ies claims etc The company may be required to recover and destroyion may result in severe penalties

nsiderations allow May consist of detailed reports or more concisepany is usually identified In some countries serious offences may beress

ed according to the number andor seriousness of the offencesto hundreds of thousands of dollars

ening is optional

a companyrsquos procedures or training may be the cause of a serious or

the code regulatory system will not apply to the company and externalls will therefore take effect routinely Suspension may mean that thecomply with the national association code

y useful if recipients of the material may have been misled It will be atny

l (or exceptionally the only) sanction options


sanctions is mainly based on actions that support thevoluntary commitment to good behavior such as publicdisclosure of the details of the breach where local laws per-mit In circumstances where companies appear not to havedemonstrated the necessary commitment to code compli-ance or where the breach is particularly serious they maybe suspended or expelled from membership of the local as-sociation that administers the code The self-regulationsystem therefore relies on a genuine commitment by com-panies to take the rules seriously For international com-panies this commitment is reflected in their internalcontrol systems governing promotional activities

Company controlsResearch-based pharmaceutical companies operate inter-nationally and have global company codes of conductand detailed standards that apply to many of their activ-ities including sales and advertising These company pol-icies encompass the requirements of applicable nationalcodes the IFPMA international code and legal obliga-tions However company compliance standards oftenadd another layer of detail and expand further the scopeof activities controlled These internal codes are oftenavailable on company websites and many can beaccessed through the IFPMA website [27]Companies also set out approval procedures for their

communications Prior to use materials and activitiesare approved by designated individuals who are respon-sible for checking acceptability against all applicablelaws regulations and codes In Europe and several othercountries there must be a final approval of advertisingby a designated doctor or pharmacist In France andBelgium the ldquoresponsible pharmacistrdquo has a legally con-stituted responsibility for such approvals In addition toensuring compliance with regulations and codes thephysicians and pharmacists who certify promotional ac-tivities also have a responsibility as healthcare profes-sionals to patient welfare and are of course subject tothe codes of conduct of their professional bodies Com-pliance with rules and ethics are not always synonymousan activity can be legal but not ethical or consideredethical by many but not legal What is ethical is open tointerpretation and the concept of appointing doctorsand pharmacists to approve company outputs reflects aresponsibility to patient welfare that goes beyond com-pliance with written standardsA number of pioneering initiatives in setting new stan-

dards and transparency requirements have resulted fromindividual company actions Greater transparency onengagements with healthcare professionals has been ini-tiated in the US and Europe by several companiesAdoption by other companies or indeed by the indus-try-wide codes of practice often follows An example ofindustry-wide adoption has been the recent European

Disclosure Code relating to transfers of value from com-panies to healthcare professionals [18]

Complaint proceduresHealthcare professionals or indeed anyone includingmembers of the public journalists activists and competi-tor companies who have concerns about pharmaceuticaladvertising or activities of pharmaceutical companies mayalways raise their concerns There are a number of avail-able options for involving the types of codes described inthis article

Contact the companyPeople with complaints or questions can approach thelocal company affiliate andor the international headquar-ters Company compliance departments usually welcomeconcerns being brought to their attention and many run aconfidential ldquocontact usrdquo system ndash often on their websiteContacting the company can be the most rapid means ofresolving a concern Company standards in general covera broader spectrum of activities than external codes andregulations and may well govern activities not subject tospecific external rules If the company disagrees with thecomplainant the complainant may still resort to the othermethods detailed below The complaints are usually keptconfidential and do not result in the issue becoming pub-licly known which means other companies cannot there-fore learn from the case However for simple concerns itcan be a quick and efficient method of resolution Inter-company dialogue is also often the first line of approachwhen one company is concerned about the activities ofanother and can lead to rapid resolution of the matter Al-though such dialogue is encouraged care is needed to en-sure compliance with competition laws

Contact national code of practice bodyAlmost all codes of practice have an associated complaintsresolution process This usually involves detailed consider-ation of the complaint by a panel of people independentof the company concerned sometimes including practis-ing healthcare professionals andor regulatory body repre-sentatives In some cases the process is overseen bylawyers Code adjudication processes will lead to a judg-ment on the matter by reference to the relevant codewhich will often be broader in scope than the law and reg-ulations The process for adjudicating complaints variesbetween countries and the details are often dependent onlocal legal and regulatory constraints Where possibleunder local legislation full transparency is encouraged bymaking public details of the complaint and the companyconcerned Local codes often cover a wider spectrum ofactivities than regulations and the IFPMA Code


Contact IFPMAWhen national codes cannot be applied for examplewhen the company involved is not subject to the localcode or no IFPMA-affiliated association exists in thecountry concerned and providing the company involvedis a direct member of the IFPMA or belongs to anIFPMA-affiliated association in at least one country thecomplaint can be processed by the IFPMA It will be ad-judicated under the IFPMA code operating procedure(Article 13) assuming of course that the subject of thecomplaint is within the scope of the code The IFPMACode does not however operate as a higher authoritythat could overturn a decision made under a nationalcode of practice processAlthough the pharmaceutical industry advocates using

the available self regulation options there may be occasionswhen this is not an option for example if a local companyis not covered by the various codes (see DevelopingEconomies section below) Also laws and regulationscommonly duplicate requirements of the national self-regulatory codes The involvement of legal and govern-ment regulatory processes therefore remains an optionif resolution through Code of Practice procedures isnot possible or appropriate

Developing economiesMost developed nations have well-established legal sys-tems regulatory agencies and pharmaceutical industrycodes that provide effective control of the advertising ofprescription medicines However these systems may notbe available in all developing nations The situation isfurther complicated because unlike in Europe andNorth America international pharmaceutical companiesmay supply only a small proportion of prescription med-icines in some countries This has practical implicationsbecause often only the international companies arebound by the worldwide standards set out in the IFPMACode As a result the more detailed provisions in na-tional codes as well as the complaint resolution mecha-nisms that may accompany those codes leave othersectors within the pharmaceutical industry (eg manydomestic manufacturers) to operate under different stan-dards and possibly less scrutiny International companiesdo not however view the additional controls imposed bytheir codes as a disadvantage In fact the opposite may betrue with the application of ethical standards of advertis-ing practice seen by many as a positive advantageA further complication in our experience relates to

culturally different attitudes to raising concerns andcomplaints Some societies do not commonly attempt toresolve concerns through formal complaints mecha-nisms This could lead to a situation where clear rulesand effective control mechanisms exist but they areunder-utilized However despite the differences in local

controls a broad range of standards is applied uniformlyworldwide to multinational pharmaceutical companies Inaddition since these companies are typically active in theUS and UK action could potentially be taken under theUS Foreign Corrupt Practices Act andor the UK BriberyAct if certain inappropriate interactions with healthcareprofessionals in other countries were suspectedAs China India Latin America and Africa have be-

come the focus of increased business activity for inter-national pharmaceutical companies it is important toreview significant national developmentsIn China research-based international pharmaceutical

companies represent a relatively small proportion of thetotal market although their presence is growing and sev-eral have committed major research and manufacturinginvestment there The trade organization (RDPAC) thatrepresents international pharmaceutical companies inChina has a code of practice [28] closely based on theIFPMA Code However legal controls dominate and thestatus of the voluntary code remains uncertain For ex-ample advertisements must be submitted to the Chineseregulatory authorities for approval before being issued [29]In India the majority of pharmaceutical companies are

national and do not operate in other countries Thereare several thousand such companies which are repre-sented by national trade associations Although these as-sociations have codes of practice they are not bound bythe standards and procedures set out by the internationalIFPMA Code International companies including someIndia-based companies that operate internationally aremembers of OPPI (Organization of PharmaceuticalProducers of India) and are governed by its advertisingcode [30] which is closely linked to the IFPMA CodeRecently there has been a welcome developmentwhereby a single national pharmaceutical promotioncode (Unified Code) has been proposed to harmonizestandards across pharmaceutical sectors Modern legis-lation governing pharmaceutical advertising is lackingalthough the Drugs and Magic Remedies (ObjectionableAdvertisements) Act 1955 [31] is still in forceIn South Africa the local industry associations includ-

ing those representing makers of medical devices diag-nostics and generics as well as prescription and overthe counter medicines have produced a joint code [32]in line with legal provisions in the Medicines Act Imple-mentation began in autumn 2011 An independent en-forcement authority the Marketing Code Authority hasbeen established under the code which includes detailedenforcement procedures and the application of extensiveand stringent sanctions in cases of code breaches TheMarketing Code Authority is fully operational and in-cludes a certification process for industry professionalsSouth Africa is a good example of the willingness of allstakeholders to work together


In Mexico collaboration between the local and inter-national pharmaceutical industry medical associationsmedical schools government bodies and others led tothe agreement in 2008 of joint mandatory transparencyguidelines This arose out of the creation in 2005 of aCouncil of Ethics and Transparency (CETIFARMA) aswell as the more restrictive standards for industry busi-ness conduct brought about by the 2006 revision of theIFPMA Code The council is an autonomous and inde-pendent body that operates mandatory codes coveringethics and transparency good promotional practicesand interaction with patient organizations [33] Compli-ance with the code is monitored and sanctions can beapplied There is also a voluntary award system basedon an independent evaluation of company compliancewhereby companies are certified for a two-year periodafter which they have to be evaluated againIt can be concluded that several individual emerging na-

tions have made significant advances in the regulation ofthe advertising of prescription medicines The exam-ples of unified codes covering different healthcare sec-tors and of collaborative codes developed withgovernment and healthcare professional organizationsrepresent an approach for emulation across developingand developed nations

Recent developmentsIndustry codes relating to communication practices areoften able to be more representative of sound businesspractices than laws or regulations because codes can beproactively modified to reflect current needs and trendsSince the first codes relating to pharmaceutical commu-nications were adopted in the 1950s periodic updateshave served as a mechanism for addressing the changingnational landscape as well as preventing potential inci-dents in business practices In recent years code updateshave primarily related to promotional practices and in-teractions between pharmaceutical companies and otherstakeholders That area reflects the topics of debate andcriticism in the lay and medical literature

2006 update to the IFPMA CodeThe 2006 update to the IFPMA Code of PharmaceuticalMarketing Practices marked a significant development incommunication practices for IFPMA member companiesand associations [34] Overall that revision simplified thelanguage of the previous code and expanded the rulesrelating to company interactions with healthcare pro-fessionals In addition it revised compliance proceduresand established a global Code Compliance Network(CCN) Importantly the 2006 Code reinvigorated theefforts of member companies and associations to raisepublic awareness of the self-regulatory regime manypharmaceutical companies had adopted

The revised sections relating to interactions withhealthcare professionals provided increased clarity oncompany-sponsored events hospitality and gifts Com-pany sponsorship of international events such as con-gresses conferences and symposia was narrowly limitedto educational or scientific purposes In other words in-formation relating to pharmaceutical products at suchevents was limited to providing participants with scientificand educational information In addition stricter ruleswere put in place relating to company-hosted events re-quiring them to be held at venues conducive to the scien-tific or educational purpose of the meeting It was madeclearer that practices such as providing event participantswith extravagant meals trips to exotic locations for meet-ings theatre tickets rounds of golf or paying for accom-panying guests such as spouses were not acceptableSimilarly rules affecting gifts to healthcare profes-

sionals were strengthened Personal gifts such as CDsDVDs theatre or sporting tickets or anything for thepersonal benefit of a healthcare professional were expli-citly banned Promotional aids of minimal value andrelevant to professional practice were still allowed (egbranded pens and pads) as were items of medical utilityfor patient care (eg textbooks and anatomical models)and inexpensive and infrequent cultural courtesy giftssuch as those given traditionally for significant religiousfestivals (eg moon cakes) Because these new provisionswere implemented worldwide local codes were encour-aged to provide details of the costs and types of itemthat could be offeredClarifying the restrictions on hospitality and gifts was

significant but as these rules were applied globally theywere not without opposition In some countries particu-larly those where personal relationships form the basisof business relationships healthcare professionals had be-come accustomed to companiesrsquo ldquogenerosityrdquo The reasonswhy such ldquobenefitsrdquo were no longer available had to be ex-plained to some healthcare professionals Those discus-sions helped to highlight the ethical responsibilities ofhealthcare professionals and the role they play in ensuringethical and professional interactions Such responsibilitiesare increasingly reflected in healthcare professionalsrsquo codesof conduct [35]The IFPMA Code Compliance Network (CCN) estab-

lished by the 2006 revision of the IFPMA Code brings to-gether over 100 compliance experts representing memberassociations and companies CCN members meet regu-larly to discuss the latest developments and issues in thefield of ethical promotion of medicines The goal is to ex-change experiences and ensure effective code implementa-tion at local and national levelsFinally the 2006 revision included a section that fur-

ther elaborated on code complaint procedures outliningprocedural and substantive requirements for validation


referral and adjudication In addition the section in-cluded membersrsquo obligations in the event a complaintwas lodged about them If they were found be in breachof the Code given other enumerated circumstances ashort summary describing the complaint and the deci-sion would be made public

2012 update to IFPMA CodeThe IFPMA Code was again expanded in 2012 A newtitle The IFPMA Code of Practice (omitting earlier refer-ence to marketing practices) reflected the extendedscope beyond marketing activities In particular the2012 revisions addressed fees for services clinical re-search transparency and interactions with patient orga-nizations In addition companies were required to trainemployees on relevant conduct practices reflected in theCode Finally the Codersquos comprehensiveness was im-proved by clarifying certain articles and extending itsscope to such issues as the commissioning of advisoryboards and support for continuing medical education(CME)A significant addition was the listing of lsquoGuiding

Principlesrsquo which identify the underlying principles onwhich the detailed rules that follow had been basedThis was considered useful because no set of code rulescan hope to cover all situations and stating underlyingprinciples should help interpretation of individual casesand when the IFPMA minimum standards are incorpo-rated in the more detailed local codesGuiding principles of the 2012 IFPMA Code of

Practice

1 The health-care and well-being of patients are thefirst priority for pharmaceutical companies

2 Pharmaceutical companies will conform to highstandards of quality safety and efficacy asdetermined by regulatory authorities

3 Pharmaceutical companiesrsquo interactions withstakeholders must at all times be ethical appropriateand professional Nothing should be offered orprovided by a company in a manner or on conditionsthat would have an inappropriate influence

4 Pharmaceutical companies are responsible forproviding accurate balanced and scientifically validdata on products

5 Promotion must be ethical accurate balanced andmust not be misleading Information inpromotional materials must support properassessment of the risks and benefits of the productand its appropriate use

6 Pharmaceutical companies will respect the privacyand personal information of patients

7 All clinical trials and scientific research sponsored orsupported by companies will be conducted with the

intent to develop knowledge that will benefitpatients and advance science and medicinePharmaceutical companies are committed to thetransparency of industry-sponsored clinical trials inpatients

8 Pharmaceutical companies should adhere toapplicable industry codes in both the spirit and theletter To achieve this pharmaceutical companieswill ensure that all relevant personnel areappropriately trained

Companiesrsquo engagements with healthcare professionalsproviding consulting services such as scientific consult-ing market research and advisory board participationwere elaborated in the 2012 revision The goal was toensure that contractual relationships are clearly definedand documented In part the Code requires a writtencontract or agreement and a clear business need for theservices provided Remuneration must reflect fair marketvalueAnother new section (Article 9) relates to clinical re-

search and transparency This addition to the Code re-flects a long-standing commitment to disclose clinicaltrial information in line with the joint disclosures issuedby international and national industry associations [36]It emphasizes the industryrsquos commitment to transpar-ency in clinical research by including it within themandatory requirements of a code of practice Similarlya section on company support for continuing medicaleducation (CME) has been added (Article 10) This sec-tion reaffirms that the primary purpose of CME is to en-hance medical knowledge and requires any companycontributions to content to be fair balanced and object-ive Similar provisions apply to CME events as to pro-motional eventsRules on companiesrsquo interactions with patient organi-

zations explicit in the 2012 IFPMA Code (Article 11)are for the most part based on European standards [37]The rules are designed to safeguard the independence ofpatient organizations and ensure that support by com-panies is appropriate The involvement of the companyand the nature of that involvement must be clear fromthe outset Written documentation must be in place andarrangements for meetings that companies support aresubject to similar restrictions to those that apply tohealthcare professional meetingsCertain existing requirements were clarified in the 2012

edition For instance entertainment or social activitiescannot be provided or funded by companies whereas pre-vious versions allowed modest entertainment The operat-ing procedure for handling complaints was expanded andnew standard operating procedures were added Underthe 2012 Code the outcome of all complaints will be pub-lished although no-breach complaints will not identify the


products or company involved This revision aims to pro-vide stakeholders with additional guidance on acceptablebusiness practices Similarly the ldquoQuestions and Answersrdquosection has been expanded to provide more detail regard-ing key provisions of the Code Nevertheless because thevast majority of complaints are dealt with through na-tional code procedures the IFPMA Code complaint sys-tem is unlikely to see a big increase in volume

Beyond 2012In recent years many national codes have been updatedand expanded [34] including those in Europe (EFPIA)[18] the US (PhRMA) [16] Canada (RxampD) [38] andAustralia (Medicines Australia) [39] These often have abroader scope than the IFPMA Code Certain nationalcodes have taken a lead with rules or guidance in newareas such as digital media communications [4041]Even so the 2012 update of the IFPMA Code requiredeach national code to validate its coverage against theexpanded global baseline rules Many already coveredthe new areas but others needed revision to ensure thatnational provisions reflect the IFPMA CodeNational or regional code changes do not have a direct

effect on requirements outside their jurisdiction (eg inmany developing countries) However national associa-tions share their experiences and have driven changes tothe IFPMA Code as have updates by internationalpharmaceutical companies to their internal codes of con-duct standards and procedures [42] These globally oper-ating companies have had to make decisions about whatthey will commit to worldwide which may go beyond thealready high standards set out in the IFPMA Code andother national codes and regulations Another importantway of evolving requirements is through individual com-panies taking a lead in particular areasThe 2014 lsquoConsensus Framework for Ethical Collabor-

ation between Patientsrsquo Organisations HealthcareProfessionals and the Pharmaceutical Industryrdquo [5]which the international pharmaceutical industry sup-ported alongside the international representative bodiesfor doctors pharmacists nurses and patients brings to-gether in one document shared principles which canserve as a valuable model for similar initiatives at the na-tional level

ConclusionsThe attention and resources devoted to regulatory com-pliance regarding communication about prescriptiononly medicines is probably at an all-time high Howeverno set of rules is beyond improvement and changes inhealth systems as well as advances in communicationtechnology will mean that codes regulations and lawswill continue to evolve if they are to support optimal useof medicines to benefit patients

Continuing experience with the operation of existingcodes will help inform future developments particularlyin rapidly developing countries where internationalpharmaceutical company activities are expanding yetlocal manufacturers may not be subject to establishedcodes of practice Future developments in these coun-tries should strive for international harmonization embra-cing all healthcare sectors but also take into accountnational differences and simultaneously encourage broaderparticipation and endorsement of codes across the industryoperating in these countriesThe IFPMA Code was extensively revised in 2006 and

again in 2012 It is now well-established as an inter-national model for effective local codes Continued as-sessment of of national industry codes of practice is isappropriate to ensure that companies continue to meetthe needs of patients and prescribers Additionally indi-vidual companies will continue to pioneer additionalstandards approaches and initiatives Areas that are be-ing addressed at national and company level include afocus on increased transparency of the relationships be-tween companies and both individual healthcare profes-sionals and healthcare organizations Low cost promotionalaids are being increasingly restricted or banned altogetherby companies and national or regional codesLaws and regulations may change more slowly but

in countries where there are perceived gaps we can ex-pect clarification in the form of new regulations andguidanceThe pharmaceutical industry must continue to serve as a

trusted partner in healthcare provision Industry codes ofpractice can form the foundation for governing companiesrsquointeractions and communications and therefore play an im-portant part in the relationship between companies andother stakeholders in healthcare provision Laws and regu-lations will remain important and legal action will be ap-plied when needed Nevertheless it will be important toavoid a ldquobox-tickingrdquo approach where the only question isldquoIs it legal to do thatrdquo but rather to also encompass acode-based evaluation that goes beyond legal requirementsInternational companies have established global in-

ternal standards but they represent only a small share inthe healthcare market in many developing countriesand it would be appropriate for unified self-regulatorycodes to cover all sectors of the pharmaceutical marketWe have already seen such developments in Mexico andSouth Africa and such a model has also been proposedin India A model of cooperation between industry codesand legislation already works well in some countriesparticularly in Europe and Australia Such a model couldbe equally successful in developing nations

AbbreviationsCCN Code Compliance Network (a committee of IFPMA)CETIFARMA Council of Ethics and Transparency (Mexico) CME Continuing


Medical Education DTCA Direct to Consumer Advertising EFPIA EuropeanFederation of Pharmaceutical Industries amp Associations FCPA ForeignCorrupt Practices Act (USA) IFPMA International Federation ofPharmaceutical Manufacturers and Associations MCA Marketing CodeAuthority (South Africa) OPPI Organization of Pharmaceutical Producers ofIndia PhRMA Pharmaceutical Research and Manufacturers of America (USA)RDPAC Research amp Development-based Pharmaceutical Association Committee(China) RampD Research and Development RxampD Canadarsquos Research-BasedPharmaceutical Companies

Competing interestsThe authors are each employed by companies or organizations related tothe pharmaceutical industry and IFPMA IFPMA member companies researchdevelop manufacture and supply biopharmaceutical products and vaccinesglobally IFPMA member associations represent the pharmaceutical industryat a national level As employees in the pharmaceutical industry someauthors may have other financial interests in pharmaceutical companies

Authorsrsquo contributionThis publication is the product of extensive collaboration between themembers of IFPMArsquos Code Compliance Network (CCN) All authorscontributed content and ideas to the manuscript which was based on aninitial draft by PW All authors read and approved the final manuscript

Authorsrsquo informationHS CN KN TM JZI JF and PW are current or past members of the CodeCompliance Network of the International Federation of PharmaceuticalManufacturers and Associations (IFPMA CCN) 15 Chemin Louis-Dunant POBox 195 1211 Geneva 20 Switzerland

AcknowledgementsErnest Kawkarsquos editorial contributions are warmly welcomed

Author details1Pharmaceutical Research and Manufacturers of America (PhRMA)Washington DC USA 2The National Association of the PharmaceuticalIndustry in Spain (Farmaindustria) Code Surveillance Unit Madrid Spain3International Federation of Pharmaceutical Manufacturers and Associations(IFPMA) 15 Chemin Louis-Dunant PO Box 195 1211 Geneva Switzerland4Formally Pharmaceutical Industry Association of South Africa (PIASA)Johannesburg South Africa 5Canadarsquos Research-Based PharmaceuticalCompanies (RxampD Canada) Ottawa Canada 6The Association of the BritishPharmaceutical Industry (ABPI) Prescription Medicines Code of PracticeAuthority (PMCPA) London UK 7Paul Woods Compliance Ltd Macclesfield UK

Received 2 July 2013 Accepted 9 March 2014Published 29 March 2014

References1 Healthy Skepticism [httpwwwhealthyskepticismorgglobal]2 Brennan D Speech Fifth International Pharmaceutical Regulatory and

Compliance Congress Istanbul 4 May 2011 2011 [httpwwwinternationalpharmacongresscompast2011indexhtml]

3 Directive 200183EC of the European Parliament and of the Council of 6November 2001 on the Community code relating to medicinal products forhuman use [httpeur-lexeuropaeuLexUriServLexUriServdouri=CELEX32001L0083ENNOT]

4 Criminal penalties for acts involving Federal health care programs USA SocialSecurity Administration 42 USC sect 1320a-7b (b) httpwwwssagovOP_Homessacttitle111128Bhtm

5 Consensus Framework for Ethical Collaboration between Patientsrsquo OrganisationHealthcare Professionals and the Pharmaceutical Industry 2014 2014 [httpwwwifpmaorgfileadmincontentPublication2014Consensus_Framework-vFpdf]

6 What are EU directives httpeceuropaeueu_lawintroductionwhat_directive_enhtm

7 United States Department of Justice Foreign Corrupt Practices Act (see 15 USC sectsect 78dd-1 et seq) httpwwwjusticegovcriminalfraudfcpa

8 UK Government Bribery Act 2010 2010 [httpwwwlegislationgovukukpga201023contents]

9 Misbranded drugs and devices USA Food and Drugs Administration 21 USC sect 352 httpwwwfdagovdownloadsAboutFDACentersOfficesCDERucm118003pdf

10 Health Canada Drugs and health products regulatory requirements foradvertising [httphc-scgccadhp-mpsadvert-publicitindex-engphp]

11 Government of Australia Therapeutic Goods Act 1989 1989 [httpwwwaustliieduauaulegiscthconsol_acttga1989191]

12 US Food and Drug Administration The Office of Prescription Drug Promotion(OPDP) [httpwwwfdagovAboutFDACentersOfficesOfficeofMedicalProductsandTobaccoCDERucm090142htm]

13 Medicines and Healthcare products Regulatory Agency Advertising ofmedicines [httpwwwmhragovukHowweregulateMedicinesAdvertisingofmedicinesindexhtm]

14 IFPMA Member Association Codes [httpwwwifpmaorgabout-ifpmamembersassociationshtml]

15 International Federation of Pharmaceutical Manufacturers amp AssociationsIFPMA Code of Practice [httpwwwifpmaorgethicsifpma-code-of-practiceabout-ifpma-code-of-practicehtml]

16 Pharmaceutical Research and Manufacturers of America PhRMA code oninteractions with healthcare professionals Washington DC PhRMA 2009httpwwwphrmaorgsitesdefaultfilespdfphrma_marketing_code_2008pdf

17 International Federation of Pharmaceutical Manufacturers amp AssociationsCode of Pharmaceutical Marketing Practices 2006 Geneva IFPMA 2006[httpwwwifpmaorgethicsifpma-code-of-practiceabout-ifpma-code-of-practicehtml]

18 European Federation of Pharmaceutical Industries and Associations EFPIACode of Practice on the promotion of prescription-only medicines to andinteractions with healthcare professionalsrsquo lsquoEFPIA Code of Practice onrelationships between the pharmaceutical industry and patient organizationsrsquoEfpia Code on disclosure of transfers of value from pharmaceutical companies tohealthcare professionals and healthcare organizations [httpwwwefpiaeu]

19 See eg Sherman Antitrust Act 15 USC sectsect 1ndash7 as amended by the ClaytonAct 15 USC sect 12ndash27)

20 PhRMA Guiding Principles on Direct to Consumer Advertising aboutPrescription Medicines 2009 httpphrmaorgsitesdefaultfilespdfphrmaguidingprinciplesdec08finalpdf

21 Massam D The development of controls on the promotion ofprescription medicines ESRA Rapporteur 1999

22 US v Caronia 2012 703 F3d 149 (2d Cir 2012)23 Prescription Medicines Code of Practice Authority AUTH1951207 and AUTH

1952207 and AUTH1953207 and AUTH1954207 and AUTH1955207 ndashPharmacists v AstraZeneca [httpwwwpmcpaorgukcasesPages1951aspx]

24 Medicines and Healthcare products Regulatory Agency Advertisingcomplaint Rosuvastatin lsquoThe new NICE guidance on the use of statins inpracticersquo Pharmaceutical Journal Insert - 20 January 2007 2007 [httpwwwmhragovukHowweregulateMedicinesAdvertisingofmedicinesAdvertisinginvestigationsCON2030519]

25 Clause 18 Association of the British Pharmaceutical Industry ABPI code ofpractice for the pharmaceutical industry 2011 London ABPI 2011


27 IFPMA website Member Companies httpwwwifpmaorgabout-ifpmamemberscompanieshtml

28 China Association of Enterprises with Foreign Investment RampD-BasedPharmaceutical Association Committee RDPAC code of practice on thepromotion of pharmaceutical products Beijing RDPAC 2012 [httpwwwifpmaorgfileadmincontentAbout20us220MembersAssociationsCode-ChinaRDPAC_Code_of_Practice_2012_print_final_webpdf]

29 China Food and Drug Regulatory Information Network Provisions for drugadvertisement examination [httpformersfdagovcncmswebwebportalW45649037A48335975html]

30 Organisation of Pharmaceutical Producers of India OPPI code of pharmaceuticalpractices 2012 Mumbai OPPI 2012 [httpwwwindiaoppicom]

31 The Drugs and Magic Remedies (Objectionable Advertisements) Act1955 1955 [httpwwwmedindianetindian_health_actthe-drugs-and-magic-remedies-act-1955htm]

32 Marketing Code Authority of South Africa Code of marketing practice[httpipasacoza]

33 Consejo de Eacutetica y Transparencia de la Industria Farmaceacuteutica (CETIFARMA)Codes of the pharmaceutical industry established in Mexico Mexico


Cetifarma 2010 httpwwwcanifarmaorgmxdescargables04_cetifarma03_CODES_OF_THE_PHARMACEUTICAL_INDUSTRY-2010pdf

34 International Federation of Pharmaceutical Manufacturers amp AssociationsGlobal code comparison [httpwwwifpmaorgethicsifpma-code-of-practiceglobal-code-comparisonhtml]

35 World Medical Association WMA statement concerning the relationshipbetween physicians and commercial enterprises [httpwwwwmaneten30publications10policiesr2indexhtml]

36 EFPIA IFPMA JPMA PhRMA Joint position on the disclosure of clinical trialinformation via clinical trial registries and databases (updated November 2008)and Joint position on the publication of clinical trial results and the scientificliterature 2010 [httpclinicaltrialsifpmaorgclinicaltrialsfileadminfilespdfsENRevised_Joint_Industry_Position_Nov_2008pdf] [httpclinicaltrialsifpmaorgclinicaltrialsfileadminfilespdfs20100610_Joint_Position_Publication_10Jun2010pdf]

37 EFPIA Code of Practice on relationships between the pharmaceutical industryand patient organizations 2012 [httpwwwefpiaeudocuments2361EFPIA-Code-of-Practice-on-relationships-between-the-pharmaceutical-industry-and-patient-organisations-Amended-by-decision-of-the-General-Assembly-in-June-2011]

38 Canadarsquos Research-Based Pharmaceutical Companies (Rtimes amp D) Code of EthicalPractices httpwwwcanadapharmaorgCMFilesCommitment_to_EthicsWithHealthCareProfessionalsCode_of_Ethical_Practices2012_CodeofEthicalPractices_ENFinalpdf

39 Medicines Australia Code of conduct [httpmedicinesaustraliacomaucode-of-conduct]

40 Prescription Medicines Code of Practice Authority Digital communicationsLondon UK PMCPA 2012 [httpwwwpmcpaorgukadvicedigital20communicationsDocumentsPMCPA20-20Digital20Communications202320Octoberpdf]

41 Association of Research-Based Pharmaceutical Companies (AIFD Turkey) Digitalcommunications in the pharmaceutical sector - AİFD User Guid Istanbul AIFD2012 [httpwwwaifdorgtrenHakkimizdaTanitim-ilkeleriaspx]

42 See for example GlaxoSmithKline Responsibility reports and resources UKGlaxo SmithKline 2014 httpwwwgskcomresponsibilityresponsibility-reports-and-resourceshtml

doi1011861747-5341-9-7Cite this article as Francer et al Ethical pharmaceutical promotion andcommunications worldwide codes and regulations Philosophy Ethics andHumanities in Medicine 2014 97

Submit your next manuscript to BioMed Centraland take full advantage of

bull Convenient online submission

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Abstract

Introduction

Analysis of the current situation

Control systems

Laws and regulations

Industry codes of practice

Scope of activities covered by codes of practice

Product claims

Pharmaceutical industry interactions with healthcare professionals

Code of practice sanctions

Company controls

Complaint procedures

Contact the company

Contact national code of practice body

Contact IFPMA

Developing economies

Recent developments

2006 update to the IFPMA Code

2012 update to IFPMA Code

Beyond 2012

Conclusions

Abbreviations

Competing interests

Authorsrsquo contribution

Authorsrsquo information

Acknowledgements

Author details

References

Francer et al Philosophy Ethics and Humanities in Medicine 2014 97 of 17httpwwwpeh-medcomcontent917

distinctions between and among these categories arguablymatters less to patient welfare than the truthfulness anddescription of the scientific basis of conclusions aboutmedicines It should also be noted that prescribers receiveinformation about medical products from a wide varietyof sources including clinical trial summaries posted bycompanies on government registries as well as the medicaland scientific literatureA range of quality control mechanisms are employed by

governments pharmaceutical companies and industry as-sociations to evaluate the acceptability of companiesrsquo pro-motional communications and interactions with healthprofessionals (Figure 1) There are systems to take actionwhen concerns are raised and various interest groups alsomonitor and comment publicly on companiesrsquo promo-tional activities [1]Over the past decade pharmaceutical advertising prac-

tices have changed significantly [2] Laws and regulationshave also increased during this period but in manycountries the research-based pharmaceutical industryhas implemented various mechanisms to self-regulatecommunication and promotional activities which en-compass but go beyond statutory legal requirements Forexample many pharmaceutical companies have substan-tially expanded compliance functions to ensure that inter-actions and communications with healthcare professionalsand patients are appropriate Many compliance depart-ments issue internal standards and operating proceduresthat guide employeesrsquo communications activity and em-ployees are trained on these internal requirements on a

Figure 1 Summary of different code and regulatory mechanisms app

regular basis The goal is to supply healthcare providerswith the threshold amount of information needed for in-formed treatment decisionsCompaniesrsquo standards and operating procedures relat-

ing to communications often go beyond the require-ments imposed by laws and regulations However nocompliance documentation can cover all possible situa-tions Corporate culture is a key aspect of successfulself-regulation When employees understand that com-munication activities are for the benefit and welfare ofpatients the rules governing these activities are put incontext Compliance departments can thus play a criticalrole in educating and shaping a companyrsquos values andcultureAnalyzing communication activities requires proper

identification of the parties involved Commentary oftenattributes isolated activities to the whole pharmaceuticalindustry It is critical to distinguish not only betweenresearch-based and generic-based companies but alsobetween different types of product (ie diagnostic kitsmedicines or medical devices) This paper focuses ex-clusively on the communication activities of research-based pharmaceutical companies in relation to medi-cines that are prescribed National and regional differ-ences in medical business and cultural attitudes shouldalso be acknowledgedCurrent mechanisms governing pharmaceutical com-

munications comprise industry codes of practice in-ternal company procedures laws and regulations andcountries have put in place different combinations of

lying to international pharmaceutical companies




































Franceret


anitiesin

Medicine

201497Page

4of

17httpw

wwpeh-m

edcomcontent917













Global




Regional







National


















Etickyacute Kodex


























































































































sab [14]




ening is optional






































Practice























































































Abstract

Introduction


Control systems




Product claims



Company controls


Contact the company


Contact IFPMA


Recent developments



Beyond 2012

Conclusions

Abbreviations

Competing interests



Acknowledgements

Author details

References




































Franceret


anitiesin

Medicine

201497Page

4of

17httpw

wwpeh-m

edcomcontent917













Global




Regional







National


















Etickyacute Kodex


























































































































sab [14]




ening is optional






































Practice























































































Abstract

Introduction


Control systems




Product claims



Company controls


Contact the company


Contact IFPMA


Recent developments



Beyond 2012

Conclusions

Abbreviations

Competing interests



Acknowledgements

Author details

References













Global




Regional







National


















Etickyacute Kodex


























































































































sab [14]




ening is optional






































Practice























































































Abstract

Introduction


Control systems




Product claims



Company controls


Contact the company


Contact IFPMA


Recent developments



Beyond 2012

Conclusions

Abbreviations

Competing interests



Acknowledgements

Author details

References













































































































sab [14]




ening is optional






































Practice























































































Abstract

Introduction


Control systems




Product claims



Company controls


Contact the company


Contact IFPMA


Recent developments



Beyond 2012

Conclusions

Abbreviations

Competing interests



Acknowledgements

Author details

References


































Practice























































































Abstract

Introduction


Control systems




Product claims



Company controls


Contact the company


Contact IFPMA


Recent developments



Beyond 2012

Conclusions

Abbreviations

Competing interests



Acknowledgements

Author details

References










































































Abstract

Introduction


Control systems




Product claims



Company controls


Contact the company


Contact IFPMA


Recent developments



Beyond 2012

Conclusions

Abbreviations

Competing interests



Acknowledgements

Author details

References