pif code of ethics 08 final (id 3978)

8/3/2019 PIF Code of Ethics 08 Final (ID 3978)

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Code of Ethics

PHARMA INDUSTRY FINLAND (PIF)2008


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CONTENTS

I Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3

II Code for the marketing of medicinal products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4

III Code for the good medical sales representation practices . . . . . . . . . . . . . . . . . . . . . .12

IV Code for the co-operation between the pharmaceutical industryand patient organisations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14

V Code for health awareness information and other information onhealth and diseases targeted at consumers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15

VI Monitoring of the compliance with the codes, preliminary inspection,sanctions and other stipulations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18


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I INTRODUCTION

Correct information on pharmaceuticals promotestheir correct use. The purpose of marketing activities,sales promotion and advertising is to provide health-care professionals with updated information onmedicines for the prevention, alleviation and cure ofdiseases. As a result, there is less need for moreexpensive medical treatments, people are able tomaintain their ability to work or restore it morequickly, and as medicines help to maintain betterhealth, the overall healthcare expenditure is smaller.The marketing of non-prescription medicines to con-sumers provides them with information about theavailable treatment options in cases where the treat-ment of the illness does not call for medical atten-tion, directing the consumers towards the correct andsafe use of medicines.

The objective of the voluntary guidance is toincrease the reliability of the marketing of medicinesand to promote the information value of the market-ing message vis--vis the consumers and healthcareprofessionals, thus contributing to an appropriate useof medicines. The research, development and produc-tion of medicinal products meet the highest qualitystandards. The same objective also applies to the

marketing of medicinal products.The pharmaceutical industry performs researchon medicines, introducing them to the market for thepharmacy professionals as well as physicians, dentistsand veterinarians to dispense, prescribe or use for thetreatment of the patients. The healthcare profession-als also play a core role in the collecting of the phar-maceutical research and other information. In orderto guarantee pharmaceutical development and prop-er use of medicines, the co-operation between thepharmaceutical industry and the healthcare profes-

sionals is of vital importance. The co-operation musttake place in the framework of unambiguous andtransparent guidelines.

Representing the medicine users and their closeones, the patient organisations play a significant role.

The co-operation between patient organisations andpharmaceutical companies is necessary but it mustbe transparent by nature, conducted in the frame-work of clear guidelines so that the autonomy of bothparties is safeguarded.

The consumers and patients have an increasingneed to obtain information on various diseases. Thepharmaceutical industry can also provide such infor-mation, having substantial information on variousdiseases as well as on their prevention, diagnosis andtreatment. The information disseminated by thepharmaceutical companies is complementary to thatgiven by, among others, the healthcare professionalsand the Authorities, and it has to meet the high eth-ical requirements related to the quality and objectiv-ity of the information.

The legislator and the medicines control authori-ties regulate and monitor some of the themes cov-ered by the present Code of Ethics. The voluntary eth-ical control by the pharmaceutical industry is com-plementary to their work.

The present Code of Ethics incorporates the fol-lowing guidelines and instructions regarding phar-maceutical marketing and other information dis-tributed by the pharmaceutical companies, as well asthe co-operation between the pharmaceutical indus-

try and its various stakeholder groups.- Code for the Marketing of MedicinalProducts

- Code for the Good Medical SalesRepresentation Practices

- Code for the co-operation between thepharmaceutical industry and patientorganisations

- Code for health awareness information andother information on health and diseasestargeted at consumers

Moreover, the Code of Ethics also includes a sec-tion on the monitoring of the compliance of theabove codes, on preliminary inspection operations, onthe sanctions following from non-compliance as wellas on certain other stipulations.

Code of EthicsPharma Industry Finland (PIF) 2008


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The Code of Ethics sets forth generally acceptedoperative principles which the pharmaceutical com-panies shall comply with in their operations. In partic-ular, the purpose of the Code of Ethics is to ensurethat the healthcare professionals and consumersreceive correct information on the medicines and theiruse and that the co-operation between the pharma-ceutical industry and its co-operation partners istransparent, respecting the autonomy of both parties.

Distributing information on medicines is theresponsibility and social obligation of any pharma-ceutical company. Without it, the information aboutnew medications would spread slowly which wouldbe a disadvantage, especially for patients awaitingtreatment. The pharmaceutical companies play acentral role in the production and distribution ofinformation on medicines.

The principles behind the Code for the Marketingof Medicinal Products are based on legislation relat-ing to medicinal products, marketing, consumer pro-tection and competition, on the International Code ofMarketing Practice as well as on the Codes of Phar-maceutical Marketing Practice published by EFPIA(European Federation of Pharmaceutical Industriesand Associations) and IFPMA (International Federa-tion of Pharmaceutical Manufacturers Associations).In formulating the Code, the following EU legislationhas also been taken into account: the Directives2001/83/EC and 2004/27/EC of the European Parlia-ment and of the Council on the Community coderelating to medicinal products for human use; theCouncil Directive 89/552/EEC and 2007/65/EC on thecoordination of certain provisions laid down by law,Regulation or administrative action in Member Statesconcerning the pursuit of television broadcastingactivities; the Directive 2005/29/EC of the EuropeanParliament and of the Council concerning unfairbusiness-to-consumer commercial practices in theinternal market; as well as the Council Directive

84/450/EEC relating to the approximation of thelaws, regulations and administrative provisions of theMember States concerning misleading advertising.

The Code for the Good Medical Sales Representa-tion Practices is a recommendation jointly issued byPharma Industry Finland and Association of FinnishLocal and Regional Authorities. In preparing theabove document, the recommendation for quality cri-teria for sales promotion of medicines issued byNational Agency for Medicines in 2007 was alsotaken into consideration.

The instructions regarding the co-operationbetween the pharmaceutical industry and patientorganisations have been prepared in line with thecorresponding EFPIA Code of practice from 2007, inparticular.

II CODE FOR THE MARKETING OFMEDICINAL PRODUCTS

SCOPE OF APPLICATION

1 Relationship to other regulations. In the mar-keting of medicinal products, the companies mustcomply not only with legislation and guidance givenby the Authorities but also with this Code. In theirinternational marketing operations, the pharmaceuti-cal companies must meet, at a minimum, the require-ments imposed by the EFPIA and IFPMA Codes.

The present Code must also be followed in mar-keting targeted to Finns abroad or in internationalconferences. In these cases, the marketing operationsmust also be in line with the rules and regulationsissued by the local Authorities.

The Supervisory Committee for the Marketing ofMedicinal Products and the Inspection Boards onlyapply the present Code.

2 Definitions. The term pharmaceutical compa-ny refers to an enterprise engaged in the marketingor importation of medicines, to a holder of a market-ing authorisation or to other business enterpriseinvolved in marketing of medicinal products.

The marketing of medicinal products refers toany information, order acquisition or incentive mea-sures, with the purpose of promoting the prescrip-tion, supplying, purchase or use of medicines. Suchmeasures include, for instance, advertising targetedat consumers as well as the advertising and sales pro-motion targeted at healthcare professionals, theoperation of medical sales representatives and thedistribution of free samples of medicinal products.

Healthcare professionals refers to persons who intheir work prescribe, handle, distribute or in practiceadminister medicines to patients or who otherwiseneed medicine-related information in their work.

Consumers refers to all persons other than thehealthcare professionals.

3 Scope of application. The Code applies to allforms of marketing utilised by the pharmaceuticalcompanies in their marketing operations, from per-son-to-person marketing to the operations takingplace through the media. As appropriate, the Codealso applies to the marketing of veterinary medicines.

The following does not fall within the scope ofapplication of the Code

a) products other than those meeting thedefinition of medicines set forth in theMedicines Act (395/1987);

b) the summary of product characteristics, thepackage leaflets and labelling;


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c) the replies to specific questions about themedicine and the non-commercial materialeventually related to the reply;

d) informative notices regarding, for example,changes in packaging or warnings aboutadverse effects;

e) product and price lists which do not containany claims related to the medicinal product;

f) general statements related to health anddiseases if the direct objective of suchstatements is not the promotion of the salesof a medicine;

g) scientific material published by the pharma-ceutical industry, if the direct objective ofsuch material is not the promotion of thesales of a medicine;

h) information focusing primarily on theoperations of the company, as well ascorporate image marketing and businessentertainment, with no direct objective ofpromoting the sales of a medicine;

i) press releases based on the statutoryinformation liability of the pharmaceuticalcompanies; and

j) distribution of free starter packs to ahealthcare unit by the personnel of apharmaceutical company.

GENERAL PRINCIPLES

4 Responsibility for compliance with the Code.The pharmaceutical company is always responsiblefor the compliance of its marketing with this Code.The pharmaceutical company is also responsible forthe marketing if it has assigned its marketing opera-tions to a third party.

5 Precondition related to the marketing authori-

sation. It is not permissible to market medicines otherthan those with valid marketing authorisations.

6 Nature of marketing. Pharmaceutical market-ing and the information on the medicine given inmarketing contexts must be matter-of-fact, present-ing the various effects of the medicine in a compre-hensive manner, thus conducive to a correct and safeuse of the medicine. The information on the medicinemust be updated and based on the latest knowledge.The commercial nature of pharmaceutical marketing

must not be hidden, and the marketing must bedesigned so that the recipient easily recognises it aspharmaceutical marketing.

The marketing of a medicine must be based onthe most recent adopted summary of product char-

acteristics. Minor deviations from the summary ofproduct characteristics are acceptable in case of seri-ous diseases, if there is clear proof that the treatmentaccording to the latest knowledge is superior to ear-lier treatments. Such marketing must, however, high-light the valid summary of product characteristics.

The marketing material must not fail to mentionsuch material facts, the omission of which may givean erroneous impression of the medicine, its compo-sition, origin, medical significance or quality.

Marketing may not refer to a clinical trial in sucha way as to give an erroneous impression of the out-come, scope or significance of the trial.

Without justified reason, the marketing of medic-inal products must not use the word safe or main-tain that the product has no adverse effects or thatits use is not associated with the risk of dependency.

A medicine must not be marketed as a noveltyafter one year of its introduction to the market. Like-wise, the change in the price, reimbursement status,indication, package size or other similar aspect mustnot be marketed as a novelty after one year from theimplementation of such changes.

The information on the medicine given in market-ing contexts must be reliable, and it must not containsuch verbal or visual presentations or other effects asmay be misleading.

The information on a medicine must be given insuch a manner as to allow for the recipients to famil-iarise themselves with the information in the adver-tisement without difficulty.

It is not the purpose of this Code to prevent theexchange of medical or other scientific information.

7 Reminder advertisements. If the only purposeof a medicine advertisement is to be a reminder ofthe name of the medicine, the advertisement maycontain only the name or trade name of the medicine,the name of its active substance and the trademark

of the medicine, as well as the name of the holder ofthe marketing authorisation, the marketer, importeror manufacturer and its company logo. The name ofthe medicine refers to its trade name, accompaniedby the strength and pharmaceutical form.

8 Good practices of the marketing of medici-nal products. The marketing of medicinal productsmust comply with good practices in a way thatinspires trust and respect. Insulting or tastelessexpression are not allowed, and the marketing must

not contain such verbal or visual presentations asmay denigrate or offend any professional group,patient group, product or pharmaceutical companyor cast a suspicion on them. The marketing mustnot contain violence, sexual behaviour or criminal


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actions, or any reference to them without a directassociation with the approved indication of themedicine.

The marketing of medicinal products must pro-mote the good public image of the pharmaceuticalindustry. Such marketing must not jeopardise thepublics trust in the impartiality of prescribing or dis-pensing of medicines.

9 Comparisons. The comparisons between dif-ferent medicines, active substances, excipients orother characteristics must be matter-of-fact and reli-able. The visual and price comparisons between prod-ucts must be clearly justified. The objects of compar-ison must be clearly specified.

The price comparisons must include mutuallycomparable packages and dosages. Price comparisonsmust clearly indicate the medicines involved andtheir trade names.

Comparisons between active substances must bebased on scientific evidence.

If comparisons are used, the time when the com-parison was made or a study report was publishedmust be indicated.

The requirement of matter-of-factness and cor-rectness of information are particularly underlined asfar as comparisons are concerned.

In the marketing of non-prescription medicines toconsumers, special attention must be paid to the lim-itation under Article 13, Paragraph 1 b) of the presentCode.

10 Scientific service unit. The pharmaceuticalcompanies must have a scientific service unit respon-sible for the information distributed on the medicinesof the company and for the correctness of such infor-mation as well as on the control of the non-inter-ventional studies under Article 37 hereunder.

The scientific service unit must employ at least

one physician or pharmacist with a Master's or Bach-elors Degree, with adequate conversance and experi-ence, responsible for the approval of the companysmarketing measures before their publication, includ-ing events, advertisement gifts and market studies.This person must ensure that the final form of themarketing measure complies with the present Codeand the legislation on pharmaceuticals marketing.Moreover, he or she must control the implementationof the non-intervention studies under Article 37,ensuring that the study plan complies with the pre-

sent Code and the applicable legislation.Any company staff member involved in the mar-keting of medicinal products or non-interventionstudies must be fully aware of the rules contained inthe present Code.

INSTRUCTIONS FOR GOOD CONSUMERMARKETING PRACTICE

11 Pharmaceuticals marketed to consumers. Onlynon-prescription medicines can be marketed to con-sumers.

However, it is permissible to distribute publicinformation on a vaccination campaign approved bythe competent Authorities.

According to this Code, it is not prohibited to tar-get information on prescription-only medicines atconsumers if such information only contains infor-mation that is equal to the details included in thesummary of product characteristics or the packageleaflet.

According to this Code, it is neither prohibited totarget impartial and matter-of-fact information atconsumers on the characteristics of diseases or issuesrelated to their prevention, diagnosis and treatment.Such health information can also refer to prescrip-tion-only medicines if the information is of impartialand matter-of-fact nature, covering all alternativemedicines on the market. In such cases, sufficientinformation on non-medicinal forms of treatmentmust also be given.

In questions related to personal health, the con-sumers must be advised to turn to their physician orother healthcare professionals.

It is prohibited to market medicinal products con-taining narcotics or psychotropic substances (asreferred to in the international conventions on nar-cotics and psychotropic substances) to consumers.

Disguised advertising of medicines is prohibited.

12 Minimum information in an advertisement fora medicine. An advertisement for a medicine mustcontain at least the following information:

a) name of the medicine and the activesubstance if the medicine in question only

contains one active substance;b) indication of the medicinal product;c) necessary information for the correct and

safe use of the medicine as well as anyspecial precautions of use, interactions andadverse effects significant for the safe use ofthe medicine;

d) explicit advice to read the package leaflet orthe user instructions contained in thepackage;

e) name of the marketing authorisation holder,

importer or marketer; andf) in the marketing of veterinary medicines,also the approved target species of themedicine, as well as the maximum residuelimits.


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As an exception to the above, reminder advertise-ments referred to under Article 7 above are permitted.

13 Prohibited information. A pharmaceuticaladvertisement must not give information or impres-sion which

a) gives an impression that consulting aphysician or the treatment recommended bythe physician is not necessary for a diseasethat would normally require medical care;

b) suggests that the effects of the medicine areguaranteed and that they are not associatedwith any adverse effects, or that the effectsare equal or superior to those of anothertreatment or medication;

c) suggests that the medicine would improvethe users normal good health, or claimwithout justification that their health woulddeteriorate without the use of the medicinalproduct;

d) is targeted at children;e) suggests that the medicinal product is a

nutritive product, cosmetic product or otherconsumer good;

f) suggests that the efficacy or safety of themedicinal product is based on its naturalorigins;

g) is liable to lead, in self-medication use, towrong diagnosis or treatment due to adetailed case report contained in it;

h) refers to recovery allegations throughinappropriate, intimidating or misleadingexpressions;

i) uses inappropriate, intimidating ormisleading expressions or visualpresentations of the changes caused by thedisease or trauma in the body, or of theeffects of the medicinal product in the bodyor in a part thereof; or

j) contains a reference to the medicine havinga marketing authorisation.Misleading or inappropriate expressions are alle-

gations or other expressions or advertisement ele-ments which

- emphasise the presence or lack of suchingredients in the product as have nomaterial pharmacological or health-promotional significance;

- exaggerate or over-dramatise symptoms ortheir alleviation;

- give a misleading or one-sided picture of theefficacy of the product; or- strongly divert the consumers attention

from the subject matter of theadvertisement.

14 Use of study results and the use of sources.The study results and their sources used in pharma-ceutical marketing must be reliable, and they mustnot be used to give a wrong or misleading impressionof the medicine or its medical significance. Refer-ence to the source material must be made so thatthe source can be identified without difficulty.

15 Special groups. Pharmaceutical marketingmust not exploit the non-expertise or distress ofconsumers or consumer groups.

Special prudence must be applied to the use ofchildren in pharmaceutical advertisements. Market-ing of medicines intended for childrens use must betargeted at adults.

16 Use of prestige or celebrity. Pharmaceuticalmarketing must not contain direct and active rec-ommendations to use the medicine, given by scien-tists, healthcare professionals or celebrities.

17 Sponsorship. A company can engage in spon-sorship only through its business name or logo.

Sponsorship comprises any operations the pur-pose of which is to support one or several persons,company or event, or part thereof, financially or oth-erwise, in such persons or partys scientific, artistic,sport-related or other pursuit and which entail rightsconferred to the sponsor to promote its own businessoperations by using the sponsored person or party.

When sponsoring TV or radio broadcasts, thesponsorship element must be clearly and understand-ably separate from the rest of the programme offer orprogramme intros through the showing of the com-pany name or logo. The name or logo of the compa-ny must be shown immediately before the pro-gramme or at its end (sponsor logo).

Sponsorship must not encourage the viewers topurchase the sponsors or a third partys products.

For the rest, sponsorship is subject to the market-ing instructions contained in the present Code.

18 Co-operation with patient organisations. Phar-maceutical companies can collaborate with patientorganisations. Such co-operation must be transparentand in line with the stipulations of this Code, and ininternational co-operation, also with the stipulationsof the applicable EFPIA Code. Moreover, the co-opera-tion must comply with the Code for the co-operationbetween the pharmaceutical industry and patient

organisations issued by Pharma Industry Finland.

19 Forbidden measures in consumer marketing.Pharmaceutical marketing to consumers must notinvolve competitions with prizes.


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If the consumer buying a non-prescriptionmedicine will receive another commodity or otherbenefit (the so-called giveaway) at the same price,such an offer must not entice the consumer to pur-chase or use the medicine unnecessarily, and it mustnot endanger the appropriate dissemination of theinformation on the correct and safe use of medicinesto consumers.

It is forbidden to distribute free samples ofmedicinal products to consumers.

INSTRUCTIONS FOR GOOD PRACTICE INMARKETING TARGETED AT HEALTHCAREPROFESSIONALS

20 Objective of information on a medicine. Theobjective of the information given on a medicine is tomaintain and promote the professional expertise ofthe healthcare professionals related to the use ofmedicines, as well as to promote patient safety.

21 Targeting of pharmaceutical marketing mea-sures. Non-prescription medicines can be marketedto all healthcare professionals. The marketing of pre-scription-only medicines must be targeted at suchpersons authorised to prescribe or supply medicinesas can reasonably be expected to need the informa-tion on the medicine in question. As regards the pre-scription-only medicines, the other groups of health-care professionals can only be subject to guidanceand training related to the correct and safe use of themedicine.

A pharmaceutical company must not deliveradvertising or other direct marketing material to per-sons who have declared they do not want it.

22 Contents of information on a medicine. Allinformation on a medicine must contain, at least, the

information which is consistent with the most recentadopted summary of product characteristics of theproduct and which is essential for the physician to beable to prescribe the medicine. The information on amedicine will contain the legal conditions of supplyas well as health insurance reimbursement criteria,average medication costs as well as the retail pricesof different package sizes, if possible.

As an exception to the above, reminder advertise-ments referred to under Article 7 above are permit-ted.

Marketing material made available at exhibitionstands or distributed to the participants in interna-tional events may refer to medicinal products or indi-cations of products with no marketing authorisationin the country where the event is organised if

a) this material is accompanied withinformation on the countries where theproduct or indication has a marketingauthorisation, and the material clearly showsthat the product or indication has nomarketing authorisation in the countrywhere the event takes place;

b) the information on the medicine isaccompanied with a clarifying noticespecifying that the information differs inaccordance with the marketingauthorisations in force in each separatecountry; and

c) this is permitted by the national legislationof the place where the event takes place.

23 Special requirements related to informationon a medicine. The information on a medicine must

- be accurate, correct and verifiable;- give objective and impartial information on

the beneficial and adverse effects of themedicine;

- be clear and easily understandable; and- be sufficiently complete so that the reader

can form an opinion on the therapeuticvalue of the medicinal product.

24 Dating of marketing material. Pharmaceuticalmarketing material must indicate the date (monthand year) in which the material was compiled, or thelatest revision was made.

25 Results of clinical trials. Any study resultsincluded in the material for the marketing ofmedicinal products must have been published inarticle form in a scientific journal. Moreover, it ispermissible to include in the material for the mar-keting of medicinal products articles which havebeen accepted for publication in a scientific jour-

nal, as well as the results of trials or studies sub-mitted to the regulatory Authorities in associationwith marketing authorisation applications.

The use of unpublished materials, such asabstracts, posters or similar materials which have notbeen published in scientific journals, is prohibited.

As an exception to the above, reference can bemade to such study results which do not meet thecriteria in Paragraph 1, if they can be deemed to havematerial significance for the medication of patients.New information has material significance if it refers

to a serious disease and if there is clear proof that thenew treatment is superior to the earlier treatments.The unpublished study results must meet the

same quality criteria applied to published results. Theuse of unpublished study results is subject to the


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consent of the responsible investigator. If the phar-maceutical marketing refers to unpublished studyresults, additional information on the contents mustbe given upon request.

The reference to study results must be associatedwith explicit information on the trial arrangements(e.g., in vivo, in vitro, animal testing).

26 Sources of information in the marketing ofmedicinal products. Reference to the materials usedas the source of the information in the marketing ofmedicinal products must be made in a mannerallowing the identification of the source without dif-ficulty. Quotations, tables, figures and other corre-sponding illustrative material must be reproducedaccurately so that the subject contents are notchanged.

If the information is based on material related toanother medicine or pharmaceutical form, the infor-mation must not unjustly lead to the assumption thatthe material would refer to the medicine or pharma-ceutical form being marketed.

As concerns the use of results of clinical trials inthe marketing of medicinal products, see Article 25 ofthe Code for detailed instructions.

27 Information liability. If the clinical use of themedicine reveals new important aspects, informationthereof must be given in an appropriate manner.

Pharmaceutical information on new seriousadverse effects, contraindications, limitations of indi-cations or withdrawal of production lots ormedicines, must be given in writing. The expressionErittin trke Mycket viktigt (Extremely impor-tant) or similar phrases can be used only in such con-texts.

28 Medical sales representatives. In order toensure the distribution of correct information, the

pharmaceutical company must ensure that a persongiving verbal information in the context of medicinalproduct marketing meets, or he/she will be trained,no later than within one year from the start of med-ical sales representative work, to meet at least thelevel of a registered medical sales representative(RLE) or registered medical sales representative ofself-care medicines (ILE). Verbal information mustmeet the criteria imposed in the Code on any infor-mation and it must be based on written documents.

Moreover, the specific Code for the Good Medical

Sales Representation Practices must be followed inmedical sales representation events taking place inthe public healthcare units. The guidance in questionmust also be followed, as applicable, in the sales rep-resentation events taking place in pharmacies and in

the framework of private healthcare, targeted at per-sons entitled to prescribe or supply medicines.

During their visits, the medical sales representa-tives must provide their clients with the summary ofproduct characteristics of each medicine presented aswell as the respective price and reimbursement data,or make the information available to them throughother means.

All the significant information given to the med-ical sales representatives in relation to the clinicaluse of the medicine they are presenting, and espe-cially to the possible adverse effects of the same,must be forwarded by them to the scientific serviceunit referred to under Article 10 above.

At the request of the Secretary of the InspectionBoard or the Supervisory Commission, the companymust provide these bodies with the presentationmaterial used by the medical sales representative.

29 Events organised or sponsored by the pharma-ceutical industry. The emphasis of the events must berelated to pharmaceutical information or research orother medical education so that most of the timespent by the participants involves a scientific pro-gramme or training. The participants must always beprovided with a written programme of the event.

When the company organises or sponsors anevent, this must always be made clear.

Pharmaceutical companies can participate in theexpenses of further or complementary training only ifthe company is provided with sufficient conditions toactively distribute information.

Such events must be organised in a place that isappropriate in view of the demands of scientific ortraining programme implementation. The eventsmust not be organised in venues that are renownedfor their entertainment facilities or are extravagant.The event can be organised abroad if there is a validscientific or training-related justification to do so.

The event itself and the travels must be organisedso that, excluding the travelling days, most of thetime spent by the participants involves a scientificprogramme or training.

The target group of the events must be constitut-ed by healthcare professionals, and the expensesincurred for the events must be materially related tothe scientific programme or training.

If persons employed by the public healthcare areprovided with the opportunity to participate, duringworking hours, in events organised or sponsored by

the pharmaceutical industry, the invitation to theevent must be addressed to the healthcare unit inquestion, considering the instructions and ruleswhich apply to the allocation of support by externalparties within that healthcare unit.


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30 Hospitality. In events or sessions organised orsponsored by the pharmaceutical industry, the usuallocal norms of hospitality will be followed. The hos-pitality can extend only to the registration costsrelated to a scientific or training event, as well as tothe travelling, accommodation and meal expenses.Hospitality must be reasonable, matched to the cir-cumstances and secondary in view of the purpose ofthe event, and it must not be extended to partiesother than the healthcare professionals.

An exception to the stipulations in Paragraph 1,the representatives of pharmaceutical companiescan, however, participate as guests in the eveningprogrammes organised in association with medicalevents, training sessions of specialist societies andcorresponding scientific or training events, the day-time scientific or training programmes of which thepharmaceutical companies have sponsored, if

a) there is more than one companysponsoring the scientific or trainingprogramme;

b) the sponsorship allocated to theorganisation of the scientific or trainingprogramme is justified in extent;

c) the hospitality related to the eveningprogramme is reasonable and suitable inview of the situation, and the eventualentertainment element is secondary;

d) the eventual participation fee charged forthe evening programme is the same for eachparticipant;

e) no single company is the designated sponsorof the evening programme; and

f) no medicines are marketed during theevening programme.

The healthcare professionals must not be offeredor paid a compensation merely for their use of timeto participate in an event arranged or sponsored by apharmaceutical company.

The obligation to arrange for hospitality or forother benefits, such as economic compensations,must not constitute the precondition for the organi-sation of an appropriate information event.

The hospitality must not extend beyond theexpenses a typical guest of the event would be pre-pared to cover themselves, should they pay for theirown expenses.

31 Incentives, advertising gifts and other supportmeasures. The distribution and offer of advertising

gifts related to the marketing of medicinal productsmust be reasonable. The advertising gifts must haveminor economic significance for the recipient, andthey must have a bearing on their professional oper-ation.

Healthcare professionals must not be offered orotherwise provided with direct or disguised economicincentives or inducements.

It is prohibited to support the leisure activities ofhealthcare professionals or their associations.

32 Market research. Market research can be usedto obtain information, e.g., about medicinalbehaviour, use of medicines and treatment practices,with the objective of promoting the correct use ofmedicines and patient safety. In organising marketresearch, special attention must be paid to the pro-tection of the privacy of the patients and those whoare the objects of the research. The questions mustrespect the objectiveness principle. Market researchmust not have an impact on the treatment of indi-vidual patients.

Market research must be of limited scope, such asone-off telephone interviews or questionnaires sentby mail, email or the Internet, and the opinion of thehealthcare professionals must not be asked repeated-ly, considering the frequency of the contacts in gen-eral and the contacts related to a specific researchproject in particular.

The compensation paid for the participation ofthe research must be of reasonable economic value.

33 Competitions. The competitions organised formarketing purposes must be associated with thecompany or the product. The prizes must be of rea-sonable economic value and associated with the pro-fessional activities of the participants.

34 Free samples of medicines. Free samples ofmedicines can be given only to persons who are autho-rised to prescribe or supply them, who factually pre-scribe or supply the medicinal product in question, andtherefore benefit from the opportunity to familiarisethemselves with the product in question. A free sam-

ple of medicine refers to the smallest marketed pack-age size of the medicinal product, given for free to therecipients to allow them to familiarise themselves withthe product. Each recipient can be given only one freesample of each medicinal product, strength and phar-maceutical form in one calendar year.

A prescription-only medicine sample can only begiven to a person authorised to prescribe suchmedicines. If the prescription of a medicine is subjectto a supply limitation, such sample can only be givento a physician who is entitled to prescribe such

medicines. Dosage devises can also be given to otherpersons. Narcotics, including psychotropic substancesas well as substances with primary effects on thecentral nervous system, must not be distributed asfree samples.


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Free starter packages must not be used in themarketing of medicinal products.

A free medicine sample will be delivered againsta written request provided with a signature and date.Each sample must be accompanied with a respectivesummary of product characteristics.

The pharmaceutical company must keep recordsof the free samples of medicines given in each calen-dar year. These records must be kept until the end ofthe year following the calendar year to which therecord liability refers. On request, the records must besubmitted to the Supervisory Commission for theMarketing of Medicinal Products or to InspectionBoard II subject to it.

35 Donations and grants for the support ofhealthcare or research. Donations, grants and bene-fits in kind to institutes, organisations or associa-tions, the members of which are constituted byhealthcare professionals or which provide healthcareor are engaged in research and which do not other-wise fall within the scope of application of the pre-sent Code, are permissible only if their purpose is tosupport healthcare or research and the donator or theparty giving the grant documents the respectiveinformation, keeping records of them. The donationsor grants must not constitute an incentive for therecommendation, prescription, purchase, supply, salesor administration of a particular medicinal product.

Making donations or giving grants to individualhealthcare professionals is not permitted, with theexception of grants for investigator-initiated clinicaltrials with an appropriate study protocol, which havebeen approved by the regulatory Authorities andethics committee and which otherwise comply withthe requirements set in the legislation for clinicaltrials.

The pharmaceutical companies are encouraged topublish the information on the donations, grants and

benefits in kind in line with the present Article.

36 Use of consultants. The use of healthcare pro-fessionals as a group or as individual consultants oradvisers is admissible. For example, they can act asspeakers or chairpersons in meetings or trainingevents, participate in medical or scientific studies orclinical trials or participate in the meetings of advi-sory committees or participants of market research incases where compensation is paid for their participa-tion or their travelling costs are reimbursed.

The arrangements related to such consultant orother services must meet the following criteria:a) Before the services start, a written contract

is made with the person in question or thecompany owned by the person, specifying

the nature of the services offered and thecriteria for the fee payable for them in linewith Paragraph g) hereunder;

b) The service need must be identified clearlybefore the request for the services and thesigning of the eventual contracts made withthe consultants;

c) The selection criteria of the consultants aredirectly related to the identified serviceneeds, and the persons responsible for theselection of the consultants have sufficientexpertise to evaluate whether the healthcareprofessionals in question meet such criteria;

d) The number of the healthcare professionalsretained for the job must not exceed thereasonable number required to meet theservice need;

e) The pharmaceutical company constituting aparty to the contract keeps records of theservices provided by the consultants;

f) The use of healthcare professionals asservice providers does not constitute anincentive to recommend, prescribe, purchase,supply, sell or administer a particularmedicinal product;

g) The fee payable for the services is reasonableand in line with the valid market price ofsuch services. Nominal consultantarrangements must not be used as a pretextfor the compensations paid to healthcareprofessionals.

In their written consultant contracts, the phar-maceutical companies must include a term wherebythe consultant is liable to disclose his or her consul-tation relationship to the company whenever he orshe writes or speaks in public about the issue consti-tuting the object of the contract or otherwise relatedto the company. Likewise, the companies providingpart-time employment to healthcare professionals

who continue to exercise their profession, are invitedto ensure that such a person is obliged to disclosehis/her employment relationship with the companywhenever he/she writes or speaks in public about theissue constituting the object of this employmentrelationship or otherwise related to the company. Thestipulations under this Paragraph also apply to writ-ten or oral presentations other than the marketing orsales promotion of medicines.

This stipulation does not apply to the marketresearch referred to under Article 32.

If a healthcare professional participates as a con-sultant in an event, the stipulations under Article 29and 30 regarding the events arranged and sponsoredby the pharmaceutical industry and the respectivehospitality also apply.


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37 Non-interventional studies on medicines witha marketing authorisation. Non-interventional stud-ies refer to trials where the medicinal product is pre-scribed in the usual manner in line with the condi-tions of the marketing authorisation. The treatmentstrategy chosen for an individual patient is not deter-mined in advance in the study protocol but is basedon the normal treatment practice. The decision on theprescription of a medicine is independent of theinclusion of the patient in the study. No additionaldiagnostic or other monitoring procedures areapplied to the patients. Epidemiological methods areused for the analysis of the information collected.

Prospective non-interventional studies, wherebyindividual healthcare professionals collect patientdata, are permitted under the following conditions:

a) The study is made for a scientific purpose;b) The study is accompanied with a written

study protocol and with written contractsbetween the healthcare professionals or theunits at which the study will take place andthe company financing the study. Thecontracts must specify the nature of theservices provided and the criteria of thecompensation payable for the services;

c) The compensation payable for the services isreasonable, reflecting the fair market priceof such services;

d) Whenever possible, the study protocol isapproved by an ethics committee;

e) The Personal Data Act is followed inconnection with the study;

f) The study does not constitute an incentivefor the recommendation, prescription,purchase, supply, selling or administration ofa particular medicinal product;

g) The companys scientific service unit hasapproved the study protocol, monitoring theprogress of the study;

h) The company must analyse, or have anotherparty analyse, the results of the study, andthe scientific service unit must be providedwith the respective summary within areasonable time. The scientific service unitmaintains records of these summaries,stored for a reasonable period of time. Thesummary report must be sent to allhealthcare professionals participating in thestudy, and, upon request, also to the use ofthe competent bodies of the Supervisory

Commission for the Marketing of MedicinalProducts. If the results of the study areimportant for the evaluation of the risk-benefit relationship of the medicinalproduct, the summary report must also be

sent immediately to the competentAuthorities;

i) The medical sales representatives canparticipate in the implementation of thestudy in an administrative capacity only,under the control of the scientific serviceunit. The scientific service unit must ensurethat the medical sales representatives havereceived proper training for theimplementation of the study.

Corresponding principles must also be followed,as applicable, to the epidemiological studies, registerstudies and other studies of retrospective nature.

III CODE FOR THE GOOD MEDICALSALES REPRESENTATION PRACTICES

38 Medical sales representations. The term med-ical sales representation refers to the meetings,mainly taking place on the initiative of the pharma-ceutical companies, between their medical sales rep-resentatives and physicians. Their objective is to dis-seminate information on the medicinal product pre-sented, in order to promote the sales of the productin question. At its best, medical sales representationprovides the actively practicing physicians and phar-macists with updated state-of-the-art informationon medicines and their correct use. In addition tomarketing, the medical sales representative transmitsinformation on the results of the clinical trials on themedicine being presented, to promote the correct useof the medicinal product in question.

39 Purpose of the Code. The purpose of the pre-sent Code is to provide instructions for the healthcareunits using medicines and the pharmaceutical com-panies marketing them, regarding the medical repre-sentation taking place during the physicians working

hours. However, the ultimate decision on the imple-mentation of medical sales representation events istaken by the management of the healthcare unit inquestion.

40 Enhancing proper pharmacotherapy. Theactivities of the medical sales representatives must befitted in as a flexible part of the working day of thehealthcare unit and the physicians working there, sothat they enhance proper pharmacotherapy withoutdisturbing the operation of the unit or the patients.

41 Medical sales representation related to pre-scription-only medicines. Medical sales representationevents to promote the sales of prescription-onlymedicines can be targeted only at persons entitled to


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prescribe or dispense such medicines. However, theprinciples of this Code must also be followed, as appli-cable, in situations in which the representatives ofpharmaceutical companies instruct and train nurses inthe correct and safe use of the medicine.

42 Good medical sales representation practices.The pharmaceutical companies and healthcare unitsshould respect the following principles of good medi-cal sales representation practices in the respectiveevents:

a) The medical sales representative must possessthe necessary basic knowledge in order to beable to provide as complete informationabout the medicinal product as possible. Themedical sales representative must have theregistered medical sales representative (RLE)or registered medical sales representative ofself-care medicines (ILE) diploma, orotherwise possess the knowledge required forthe proper performance of the work.

b) The medical sales representations must bebased on advance agreements on the visittimetable.

c) The healthcare unit compiles clearinstructions regarding the procedure for thepharmaceutical companies to book medicalsales representation visits, also indicatingrespective contact persons. The instructionsare based on solutions that are purposefulfrom the perspective of the units operation.The instructions contain information as tothe person and the procedure (by phone, byemail) and times of booking the medicalsales representation visits. Instructionsspecific to each unit should be given to thepharmaceutical companies, for example,through Pharma Industry Finland. Thepharmaceutical companies must follow the

instructions given by the healthcare unitregarding the booking of the visits in orderto avoid unnecessary contacts that mightdisturb the operation of the unit.

d) The medical sales representation activitiestaking place in the healthcare unit premisesmust be arranged in the physiciansconsulting room, the medical staffs commonroom or other similar premises assigned bythe healthcare unit for presentationpurposes, to allow for the presentation to

take place in privacy, without disturbing theother activities of the healthcare unit. Themedical sales representations can also bearranged in premises other than those of thehealthcare unit.

e) Reasonable time must be reserved for themedical sales representations, and theparties should, as far as practicable, respectthe agreed starting and ending hours.Eventual cancellations of the visits must bemade in good time.

f) Medical sales representation must be basedon the therapy-approach: the medicinespresented must be necessary in view of thework of the physicians participating in theevent, considering their experience andspeciality, the novelty of the medicinalproduct being presented or the new researchdata on the medicine. In their work, themedical sales representatives must focusprimarily on the medicinal productscheduled for the event in question.

g) The information about the medicine given atthe medical sales representation event mustcorrespond to the latest adopted summary ofproduct characteristics and be accurate,correct, reliable as well as sufficientlycomplete and clear. The material used in thepresentation must give a true and fair overallpicture of the medical significance of themedicinal product being presented.

The marketing material must alwayscontain information in line with the adoptedsummary of product characteristics,indicating the correct and safe use of themedicine. Moreover, the information on themedicinal product must contain the legaldispensing conditions, health insurancereimbursement criteria, average medicationcosts as well as the retail prices of differentpackage sizes, if possible.

The adverse effects, interactions andcontraindications of the medicine as well asother aspects related to the safe use of the

medicinal product must be presented in asufficiently clear manner.The study results presented by the

medical sales representative, not included inthe summary of product characteristics, mustcorrespond to or support the information inthe summary of product characteristics.

Any quotes, figures and tables fromliterature or research reports mustcorrespond to the original. Different studyresults must not be combined, for example,

for purposes of comparisons betweendifferent products.The origins of the information used in

the presentation must be indicatedaccurately, and the sources used must be


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available to those participating in the event.If reference is made to unpublished researchmaterial, it must be provided for theparticipants if so requested.

h) The hospitality offered at the medical salesrepresentation events must be reasonable,suitable for the situation and secondary tothe scientific and training contents of themedical sales representation in question. Asfar as hospitality is concerned, the generalinstructions related to the accepting ofhospitality by officials as well as the Codefor the Marketing of Medicinal Products ofPharma Industry Finland must be followed.

i) Free samples of pharmaceuticals can begiven only to persons who are authorised toprescribe or supply them, and as regardsprescription-only medicines, only to thosewho are entitled to write prescriptions. Thesample must correspond to the smallestmarketed package size of the product inquestion. In one year, each recipient can begiven one sample package of each strengthand pharmaceutical form of each medicinalproduct. The free sample is delivered againsta written, signed and dated request,accompanied by the products summary ofproduct characteristics.

j) The use of starter packs in the marketing ofmedicinal products is prohibited. However,during their presentation visits, the medicalsales representatives can provide thehealthcare unit with the necessary starterpacks.

k) The member companies of Pharma IndustryFinland are committed to following the Codefor the Marketing of Medicinal Products, apart of which the current Code constitutes.Responsible for following the respect of the

Code, the Supervisory Commission for theMarketing of Medicinal Products and theInspection Boards subject to it, may imposesanctions defined in the Code on companiesbreaking the Code.

43 Presentation events during the physicians freetime. Physicians are free to decide whether or notthey intend to participate in medical sales represen-tation events at their free time. When organisingsuch events, the stipulations of the obligations of

civil servants and employees of public corporationsmust be taken into consideration. Hospitality or otherbenefits that are offered must not jeopardise thepublic trust in the Authorities, civil servants oremployees of public corporations.

44 Responsibility for compliance with the Code.In addition to the activities of its own staff, the phar-maceutical company is also responsible for the activ-ities of assisting parties, such as the subcontractorsproviding medical sales representation services.

IV CODE FOR THE CO-OPERATIONBETWEEN THE PHARMACEUTICALINDUSTRY AND PATIENTORGANISATIONS

45 Patient organisations. The term patientorganisations refers to organisations of public utility,including their local and regional associations andcentral organisations, constituted around a certainillness, disease or injury or a group thereof, with themajority of the members being patients or their closeones taking care of them. The patient organisationsrepresent or promote the interests of the patients ortheir close ones.

46 Prohibition of marketing of prescription-onlymedicines. The marketing of prescription-onlymedicines to consumers is prohibited. This prohibitionalso applies to the co-operation with the patientorganisations.

47 Agreement on support provided. A written

agreement between the pharmaceutical companyand patient organisation must be made on the finan-cial support or any other significant sponsorship,direct or indirect. The agreement must specify theamount of the funding provided or describe the othertype of support, indicating the purpose of the spon-sorship. The pharmaceutical company must have aclear procedure for the approval of such agreements.

48 Patient organisations logo and other materi-

als. The pharmaceutical company can use the patientorganisations logo or other material in its own oper-ations only upon a written consent of the patientorganisations, covering the purpose and means of useof the materials.

49 Materials published by the patient organisa-tion. The pharmaceutical company must not try toinfluence the contents of the materials published bythe sponsored patient organisation in a way promot-ing its own commercial interests.

50 List of the sponsored organisations. The phar-maceutical company must publish an annual list ofthe sponsored patient organisations. The list must beaccompanied by a brief description of the nature of


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the sponsorship. The information published must bereadily accessible to those looking for such data.

51 Transparency. The pharmaceutical companymust ensure that its sponsorship to the patientorganisation is public by nature, and that such sup-port is clearly disclosed, as applicable, on the occa-sion of the sponsored activities.

52 Principle of multiple sponsorship. A pharma-ceutical company cannot be the only founding mem-ber of a patient organisation or require that it shouldact as the sole funder of a patient organisation or asignificant form of its activities.

53 Events. An event sponsored or organised by apharmaceutical company must be held in a place thatis appropriate from the point of view of the material-isation of the main purpose of the event. The eventsmust not be organised in venues that are renownedfor their entertainment facilities or are extravagant.The event can be organised abroad if the majority ofthe participants come from countries other than Fin-land or if the purpose or theme of the event calls forresources or expertise justifying the organisationabroad.

54 Hospitality. The hospitability offered at eventssponsored or organised by a pharmaceutical compa-ny must be of a reasonable level, secondary to themain purpose of the event. The hospitality can extendonly to the registration costs related to the event, aswell as to the travelling, accommodation and mealexpenses.

55 Responsibility for compliance with the Code.The pharmaceutical company is responsible for thecompliance with the Code when co-operating withthe patient organisation. The pharmaceutical compa-

ny is responsible for the compliance with the Codealso when using the assistance of third parties.

V CODE FOR HEALTH AWARENESSINFORMATION AND OTHERINFORMATION ON HEALTH ANDDISEASES TARGETED ATCONSUMERS

HEALTH AWARENESS INFORMATION

56 Objectives and nature of health awarenessinformation. The aim of health awareness informa-tion is to encourage the consumers to maintain agood state of health both personally and among

those close to them, to help them identify diseases,their symptoms and risks and to guide them in thesearch for further information for health promotionand treatment of diseases. The premise of the dis-ease-awareness information must be the diseaseitself and its diagnostics, rather than the presentationof various therapy options.

Health awareness information must be matter-of-fact by nature, reliable, high-quality and in goodtaste so that the information supports the positiveimage of the pharmaceutical industry. Written inclear terms and expressions, the language used mustbe comprehensible to the consumers. The premisemust be the targeting information at an audiencepossessing the knowledge of an average reader. Theinformation must cover the essential factors relatedto the disease.

57 Balanced picture of the disease. In healthawareness information, the impacts of the diseasemust be described realistically. The consumersshould not be frightened and the consequences ofthe diseases must not be overly dramatised. Healthawareness information must not entice the con-sumers to unjustified use medicines or to seekunnecessary treatment.

58 Prohibition of marketing of prescription-onlymedicines. Health awareness information must notcontain marketing of medicines to consumers. Inother words, it must not promote the use of any par-ticular medicinal product or products. The marketingof prescription-only medicines, including disguisedadvertising, is categorically prohibited.

59 Impartial presentation of therapy options.Information on the various therapy options can begiven as part of the health awareness information. Inthat case, the information must cover all therapy

options, including the eventual pharmacotherapiesand other factors potentially influencing the treat-ment or prevention of the disease in question, such aschanges in living habits.

No therapy option must be presented in such away as to encourage the consumers to turn to aphysician for a particular medicine prescription. Ther-apy options must be presented in an equal and neu-tral manner, without highlighting any specific option.The choice of the therapy best suited to an individu-al patient always takes place as collaboration

between the patient and the physician. Healthawareness information must in no way direct thechoice between different therapy options.

Health awareness information may also includeinformation about the prescription medicines used


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for the treatment of diseases. Should informationabout pharmacotherapies be given, all medicinesused for that particular disease must be mentioned.If the trade names of medicinal products are men-tioned, the names of all products must be given in anequitable manner.

The criteria for neutral and unbiased presentationof the therapy options include the following:

a) No comparisons between various therapyoptions are made;

b) No single therapy option is accentuated, forexample, through the choice of words,colours or images, or by using differentfonts, highlights or other similar tools andelements;

c) The positive features of no single therapyoption are accentuated, highlighting thenegative features of the other options;

d) No categorisation of the therapy options ismade without justifiable cause, for exampleby classifying them into leading or mostrecent products that are widely presentedand into other or older options with a morelimited presentation;

e) No single therapy option is recommended inthe articles written by healthcareprofessionals or in patient narratives; and

f) The technical user instructions, such asdosing information, are either given for allproducts or not given at all.

If there is only one therapy option for the diseasein question, the health awareness information mustbe realised with special care, in order not to interpretsuch information as disguised marketing of a pre-scription-only medicine to consumers. The descrip-tion of dosage devices usable for the medicinal prod-ucts of one single pharmaceutical company only canalso qualify as disguised marketing.

60 Correctness of information and use ofresearch findings. The information given must alwaysbe updated and true, and never apt to mislead theconsumers.

If the health awareness information include ref-erence to study results, such data must always comefrom articles in scientific publications. References tosources must be given in an appropriate manner.

The sources for general health and disease infor-mation must primarily include research other thanthat by the pharmaceutical company.

The information given together with the studyresults must be impartial and neutral. Therefore, thehealth awareness information must not includeresearch-based data that would direct the choicetowards a particular therapy option. Moreover, the

eventual references to Current Care Guidelines mustbe neutral so that they would not direct towards aparticular therapy option. When referring to particu-lar Current Care Guidelines, the source must be indi-cated, always giving the latest updated version in thequotation.

61 Use of tests. The use of various tests measur-ing the consumers state of health is allowed inhealth awareness information if such tests are scien-tifically validated and have been published in a sci-entific publication.

62 Use of prestige and celebrity. Health aware-ness information must not contain direct and activerecommendations to use the medicine, given by sci-entists, healthcare professionals or celebrities.

63 Use of children and other special groups. Spe-cial prudence must be applied to the use of childrenin health awareness information. Health awarenessinformation must not be targeted at children, noteven when paediatric diseases are concerned.

Health awareness information must not exploitthe non-expertise or distress of consumers.

64 Competitions. If competitions are associatedwith health awareness information, the eventualprizes must be of reasonable value. When organisingthe competitions, the stipulations and instructions ofthe Consumer Protection Act and ensuing ordersmust be taken into account.

65 Visual image of health awareness informa-tion. The visual image (including illustrations orcolours) of health awareness information must notbe the same as the image used in the marketing ofthe prescription-only medicine used for the treat-ment of the disease in question to healthcare pro-

fessionals. The use of the same visual image is seenas disguised marketing of the prescription-onlymedicine to consumers. Moreover, the use of pack-age images is prohibited.

66 Reference to further information. Healthawareness information may refer the consumers tofurther information on the disease in question(including the Authorities, physicians, healthcarenurses and other healthcare professionals, pharma-cies or other healthcare units as well as patient

organisations).

67 Health awareness campaigns. If health aware-ness information is channelled through several media,or the material is composed of various elements, for


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example one single TV spot or outdoor advertisementmay be limited in content, if the necessary additionalinformation is available from other sources, such asthe Internet or patient guidebook, and the more lim-ited material makes reference to such additionalinformation. If, for example, the TV spot refers to anInternet site, such a site must meet the criteriaimposed on health awareness information. This alsoapplies to all other materials and events associatedwith the health awareness campaign.

68 Special stipulations concerning Internet sites.If the Internet site containing health awarenessmaterial includes links, the following principles mustbe followed:

a) The link must not lead directly toinformation including pharmaceuticalmarketing;

b) There can either be links to the sites of allparties offering pharmacotherapy options, oralternatively, no links to any such partiessites;

c) The links must always lead to the homepage of the company, not to their productpages;

d) No links to foreign pages must be given,with the exception of the companysinternational homepage with noprescription-only medicine marketing;

e) If the material includes a link to thesummary of product characteristics orpackage leaflet of one medicine, there mustalso be links to the summaries of productcharacteristics or package leaflets of allmedicinal products used for the treatmentof the disease in question; and

f) The links to the homepages of patientorganisations and similar parties are allowedif they do not include marketing of

prescription-only medicines to consumers.All Internet sites targeted at Finns, with theaddress formulated as "www.disease.fi" (such aswww.migraine.fi), must always meet the criteria forthe dissemination of health awareness informationas defined in the present Code. This will also apply tothe health awareness sites accessible through a linkfrom the homepage of the pharmaceutical company.

69 Name and responsibility of the company. Thehealth awareness information must always clearly

indicate the pharmaceutical company responsible forsuch information. The companys contact data canalso be given.

As far as the material produced is concerned, thepharmaceutical company is always responsible for

the compliance with the present Code, including anyoperations of an assisting third party. For example,no articles written by healthcare professionals ortheir interviews or patient narratives must advertiseany particular therapy option.

Health awareness information can give neutralgeneral information about the pharmaceutical com-pany in question.

PATIENT INSTRUCTIONS DISTRIBUTED ASSUPPORT MATERIAL WITH THERAPIESPRESCRIBED BY PHYSICIANS

70 Purpose of patient instructions. Pharmaceuti-cal companies can produce patient instructionsabout the use of a particular prescription-onlymedicine, distributable by physicians and otherhealthcare professionals to patients with prescrip-tions of said medicines. The patient instructions actas support material for the pharmacotherapy pre-scribed for the patient, and are not deemed to beconsumer marketing of prescription-only medicines,provided that the principles under Articles 71-73 arerespected.

71 Contents of patient instructions. The infor-mation contained in the patient instructions must

be neutral, unbiased, true and matter-of-fact. Thepatient instructions may contain general informa-tion about the disease in question and about itstreatment, as well as "package-leaflet-like" infor-mation about the prescription-only medicine and itscorrect and safe use. Patient instructions must notcontain any marketing elements, such as compar-isons of different therapy options or advertising-type highlighting of the medicinal product or itsproperties.

72 Visual image of patient instructions. Thepatient instructions may use the same colours as thepackage of the medicinal product in question, orshow its image.

73 Distribution of patient instructions. Patientinstructions must always be delivered by the compa-ny to physicians or other healthcare professionals,and they must not be generally available to con-sumers, for example in physicians waiting rooms orthe pharmaceutical companies homepages. When

delivering the material, the recipient must beinformed clearly that the patient instructions aremerely intended for particular patients to support thetreatment prescribed for them, and are not generallydistributable to all patients.


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VI MONITORING OF THE COMPLIANCEWITH THE CODES, PRELIMINARYINSPECTION, SANCTIONS ANDOTHER STIPULATIONS

THE SUPERVISORY COMMISSION FOR THEMARKETING OF MEDICINAL PRODUCTS ANDTHE INSPECTION BOARDS

74 Competence. The Supervisory Commission forthe Marketing of Medicinal Products, hereinafterthe Supervisory Commission as well as two Inspec-tion Boards subject to it, are charged with the task ofmonitoring and directing the matter-of-factness andcompliance with the respective Codes of pharmaceu-tical marketing, medical sales representation activi-ties, co-operation between the pharmaceutical com-panies and patient organisations as well as thehealth awareness information and other informationon health and diseases.

At the request of Pharma Industry Finland, theSupervisory Commission can also issue opinions onmarketing or on individual marketing measures onthe basis of the EFPIA or IFPMA Codes, in force ateach given time.

The Supervisory Commission issues the opinionsto outside parties.

75 Inspection Boards. The Supervisory Commis-sion acts as an umbrella for two Inspection Boards:Inspection Board I, involved in pharmaceutical mar-keting targeted at consumers, the co-operationbetween pharmaceutical companies and patientorganisations as well as health awareness informa-tion and the distribution of other information onhealth and diseases, and Inspection Board II, whichfocuses on pharmaceutical marketing to healthcareprofessionals and the operations of medical sales

representatives.

Joint rules covering the procedure at theSupervisory Commission and Inspection Boards

76 General rules on the initiation of cases. Thecases examined by the Inspection Boards are initiat-ed through the board's own control initiatives, com-plaints or preliminary inspections.

The cases examined by the Supervisory Commis-

sion are initiated on the basis of appeals by a partyto the case, referrals by one of the Inspection Boards,or requests of opinion.

If a case has already been initiated and is beingexamined by the Authorities, the Supervisory Com-

mission or Inspection Boards cannot issue a decisionuntil such proceedings have been finalised. After afinal and legally valid decision by the Authorities hasbeen issued, the case can be decided in the mannerreferred to under Article 74, Paragraph 1, consider-ing the dimensions of the decision by the Authoritiesas well as the eventual sanctions imposed.

Any disputes between pharmaceutical compa-nies should be resolved primarily between theinterested companies. The companies can onlyagree to end an incorrect action, not to approve ofan action contrary to the Code. In situationsreferred to in Article 107, Paragraphs 4 and 5 of thepresent Code of Ethics, or in cases of marketing ofnon-prescription medicines to consumers, the dis-pute needs not be solved between the companies inquestion before submitting the case to the Inspec-tion Board.

When a company contacts another pharmaceu-tical company to solve a dispute, it must specify thepoints in the marketing or other measure which itrequests to be deleted or changed, as well as therules in the present Code which underpin its request.The contact must be taken in the language used inthe marketing or other measure in question. Theeventual reply given as a result of the contact mustalso be compiled in the language used in the mar-keting or other measure in question.

Should the companies not be able to find a solu-tion in the case within seven working days from thefirst verifiable contact, the dispute can be submittedto the Inspection Board. The dispute must be sub-mitted to the Inspection Board within 30 days fromthe first verifiable contact, on pain of the case oth-erwise lapsing. Before filing the complaint, the othercompany must be notified, in a verifiable manner,about the case being submitted to the InspectionBoard, unless the situation at hand is one referred toin Article 107, Paragraph 4 or 5 of the present Code

of Ethics, or if the case relates to the marketing ofnon-prescription medicines to consumers.A complaint to the Inspection Board or appeal to

the Supervisory Commission must be made in writ-ing, and signed by a person/s who is/are authorisedto sign for the business name of the company. Thecomplaint or appeal must be written, except for theattachments, in the language used in the marketingmeasure in question. The complaint or appeal mustbe clear and sufficiently specified, containing all rel-evant information related to the complaint or

appeal. If the complaint or appeal is ambiguous orincomplete, the applicant must be asked to com-plete the complaint or appeal at the preparatoryphase, within five days of the date in which thenotice of the request was served.


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If the complaint or appeal is not supplementeddespite the request to that effect, and it remains soambiguous or incomplete that it cannot constitutethe basis for further examination, the complaint orappeal will be dismissed without examining its mer-its. A separate decision will be made regarding thedismissal.

A dispute between pharmaceutical companiesrelated to a violation of the present Code of Ethicsmust be solved following the order and system pre-scribed by the Code of Ethics, before submitting thecase to the Authorities.

The Inspection Boards can take up the case ontheir own initiative under circumstances described inArticles 90 and 91 of the present Code.

The documents submitted to the InspectionBoards or Supervisory Commission can be sent bymail, fax or email.

77 Limitation period. Any violation against thepresent Code must be submitted to the complaintsystem described in the Code within one year of theviolation.

78 Hearing of experts and requests for opinions.The Supervisory Commission and the InspectionBoards can hear experts and ask for opinions.

79 Minutes and decisions. Minutes will be kept

of the meetings, recording the meeting participants,agenda, decisions and relevant motivations in mat-ters other than those related to the compliance withthe present Code of Ethics, disagreeing opinions aswell as a list of documents attached to the Minutes.

As regards issues related to the compliance withthe present Code of Ethics, a separate decision willbe written on each issue, including the complaintmade, the marketing measure examined or its writ-ten description, replies, opinions obtained, motiva-

tions, names of those participating in the decision-making, as well as any disagreeing opinions.The Minutes and the decisions will be signed by

the Chairperson of the Supervisory Commission orInspection Board (or if the Chairperson is impeded,the Vice Chairperson) and the Secretary. The deci-sions will be sent to the parties involved by mail.

No appeal can be lodged against the decisions ofthe Supervisory Commission.

80 Disqualification. As concerns the disqualifi-

cation of the Chairmen and Members of the Super-visory Commission and Inspection Board, the stipu-lation on the bias of Arbitrators will apply. More-over, in order to maintain reliability, the Chairper-son or Member must disqualify themselves if they

have been employed full-time in one of the compa-nies involved in the case during the past five years.Persons employed by a pharmaceutical companymust not participate in the examination of a case ifthey or their employers could draw special benefitsfrom the decision.

If the Supervisory Commission returns an issueto the examination of the Inspection Board, theMembers of the Board that had earlier participatedin the discussion of this case in subsequent super-vision must refrain from examining it again, if thecase can still be solved respecting the quorum cri-teria.

The Supervisory Commission can examine therequest to correct its own decision in the samecomposition that made the original decision.

81 Confidentiality commitment. The Board ofDirectors of Pharma Industry Finland must requestfrom the Chairmen, Members and Secretaries of theSupervisory Commission and the Inspection Boardsa commitment of confidentiality regarding the doc-uments involved in the examination of a case, andthe documents or copies thereof must not be givento anyone other than those participating in the dis-cussion of the case or the parties to the case, with-out the consent of the party to whom the documentrefers. Moreover, the Members or Secretaries of theSupervisory Commission and Inspection Board mustnot disclose apart from the decision or opinionissued anything of the matters that have come upduring the discussion of the case.

82 Complementing the Supervisory Commissionor the Inspection Boards. If a Member resigns fromthe Supervisory Commission or Inspection Board inthe middle of the term, or is otherwise permanent-ly impeded from fulfilling his/her responsibilities,the appointing party, Pharma Industry Finland, will

nominate a new Member to act as a substitute untilthe end of the term.

83 Financial administration. The Secretary of theSupervisory Commission is in charge of its financesand administration. The Secretary has the sole rightto make all decisions related to the finances of theCommission.

The expenses incurred for the operation of theSupervisory Commission will be covered primarily bythe funds accumulated from processing and prelim-

inary inspection charges, sanction payments andcontractual penalties. Pharma Industry Finland willcover the eventual deficit in the Commissionsaccounts, and is entitled to receive the surplus, ifany.


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The Supervisory Commission constitutes a unitwhich is financially independent of Pharma IndustryFinland. Constituting a part of Pharma Industry Fin-lands overall budget, the Supervisory Commissionwill present its own budget for the following calen-dar year for Pharma Industry Finlands approval. Theoperating result of the Supervisory Commission willbe recorded and specified under Pharma IndustryFinlands Income Statement.

The outside experts heard by the SupervisoryCommission and the Inspection Boards will receive areasonable compensation for the work performed.The expenses incurred for the hearing of experts orfor other clarifications may also be imposed on thecompanies involved.

The Supervisory Commission will issue an annu-al report on its operation. The annual report will besent to the major stakeholders of the SupervisoryCommission for their information.

Supervisory Commission

84 Composition of the Supervisory Commission.The Supervisory Commission is constituted by itsChairperson, five Members and Secretary.

The Board of Pharma Industry Finland appointsthe Supervisory Commission, nominating its Chair-person, Vice Chairperson, four ordinary Members andtheir personal substitutes. Moreover, the Board ofPharma Industry Finland also appoints five personsemployed by pharmaceutical companies, amongwhom one person, with no impediments, will be sep-arately chosen to join the examination of the case athand at any given time.

The substitute of the Member employed by apharmaceutical company is the Director General ofPharma Industry Finland.

Pharma Industry Finland also appoints the Secre-

tary of the Commission, and the substitute of theSecretary.The term of the Chairperson and Members of the

Commission is three calendar years so that every yeartwo Members, with substitutes, will resign in turn.The Chairperson, Vice Chairperson, Member or sub-stitute can be re-elected for the maximum of threesubsequent terms.

85 Secretary of the Supervisory Commission. TheSecretary of the Supervisory Commission acts as the

presenting official, keeps the Minutes of the Com-mission meetings and administers the Commissionsfinances. The Secretary has no vote in decision-mak-ing. If the Secretary is disqualified or impeded fromexamining a case, the respective functions exclud-

ing the financial administration will be covered bythe Secretarys substitute.

86 Supervisory Commission meetings and quo-rum. The Supervisory Commission will be convenedby the Chairperson, or if he is impeded, by the ViceChairperson.

The Secretary of the Supervisory Commission willpropose to the pharmaceutical companies which areparties to the case, a non-biased person employedby a pharmaceutical company to be adopted as aMember to discuss the case. If the pharmaceuticalcompany, party to the case, is opposed to the pro-posal of the Secretary, a substitute Member will beconvened.

The summons to the meeting must be sent to theMembers no later than seven days prior to the meet-ing. A Member recognising his own bias must informthe Secretary of the Supervisory Commission of suchcircumstances without delay, and the Secretary willsummon the substitute Member.

The Supervisory Commission constitutes a quo-rum when the Chairperson or Vice Chairperson and atleast two Members or the substitute Members arepresent.

The decisions of the Supervisory Commission willbe taken by simple majority. In case of an even vote,the Chairperson will cast the deciding vote.

87 Main responsibilities of the Supervisory Com-mission. The Supervisory Commission shall

a) examine the appeals against the decisionsmade by the Inspection Boards as well asthe issues submitted by the Boards underArticle 107, Paragraphs 4 or 5 of the presentCode;

b) if necessary, discuss and issue opinions onquestions which are related to pharma-ceutical marketing, good medical sales

representation practices, co-operationbetween pharmaceutical companies andpatient organisations as well as healthawareness information and the distributionof other information on health and diseases,in principle, or which set guidance for thework of the Inspection Boards.

88 Hearing. Before issuing its opinion, theSupervisory Commission shall hear the parties, therights of which are involved in the case and which

have not yet had the opportunity to express theirviews in this context, and, at the discretion of theSecretary of the Supervisory Commission, the Inspec-tion Board involved. The hearing can take place byletter, fax or email.


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The reply must be given within a short timeframedetermined by the Secretary of the Supervisory Com-mission. The deadline must not be shorter than sevendays or exceed 14 days, save for exceptional reasons.Failure to give a reply does not constitute an obsta-cle to the examination of the case by the Superviso-ry Commission. The reply must be written, except forthe attachments, in the language used in the mar-keting measure in question.

The replies given will be sent to the other partiesfor their information.

89 Scope of the examination. The SupervisoryCommission will make the decisions on the appealsand on the issues submitted by the Inspection Boardson the basis of the material provided by the partiesor the Inspection Board, and is not liable to acquireany further information on the case at hand. At itsdiscretion, the Supervisory Commission can alsoexamine the marketing or other measure beyond thescope defined in the appeal, as far as the case con-cerns issues taken up by the Inspection Board on itsown initiative.

Inspection Boards

90 Competence of Inspection Board I. InspectionBoard I controls pharmaceutical marketing targetedat consumers, co-operation between the pharmaceu-tical industry and patient organisations as well ashealth awareness information and other informationon health and diseases targeted at consumers. Inspec-tion Board I can take up a marketing or other measureof a pharmaceutical company under examination onits own initiative or on the basis of a complaint.

91 Competence of Inspection Board II. InspectionBoard II controls the marketing targeted at health-

care professionals as well as medical sales represen-tative activities, and, on request, resolves marketing-related disputes. In matters of principle, InspectionBoard II can initiate proceedings under the presentCode on its own initiative.

92 Composition of the Inspection Boards. Inspec-tion Board I has five Members or their personal sub-stitutes and the Secretary, as well as a veterinarymedicine expert member or a personal substitutewho will only participate in the discussion of cases

which are related to the marketing of veterinarymedicines. Inspection Board II has four Members ortheir personal substitutes and the Secretary, as wellas a veterinary medicine expert member or a person-al substitute who will only participate in the discus-

sion of cases which are related to

pif code of ethics 08 final (id 3978)

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