Code of Ethical Practices - University of Ottawa · Chief Pharmacist must authorize the. Code of...

Code of Ethical

PRACTICES

Integrity

Trust

january 2010

www.canadapharma.org

http://www.canadapharma.org

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Code of Ethical Practices

Table of Contents

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Health Care Professional . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Mission Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Mission Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

1. GUIDING PRINCIPLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

2. ADVERTISING AND INFORMATION DISSEMINATION . . . . . . . . . . . . . . . . . . . 3

3. CLINICAL EVALUATION PACKAGES (“SAMPLES”) . . . . . . . . . . . . . . . . . . . . . . . . 4

4. EDUCATION FOR HEALTH CARE PROFESSIONALS. . . . . . . . . . . . . . . . . . . . . . . 5

4A. CONTINUING HEALTH EDUCATION (CHE) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

4B. SPONSORSHIP TO INTERNATIONAL CONTINUING HEALTH EDUCATION EVENTS, SCIENTIFIC SYMPOSIA, CONGRESSES . . . . . . . . . . . . . 8

5. CONVENTION/CLINIC DISPLAYS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

6. DONATIONS OR FINANCIAL SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

7A. GIFTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

7B. HOSPITALITY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

8. REPRESENTATIVES OF PHARMACEUTICAL COMPANIES . . . . . . . . . . . . . . . . 11

9. POST REGISTRATION CLINICAL STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

10. PRICE-RELATED MATTERS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

11. SERVICE-ORIENTED ITEMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

12. MARKET RESEARCH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

13. ADVISORY BOARDS/CONSULTANTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

14. PRIVACY OF PATIENT INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

15. ENFORCEMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16


Introduction

Canada’s Research-Based Pharmaceutical Companies(Rx&D) are aware of and adhere to the ideals of afree and fair society. These ideals include individualfreedom, respect for the views of others, the freedomto trade and carry on commerce and the freedom thatallows science and medicine to advance their knowledgebases. In recognition of its role in the internationalpharmaceutical community, Rx&D is a member ofthe International Federation of PharmaceuticalManufacturers Associations (IFPMA). The IFPMA is a non-governmental organization representingpharmaceutical associations in 51 countries aroundthe world. Part of its mission is:

“To promote and support continuous development, throughoutthe pharmaceutical industry, of ethical principles and practicesvoluntarily agreed on....”

As a member of the IFPMA, Rx&D stronglysupports IFPMA’s mission and the principles of itsCode of Pharmaceutical Marketing Practices.

We urge our Member companies and organizations(Members) to publicly affirm their corporatecommitment to honour the principles and ideals that IFPMA has set for our industry.

Health Care Professional

In this document, the term health care professionalmeans an individual who is currently practicingmedicine, nursing, or dispensing medicines in Canada.

Mission Statement

Members share the mission to improve the health of Canadians through the discovery, development,manufacture, and distribution of innovativeprescription medicines. Implicit in this mission arecommitments to undertake and promote research, to implement product stewardship, to ensure thathealth care professionals and patients receive theeducation and information to use Members’ productsand services appropriately, and for Members toobserve their social responsibilities and role toimprove the health and social environments thatCanadians enjoy.

Mission Overview

In order to discharge their shared mission, Memberscommit themselves to conscientious pursuit ofresponsibilities in the following areas:

(i) Research and Development. Members willconduct and sponsor scientific research in orderto develop knowledge that will benefit Canadians,within the ethical framework of Canadian societyand scientific associations. This commitmentincludes: (a) Appropriate input into research design; (b) Unbiased sampling and study design; (c) Proper selection, recruitment and

protection of subjects, including patientand non patient subjects;

(d) Unbiased interpretation of study data; (e) Appropriate disclosure of study results; and (f) Observance of the above principles in

basic, clinical, outcome, and other research.

(ii) Product Stewardship. Members accept theiraccountability for the proper manufacture,distribution, and use of their products.Accountability includes: (a) Maintaining good manufacturing practices; (b) Ensuring appropriate use and reducing

risks of misuse; (c) Ensuring safe handling, transportation, and

preservation of medications, includingstorage and disposal;

(d) Delivering safe and effective medications;and

(e) Ensuring conscientious protection ofenvironmental interests.

(iii) Provider and Patient Education andInformation. Members accept the obligation to ensure that Canadian health care professionalsand patients have access to education andinformation about the appropriate uses of theirproducts and services. That obligation includes:(a) Providing balanced representation of the

benefits and risks of their products; (b) Using non-coercive and non-inducing

means and methods of communications; (c) applying this provision of the Code of

Conduct (Code) to continuing healtheducation initiatives, clinical evaluationpackages (sampling), dealings with medicalrepresentatives, market research undertakings,and to whatever other areas it is applicable;

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(d) Working only within frameworks approvedby Health Canada, the PharmaceuticalAdvertising Advisory Board (PAAB), andother relevant bodies;

(e) Upholding the principles, letter, and spiritof this Code; and

(f) Informing health care professionals andpatients about appropriate uses of theirproducts and services for individualcircumstances.

1. GUIDING PRINCIPLES

• The health and well-being of patients and allCanadians is our first priority.

• All interactions with health care professionalsare to be conducted in a highly professional,business like, and ethical manner.

• All product information provided to healthcare professionals must be accurate and fairbalanced.

• Clinical trials are developed to further science.

• All Members must adhere to the Code and itsintent as a condition of membership.

• No monetary or other consideration is to begiven to health care professionals for thepurpose of gaining access or influence.

• The purpose of Continuing Health Education(CHE) is to provide balanced and unbiasededucation to health care professionals.

• The only acceptable form of hospitality forhealth care professionals are modest mealsand/or refreshments.

• Grants, donations and service-oriented itemsare never to be provided to health careprofessionals to promote specific prescriptionmedicines.

• Members’ sales representatives may notparticipate in market research, clinical studies, advisory boards and/or consultancyarrangements.

• Advisory boards and consultants are only tobe used to gather scientific or commercialguidance.

2. ADVERTISING ANDINFORMATION DISSEMINATION

2.1 The prescription medicines that Members haveresearched, developed, produced and/or marketedare sold mainly in pharmacies and hospitals.

2.2 Advertising

2.2.1 All Members agree to follow the Code ofAdvertising Acceptance of the PharmaceuticalAdvertising Advisory Board (PAAB) andGuidelines for General Advertising, SuppliedAdvertising Inserts, & Journal Supplements ofthe Canadian Association of Medical Publishers(CAMP). To the extent the IPRC receives and isguided by information provided regarding abreach of either of these documents, a Memberwhich breaches either of these documents mayalso be found to be in breach of this Code.

The PAAB is made up of organizations whichrepresent health professionals and institutions,consumers, pharmaceutical manufacturers, themedia, advertising firms, and invited non-votingobservers. The Therapeutic Products Directorate(TPD) of Health Canada acts as advisor andresource body to the PAAB, while still maintainingits authority under the Food and Drugs Act andRegulations.

The PAAB sets its own policies for the use of itsCode of Advertising Acceptance, selects its ownChair and retains a permanent Commissioner ofPharmaceutical Advertising. The Commissioneris responsible to the PAAB for pre-clearance ofproduct advertising, based on the requirementsof the PAAB Code.

If the TPD feels that any advertising materialspose a threat to health under the terms of theFood and Drugs Act and Regulations, it can ask that these materials (even if they have beenapproved by the PAAB) be held back and notused. The PAAB Code describes what actionswill be taken should this occur.

Copies of the PAAB Code of AdvertisingAcceptance can be obtained from the PAAB at 375 Kingston Road, Pickering, Ontario,L1V 1A3 or Web site: www.paab.ca

Copies of CAMP’s Guidelines for GeneralAdvertising, Supplied Advertising Inserts, &Journal Supplements can be obtained from 1001 Maisonneuve Boulevard. West, Suite 1000,Montreal, Quebec H3A 3E1 or Web site:http://camponline.org

http://www.paab.ca

http://camponline.org


2.3 New Product Information

2.3.1 While Members know they are the mainsource of information about their products, they are also aware that, through the media,news about new prescription medicines mayreach the public before this news has reachedhealth care professionals.

Members must take the following steps in orderfor this not to occur:

2.3.2 Product information (such as the productmonograph or excerpts from it) must be sent to those identified in Section 2.3.3 in a timelymanner before the product is launched on themarket.

2.3.3 The information must be sent to all knowndrug information centres, poison control centres,faculties of medicine and pharmacy acrossCanada, and national medical associations.

2.3.4 At any public relations event to announce a new product, a new indication for an existingproduct or new scientific findings, Membersmust ensure that all of the facts given to themedia are correct and objective.

2.4 Signing of Promotional Materials byMedical/ Scientific Personnel

Promotional materials are communicationswhose purpose is to promote a Members’product(s). Such communications must not besigned by personnel who work in medical,regulatory or medical/scientific informationservices. Nor should they be signed by someoneacting on their behalf, regardless of to whomthey report. Signed communication from allsuch personnel should be limited to:

(i) Responses to medical/scientificinformation requested by the health careprofessional; and

(ii) Essential, new medical safety informationwhich has not been requested (forexample, covering letters for new productmonographs and letters that advise onproduct safety, the withdrawal of aproduct, new warnings, precautions andcontraindications).

2.5 Health Care Economic Studies

2.5.1 Members endorse health care economicstudies (or pharmacoeconomic evaluations) thatlook at the costs and results of alternativetherapies. Advertising or promotional campaigns

that include the results of such studies must bereviewed and approved by the PAAB followingthe same approval system that applies to productsor services that contain clinical claims. Claimsmade as a result of a pharmacoeconomic study or model should be consistent with the Guidelines for Economic Evaluation ofPharmaceuticals: Canada.

3. CLINICAL EVALUATIONPACKAGES (“SAMPLES”)

3.1 General Principle

3.1.1 Members believe that the timely distributionof Clinical Evaluation Packages (CEPs) to healthcare professionals, following the rules set out by the Food and Drugs Act and Regulations,provides benefits to both patients and healthcare professionals.

3.1.2 CEPs must be dispensed by health careprofessionals only. Their main use is to beginimmediate treatment, as necessary. They can also be used, when appropriate, to determine apatient’s clinical response to drug therapy beforea full course of therapy is prescribed.

3.2 Definition

3.2.1 For the purpose of this Code, a ClinicalEvaluation Package (CEP) is: a package containinga limited quantity of a pharmaceutical productsufficient to evaluate clinical response; distributedto authorized health care professionals free ofcharge, for patient treatment.

3.2.2 In addition to the Food and Drugs Act and Regulations governing the manufacture,packaging, storage, and distribution of CEPs,the following regulations also apply:

3.2.3 Distribution

(i) CEPs shall only be given to authorizedhealth care professionals who have filledout a request form for the CEP. Therequest form must be fully completed by the health care professional beforebeing passed on to authorized companypersonnel (such as the Members’representative or another designatedemployee) for signature.

(ii) An essential part of the CEP serviceinvolves providing the health careprofessional with prescribing information.This information is to be shared withhis/her patient.

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(iii) The Member should also provide fullprescribing information on the CEP for a minimum of two years following theintroduction of a product to the Canadianmarket. A shorter version of the disclosuremay be provided two years after theproduct is first introduced.

(iv) All free goods (or CEPs) given to a healthcare professional as part of an order mustbe included on the invoice. If no order is made when the free goods are supplied,the goods must be documented on aseparate NO CHARGE invoice.

(v) The number of CEPs provided to a healthcare professional will not be consideredexcessive, as long as the health careprofessional believes that amount isrequired for the proper evaluation ofclinical response.

(vi) CEPs provided to hospitals must conformto hospital regulations. The hospital’sChief Pharmacist must authorize theacceptance of CEPs before any CEPdistribution begins.

(vii) It is not appropriate to distribute CEPsat conventions.

(viii) It is unethical, and may be cause fordismissal, for a Member representative to sell, trade or give way CEPs or stockpackages to anyone, for any reason, that is not set out in Members policy.

3.2.4 Storage

(i) Rules and safeguards to prevent theftand/or unauthorized distribution of CEPsmust be in place at all times.

(ii) All CEPs must be stored in locked cabinets,storage areas, or rooms which are onlyaccessible to Member representatives orother authorized people.

(iii) Members must direct their employees to store CEPs in conditions that willmaintain their stability, integrity andeffectiveness.

3.2.5 Disposal

(i) Members are responsible for ensuring that all excess and/or expired CEPs oftheir own manufacture are returned to theMembers’ storehouse or head office.

3.2.6 Inventory

(i) Members must ensure that a complete andaccurate inventory of all CEPs held byMember representatives is conducted atleast once a year. Inventory will be takenby an auditor assigned by the Member, notby the representative who holds the CEPs.

4. EDUCATION FOR HEALTH CAREPROFESSIONALS

4.1 Preceptorships

4.1.1 Definition

Health care professionals’ preceptorships areeducational programs that should facilitatelearning and transfer of skills and knowledgefrom one health care professional to another.These programs allow a local health careprofessional to spend time with a qualified expertin the field, to gain a better understanding andinsight into a therapeutic area or disease state.

4.1.2 General Principle

In order to facilitate the transfer of knowledgeand skills among qualified health care professionals,Members may support a preceptorship program.Reimbursement for the expert’s travel andaccommodation if necessary, and honoraria are acceptable.

Participants in the program may not be reimbursedfor any costs or provided honoraria. As anexception to the general principle, a maximumof five health care professionals, per calendaryear, per brand, may participate in a preceptorshipprogram in a recognized center of excellence. In this instance, travel and accommodation maybe reimbursed.

4.2 Speaker Training – new productsor indications

4.2.1 Rationale

As new products or new indications areapproved by Health Canada, a need may arise to train a small number of key opinion leadersaround this information. These health careprofessionals are an appropriate group ofpractitioner/prescribers to disseminate thisinformation to their colleagues.


4.2.2 Definition

A small group of selected health care professionalstrained on new products or new indications forthe sole purpose of disseminating this informationat subsequent events. These training meetingscalled “Speaker Training” are designed to train a very select group of key opinion leaders onnew products or new indications that meet therequirements of Health Canada regulations.

4.2.3 General Principles

Speaker training meetings should involve theselected group of key opinion leaders in therelated field to meet at an appropriate venuewithin Canada. Travel and related expensesincluding fair and reasonable honoraria may be reimbursed. Appropriate hospitality may beprovided (Section 7B); however no other socialevents (Section 4A.3.4) should be conducted.These participants must have a contract with themember companies to participate in the meetingand deliver subsequent training to health careprofessionals.

4.2.4 Number of Participants/SpeakerTraining Sessions

The number of speaker training sessions mustbe limited. Members may only have a limitednumber of speaker training sessions consistentwith the need to train this very select group ofkey opinion leaders.

Speaker training sessions may not include morethan 20 health care professionals per meeting.

4.2.5 Special Circumstances

Speaker Training by an International key opinionleader.

• Should the need arise for Canadian key opinionleaders to be trained by an International keyopinion leader from a country where the newproduct or indication is available thenMembers have the following options:

– Invite the International key opinion leaderto Canada to conduct the training; or

– Send a maximum of five Canadian key

opinion leaders per new product orindication to a recognised centre ofexcellence to receive the training. In thisinstance travel and accommodation may be reimbursed.

4A. CONTINUING HEALTHEDUCATION (CHE)

This Section applies to all Members, who arealso responsible for the activities of any thirdparty which organizes Continuing HealthEducation (CHE)1 events on their behalf.

4A.1 Mission Statement

4A.1.1 The purpose of CHE is to provide andpromote high quality health education programsfor health care professionals, in partnership withgroups that provide accredited CHE programs,such as:

• University faculties of health sciences;

• Health care associations; and

• Other Canadian accrediting CHE bodies.

The partnerships should be based on sharedhealth values and mutual respect.

CHE programs serve to enhance knowledge andunderstanding of advances in health research,health sciences and clinical practice so thathealth care professionals can, in turn, providesuperior health care to patients. The benefits ofthis impact all Canadians.

4A.1.2 When embarking on such partnerships,Members will:

• Support, where possible, the principles andpractices of CHE programs established byprofessional bodies such as:

– The Royal College of Physicians andSurgeons;

– The College of Family Physicians ofCanada;

– The Federation of General Practitioners ofQuébec (FMOQ);

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1 The phrase Continuing Health Education is intended to apply to all health care professionals, so that the word “health” may be replaced by“medical”, “nursing”, “dental”, “pharmacy” etc. depending on the audience.

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– The Federation of Medical Specialists ofQuébec (FMSQ);

– The Québec Council on ContinuingMedical Education (CEMCQ);

– The Canadian Council on ContinuingEducation in Pharmacy (CCCEP); and

– Other Canadian accrediting bodies.

• Provide a balanced program of currentscientific, biomedical, or other relevantinformation that adds to knowledge andenhances best practices in the health careprofessions.

• Contribute organizational expertise andresources.

4A.2 Definition of Continuing Health Education

Members are committed to separating CHEfrom other types of activities. CHE programsmust be accredited or they must meet theprinciples for CHE described in Section 4A.2.3.Only those programs that meet and follow thesecriteria are considered CHE events under thisCode.

4A.2.1 CHE consists of those educationalprograms which serve to maintain, develop, orincrease the knowledge, skills and competencewhich a health care professional uses to providecare to patients, or service to the professions.

4A.2.2 The content of CHE programs mustreflect that body of knowledge and skills whichis accepted by the professions as constituting thebasic health sciences, clinical sciences andclinical practice of the professions.

4A.2.3 A CHE program must adhere to thefollowing principles of adult learning:

• A learning needs assessment must beconducted;

• A member of the target audience must helpdesign and develop the program;

• Clear learning objectives must be identifiedbased on the needs assessment, and theobjectives must be reflected in the program;

• The program must be interactive; and

• A final evaluation which outlines how thelearning objectives were achieved, must beconducted.

If these five principles are not met, the programcannot be promoted or designated as “educational.”

4A.3 General Principle

Symposia, congresses and other CHE programsare vital ways for Members to dispense knowledge,and for health care professionals to share theirexperiences with each other. The main goal ofsuch meetings must be the enhanced well-beingof all Canadians, through better health care. Forthis reason, the educational program must be the main focus of, and reason for, sponsoring orparticipating in an event.

These requirements apply to all types of CHEprograms, including events organized by theMember and events organized through a third party.

4A.3.1 The program’s scientific content (asdescribed in Section 4A.2.2) must be developedby consensus among the Member(s) and theirCHE partner(s).

4A.3.2 The kinds of resources needed toorganize the program (i.e. financial, people,expertise, technology) must also be agreed uponby the Member(s) and their CHE partner(s). The partners shall adopt an “open book” styleof accounting; each partner has the right toknow the financial, personnel and technologicalresources spent on, or donated to, a CHEprogram.

4A.3.3 In order to avoid timing conflicts orduplication of programs, Members and/or theprogram partner should inform local scientificand/or professional bodies of the dates andtimes of a CHE program.

4A.3.4 Member companies should not beinvolved in the development of, or payment forsocial functions conducted in conjunction withany CHE event.


4A.3.5 Grants and honoraria may be provided to health care professionals who speak at ormoderate CHE programs. Such grants and/orhonoraria do not apply to other health careprofessionals attending the program.

4A.3.6 Representatives of Members who attenda CHE program must follow the standards andguidelines outlined in the following sections ofthis Code:

• Section 1 – General Principles;

• Section 3 – Clinical Evaluation Packages; and

• Section 8 – Representatives ofPharmaceutical Companies.

4A.3.7 For events that have not been accredited,or which do not meet the principles of adultlearning described in Section 4A.2.3, but whichinvolve the presenting of medical/scientificinformation, organizers must conform to thespirit of Section 4 and, in particular, must adhereto Sections 4A.3.4 and 4A.3.5.

4A.3.8 The CHE programs organized byMembers or through a third party are designedfor health care professionals and invitations areto be extended only to health care professionals.These programs must not be offered to thespouses/companions or family members ofhealth care professionals unless they are invitedhealth care professionals as well. It is recognizedthat health care professionals may wish to travelwith their spouses/companions or family members.Should they choose to do so, the planning andcosts of the travel, accommodation, and mealsand beverages of the spouses/companions orfamily members are the responsibility of thehealth care professionals. Members must not in any way offer support or facilitate the traveland accommodation arrangements ofspouses/companions or family members ofhealth care professionals, or extend hospitality to them, unless they are invited health careprofessionals as well.

4B. SPONSORSHIP TOINTERNATIONAL CONTINUINGHEALTH EDUCATION EVENTS,SCIENTIFIC SYMPOSIA,CONGRESSES

4B.1 Definition – International CHE events

International CHE Events are defined as eventsthat have been approved, endorsed, or sponsoredby learned societies, and professionalassociations or bodies.

International CHE Events must take placeoutside of Canada in order for this Section toapply; when held in Canada, Section 4A applies.

4B.2 General Principle

In addition to their commitment to provide and promote, high quality health educationprograms for health care professionals inCanada, Members have a role to play in ensuringthat Canadian physicians are educated and keptinformed on developments in health research,health sciences, and clinical practice at theinternational level. To that end, they may receiveand consider requests from individual physicians,specialty societies, and/or academic institutionsfor financial assistance to participate ininternational CHE events. In addressing thissituation, both the supporting Member and therecipient(s) of the financial support shouldproceed on the understanding that the ultimateobjective in exposing Canadian health careprofessionals to international CHE events is toimprove health care for Canadians.

4B.3In considering such requests, Members mustcomply with the following requirements:

• The request must be received in writing, and must include all details of the program,as well as the specifics of the educationalprogram(s) to be delivered by the participant(s)on their return to Canada.

• The Member providing the support mustrespond to the request in writing, outliningthe conditions/requirements underpinningthe financial support.

• The Member must require the individual toadvise whether or not he/she has requestedsupport from more than one Membercompany to attend the same event.

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• The individual(s)/organization(s) requestingthe support must be required to share withCanadians the benefit of knowledge gainedthrough (a) the submission of a report orpaper to the supporting company, and (b) through a written report to the specialtysociety/academic institution or (c) a verbalpresentation to health care professionals.Such papers and/or presentations mustinclude a statement by the author/presenteracknowledging that financial support toattend the international CHE event wasreceived, and such acknowledgement mustidentify the company from which the supportwas received.

• Members may provide financial support for a maximum of ten (10) individuals to any one international CHE event. Notwithstandingthe provisions in Section 7B.1.3. a membercompany may extend hospitality to all theirduly sponsored health care professionals to international CHE event. For hospitality,please refer to sections 7B.1.4 andsection 7B.1.5.

5. CONVENTION/CLINICDISPLAYS


Convention/Clinic displays allow for enhancedinteraction between health care professionalsand the pharmaceutical industry. The mainpurpose of such displays must be the presentationof accurate information about the product(s) on display.

5.1.1 At least one qualified representative of theMember must be on site at all times after theconvention/clinic display is set up, and until it is dismantled.

5.1.2 Where no exhibit space is available, aMember may not make a contribution towards a convention display.

5.1.3 Promotional and educational materialavailable at the display shall not presentinformation or claims that differ in any wayfrom the official product monograph(s).

5.1.4 Reprints of scientific and medical papersmay be distributed at the display, provided theyare reprinted verbatim, and are not presented ina manner which differs in any way from theofficial product monograph(s).

5.1.5 Giving out CEPs at convention/clinicdisplays is not permitted.

5.1.6 Member representatives who are lookingafter a display must abide by all standards ofbehaviour for pharmaceutical representatives, asset out in this Code.

5.1.7 The fee a Member pays for exhibit spacemust not include additional donations to theassociation holding the convention. Additionaldonations must be reported as such.

5.1.8 If a Member sponsors a public relationsevent associated with a convention, the cost ofthat event must not exceed the cost of a singleexhibit.

5.1.9 Sponsorship of Member-specific socialfunctions is not permitted.

5.1.10 Members must not pay for or make adonation to displays set up on an ongoing basisat clinics/hospitals.

6. DONATIONS OR FINANCIALSUPPORT


As a demonstration of good corporate citizenship,Members recognize their responsibility to supportworthwhile activities both within and outsidetheir communities.

A rationale and clear objective consistent withthe Guiding Principles of the Code of Conductshould accompany all requests for financialsupport. When accepting a request Membersshould clearly indicate in writing to the requestingparty what the Member is supporting.

6.1.1 Donations, including donations in kind,may be provided to organizations involved inpromoting artistic, charitable, cultural, community,educational, humanitarian, health, philanthropic,and sporting activities. Members must ensurethat such support is not undertaken for productpromotional reasons, and is not directed toproduct promotion purposes. Acknowledgementby the recipient organization of such supportmust be restricted to an appropriate statementof support, and the corporate name and logo ofthe donating Member.


6.1.2 Where Members provide financial supportto a charity and/or non-profit organizationthrough such avenues as the purchase of a tableor tables at a dinner or other social event, orthrough the purchase of a foursome or foursomesat a golf tournament, or similar activity, individualsinvited to sit at the corporate table(s), or to playgolf as part of the foursomes, should not behealth care professionals.

6.1.3 Members must never provide a donation,directly or indirectly, in order to have access to a health care professional.

6.2 Access Fees

Under no circumstances shall a Member companypay a “clinic room rental fee”, “clean-up fee” orany other similar type “fee” that can reasonablybe construed as a direct or indirect payment inorder to gain access to a HCP.

7A. GIFTS

7A.1 General Principle

Members recognize their responsibility to ensurethe appropriateness and professionalism of theirinteractions with health care professionals.

7A.1.2 Members must not offer to any health careprofessional, or to any member of a health careprofessional’s clinical/administrative staff, anygift – in cash or in kind, or any promotional aid,prize, reward, or any other item which is intendedfor personal/family benefit, or pecuniary advantage.

7B. HOSPITALITY

7B.1 Definition

In order to facilitate greater interaction aroundour business, Members may provide modestmeals/refreshments to health care professionals.The primary objective of the hospitality shouldbe to create the appropriate venue and interaction.Hospitality should not be utilized as the primaryaccess to meet with health care professionals,but as an opportunity to expand the businessdiscussions.

Members are prohibited from reimbursingemployees for activities such as but not limitedto golf, hockey, theatre and the spa. Memberemployees should not partake in such activitieswith health care professionals outside of thelimited exceptions as described in Section 6.1.1or as part of congresses/symposia that areincidental to these events and which are notorganized by Member companies.

7B.1.2 During interactions with health careprofessionals, Members may only providerefreshments/meals to participants that aremodest in content and cost. In all instances, the provision of refreshments/meals must beclearly incidental. No other form of hospitalityor entertainment is to be provided.

7B.1.3 A maximum of five (5) health careprofessionals is permitted, per interaction.Although there may be more than one Memberrepresentative in attendance, the number ofhealthcare professionals cannot be increased to result in larger groupings.

7B.1.4 Under no circumstances canrefreshments/meals be extended to spouses/companions of health care professionals unlessthe spouse/companion is himself/herself ahealth care professional.

7B.1.5 As the interpretation of modest canclearly vary across the country depending on city or province, the onus is on Members toensure that the venue is not excessive and/or“five star”. Acceptable examples would be a meal/refreshment at any of the national “mid-range” hotel chains (e.g., Marriott, Hyatt,Sheraton) or similar types of local venues.

7B.1.6 While hospitality in the form of modestrefreshments/meals may be offered duringinteractions, providing tickets, vouchers, ordefraying the costs of this or any other event isnot permitted.

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8. REPRESENTATIVES OFPHARMACEUTICAL COMPANIES


8.1.1 Representatives of pharmaceuticalcompanies represent both their company and the pharmaceutical industry as a whole in the eyes of health care professionals. They are the main point of contact between thepharmaceutical industry and other partners in Canada’s health care sector.

8.1.2 For this reason, the industry establishesand maintains high standards in the recruitmentand selection (within the principles of employmentequity) of representatives, to ensure that well-qualified people are hired. Ideally, Memberrepresentatives should be graduates of universitiesor community colleges or hold a designation inthe health care field.

8.2 Standards for Employment and Training

8.2.1 When a representative is hired, supervisedtraining must be provided to enable the personto become familiar with and carry out theirresponsibilities. This training will require newemployees to acquire both technical and scientificinformation on Member products, as well asknowledge of the ethical principles and standardsof conduct set out in this Code.

8.2.2 From time to time, Members shall conductrefresher courses for representatives. Membersshould also encourage all representatives to takecourses of study and self-improvement.

8.2.3 To ensure professional standards for theindustry, Member representatives must pass theaccreditation course offered by the Council forContinuing Pharmaceutical Education (CCPE)within two years of their employment.

8.2.4 Member representatives must display thehighest professional and ethical standards at alltimes. This must be reflected in both their conductand appearance. Representatives are expected to understand and abide by established codes of conduct and courtesy in physicians’ offices,clinics, hospitals, retail pharmacies and whereverthey may appear in a professional capacity.

8.2.5 Representatives must provide full andfactual information on products, withoutmisrepresentation or exaggeration.Representatives’ statements must be accurateand complete; they should not be misleading,either directly or by implication. Their assertionsmust be scientific and should not vary in anyway from the official product monograph andcurrent Canadian medical thinking.

8.2.6 Member management shall work withrepresentatives on a regular basis to ensureappropriate information exchange occurs asstated in Section 8.2.5.

8.2.7 Under no circumstances shall Memberrepresentatives pay a fee in order to gain accessto a health care professional.

9. POST REGISTRATION CLINICALSTUDIES

9.1 Definition

A post registration clinical study (for the purposesof this Section 9, “study” or “studies”) is anystudy within the approved indications that isconducted after Health Canada’s Notice ofCompliance has been issued for a drug or product.

A study with the underlying purpose tofamiliarize HCPs and/or patients with the useof a drug or encourage its prescription, oftenreferred to as “seeding” or “experience” trials, is not an acceptable study.


9.2. General Principle

9.2.1 The main purpose of a study will be toanswer a scientific question which requiresobtaining and evaluating data on safety and/orefficacy, effectiveness, cost effectiveness, quality oflife, functional or other socio-economic factorsthat have to do with clinical use of the medicine.

9.2.2 Studies must provide a scientific frameworkfor investigation of the medicine in broader orspecial populations.

9.2.3 All studies must have a clearly definedobjective which is amenable to scientific reviewand testing. Duplication or redundancies instudies must be medically and ethically justifiable.

9.2.4 The company must ensure that studies aredesigned/approved and administered by qualifiedpeople in the medical/scientific department, usingthe same kinds of methodology (i.e. the planning,protocol development, monitoring and datainterpretation) that apply to pre-marketing trials.

As the post-registration clinical study may includethe dissemination of devices or diagnosticequipment (including, without limitation, bloodpressure monitors and glucose meters) for useby the physician or the subject as part of theclinical study, it is the company’s responsibility toensure that this material is appropriately distributedprior to the study and collected subsequent tothe study, by the medical/scientific department.Member companies must maintain a record ofdissemination to health care professionals anduse reasonable methods to retrieve thisequipment from the health care professionalsupon the completion of the study.

Other company representatives’ role in theprocess must be limited to the distribution andcollection of materials pertinent to the study, onbehalf of the medical/scientific department.

9.2.5 Studies must be carried out in accordancewith the Food and Drugs Act and Food and DrugRegulations, other applicable federal and provinciallegislation, guidelines issued by Health Canada,and applicable privacy legislation. Such studiesare to be conducted in accordance with the Food and Drugs Act and Food and Drug Regulations(including the principles of Good ClinicalPractice described therein), the International

Conference on Harmonization-Good ClinicalPractice: Consolidated Guideline, and the Tri-Council Policy Statement: Ethical Conductfor Research Involving Humans.

9.2.6 Studies must be carried out using a writtenprotocol that will provide answers to specificresearch questions. All studies must be consistentwith good clinical practice. The protocol mustbe designed to ensure scientifically meaningfulresults, and should contain details about thefollowing:

(a) Study background/scientific rationale;

(b) Study objective;

(c) Study design;

(d) Study population;

(e) Adverse event reporting;

(f) Sample size based on primary and/orsecondary endpoint;

(g) Description of measures to minimize bias(such as randomization or blinding);

(h) Study methodology;

(i) Duration of subject participation and studyduration;

(j) Data collection method;

(k) Predefined statistical plan consistent withthe objectives; and

(l) Appropriate external reporting of results(e.g. in a peer reviewed journal or on aclinical trial website).

9.2.7 Researchers must collect data according tothe protocol and keep the research results on filewith the Member as required by applicable lawand/or regulations.

9.2.8 After the data is collected but before the study is published, the researchers andmedical/scientific department of the Membermust jointly review the scientific evaluations of data.

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9.2.9 Researchers’ pay must reflect costs incurredin conducting the study, such as professionalfees, salaries of study staff, and laboratory tests.Payment may be in the form of a monetarygrant, travel to attend scientific and medicalmeetings, and/or equipment, provided the latter is needed for and relevant to the study.Agreements between member companies andHCPs for the study must be clearly defined,constitute part of the investigator and companyfiles, and any remuneration should be fair andreasonable.

9.2.10 Payment to researchers must not be basedon continuing administration of the medicineunder study to patients after the researcher hascompleted the study protocol.

9.2.11 Material provided to the physician to outlinethe protocol, procedure, patient treatment andcollection of data in a study should be clear andconcise. The material should not incorporate thebranding of the product, i.e. colours, images orother marketing/mnemonic devices that are anextension of the advertising material.

9.2.12 Any correspondence or presentations toinvestigators during the course of a study shouldhave no product or branding claims.

9.2.13 If product is supplied to the physician to use in the study, it should be labelled “Forclinical trial use only”.

9.2.14 Investigator meetings in the context ofstudies can be organized for any of the followingreasons: a) review the protocol; b) reviewworking processes; c) review of SAE, ICH andGCP guidelines; d) training of investigationalsite personnel in study conduct; e) review studyprogress and issues; or f) review the results ofthe study in which they participated. Theattendees at such meetings should be limited tocompany personnel from the medical/scientificdepartments and if warranted, other companypersonnel who have an essential role in thefunctioning of the study from the design,conduct or management perspective.

When these studies are national only in scopethe meeting must be held in Canada.

Section 13.6 should be referred to with regardsto social interaction.

All standard communications with investigatorsin preparation for the meeting should be wordedaccordingly.

10. PRICE-RELATED MATTERS

10.1 All Members must abide by federal andprovincial laws and regulations relating tomarket pricing. Rx&D supports the principle ofActual Acquisition Cost (AAC). All Membersshall cooperate with provincial governments toenforce this principle.

10.1.1 Actual Acquisition Cost is defined as thetrue transaction cost of a medicine, includingthe direct and/or indirect benefits that accrue tothe purchaser.

11. SERVICE-ORIENTED ITEMS


Members must ensure that the distribution ofservice-or14iented items is not carried out forproduct promotional purposes. Members mustnot conduct “special promotions” which cannotbe justified if subjected to scrutiny by membersof the health professions and the public. Membersshould also use good judgement by choosingmodes of advertising that will uphold thisgeneral principle.

11.2 Members may distribute acceptable service-oriented items to health care professionals.Acceptable service-oriented items are defined as items whose primary goal is to enhance thehealth care professional’s/patient’s understandingof a condition or its treatment. Such items maybear the corporate name and logo of the donor,but must not bear the name of any medicine.


The following are some examples (but notlimited to) of service-oriented items that havebeen consistently ruled by the Industry PracticesReview Committee (IPRC) to be in contraventionof the Code:

• Agendas, bookmarks, calendars (desktop & wall);

• Calendar pads, daybooks, desk clocks;

• Diaries, fridge magnets, kit folders;

• Mouse pads, note pads, Obus Forme backsupports;

• Paperweights, pens & penholders, plasticportfolios;

• Pocket diaries, Post-it Notes, stirrup covers;

• Stress/rehabilitation balls and similar so-called patient aids;

• Stationery items, such as patient appointmentcards containing patient information;

• Product-bearing advertising;

• Tote bags (single sponsorship); and

• Bags with a corporate logo (singlesponsorship).

11.3 Each part of a multi-component service-oriented item must comply with Sections 11.1and 11.2.

12. MARKET RESEARCH

12.1 Definition

Market research links the consumer, customer andpublic to the marketer through information –information that points out and defines marketingopportunities and problems; information thatgenerates, refines, and evaluates marketingprograms; information that monitors marketingperformance; and information that improvesunderstanding of marketing as a process.

Market research details the information neededto address these issues, designs the method forcollecting information, manages and implementsthe data collection process, analyzes the results,and communicates the findings and theirimplications.

This section applies to market research carriedout within the framework of various activitiesincluding studies, individual and group interviews,and focus groups, etc.


12.2.1 The purpose of an individual or groupinterview must be made clear to the participant(s).

12.2.2 Market research must not be a disguisefor selling or developing sales contacts.

12.2.3 Market research must not deliberatelysway the opinion(s) of the participant(s).

12.2.4 Honoraria offered to health careprofessionals who gather or provide marketresearch information should be based on ratessimilar to (and not higher than) their usual rateof pay.

12.2.5 Even when a consent form is signed, the confidentiality of participant(s) must bepreserved. The identity of the participant(s)must not be revealed for purposes of promotingMember products to them in the future.

12.2.6 Direct contact and administration withthe participants in the market research projectshould be limited to marketing researchpersonnel only with no sales representativeinvolvement. There should be no follow-up bysales representatives derived specifically from the market research contacts.

12.2.7 The market research questionnaire orprogram should not be designed in a mannerthat could be interpreted to be leading to aspecific product conclusion.

HCPs should not leave any market researchmeetings with any kind of promotional material.

Members are committed to separating marketresearch from other types of activities.

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13. ADVISORYBOARDS/CONSULTANTS


13.1.1 It is recognized that Members will seekadvice and guidance from health care professionalsin the conduct of various aspects of theirbusiness operations, including but not limited to, product development, research program,medical/scientific, and marketing issues. On such occasions, health care professionals assume the consultant’s role providing advice,knowledge, and expertise to the Member.

13.1.2 It is recognized that advisory boards/consultants panels may be constituted at theregional, provincial and national levels. This willensure the selection of individuals who haverecognized expertise in the areas in which theadvice is needed, and that such advice reflectsany geographical differences in attitudes/medical practice, procedures, etc.

13.2 Definitions

13.2.1 To ensure consistency of terminologyacross Members, one should refer to “AdvisoryBoard” when there is a contract/agreementbetween the consultant and the Member,enabling the individual to achieve a degree offamiliarity with the Member and its operations.Generally, the purpose of these Advisory Boardsis to advise Members on aspects of thedevelopment of a drug discovery to maturity(from pre to post launch).

13.2.2 “Consultants panels/meetings”: when ameeting is held with a specific group of expertswhere input is required to develop plans forproduct issues or opportunities.

13.3 When entering into such arrangements,Members must be guided by the following:

• The purpose and objectives of the interactionmust be clearly defined by the Member in itsinitial correspondence on the event;

• There must be a written contractualagreement confirming the purpose andobjectives of the consultation outlining thenature of the services to be provided.

• Documentation relevant to the consultationand its identified objective should be attachedto the contractual agreement; and

• Remuneration must be in the form of anhonorarium (fair and reasonable). Travel,accommodation and out-of-pocket expensesin providing the consulting service, wherewarranted, may be reimbursed.

13.4 Number of Advisory Board Member/Consultants

The number of advisory boards/consultantsmeetings must be limited. Members may only havea limited number of advisory boards/consultantsmeetings consistent with the need to gatherscientific input or commercial guidance.

An advisory board/consultant panel may notinclude more than 20 healthcare professionalsper meeting.

13.5 Meeting Location

Meetings of advisory boards/consultants panelsmust be held in Canada. The only exception isthat they may be held in conjunction withinternational CHE events (Section 4B) providedthat no travel or accommodation expenses are tobe paid by the Member convening the meeting.If the advisory board meeting occurs before orafter the international event ends, the Membermay reimburse the HCP for room accommodationsin conjunction with the advisory board.

13.6 Social Interaction

No social activity should be organized inconjunction with advisory boards/consultantspanels other than providing refreshments or a modest meal. The guidelines with respect to travel and hospitality for CHE programs set out in Section 4.A.3.8 also apply to travel and hospitality related to advisoryboards/consultants panels.


13.7 Participation

As the purpose of the activity is to seekconsultation, at least one person from HeadOffice must be present to guide the meetingdiscussion.

Involvement of sales representatives and theirdirect supervisors is prohibited.

13.8 Special Circumstances

Meeting organized by Corporate Head Office(international affiliate)

An advisory board/consultants panel may beorganized by International affiliate. Thesemeetings if held outside of Canada may includea maximum of 10 Canadian health careprofessionals, per brand, per year (experts intheir fields). Honorarium and reimbursement of travel and accommodation expenses may beprovided. As indicated in Section 13.3 above,contractual agreements should be entered intofor these meetings as well.

14. PRIVACY OF PATIENTINFORMATION

14.1 All Members must abide by federal/provincial/territorial laws and regulations pertaining toprivacy of patient information.

15. ENFORCEMENT

15.1 Complaints about any breach of this Codeshould be sent in writing to the IndustryPractices Review Committee (IPRC) at Rx&D’sOttawa office. The IPRC will decide on thevalidity of the complaint. Complaints regardingpotential Code breaches that are determined tohave occurred more than one hundred andtwenty (120) days after the event(s) giving rise tothe complaint(s) became known to, or reasonablyought to have been known to, the complainant,will not be considered by the IPRC.

15.2 Response Time

The IPRC will convene within two weeks ofreceipt of written notification to decide on thevalidity of the complaint.

5.2.1 Valid Complaint

The IPRC will adjudicate the complaint duringthe meeting and will render a decision when theCommittee is convened, if possible, or no laterthen three business days following the meeting.The IPRC decision will be written and providedto the parties involved no later than threebusiness days following the decision.

15.2.2 Invalid Complaint

Should the IPRC determine the complaint isinvalid; the IPRC will reject the complaint with a written explanation, while the Committee isconvened.

15.3 Violations

Each unique violation as determined by theIPRC shall normally count as one (1) violation.However, it is within the discretion of the IPRCto count any violation as two (2) violations, if it determines that such violation is intended todeliberately contravene the Code. A violationwill be deemed to be deliberately in contraventionof the Code when it is clearly not in compliancewith any one of the Guiding Principles listed inSection 1.

15.4 Penalties

The following penalties apply to Members,which violate the Code during a 12-monthcalendar year:

• Upon first violation: Publication of theinfraction on the Rx&D website and a fine of $10,000;

• Upon second violation: Publication of theinfraction on the Rx&D website and a fine of $15,000;

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• Upon third violation: Publication of theinfraction on the Rx&D website, a fine of$25,000, and, the chief executive officer(CEO) of the Member must appear beforethe Rx&D Board of Directors (BOD), atwhich time he/she must provide a detailedexplanation of the violations and acomprehensive written action plan to ensureremediation;

• Each additional violation after a third one:Publication of the infraction on the Rx&Dwebsite and a fine of $50,000; and

• All postings will remain on the website for 24 months from the date of the finaldecision.

15.4.1 Compliance Statement

• Within ninety (90) days of the final decision date with respect to any Code infraction, theMember must clearly indicate in writing toRx&D that they have halted the activity orotherwise addressed the issue that caused the infraction. A copy of this compliancestatement will be posted on the Rx&Dwebsite with the relevant decision of theIPRC.

• In the event that Rx&D determines that the Member has not complied with thisrequirement, the Member will be deemed tohave deliberately contravened one of theGuiding Principles, and the penalties set outin Section 15.3, 15.5.1 and 15.5.2 will apply.

• In exceptional circumstances, a Member,acting in good faith, may believe that morethan ninety (90) days will be required tocomply with this Section 15.4.1. In this case,the Member must file a written extensionrequest with Rx&D within ten (10) days ofthe decision date, providing a detailedsupporting rationale for the request, and anestimate of the time required. Rx&D willforward the extension request to the IPRCwho will evaluate the extension request andmake a recommendation to the Rx&DExecutive Committee (EC) within ten (10)days of its receipt. The EC, in its solediscretion, may elect to grant such anextension to the Member.

15.5 Repeat Offenders/Recidivists

In the event that any Member has five or moreviolations in one calendar year, or has twosuccessive calendar years with at least threeviolations in each calendar year:

The Rx&D Executive Committee (EC) willconvene and place the Member with suchviolations on a 12-month probationary period;probationary period to begin immediatelyfollowing the EC decision. The probationarymeasures to be directed by the EC shall include,but may not be limited to, the following:

• CEO will provide a written and verbal updatequarterly at BOD meetings for a 12-monthperiod, beginning at the next scheduled BODmeeting, regarding remediation actions taken;

• Rx&D will communicate in writing with theCEO and Chair of the Board of the Memberand its parent company, informing them ofthe situation;

• The Member will communicate its probationarystatus to all health care professionals involvedin its infractions indicating the sections of the Code violated as well as the steps theMember will be taking to ensure that theyabide by the Code in the future; and

• If the Member is found in violation of theCode during its probationary period, the ECwill reconvene to determine if the violation isa just cause for the following action:

– Expulsion from Rx&D. In the event that aMember is expelled from Rx&D, notice ofsuch shall be posted on the Rx&D Web site.

15.5.1 Deliberate Contravention

Any action found to deliberately contravene anyof the Guiding Principles (Section 1) may be ajust cause for expulsion. The BOD has discretionto determine if any other action is just cause forexpulsion.


15.5.2 Urgent Hearing

The EC can hold a hearing when the matter isconcerning a deliberate contravention of one ofthe Guiding Principles.

15.5.3 Membership Reapplication

The Company may reapply for membershipafter a 24-month period upon providingevidence of its improved complianceenvironment. The readmission is subject to the BOD’s approval.

15.6 Appeal (process open to both parties)

Should either party not accept the IPRC decision,or should the IPRC not be able to decide on thematter, either party involved in the complainthas recourse to an appeal.

15.6.1 The parties to the appeal shall be:

• A representative of each of the partiesinvolved in the complaint;

• A representative of the IPRC, appointed bythe President of Rx&D; and

• A panel of three arbitrators:

– To which the parties have agreed upon;

– The arbitrators must have expertisepertaining to the matter of the complaint;and

– If no agreement is reached on the choiceof one or more of the three potentialarbitrators within five business days of thenomination of any arbitrator, the Presidentof Rx&D shall appoint them at his/herown discretion.

15.6.2 The notice of appeal must be sent inwriting to the IPRC, at Rx&D’s offices inOttawa, within 10 business days of receipt ofthe IPRC’s decision.

15.6.3 The appeal must be heard within fourweeks of receipt by the IPRC of the notice of appeal.

15.6.4 The panel will render its decision whilethe Panel is convened, when possible, or no laterthan three business days following the hearing.

15.6.5 The panel decision will be provided inwriting to the parties no later than three businessdays following the hearing.

15.6.6 The panel decision shall be final, and theMember in question must adhere to it as acondition of continued membership in theAssociation. Such decisions shall be implementedimmediately, including necessary remedial actionrelated to the violation(s).

15.7 Cost

• Any costs incurred by any of the parties(Members) involved in the appeal, must bepaid by them, respectively;

• Cost resulting from the appointment andparticipation of the arbitrators’ panel will bepaid by the party which loses the appeal; and

• When a complaint is found to be invalid bythe IPRC, the complainant will pay any costincurred to convene the IPRC.

15.8 No Appeal is Filed

If no appeal is filed in the time frame describedin 15.6.2, the IPRC’s decision will be consideredfinal and the Member found in violation of theCode must adhere to the decision as a conditionof continued membership in Rx&D.

15.9 Industry Practices Review Committee

Formerly known as the Marketing PracticesReview Committee (MPRC).

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IPRC Members

Permanent members and one to two ad hocmembers will form the IPRC:

• Two Member representatives, as appointed bythe BOD;

• Two external representatives, health careprofessionals appointed by the BOD;

• The lead of the IPRC as appointed by theRx&D President; and

• Rx&D’s General Counsel.

Additional members can be:

• One individual appointed by the Rx&DPresident;

• One representative from PharmaceuticalAdvertising Advisory Board (PAAB), asrequired; and/or

• One external representative from thescientific community, as required, asappointed by the IPRC.

Rx&D CONTACT

55 Metcalfe Street, Suite 1220

Ottawa, ON K1P 6L5

Telephone: (613) 236-0455 Fax: (613) 236-6756

www.canadapharma.org

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http://www.canadapharma.org

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