Our Code of Practice for promotion and scientific engagement(prescription medicines)

Our Code of Practice for promotion and scientific engagement (prescription medicines) GSK Cross-Business STD_344428 (2.0) Our Code of Practice for promotion and scientific engagement 1

Who does this Code apply to? Principles of Our Our intentions and actions are driven • Vaccines Code of Practice by our values: • Pharma (including Pharma R&D) Patient focus Integrity • ViiV Healthcare Respect for people • Consumer Healthcare Transparency These business units have separate codes • Activities are intended to enhance healthcare and benefit those who use our medicines.

• Materials and activities that we initiate, arrange or fund, disclose GSK’s specific involvement. This declaration of involvement is clearly visible.

• Activities never discredit or reduce confidence in GSK or our industry.

• Activities are carried out in a responsible, ethical and professional manner in compliance with applicable regulatory and legal requirements.

Where activities or interactions are organised or arranged from a business unit or LOC and aimed at individuals from a number of countries or from another country, the relevant Country Medical Directors (CMDs) are consulted to ensure applicable requirements are followed.

Icons used throughout this Code

More information elsewhere in this Code

Further information

Reference to POL, SOP, STD and other GSK documents

Reference to digital resources including: Connect GSK and Compliance Document Management System (CDMS)

Definitions of terms in this document can be found in the glossary See appendix 3: Glossary 2 Our Code of Practice for promotion and scientific engagement 3

Why do we have What does this standard (code) address? Who needs Our staff follow this code and relevant this standard? Our external interactions follow high ethical and professional to follow it? requirements when undertaking the activities standards and reflect GSK values. This ensures these described. This code does not cover every situation. Our staff apply GSK values, interactions benefit patients and enhance the practice See section 2.3 their judgement and/or seek guidance from of medicine. for accountabilities for relevant staff (eg line managers, Legal, scientific engagement This code provides our global standards for promoting Medical and Compliance) when needed. prescription medicines and vaccines (referred to as medicines in this code) and engaging about our science Managers of staff involved in activities and our prescription medicines in a non-promotional manner. covered by this code are responsible for It applies to Vaccines and Pharma (including Pharma R&D). ensuring staff are adequately trained on the It excludes ViiV Healthcare and Consumer Healthcare who relevant requirements. have separate codes. Managers are accountable for breaches of this code (and other relevant requirements) by For non-prescription medicines and other products refer to their staff when the manager knew, or should STD-CHC-401: Consumer Healthcare code for promotion have reasonably known, that such breaches STD-CHC-401: and scientific engagement. were taking place. Consumer Healthcare code for promotion and Other written standards are followed when interacting with Business owners who select and engage scientific engagement specific audience groups or undertaking specific activities agencies, suppliers (such as contract which are not included in this code. sales forces, consultants, market research See appendix 1 agencies, advertising agencies, medical communication agencies, and public relations agencies) and distributors are accountable Other key GSK written standards relevant for our external for ensuring these parties are trained and interactions are provided in appendix 2. comply with this code and other relevant See appendix 2 requirements.

Business Development is responsible Local requirements for ensuring alliance transactions include contractual language that implements this Local laws, regulations and applicable industry codes are code and relevant requirements where followed (where local or regional industry codes do not exist applicable. Go to Connect GSK the IFPMA Code of Practice is applicable). Find: Ways of working Heads of our business units and General Search for: In addition to these local standards, the global Managers of Local Operating Companies IFPMA Code of Practice requirements provided in this code are followed (LOCs) are accountable for ensuring this unless a stricter approach is adopted due to: code and relevant requirements are met. • Local, regional or business unit specific GSK standards or restrictions. GSK Chief Medical Officer is accountable for the content of this code and Medical • Local laws, regulations or applicable industry codes. are responsible for governance frameworks to support implementation of this code.

POL-GSK-409: Medical governance policy Scientific engagement Other non-promotional General Further information 5 1 Promotion 2 (non-promotional) 3 activities 4 requirements 5 and appendices

p19 p19 p41 p21 p21 p57 p61 p67 p37 p59 p69 p66 p60 p33

for external interactions external for Appendix Glossary 3: Abbreviations 4: Appendix Funding HCPs and OHS attend to congresses scientific/medical Funding of HCPs and OHS attend to meetings promotional stand-alone Discounts, rebates and other terms commercial Appendix Key written 2: standards in promotional meetings promotional in aids Promotional Medical/R&D involvement Medical/R&D involvement communication Scientific of our research Supporting independent Supporting independent medical education medical payers, with interactions Scientific governments and public health

Gifts

Co-promotion

Samples 5.5 5.6 1.8 4.5 4.6 4.7 4.8 5.4 1.6 1.7 2.6 1.9 2.7 2.8 organisations

p9 p8 p17 p12 p13 p24 p27 p47 p28 p25 p29 p52 p49 p46 p46 p56 p55 p64 p64 p65 p54

Promotional meetings meetings Promotional Healthcare support services or the general public Disease awareness for patients for the general public Principles for scientific engagement scientific for Principles Information about our medicines services provide to Meeting venues Principles for promotion for Principles advertising consumer to Direct Introduction Accountability and approval Engagement of HCPs and OHS If you have concerns standards written GSK 1: Appendix for activities and interactions with audience groups not covered by this code Promotional information Promotional Use and selection of vendors Items of medical/educational utility Funding of scientific/medical of Funding congresses and other third party meetings insights and information Seeking external advice,

Hospitality

Detailing

Monitoring

1.4 1.5 3.3 3.4 3.2

4.2 5.1 1.3 2.1 2.2 2.3 3.1 4.1 4.3 4.4 5.2 5.3 1.1 1.2 2.4 2.5

Further information appendices and General requirements Other non-promotional activities Promotion Scientific engagement (non-promotional)

5 4 3 2 1

Contents Our Code of Practice for promotion and scientific engagement 4 6 Our Code of Practice for promotion and scientific engagement 7 Promotion External references relating to this section Go to Connect GSK

• POL_132175: Policy for Find: Ways of working use of digital channels Search for: Pipeline presentations • SOP-GSKF-414: Copy Approval SOP Find: Ways of working ViiV Healthcare • SOP_375788: Conducting Search for: Code of Practice promotional webinars • STD-GSK-512: Travel, Find: International medical IMED ref meetings and expense Search for: materials standard for GSK employees 1.1 Principles for promotion p8 • STD-GSKF-415: Standards 1 1.2 Promotional information p9 for external interactions by Medical and R&D staff Go to CDMS 1.3 Direct to consumer advertising p12 • SOP-GSK-007: Interactions Find: EDOC compliance 1.4 Promotional meetings p13 with officials from government Search for: Commercial and inter governmental practices policies 1.5 Detailing p17 agencies 1.6 Medical/R&D involvement p19 • SOP_344448: Engaging in promotional meetings with healthcare professionals (HCPs) 1.7 Samples p19 to provide services 1.8 Promotional aids p21 • SOP_54813: Medical Information responses to 1.9 Co-promotion p21 healthcare professionals and consumers • STD-CHC-401: Consumer Healthcare Code of Practice 9 1 Promotion

Policy for use of digital channels See section 3 See section 2 POL_132175: Disease information proactively provided for HCPs/ for provided proactively Disease information OHS meets the requirements of this section unless information disease awareness non-promotional is it beto passed on patients to follows promotion for channels digital of use The the requirements of this section and POL_132175: or a scientific engagement activity engagement scientific a or Abbreviated prescribing information (API) or full full (API) or information prescribing Abbreviated information this to direction (or information prescribing if this is specifically permitted by legal and regulatory requirements). The date of preparation/approval and a unique tracking claims no where space-constrained items For code. alternative an advertisements) reminder (eg made are required. is tracking/recall for mechanism more from audiences to targeted channels digital For than one country, users from a single country are able accessto the API or full prescribing information for country. their Promotional material (printed and electronic) that includes includes that electronic) and (printed material Promotional includes: medicine, the benefitfor claims • • • prescribing included to reference (without itself material The information) must not give a misleading impression of the medicine and its uses. It must reflect the balance of risks and of claims qualifications or limitations significant benefits. Any are disclosed and included clearly in the body of the material. Relevant information on the type of evidence available double(eg blind or open label clinical trial), side-effects, doses relevant indications, precautions, contraindications, included. is administration of methods and/or claims information, for basis statistical sound a is There Differences which material. promotional in comparisons and do not reach statistical significance must not be presented in which a way is misleading. 1.2 Promotional information

Promotional materials may not necessarily be limited necessarily limited be not may materials Promotional usingto only the verbatim of the approved product information Promotional label’). (‘the information respects the context and intent of information in the approved label, and statements from the label may not be reproduced outof context. • Consistent with locally approved prescribing information information prescribing approved locally with Consistent (API) (where it includes benefit claims for the medicine). and balanced. balanced. and (verifiable). substantiation of Capable Based on relevant evidence and sufficiently complete enableto the recipient form to their own opinion of the medicine. misrepresentation, exaggeration, distortion, by – Misleading undue emphasis, omission or in any other way. Knowingly offensive disparaging. or Disguised in any way. Clear, legible, up date, to accurate,objective fair, or interest in the particular information can be reasonably be can particular information the in interest or prescribing approved locally the on based expected information. Nothing is offered or provided in that a way has an prescription, recommendation, the on influence inappropriate our of administration or dispensing supply, purchase, medicines. Our employees do not use any inducement or deception gainto access or obtain an appointment with healthcare healthcare staff (OHS). professionals (HCPs)/other The frequency and timing of appointments does not cause inconvenience. is: information promotional Our • We onlyWe promote medicines in a country after marketing authorisations have been granted in that country. indication(s), approved for only promoted are medicines Our information. prescribing approved locally with consistent need their where those at directed only is Promotion • • not: is information promotional Our • • • •

1.1 Principles promotion for Our Code of Practice for promotion and scientific engagement Section 1 Promotion 8 11 1 Promotion

Clearly indicate the precise source(s) of the artwork. or adaptation where except reproduced; faithfully Are laws, local with comply to order in required is modification case industry which codes, applicable in or regulations it is clearly stated that the artwork has been adapted modified. and/or Are authorised foruse in accordance with relevant copyright law. Valid. Current. obtaining or references published citing (by Verifiable individual the from material promotional the of approval organisation). or and information prescribing approved the with Consistent approved by the same criteria as any promotional claim. Claims must notimply that a medicine, or an active ingredient, has some special merit quality or property unless substantiated. be can this The use of in-vitro laboratory or animal data support to claims of a health benefit is permitted only where the type of data are made clear and there is an established link between that data and the health benefit(eg a publicly available consensus by the scientific community and/or regulatory authorities). It must not be stated that a GSK medicine has no side effects, toxic hazards or risks of addiction or dependency. The word ‘safe’ must never be used describe to effects on patients, and the words ‘safely’ or ‘safer’ must never be used qualification. without medicines our describe to The word ‘new’ and equivalent terms are only used to presentations uses, indications, (or medicines our describe or formulations) that have been generally available in the relevant country for less months. than 12 Artwork, and graphs, photographs including illustrations, in included and publications from taken are which tables material: promotional • • • like Endorsements, the and testimonials quotations, attributed individuals to or organisations such asgovernment are: agencies independent bodies, or professional agencies, • • • •

Medicine X reduced the relative risk of myocardial infarction by 50% compared placebo to risk (the of myocardial infarction for medicine X was 5% and for placebo it was 10%). Medicine X reduced the relative five year risk of prostate reduction (the placebo to compared 50% cancer by for medicine X was 25% andfor placebo it was 50%). as a statement of fact. Patient numbers are included when expressing data as percentages. Whereclinical a or scientific issue exists which has not been resolved in favour of one generally accepted view, the issue is treated in a balanced manner. references clear to, referred are studies published Where material. the in included are provide that medicines different Comparisons between are placebo) a (including comparator a to relative information based on relevant and comparable aspects of the medicines. Communication of efficacy and safety data includes the example: for rates, absolute • • Claims for superior potency of a medicine (ie the medicine has a lower effective dose) are avoided unless they can be linked a practical to advantage such as a reduction in adverse reactions or cost of effective dosage. Price comparisons are made on the basis of equivalent dosage compare to example, For same indications. the for requirements the cost per ml for topical preparations is likely mislead to unless it can be shown that their usage ratesare similar. Any claim involving the economic evaluation of a medicine reflects the dataavailable and does not exaggerate its evaluation economic an in made significance. Assumptions are clinically relevant and consistent with the prescribing information. Medicines must not be stated as being ‘better’ or ‘superior’ comparator. the to reference without Medicines must not be stated as being the best, greatest, strongest other (or superlative words that indicate the highest quality or degree) unless it can be substantiated

continued 1.2 Promotional information Our Code of Practice for promotion and scientific engagement Section 1 Promotion 10 13 1 Promotion

All promotionalmeetings Meetings (including third party medical education events) that we influence(eg by suggesting or providing content or by selecting/recommending speakers) are GSK meetings promotional are They meetings. promotional whether or not they are awarded continuing medical education(CME) points other or continuous professional credits. development 1.4.1 proactively to is meetings promotional our of purpose The provide scientific or medical information about our diseases. associated the and/or medicines authorised Where hospitality is provided at a meeting, it is incidental and the scientific or medical content of the meeting accounts for at least twothirds of the total duration. • Promotional meetings only occur when we are able to ensure that the meeting adheres the to requirements of code this of requirements relevant other and section this including that the data presented and materials provided do not promote off-label use of our medicines. For any promotional meeting, it is the scientific content of the programme that attracts a delegate attend. to disease areas in permitted only are meetings Promotional where we have an authorised medicine. 1.4 Promotional meetings

Copy approval SOP-GSKF-414: In all countries except the USA and Canada the address responsible agent the or pharmaceutical company the of promotional on included is product the marketing for material. Promotional material produced byabove country business units for distribution LOCs to follows this code. See section patients 3.2 for awareness disease for or the general public.

Follow requirements set by the organisation (for example example (for organisation the by set requirements Follow written approval inadvance of the final promotional material that contains or implies an endorsement by the organisation may be required). be may organisation the Does not encourage unnecessary or inappropriate use. limitations appropriate applicable, where Indicates, theto use of medicines. about bring may imagery which or language Avoids fear or distress. • that material promotional with included is API) that (eg claim. benefit a makes available readily is claims support promotional to Information reasonablerequests. any to response in provided is and A procedure for reporting adverse events is included in the body of the material or in prescribing information Prescription medicines are not advertised to the general the advertised to not are medicines Prescription public unless it is expressly permitted by local laws, industry codes. prohibition applicable This or regulations does not apply public to health activities such as vaccination authorities. licensing relevant by approved campaigns Advertising and promotion of our medicines the to public: general • • • The introduction of a new medicine is not made known to the general public until reasonable steps have been taken inform to the appropriate HCPs of its availability.

1.2 Promotional information 1.3 Direct to consumer advertising continued Our Code of Practice for promotion and scientific engagement Section 1 Promotion 12 15 1 Promotion

Interactions with officials with Interactions Standards for external interactions interactions external for Standards GSK speakers and attendees External speakers External HCPs/OHS who agree to speak without payment The majority of expected attendees are from outside the venue country and from countries where the authorised. is use or medicine Materials include a statement that the medicine or use is not authorised in the country where the meeting held. is applicable regulations, laws, local the by permitted is It industry codes and local GSK standards for the place. congress takes the country where

STD-GSKF-415: • • • Promotional information on a medicine may be presented presented be may medicine a on information Promotional at an international congress held ina country where the relevant medicineor use is not authorised and the applies: following • 1.4.3 Medical/ Commercial and/or trained Appropriately R&D staff may present on our medicines and/or the meetings promotional disease areas at associated (see by Medical and R&D staff). Our staff who speak, attend or participate in meetings GSK. by employment their about transparent are 1.4.4 Government Officials:We do not pay HCPs/OHS who are considered Government Officialsto speak on topic any unless there is an approved exception by a CET member or delegate. also We do not pay for travel, accommodation or meals SOP-GSK-007: (see from government and inter governmental agencies). HCPs/OHS: do not We pay HCPs/OHS speak to on our behalf other to HCPs/OHS about our medicines and/or the areas. disease associated 1.4.5 may engageWe HCPs/OHS speak to about our medicines and/or the associated disease areas without a fee for that service. STD-GSKF-415: externalStandards for Medical by interactions and R&D staff SOP-GSK-007: officials with Interactions from government and inter governmental agencies

Travel, meetings and expense expense and meetings Travel, Conducting promotional webinars promotional Conducting See section 2 STD-GSK-512: employees GSK for standard SOP_375788: Go to Connect GSK Find: of working Ways presentations Pipeline for: Search Material (including content of presentations) of content (including Material For information regarding procurement for meetings, for procurement regarding information For STD-GSK-512: to refer Promotional meetings include GSK stand-alone GSK stand-alone include meetings Promotional at symposia satellite sponsored GSK and meetings, programmes congresses, speaker scientific/medical webinars. promotional and the of overview non-promotional level high A medical of programme core the in Presentations Medical Independent for meetings congresses or promotional. not are Education R&D pipeline at promotional meetings is permitted is meetings promotional at pipeline R&D provided: specific requirements following

See sections and 1.2 1.1

1.4.2 requirements the follow meetings promotional for Materials andof 1.2. sections 1.1 API or full prescribing information required (as by local at available be must codes) applicable or regulations the meeting. Alternatively, if specifically permitted by local laws, regulations or applicable industry codes, applicable reference or regulations laws, permitted. is information prescribing to direction or relating communications in disclosed is involvement Our with local requirements of the country in which the meeting invited directly specific Where HCPs/OHS are held. is from outside the country where the meeting is held the meeting,(or or a recording of the meeting, is targeted thethem), to material meets the relevant requirements of the HCPs/OHS home country the material (eg is approved as consistent with the prescribing information of HCPs/ OHS home country). to theto meeting and in any published proceedings. The visible. clearly is role GSK’s of declaration Materials are reviewed and approved for compliance

continued 1.4 Promotional meetings Our Code of Practice for promotion and scientific engagement Section 1 Promotion 14 17 1 Promotion

Commercial booths at meetings If an HCP asksan off-label question or asks a question that requires a written response, the question is captured and submitted Medical to Information. Alternatively the HCP may be referred the to GSK Medical Information booth if there is one at the meeting. See sections and 1.2 1.1

1.4.7 Commercial boothsare staffed by those who are trained discussto our medicineswith delegatesconsistent with the prescribing information and in accordance with relevant rules. promotional Competitions (including raffles and lotteries), gifts, (basic permitted not are entertainment and recreation refreshments such as tea and coffee are permitted). Non-competitive quizzes that relate scientific/medical to knowledge or skill in the relevant disease area are permitted. The following applies sales to representatives and others who detail our medicines. Sales representatives are given adequate training and have provide to them enable to sufficientknowledge scientific relevant and accurate information about the medicines detail. they Sales representatives ensure they do not mislead as their to represent. they company the or role identity, The use of unapproved materials is not permitted, including unapproved medical papers or extracts of any articles, even if these are published in peer reviewed journals. Materials relating medicines to or indications that do not have distributed or to referred not are authorisation marketing sales representatives. by Sales representatives must not solicit any requests for medicines. our on information off-label 1.5 Detailing

Engaging with healthcare healthcare with Engaging GSK sponsored satellite symposia I am a paid consultant/investigator for GSK, and GSK has reimbursed my travel costs for this engagement but I have not been paid and will not be paid for this engagement.” speaking “ clear verbal disclosure at the beginning of each speaking engagement highlight to any payment for travel or other costs (covering the month last period) 12 that they may have received from GSK – for example: The scientific and medical content of a satellite symposium and the appropriateness of the speaker faculty are approved by the relevant CMD or designee for the country in which the event occurs above (see for additional approvals for HCPs/OHS who agree speak to without implemented be may arrangements Logistical payment). a by non-medical teams or a contracted vendor. or designee of the country in which the unpaid HCP/OHS resides. speaker is approval designee CET or prior member Additional required for any air travel or overnight accommodation. No costs may be reimbursed by payment directly the to speaker. HCP/OHS requireWe the speaker make to an appropriate and as a factor in selecting the HCPs/OHS provide to other services or participate to in our research). This is approved in advance by the General Manager Unpaid speakers may not receive any other quid pro quo speaking unpaid consider not do we (ie arrangements 1.4.6 Medical Commercial or under be may symposia Satellite budget. Medical has accountability for the content of GSK symposia. satellite sponsored • • • those and obligations our define to required are Contracts requirements, contract standard to addition In speaker. the of the following is included in contracts with unpaid speakers: • We may arrange and pay reasonable transportation/ pay and arrange may We speaker. HCP/OHS unpaid an for accommodation/meals • Our SOP on engaging HCPs/OHSprovide to a service is followed SOP_344448: (see services). provide to (HCPs) professionals •

1.4 Promotional meetings SOP_344448: SOP_344448: healthcare with Engaging (HCPs) professionals services provide to

continued Our Code of Practice for promotion and scientific engagement Section 1 Promotion 16 19 1 Promotion

Standards Standards Samples are not providedfor clinical studies or compassionate use or address to issues of patient medicines. our access to OHS unless there is an exception approved by the CMD designee.or R&D/Medical staff do not discuss clinical research or the in HCPs/OHS with activities engagement scientific sales representative. a of presence on information or data presenting proactively When our medicines and/or the associated disease areas at promotional meetings, Medical/R&D staff are acting in STD-GSKF-415: capacity and promotional a for external interactions by Medical and R&D staff applies. Samples are small supplies of medicines given HCPs to freeof charge. The purpose of samples is familiarise to patients, in use its and medicine particular a HCPs with medicine. the with experience patient facilitate to and/or • Samples of vaccines are not permitted. Samples of other medicines can be given HCPs/OHS to authorised to local meets this provided medicine that supply or prescribe global, any industry and codes applicable regulations, laws, regional or local GSK requirements for specific medicines. R&D/Medical staff do not accompany sales representatives in the fieldtype1:1 to meetinteractions in with HCPs/ 1.7 Samples 1.6 Medical/R&D involvement in promotional meetings STD-GSKF-415: externalStandards for Medical by interactions and R&D staff

Medical Information responses Medical Information Go to CDMS compliance EDOC Find: Commercial policies practices for: Search In the USA, journal reprints and clinical practice commercial the following distributed be may guidelines policies: practices the regarding questions certainFor unsolicited availability of data, where permitted by local laws, approve codes, applicable Medical may or regulations respond to personnel field for appropriate is it that “Yes, there“Yes, is data available” in the course of referring the question Medical to Information. Deliver Medical Information written responses to to responses written Medical Information Deliver HCPs/OHS. Receive a copy of the Medical Information responses answered. been has request their Request Medical Information responses for their own use. sent HCPs/OHS; to they can receive notification that Sales representatives receiving unsolicited requests for for requests unsolicited receiving representatives Sales written a requiring those or information, medical off-label Medical Information the to requests forward such response, SOP_54813: (see function Responses consumers). and professionals healthcare to medicalto informationrequests are sent directly the to HCP/OHS requesting the information. information. the requesting HCP/OHS Sales representatives must not: • • • prescribing approved current, supply representatives Sales information if requested by an HCP/OHS.

SOP_54813: SOP_54813: Medical Information healthcare responses to professionals and consumers continued 1.5 Detailing Our Code of Practice for promotion and scientific engagement Section 1 Promotion 18 21 1 Promotion

IMED materials ref Go to Connect GSK medical International Find: Search for:  R&D/Medical staff are not permitted provide to branded HCPs/OHS. to aids promotional For Japan and countries in Europe: No promotional aids are permitted other than pens and pads at GSK meetings or meetings funded by GSK. They do not carry branding. product For countries in EMAP: Promotional aids are listed on Connect GSK. In the USA and Canada promotional aids are not permitted. Subject to applicable competition law and guidance guidance and law competition applicable to Subject issued for particular types of deal, where a third party is co-promoting or promoting a GSK medicine (ie we own party third the complies authorisation), marketing the with the standards set out inlocal laws, regulations and Promotional code. this industry and codes applicable party third are the by carried out activities and materials approved by GSK in accordance with relevant approval processes. Where we co-promote or promote a third party’s medicine (ie where they own the marketing authorisation) we comply industry codesapplicable and regulations laws, local with and this code. seek We agreement from the third party complyto with the standards set out in this code. Promotional aids (sometimes called brand reminder items) items) reminder brand called (sometimes aids Promotional can be given HCPs/OHS to provided they are of minimal bevalue defined (to and documented locally), relevant theto professional activities of the recipient and provided basis. infrequent an on company and carry branding may product aids Promotional branding. 1.9 Co-promotion 1.8 aidsPromotional

Consumer HealthcareConsumer ViiV Healthcare Code of Practice Code of Practice Go to Connect GSK Find: of working Ways Search for:  STD-CHC-401: Refer the to Codes of Practice for ViiV Healthcare regarding requirements Healthcare for Consumer and products. those samples for Within Europe, quantities of samples of prescription prescription of samples of quantities Europe, Within medicines are limited four to samples per year per HCP for a restricted two year period post-launch. Each LOC within Europe determines the launch date that will trigger the start of this two year sampling ‘window’ for each new medicine or indication. The rationale for providing samples. providing for rationale The which presentations and medicines of list approved An can be offered as samples (pack size are not larger than the smallest presentation available within that country). Acceptable volumes. sample distribution. of Duration requirements storage including requirements Distribution required, if refrigeration appropriate (eg needed where security of samples, inventory management). Labelling (each sample is be to marked ‘free product sample – not for resale’ or words that to effect and approved other or information prescribing by accompanied information). product sample distributions, track and Processes monitor to enable recall and audit. Local requirements, accountabilities, processes and processes and accountabilities, requirements, Local governance of samples are documented in a local SOP includes: which • • • • • • •

1.7 Samples continued Our Code of Practice for promotion and scientific engagement Section 1 Promotion 20 22 Our Code of Practice for promotion and scientific engagement 23 Scientific External references relating to this section Go to Connect GSK

engagement • STD-GSKF-415: Standards for external Find: GSK global interactions by Medical and R&D staff Search for: Scientific engagement (non-promotional) • POL_132175: Policy for use of digital Find: GSK global channels Search for: Scientific engagement – vendor • STD_340448: Standard for interacting with Find: Ways of working patient organisations Search for: Guidance for when a contract is required • SOP-GSK-301: Procedure on protecting and mitigating risk from internal and external Find: Medicines and vaccines communication activities Search for: Guidance on the conduct of 2.1 Introduction p24 primary market research in GSK Pharma • SOP_297780: US Pharma market research: 2 2.2 Principles for scientific engagement p25 criteria for designing and executing market Find: Ways of working research conducted in the US Search for: GSK Publication Handbook 2.3 Accountability and approval p27 • SOP_54813: Medical Information responses Search for: ABAC requirements 2.4 Use and selection of vendors p28 to healthcare professionals and consumers Search for: ABAC framework • SOP-GSKF-416: Scientific engagement of 2.5 Seeking external advice, p29 Find: Ways of working individual and groups of patient caregivers insights and information Search for: Moore model and consumers to seek advice, insights and 2.6 Scientific communication of our research p33 information Find: Ways of working Search for: IME agreement contract 2.7 Supporting independent medical education p37 • SOP_344448: Engaging with Healthcare Professionals (HCPs) to provide services 2.8 Scientific interactions with payers, p41 • POL-GSKF-408: Policy on human subject governments and public health research Go to CDMS organisations • SOP_53431: Public disclosure of human Find: EDOC compliance subject research (Pharma) Search for: US commercial • SOP_9000026959: Public disclosure practices policies of human subject research (Vaccines) • POL-GSK-016: Policy on grants and donations Go to access.gsk.com

• SOP-GSK-016: Grants and donations SOP Search for: Process map for IME • SOP-GSK-007: Interactions with officials from government and inter governmental agencies Scientific engagement

25 2 (non-promotional)

The intention is clear, transparent and non-promotional. and transparent clear, is intention The The activity would not be perceived as being promotional. The timing and scale are proportionate the to need. scientific There is a legitimate need for the activity at the time occurs.it being promotional or being designed to influencethe designed being to or promotional being medicines. our of use or sale supply, prescription, of stages early the startsin engagement Scientific cycle life the throughout continues and development medicine. the of Scientific engagement with external communities is is communities external with engagement Scientific fundamental the to progress of medical science and meetingto the needs of patients and public health. Our physicians and scientists engage in the highest increase to dialogue scientific peer-to-peer of standards understanding of diseases and develop effective therapies. treatment and prevention scientific legitimate by driven is engagement Scientific proportionate and balanced, appropriate is It need. theto scientific need and intent. are behaviours or activities engagement Scientific not promotional and do not have the appearance of Whether a proposed activity or material meets the principles the meets material activity proposed or a Whether with judgment medical requires engagement scientific for proportionality perception, and intent, of consideration timing ensure to that: • • • • 2.2 Principles scientific for engagement

Standards for external external for Standards See appendix 1 appendix See See section1.6 STD-GSKF-415: interactions by Medical and R&D staff R&D/Medical staff do not discuss clinical research There are other activities that involve the non- or scientific of exchange and interaction promotional research, of conduct the in as such information medical preparation (including authorities regulatory engaging responses information medical providing meetings), for investigational of use compassionate enabling and medicines. For these activities please refer the to 1). appendix see (eg standards written relevant HCPs/OHS with activity engagement scientific a or Under scientific engagement, the scientific scientific the engagement, scientific Under in papers research includes our of communication peer reviewed journals and presentations in the core congresses. medical of programme on information or data presenting proactively When our medicines and/or their disease areas HCPs/OHS to at promotional meetings, Medical/R&D staff are acting capacity. promotional a in sales representative. a of presence the in Seeking external advice, insights and information. and insights advice, Seeking external research.our of communication Scientific education. medical Supporting independent Scientific interactions with payers, governments organisations. health public and and proportional the to scientific need. There is a clear promotional and engagement scientific between distinction activities. are: code this by covered activities engagement Scientific • • • • of disease, and improving patient care. patient improving and disease, of scientific with associated materials and activities The intent, and nature in non-promotional are engagement Scientific engagement is the non-promotional interaction interaction non-promotional the is engagement Scientific andexchange of informationbetween GSK and external communities in order advance to scientific and medical development appropriate the includes This understanding. medicines, our understanding management of use the and

2.1 Introduction Our Code of Practice for promotion and scientific engagement Section(non-promotional) engagement 2 Scientific 24 Scientific engagement

27 2 (non-promotional)

. The Business Owner ensures that within two weeks of the approval Where activities or interactions are organised or or organised are interactions or activities Where arranged from a Business Unit or LOC and aimed at individuals from a number of countries or from another ensure to CMDs consulted are relevant the country, followed. are requirements applicable Prior the to assignment ofthe MDL/VDL for a medicine, the most appropriate member of the R&D leadership team from within the relevantresearch unit is accountable for are engagement scientific of principles the that ensuring applied. appropriately Accountability and approval for scientific engagement engagement scientific for approval and Accountability activities resideswithin our Medical Governance Framework ensureto that the content, frequency, and other aspects proportionate and appropriate are engagement scientific of genuineto scientific and public health need. under are activities engagement scientific for Budgets R&D/Medical accountability. The relevant Medicine or Vaccine Development Leader and (MDL/VDL)engagement scientific for accountable is Commit from activities engagement scientific of approval to Medicineto Development marketing to authorisation. • Once a medicine new indication) (or receives marketing authorisation in at least one market key USA, (eg EU or a activities post-authorisation for approval market), franchise is in line with the level in the organisation where the activity is organised, eg relevant Global Medical Affairs Leader (GMAL or assigned individual where there is not a GMAL) for a global activity, Area Medical Lead for an area activity, Country Medical Director (CMD) for a LOC activity (in countries where a CMD role does not exist, the Area Medical Director is accountable). scientific the from available are templates Approval website engagement completed is template approval signed the relevant where and stored following instructions on the scientific website engagement granted. being Go to Connect GSK Find: GSK global Scientific for: Search engagement 2.3 Accountability approval and

Procedure protecting on Standard for interacting with with interacting for Standard STD_340448: patient organisations patient SOP-GSK-301: and mitigating risk from internal and external activities communication Scientific engagement with patient advocacy groups groups advocacy patient with engagement Scientific and the media follow these principles: The context of any activity isconsidered in deciding what is significant a when launch before particularly just appropriate, be could activities engagement scientific in increase perceived as being promotional in intent. The use of digital channels for scientific engagement follows the requirementsof this section and follows POL_132175: Policy for use of digital channels. Policy for for Policy

2.2 Principles scientific for engagement POL_132175: use of digital channels continued Our Code of Practice for promotion and scientific engagement Section(non-promotional) engagement 2 Scientific 26 Scientific engagement

29 2 (non-promotional) ).

What is not included What can we do Where care is needed SOP_297780: criteria research: Pharma market US Requirements Requirements Pre-planned informal discussions with individuals individuals with discussions informal Pre-planned groups.or Advisory type boards consultancy and 1:1 (advice basis). consultancy a on individuals from seeking Spontaneous discussions at scientific/medical scientific/medical at discussions Spontaneous congresses. Advisory boards that are not related to disease areas, to related not are Advisory that boards medicines or the development or use of medicines. Market research/focus groups see (eg Guidance on the conduct of primary market research in GSK Pharma and research conducted market executing and designing for in the US). 2.5.3 The requirements below do not apply to: • • 2.5.4 Advisory(a) type boards consultancy and 1:1 Advice may be sought during the lifecycle of a medicine if there is a legitimate, documented need and the information is not already available through literature, databases or other advice seeking previous sources activities. including internal The scale and timing of the advice seeking activity is appropriate the to scientific need. The proposed agenda is focused on obtaining input. Only data relevant the to specific advice being sought participants. with shared is 2.5.1 and insights questions), pre-determined (on advice Seek research,diseases, scientific medicine to related information access, market disease management, development, through: matters related medicine other or commercialisation  (a)  (b)  (c) 2.5.2 Interactions described in this section are not used as a vehicle publicise to data. Care is needed ensure to scientific tone/intent. in promotional become not do discussions spontaneous and discussions informal pre-planned For discussions at congresses, care is needed so that the discussion does not evolve into a situation where a contract Guidance (see needed foris when a contract is required

US Pharma market research: research: Pharma market designing for criteria market executing and in research conducted the US Go to Connect GSK Find: of working Ways Guidance for: Search vaccinesand Guidance for: Search SOP_297780: for when a contract is required Go to ConnectGSK MedicinesFind: on the conduct of researchprimary market in GSK Pharma 2.5 Seeking external advice, insights and information

). This limitation does not include consultants who are are who consultants include not does limitation This under contract provide to guidance and advice, or vendors agencies, travel support logistical (eg provide only who event management). Firewall and training assessment is checked for each vendor prior each to new engagement. It is recommended that an approved procurement process is used. If Procurement is not involved in the contracting process, assumes local business responsibility owner the for declarations, firewall organisational contracts, maintaining and annual training certifications(see scientific website engagement External vendors do not developscientific engagement plans or content selection (eg and interpretation of scientific data). Vendors can be used for operational support formatting, (eg references, artwork, researching design, editing, copy layout, printing, logistics and overall project management) when the GSK. within available not capacity are or capabilities required support for operational provide to engaged Vendors the development of content copy (eg editing, researching GSK understand is and trained are that references) content. approving and reviewing for responsible support those are operational for engaged Vendors that have organisational firewall protections if they they if protections firewall organisational have that activities promotional and engagement support scientific (‘dual purpose’ vendors). • •

2.4 selection and Use vendors of Go to Connect GSK Find: GSK global Scientific for: Search engagement Our Code of Practice for promotion and scientific engagement Section(non-promotional) engagement 2 Scientific 28 Scientific engagement

31 2 (non-promotional)

). Medical Information responses Medical Information SOP_54813: These discussions do not involve proactively providing medicines. discussion our about Limited information medicines our about information available publicly of is permitted in order ask to a question or discuss statements made by HCPs/OHS examples (see below). provided be also may medicines our on Information in response a specific to unsolicited question (see not readily available through the scientific literature or other local include sources. Examples may available publicly presentation typical or disease, specified a of prevalence clinic. the type in patient particular a of characteristics Pre-planned informal discussions to understand a disease a understand to discussions informal Pre-planned specific a to related management patient general or disease. Contacting an expert HCP obtain to information which is to healthcare professionals and consumers). and professionals healthcare to Written agreements or contracts are not required. to relevant information and importantWhere insights our science and/or our medicines is obtained, it is shared with relevant GSK colleagues. and information. and • (c) Spontaneous discussions at scientific/medical scientific/medical at discussions Spontaneous (c) congresses In the context of a scientific forum such as a scientific/ medical congress, Medical/R&D staff may interact with HCPs/OHS on a spontaneous basis gain to insights is proportionate in length and frequency, and based upon scientificenhance understanding. our to need genuine a pre- limited through information and insights Gaining require usually not does discussions informal planned written agreements or contracts Guidance (see for when a contract is required Documentation of the outcome of interactions via a contact report (stored in a business unit or LOC defined system) is required ensure to learning across relevant parts organisation. the of interactions: Examples permitted of • • The extent of informal discussions led by medical • •

Medical SOP_54813: SOP_54813: Go to Connect GSK Find: of working Ways Guidance for: Search for when a contract is required to responses Information healthcare professionals consumers and

Medical Information responses to healthcare to responses Medical Information Go to CDMS compliance EDOC Find: policies practices commercial US for: Search In the USA advice-seeking activities by US Commercial applicable with compliance in conducted are policies: practices commercial US May be pre-arranged. be May credibility. and integrity objectivity, scientific Maintain Are for our staff listen to and learn, and not provoke to the about opinions change or influence discussion of, merits of our medicines. (Medical/R&D staff lead the where attend staff commercial may senior discussions; there is a documented reason for their attendance). (b) Pre-planned informal discussions with individuals individuals with discussions informal Pre-planned (b) groups or Medical/R&D staff may interact with HCPs/OHS on a limited basis gain to insights and information. These discussions: scientific • • Do not involve proactively providing information about (see question unsolicited specific a to response in provided SOP_54813: STD-GSKF-415: and consumers and professionals Standards for external interactions by Medical and R&D staff). •  these activities. Other functions can be involved if relevant be medicines may our on information medicines; our Medical/R&D is accountable and holds the budget for for budget Medical/R&D the holds and accountable is theto need. Advice is sought from as few people as necessary. They their and advice the provide to qualified appropriately are qualifications documented. If 12 moreadvisors than are documented. is rationale the required, Only GSK staff who have an active and documented role participate advice the record or necessary obtain is which to in the meeting. The advisory nature of the interaction is made clear in materials, and plans) internal (including documentation and the specific advice being sought is made clear. The output and the we will way use the advice is documented. Medical

SOP_54813: SOP_54813: to responses Information healthcare professionals consumers and STD-GSKF-415: externalStandards for Medical by interactions and R&D staff continued 2.5 Seeking external advice, insights and information Our Code of Practice for promotion and scientific engagement Section(non-promotional) engagement 2 Scientific 30 Scientific engagement

33 2 (non-promotional)

Policy on human subject research subject human on Policy What can we do Where care is needed Requirements Provide medicine related information in response response in information related medicine Provide unsolicitedto requests from an HCP/OHS. Provide information aboutongoing clinical trials and/ or medical information in response unsolicited to booths. scientific/medical at requests On a limited basis, provide a forum at congresses for two-way discussion and debate on the results of our science (scientificworkshop). • • • Other congress activities communicate to ordiscuss science: our We publiclyWe disclose our clinical research according theto principles and requirements of POL-GSKF-408: includes research. This subject human on Policy postings on internet registers, congress presentations congress presentations registers, internet on postings (oral orposters) as part of core congress programs, publications. manuscript and Support the development of treatment guidelines by information. scientific providing by societies medical The number of publications and congress abstracts (oral or poster presentations) is driven by legitimate medical/scientific need and not a desireto increase congress and Publications publicity. or citations Data in included are poster) or (oral presentations Plans. Dissemination promotional and scientific of separation clear is There congresses. medical/scientific at activities 2.6.1  (a) (b)  (b) (a) Scientific public disclosure of our research our of disclosure public Scientific (a) follows disclosure research, public subject human For POL-GSKF-408: requirements. applicable and Once an investigational medicine enters Phase II, the importance scientific of consider we that data pre-clinical or relevant for patient care is submitted for publication as the data become available. (c)  (c) 2.6.2 ensure: To • • 2.6.3

POL-GSKF-408: Policy on human subject research POL-GSKF-408: Policy on human subject research 2.6 Scientific communication research our of

Scientific engagement of of engagement Scientific Standards for external external for Standards Standard for interacting with with interacting for Standard Engaging with healthcare with Engaging interactions by Medical and R&D staff SOP_344448: services provide to (HCPs) professionals STD_340448: SOP-GSKF-416: and caregivers patient of groups and individual information and insights advice, seek to consumers STD-GSKF-415: patient organisations patient See also See at the congress whether the new guidelines are likely Ad hoc unplanned discussions at scientific/medical a congress staff and R&D/Medical between congress more learning in interested are we where delegates about their science, and there is no promotional intent purpose. or New patient management guidelines which may or may a congress.Our R&D/Medical staff may ask a few HCPs impactto the they way manage their patients. Our R&D/Medical staff may ask questions of HCPs/OHS who are presenting data at a congress. The questions are scientific and based on the data described in the our to relate not may or may which presentations, medicines. An HCP publishes a paper which includes data based on medicines, R&D/Medical competitor and medicines or our staff may wish ask to the HCP/OHS some questions results. the about not include reference to our medicines are presented at at presented are medicines our to reference include not Examples of permitted interactions: Examples permitted of • • • •

continued 2.5 Seeking external advice, insights and information Our Code of Practice for promotion and scientific engagement Section(non-promotional) engagement 2 Scientific 32 Scientific engagement

35 2 (non-promotional)

staff Activities only. conducted from scientific the booth distribution pro-active no is there and non-promotional are or display of data or information on our medicines. Scientificworkshops scientific compelling and exceptional an is there When justification, Medical/R&D staff from above country business units may fund and organise a scientificworkshop within there congress where global/regional a of infrastructure the scientific furtherfide bona for justification scientific a is fund not do research (we our on debate and discussion of travel or accommodation for individuals attend). to (b) Other(b) congress activities communicate to or discuss scienceour statements requests and unsolicited to Responses response in information Medical/R&D provide staffmay anto unsolicited request from an HCP/OHS or respond to a statementto made by a congress delegate. Any verbal response information medical the with consistent is response respond only to tailored is response The relevant). (where theto specific question asked or the statement made. permitted interactions of Examples Ad hoc unplanned discussions at a scientific/medical congress between our R&D/Medical staff and congress delegates who are interested in learning more about our science and instigate the discussion, and there is purpose. or intent promotional no discuss spontaneously staff may R&D/Medical Our a statement about our medicines made by a congress that information balanced factual, provide to delegate statement. that supports challenges or Scientific/medical information booths information medical provide to booths Scientific/medical GSK sponsored recruiting currently on information and/or physically are they provided permitted are trials clinical separate from commercial booths, with at least a tall dividing wall. or partition Medical/R&D by staffed are booths Scientific/medical

Public disclosure of human human of disclosure Public Public disclosure of human subject subject human of disclosure Public research (Pharma) SOP_9000026959: research (Vaccines) subject Go to Connect GSK Find: of working Ways handbook publication GSK for: Search SOP_53431: See also See on information available in the public domain; are of scientific of are domain; public the in available information on or medical significanceto the intended audience; are factual, local with accordance in and non-promotional balanced, industry codes. applicable and regulations laws, Medical/R&D staff may present a therapy area pipeline overview medical to audiences in response an to unsolicited information based on is presented information The request. domain. public the in available in the core part of medical congresses in response medical/scientific legitimate from requests unsolicited to societies a therapy (eg area pipeline overview), are based journal guidelines are more restrictive). do not We pay for reimburse may articles presentations. We of authorship or plenary or authorship with associated expenses reasonable expenses travel research (eg our of congress presentations related attendance to at author meetings or plenary congress presentations). selected congress is target the congress presentations For according the to scientific/medical significance and the Data the with consistent data the for audience appropriate manner timely a in submitted is data New Plan. Disclosure and is not delayed increase to impact just prior launch. to Scientific and medical presentations made by our staff The scientist or physician responsible for the study is study the for responsible physician or scientist The publications/ other and primary publication the for accountable study. the from further data include that presentations meet authors presentations, and publications For International Committeeof Medical JournalsEditors (ICMJE) the (where authorship guidelines journal or guidelines

continued 2.6 Scientific communication research our of Our Code of Practice for promotion and scientific engagement Section(non-promotional) engagement 2 Scientific 34 Scientific engagement

37 2 (non-promotional)

Policy on grants and Grants and donations SOP). What can we do Where care is needed Medical education comprises activities that maintain, maintain, that activities comprises Medical education knowledge, skills, increase and the or develop, HCPs/ that performance relationships professional and OHS use provide to services for patients, the public or the profession. These activities can be independent or education medical independent only non-independent; code. this under engagement scientific considered is See section 1

Activities where CME other or Continuing Professional Development points (CPD) are given participants to does not necessarily mean that the activity is independent. Similarly, the absence of these points does not necessarily mean that the activity is non-independentmedical education. Exception: Funding independent medical education in in education medical independent Funding Exception: pre-authorisation a have only we where disease area a medicine or indication is permitted when it is related to a significant global public health concern and approved by the GSK CMO or delegate. Independent Medical Education (IME) Medical Education comprises activities Independent HCPs/OHS without for implemented or delivered are that audience or faculty speaker content, on influence GSK selection. • 2.7.1 canWe provide grant funding for independent medical education that adheres the to requirements of this section and our policies andSOPs on providing grants and donations POL-GSK-016: (see SOP-GSK-016: and donations Other types of funding such as ‘fee for service’ for independent permitted. not are education medical only is education medical independent for funding Grant permitted in disease areas where we have an authorised medicine. • 2.7.2 Where we have any influence on the education activity it is not independent medical education and in such cases the activity is conducted in accordance with section 1 code. this of Grants Policy on grants and donations and grants on SOP-GSK-016: POL-GSK-016: SOP donations and 2.7 Supporting independent medical education

See section 2.8

The workshop focus is on research which is presented presented is research which on is focus workshop The at the congress; presentation of data is limited enabling to debate. and discussion the Such workshops are for a limited number of delegates (no more than 30 via prior registration) and may include include may and registration) prior via 30 than more (no data relatedan to unauthorised medicine or indication. require plan and approach justification, documented The approval from all the following: the CMD in the country where the workshop is planned, the MDL/VDL and Chief Medical Officer(CMO) or delegate. Official bodies (eg agencies and committees) of of committees) and agencies (eg Official bodies governments and regulatory authorities may have clearly defined and regulated procedures for the industry support the to packages information of submission official of recommendations. development Our staff declare conflicts of interest if they are involved society. medical the of decision-making the in • • (c) Support(c) for the development of treatment guidelines societies medical by If we do not have an authorised medicine in a given therapy scientific and medical area, provide staff Medical/R&D can information for the development of a treatment guideline in society. medical a from request unsolicited an to response In these circumstances and upon invitation, we can questions answer and meetings to information contribute discussions. in When we have an authorised medicine in a given therapy area and there is no treatment guideline endorsed by a medical society, orwhen existing guidelines need updating, Medical/R&D staff can proactively contribute our data and perspectives. In either of the above situations, support provided for the when considered only is guidelines of revision or generation our participation brings scientific or medical value for the disclosed. clearly is participation GSK patients. of benefit •

2.6 Scientific communication research our of continued Our Code of Practice for promotion and scientific engagement Section(non-promotional) engagement 2 Scientific 36 Scientific engagement

39 2 (non-promotional)

. This assessment is developed Is in an area aligned with our interests. clinical or scientific high-quality, non-promotional, Is education in a disease area where we have an authorised exception. CMOa approved is there or medicine need educational based evidence an Addresses identified(eg by the applicant citing external experts audit clinical reviews, literature society, medical a or review). record patient from evidence or Has the objective of improving the diagnosis, prevention or treatment of disease; enhancing the management/care of patients, which may include the appropriate use of our medicines; or benefiting public health. Repetition of similar differenta (eg justification requires activities/programmes audience). target the enables design programme applicable,Where the proposed level of education assessment. number a through education of provision the Includes of initiatives or a variety of formats. Includes plans assess to HCPs/OHS knowledge change in order assess to the quality, effectiveness and educational impact of the funded activity. It is recommended that the programme assess knowledge transfer as a minimum of Level 3 of the model Moore and performed by the IME provider, not GSK. Includes plans make to public the outcomes or results of the activity. Mandatory requirements that the proposed education education proposed the that Mandatory requirements programme: • • • • • While not mandatory, the preference is that the education programme: • • • Go to Connect GSK Find: of working Ways model Moore for: Search )

) ABAC

See section 2.4 Requirements

We may makeWe a minimum of three specific potential applicants aware of the call for proposals by contacting them directly. This can only be done after the call for fewer Contacting available. publicly made is proposals than three third partiesrequires approval in line with the level in the organisation where the activity is organised eg GMAL for a global activity, Area Medical Lead for an area activity, CMD for LOC activity. Meets our Anti-bribery and corruption ( requirements. programmes Education independent. and credible Is education such Where preferred. are providers education providers do not exist within a country or if they exist but do not meet our requirements our ABAC (eg framework our meet who providers education non-accredited requirements can receive grant funding. Where relevant for medical (eg education companies), vendors for requirements engagement scientific our meets section (see activities support also promotional they where It2.4). is preferred that these companies are accredited provider. accredited an with work or providers education that are delivered or implemented by accredited That the budget and expenses are reasonable, appropriate reasonable, appropriate are expenses and budget the That and directly related the to development and conduct of the activity. educational proposed a proposal where we publicly call for proposals in our areas journal websites, GSK public through (eg interest funding of or newspaper advertisements). This call for proposals may details other processes, and application timelines include prior month least one at available publicly made is and process closing. application the to • Grant proposals are reviewed under Medical accountability (Commercial functions are not involved). Proposals that are endorsed by Medical are then considered by the relevant Grants and Donations Committee SOP-GSK-016: (see Grants and donations SOP). against proposals grant considers Medical review The including: pre-defined criteria applicant: the That • 2.7.3 Grant funding isin response a proposal. to This may be a proposal which is not prompted by us.It may also be • • • Grants

Go to Connect GSK for: Search requirements ABAC Go to Connect GSK for: Search framework ABAC and donations SOP donations and SOP-GSK-016: Our Code of Practice for promotion and scientific engagement Section(non-promotional) engagement 2 Scientific continued 2.7 Supporting independent medical education 38 Scientific engagement

41 2 (non-promotional)

Interactions with officials from government officialsgovernment with from Interactions and local rules when interacting with What can we do Where care is needed What is not included See section 4.8

Clinical research and partnership agreements between between partnership agreements and research Clinical on negotiations commercial and governments GSK and before initiated distributors specialty with terms business authorisation. marketing Non-medicine related interactions to provide industry provide to interactions related Non-medicine policy related science policy, public on perspectives disease including activities management health and medicine, evidence-based delivery, care management, payment/benefit and technology information health structures. product-price to related information business Providing section (see regulatory contracts with 4.8) interactions government executives/legislative authorities, from requests organisations US Congress, (eg UK Parliament). • Interactions with government officials with comply government with Interactions SOP-GSK-007: and inter governmental agencies. These stakeholders may may These stakeholders agencies. governmental inter and strictest the circumstances these HCPs/OHS. In be also apply. requirements 2.8.1 Engage on our science while respecting the principles of public and governments payers, with engagement scientific organisations. health 2.8.2 Particular care istaken adhere to our to ABAC requirements officials.government 2.8.3 The requirements below do not apply to: • •

Go to Connect GSK for: Search requirements ABAC SOP-GSK-007: officials with Interactions government from and inter governmental agencies 2.8 Scientific interactions payers, with governments health public and organisations

with GSK which includes includes which GSK with Go to access.gsk.com to Go Search for: Process map for IME The process map for IME can be found here: See sections 4.2 and 4.3

If required by relevant laws, regulations or applicable or regulations laws, relevant by required If information with us industry codes, IME provide providers on payments and other transfers of value made HCPs/ to OHS using our funding, obtaining consent do to so from theHCP/OHS, enable to us fulfil to any transparency IME provide providers obligation. disclosure or policy this information after the activity has been undertaken ensureto we do not influence HCP/OHS selection. GSK does not in any influence way the content. GSK does not review, edit or otherwise offer comments on the content, potential speakers/faculty, or delivery of the programme. non-GSK medicines (including medicines) to related Data is in line with the approved label. participants programme to clear makes IMEThe provider that it is supported by GSK funding. For example, “this educational activity was supported by an educational grant GlaxoSmithKline.” from The IME provider agrees that we may publicly disclose the funding we provide as part of our voluntary or regulatory requirements. disclosure The financial interests in GSK of the faculty and those in a position control to content are declared as part requirements. regulatory and Our relevant requirements with regard venues to and hospitality for HCPs/OHS are met. of the programme’s disclosure of conflicts of interest. interest. of conflicts of disclosure programme’s the of legal relevant meets programme educational The • Where grant requests are endorsed by Medical and and Medical by endorsed are requests grant Where approved by the relevant grants and donations committee, the applicant signs a contract the following provisions in addition standard to contract requirements: • • • • • • •

Go to Connect GSK Find: of working Ways for: Search IME agreement contract Our Code of Practice for promotion and scientific engagement Section(non-promotional) engagement 2 Scientific continued 2.7 Supporting independent medical education 40 Scientific engagement

43 2 (non-promotional)

Examples of permitted activities Proactive contacts with governments, payers, purchasers and needs understand to organisations health public and matters including progress/developments, our discuss of public health public (eg health programmes, vaccination programmes/calendars, new budgetary of impact therapies). Responding specific to requests(eg provision of medical/ already is which information pipeline data, or economic in the public domain). share may we specifications, tender to response In data requested which may not be reflected in the immunity, herd regarding data (eg label product relevant effectiveness, alternative schedules, health economic assessments or not published (recent clinical data, health economic assessments or assumptions). Proactive contact with government personnel eg US Centres for Disease Control and Prevention personnel,(CDC) including the CDC liaisonsACIP to Working Groups for the purpose of sharing scientific stakeholders these by expected where information, interaction. for procedures CDC established to according andemployees of governmental, payer and public health approval prior require not do and permitted are organisations where there is no pre-determined intent gain to adviceor information. disseminate proactively to 2.8.5 • • • • Unplanned spontaneous discussions between our staff our between discussions spontaneous Unplanned

Requirements See section 2.5

This can include discussions related to disease areas to related discussions include can This of mutual interest, our medicines in development, or new authorised medicines. for indications to us allow stakeholders these Discussions with contribute to public health preparedness health public (including to contribute understand regarding needs budgetary their to planning), our medicines, and respond to specific to requests for data. Data pre-authorisation include may which information which is not in the public domain may beshared under a from approval is there where or agreement confidentiality the relevant Business Unit Head or designee. Selection and number of people approached and timing/ and approached people of number and Selection need. the to proportionate is interactions the of frequency 2.8.4 governments, of employees with engagement Scientific agents advising their or agencies reimbursement Centre for Effectiveness Research), and public health organisations WHO, (eg CDC, NIH) is permitted following section. this of requirements the • • for their validation by providing (eg an agenda and/or agreement). written requesting If advice is being sought and individuals are engaged to provide that advice then section 2.5 on seeking external advice, insights and information is followed. (eg National(eg Institute for Clinical Excellence (NICE), organisations/governments by set Requirements on pathways for interactions are followed and specific objectivesfor interactions are defined and documented prior theto interaction eg in meeting agendas. When pathways for interaction do not exist, we validate that the proposed explicitly by expectations organisation’s the meets interaction communicating our plans for the interaction and asking • these with interactions pre-authorisation for Accountability stakeholders may be with a range of staff (Public Affairs, LOC General Managers, Market Access functions, Medical). from prohibited not are functions commercial Staff from participating in these interactions; however discussion of accountability. Medical under are data scientific and medical

continued 2.8 Scientific interactions payers, with governments health public and organisations Our Code of Practice for promotion and scientific engagement Section(non-promotional) engagement 2 Scientific 42 44 Our Code of Practice for promotion and scientific engagement 45 Other External references relating to this section

non-promotional • STD_340448: Standard • ABPI Code of for interacting with patient Practice for the organisations Pharmaceutical Industry, activities Section 20 • SOP-CGA-100: Global product and pipeline media www.pmcpa.org.uk/ materials development and thecode/Interactive approval procedure Code2015/Pages/ clause20.aspx • POL_132175: Policy for ABPI guide and use of digital channels •  case studies on 3.1 Information about our medicines p46 • SOP-GSKF-400: Procedure Joint Working with 3 for the general public for identification and tracking the Pharmaceutical of adverse events through 3.2 Disease awareness for patients p46 Industry PSP (MR and IDM activities www.abpi.org.uk/our-work/ or the general public that may generate human library/guidelines/ safety information for GSK 3.3 Healthcare support services p47 Documents/joint_working_ products) with_the_pharmaceutical_ 3.4 Items of medical/educational utility p49 industry.pdf Other non-promotional

47 3 activities

Policy for use of digital channels POL_132175: Disease awareness includes information about the prevention, of disease, methods of characteristics treatments. available and screening provided be may information Disease awareness through digital channels subject this to section and POL_132175: medicine within that disease or therapy area unless this is approved in line with the level in the organisation where the activity is organised GMAL (eg for a global activity, CMD for a local activity). acknowledgement an includes material Disease awareness of GSK involvement and/or funding where applicable. Healthcare support services or services are directly provided, patients. and/or (HCO) organisations healthcare to indirectly, These services are non-promotional and have the objective of achieving better healthcare outcomes for patients, system healthcare a benefitting or care patient enhancing while maintaining patient care funding (eg a nurse identify to high risk patients for assessment and health management, Where planning). budget for data economic of analysis applicable and/or regulations laws, local by permitted industry codes we can provide these services. Eligibility of medical practices receive to the service is based upon objective criteria linked the to defined purpose. It is not linked the to prescription or use of our medicines. appropriate of selection the include which decisions, Clinical medicines or the development of treatment management prescriber. the of responsibility the are plans, maintained. is confidentiality Patient processing and monitoring Measures for established are any adverse event reports that may be received in the course support healthcare service. any of support healthcare services provide is to proposal Any reviewed and approved in advance by Medical and Legal regulations. and laws applicable with compliance ensure to Accountability can be with Medicalor Commercial. 3.3 Healthcare support services

Global product and pipeline media media pipeline and product Global Standard for interacting with with interacting for Standard

STD_340448: patient organisations patient SOP-CGA-100: procedure approval and development materials This includes for example, information provided in in provided information example, for includes This patient and journalists from enquiries to response proactive through provided advisory information groups, reference and press releases) (eg activities media websites. public on information See section 1.3 See section 3.2

Is factual, balanced and consistent with the locally locally the with consistent and balanced factual, Is information. product approved Does not raise unfounded hopes of successful treatment. Is not misleading about the safety of the medicine. Is not intended or designed encourage to the patient askto their HCP prescribe to a specific GSK medicine. For disease awareness for patients or the general public: is not conductedis not until after marketing authorisation. patients/ to provided not is information Disease awareness prescription only the have we where public general the not have an authorised medicine for a particular disease, public general patients/the for activity awareness disease Non-promotional disease awareness information directed directed information disease awareness Non-promotional patients/theto general public may be provided directly or via an HCP/OHS. This information is not intended or designed encourageto patients ask to their HCP prescribe to a specific GSK medicine. A statement is included that the advice. medical personal for HCP an consult must individual Disease awareness campaigns do not contain any product branding. It is not permitted associate to HCP/OHS-directed disease awareness public with materials promotional campaign materials via (eg use ofbrand imagery/colours). Where there ismedicine a in development and we do For direct to consumer advertising: consumer to direct For Non-promotional information about our medicines which which medicines our about information Non-promotional indirectly: or directly either public the to available made is • • • •

3.2 Disease for awareness the or patients generalpublic 3.1 about Information for medicines our public general the Our Code of Practice for promotion and scientific engagement Section activities non-promotional 3 Other 46 Other non-promotional

49 3 activities

Patient programmes following prescription following programmes Patient by R&D staff clinical to investigators where the items are unrelated the to conduct of the study. Items of medical/educational utility include so-called so-called include utility medical/educational of Items gain to patients enable which support items’ ‘patient instruction and experience using their medicines while Examples HCP/OHS. an supervision of the under ingredient) active no (with devices inhalation include and devices intended assist to patients learn to how to self-inject, which are not passed onto patients keep. to These items may bear the name of a medicine and/or is detail such if only medicines about information essential for the proper use of the item by patients. provided not are utility medical/educational of Items This section does not apply in to vitro diagnostic tests testing. clinical for provided

3.3.1 patients programmes for adherence) Compliance (or following administered only are medicines our prescribed initial involvement and endorsement of anHCP involved in the treatment of relevant patients. authorisedAccesses Medicines our Programmes for to by reviewed are support affordability) to those (ie medicines Medical and Legal. They are not an improper inducement for HCPs prescribe to our medicines, or for the patient request to our medicines. They do not constitute advertising of medicines theto patient except where expressly permitted by local laws. patient enhance which utility medical/educational of Items care, the responsible use of medicines or are beneficialto the provision of medical services, can be provided HCPs/OHS. to if charge of free provided offered or be may items Such they are infrequent and of modest be value defined (to and documented locally). These items can be company branded but are not product branded exception (see below for support items). patient Items we provide do not subsidise the routine operations of any medical practice and may not be provided on long term loan an to HCP/OHS or practice other than in the context of conducting a clinical study. Items of medical/educational utility are not provided for sales representatives or other GSK representatives gain to access a medicalto facility. 3.4 medical/ of Items educational utility

Procedure for identification identification for Procedure and tracking of adverse events through PSP (MR and IDM activities that may generate human GSK products) for information safety SOP-GSKF-400: ABPI Code of Practice for the Pharmaceutical Industry, Section 20 www.pmcpa.org.uk/thecode/ InteractiveCode2015/Pages/clause20.aspx ABPI guide and case studies on Joint Working Industry Pharmaceutical the with www.abpi.org.uk/our-work/library/guidelines/ Documents/joint_working_with_the_ pharmaceutical_industry.pdf For guidance see guidance For healthcare support services. Information collected in the course of providing a or healthcare promotion support service for used not is shared not is information This activity. promotional plan to sales representatives. with Healthcare support branded services company be can – they do not include the brand or name of our medicines. support healthcare service the are to related Materials non-promotional. Sales representatives may introduce, but do not provide, deliver, demonstrate or have other involvement in is designed achieve. to The remuneration of those involved in the provision of the healthcare support service is not linked sales to of our medicines. The recipient signs a contract with GSK which sets out the details of the service, including activities be to performed • healthcaresupport successThe the service of monitored is directly criteria to reference by measured only and regularly related the to improved health outcomes that theservice by the service provider, the responsibilities of the recipient recipient the of responsibilities the service provider, the by and the defined duration of the service. Involvement of GSK in the provision of healthcare support services is made clear HCPs/OHS to involved and service. the of recipients from Healthcare support separate services kept are promotional activities. • • •

3.3 Healthcare support services continued Our Code of Practice for promotion and scientific engagement Section activities non-promotional 3 Other 48 50 Our Code of Practice for promotion and scientific engagement 51 General External references relating to this section Go to Connect GSK

requirements • SOP_344448: Engaging Search for: with healthcare professionals Corporate security (HCPs) Find: Ways of working • POL-GSK-016: Grants Search for: Process map and donations policy Search for: • SOP-GSK-016: Grants ABAC requirements and donations SOP Find: Ways of working Search for: IME grant agreement contract 4.1 Engagement of HCPs and OHS p52 to provide services Find: Code of Conduct 4 and Our values and 4.2 Meeting venues p54 standards resource centre Search for: Pricing risk 4.3 Hospitality p55 governance framework 4.4 Funding of scientific/medical congresses p56 and other third party meetings 4.5 Funding HCPs and OHS to attend p57 scientific/medical congresses 4.6 Funding of HCPs and OHS to attend p59 stand-alone promotional meetings 4.7 Gifts p60 4.8 Discounts, rebates and other p61 commercial terms General

53 4 requirements

See section 1.4.5 See section 2.6.3 Annual cap In the USA, please refer the to annual cap that has been set. For all US HCP engagements, please refer the to process.existing Outside the USA, the maximum cap that an LOC We do notWe pay HCPs/OHS speak to about our medicines orassociated diseases other to HCPs/OHS. Where HCPs/OHS agree speak to without payment the for specific requirements service are this there for transportation/ of payment and arrangement exceptional accommodation/meals. do notWe pay for authorship of peer reviewed articles reimburse may plenary We congress presentations. or activities. these with associated expenses reasonable In countries where compensation for traveltime is permitted, it is not automatically offered as part time travel for Compensation engagement. the of is calculated as a separate component on an hourly basis, and added the to hours engaged for the actual activity. If there is no set fee schedule involving compensation for travel time the fee is not more than 50% of the fair market value hourly rate multiplied by the number of hours capped at one hours) day (8 journeys). two as count return and (outbound journey per can set is the upper limitof fair market value hourly fee x 20 days x 8 hours per day.

in consultation with the CMD. The cap covers payments made the to HCP/OHS such as the fee for service and compensation for travel time. Unless required by local laws or regulations, the cap excludes subsistence, travel costs airfare) (eg and activities or trials clinical for Payments accommodation. can Exceptions excluded. are trials clinical to related be approved by the Regional Head of Medical Affairs 4.1.1 Each LOC sets an annual maximum financial (cap) limitfor the fees for service that can be paid directly an to individual HCP/OHS within their country. This cap applies whether the HCP/OHS is engaged by the LOC or any other part of GSK. •

Engaging with healthcare professionals with Engaging Local guidelines. industry regulator Local medical association or similar, or industry guidelines. Categorisation of the HCP/OHS Doctor (eg – Professor, pharmacist). nurse, GP, lecturer, documented is schedule fee local the for justification The and locally approved by the appropriate governance body Risk(eg Management and Compliance Board (RMCB)). Any exception the to fee schedule is reviewed and approved by the Regional Medical Director or designee. SOP_344448: SOP_344448: (HCPs) provide to services is followed. Information provided an to HCP/OHS is limited the to information that is necessary provide to the services. Payments follow the principle of fair market value (FMV). FMV rates are based on applicable documented rates/ fee schedules set by the CMD in the LOC in the country factors following The domiciled. is HCP/OHS the where considered: are • • • • Business class or premium economy air travel may be service, a provide to engaged HCPs/OHS for provided where the total flying time one way is more than five receipts. of submission to subject It is appropriate compensate to an HCP/OHS for travel time only where the travel is long distance (more than five hours), when the travel is required complete to the service and if the HCP/OHS is not already travelling for another purpose. If compensation for travel time is offered, a clear and documented is calculation the for methodology consistently. applied hours. by train Travel may be business or first class. incurred expenses reasonable reimburse also may We by the HCP/OHS in the provision of the services, Engaging

SOP_344448: SOP_344448: with Healthcare Professionals (HCPs) 4.1 Engagement HCPs of and provide OHSto services Our Code of Practice for promotion and scientific engagement Section requirements 4 General 52 General

55 4 requirements

In Europe the use of hotels of more than a 4 star rating is not permitted. See section 4.4

Where an international meeting is organised by LOCs, LOCs, by organised is meeting international an Where this is approved by the relevant Area Medical Director. International meetings organised by above country business units are approved by the MDL/VDL or GMAL equivalent)(or depending on who is accountable for the event. We may organise international meetings for attendees attendees for meetings international organise may We logistics, efficiencies the where countries, different from justify to demonstrated be can scale of economies and meeting. international an • Payments may not be made individual to HCPs or groups of HCPs either directly or indirectly, rent to meeting rooms. Any meals (food and beverages) provided incidentally invitedto attendees of scientific, promotional or business meetings do not exceed the local GSK monetary threshold where the event takes place. do notWe invite guests or spouses of those we invite and we do not provide or pay for any hospitality or make arrangementsfor guests or spouses attend. to do notWe organise or fund meetings for HCPs/OHS that are of a social or sporting nature. No entertainment or other leisure or social activities are paid paid are activities social or leisure other or entertainment No for or organised by us at any time including in connection stand-alone meetings. includes or This funded our with HCPs/OHS. individual for activities 4.3 Hospitality

are consulted when consulted are Records and disclosures See section 4.4

Are not held at locations which could reasonably be could which locations at held not Are perceived as lavish or extravagant for a business meeting or conference, or at venues which are recognised for be a justifiable venue where the meeting does not coincide with a sporting event. the to risks the where accommodation safe Provide Corporate minimised. be can attendees of security Investigations Security and necessary. placeTake in approved venues; each LOC maintains an approved list of venues in their country suitablefor meetings.our their entertainment, sports or leisure facilities. A venue, venue, A facilities. leisure sports or entertainment, their such as a sports stadium, with conference facilities may Is held during a third party international meeting specific the outside but congress), medical/scientific (eg or programme; meeting the of times The meeting has been approved in writing by the Regional President or designee. or President Regional financial support: financial of services provided by the HCP/OHS in their country. required. if disclosure for available are These records GSK meetings and meetings where we provide 4.1.2 Each LOC keeps detailed records of the fees paid, respect in value, of transfers and reimbursed expenses • • • Our meeting venues are selected minimise to travel time for delegates. for LOC meetings are attended only by HCPs/OHS from that country and are held in the country where the LOC is based meeting: unless the • •

4.1 Engagement HCPs of and provide OHSto services Go to Connect GSK security Corporate Find: 4.2 Meeting venues continued Our Code of Practice for promotion and scientific engagement Section requirements 4 General 54 General

57 4 requirements

). . with GSK which includes agreements: agreements: includes which GSK with Selection of medical congresses Selection of independent third parties Not provide to cash payments directly HCPs/OHS to or their affiliated organisation eg university. Payments travel/ or organiser, conference the to directly made are agencies. accommodation Not provide to the names of HCPs/OHS GSK to unless required by local laws and/or meet to local requirements. disclosure • • In disease areas where we have an authorised medicine. the meet and educational and/or medical Scientific, requirements of this code in respect of the venue and offered.hospitality independent.Is and credible Meets our requirements ABAC Has infrastructure and resources in place advertise to theavailable award, review and evaluate applications, the of provision the manage decisions, communicate documentation. audit-ready maintain and awards Has processes for management, tracking and funds. of disbursement controls.Has governance independent Signs a contract to whomto the HCP/OHS can apply process (see map The selection of HCPs/OHS receive to funding ismade party. third the by independently 4.5.1 may provideWe financial support for HCPs/OHSto attend are: that party) third independent an (via congresses medical • • Medical approve the selection of congresses as part of business plans. 4.5.2 organisers) congress (including party: third independent The • • • • • • We do notWe provide direct financial supportto HCPs/OHS attendto medical congresses. may onlyWe provide financial support for HCPs/OHSto travel and attend medical congresses by providing funds party third independent other or congress organiser the to

Go to ConnectGSK for: Search requirements ABAC Go to Connect GSK Find: of working Ways Search for: IME grant agreement contract Go to Connect GSK Find: of working Ways Search for: Process map 4.5 HCPs Funding OHS and to scientific/ attend medical congresses

). and SOP-GSK-016

POL-GSK-016 See section 4.2 Before marketing authorisation of a medicine, medicine, a of authorisation marketing Before sponsorship or fee for service funding of medical/ under disease is area that congressesscientific in Medical accountability. marketing Following Medicalby held be may budget the authorisation Commercial.or See section 2.7 •

The scientific content is reputable and alignedto our interests. medical or scientific The venue meets our requirements and hasappropriate any from separated clearly are which facilities that facilities leisure or sports, tourist entertainment, may be present. be may Incidental and substantially less than the funding being sought follows our grantsand donations policy and SOP (see Equivalent the to funding being sought follows processes for sponsorship or fee for service funding. (Note: We medical/scientific at presence a seek proactively may sponsorship (eg payments making by congresses or fee for service) enable to promotional activities engagement scientific or space) booth commercial (eg place. take to space) booth scientific (eg activities Before marketing authorisation, we do not fund medical congresses to enable promotional activities activities promotional enable congressesmedical to (eg commercial booth space, GSK sponsored satellite satellite sponsored GSK space, booth commercial (eg symposia). We only provide financial support for medical/scientific medical/scientific supportfor financial provide only We congresses other(or third party meetings) when: • •

Congress funding and activities are reviewed by the LOC in the country in which the congress takes place ensure to applicable and regulations laws, local with compliance industry codes. Funding in response an to unsolicited request froma congress or other third party meeting organiser where the value of any service, privilege or benefit provided in return for the payment is: • For support of independent medical education: medical independent supportFor of • • Grants Grants

and donations SOP donations and POL-GSK-016: Policy Donations and SOP-GSK-016: 4.4 Funding of scientific/medical congresses and party third other meetings Our Code of Practice for promotion and scientific engagement Section requirements 4 General 56 General

59 4 requirements

Exceptions are not permitted for local in-country meetings where HCPs/OHS are from the same hospital, practice or town/city where travel time or typically are meetings Such issue. an not is distance sales representatives. by arranged meetings national for considered be may Exceptions for HCPs/OHS who would need travel to from across the country where the travel distance, time and cost may be more significant. Such meetings are notto be sales representatives. the by organised See section 1.4.5 • •

HCPs/OHSwho can share learning with a larger community after the conference because they teach in colleges or postgraduate units, or are part of a larger network of HCPs/OHS anticipatingfeedback from conference. the The General Manager of the LOC in the country of the HCP/OHS and the relevant CET member or designee exceptions. approve Note: a contract is not required. • possibilityHCPs/OHS the financial about enquiring of party third independent the to support referred are (ie we do not select HCPs/OHS that are referred). do notWe assist HCPs/OHS in making applications. do notWe pay for or arrange travel or accommodation for meetings. promotional stand-alone our attend to HCP/OHS An exception can only be obtained if the rationale for the arrangement of travel or accommodation for each individual HCP/OHS attend to is documented and approved based on the country where the HCP/OHS resides. These approvals are required before any contact with HCPs/OHS and/or planned. are arrangements accommodation or travel • Where exceptions are approved, the same travel and governance and restrictions arrangement accommodation applies. speakers HCPs/OHS unpaid for 4.6 Funding of HCPs OHS and stand- attend to alone promotional meetings

). process map Selection of HCPs/OHS To ensure recipientsTo are made aware that GSK has programme. the for funding grant provided allow independentTo audit by GSK or a third party we employ. we • • operate a scheme through which we can provide funding for HCPs/OHS attend to or the scheme does not meet the party third may independent another above, requirements (see selected and sought be Where the medical congress does will not (or not) The monitoring does not identify or reveal the names of HCPs/OHS selected, unless there is reason suspect to funds. our of mismanagement HCPs/OHS who can show scientific interest in the conference, or can show benefitsto their patients from attending. HCPs/OHS who are participating in the conference as presenters or have other active participation in original research or scientificwork that is being presented. • third parties our ABAC (eg framework). The General Manager is accountable for approving the third party and provided expenses and budget associated approving for of Business Units, or Area Medical Directors as appropriate are accountable for congresses and third parties managed at an above country level. monitorWe the third party(s) chosen provide to funding ensureto compliance with the agreed contracts. OHS for whom funding has been made available resides, engaging for controls our following for accountable is theto third party. The Franchise Medical Heads, CMOs management financial appropriate on focuses Monitoring and disbursement applicants to that align with the guidance for HCP/OHS selection we provide below), (see or the to party third independent the by created criteria selection funds. provided we which to • 4.5.3 The selection of HCPs/OHS receive to funding is made made are decisions us. These from influence without independently by the third party based on merit and need. may provideWe non-mandatory guidance the to HCPs/ for party criteria selection third on independent OHS such as: • • The General Manager in the country where the HCP/

4.5 HCPs Funding OHS and to scientific/ attend medical congresses Go to Connect GSK Find: of working Ways Search for: Process map

continued Our Code of Practice for promotion and scientific engagement Section requirements 4 General 58 General

61 4 requirements

This section comes under Commercial under comes section This accountability. A pricing risk assessment must be performed and and performed be must assessment risk pricing A the governs that framework documented a be must there levels of pricing, discounts, rebates, free goods and other rationale the contains framework This terms. commercial for commercial terms and is reviewed by Legal. writing in documented offered are Commercial terms ensureto transparency. The framework specifies the documents required. Any discount, rebate or other payment is made via an approved financial method(eg invoice, bank transfer or cheque) and does not take the form ofcash or other cash equivalent. Discounts, rebates and other payments books our in recorded appropriately and accurately are records.and Anyschemes which enable HCPs/OHS obtain to personal are medicines of purchase the to relation in benefits unacceptable even if they are presented as alternatives terms. commercial to Discounts, rebates, free of charge goods and other other and goods charge of free rebates, Discounts, assessedare margin or price to relating terms commercial using the pricing risk governance framework and regulations. and laws applicable customer purchasing the when taken is care Particular is also anHCP/OHS, ensure to that the commercial terms would not unduly influence themto prescribe, dispense or recommend a medicine inappropriately or act to in a way that is not in the best interests of patients or the relevant healthcare system. Business units and LOCs ensure that their supply requirements: following the with comply arrangements • • • •

Go to Connect GSK Conduct Code of Find: and Our values and standards resource centre risk Pricing for: Search framework governance 4.8 Discounts, other and rebates commercial terms

Cultural courtesy items courtesy Cultural

See below See See section 1.8 on promotional aids See section 3.4 on items of medical/ educational utility  Wherever such an exception applies, it is documented documented is it applies, exception an such Wherever and approved by the local or area RMCB with the rationale for respecting the relevant holiday(s), together with the and (minimal/modest limits cost and frequency permitted proportionate within the country) for the items. The limits for cultural courtesy items in any country are consistent across business units in that country. or given HCPs/OHS.to Gifts are anything of value, given as a mark of friendship business future of hope the express to or appreciation or value or consideration of expectation without success and in return. Gifts for the personal benefit of HCPs/OHS are not permitted. Provision of cash or cash equivalents as gifts permitted expressly items the Except for prohibited. is in this codebelow (see and sections and 1.8 3.4) no gift, benefit in kind, or financial advantagemay be offered 4.7.1 Cultural courtesy items for HCPs/OHS (ie itemsgiven religious or cultural national significant acknowledge to holidays) are not permitted, other than by exception in some countries in EMAP and Japan where it is considered local under permitted and customs local of respectful fully a in done is it provided and regulations and laws way. transparent •

4.7 Gifts Our Code of Practice for promotion and scientific engagement Section requirements 4 General 60 62 Our Code of Practice for promotion and scientific engagement 63 Further External references relating to this section

information • POL-GSK-409: Medical www.gsk.com/integrity and appendices governance framework Go to Connect GSK

Find: Who we are Search for: Business Unit Compliance Officer

5.1 Monitoring p64 5 5.2 If you have concerns p64 5.3 Appendix 1: GSK written standards p65 for activities and interactions with audience groups not covered by this code 5.4 Appendix 2: Key written standards p66 for external interactions 5.5 Appendix 3: Glossary p67 5.6 Appendix 4: Abbreviations p69 Further information

65 5 and appendices

Copy approval process for materials Human subject research subject Human Disclosure of transfers of value HCPs to Global product and pipeline media pipeline Global and product Humanitarian product donations standard standard donations product Humanitarian Interactions with officials from government officials government with from Interactions Grants and donations SOP Procedure mitigating and protecting on Compassionate use of GSK Humanitarian product donations policy donations product Humanitarian Travel, meetings and expense standard standard expense and meetings Travel, Policy on grants and donations Policy on protecting and mitigating risk Engaging with healthcare professionals with Engaging Standard for interacting with patient patient with interacting for Standard US Pharma market research: criteria criteria research: Pharma market US Policy for use of digital channels Medical Information responses to healthcare to responses Medical Information materials development and approval procedure approval and development materials STD_340448: organisations STD-GSK-512: SOP-GSKF-414: under the GSK Code of Practice forpromotion and interactions customer SOP_54813: consumers and professionals POL-GSK-016: SOP-GSK-016: POL-GSKF-408: POL_132175: SOP_344448: services provide to (HCPs) SOP-GSKF-417: Europe/Russia/Ukraine/Turkey HCOs in and domiciled POL-GSK-303: SOP-GSK-303: response emergency and procedure operating SOP-GSK-007: and inter governmental agencies POL-GSK-301: activities communication external and internal from SOP-GSK-301: activities communication external and internal from risk SOP-CGA-100: for designing and executing market research conducted research conducted market executing and designing for in the US for GSK employees POL-GSK-406: medicines investigational research primary of market conduct the on Guidance in GSK Pharma SOP_297780: • • • GSK written standard written GSK • • • • • • • • • • • • • • • • •  •

Interacting with patient groups meetings for Procurement Activity/audience group Activity/audience promotional Approving materials Medical Information grants Providing donations and healthcare Engaging other and professionals provide healthcare staff to servicea product Humanitarian donations Interacting with Interacting with media the Clinical researchClinical engagement external for officialsgovernment Using digital channels digital Using Compassionate use Compassionate Market researchMarket 5.3 and activities GSKfor standards written 1: Appendix code this by covered not groups audience with interactions

. ). If you are aware of violations of POL-GSK-409 or through speak up channels. speak up through or findyour localTo speak up integrity line number to or report www.gsk.com/integrity visit: please online, If you are out of compliance or feel you are unable comply to with the procedure please contactyour Business Unit OfficerCompliance this written standard, please report them to Compliance to report please them standard, written this Management monitoring Management Local management is responsible for ensuring effective change and embedding plans are in place. A review of this procedure occurs every two years for improvement. Independent business monitoring independent that ensuring for accountable are owners Risk standard. this for clear are expectations monitoring business If you have concerns about how apply to this written standard bring them the to attention of your manager and/or raise them through the Medical governance framework (see Medical

www.gsk.com/integrity Go to Connect GSK Find: Who we are BusinessSearchfor: Unit Compliance Officer POL-GSK-409: POL-GSK-409: framework governance 5.2 have If you concerns 5.1 Monitoring Our Code of Practice for promotion and scientific engagement Section appendices and information 5 Further 64 Further information

67 5 and appendices

means a body of HCPs refers, for the purposes of this that specialise in a particular aspect of of aspect particular a in specialise that medicinal practice and who meet discuss to matters other and data/policies/guidelines of mutual interest advance to patient care discipline. that within Medicine non-prescription and prescription Code, to vaccinesmedicines and On material label promotional that means must be consistent with the approved conditions of use local (eg product label). Other healthcare staff means (OHS) any person who, in the course of their recommend, purchase, may employment purchase, the influence or use, or supply supply or use, of medicines. Other healthcare staff includes but is not limited to management, assistants, hospital pharmacy primary of managers, care members formulary committees, and payer bodies appraisal agencies, health staff as in such and bodies pricing bodies, reimbursement funds. sick comprises programmes education Medical or activities which have the intent to provide education HCPs to which is across therange of scientific information and relevant options therapeutic/prophylactic a diseaseto state, balanced, comprehensive and up-to-date, and which may or may not result in the award of continuing medical participants. to points (CME) education These activities are intended improve to and enhance the HCP’s skill engage to their patients and deliver care. Medical society

are

are Glossary refers to a non-monetary award, non-monetary award, a to refers refers a financial to award. 5.5 Appendix 3: information prescribing Abbreviated refers a shortened to or ‘abbreviated’ version of the full prescribing information information prescribing full the of version product of label/summary product the (eg characteristics). Donation services, products, as such equipment, subsidies, employee’s time or other assets. Grant Stand-alone promotional meetings meetings we initiate, intended for HCPs/ OHS, hosted independently of a congress or other third party meeting, which relate our to disease related and/or uses, and medicines or therapy areas. symposia satellite Sponsored symposia which we fund and organise within officially and recognised of, infrastructure the a medicalby, congress. Healthcare organisation means (HCO) any private or public sector organisation, organisation, sector public or private any comprised is that association or institution healthcare provides that HCPs and/or of services, and also includes a clinic or medical practice consisting of one or more HCPs. Healthcare refers professional (HCP) anto individual who in the course of their to authorised is activities professional administer supply, purchase, prescribe, or dispense medicines or medical devices.

Procedure for identification and tracking Planning, tracking execution and Disclosureof transfers of value HCPs to Transparency data operations and and operations data Transparency Procedure on sanctions and export control Privacy of personally identifiable personally of Privacy Management of human safety information information safety human of Management Anti-bribery and corruption policy Policy on sanctions and export control POL-GSK-010: information ABAC ABAC POL-GSK-400: GSK products for SOP-GSKF-400: research, and support programmes, market patient of interactive digital media that may generate human safety GSK products for information POL-GSK-007: Anti-bribery and corruption framework. Third party procedures guidance and SOP-GSKF-417: Europe/Russia/Ukraine/Turkey HCOs in and domiciled POL-TDOR-001: (TDOR)reporting policy POL-GSK-014: SOP-GSK-014: SOP-GSKF-420: engagements HCP/HCI US of • Written standard Written •  • • • •  • • • • •

Key written standards for external interactions external for standards written Key

Maintaining privacy confidentiality and Interactions with US healthcare professional (HCPs) and a US reimbursed government product Topic area Topic ABAC framework for for framework ABAC parties third engaging Safety reporting third of Engagement parties transfers of Disclosure value of Sanctions and export control 5.4 Appendix 2: Our Code of Practice for promotion and scientific engagement Section appendices and information 5 Further 66 Further information

69 5 and appendices

Anti-bribery andcorruption information prescribing Abbreviated The Centers for Disease Control and Prevention Team Executive Corporate Director Country Medical Continuing Medical Education Development Professional Continuing Fair market value Global Medical Affairs Leader Healthcare organisations International Committee of Medical Journals Editors Pharmaceutical of Federation International Associations & Manufacturers Interactive digital media Medical Education Independent Companies Operating Local Leader Development Medicine researchMarket National Institute for Clinical Excellence National Institutes of Health information Prescribing support programmesPatient Board Compliance and Management Risk reporting and operations data Transparency Leader Development Vaccine Organization Health World Abbreviation ABAC API CDC CET CMD CME CPD FMV GMAL HCO ICMJE IFPMA IDM IME LOC MDL MR NICE NIH PI PSP RMCB TDOR VDL WHO 5.6 Abbreviations 4: Appendix

is any Glossary means any transfer of refers any to activity undertaken

Direct transfers of value those are made directly by GSKor to for the benefit recipient. a of Indirect transfers of value those are made on behalf of GSK or to for the benefit of a recipient, or transfers of value made where GSK and intermediate an through knows orcan identify the recipient. 5.5 Appendix 3: value, whether of money, in kind or otherwise, Promotional activity/material Promotional value of Transfer or promotes the prescription, supply, sale, supply, prescription, the promotes or GSK products. of use or distribution advertises that material activity/branded sale, supply, prescription, the promotes or GSK products. of use or distribution made directly or indirectly or to for the a recipient. benefit of •  •  by GSK or on itsbehalf that advertises continued Promotion Our Code of Practice for promotion and scientific engagement Section appendices and information 5 Further 68 www.gsk.com

Head Office and Registered Office GlaxoSmithKline plc 980 Great West Road Brentford, Middlesex TW8 9GS United Kingdom GSK Cross-Business Tel: +44 (0)20 8047 5000 STD_344428 (2.0) Registered number: 3888792 Previously STD-GSK-401/002

GlaxoSmithKline plc 2016 V2 (January 2016)