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NJE-192515.016-20050310-sugnHR1 CONFIDENTIAL Update on International Medical Affairs This report is solely for the use of client personnel. No part of.

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Presentation on theme: "NJE-192515.016-20050310-sugnHR1 CONFIDENTIAL Update on International Medical Affairs This report is solely for the use of client personnel. No part of."— Presentation transcript:

1 NJE-192515.016-20050310-sugnHR1 CONFIDENTIAL Update on International Medical Affairs This report is solely for the use of client personnel. No part of it may be circulated, quoted, or reproduced for distribution outside the client organization without prior written approval from McKinsey & Company. This material was used by McKinsey & Company during an oral presentation; it is not a complete record of the discussion. March 30, 2005, 4:45-5:30 p.m. Alexander Petersen, McKinsey Stanley Bukofzer, Abbott Laboratories

2 NJE-192515.016-20050310-sugnHR1 1 AGENDA Alexander Petersen, McKinsey & Company Stanley Bukofzer, Abbott Laboratories 4:45 5:00 5:15 A map of international medical affairs Managing the complexity – One perspective Questions from the audience

3 NJE-192515.016-20050310-sugnHR1 2 INTRODUCTION Medical affairs is a complex area to manage internationally Local-level officials, doctors, and industry figures have their own views of compliance and proper medical affairs conduct, resulting in a tremendous diversity of regulations, guidance, and norms across different national contexts At the same time, there are regional forces that are increasingly influential on local-level opinion and policy Managing medical affairs without taking into account local and regional variation can create compliance and business risk Five specific areascommunications with physicians, meetings and conventions, clinical trials, medical education, and direct- to-consumer informationprovide a vivid demonstration of the diversity of international affairs

4 NJE-192515.016-20050310-sugnHR1 3 When the government implemented the CTD in Belgium, they went too far. For several months, academic trials were halted. –Belgian Medical Director I was hired as the head of medical affairs; now, I spend most of my time being the head of risk management –Italian Medical Director With countries constantly changing their rules, it is getting harder and harder for headquarters to set meaningful global standards - Head of medical affairs, global pharmaceutical company The Medical Visits Charter would have been much worse if the industry had not proposed its own reforms –French Medical Director WHAT INDUSTRY IS SAYING – EXAMPLES

5 NJE-192515.016-20050310-sugnHR1 4 SUMMARY OF COUNTRY DATA Communications with physicians More restrictive Meetings and conventions Clinical trials Medical education Direct-to-consumer information Less restrictive NZ

6 NJE-192515.016-20050310-sugnHR1 5 COMMUNICATIONS WITH PHYSICIANS Frequency of office visits Other channels of communication (phone, fax, email) Limitations on leaving samples Increasing restrictions Germany Italy UK Sweden Portugal EFPIA France Japan

7 NJE-192515.016-20050310-sugnHR1 6 Japan COMMUNICATIONS WITH PHYSICIANS Frequency of office visits Other channels of communication (phone, fax, email) Limitations on leaving samples Increasing restrictions Germany Italy UK Sweden Portugal EFPIA France EFPIA expects us to ask for prior permission of a doctor to send him/her a fax, e-fax, email, automated calls or text messages It is even illegal to track doctor prescribing information The rules arent quite clear, but it would be risky to make more than 5 visits/year to a doctor

8 NJE-192515.016-20050310-sugnHR1 7 MEETINGS AND CONVENTIONS Social activities/hospitality a pharmaco can pay for at a meeting Reimbursement for travel and expenses Limitations of international conferences Increasing restrictions EFPIA 2005 Portugal Sweden Italy U.K. France Germany Japan

9 NJE-192515.016-20050310-sugnHR1 8 MEETINGS AND CONVENTIONS Social activities/hospitality a pharmaco can pay for at a meeting Reimbursement for travel and expenses Limitations of international conferences Increasing restrictions EFPIA 2005 Portugal Sweden Italy U.K. France Germany In Sweden conferences have to take place close to participants place of work. We rarely think of organizing international conferences. We even have rules on what kinds of drinks we can serve physicians Japan

10 NJE-192515.016-20050310-sugnHR1 9 CLINICAL TRIALS Mandatory reporting of trial outcomes and adverse events Insurance requirements Number of enrollees Increasing restrictions Germany U.K. Sweden Portugal France Italy *Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases, January 6, 2005, signed by EFPIA, IFPMA, JPMA, and PhRMA Joint Position* Belgium Japan

11 NJE-192515.016-20050310-sugnHR1 10 Japan CLINICAL TRIALS Mandatory reporting of trial outcomes and adverse events Insurance requirements Number of enrollees Increasing restrictions Germany U.K. Sweden Portugal France Italy *Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases, January 6, 2005, signed by EFPIA, IFPMA, JPMA, and PhRMA Joint Position* Belgium We virtually had to halt academic studies as no one could afford insurance. If a pharmacist hurt his back while lifting a box, that was considered part of the trial! We made a huge step forward and committed that we would publish all non-exploratory data, but medical journals are already calling this another marketing trick

12 NJE-192515.016-20050310-sugnHR1 11 MEDICAL EDUCATION Limits on content Financial limits of sponsorship Independence of pharmaco from those who receive funds (speakers, CME) Increasing restrictions U.K. France Germany Portugal Italy

13 NJE-192515.016-20050310-sugnHR1 12 MEDICAL EDUCATION Limits on content Financial limits of sponsorship Independence of pharmaco from those who receive funds (speakers, CME) Increasing restrictions U.K. France Germany Portugal Italy In France, continuing medical education is not yet on the authorities radar

14 NJE-192515.016-20050310-sugnHR1 13 DIRECT-TO-CONSUMER COMMUNICATIONS Restrictions on direct-to consumer communication –Television –Print ads Increasing restrictions New Zealand U.K. France Germany Portugal Italy Japan

15 NJE-192515.016-20050310-sugnHR1 14 DIRECT-TO-CONSUMER COMMUNICATIONS Direct-to consumer communication –Television –Print ads Increasing restrictions DTC is like GMOs. Europeans dont like them, and its not likely to change short term The EU has a working group assessing DTC… its first results are expected in 3 years from now New Zealand U.K. France Germany Portugal Italy Japan

16 NJE-192515.016-20050310-sugnHR1 15 MANAGEMENT CHALLENGES DRIVEN BY LOCAL DIVERSITY Do I need to rethink my model of communicating medical information to customers? How do I stay abreast of the new developments, especially in making sure country operations are always compliant? Should I attempt to have a single set of comprehensive corporate-wide guidelines around medical affairs? Without a corporate-wide standard, how do I explain my compliance posture to my customers? How do I coordinate trial strategy in a world of more transparency?

17 NJE-192515.016-20050310-sugnHR1 CONFIDENTIAL Managing the Complexity – One Perspective Stan Bukofzer Divisional Vice President and Head of Global Medical Affairs

18 NJE-192515.016-20050310-sugnHR1 17 DIVERSITY OF GLOBAL MEDICAL AFFAIRS (GMA) RESPONSIBILITIES CREATES MANAGEMENT CHALLENGES Irrespective of the specific structure, key activities include Creating and disseminating science Ensuring legal, ethical and regulatory standards Function efficiently and in an integrated fashion Management challenges include Diversity of responsibility Global scope Local and regional variation of the laws Global Clinical Operations Medical Science Liaisons Publications Drug Information Services Area and Affiliate Medical Departments HEOR GLOBAL MEDICAL AFFAIRS (GMA) Health Economics and Outcomes Research

19 NJE-192515.016-20050310-sugnHR1 18 ABBOTTS GUIDING PRINCIPLES TO MANAGE GMA Structural separation of GMA from commercial GMA reporting to R&D Centralized decision making within GMA Simple and clear processes Cross functional communication teams that include regional and local structures Specific Communication Channels Application of global clinical SOPs Clear Understanding of Legal and Regulatory Requirements as well as ethical and best practices Standardized clinical training world-wide

20 NJE-192515.016-20050310-sugnHR1 19 INDUSTRY APPROACHES TO GMA REPORTING STRUCTURE VARIES – ABBOTT SEPARATES GMA FROM COMMERCIAL, BY GMA REPORTING TO R&D (MODEL 2) Source:McKinsey Model 1 Trend away from this model in recent years, but some now reconsidering post OIG guidelines R&D Medical Affairs Commercial organization Majority of pharmacos have this structure International Medical Affairs decentralized Commercial organization Medical Affairs R&D Model 2

21 NJE-192515.016-20050310-sugnHR1 20 QA ABBOTT GMA USES CENTRALIZED DECISION MAKING PROCESS WITH REGIONAL TACTICAL CONTROL Global Project Team Global Project Head Operations Director/Manager Global Marketing Director Global Medical Director Regulatory Affairs CMC HEOR Discovery Medical services PreclinicalLCM Statistics/DM Clinical Staff Clin Pharm Legal Commercial/Mktg Management committee US based Global Project Team decides on the Business strategy and need for HEOR

22 NJE-192515.016-20050310-sugnHR1 21 ABBOTT GMA USES CENTRALIZED DECISION MAKING PROCESS WITH REGIONAL TACTICAL CONTROL US based Global project team decides on the Business strategy and need for HEOR GMA HEOR team in US/ Ex US work on a strategy and decide on what projects are needed.g. QOL, economic model etc Core dossier sent to region/ country where GMA HEOR scientist adapts package for local market e.g. NICE submission Affiliate based field scientist presents info to appropriate payer etc Factory: Scientific info produced centrally Regional packaging into appropriate format Local delivery by affiliate based scientist Global Project Team

23 NJE-192515.016-20050310-sugnHR1 22 CENTRALIZED DECISION MAKING WITH REGIONAL TACTICAL CONTROL Abbott adheres to PhRMA guidelines and International disclosure guidelines for all clinical trials Affiliate submits protocols to Central LU, Germany group for oversight of quality, science etc and approval – study conducted by affiliate(s) Phase 1-3 clinical activities ex US IIS and PMS studies Trial type Trial execution Managed by our internal global CRO, which is HQ in LU, Germany, and conducted by locally based study managers and CRAs in each country Results GMA Abbott Park, US Communication Trial concept and ownership dependant on product type Non-GPT (Regional/local based) Global Project Team (US based-cross functional team ) Same set of necessary qualifying criteria

24 NJE-192515.016-20050310-sugnHR1 23 CENTRALIZED DECISION MAKING WITH REGIONAL TACTICAL CONTROL Affiliate medical departments and area medical directors Affiliate General Managers International Business Division Affiliate Medical Directors Global Project Team Global Pharmaceutical RD Develop infrastructure of Affiliate Medical Departments if necessary thru matrixing resources Responsible for everything local Compliance with global and local SOPs,local laws, and best practices Medical and regulatory strategy and execution Local clinical trials Local Medical/Marketing support Established Excellence Teams to ensure alignment between commercial and scientific team initiatives Coordinate activities with GPTs so that the team has a one stop communication with the world – about 3-5 products per AMD Global Medical Affairs Area Medical Directors

25 NJE-192515.016-20050310-sugnHR1 24 GLOBAL MEDICAL AFFAIRS HAS DEVELOPED A STRONG SET OF GLOBAL SOPs BASED ON A CLEAR UNDERSTANDING OF LEGAL REGULATORY REQUIREMENTS Try to keep abreast of rapidly changing environment Trends in legislation at state and federal/country level Address new requirements in their formative stages Participate in industry organizations Bench mark and apply Best Practices Standard global SOPs generally use US/ EU laws and regulations as a base – where affiliate more stringent/ different local laws exist, an additional local SOP will be issued Where applicable ICH practice guidance are reflected – many not yet actually adopted, but best practice dictates use

26 NJE-192515.016-20050310-sugnHR1 25 CROSS FUNCTIONAL TEAMS ARE UTILIZED TO ACQUIRE INPUT AND COMMUNICATE SPECIFIC INFORMATION (E.G., SOP CHANGES, NEW REGULATIONS ETC.) Disseminate Development Staff Forum AMD Meetings Monthly highlights Global Clinical Operations Director Forum Global Project Head Forum Assistant Clinical Directors Forum

27 NJE-192515.016-20050310-sugnHR1 26 STANDARDIZED TOOLS FOR CLINICAL TRAINING WORLD- WIDE (e.g. TRAINING MATERIALS AVAILABLE THROUGH WEB BASED PORTAL) Web Site Central Repository for Training allowing Global Access to CBTs and Training links Single site ensures Consistency/Training Requires minimal internal IT support Is compatible with Abbotts other training systems Mandatory legal and ethical training of relevant roles

28 NJE-192515.016-20050310-sugnHR1 Appendix

29 NJE-192515.016-20050310-sugnHR1 28 COUNTRY FACTS: USA VS. EUROPE Communications with Physicians Clinical Trials Key facts Samples and visits are generally left up to the companys discretion MSLs pretty prevalent for KOL communications Vs. Europe Varies by country, but generally more restrictive than USA MSL is still a growing role in Europe. Growth wont be even, because some countries are still less restrictive (e.g. Portugal, Germany) so reps are still an effective information channel Meetings and Conventions Medical Education Direct to Consumer Information FMV for speakers No special limitations on international meetings Some countries discourage international meetings (though none ban it) IIS (non-sponsored) trials AE reports are discretionary IIS AE reporting is mandatory Pharmaco cannot provide the content Cannot hire presenters w/in the company Must mention all therapies for a condition Very little guidance at this point DTC advertising allowed, but with content control from DDMAC DTC advertising being considered in EU review that will produce report three years from now, but observers think cost control, doctors resistance will never let it happen

30 NJE-192515.016-20050310-sugnHR1 29 EFPIA AND THE JOINT POSITION Communications with Physicians (EFPIA) Clinical Trials (EFPIA) Key facts Need prior permission of a doctor to send him/her a fax, e-fax, email, automated calls or text messages Avoid inconvenience due to frequent visits, but no target number of visits recommended Quotes or anecdotes Meetings and Conventions (EFPIA) Entertainment cannot be provided by a pharmaco International events discouraged in some cases Meals and accommodations can be reimbursed, but not social activities EFPIAs new code of conduct, finalized at the end of 2004, says post-authorization studies must not be promotionalthey must have a primarily educational or scientific purpose Publication of Phase IV data will make the market intensely competitive – a French pharmaceutical Medical Director The Joint Position endorsed by the major pharmaceutical associations of Europe, the US and Japan will require all non-exploratory trial data to be published by September, 2005 The Joint Position does not resolve the level of detail into the data that will be available Industry is concerned about data mining by trail lawyers and public misinterpretation of data Clinical Trials (Joint Position)* *Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases, January 6, 2005, signed by EFPIA, IFPMA, JPMA, and PHRMA. The EFPIA code should not be underestimatedin the future it will have increasing influence on clinical trials – a Belgian pharmaceutical Medical Director

31 NJE-192515.016-20050310-sugnHR1 30 COUNTRY FACTS: FRANCE Communications with Physicians Clinical Trials Key facts New rules put in with Medical Visits Charter (December, 2004) –Reps cannot give samples –Reps cannot recruit doctors for post-marketing trials –Cannot denigrate other products in the same generic group Quotes or anecdotes Meetings and Conventions Medical Education Direct to Consumer Information Government publishes strict guidelines about expenses that can be reimbursed You can only buy a doctor a third-class ticket on a train! Seeding trials are illegal Minimal guidance Not allowed Industry fears that marketing practices will be punished not only directly, but indirectly and unofficially, through pricing – a French pharmaceutical Medical Director Companies were pleasantly surprised that their proactive proposal was accepted. The Medical Visits Charter would have been much worse if the industry had not proposed its own reforms – a French pharmaceutical Medical Director

32 NJE-192515.016-20050310-sugnHR1 31 COUNTRY FACTS: GERMANY Communications with Physicians Clinical Trials Key facts No specific limits on numbers of samples Requests for samples, however, must be in writing Visits are very free Pharmaco-political speakers (similar to MSL) started 10 years ago for KOL management, each company has 3-10 of these Quotes or anecdotes Meetings and Conventions Medical Education Direct to Consumer Information VFA code of 2004 warned against excessive spending Cannot reimburse for trips of shorter than 6 hours Social activities cannot be reimbursed Lower regulation of observational trialsPharma companies still use observational trials to try to get physicians to switch from a well-established drug – Industry observer Speaker fees must be paid by principle of equivalence which implies a reasonable standard. However, each company must interpret what they think a fair value is for speaker fees Not allowed Gone are the days when you can fly a doctor to Oslo to see the opera – German physicians association member It is an unwritten rule that you will buy doctors dinner at a meeting. Sometimes they go just for the dinner. - German physicians association member

33 NJE-192515.016-20050310-sugnHR1 32 COUNTRY FACTS: ITALY Communications with Physicians Clinical Trials Key facts Illegal to track prescribing habits MSL use varies 3-5 rep visits per year Quotes or anecdotes Meetings and Conventions Medical Education Direct to Consumer Information Regional government up to ~26,000 Euro, above which Ministry of Health must approve 60 days prior approval if more than 10 doctors Local/regional ethics committees approve trials The 300+ committees can sometimes be at the level of one hospital Approvals for multi-site trials can be slow due to separate administrative and clinical approvals Minimal guidance Not allowed The regional governments have decided that pharma marketing is a financially and ethically acceptable area to target – an Italian pharmaceutical Sales Manager The meaning of many rules are not written. You need to understand how they will be interpreted – Italian Medical Director

34 NJE-192515.016-20050310-sugnHR1 33 COUNTRY FACTS: PORTUGAL Communications with Physicians Clinical Trials Key facts Common sense and moderation used for frequency of office visits No limitations on sampling Quotes or anecdotes Meetings and Conventions Medical Education Direct to Consumer Information Moderate level of entertainment Reasonable fees and travel expenses can be reimbursed International meetings not subject to special scrutiny Pharmacos can still pay for trial costs as a supporter in some circumstances Being a sponsor involves using comparators No specific guidance Not allowed

35 NJE-192515.016-20050310-sugnHR1 34 COUNTRY FACTS: SWEDEN Communications with Physicians Clinical Trials Key facts National funding structure altered in 2002 so that counties were more accountable for medical costs The average physician began thinking more about costs, and more suspicious of the marketing material presented by sales reps Quotes or anecdotes Since the changes in 2002, 25% of doctors will not meet sales reps anymore. Pharmacoeconomics studies are much more important now. Individual doctors have come to expect cost-benefit data to help guide them - Swedish physician & county medical official Meetings and Conventions Medical Education Direct to Consumer Information Extremely modest meals (including no spirits) MDs employer must pay 50% of travel costs No company sponsored social activities Most international events strongly discouraged There is still too much anxiety. It is sad, really. There are a lot of opportunities for learning that are being lost. The pendulum has gone too far in the other direction. We hope that in a year, there will be the same opportunities as before - a Swedish physician & county medical official TBD Minimal guidance Not allowed

36 NJE-192515.016-20050310-sugnHR1 35 COUNTRY FACTS: UK Communications with Physicians Clinical Trials Key facts Need prior permission of a doctor to send him/her a fax, e-fax, email, automated calls or text messages 10 samples/doctor/year Samples by written request only Industry association recommends 3 visits/year Quotes or anecdotes Meetings and Conventions Medical Education Direct to Consumer Information Reasonable standards of hospitality International conferences acceptable for valid and cogent reasons 100% of travel expenses can be reimbursed In January, 2005 launched site that lets patient directly report adverse events to the government UKs NICE is nice because it is transparent – Belgian medical director Physicians association approves continuing medical education programs MHRA recently changed password requirement to a recommendation only on websites with information for physicians Patients want more information, but we are not sure how to communicate it – Head of Global Affairs

37 NJE-192515.016-20050310-sugnHR1 36 COUNTRY FACTS: ARGENTINA Communications with Physicians Clinical Trials Key factsQuotes or anecdotes Meetings and Conventions Medical Education Direct to Consumer Information Salesmen call on physicians twice monthly average. Visits for AVONEX and HUMIRA are more frequent. It is not necessary to arrange meetings beforehand. There are restrictions to the delivery of samples. The number of guests depends on budgetary issues. Reservations for international congresses are made through Abbott Chicago. No compensation is granted for income loss. Trips on tourist class. Additional meals are covered if within reasonable values. Independent and institutional committees approve trials. PMOs and EAPs are not allowed. MOHs approval may be slow when certain populations are involved. Promotional pieces contain references. Requests for full papers made by health care professionals are answered through our Medical Division. DDLs are distributed as needed. Distributed through our Medical Division. For products such as AVONEX and HUMIRA there are paramedical patient assistance programs.

38 NJE-192515.016-20050310-sugnHR1 37 COUNTRY FACTS: MEXICO Communications with Physicians Clinical Trials Key factsQuotes or anecdotes Meetings and Conventions Medical Education Direct to Consumer Information Physicians Associations and Societies approves continuing medical education programs by speciality Congresses and Symposia are the main way to promote launches and key findings of products. Pharma Industry covers most of the invitees Product registration do not require a clinical trial, although it is desirable to have some experience. Current trend to implement Pharmacoeconomic trials from earlier phases Congresses and Symposia are the main way to promote launches and key findings of products. Pharma Industry covers most of the physician invitees. Trend to be more selective rather than inviting larger amount of physicians No specific limits on numbers of samples Promo materials must be submitted to MoH for approval of claims. Future changes in the National law regarding promotion rules

39 NJE-192515.016-20050310-sugnHR1 38 COUNTRY FACTS: BRAZIL Communications with Physicians Clinical Trials Key factsQuotes or anecdotes Meetings and Conventions Medical Education Direct to Consumer Information Regulatory restrictions for promotional claims; Claims against competitors allowed since based on published data; No limits for visits, no prior permission request; Physicians can be invited to participate in PMOS; Samples allowed, no amount limits. TBD Regulatory restrictions about promotional contents and sponsorship; 100% of travel expenses can be reimbursed, never including entertainment; Promotion restricted to healthcare professionals; students not allowed at exhibition area. TBD Continuous improvements on regulations; Specific rules for Early Access Programs; PMOS allowed; Sponsorship means any kind of support; TBD CME organized by pharmacos, medical societies or upon agreement between both; Kind of activity not frequently done by local pharmacos; TBD Regulatory restrictions for DTC regarding contents and targets; Just OTCs are allowed to be promoted to consumers; prescribed drugs never. TBD

40 NJE-192515.016-20050310-sugnHR1 39 Government published guidelines about reasonable expenses for honorarium, travel and food, etc. in case of physicians of national/public hospitals. Those physicians need prior permission by the institutes when attending the meetings. Social activities/hospitality a pharmaco can pay for at a meeting Highly stricted for physicians who are goverment employees. Reimbursement for travel and expenses Same as above for the physicians who are goverment employees. Under the contract, reimbursement and travel are often included in the study fee and no direct reimbursement to physicians. For ad-hoc meetings, not many restrictions for private university/hospital physicians but for goverment employee physicians need written permission from their hospitals Limitations of international conferences It is difficult to invite goverment employee physicians to a company sponsored conferences if of which purpose is to advertise either specific compnay or product. There should be always publicity Communications with Physicians Clinical Trials Meetings and Conventions Medical Education Direct to Consumer Information COUNTRY FACTS: JAPAN Key facts Regulated by the rule from Japan Pharmaceutical Manufacturers Association. For example, invitation to dinner is not allowed in case of physicians of national/public hospitals. - Frequency of office visits: Frequent visit is required. On the other hand, physicains working for National Univ./Hospital need to get special approval from their hospitals when honorium is paid by company. - Other channels of communication (phone, fax, email) Telephone, e-mail are less welcome comparing to western countries but face-to-face. Cannot support investigator-initiated study for non-registration purpose without IND Mandatory data reporting Yes Adverse events Yes Mandatory reporting of unfavorable outcomes Yes Insurance requirements No # enrollees Not many because no insentive to physicians (money is to be paid to hospitals not to individual physicians) … Individual Product DTC is illegal Password protection for physician info on websites Only required to answer Yes or No to a question "Are you medical people ?" No password protection. Promotion permitted on the physician/professional part of the site Only product information (package insert and interview form) Other criteria that define the difference between consumer ?information? and ?advertising? No advertisement with product on newspaper, TV, magazine, and radio etc.

41 NJE-192515.016-20050310-sugnHR1 40 ITALYS PROSECUTION OF GSK IN 2003-2004 REVEALS THE COMPLIANCE RISK INHERENT IN MARKETING & MED AFFAIRS The Guardia di Finanza (GiF) have alleged that the Italian subsidiary of GSK, based in Verona, had spent 228 million Euros ($278 million) between 1999 and 2002 on cash, gifts and bribes to doctors and other medical professionals to encourage them to prescribe GSK's drug products. The most serious allegations are that 60 Italian oncologists received payments for every patient treated with GSK's small cell lung and ovarian cancer treatment Hycamtin (topotecan). The police said GSK employees disguised incentives and gifts under names such as medical phase IV, field selling and other promotional expenses. Alleged gifts ranged from foreign holidays to cameras and computer equipment, as well as straight cash payments Source:300 GlaxoSmithKline employees named in illegal incentives probe in Italy. Pharma Marketletter, June 7, 2004 Italys regulations pre-date 2003-04 and are among the most strict in Europe It is illegal to collect prescribing information on specific doctors Sales reps (information agents) must report to R & D, not Marketing Information agents can only go to a doctors office by prior appointment These regulations were not always enforced. The GSK case may indicate a future trend of tougher enforcement. The stakes in this case were high: management was left vulnerable to criminal charges, including 73 directors and the managing director of GSKs Italian subsidiary

42 NJE-192515.016-20050310-sugnHR1 41 SWEDEN RECENTLY ENACTED REGULATIONS ON DOCTOR MEETINGS STRICTER THAN MOST EUROPEAN COUNTRIES* *Agreement On Forms Of Cooperation Between Pharmaceutical Companies And Medical Professionals In The Public Healthcare Sector signed by the Landstingsförbundet (the Federation of Swedish County Councils) and Läkemedelsindustriföreningen (the Swedish Association of the Pharmaceutical Industry) in June, 2004 ** An exception is allowed for one region, southern Denmark Host companies can reimburse doctors no more than 50% of their costs for attending a conference Travel should only be in economy class, unless there is a negligible price difference for business class No social or recreational activities may be provided by the host company. Meals at conferences should be extremely modest. Alcoholic drinks in the form of wine and beer may only be offered in limited quantities and only with food. No spirits may be offered. Conferences should take place at participants place of work or in the same town or city or as near as possible, deviating only when pedagogical, practical, economic or other similar reasons so dictate Conferences outside Sweden are only permitted… if the majority of participant professionals are not from Sweden and equivalent sessions cannot be held within the country.** Similar limitations apply to site visits to international studies

43 NJE-192515.016-20050310-sugnHR1 42 EXTRA

44 NJE-192515.016-20050310-sugnHR1 43 Industry approaches to GMA reporting structure varies. -Abbott separates GMA from commercial, by GMA reporting to R&D.(model 2) Description of pharmacos with this structure Reporting structure Industry examples Trend away from this model in recent years, but some now reconsidering post OIG guidelines –We knew wed get closer integration with Marketing if it reported there, but didnt feel comfortable with it R&D Medical Affairs Novartis Merck Pfizer GSK Abbott Commercial organization Majority of pharmacos have this structure International Medical Affairs decentralized AstraZeneca J&J Pharmacia Schering-Plough Aventis Commercial organization Medical Affairs R&D Source:McKinsey None today; however, growing debate –Medical Affairs should be on the same level as Commercial and R&D –Having it report to either R&D or Commercial is suboptimal R&DMed Affairs None Commercial Organization

45 NJE-192515.016-20050310-sugnHR1 44 DIVERSITY OF GLOBAL MEDICAL AFFAIRS (GMA) RESPONSIBILITIES CREATES MANAGEMENT CHALLENGES Global Clinical Operations Medical Science Liaisons Publications Drug Information Services Area and Affiliate Medical Departments HEOR GLOBAL MEDICAL AFFAIRS (GMA) Health Economics and Outcomes Research (HEOR)


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