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AGENDA 4:45 5:00 5:15 A map of international medical affairs

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0 Update on International Medical Affairs
NJE sugnHR1 NJE sugnHR1 CONFIDENTIAL Update on International Medical Affairs Alexander Petersen, McKinsey Stanley Bukofzer, Abbott Laboratories March 30, 2005, 4:45-5:30 p.m. 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.

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

2 NJE sugnHR1 NJE sugnHR1 INTRODUCTION Examples of regional regulation: The EU’s Clinical Trial Directive (EUCTD) implemented fully by May, 2004 EFPIA’s members revising their codes for 2005 on marketing practices The “Joint Position” signed by major international associations calling for the publication of non-exploratory trial data by September, 2005 Some country examples Sweden’s restrictions on meetings exceed the coming EFPIA regulations in several dimensions Belgium’s rules around clinical trials (e.g. insurance standards) have made trials much more difficult there compared to other parts of Europe While most of the world allows leaving samples, with varying levels of constraints, France has banned them altogether 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 areas—communications with physicians, meetings and conventions, clinical trials, medical education, and direct-to-consumer information—provide a vivid demonstration of the diversity of international affairs

3 WHAT INDUSTRY IS SAYING – EXAMPLES
NJE sugnHR1 NJE sugnHR1 WHAT INDUSTRY IS SAYING – EXAMPLES COMMENTARY FOR EACH BULLET Bullet 1: Though the EU is gradually becoming more active, there is plenty of diversity at the country level. The Belgian example is interesting as an example of EU harmonization actually leading to increased diversity Bullet 2: The mission of medical affairs is to provide medical information to patients and doctors. But compliance concerns, especially driven by the cynicism of regulators and industry towards marketing practices, affects medical affairs activities as well. Bullet 3: All the country diversity makes establishing standard globally challenging. You have to rely a lot on country operations for the lead. HQ can do procedural things (e.g. reviews, requiring written guidelines) but the insight from HQ about whether the right things are going on is more difficult Bullet 4: The Medical Visits Charter, enacted recently (end of 2004) did have a controversial measure in it—banning samples. But if industry assn LEEM hadn’t made a proposal to the government, things may have been worse 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

4 SUMMARY OF COUNTRY DATA
NJE sugnHR1 NJE sugnHR1 SUMMARY OF COUNTRY DATA TWO INTERESTING THINGS ABOUT THIS PAGE Some countries clump (e.g. Portugal) but others are split (e.g. Germany, Italy) Med Ed (largely unregulated today) is a test case. In 5 years, will countries spread out? In what pattern? We can’t predict it Less restrictive More restrictive Communications with physicians Meetings and conventions Clinical trials Medical education Direct-to-consumer information NZ

5 COMMUNICATIONS WITH PHYSICIANS
NJE sugnHR1 NJE sugnHR1 COMMUNICATIONS WITH PHYSICIANS (see next slide for notes) Frequency of office visits Other channels of communication (phone, fax, ) Limitations on leaving samples Italy Sweden UK Japan Germany Increasing restrictions Portugal France EFPIA

6 COMMUNICATIONS WITH PHYSICIANS
NJE sugnHR1 NJE sugnHR1 COMMUNICATIONS WITH PHYSICIANS THE BACKLASH AGAINST MARKETING AFFECTS COMMUNICATION OF SCIENTIFIC INFO TO DOCTORS European countries are cracking down on sales practices and restricting pharmaco access to physicians. For example, in Italy, after the GSK investigation, authorities are really enforcing rules that had been dormant for a long time. The effects are spilling over to medical affairs whose work is getting harder and harder. EFPIA is now trying to set some European standards and show the industry’s good will. US comparison Use of MSL is very weak in Europe compared to US. The fact that there are varying levels of restrictions about reps reaching out to doctors in Europe suggests that growth of MSL will vary. It is happening now in Italy, but it is unlikely to happen soon in Portugal and Germany Frequency of office visits Other channels of communication (phone, fax, ) Limitations on leaving samples “It is even illegal to track doctor prescribing information” “The rules aren’t quite clear, but it would be risky to make more than 5 visits/year to a doctor” “EFPIA expects us to ask for prior permission of a doctor to send him/her a fax, e-fax, , automated calls or text messages” Italy Sweden UK Japan Germany Increasing restrictions Portugal France EFPIA

7 MEETINGS AND CONVENTIONS
NJE sugnHR1 NJE sugnHR1 MEETINGS AND CONVENTIONS (see notes on next slide) Social activities/hospitality a pharmaco can pay for at a meeting Reimbursement for travel and expenses Limitations of international conferences EFPIA 2005 Sweden Italy France Germany Japan Increasing restrictions U.K. Portugal

8 MEETINGS AND CONVENTIONS
NJE sugnHR1 NJE sugnHR1 MEETINGS AND CONVENTIONS COUNTRIES HAVE VERY DIFFERENT FEELINGS ABOUT MEETING “PERKS” Sweden went very far European countries have very different points of view on meetings and conventions. For example, in Sweden, recent apparently unrelated scandals around bribery in state-owned liquor stores, caused the pharma industry to exercise extreme caution as to how much and which type of alcohol can be served at medical conventions! Avoiding the appearance of impropriety has become an essential theme in Sweden, for example making it difficult to organize country-wide or international medical conventions. US comparison US doesn’t particularly try to restrict international meetings, which EFPIA and the stricter countries are trying to discourage. Social activities/hospitality a pharmaco can pay for at a meeting Reimbursement for travel and expenses Limitations of international conferences “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” EFPIA 2005 Sweden Italy France Germany Japan Increasing restrictions U.K. Portugal

9 Increasing restrictions
NJE sugnHR1 CLINICAL TRIALS Mandatory reporting of trial outcomes and adverse events Insurance requirements Number of enrollees Joint Position* France Belgium Germany U.K. Italy Japan Sweden Increasing restrictions Portugal * 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

10 Increasing restrictions
NJE sugnHR1 NJE sugnHR1 CLINICAL TRIALS Explain the CTD implementation story for Belgium. Explain that the joint position thing comes from a head of public affairs US comparison One major difference with USA is that in investigator-initiated studies (IIS), adverse events reporting is discretionary, but in Europe it is not generally required “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!” Mandatory reporting of trial outcomes and adverse events Insurance requirements Number of enrollees Joint Position* France Belgium Germany U.K. Italy Japan Sweden Increasing restrictions “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” Portugal * 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

11 Increasing restrictions
NJE sugnHR1 NJE sugnHR1 MEDICAL EDUCATION WHAT’S NEXT WITH MEDICAL EDUCATION? Leaving aside rules about meeting spending, there are very few specific limitations on Med Ed in Europe. You can hire pharma members There is no explicit guidance about payment Clients of ours are saying that in a few years medical education is going to be more regulated. What will the graph look like? Will you have countries scattered all over? US comparison US is more restrictive, because they don’t let the pharmacos hire their own doctors, and pharmacos need to use fair market value Limits on content Financial limits of sponsorship Independence of pharmaco from those who receive funds (speakers, CME) Italy Germany Portugal U.K. Increasing restrictions France

12 Increasing restrictions
NJE sugnHR1 NJE sugnHR1 MEDICAL EDUCATION WHAT’S NEXT WITH MEDICAL EDUCATION? Leaving aside rules about meeting spending, there are very few specific limitations on Med Ed in Europe. You can hire pharma members There is no explicit guidance about payment Clients of ours are saying that in a few years medical education is going to be more regulated. What will the graph look like? Will you have countries scattered all over? US comparison US is more restrictive, because they don’t let the pharmacos hire their own doctors, and pharmacos need to use fair market value Limits on content Financial limits of sponsorship Independence of pharmaco from those who receive funds (speakers, CME) Italy Germany Portugal U.K. Increasing restrictions France “In France, continuing medical education is not yet on the authorities’ radar”

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

14 DIRECT-TO-CONSUMER COMMUNICATIONS
NJE sugnHR1 NJE sugnHR1 DIRECT-TO-CONSUMER COMMUNICATIONS It continues to be very difficult to communicate medical information to patients in Europe. Television is a no-go, and the internet is highly regulated. On the other hand, in countries like New Zealand and of course the US, DTC has become part of patients’ everyday life. Direct-to consumer communication Television Print ads “DTC is like GMOs. Europeans don’t like them, and it’s not likely to change short term” Italy Germany “The EU has a working group assessing DTC… it’s first results are expected in 3 years from now” Portugal U.K. France Japan New Zealand Increasing restrictions

15 MANAGEMENT CHALLENGES DRIVEN BY LOCAL DIVERSITY
NJE sugnHR1 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?

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

17 NJE sugnHR1 DIVERSITY OF GLOBAL MEDICAL AFFAIRS (GMA) RESPONSIBILITIES CREATES MANAGEMENT CHALLENGES Area and Affiliate Medical Departments 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 Drug Information Services Publications GLOBAL MEDICAL AFFAIRS (GMA) Medical Science Liaisons Management challenges include Diversity of responsibility Global scope Local and regional variation of the laws HEOR Global Clinical Operations Health Economics and Outcomes Research

18 ABBOTT’S GUIDING PRINCIPLES TO MANAGE GMA
NJE sugnHR1 ABBOTT’S 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

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

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

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

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

23 CENTRALIZED DECISION MAKING WITH REGIONAL TACTICAL CONTROL
NJE sugnHR1 CENTRALIZED DECISION MAKING WITH REGIONAL TACTICAL CONTROL Affiliate medical departments and area medical directors International Business Division Global Pharmaceutical RD 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 Affiliate General Managers Global Medical Affairs Global Project Team Coordinate activities with GPTs so that the team has a one stop communication with the world – about 3-5 products per AMD Affiliate Medical Directors Area Medical Directors Established Excellence Teams to ensure alignment between commercial and scientific team initiatives Develop infrastructure of Affiliate Medical Departments if necessary thru matrixing resources

24 NJE sugnHR1 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

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

26 NJE sugnHR1 NJE sugnHR1 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 Abbott’s other training systems Mandatory legal and ethical training of relevant roles

27 Appendix NJE-192515.016-20050310-sugnHR1

28 COUNTRY FACTS: USA VS. EUROPE
NJE sugnHR1 NJE sugnHR1 COUNTRY FACTS: USA VS. EUROPE Key facts Vs. Europe Communications with Physicians Samples and visits are generally left up to the company’s discretion MSL’s pretty prevalent for KOL communications Varies by country, but generally more restrictive than USA MSL is still a growing role in Europe. Growth won’t be even, because some countries are still less restrictive (e.g. Portugal, Germany) so reps are still an effective information channel Meetings and Conventions FMV for speakers No special limitations on international meetings Some countries discourage international meetings (though none ban it) Clinical Trials IIS (non-sponsored) trials AE reports are discretionary IIS AE reporting is mandatory Medical Education 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 Direct to Consumer Information 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

29 EFPIA AND THE “JOINT POSITION”
NJE sugnHR1 NJE sugnHR1 EFPIA AND THE “JOINT POSITION” Key facts Quotes or anecdotes Communications with Physicians (EFPIA) Need prior permission of a doctor to send him/her a fax, e-fax, , automated calls or text messages Avoid “inconvenience” due to frequent visits, but no target number of visits recommended 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 Clinical Trials (EFPIA) EFPIA’s new code of conduct, finalized at the end of 2004, says post-authorization studies must not be promotional—they must have a primarily educational or scientific purpose “The EFPIA code should not be underestimated—in the future it will have increasing influence on clinical trials” – a Belgian pharmaceutical Medical Director Clinical Trials (“Joint Position”)* 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 “Publication of Phase IV data will make the market intensely competitive” – a French pharmaceutical Medical Director * “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.

30 COUNTRY FACTS: FRANCE Key facts Quotes or anecdotes
NJE sugnHR1 NJE sugnHR1 COUNTRY FACTS: FRANCE Key facts Quotes or anecdotes Communications with Physicians 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 “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 Meetings and Conventions Government publishes strict guidelines about expenses that can be reimbursed “You can only buy a doctor a third-class ticket on a train!” Clinical Trials “Seeding” trials are illegal Medical Education Minimal guidance “Industry fears that marketing practices will be punished not only directly, but indirectly and unofficially, through pricing” – a French pharmaceutical Medical Director Direct to Consumer Information Not allowed

31 COUNTRY FACTS: GERMANY
NJE sugnHR1 NJE sugnHR1 COUNTRY FACTS: GERMANY Key facts Quotes or anecdotes Communications with Physicians 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 “It is an unwritten rule that you will buy doctors dinner at a meeting. Sometimes they go just for the dinner.” - German physician’s association member Meetings and Conventions VFA code of 2004 warned against “excessive” spending Cannot reimburse for trips of shorter than 6 hours Social activities cannot be reimbursed Clinical Trials Lower regulation of observational trials “Pharma companies still use observational trials to try to get physicians to switch from a well-established drug” – Industry observer Medical Education 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 “Gone are the days when you can fly a doctor to Oslo to see the opera” – German physician’s association member Direct to Consumer Information Not allowed

32 COUNTRY FACTS: ITALY Key facts Quotes or anecdotes
NJE sugnHR1 NJE sugnHR1 COUNTRY FACTS: ITALY Key facts Quotes or anecdotes Communications with Physicians Illegal to track prescribing habits MSL use varies 3-5 rep visits per year “The meaning of many rules are not written. You need to understand how they will be interpreted” – Italian Medical Director Meetings and Conventions Regional government up to ~26,000 Euro, above which Ministry of Health must approve 60 days prior approval if more than 10 doctors “The regional governments have decided that pharma marketing is a financially and ethically acceptable area to target” – an Italian pharmaceutical Sales Manager Clinical Trials 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 Medical Education Minimal guidance Direct to Consumer Information Not allowed

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

34 COUNTRY FACTS: SWEDEN Key facts Quotes or anecdotes
NJE sugnHR1 NJE sugnHR1 COUNTRY FACTS: SWEDEN Key facts Quotes or anecdotes Communications with Physicians 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 “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 “Extremely modest” meals (including no spirits) MD’s 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 Clinical Trials TBD Medical Education Minimal guidance Direct to Consumer Information Not allowed

35 COUNTRY FACTS: UK Key facts Quotes or anecdotes
NJE sugnHR1 NJE sugnHR1 COUNTRY FACTS: UK Key facts Quotes or anecdotes Communications with Physicians Need prior permission of a doctor to send him/her a fax, e-fax, , automated calls or text messages 10 samples/doctor/year Samples by written request only Industry association recommends 3 visits/year Meetings and Conventions “Reasonable” standards of hospitality International conferences acceptable for “valid and cogent” reasons 100% of travel expenses can be reimbursed Clinical Trials In January, 2005 launched site that lets patient directly report adverse events to the government “UK’s NICE is ‘nice’ because it is transparent” – Belgian medical director Medical Education Physician’s association approves continuing medical education programs Direct to Consumer Information 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

36 COUNTRY FACTS: ARGENTINA
NJE sugnHR1 NJE sugnHR1 COUNTRY FACTS: ARGENTINA Key facts Quotes or anecdotes Communications with Physicians 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. Meetings and Conventions Independent and institutional committees approve trials. PMOs and EAPs are not allowed. MOH’s approval may be slow when certain populations are involved. Clinical Trials Promotional pieces contain references. Requests for full papers made by health care professionals are answered through our Medical Division. DDLs are distributed as needed. Medical Education Distributed through our Medical Division. For products such as AVONEX and HUMIRA there are paramedical patient assistance programs. Direct to Consumer Information

37 COUNTRY FACTS: MEXICO Key facts Quotes or anecdotes
NJE sugnHR1 NJE sugnHR1 COUNTRY FACTS: MEXICO Key facts Quotes or anecdotes Communications with 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 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 Meetings and Conventions Clinical Trials 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 Medical Education Physician’s 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 Direct to Consumer Information

38 COUNTRY FACTS: BRAZIL Key facts Quotes or anecdotes
NJE sugnHR1 NJE sugnHR1 COUNTRY FACTS: BRAZIL Key facts Quotes or anecdotes Communications with Physicians 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 Meetings and Conventions 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 Clinical Trials Continuous improvements on regulations; Specific rules for Early Access Programs; PMOS allowed; Sponsorship means any kind of support; TBD Medical Education CME organized by pharmacos, medical societies or upon agreement between both; Kind of activity not frequently done by local pharmacos; TBD Direct to Consumer Information Regulatory restrictions for DTC regarding contents and targets; Just OTCs are allowed to be promoted to consumers; prescribed drugs never. TBD

39 COUNTRY FACTS: JAPAN Key facts
NJE sugnHR1 COUNTRY FACTS: JAPAN Key facts Communications with Physicians 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, ) Telephone, are less welcome comparing to western countries but face-to-face. Meetings and Conventions 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 Clinical Trials 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) Medical Education Direct to Consumer Information 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.

40 NJE sugnHR1 ITALY’S PROSECUTION OF GSK IN 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” Italy’s regulations pre-date 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 doctor’s 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 GSK’s Italian subsidiary Source: “300 GlaxoSmithKline employees named in illegal incentives probe in Italy.” Pharma Marketletter, June 7, 2004

41 NJE sugnHR1 NJE sugnHR1 SWEDEN RECENTLY ENACTED REGULATIONS ON DOCTOR MEETINGS STRICTER THAN MOST EUROPEAN COUNTRIES* 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 * “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

42 NJE sugnHR1 NJE sugnHR1 EXTRA

43 NJE sugnHR1 NJE sugnHR1 Industry approaches to GMA reporting structure varies. -Abbott separates GMA from commercial, by GMA reporting to R&D.(model 2) Trend away from this model in recent years, but some now reconsidering post OIG guidelines “We knew we’d get closer integration with Marketing if it reported there, but didn’t feel comfortable with it” R&D Medical Affairs Novartis Merck Pfizer GSK Abbott Commercial organization Reporting structure Commercial organization R&D R&D Med Affairs Commercial Organization Medical Affairs Description of pharmacos with this structure Majority of pharmacos have this structure International Medical Affairs decentralized 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” AstraZeneca J&J Pharmacia Schering-Plough Aventis Industry examples None Source: McKinsey

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


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