nje-192515.016-20050310-sugnhr1 confidential update on international medical affairs this report is...
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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 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
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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
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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 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
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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
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SUMMARY OF COUNTRY DATA
Communications with physicians
More restrictive
Meetings and conventions
Clinical trials
Medical education
Direct-to-consumer information
Less restrictive
NZ
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COMMUNICATIONS WITH PHYSICIANS
•Frequency of office visits•Other channels of communication (phone, fax, email)•Limitations on leaving samples
Incr
easi
ng
res
tric
tio
ns
Germany
Italy
UK
Sweden
Portugal
EFPIA
France
Japan
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Japan
COMMUNICATIONS WITH PHYSICIANS
•Frequency of office visits•Other channels of communication (phone, fax, email)•Limitations on leaving samples
Incr
easi
ng
res
tric
tio
ns
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 aren’t quite clear, but it would be risky to make more than 5 visits/year to a doctor”
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MEETINGS AND CONVENTIONS
•Social activities/hospitality a pharmaco can pay for at a meeting
•Reimbursement for travel and expenses•Limitations of international conferences
Incr
easi
ng
res
tric
tio
ns
EFPIA 2005
Portugal
Sweden
Italy
U.K.
FranceGermany
Japan
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MEETINGS AND CONVENTIONS
•Social activities/hospitality a pharmaco can pay for at a meeting
•Reimbursement for travel and expenses•Limitations of international conferences
Incr
easi
ng
res
tric
tio
ns
EFPIA 2005
Portugal
Sweden
Italy
U.K.
FranceGermany
“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
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CLINICAL TRIALS
•Mandatory reporting of trial outcomes and adverse events
• Insurance requirements•Number of enrollees
Incr
easi
ng
res
tric
tio
ns
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
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Japan
CLINICAL TRIALS
•Mandatory reporting of trial outcomes and adverse events
• Insurance requirements•Number of enrollees
Incr
easi
ng
res
tric
tio
ns
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”
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MEDICAL EDUCATION
•Limits on content•Financial limits of sponsorship• Independence of pharmaco from those who receive
funds (speakers, CME)
Incr
easi
ng
res
tric
tio
ns
U.K.
France
Germany
Portugal
Italy
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MEDICAL EDUCATION
•Limits on content•Financial limits of sponsorship• Independence of pharmaco from those who receive
funds (speakers, CME)
Incr
easi
ng
res
tric
tio
ns
U.K.
France
Germany
Portugal
Italy
“In France, continuing medical education is not yet on the authorities’ radar”
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DIRECT-TO-CONSUMER COMMUNICATIONS
•Restrictions on direct-to consumer communication–Television–Print ads
Incr
easi
ng
res
tric
tio
ns
New Zealand
U.K.
France
Germany
Portugal
Italy
Japan
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DIRECT-TO-CONSUMER COMMUNICATIONS
•Direct-to consumer communication–Television–Print ads
Incr
easi
ng
res
tric
tio
ns
“DTC is like GMOs. Europeans don’t like them, and it’s not likely to change short term”
“The EU has a working group assessing DTC… it’s first results are expected in 3 years from now”
New Zealand
U.K.
France
Germany
Portugal
Italy
Japan
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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?
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CONFIDENTIAL
Managing the Complexity – One Perspective
Stan Bukofzer
Divisional Vice President and Head of Global Medical Affairs
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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 lawsGlobal Clinical Operations
Medical Science Liaisons
PublicationsDrug Information Services
Area and Affiliate Medical
Departments
HEOR
GLOBAL MEDICAL
AFFAIRS (GMA)
Health Economics and Outcomes Research
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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 includeregional 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
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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 2Model 2
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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
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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
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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
ResultsGMA 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
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CENTRALIZED DECISION MAKING WITH REGIONAL TACTICAL CONTROLAffiliate 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
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
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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
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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
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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
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COUNTRY FACTS: USA VS. EUROPE
Communications with Physicians
Clinical Trials
Key facts
• Samples and visits are generally left up to the company’s discretion
• MSL’s 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 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
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
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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
• 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
“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 underestimated—in the future it will have increasing influence on clinical trials” – a Belgian pharmaceutical Medical Director
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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
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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 trials “Pharma 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 physician’s association member
“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
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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
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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
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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 officialMeetings and
Conventions
Medical Education
Direct to Consumer Information
• “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
• TBD
• Minimal guidance
• Not allowed
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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
“UK’s NICE is ‘nice’ because it is transparent” – Belgian medical director
• Physician’s 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
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COUNTRY FACTS: ARGENTINA
Communications with Physicians
Clinical Trials
Key facts Quotes 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. MOH’s 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.
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COUNTRY FACTS: MEXICO
Communications with Physicians
Clinical Trials
Key facts Quotes or anecdotes
Meetings and Conventions
Medical Education
Direct to Consumer Information
• 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
• 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
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COUNTRY FACTS: BRAZIL
Communications with Physicians
Clinical Trials
Key facts Quotes 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
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• 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: JAPANKey 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.
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ITALY’S 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
Italy’s 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 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
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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
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EXTRA
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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 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
• 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&D Med Affairs
• None
CommercialOrganization
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DIVERSITY OF GLOBAL MEDICAL AFFAIRS (GMA) RESPONSIBILITIES CREATES MANAGEMENT CHALLENGES
Global Clinical Operations
Medical Science Liaisons
PublicationsDrug Information Services
Area and Affiliate Medical
Departments
HEOR
GLOBAL MEDICAL
AFFAIRS (GMA)
Health Economics and Outcomes Research (HEOR)