NJE-192515.016-20050310-sugnHR1 CONFIDENTIAL Update on International Medical Affairs This report is...

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


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


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


Medical Education


• 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


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


Medical Education


• 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


Clinical Trials

Key facts

• Illegal to track prescribing habits• MSL use varies• 3-5 rep visits per year

Quotes or anecdotes


Medical Education


• 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


• 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


Clinical Trials

Key facts

• “Common sense and moderation” used for frequency of office visits

• No limitations on sampling

Quotes or anecdotes


Medical Education


• “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


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


• “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


• Not allowed

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COUNTRY FACTS: UK


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


Medical Education


• “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


Clinical Trials

Key facts Quotes or anecdotes


Medical Education


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


Clinical Trials



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

• 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


Clinical Trials



Medical Education


• 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


Clinical Trials


Medical Education


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


• Majority of pharmacos have this structure

• International Medical Affairs decentralized

• AstraZeneca• J&J• Pharmacia• Schering-Plough• Aventis


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

NJE-192515.016-20050310-sugnHR1

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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)

NJE-192515.016-20050310-sugnHR1 CONFIDENTIAL Update on International Medical Affairs This report is...

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