Insert Slide Title - Global Health Care, LLC · Insert Slide Title. Cecilia Abe, MBA. Sandra González, Esq. Jan Oliver Huber. Louis Ramos, Esq. D. Jeffrey Campbell, Esq. PCF Latin

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Cecilia Abe, MBASandra González, Esq.

Jan Oliver HuberLouis Ramos, Esq.

D. Jeffrey Campbell, Esq.

PCF Latin American Pharmaceutical and Medical Device Compliance Congress

Mexico City, MexicoJuly 30, 2014

Cecilia Abe, MBA LATAM Regional Compliance Officer, Sanofi‐Aventis

Sandra González, Esq.

Manager of Regulatory and Compliance Services, Porzio

Life Sciences, LLC.

Jan Oliver HuberGeneral Secretary, Austrian Pharmaceutical Industry Association (PHARMIG)

Louis Ramos, Esq.

Lead Compliance Counsel for Latin America, International R&D andManufacturing, Pfizer Inc.

D. Jeffrey Campbell, Esq.

President and Chief Executive Officer, Porzio

Life Sciences, LLC. (Moderator)

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Key trends in global transparency

Extraterritorial impact of US and European requirements on Latin American Operations

Managing data privacy and physician consent

Potential developments in Latin America

3

4

“Disclosure 

brings 

about 

accountability, 

and 

accountability 

will 

strengthen 

the 

credibility 

of 

medical 

research, 

the 

marketing 

of 

ideas 

and,

ultimately, 

the practice of medicine. The lack of transparency regarding payments made 

by 

the 

pharmaceutical 

and 

medical 

device 

community 

to 

physicians

has 

created 

a 

culture 

that 

this 

law 

should 

begin 

to 

change 

substantially. 

The 

reform 

represented 

by 

the 

Grassley‐Kohl 

Sunshine 

Law 

is 

in 

patients' 

best 

interests.”

‐

Senator Charles Grassley, co‐author of the Sunshine Act

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Who/what is reportable?Who has to report (pharmaceutical vs. medical device)?How is it reported (publication on company website vs. government website)?Aggregate data vs. detailedLaws vs. code (e.g., EFPIA)Managing consent, data privacy, cross‐border spendContinual vs. biannual vs. yearly reporting?Languages:  English, Spanish or Lithuanian?Reporting on 3 levels:  local/national/international

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Key:White –

No Reporting Red –

Existing ReportingPink –

Reporting is Coming

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The European Federation of Pharmaceutical Industries  and Associations (“EFPIA”) represents the 

pharmaceutical industry operating in Europe

33 European 

National 

Pharmaceutical 

Industry 

Associations 40 40 

Leading Leading 

CompaniesCompanies

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Austria DenmarkBelgium

Finland France Germany Greece Ireland Italy

Netherlands Norway Poland Portugal Russia

Spain Sweden Switzerland Turkey

United Kingdom 9

Bulgaria Croatia

Ukraine

Romania

Serbia

Cyprus Czech Republic Estonia

Hungary Latvia

Lithuania Malta

Slovakia Slovenia

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US Sunshine Act & Global Global  Transparency Trends

Mexico, July 30, 2014

Jan Oliver HuberSecretary General, Pharmig

The importance of transparency

successful research needs cooperation with Healthcare Professionals

essential to define basic rules of this cooperation in a transparent and fair manner

growing public interest in the nature of the pharmaceutical industry‘s relationships

Goal: strengthen the legitimate relationship between pharmaceutical companies and Healthcare Professionals by making these more transparent

Impact on Europe

European Commission – Process on Corporate Responsibility in the Field of Pharmaceuticals

List of Guiding Principles Promoting Good Governance in the Pharmaceutical Sector ‐> Outcome: e.g. full transparency of financial transactions

EFPIA (European Federation of Pharmaceutical Industries and Associations) supports principles –Disclosure Code since 2013‐> disclose transfers of value to healthcare professionals and healthcare organisations

Austria

self regulation instead of regulation by law 

through self regulation (Pharmig CoC)Pharmaceutical Industry demonstrateshigh level of responsibility

Ethical collaboration – high quality patient care

Challenges

specific local legislation (data privacy)

challenging local cultures

bridging gaps (professional integrity vs.transparency)

Thank you for your  attention.

Payment made to a US licensed physician (regardless of where spend occurred) by an “applicable manufacturer”

Payment made to a European licensed healthcare professional by a Latin American company affiliated with an EFPIA member company

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Key:White –

No Reporting Red –

Existing ReportingPink –

Reporting is Coming

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Countries in Latin America with current or proposed data privacy laws 18

Crystal Ball…

oWhere do we go from here?

oWhat, if anything, will change?

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Thank

you

for attending today’s

session

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