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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
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“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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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
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)
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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