digging deeper: focus on best practices compliance · digging deeper: focus on best practices...
TRANSCRIPT
Digging Deeper: Focus on Best Practices
Medical Affairs Compliance
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Dr Kelvin Tan MRCP (UK)
Vice President Medical Affairs APErinn Hutchinson
Partner, PricewaterhouseCoopers
Digging Deeper: Focus on Best Practices Medical Affairs Compliance
• Joint forum⁻
Kelvin Tan Medical Affairs, Allergan AP
⁻
Erinn Hutchinson, Partner, PricewaterhouseCoopers
• Focus on Best Practice⁻
Share some personal insights
⁻
Scenario based approach⁻
Open forum for discussion
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Agenda
• Medical Affairs trends• Allergan Medical Affairs structure• Discussion scenarios• Questions
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Medical Affairs Trends
• In the last two years, pharmaceutical and medical device companies have expanded their medical science liaison (MSL) operations to include new and larger teams in Europe and Asia
• In 2012, 67% have MSL teams in Europe, up from 41% in 2010; and 21% have teams in Asia, up from 7%
• On average, pharmaceutical medical affairs organizations employ 48 MSLs in the U.S, nearly twice as many liaisons as they staff in Europe. Companies have an average 11 MSLs on staff throughout Asia.
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http://www.cuttingedgeinfo.com/2012/medical‐science‐liaison‐teams‐expanding‐europe‐asia/http://global.factiva.com/aa/?ref=CHWKNW0020120914e89i0001k&pp=1&fcpil=en&napc=p&sa_from=http://global.factiva.com/aa/?ref=CHWKNW0020120810e88e0007k&pp=1&fcpil=en&napc=p&sa_from=
What has happened in U.S. and Europe?
• Transparency reporting requirements in U.S., Europe, Australia and Japan
• Complex internal and external procedures• Expansion of global and local CPD programs
into emerging markets• Shift in control of certain activities from
commercial to medical affairs
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What’s happening in China Now?
• Drug Administration Law is pending and has been cited as a priority by the Chinese government
• “Building a 21st Century Pharmaceutical Regulatory System” (June 2013), aiming to:⁻
Increase transparency and outside participation in the drug evaluation and approval process
⁻
Promote a scientific administration, i.e., a drug administration system that performs science-based reviews and issues science- based decisions
⁻
Full adoption of international norms for clinical trial applications⁻
Promote R&D in China⁻
Promote expert independent scientific advice
What does this trend mean?
• China is following the roadmap of U.S. and Europe to separate drug commercialization activities from scientific communication
• Increasing difficulties to reach KOLs as they may be reluctant to attend activities that may negatively affect their status
• Medical Affairs Functions and MSLs will become more important in conducting business in the industry:⁻
Compliant with the regulations
⁻
Provide access to highly influential physicians and medical researchers
⁻
Bring exposure to key healthcare decision-making bodies, such as payers
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The duties of a doctor registered with the General Medical CouncilPatients must be able to trust doctors with their lives and
health.
To justify that trust you must show respect for human life
and make sure your practice meets the standards expected of you
in four domains.
1.Knowledge, skills and performance
2. Safety and quality
3. Communication, partnership and teamworkWork with colleagues in the ways that best serve patients' interests
4. Maintaining trustBe honest and open and act with integrity.Never abuse your patients' trust in you or the public's trust in
the
profession
Why does Medical Affairs have a role in compliance?
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Scope of Medical Affairs organizations Global Medical Affairs
– Medical information –
preparing standard
responses
– Medical
communications –
phase IV pubs strategy
– Advisory Boards
– Trials
–
phase I‐IV
strategy, phase IV
execution
– IIT
–
strategy and
execution
– Medical
communications
–
phase I‐IV pubs
execution
– Medical information –
Call centers
– Medical education –
strategy, CME execution
– Medical field
–
KOL
strategy, direct
exchange with KOLs
– Biostatistics
– Epidemiology
– Pharmaco‐vigilance
– Medical education –
training internal
stakeholders
– Medical communications ‐
phase I‐III pubs
strategy, internal and other external
medical communications
– Medical field –
Direct exchange with non‐
KOL MDs, other HCPs, payors, regulators
– Trials –
phase I‐III execution
– HEOR
–
strategy and execution
– Strategy
–
LCM strategy; brand strategy;
medical strategy
– Congress presence
– Promotional material review
– Regulatory affairs
– Drug safety
SOURCE: McKinsey Medical Affairs Benchmarking
Over 75% of companies
51-75% of companies
25-50% of companies
Sole or joint MA ownership of activity1
CUSTOMER CUSTOMER FOCUSFOCUS
IMPACTIMPACT
PEOPLE & PEOPLE & PASSIONPASSION
COLLABORATIONCOLLABORATION
INNOVATIONINNOVATION
INTEGRITYINTEGRITY
Every action we take is with an eye on the “Three Ps:”
the
patients
who
benefit
from
our
products,
the
physicians who trust our products and the payers who
recognize the value of our products.
We
make
an
impact
– going
the
extra
distance
to
get
the very best results, applying the highest standards to
all that we
do. We value and reward smart,
fast
action
that gets meaningful results.
We
succeed
primarily
through
our
people,
whose
talent
brings
quality
to
our
work
and
whose
passion
brings
commitment
– not
just
from
processes
and
structures
alone.
We
are
committed
to
sharing
our
knowledge
and
collaborating
as
a
team
to
reach
common
goals.
We
promote and encourage different personal and cultural
perspectives that drive new thinking.
We
are
uncomfortable
with
the
status
quo.
We
adapt,
we
improve,
we
have
the
courage
to
thoughtfully
take
risks
as
a
team
and
seize
new
opportunities
– for
the
company and ourselves.
We
get
results
the
right
way,
without
cutting
corners.
We
are
transparent,
clear
and
respectful
in
our
dealings
with customers, co‐workers and partners.
Global Values
Practical Steps
1.
Reference internal benchmarks
2.
Reference external benchmarks
3.
Seek advice
4.
Moral compass ‐
Do the right thing
5.
Focus on the Patient
6.
Assess the risk
7.
Make a recommendation
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Scenario 1
• You receive an unsolicited request for an educational grant donation from an independent academic society
• They have approached multiple different pharmaceutical companies to sponsor their meeting
• They send you a copy of the agenda which includes references to off-label uses of classes of medication that your company and others promote
• What are your considerations?
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Scenario 2
• You (Compliance & Medical Affairs) are asked to approve a company sponsored educational meeting for HCPs
• The cross-functional team responsible for the meeting wish to hold the meeting in Country X, where all your company’s products are approved
• The country subsidiaries wish to send delegates from their countries, but you note that not all products are approved in all the countries
• What are your considerations?
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