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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What makes me qualified to talk to you about  Compliance? 

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Why does Medical Affairs have a role in compliance? 9

10

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? 

Medical Affairs: Who are we and what do we do?

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Who are we and what do we do?12

1

3

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

What’s my process?14

Seek advice15

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

The Red Faced Test……17

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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Discussion Scenarios

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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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Any questions?