In an era of increasing regulatory scrutiny and changing social environment there are increasing complex demands for compliance teams related to globalisation, information privacy and security, HCP interactions and external reporting requirements. In this ebook, we share the thoughts of industry representatives on what they find the biggest challenges faced in their day to day work. They also give insight and thoughts on the implications to the industry and how the compliance role will change over the next 5 years.

1. Essential insights into
Pharma compliance

2. In an era of increasing regulatory scrutiny and
changing social environment there are increasing
complex demands for compliance teams
related to globalisation,information privacy and
security,HCP interactions and external reporting
requirements.
In this ebook,we share the thoughts of industry
representatives on what they find the biggest
challenges faced in their day to day work.They
also give insight and thoughts on the implications
to the industry and how the compliance role will
change over the next 5 years.
I hope you enjoy this ebook and more importantly
find it informative and thought provoking.
Bernadette Stansfield
bstansfield@healthnetworkcommunications.com
+44 (0) 207 608 7057

3. VIEWPOINT:
Challenges in Compliance
What are the specific risks for pharma with regards to
bribery, corruption and trust? How do you minimise
these risks?
There will always be inherent issues here.We rely on the middle man to ensure
transparent and fully compliance communication with the end consumer and so
all we can do is influence them accordingly.It is a critical issue that demands a
lot of attention.
How do you see the compliance role changing in the
next 5 years?
The compliance role is becoming an increasingly professional role and will
continue to do so achieving a career status of its own.
Ana Prada
EMEA Corporate Counsel,Ethics & Compliance
Baxter Healthcare
What are the biggest challenges in compliance
currently?
Europe has reached a different level of sophistication in relation to compliance
requirements and it is not always easy for global companies to truly understand
what is required – requirements are of simpler in different countries/regions.
There are also several challenges around aggregating data effectively and
identifying the best most reliable data to use when reporting.Other challenges
in Europe specifically are around the fact the medical and marketing teams
often work very separately,unlike the USA.It makes compliance adherence
more difficult to maintain throughout the company so how can we encourage
communication and cooperation between the different departments.
How are greater transparency requirements in Europe
affecting compliance?
How is the EFPIA code affecting different companies across Europe? How is
everyone tackling the transparency requirements – what are the success stories?
And how do you set a standard across boarders?
In essence the transparency requirements will improve company image.The
means of achieving transparency can be criticized but not the end result – there
very clearly benefits to it.

4. VIEWPOINT:
How to keep trust
What are the specific risks for pharma with regards to
bribery, corruption and trust? How do you minimise
these risks?
Trust is not a risk – the question that most people in the pharma industry
leadership are asking is how to keep trust.That is dependent on clear processes,
sanctioning guidelines,working on the prevention of bribery and corruption and
ongoing strict monitoring practices.
How do you see the compliance role changing in the
next 5 years?
The compliance role as been visibly strengthened and given increased
credibility.In the next 5 years efforts have to be made to empower the role so
that compliance strategies can be easily enforced throughout the organization.
The compliance role should move from a‘ticking boxes and reporting role’to a
business partner role at the heart of all business processes.
Martina Heidelberger
EMEA Compliance Manager
F.Hoffmann-La Roche LTD
What are the biggest challenges in compliance
currently?
Interaction with HCPs:determining exactly what we want from sales reps,
how we would like them to communicate and interact with HCP – what are our
expectations and how realistic are they? It is our obligation to help the company’s
employee’s work in a compliant way.Also how to manage business partners and
third parties effectively and ensure they are working in a compliant way.
How are greater transparency requirements in Europe
affecting compliance?
The transparency requirements are very positive,but there is a substantial
amount of bureaucracy that that requires more resources and leads to more
expense.

5. VIEWPOINT:
Changing compliance role
What are the specific risks for pharma with regards to
bribery, corruption and trust? How do you minimise
these risks?
There are still issues with business conduct.There are a lot of grey areas and
companies as well as individuals do not always perform in the most ethical way.
We need to have a better look at what is happening in practice and determining
what training is needed to highlight ethical issues and correct them.
How do you see the compliance role changing in the
next 5 years?
The compliance role is changing dramatically - there is definitely more
accountability not only to compliance but also to the business.There is a now a
requirement to explain why everything is being done and what is allowed.It is
important to clearly explain to colleagues in all departments the potential impact
that lack of compliance can have on the business and to improve processes.
Thierry Meulenbroek
Head of Medical Compliance
Abbvie
What are the biggest challenges in compliance
currently?
Transparency,reporting requirements and monitoring strategies.What is
allowed and what isn’t – there is still a lot of confusion about this.
How are greater transparency requirements in Europe
affecting compliance?
They are having a huge impact on the pharmaceutical industry.Very often
transparency without the right context can be misinterpreted by the media and
general public and this causes a lot of problems for pharmaceutical companies.
How pharmaceutical companies capture,use and disseminate data.

6. VIEWPOINT:
Escalated importance of
compliance
What are the biggest challenges in compliance
currently?
This is always on the dashboard – the key is constant monitoring and ongoing
correction of practice when and where needed.It is important to keep an eye out
for any potential misappropriation and misrepresentation and to use transparent
and strict financial controls.
What are the specific risks for pharma with regards to
bribery, corruption and trust? How do you minimise
these risks?
This has escalated in importance in the last 2 years which has led to the
proliferation of new rules and is likely to continue to grow.
Jeffrey Gibbs
Vice President Internal Audit
Biogen Idec
How do you see the compliance role changing in the
next 5 years?
Navigating EFPIA – expense code,keeping up with individual contract
operational stand points.There is a growing need to support research on global
developments in R& Evolving regulation and legal visibility into other countries.
Clinical data transparency,public disclosure trade associations – data sharing.
How are greater transparency requirements in Europe
affecting compliance?
Greatly affecting the industry the question is will they subscribe to the
principals? Issues are not confined to Europe however and are having a global
impact.They question is how are pharmaceutical companies in Europe going
to ensure regulatory compliance?What finance systems will they be using for
tracking/monitoring and reporting?

7. VIEWPOINT:
What is the right amount of
reporting, monitoring and
transparency
What are the biggest challenges in compliance
currently?
Anti-bribery is becoming more topical.What measures are being taken to
enforce this by the big pharma companies?
What are the specific risks for pharma with regards to
bribery, corruption and trust? How do you minimise
these risks?
The compliance role needs more professionalism – it should be a seen as a
career path in its own right and needs more education around it and training
schemes.But the question is how do you gain support from a company for this?
Matthijs Blokland
Former Managing Director
Nefarma
How do you see the compliance role changing in the
next 5 years?
Transition of roles and national regulations – what is happening and how will it
affect the pharma industry .
How are greater transparency requirements in Europe
affecting compliance?
Now you need to show that you are compliant – how can this be done effectively?
There is a significant amount of bureaucracy so what is the right amount of
reporting,monitoring,transparency etc?

8. VIEWPOINT:
Taking into account patient
views
What are the biggest challenges in compliance
currently?
There are and always will be big risks for pharma with regards to bribery,
corruption and trust.Transparency is essential in fighting these risks:doctors
must be informed and involved at all stages of the pharmaceutical programmes
from trials,to clinical surveying after marketing campaigns.There needs to be a
culture of openness.
What are the specific risks for pharma with regards to
bribery, corruption and trust? How do you minimise
these risks?
This is still fairly unpredictable and is research and investment dependent.But
ideally the compliance role needs
Prof.Vincenzo Costigliola
President
European Medical Association
How do you see the compliance role changing in the
next 5 years?
To understand and take into account the point of view of the patients.What are
their expectations and how can they be factored into compliance regulations,
requirements and strategies in the long-term.
How are greater transparency requirements in Europe
affecting compliance?
More and more transparency is needed from the pharmaceutical companies
throughout Europe.However there are limitations – patient safety should under
no circumstances be jeopardized and so interactions with HCPs must be
optimized for this purpose.

9. VIEWPOINT:
Marketing and compliance
working together effectively
What are the biggest challenges in compliance
currently?
When it comes to anti-corruption,trust etc,it is important for pharmaceutical
companies to start embracing the notion of morality and ethics as part of their
strategy and not just follow the rules.This issues will always be there,but there
needs to be stronger companywide awareness of the issues an not just a ticking
box approach.
What are the specific risks for pharma with regards to
bribery, corruption and trust? How do you minimise
these risks?
It is an evolving role that will continue to grow alongside evolving regulations.It
will take on a more central position within the industry.
Paul Dixey
Managing Partner
Bluelight Partners
How do you see the compliance role changing in the
next 5 years?
Getting marketing and compliance teams to work together successfully – they
are almost on opposite ends of the spectrum in terms of what they want to
achieve and so they need to understand the benefits of working together.There
are always challenges around developing global compliance programmes
and how what strategy to use – should the same approach be used in different
countries,or do different regions require a different approach?
How are greater transparency requirements in Europe
affecting compliance?
Obviously with added monitoring and reporting requirements.It would however
be interesting to address the affect that the USA Sunshine act is having on the
European Industry and determining how the industry is responding to this.

10. VIEWPOINT:
The compliance role over the
next 5 years
What are the biggest challenges in compliance
currently?
The problem is that there is still a certain amount of ambiguity in relation to this.
What is a gift?What can or can’t be sponsored?What is essentially part of the
industry/HCP interaction and what is considered superfluous.The industry’s
reputation has suffered,but what is media-led and what is accurate?
What are the specific risks for pharma with regards to
bribery, corruption and trust? How do you minimise
these risks?
The role is evolving and taking on a wider remit – it is likely to take on more
accountability within the company.
PaulWoods
Managing Director
PaulWoods Compliance
How do you see the compliance role changing in the
next 5 years?
Understanding how different companies are ensuring compliance – so many
different strategies and considerations in such a fast paced environment that it
is important to understand how everyone else is working.In particular what is
the reaction in the USA and in Europe to the Sunshine Act.Other big challenges
revolve around Clinical data transparency,more information on the FDA Code.
How are greater transparency requirements in Europe
affecting compliance?
When it comes to transparency particularly in Europe there is still a lot to be
developed.

11. VIEWPOINT:
Challenges in compliance
What are the biggest challenges in compliance
currently?
Anti-corruption is less of a concern in Europe than in other world regions such
as China.There are several reasons for this,but there are always lessons to
be learnt on how compliance teams in pharmaceutical companies react and
structure their compliance programmes in countries that are more prone to
corruption.The other issue is what do regional corruption issues do to a global
brand awareness and trust.
What are the specific risks for pharma with regards to
bribery, corruption and trust? How do you minimise
these risks?
In the future compliance roles may differ according to the size of the company.
Different sized pharmaceutical companies have different requirements and
challenges and so the role will have to be flexible and take that into account
Diva Duong
Vice President Compliance EMEA
Cegedim Relationship Management
How do you see the compliance role changing in the
next 5 years?
One of the big challenges in compliance is in morality versus rules.Technically
pharmaceutical companies are only require to do things by the rules,however it
is increasingly important for several reasons to.
How are greater transparency requirements in Europe
affecting compliance?
When it comes to transparency Data privacy is a growing issue.The EFPIA
code still needs to be looked at in more detail to fully highlight data privacy
requirements and how to ensure full privacy.

12. DOWNLOAD THE BROCHURE FOR FULL DETAILS
Sponsored by
Created by
Compliance
strategy for
pharma
7-8 October 2014
Business Design Centre, London, UK
Got a great story or
tips to share?
We are looking for more case studies & tips for the next edition of“Essential
insights into Pharma compliance”.
Contact Bernadette Stansfield on +44 (0) 207 608 7057
or email bstansfield@healthnetworkcommunications.com
Hungry for more now?
Visit the Total Biopharma blog for all the latest industry strategy and innovation.
www.totalbiopharma.com