On overview of what is changing the Healthcare Compliance environment and how if is impacting thengeme

1. Healthcare Compliance: the relevance and impact for PCO’s and
Medical Association Clients
Caroline Mackenzie, Commercial Director
CONTENDAM Ltd

2. Consider how increased and changing healthcare
compliance is impacting the role of a PCO, the advice
and the guidance needed to medical association clients

3. Personal Background
1989 – 1990
Graduate Hotel Management Trainee
1990 – 1994
The Medicine Group
Medical Communications and pharma event
management
1994 – 1998
Concorde Services
PCO – mainly medical associations
1998 – 2006
PPSI / Parexel
Medical Communications – Pfizer Inc
2006 -
Congrex / Contendam
PCO – mainly medical associations

4. Some Basics

5. So What is Compliance?
It is the regulations and codes that determine
how commercial healthcare companies
(pharmaceutical or medical technologies)
interface with Healthcare Professionals (HCPS)

6. So What is an HCP?
ABPI definition is:
The term ‘health professional’ includes members of the
medical, dental, pharmacy and nursing professions and any
other persons who in the course of their professional activities
may administer, prescribe, purchase, recommend or supply a
medicine

7. Structure of Codes
Government
Tradebody
Corporate
Compliance Factors that Associations
and their PCOs need to consider

8. Why does it matter?

9. What we already know

10. Not Permitted

12. What’s Driving Change?

13. Companies Ruled in Breach of Codes
Annual Meeting of an All Ireland Medical Society – held in Belfast (UK)

14. Companies Ruled in Breach of Codes
Annual Meeting of an All Ireland Medical Society – held in Belfast (UK)

16. Perception is Reality

17. Perception is Reality

18. Perception is Reality

19. Current Game Changers

20. Congress Vetting
EUCOMED
EFPIA

21. New EFPIA Code On Disclosure of Transfers

22. New EFPIA Code
• Apply to interactions with Healthcare Professionals (HCPs)
taking place within Europe
• Changes are effective on 1 January 2014 or according to
national implementation plans (no later than July 2014)

23. New EFPIA Code
Article 9
INFORMATIONAL OR EDUCATIONAL
MATERIALS AND ITEMS
OF MEDICAL UTILITY
New article that sets out
requirements for the value and
purpose of informational and
educational materials and items of
medical utility
Examples
• Only ‘inexpensive’ materials, e.g.
no tablet to contain presentation, no
branded materials without purpose
of education
• Memory stick with materials, a
model ‘inexpensive’ brain etc. could
still be acceptable.
Article 10
EVENTS AND
HOSPITALITY
Article 17
PROHIBITION OF GIFTS
Revised wording of companies’
possibilities to offer meals and
beverages at events, and
establishment of national
monetary limits for the value of
meals and beverages
New article clarifying that no
gifts or pecuniary advantage
(in cash or benefit in kind)
may be supplied, offered or
promised to an HCP
Examples
• Clear guidance on country
level of acceptable monetary
limit for meals and beverages
Examples
•This includes brand
reminders such as pens,
binders, briefcases, bags etc.
that could include product or
company brand
• Companies shall not provide
any meals or beverages,
unless, in each case, the value
does not exceed the monetary
threshold set by the relevant
Member Association in its
national code

24. Considerations for PCO’s and their
Association Clients

25. Balancing Needs
Association
Company
Speakers
Speakers
Delegates
Delegates
Members
Staff

26. Likely Impact of HCP Payment Disclosure
• Greater number of self funding
delegates
• Reduced delegate numbers?
• Greater importance of selecting
right destination:
• Accessibility
• Affordable travel and Accom
• Registration and out of
pocket costs etc

27. Likely Impact of Prohibition of Gifts
• Will hit support of traditional
sponsorship items
• PCOs and associations – new
creative ideas for sponsorship
revenues
• Need to ensure that sponsor
achieves ROO

28. Smaller Exhibition Stands

29. Content is King
• Top quality science
• Education and development paramount
• Engaging and varied learning formats
• Latest cutting edge research
• Key opinion leaders / renowned speakers
• Accreditation / CPD
• Enduring content with greater out reach
• How will attendance improve delegates’ ability to treat patients?

30. The Role of the PCO?
Advisor and
guidance
Solutions
and
outreach
Reducing
costs / New
revenue
streams

31. Recommendation to Stakeholders

32. Thank you and discussion