Healthcare Compliance: the relevance and impact for PCO’s and
Medical Association Clients
Caroline Mackenzie, Commercial D...
Consider how increased and changing healthcare
compliance is impacting the role of a PCO, the advice
and the guidance need...
Personal Background
1989 – 1990

Graduate Hotel Management Trainee

1990 – 1994

The Medicine Group
Medical Communications...
Some Basics
So What is Compliance?

It is the regulations and codes that determine
how commercial healthcare companies
(pharmaceutical...
So What is an HCP?
ABPI definition is:

The term ‘health professional’ includes members of the
medical, dental, pharmacy a...
Structure of Codes
Government
Tradebody

Corporate

Compliance Factors that Associations
and their PCOs need to consider
Why does it matter?
What we already know
Not Permitted
What’s Driving Change?
Companies Ruled in Breach of Codes
Annual Meeting of an All Ireland Medical Society – held in Belfast (UK)
Companies Ruled in Breach of Codes
Annual Meeting of an All Ireland Medical Society – held in Belfast (UK)
Perception is Reality
Perception is Reality
Perception is Reality
Current Game Changers
Congress Vetting
EUCOMED

EFPIA
New EFPIA Code On Disclosure of Transfers
New EFPIA Code

• Apply to interactions with Healthcare Professionals (HCPs)
taking place within Europe
• Changes are effe...
New EFPIA Code
Article 9
INFORMATIONAL OR EDUCATIONAL
MATERIALS AND ITEMS
OF MEDICAL UTILITY
New article that sets out
req...
Considerations for PCO’s and their
Association Clients
Balancing Needs
Association

Company

Speakers

Speakers

Delegates

Delegates

Members

Staff
Likely Impact of HCP Payment Disclosure
• Greater number of self funding
delegates
• Reduced delegate numbers?
• Greater i...
Likely Impact of Prohibition of Gifts
• Will hit support of traditional
sponsorship items
• PCOs and associations – new
cr...
Smaller Exhibition Stands
Content is King
• Top quality science
• Education and development paramount
• Engaging and varied learning formats
• Lates...
The Role of the PCO?
Advisor and
guidance

Solutions
and
outreach

Reducing
costs / New
revenue
streams
Recommendation to Stakeholders
Thank you and discussion
ICCA UK and Ireland Winter Debate 2014 - Healthcare Compliance the impact on PCOs and Medical Associations
ICCA UK and Ireland Winter Debate 2014 - Healthcare Compliance the impact on PCOs and Medical Associations
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ICCA UK and Ireland Winter Debate 2014 - Healthcare Compliance the impact on PCOs and Medical Associations

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

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ICCA UK and Ireland Winter Debate 2014 - Healthcare Compliance the impact on PCOs and Medical Associations

  1. 1. Healthcare Compliance: the relevance and impact for PCO’s and Medical Association Clients Caroline Mackenzie, Commercial Director CONTENDAM Ltd
  2. 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. 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. 4. Some Basics
  5. 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. 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. 7. Structure of Codes Government Tradebody Corporate Compliance Factors that Associations and their PCOs need to consider
  8. 8. Why does it matter?
  9. 9. What we already know
  10. 10. Not Permitted
  11. 11. What’s Driving Change?
  12. 12. Companies Ruled in Breach of Codes Annual Meeting of an All Ireland Medical Society – held in Belfast (UK)
  13. 13. Companies Ruled in Breach of Codes Annual Meeting of an All Ireland Medical Society – held in Belfast (UK)
  14. 14. Perception is Reality
  15. 15. Perception is Reality
  16. 16. Perception is Reality
  17. 17. Current Game Changers
  18. 18. Congress Vetting EUCOMED EFPIA
  19. 19. New EFPIA Code On Disclosure of Transfers
  20. 20. 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)
  21. 21. 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
  22. 22. Considerations for PCO’s and their Association Clients
  23. 23. Balancing Needs Association Company Speakers Speakers Delegates Delegates Members Staff
  24. 24. 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
  25. 25. 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
  26. 26. Smaller Exhibition Stands
  27. 27. 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?
  28. 28. The Role of the PCO? Advisor and guidance Solutions and outreach Reducing costs / New revenue streams
  29. 29. Recommendation to Stakeholders
  30. 30. Thank you and discussion

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