Healthcare Compliance: the relevance and impact for PCO’s ... · PCO –mainly medical...
Transcript of Healthcare Compliance: the relevance and impact for PCO’s ... · PCO –mainly medical...
![Page 1: Healthcare Compliance: the relevance and impact for PCO’s ... · PCO –mainly medical associations Personal Background. Some Basics. So What is Compliance? It is the regulations](https://reader033.fdocuments.in/reader033/viewer/2022050218/5f643bdc1ff70729e349828a/html5/thumbnails/1.jpg)
Healthcare Compliance: the relevance and impact for PCO’s and
Medical Association Clients
Caroline Mackenzie, Commercial DirectorCONTENDAM Ltd
![Page 2: Healthcare Compliance: the relevance and impact for PCO’s ... · PCO –mainly medical associations Personal Background. Some Basics. So What is Compliance? It is the regulations](https://reader033.fdocuments.in/reader033/viewer/2022050218/5f643bdc1ff70729e349828a/html5/thumbnails/2.jpg)
Consider how increased and changing healthcare
compliance is impacting the role of a PCO, the advice
and the guidance needed to medical association clients
![Page 3: Healthcare Compliance: the relevance and impact for PCO’s ... · PCO –mainly medical associations Personal Background. Some Basics. So What is Compliance? It is the regulations](https://reader033.fdocuments.in/reader033/viewer/2022050218/5f643bdc1ff70729e349828a/html5/thumbnails/3.jpg)
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
Personal Background
![Page 4: Healthcare Compliance: the relevance and impact for PCO’s ... · PCO –mainly medical associations Personal Background. Some Basics. So What is Compliance? It is the regulations](https://reader033.fdocuments.in/reader033/viewer/2022050218/5f643bdc1ff70729e349828a/html5/thumbnails/4.jpg)
Some Basics
![Page 5: Healthcare Compliance: the relevance and impact for PCO’s ... · PCO –mainly medical associations Personal Background. Some Basics. So What is Compliance? It is the regulations](https://reader033.fdocuments.in/reader033/viewer/2022050218/5f643bdc1ff70729e349828a/html5/thumbnails/5.jpg)
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)
![Page 6: Healthcare Compliance: the relevance and impact for PCO’s ... · PCO –mainly medical associations Personal Background. Some Basics. So What is Compliance? It is the regulations](https://reader033.fdocuments.in/reader033/viewer/2022050218/5f643bdc1ff70729e349828a/html5/thumbnails/6.jpg)
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
![Page 7: Healthcare Compliance: the relevance and impact for PCO’s ... · PCO –mainly medical associations Personal Background. Some Basics. So What is Compliance? It is the regulations](https://reader033.fdocuments.in/reader033/viewer/2022050218/5f643bdc1ff70729e349828a/html5/thumbnails/7.jpg)
Structure of Codes
Compliance Factors that Associations and their PCOs need to consider
Corporate
Tradebody
Government
![Page 8: Healthcare Compliance: the relevance and impact for PCO’s ... · PCO –mainly medical associations Personal Background. Some Basics. So What is Compliance? It is the regulations](https://reader033.fdocuments.in/reader033/viewer/2022050218/5f643bdc1ff70729e349828a/html5/thumbnails/8.jpg)
Why does it matter?
![Page 9: Healthcare Compliance: the relevance and impact for PCO’s ... · PCO –mainly medical associations Personal Background. Some Basics. So What is Compliance? It is the regulations](https://reader033.fdocuments.in/reader033/viewer/2022050218/5f643bdc1ff70729e349828a/html5/thumbnails/9.jpg)
What we already know
![Page 10: Healthcare Compliance: the relevance and impact for PCO’s ... · PCO –mainly medical associations Personal Background. Some Basics. So What is Compliance? It is the regulations](https://reader033.fdocuments.in/reader033/viewer/2022050218/5f643bdc1ff70729e349828a/html5/thumbnails/10.jpg)
Not Permitted
![Page 11: Healthcare Compliance: the relevance and impact for PCO’s ... · PCO –mainly medical associations Personal Background. Some Basics. So What is Compliance? It is the regulations](https://reader033.fdocuments.in/reader033/viewer/2022050218/5f643bdc1ff70729e349828a/html5/thumbnails/11.jpg)
![Page 12: Healthcare Compliance: the relevance and impact for PCO’s ... · PCO –mainly medical associations Personal Background. Some Basics. So What is Compliance? It is the regulations](https://reader033.fdocuments.in/reader033/viewer/2022050218/5f643bdc1ff70729e349828a/html5/thumbnails/12.jpg)
What’s Driving Change?
![Page 13: Healthcare Compliance: the relevance and impact for PCO’s ... · PCO –mainly medical associations Personal Background. Some Basics. So What is Compliance? It is the regulations](https://reader033.fdocuments.in/reader033/viewer/2022050218/5f643bdc1ff70729e349828a/html5/thumbnails/13.jpg)
Companies Ruled in Breach of Codes Annual Meeting of an All Ireland Medical Society – held in Belfast (UK)
![Page 14: Healthcare Compliance: the relevance and impact for PCO’s ... · PCO –mainly medical associations Personal Background. Some Basics. So What is Compliance? It is the regulations](https://reader033.fdocuments.in/reader033/viewer/2022050218/5f643bdc1ff70729e349828a/html5/thumbnails/14.jpg)
Companies Ruled in Breach of Codes Annual Meeting of an All Ireland Medical Society – held in Belfast (UK)
![Page 15: Healthcare Compliance: the relevance and impact for PCO’s ... · PCO –mainly medical associations Personal Background. Some Basics. So What is Compliance? It is the regulations](https://reader033.fdocuments.in/reader033/viewer/2022050218/5f643bdc1ff70729e349828a/html5/thumbnails/15.jpg)
![Page 16: Healthcare Compliance: the relevance and impact for PCO’s ... · PCO –mainly medical associations Personal Background. Some Basics. So What is Compliance? It is the regulations](https://reader033.fdocuments.in/reader033/viewer/2022050218/5f643bdc1ff70729e349828a/html5/thumbnails/16.jpg)
Perception is Reality
![Page 17: Healthcare Compliance: the relevance and impact for PCO’s ... · PCO –mainly medical associations Personal Background. Some Basics. So What is Compliance? It is the regulations](https://reader033.fdocuments.in/reader033/viewer/2022050218/5f643bdc1ff70729e349828a/html5/thumbnails/17.jpg)
Perception is Reality
![Page 18: Healthcare Compliance: the relevance and impact for PCO’s ... · PCO –mainly medical associations Personal Background. Some Basics. So What is Compliance? It is the regulations](https://reader033.fdocuments.in/reader033/viewer/2022050218/5f643bdc1ff70729e349828a/html5/thumbnails/18.jpg)
Perception is Reality
![Page 19: Healthcare Compliance: the relevance and impact for PCO’s ... · PCO –mainly medical associations Personal Background. Some Basics. So What is Compliance? It is the regulations](https://reader033.fdocuments.in/reader033/viewer/2022050218/5f643bdc1ff70729e349828a/html5/thumbnails/19.jpg)
Current Game Changers
![Page 20: Healthcare Compliance: the relevance and impact for PCO’s ... · PCO –mainly medical associations Personal Background. Some Basics. So What is Compliance? It is the regulations](https://reader033.fdocuments.in/reader033/viewer/2022050218/5f643bdc1ff70729e349828a/html5/thumbnails/20.jpg)
Congress Vetting
EUCOMED EFPIA
![Page 21: Healthcare Compliance: the relevance and impact for PCO’s ... · PCO –mainly medical associations Personal Background. Some Basics. So What is Compliance? It is the regulations](https://reader033.fdocuments.in/reader033/viewer/2022050218/5f643bdc1ff70729e349828a/html5/thumbnails/21.jpg)
New EFPIA Code On Disclosure of Transfers
![Page 22: Healthcare Compliance: the relevance and impact for PCO’s ... · PCO –mainly medical associations Personal Background. Some Basics. So What is Compliance? It is the regulations](https://reader033.fdocuments.in/reader033/viewer/2022050218/5f643bdc1ff70729e349828a/html5/thumbnails/22.jpg)
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)
![Page 23: Healthcare Compliance: the relevance and impact for PCO’s ... · PCO –mainly medical associations Personal Background. Some Basics. So What is Compliance? It is the regulations](https://reader033.fdocuments.in/reader033/viewer/2022050218/5f643bdc1ff70729e349828a/html5/thumbnails/23.jpg)
New EFPIA Code
Article 9 INFORMATIONAL OR EDUCATIONAL
MATERIALS AND ITEMSOF MEDICAL UTILITY
Article 10 EVENTS AND HOSPITALITY
Article 17 PROHIBITION OF GIFTS
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.
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
Examples • Clear guidance on country level of acceptable monetary limit for meals and beverages
• 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
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 •This includes brand reminders such as pens, binders, briefcases, bags etc. that could include product or company brand
![Page 24: Healthcare Compliance: the relevance and impact for PCO’s ... · PCO –mainly medical associations Personal Background. Some Basics. So What is Compliance? It is the regulations](https://reader033.fdocuments.in/reader033/viewer/2022050218/5f643bdc1ff70729e349828a/html5/thumbnails/24.jpg)
Considerations for PCO’s and their Association Clients
![Page 25: Healthcare Compliance: the relevance and impact for PCO’s ... · PCO –mainly medical associations Personal Background. Some Basics. So What is Compliance? It is the regulations](https://reader033.fdocuments.in/reader033/viewer/2022050218/5f643bdc1ff70729e349828a/html5/thumbnails/25.jpg)
Balancing Needs
Association Company
Staff
Delegates
Speakers
Members
Delegates
Speakers
![Page 26: Healthcare Compliance: the relevance and impact for PCO’s ... · PCO –mainly medical associations Personal Background. Some Basics. So What is Compliance? It is the regulations](https://reader033.fdocuments.in/reader033/viewer/2022050218/5f643bdc1ff70729e349828a/html5/thumbnails/26.jpg)
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
![Page 27: Healthcare Compliance: the relevance and impact for PCO’s ... · PCO –mainly medical associations Personal Background. Some Basics. So What is Compliance? It is the regulations](https://reader033.fdocuments.in/reader033/viewer/2022050218/5f643bdc1ff70729e349828a/html5/thumbnails/27.jpg)
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
![Page 28: Healthcare Compliance: the relevance and impact for PCO’s ... · PCO –mainly medical associations Personal Background. Some Basics. So What is Compliance? It is the regulations](https://reader033.fdocuments.in/reader033/viewer/2022050218/5f643bdc1ff70729e349828a/html5/thumbnails/28.jpg)
Smaller Exhibition Stands
![Page 29: Healthcare Compliance: the relevance and impact for PCO’s ... · PCO –mainly medical associations Personal Background. Some Basics. So What is Compliance? It is the regulations](https://reader033.fdocuments.in/reader033/viewer/2022050218/5f643bdc1ff70729e349828a/html5/thumbnails/29.jpg)
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?
![Page 30: Healthcare Compliance: the relevance and impact for PCO’s ... · PCO –mainly medical associations Personal Background. Some Basics. So What is Compliance? It is the regulations](https://reader033.fdocuments.in/reader033/viewer/2022050218/5f643bdc1ff70729e349828a/html5/thumbnails/30.jpg)
The Role of the PCO?
Advisor and
guidance
Solutions
and
outreach
Reducing
costs / New
revenue
streams
![Page 31: Healthcare Compliance: the relevance and impact for PCO’s ... · PCO –mainly medical associations Personal Background. Some Basics. So What is Compliance? It is the regulations](https://reader033.fdocuments.in/reader033/viewer/2022050218/5f643bdc1ff70729e349828a/html5/thumbnails/31.jpg)
Recommendation to Stakeholders
![Page 32: Healthcare Compliance: the relevance and impact for PCO’s ... · PCO –mainly medical associations Personal Background. Some Basics. So What is Compliance? It is the regulations](https://reader033.fdocuments.in/reader033/viewer/2022050218/5f643bdc1ff70729e349828a/html5/thumbnails/32.jpg)
Thank you and discussion