Post on 22-Jul-2020
Healthcare Compliance: the relevance and impact for PCO’s and
Medical Association Clients
Caroline Mackenzie, Commercial DirectorCONTENDAM Ltd
Consider how increased and changing healthcare
compliance is impacting the role of a PCO, the advice
and the guidance needed to medical association clients
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
Some Basics
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)
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
Structure of Codes
Compliance Factors that Associations and their PCOs need to consider
Corporate
Tradebody
Government
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 effective on 1 January 2014 or according to
national implementation plans (no later than July 2014)
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
Considerations for PCO’s and their Association Clients
Balancing Needs
Association Company
Staff
Delegates
Speakers
Members
Delegates
Speakers
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
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
Smaller Exhibition Stands
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?
The Role of the PCO?
Advisor and
guidance
Solutions
and
outreach
Reducing
costs / New
revenue
streams
Recommendation to Stakeholders
Thank you and discussion