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