The document discusses healthcare compliance in the EU and outlines best practices for companies. It notes that soft law from industry groups like EUCOMED, EDMA and COCIR help reinforce compliance through guidelines and codes of conduct. Companies should adopt compliance programs that include written policies, compliance officers, training, reporting mechanisms, and oversight. Following soft law recommendations and having strong internal programs are important for companies to meet their compliance obligations.

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2. “It is entirely possible, under certain
circumstances and in certain countries, that
nearly every aspect of the approval,
manufacture, import, export, pricing, sale
and marketing of a drug product in a
foreign country will involve a ‘foreign
official’ within the meaning of the FCPA”.
Healthcare Compliance
Former Assistant US Attorney General Lanny
Breuer, Washington, DC, 2009
“… Cartel fines will continue to be set transparently
based on the EU Commission’s 2006 Fining
Guidelines, but substantial penalties that will ruin
any undue profits will be critical to EU cartel
enforcement”.
EU Competition Commissioner, Margrethe
Vestager, Brussels, 2014

3. Why? Ηealthcare Compliance
Did you know that...
- Since 1980, EU Member State life
expectancy has climbed up 6 years to 79
year-old in 2010?
- OECD nation health expenses have risen
to 9,5% of the GDP of Member States in
2010, climbing more than 4% since
1960?
http://www.medtecheurope.org/medtech/key-facts-figures
Moreover… did you know that...
- Healthcare Industries occupy more
than 575.000 people with a market
value of over €100 billion?
- Around €4 billion are reinvested in
R&D?
- There are more than 25.000 medical
device companies in the EU?
- It is estimated that more than 95% of
MedTech companies are SMEs, the
majority of which of a small or very
small size?
OECD Health Data, 2012

4. Why? Ηealthcare Compliance
Global ΜedTech Alliance
→Harmonization of Ethical Business Practices

5. Why? Ηealthcare Compliance
Global
ΜedTech
Alliance
Guidelines

6. Why? Ηealthcare Compliance
SALES & MARKETING ETHICS INTEREST US
ALL. HERE’S WHY:
 FOR THE HEALTHY COMPETITION OF
OUR BUSINESS
 FOR ITS DEVELOPMENT AND GROWTH
 FOR ITS PROFITIBALITY
 FOR ITS LONG-TERM POSITION
WITHIN THE MARKET
 FOR OUR STREAMLINED
COLLABORATION as Distributors,
Commercial Agents with Suppliers in
the US and the EU
 FOR OUR COLLABORATION as
Suppliers with third parties, such as
public hospitals or private medical
clinics in Greece and abroad.

7. Why? Ηealthcare Compliance-ΕU Soft Law

8. Why? Ηealthcare Compliance-ΕU Soft Law
● Members are advised to abstain from
direct sponsorships to HCP participating
in conferences organized by third parties
from 1/1/2018
● The implementation of stricter rules
regulating indirect sponsorships is also
advised.

9. Why? Healthcare Compliance-EU Soft Law
EUCOMED (European Medical Technology Industry
Association) represents the medical technology industry in ΕU.
• Headquarters: Brussels
• 68 direct corporate members
• 25 national industry associations
• 3 associate Members
• Over 4,000 local association members
→ Supports HCPs by educating them in the most ethical,
consistent and transparent way.

10. Why? Healthcare Compliance-EU Soft Law
- Eucomed Guidelines on Interactions with Healthcare Professionals (2008)
- Q&As on the Eucomed Guidelines On Interactions with Healthcare Professionals
(updated regularly)
- Eucomed Compliance & Competition Law Guidelines (2012)
- Procedural Framework (2012)
Is yearly signed by all members as a requirement of their membership renewal.
- Opinions and advisory interpretations of the Eucomed Compliance Panel
(ref. Conference Vetting System)
→ its PURPOSE is to promote
transparency and to ensure that
EUCOMED members comply with all
regulations currently in force (laws,
Codes of Conducts etc)
EUCOMED CODE COMMITTEE
↓

11. When? Healthcare Compliance-EU Soft Law
- GIFTS
must be moderate, of a small value, in compliance with any limits set by local laws and
Codes of Conduct. Their use must also be relevant to the HCP expertise.
- DONATIONS
must only be given to charitable or non profitable associations
• given the entity’s prior request, followed by a contract signed by both parties.
• company must not be linked or control in any way the entity.
- SCHOLARSHIPS
• given the entity’s prior request, followed by a contract signed by both parties.
• company must not be linked or control in any way the entity.
- EDUCATION/ SERVICE AGREEMENTS with HCP
• the HCP’s employer must be previously notified
• both parties must enter to a written agreement
• remuneration must be reasonable

12. When? Healthcare Compliance-EU Soft Law
EUCOMED COMPLIANCE PANEL
Through a special platform regarding ethics
and compliance projects in the European
MedTech industry.
NEW: CVS (Conference Vetting System) which
approves its members’ sponsorships towards
HCP in order to participate in conferences.

13. When? Ηealthcare Compliance-ΕU Soft Law
What does the
conference vetting
system do(CVS)?
-It supervises the organization of
scientific events and its compliance with
EUCOMED’s Code of Conduct.
-It determines certain standards
according to which EUCOMED members
as well as connected national associations
are allowed to sponsor HCPs participating
in scientific events.

14. When? Ηealthcare Compliance-ΕU Soft Law
What does the Conference
Vetting System (CVS) control and
how does it function?
- The scientific event’s cοntent and subject.
- Whether HCPs participating in the event are directly related to its content and
purpose
- The place of the event must be appropriate in correlation to the event’s
scientific content  ex. in cities with business centers
- SOS the selection of venues such as spas, resorts or casinos is strictly
forbidden.
- The time of the event must not be associated with vacation time
- Ease of access to the place of the event  within a short distance
from airports, train stations etc.
- The venue of the event must be a carefully selected business venue which will
promote the event’s scientific purpose without being associated with
entertainment activities
- Sponsorships of HCP regarding hospitality costs must not be excessive with
regards to
i) the amount covered (includes meals + hospitality)
ii) the hotel’s selection
Accompanying person costs are not covered!
In which way does the control take place?
Via prior notification of the event schedule, described in detail

15. When? Ηealthcare Compliance-ΕU Soft Law
CVS’s Scope
Scientific events organized by PCOs in:
ΕU + Switzerland + Russia + Turkey
Who may be elected as a member of the Committee?
 EUCOMED members, National Associations, CO’s and Medical Societies
National Associations’ members who are not direct members of EUCOMED may only apply through their national
association.
CVS operates independently from EUCOMED in order to ensure the objectivity of its opinions.

16. When? Ηealthcare Compliance-ΕU Soft Law
How does the EUCOMED COMPLIANCE PANEL
work?
Its decisions are binding for Εucomed members
→ within 90 days
≠ Penalty measures
(written reprimand, third party control,
cessation as a member)
BUT obligatory prior opinion is currently in
shakedown phase

17. When? Healthcare Compliance-EU Soft Law
EDMA (European Diagnostic Manufacturer Αssociation)
It represents the in-vitro diagnostic (IVD) technology
industry in ΕU
Headquarters: Brussels
500 Μembers
EDMA’s Code of Ethics
PURPOSE: members must comply with several
rules regarding their interaction with HCP, the
organization and hosting of scientific events and the
respect towards competition.
EDMA Executive Committee!

18. When? Healthcare Compliance-EU Soft Law
COCIR (European Coordination Committee of the
Radiological, Electromedical and Healthcare IT
Industry)
→ Ε-Health
Headquarters: Brussels
China Desk: Beijing
ΝΕW CODE OF CONDUCT ON INTERACTIONS WITH
HCPs since JANUARY 2015!
NO educational sponsorships to HCP individually
Device demonstration to HCP under the condition of
the entity’s approval- min every 6 months
Third party selection: Commercial Distributors,
Agents και Associates must be previously checked!
Reporting to COCIR

19. When? Healthcare Compliance-US Soft Law
ADVAMED (Αdvanced Medical Technology Association)
Headquarters: Washington, USA
Represents 80% of medical companies doing business in
the US.
Stricter rules:
→ gifts ≥100USD must only serve educational purposes
→ limited number of samples
→ Public Sector HCP: must not be offered meals,
refreshments, gifts
→ selection of participants cannot be made for events
organized by third parties

20. When? Healthcare Compliance-US Soft Law
PURPOSE  the compliance of all members
with the rules set on each Code of Conduct
and the adoption by each member
separately of a complete Compliance
Program including the following:
1) Written policies and procedures
2) Αssignment of a person in charge and
creation of a Compliance Committee
3) Organization of compliance and
educational seminars
4) Development of a successful
communication system
(Communication Line)
5) Adoption of internal control policies
6) Disciplinary control
7) Immediate action in order to identify
and solve problems

21. When? Healthcare Compliance-GR Soft Law
EOF (National Organization for Medicines)
Dos & Don’ts
Grants/Sponsorships to Ιnstitutions/Organizations
and Scientific Companies
Conditions:
• for research and educational purposes
• they must be well-documented and kept in a
record
• must NOT be offered as an inducement.
HCP’s are ALLOWED TO RECEIVE MODERATE GIFTS,
strictly in relation to their profession and expertise.

22. Scientific Events:
Τype Α’:
PURPOSE: STRICTLY Scientific Content
Held BY: State Entities (laboratories, Public Hospitals,
University Clinics, social security organizations, scientific
organizations & non-profit institutions)
Where: a) in Greece
b) Abroad
Τype Β’:
PURPOSE: STRICTLY Scientific Content
Held by: Companies under EOF’s authorization & State
Entities (Type A)
Where: in Greece
* medicines, biocidal products, medical devices, cosmetics
When? Healthcare Compliance-GR Soft Law

23. When? Healthcare Compliance-GR Soft Law
Scientific Events:
Τype C’:
Purpose: Information of HCP regarding products within
EOF’s responsibility
Held BY: Companies under EOF’s authorization
Where: in Greece
Τype D’:
Purpose: Specialized for a with a complete scientific
programme bringing together speakers of high caliber
a) Held BY: Companies NOT BASED IN GREECE
manufacturing products within EOF’s scope
Where: in Greece
b) Companies BASED IN GREECE manufacturing
products within EOF’s scope
Where: Greece
Via the Internet
Access codes are given to HCP given that the organizer
has obtained EOF’s approval

24. When? Healthcare Compliance-GR Soft Law
Executive 9-board Scientific Committee: evaluates
all demands
ORGANIZATION PROCESS/ΕVENT APPROVAL
Request submission (name of organizing entity, of
scientific project coordinator, title, time and place
of the event, initial budget) to EOF min 1 month
before the date of the event
For type Α’ scientific events  a request may be
submitted 5 times a year (January, March, May,
September and November) and the event’s ex post
financial report must be submitted within 4
months
For type B’,C’,D’ Scientific Events requests may
be submitted within the 10 first days of every odd
month

25. When? Healthcare Compliance-GR Soft Law
COMPANIES OBLIGATIONS:
i) Obligation to certify the attendance of the
conference on behalf of the HCP who must
present a certificate of attendance (60% of
the program’s hours)
ii) Obligation to inform EOF of the full name,
specialty, professional body and amount of
the honorary fee per speaker
Ηonorary fees to Public Sector or University HCP
are payed via ELKEA or ELKE accounts
respectively.
HCP who receive honoraria for a speech in an
event must mention this fact in a conflict of
interest statement at the 2nd slide at the
beginning of the event

26. When? Healthcare Compliance-GR Soft Law
What kind of costs may companies cover:
Registration to the event, hospitality, meals,
transportation
(from the HCP’s place of work to the place where
the event takes place)
Hospitality Costs as of May 19th 2015!
• Greece: 140€ hospitality costs + 70€ for meals
(VAT incl.)/day
• Abroad: 280€ hospitality costs + 70€ for meals
(VAT NON incl.)/day
SOS Cost coverage for accompanying persons is
strictly forbidden
Air travel costs:
For air travel, economy class tickets must be
offered, and business class tickets may be
offered only if flights exceed 4 hours

27. When? Healthcare Compliance-GR Soft Law
Sponsorships –Conferences:
HCP: Abroad 3 times/year
Εxcluded HCP:
• Speakers
• Participants in clinical studies, educational
seminars
Remuneration to HCP (honorarium)
According to EOF’s circular companies may offer
honoraria to speakers HCP, including Public Sector
HCP, participating in all type events, except type C’
events

28. When? Healthcare Compliance-GR Soft Law
Supervision-Penalties:
Ιmposed sanctions in case of non-compliance with EOF’s
circular:
i) EOF is entitled to conduct inspections during
conferences or events via its own staff or in co-
operation with the competent tax authorities and,
where it verifies that its approval has been infringed,
it may suspend the organizing entity from future
events for a period of two years.
ii) Companies manufacturing products within EOF’s
scope and do not submit an ex-post financial report
on EOF’s database, will be disqualified for 1 year, not
being able to organize type A’ ,B’, C’, D’ events in
Greece or abroad (for type A’ events).

29. When? Healthcare Compliance-GR Soft Law
SEIV (Association of Health – Research &
Biotechnology Industry)
SEIV’s Code of Ethics foresees a set of rules which
ensure the following:
- The proper distribution of medical devices
- The customers’ accurate information
- After- sales services
- The organization and hosting of Scientific
Events
- Research financing as well as
- Respect towards competition rules

30. When? Healthcare Compliance-GR Soft Law
SEIV’s Code of Ethics (article 7) defines, in
correlation with EOF’s guidelines, the following:
i) Conditions under which financing is permitted
ii) The content and type of Scientific Events
iii) Conditions under which HCPs may participate
in conferences and companies-members may
cover their participation costs. (Strictly
educational content, EOF’s prior approval,
transparency on interactions with HCP,
moderate expenses)
Εthics Committee
Role  the Committee’s role is educational as it
has as a purpose the reduction of future
defaults while also aiming to teach members to
comply with proper business behavior.
Εnforcement of Rules regarding professional
behavior

31. How? Ηealthcare Compliance: The ONLY Way ForwardOUTLINE
SΟFT LAW
→it significantly contributes on reinforcing the
regulatory compliance context both in the EU
and within each individual country
→ companies themselves must support their
compliance obligations.
HOW?
 By adopting and reinforcing a Code of Conduct
specially adjusted to their needs
→ But is there a single best Compliance Program?
Perhaps NOT, but there are a few guidelines (next slide):

32. Ηealthcare Compliance: The ONLY Way Forward