Lg 15.6.2015 gmtcc 2015 en
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Transcript of Lg 15.6.2015 gmtcc 2015 en
Michalopoulou & Associates | 40 Ag. Konstantinou st. | “Aithrio” Business Center (Α 16-18) | 15 124 Marousi Athens Greece
T : +30 210 330 52 30 | F : +30 210 330 52 32 | [email protected] | www.lawgroup.gr
“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
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
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.
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.
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.
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 ↓
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
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.
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.
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
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.
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
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!
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
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
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
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.
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
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
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
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
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
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
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).
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
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
How? Ηealthcare Compliance: The ONLY Way Forward OUTLINE
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):