SFEE Disclosure Code
October 2014
Good governance in the pharmaceutical sector
Interactions between the pharmaceutical industry and health care professionals
have a profound and positive influence on the quality of patient treatment and
the value of future research. Both parties regularly join together, during early
scientific research, clinical trials and medical education in the interests of
delivering and advancing high quality patient care.
Despite the distinct roles of the various shareholders, we are all committed to a
common goal: to constantly improve the life of patients.
The Disclosure Code is a step towards greater TRANSPARENCY and TRUST
between the pharmaceutical industry, the medical community and society
across Europe.
Why this initiative?
The reasons for introducing the Code
• Part of a series of international actions for self-regulation:
(a) Introduction of the EFPIA Disclosure Code
(b) Tajani Initiative on Transparency and Corporate Social Responsibility in
the Pharmaceutical Sector
(c) Sunshine Act already in place in the US
• Under the above, the details on interactions between health care
professionals/healthcare organisations (HCPs/HCOs) and pharmaceutical
companies must be fully transparent
Objectives
• Further strengthening of Transparency and Professional Ethics and
Responsibility
• Transparency in the interactions between HCPs/HCOs and pharmaceutical
companies
• Responding to society’s growing demand for more transparency and integrity
What will change?
Disclosure of data by pharmaceutical companies, based in Greece or abroad, on
interactions and cooperation with:
- Health Care Professionals (HCPs) resident in Greece
- Health Care Organisations (HCOs) resident in Greece
The following information will be disclosed:
-
Details of HCP/HCO (name and tax registration number)
- Level and type of transfer of value (e.g. fees for consultancy services, cost of
participation in events, honorary remuneration, etc.)
1 Jan.
2016
Start of effect with the disclosure of data referring to calendar year
2015
Data will be disclosed through a dedicated platform on the SFEE
website (www.sfee.gr), freely accessible by THE PUBLIC AT LARGE
Disclosure – Individual HCP Recipient
Α. Events/Conferences/Symposiums/Boards
Registration fees
Travel and accommodation
Β. Consultancy and other services
Fees resulting from or related to agreements between Pharma Company
and HCP for the provision of services such as:
• Education/training
• Non-medical consultancy (Commercial Advisory Boards or Expert
panels on pharmacoeconomics)
• Speeches/Lectures
• General consultancy services
Other fees and related expenses agreed in the contract will be disclosed
separately
Disclosure – Individual HCO Recipient
Α. Events/Conferences/Symposiums/Board
Cost of group registration (where HCPs are selected by a PCO)
Cost of sponsorship
Β. Consultancy and other services
Fees resulting from or related to agreements between Pharma Company
and HCO for the provision of any type of services
Γ. Donations and grants
In cash or in kind
Disclosure - Aggregate
Aggregate disclosure will apply to cases where:
► the recipient denies or revokes consent once given
► the transfer of value relates to R&D, such as:
Α. Activities relating to the planning and conduct of:
• non-clinical studies (as defined in OECD Principles on Good Laboratory Practice)
• clinical trials (Phase I,II, III & IV, as defined in Directive 2001/20/EC)
• non-interventional studies that are prospective in nature and that involve the
collection of patient data from or on behalf of individual, or groups of, HCPs
specifically for the study
Β. Εvents related to R&D:
• Investigator meetings
• Advisory boards on clinical research
• Steering committee meetings, consultancy meetings on clinical research (e,g.
biostatistics, epidemiology, etc.)
• Technical training on clinical research (e.g. laboratory processes, training on
equipment and systems, etc.
Requirements for Disclosure and
Exemptions
Requirements
• Written consent of the partner HCP/HCO
• Data will be disclosed per individual person, identified by the
following details:
• -Full name (for natural persons - HCPs)
- Corporate/Institution name (for legal persons - HCOs)
- Tax registration number
• Once given, consent may only be revoked in writing and for serious
reasons
• If consent is not given or is revoked, the pharmaceutical company will
disclose the relevant data on an aggregated basis
Exemptions
• Exempted from disclosure are the following:
•
•
•
•
•
Transfers of value exclusively relating to OTC medicines
Working meals in the context of events or otherwise
Samples of medicinal products
Medical practice items of negligible value (<€15)
Ordinary business transactions (pharmaceutical distribution chain)
Applicability and sanctions
The Disclosure Code applies to and binds all the member companies of SFEE
In the event of non-compliance, the following sanctions will apply:
Sanctions on SFEE member companies
• If the First Degree Committee, after processing a report/complaint, decides that there is a
breach of the Code, it may impose the following sanctions:
- immediate publication of the decision on SFEE’s website; and
- financial penalty
In the event of noncompliance with the above
decision, a Follow-up Review
Committee may impose an
additional financial penalty
In the event of noncompliance or
inadequate compliance
with this second decision,
the Follow-up Review
Committee may impose a
penalty of up to three
times the initial penalty
If the member still
fails to comply, the
Disciplinary Board
may consider the
expulsion of the
member
The Disclosure Code in Europe
What about the other countries of the EU?
In 2013, the General Assembly of EFPIA adopted the EFPIA
Disclosure Code
26 out of 33 countries of the EU have transposed the
Disclosure Code in line with their national law and regulation
France, Portugal and Denmark have transposed the
provisions of the EFPIA Disclosure Code into their legislation
The objectives of the Ethics & Transparency Committee
TRANSPARENCY IN ACTION
Promoting
Responsible Behaviour
across the Industry
Training all stakeholders on
the fundamental articles of
the Code and its provisions
– These will in turn
communicate with their
members and provide them
with training
Commitment by all stakeholders
to greater transparency and to
taking concrete action to foster
Ethical Behaviour
Effective implementation of the
Disclosure Code by all
stakeholders (medical
community, etc.) – Consensus
Highlighting and promoting
of positive effects from the
implementation of the
Disclosure Code
Setting an example for
change and combatting
corruption
Next steps within 2014
Information activities
15 October-15 November
October - December
June – October
Information
meetings
with Health
Care
Stakeholders
● SFEE General
Assembly
● Internal
Workshop/
“Prepare our
Members”
campaign
● Public
Information Event
► Direct Mail
Campaign
► Online / Social
Media Campaign
► Newsletters
►Awareness
Campaign
►Section
dedicated to the
Disclosure Code
on SFEE’s website
Disclosure Code
Month
“Door to Door”
Information to
Health Care
Professionals by
medical reps of
SFEE member
companies
The successful implementation of the SFEE Disclosure Code,
which is aimed at maximum transparency is crucial for
enhancing transparency and public confidence in the relations
between HPCs/HCOs and pharmaceutical companies.
Our engagement is necessary!