Clinical Trials - the Greek Legal Framework

CONTENTS
Ι. Clinical Trials Legal Framework
ΙΙ. New Clinical Trials Legislative Framework (ΔΥΓ39(a)/18910/21.2.2013 suppl.
Directive 2001/20/ΕC)
a. Approval Process
b. Types of Studies
III. Personal Data Protection (Law 2472/97 DIRECTIVE 95/46/EC) in the light of
New Ministry Decision
a. Patient Consent in Clinical Studies
IV. Legal Liability/Indemnity
a. Insurance Coverage
V. Intellectual Property & Patents (Law 2121/1993)

I.GENERAL TERMS
Clinical Trials should be conducted in accordance to:
• ΙCH-Good Clinical Practices
• Code of Medical Ethics & Provisions on Corruption (FCPA)
• Current Legislation on Clinical Studies (Trials) on medicinal products for
human use (ΔΥΓ3/89292/31.12.2003 & suppl. ΔΥΓ3α/οικ.18910/21.2.2013
Directive 2001/20/EC, ΔΥΓ3α/79602/25.1.2007 Directive 2005/28/ΕC)
• Approval conducted by the National Ethics Committee
(Ε.Ε.Δ. ΔΥΓ3/89292/2003)
• Protocol Terms & amendments
• Specific Terms and Conditions of Agreement

II. NEW LEGISLATIVE STATUS
Good Clinical Practices in the conduct of
clinical trials on medicinal products for
human use
(ΔΥΓ39(α)/οικ.18910/21.2.2013 suppl.
Directive 2001/20/EC)
on:
 Pharmaceutical Products
 Medical Devices

ΕΠΙΣΤΗΜΟΝΙΚΟΕΠΙΣΤΗΜΟΝΙΚΟ ΣΥΜΒΟΥΛΙΟ ΝΟΣΟΚΟΜΕΙΟΥ
HOSPITAL SCIENTIFIC
COUNCIL
30-day limit for objecting in
order to assign an
intervention study
Positive recommendation
(explicit or silent)
STAGE 1
HOSPITAL
ADMINISTRATION
Signature of 4-party draft
agreement & annexes
within 5 days
Hospital Signature
within 35 days
Sponsor
Principal Investigator (PI)
Hospital Administration
ΕLKE/ELKEA Manager
APPROVAL PROCESS

APPROVAL PROCESS
Hospital Signature
ΕLKE/ΕLKEA
Within 5 days
Signature within 10 days
STAGE 2
UNTIL FEB 21st 2014
A site address for electronic
approval and management of
documents in web form is foreseen
Attention!

ADVANTAGES
Industry Group
 Text
 Text
 Text
 Text
Standard Lump Sump
UPON FILE SUBMISSION:
750€
Final Approval: 70 days max
15% in favor of the
Hospital, 5% in favor of
DYPE on clinical study’s
total budget
Standard Remuneration
for all participating
institutions
Multiple-Location Clinical Studies
are promoted
Includes National Ethics
Committee legal opinion
→ 30 days
CLINICAL
TRIALS
INVESTMENTS
IN GREECE

b. Types of Studies: Prerequisites? (Α 19)
 INTERVENTIONAL STUDIES
 Protocol in EN & summary in GR
 Patient Consent Form
 Copy of all materials given to patient-participants
 Insurance Contract
 Free Grant Product Certificate - under investigation
 NON-INTERVENTIONAL STUDIES
 Protocol in EN & summary in GR
 Patient Consent Form
 Copy of all materials given to patient-participants

III. PERSONAL DATA PROTECTION
(Αrt 6) & Law 2472/97 (DIRECTIVE 95/46/ΕC)
• Collection
• Keeping
• Processing
Α) Patient & Principal Investigator (PI) Personal Data
in relation to a physical person’s data though which she or he
can be identified directly or indirectly (i.e. full name, age,
address, profession, marital status, physical characteristics,
education, employment, financial status, interests, habits)
Β) Sensitive Personal Data
In relation to a physical person’s racial or ethnic origin, political
opinions, religious or philosophical beliefs, trade union
membership
Health Information
Medication
Researcher’s Right to send Personal Data to other Group
subsidiaries in or outside EU

 COMPULSORY: the prior explicitly written and freely
revocable consent of the person (specific statement of
consent) to share information for the purpose of
processing, the recipient’s name and the name and address
of the processor.
 OBLIGATORY: the Hellenic Data Protection Authority must
be notified.
Exception:
The Principal Investigator (PI) is exempted from the obligation of
notification if the processing relates to health data given that
he/she
a) is bound by medical secrecy and
b) the data shall not be transferred or disclosed to third parties,
such as clinics, hospitals, pension funds etc.

a. PATIENT CONSENT & CLINICAL STUDY (Αrt.3)
(Informed Consent)
SOS! The patient may revoke her or
his consent at any given time.
Who makes the call?
How?
With whom?
When?
Subject to free and pure will. For minors
and incapacitated adults – under conditions
In written form, BEFORE the start of the
study and FOLLOWING an interview
A specialized physician,
i.e. the Principal Investigator (PI)
Having understood the goals and benefits of
the study along with:
- Risks, any discomfort, side effects,
- Duration and function
- The cost & insurance cover

IV. LEGAL LIABILITY/INDEMNITY
(Αrt. 10)
Restoring any damage caused by the use of the Product in accordance
with the Protocol of
Sponsor → Principal Investigator (PI) and / or Hospital → Patient
Under the following conditions:

≠ DIRECTLY RESPONSIBLE (Principal Investigator (PI), Hospital, Partners) →
Restoring any PATIENT’s damage (direct, indirect, moral)
The Sponsor is not responsible for events resulting from the underlying disease or
diagnostic results or therapeutic measures when they are not mentioned in the
Protocol.
Prior written compensation consent is required before any compensation
settlement.
Ε.L.Κ.Ε.Α./Υ.P.Ε./Ε.L.Κ.Ε. (University) = Financial Management of the Study and
only!
THERE IS NO DAMAGE COVER IF RESULTS COME
DUE TO INADEQUATE PERFORMANCE STUDY
(due to negligence, mishandling, etc.)

a. CLINICAL TRIALS INSURANCE COVERAGE (Αrt 11)
 €200.000/participant = max. liability level in case of death or
permanent incapacity for work (ΔΥΓ3/89292/31.12.2003 Ministerial
Decision Αof Finance & Health and Social Security)
The Hellenic Union Insurance Companies proposal was accepted
by the National Ethical Committee (April 4th 2012):
α) €5.000.000/clinical trial accumulated up to 50 participants or
β) €7.500.000/clinical trial for more than 50 participants

IV. INTELLECTUAL PROPERTY & PATENTS
(Law 2121/1993)
• Moral Right (non-transferable): exclusive & absolutely
connected to the project
• Asset Right (transferable): Any project that is created within
the study in accordance with the provisions of the
Intellectual Property = property of Sponsor
The moral right is independent
from the property right and remains to the author even after the
transfer of property rights.

CREATOR’s IRREVOCABLE RESIGNATION
(Αrt. 7)
The unlimited economic right (results, reports, final report)
principal investigator, other authors, collaborators = property of
Sponsor
• Sponsor’s Right to have the Study Published: without the
approval of the Principal Investigator (PI)
• Publication Right on behalf of a Principal Investigator (PI)
following the Sponsor’s approval!
Patent = ALWAYS property of the Sponsor
The Principal Investigator (PI) must delay
his/hers publication for up to 60 days in order for
a Patent Application to be filed

Clinical Trials - the Greek Legal Framework

Clinical Trials - the Greek Legal Framework

Recommended

Recommended

More Related Content

What's hot

What's hot (20)

Similar to Clinical Trials - the Greek Legal Framework

Similar to Clinical Trials - the Greek Legal Framework (20)

More from Ioanna Michalopoulou

More from Ioanna Michalopoulou (8)

Recently uploaded

Recently uploaded (20)

Clinical Trials - the Greek Legal Framework