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CLINICALTRIALS
The Greek Legal Framework
Michalopoulou@ Associates| 40 Ag. Konstantinou st.|’’Aithrio’’ Business Center (A...
CONTENTS
Ι. Clinical Trials Legal Framework
ΙΙ. New Clinical Trials Legislative Framework (ΔΥΓ39(a)/18910/21.2.2013 suppl....
I.GENERAL TERMS
Clinical Trials should be conducted in accordance to:
• ΙCH-Good Clinical Practices
• Code of Medical Ethi...
II. NEW LEGISLATIVE STATUS
Good Clinical Practices in the conduct of
clinical trials on medicinal products for
human use
(...
ΕΠΙΣΤΗΜΟΝΙΚΟΕΠΙΣΤΗΜΟΝΙΚΟ ΣΥΜΒΟΥΛΙΟ ΝΟΣΟΚΟΜΕΙΟΥ
HOSPITAL SCIENTIFIC
COUNCIL
30-day limit for objecting in
order to assign a...
APPROVAL PROCESS
Hospital Signature
ΕLKE/ΕLKEA
Within 5 days
Signature within 10 days
STAGE 2
UNTIL FEB 21st 2014
A site a...
ADVANTAGES
Industry Group
 Text
 Text
 Text
 Text
Standard Lump Sump
UPON FILE SUBMISSION:
750€
Final Approval: 70 day...
b. Types of Studies: Prerequisites? (Α 19)
 INTERVENTIONAL STUDIES
 Protocol in EN & summary in GR
 Patient Consent For...
III. PERSONAL DATA PROTECTION
(Αrt 6) & Law 2472/97 (DIRECTIVE 95/46/ΕC)
• Collection
• Keeping
• Processing
Α) Patient & ...
 COMPULSORY: the prior explicitly written and freely
revocable consent of the person (specific statement of
consent) to s...
a. PATIENT CONSENT & CLINICAL STUDY (Αrt.3)
(Informed Consent)
SOS! The patient may revoke her or
his consent at any given...
IV. LEGAL LIABILITY/INDEMNITY
(Αrt. 10)
Restoring any damage caused by the use of the Product in accordance
with the Proto...
≠ DIRECTLY RESPONSIBLE (Principal Investigator (PI), Hospital, Partners) →
Restoring any PATIENT’s damage (direct, indirec...
a. CLINICAL TRIALS INSURANCE COVERAGE (Αrt 11)
 €200.000/participant = max. liability level in case of death or
permanent...
IV. INTELLECTUAL PROPERTY & PATENTS
(Law 2121/1993)
• Moral Right (non-transferable): exclusive & absolutely
connected to ...
CREATOR’s IRREVOCABLE RESIGNATION
(Αrt. 7)
The unlimited economic right (results, reports, final report)
principal investi...
Clinical Trials - the Greek Legal Framework
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Clinical Trials - the Greek Legal Framework

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A full update on clinical trials legislation in Greece. Contents include:
Ι. Clinical Trials Legal Framework
ΙΙ. New Clinical Trials Legislative Framework (ΔΥΓ39(a)/18910/21.2.2013 suppl. Directive 2001/20/ΕC)
Approval Process
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
Insurance Coverage
V. Intellectual Property & Patents (Law 2121/1993)

Published in: Health & Medicine
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Clinical Trials - the Greek Legal Framework

  1. 1. CLINICALTRIALS The Greek Legal Framework Michalopoulou@ Associates| 40 Ag. Konstantinou st.|’’Aithrio’’ Business Center (A 16-18 )|15 124 Marousi Athens Greece T: +30 2103305230 | F: +30 2103305232 | info@lawgroup.gr| www.lawgroup.gr
  2. 2. 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)
  3. 3. 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
  4. 4. 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
  5. 5. 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
  6. 6. 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!
  7. 7. 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
  8. 8. 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
  9. 9. 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
  10. 10.  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.
  11. 11. 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
  12. 12. 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:
  13. 13. ≠ 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.)
  14. 14. 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
  15. 15. 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.
  16. 16. 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

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