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

ΕΠΙΣΤΗΜΟΝΙΚΟ ΕΠΙΣΤΗΜΟΝΙΚΟ 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

Law

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