Legal and Administrative Intricacies of the Romanian Healthcare Policies in the Field of the Human Organs Transplants

• Author: Juanita Goicovici
• Position: Assistant Professor
• Pages: 99-124

Abstract: Objectives:

The a

adoption, on 7 July 2010, of

standards of quality and s

Romanian legal system the

introduced European standa

transposing

Directive 2010/

Administration for damages

themes, in the recent special

as well as that of organ tra

exploited issue, in contempo

the analysis of jurispruden

problematic

of the human o

Directive 2010/45/EU

on

transplantation. Results:

The

for informed consent in the

proposals. Implications:

Th

human organs donations, l

Administrative Law, since th

of th e consumers of medica

national law to

the EU’s reg

standards of safety related

presentation of the new Eur

National Data bases on seriou

Keywords: administrative l

a

*

Acknowledgement: This w

396/2010.

1

Assistant Professor, PhD, “

400084, Romania. Tel.:

jgoicovici@yahoo.com.

J

Legal and Administrative Intricacie

Romanian Healthcare Policies in the

the Human Organs Transplan

Juanita GOICOVICI

1

e article elaborates o n the intricacie

s brought on the Romania

of Directive 2010/45/EU of the European Parliament and of th

safety of human organs intended for transplantation, ra

e

question of rapidly adapting its regulations and p rocedures

dards, as well as the question of har monizing its essential l

0/45/EU provisions into national l aw.

Prior Work:

Liabil

ges caused by unsafe transplant p rocedures represents one

ialized literature.

The problematic of

informed consent to org

traceability represents

an interesting, though insufficiently

porary Romanian Law.

Approach:

The author applies, as rese

ence, doctrinal writing and legal provisions in force refe

n organs transplant and donations. The paper also

discusse

n standards of quality and safety of human organs

The “opting

-in –

opting out” dichotomy is d iscussed, as com

the field of organ donations. The author also formulates

de

The pap er interests legal practitioners confronted with the p

, law students, as well as

jurists specialized in Consum

the problematic of organ transplantation also reverberates on

ical ser vices.

Value:

The anal ysis insists on the degree of c

regulations when removing disparities on donor’s consent pro

ed to the transport of human organs. The paper is also e

uropean standards on the

National Register of living d o

nor

rious adverse events.

aw; healthcare policies; organ transplants; organ donations; E

s work was supp orted by CNCSIS

-UEFISCSU, project

numb

, “Babe

-Bolyai” University of Cluj-

Napoca, 1 Mihail Kogaln

+40.26.40.53.00, fax: +40.264.59.19.06.

Correspond

AUDJ, vol. VII, no.

2

JURIDICA

99

cies of the

the Field of

lants

*

nian Law by the

f the Council

on

raising for the

res to the newly

al legislation by

bility

of Public

ne of the major

organ donations,

ly explored and

esearch method,

referring to the

sses

the text of

s intended for

ommon

standard

de lege ferenda

problematic of

umer Law and

n the protection

f co mpliance of

procedure or on

enriched by a

nors and on the

s; EU’s Law

mber PN II

-RU

alniceanu Street,

onding author:

2

, pp. 99-124

ACTA UNIVERSITATIS DANUBIUS No. 2/2011

100

1. Introductory Comments

Reforming the Romanian healthcare system has never been proven to be an easy

task, especially in terms of pertinent legislation, medical mobility or financial

sustainability and the episodic attempts, such as the adoption of Law 95/2006 on

reformative measures in the field of public health, later modified, merely

represented modest steps for the Romanian Public Administration. On the other

side of the coin, the relative urgency of the healthcare reform, after EU’s

enlargement in 2007 by accepting Romania and Bulgaria, is currently doubled by

the provocation launched for the two new Member-states in terms of

approximation of legislation in the field of consumers of medical services’ rights,

under the frame of the European Union’s law. Recently, the urgency of political

decision and legislative innovation became more salient by the adoption, on 7 July

2010, of Directive 2010/45/EU of the European Parliament and of the Council on

standards of quality and safety of human organs intended for transplantation

1

,

raising for the Romanian legal system the question of rapidly adapting its

regulation and procedures to the newly introduced European standards.

At the EU’s level, adopting Directive 2010/45/EU of the European Parliament and

of the Council on standards of quality and safety of human organs intended for

transplantation indubitably marks an important progress toward uniform high

standards of security in the mentioned area, while representing a provocation for

the Member States to modernize and harmonize national criteria of safety in the

field of organ transplants. The new European regulation brings a series of major

changes referring to the collecting of organs procedure, donor’s informed consent

and transport of human organs. For instance, the reporting system and management

concerning serious adverse events and reactions associated to the human organs

transplant are reformed, as to ensure common standards, applicable in all Member

States, along with a uniform procedure of organ traceability. Essential in the

economy of human organs transplants becomes the “characterization of donor’s”

procedure, seen as a preparatory stage, before transplantation, in which trained

medical personnel collects relevant data on the donor, respecting the two

informational settings offered in Annex A and B of the Directive discussed,

containing sets of essential minimum data, collected for each donation and of

complementary data to be collected in addition, based on the decision of the

1

Directive 2010/45/EU has been published in th e Official Journal o f the European Union L 207/14

from 6 August 2010.