European Union Regulations on Nanomedicine

• Author: Toma-Bianov, A.
• Position: Department of Law, Transilvania University of Brasov
• Pages: 103-112

Bulletin of the Transilvania University of Braşov

Series VII: Social Sciences • Law • Vol. 5 (54) No. 2 - 2012

EUROPEAN UNION REGULATIONS

ON NANOMEDICINE

Anamaria TOMA-BIANOV1

Abstract: Rapidly emerging technologies, such as nanotechnologies,

constitute significant challenges to EU regulatory framework due to the

uncertainties of development trajectories, product properties and potential

risk problems. This article analyses the emerging regulatory activities in

relation to nanomedicine, in the context of an increased awareness about

particular regulatory questions and problems that have emerged over the last

few years, in exploring the particularities of EU medical technology

regulatory framework. The main conclusion of this article is that all the

deficiencies that could be identified in the EU nanomedicine regulation

framework led to the lack of legal certainty, a principle that has high priority

in EU medical regulation policy.

Key words: nanomedicine, medical technology, EU regulatio n.

1 Department of Law, Transilvania University of Braşov.

1. Introduction

Scientific research and discoveries in

nanomedicine have provoked enormous

enthusiasm ranging from the rational to

bizarre [11], due to the highly specific

medical intervention at molecular scale for

curing disease or repairing damaged

tissues. In fact, nanomedicine is designed

to address some of the challenges caused

by both medical diagnosis and therapy by

using nanoscale materials and

nanotechnology. Using engineered

nanodevices and nanostructures, human

biological systems can be mo nitored,

repaired, constructed and controlled at the

molecular level. Nobel Prize winner

Richard Smalley forecasted that in the not-

too-distant future “nanotechnology will

have given us specially engineered drugs”

that could even make cancer “a thing of the

past.”

In the last two decades, nanomaterials

and nanotechnologies were used or were

subject to scientific research in order to be

used in the therapeutic area and in

diagnosis. For instance, in the therapeutic

area, nanoparticles are used to selectively

transport drugs to the diseased tissues or

cells. Due to the remarkable innovations of

the scientists who adopted techniques from

computer chip industry to nanoparticules

with precise control of size, shape and

composition, in the future, such

nanoparticles can be used to load a variety

of drugs and imaging agents [15] and to

deliver them to the selected cells and

tissues. Other nanoparticles were designed

to be used in photothermal therapy of

cancer [9], or in the delivery of siRNA

(short double-stranded RNA molecules) to

the cell’s cytoplasm, triggering thus the

degradation of messenger RNA and

providing targeted control of gene