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4 EPLR 161 (2020)
Stem Cell Based Products in Europe and in China: Where Are We and Where Should We Go?

handle is hein.journals/eplr4 and id is 181 raw text is: EPLR 312020

Stem Cell Based Products in Europe and in
China: Where are We and Where Should we
Vera Lucia Raposo and Li Du*
Stem cell based products are considered cutting-edge technology in the medical field and form
the basis of advanced forms of medicine, namely regenerative medicine. Although Europe (with-
in the framework of the European Union) and China have invested immense amounts of capi-
tal in these new technologies, both have become targets of criticism. In particular, concerns
have been raised regarding clinical trials, human subject protection and patient/consumer safe-
ty. This paper argues that these issues are related to the existence of laws that are out of tune
with the demands of science and technology, a complex multiplicity of regulations and an em-
phasis on innovation and profit, leading to a lack of concern for safety. Given the decisive in-
corporation of stem cell products into modern medicine, both the European Union and China
must address the related legal drawbacks and learn from each other's mistakes and successes.

I. Introduction
Stem cell research and stem cell based products (ie, bi-
ological products)' have gained considerable attention
worldwide for their potential to provide treatments
for life-threatening, debilitating and even extremely
rare diseases. However, the use of stem cell based prod-
ucts raises two main concerns. First, the regulation of
stem cell based products is challenging. The general
regulations on pharmaceutical products do not ade-
quately address these complex products, and therefore
specific provisions are required. Second, this cutting-
edge technology is associated with particular risks.
Globally, stem cell based products are perceived as a
miraculous solution to many of the diseases afflicting
humankind. However, we must remain aware of the
potential for serious health risks and adverse effects
for the users of these products. In this regard, more
innovative products carry a higher level of risk.
DOI: 10.21 552/epIr/2020/3/6
Vera Lucia Raposo is Associate Professor at the Faculty of Law of
Macau University, China and Auxiliary Professor at the Faculty of
Law of Coimbra University, Portugal. For Correspondence: <vra-
poso@um.edu.mo>. Li Du is Assistant Professor, Faculty of Law,
University of Macau, China. For Correspondence: <stephen-
1   For more information on these biological drugs and categories,
see Laure Fourrier, Sylvain Perruche and Mathieu Guerriaud, 'The
Diversity of Drug Statutes Regarding Scientific Advances: How to

This paper analyses the different legal frameworks
that are applicable to stem cell research and stem cell
based products and the related medical practices and
public policies in the European Union (EU) and Chi-
na. Using a comparative perspective, the paper aims
to identify the main drawbacks of these two legal sys-
tems and suggest some legal improvements related
to the handling of stem cell technologies based on
their mutual experiences.
II. General Legal Framework of Stem
Cell Based Products
1. Stem    Cell Based Products in the EU
In Europe, stem cell based products are generally con-
sidered 'advanced therapy medicinal products'
(ATMPs)2, ie, drugs (of a specific type).3 The excep-
Categorise a Culture Supernatant for Health Security Reasons'
(2019) 3 European Pharmaceutical Law Review 107-115.
2   Like all other drugs, ATMPs are regulated by the general frame-
work of Directive 2001/83/EC of the European Parliament and of
the Council of 6 November 2001 on the Community code relating
to medicinal products for human use J L 311 [2001] 67-128.
More specific norms have been set to address the particularities of
ATMPs, namely Regulation (EC) 1394/2007 of the European
Parliament and of the Council of 13 November 2007 on advanced
therapy medicinal products, which amends Directive 2001/83/EC
and Regulation (EC) No 726/2004, and Commission Directive


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