Stem Cell Processing (Stem Cells in Clinical Applications)

19

1.5 International Harmonization Efforts

1.5.1 A Need for Harmonization

Globally, policies and legislation regulating stem cell research and therapy are com-
plex and varied, aptly described by some authors as “a patchwork of patchworks”
(Caulfi eld et al. 2009a , b ), being shaped by different social, religious, cultural, eco-
nomic, historical, ideological, and political factors informing national laws and
policies. Despite these differences, which suggest that international binding instru-
ments or policies may be diffi cult to achieve, the setting of enforceable ethical and
professional norms and standards, as well as professional, quality, and safety stan-
dards, seems to be an achievable goal.
A range of international and regional instruments, guidelines, and regulations,
directly or indirectly related to biomedical research, exist. The United Nations
Educational, Scientifi c and Cultural Organization (UNESCO), the Council of
Europe, and the European Union, for example, have all addressed aspects of stem
cell research and its clinical applications through various reports, treaties, resolu-
tions, declarations, and guidelines. In addition, nonbinding codes of practice, guide-
lines, and recommendations by international organizations, such as the Council for
International Organizations of Medical Science (CIOMS 2012 ), the Hinxton Group
( 2015 ), the International Consortium of Stem Cell Networks (ICSCN 2015 ), the
International Stem Cell Forum (ISCF 2015 ), and the International Society for Stem
Cell Research (ISSCR 2015 ), provide a useful resource for national policy makers.
Efforts to promote international cooperation, as well as harmonizing and standard-
izing processes for stem cell banking, include those by the International Stem Cell

Jurisdiction

Permit creation

of human

embryos for

research,

including

SCNT

Prohibit

creation of

human

embryos,

including

SCNT

Permit

derivation

of hESC

lines from

excess IVF

embryos

Prohibit

derivation

of hESCs

Prohibit

derivation of

hESCs, but

permit

importation of

hESC lines

New Jersey ( New

Jersey Revised

Statutes Title

2C:11A-1 )

√ √

Oklahoma

( Oklahoma

Statute )

√ √

Virginia (Virginia

Code Ann 2001 )

√ a √

Source : Adapted from Nöthling Slabbert and Pepper ( 2015 )
a Legal position unclear, e.g., whether permitted or prohibited
b No specifi c legislation regarding hESC research

Table 1.1 (continued)

1 Stem Cell Therapy: Accepted Therapies, Managing the Hope of Society...