Biomedical Engineering Reference
In-Depth Information
naturalistic behavior. Detailed recommendations are
provided for the primate's environment (e.g. ventilation,
temperature, humidity, lighting, noise); caring for the
animal's health; housing, environmental enrichment,
breeding/weaning and euthanasia, to name just some of the
subjects addressed. Of note, ETS 123 recommends that the
training of personnel working with primates be species-
specific and should address occupational health and safety
concerns.
Oversight of the use of nonhuman primates in
biomedical research in Europe is changing. All 27 member
states of the European Union and those Council of Europe
members (that are not members of the European Union but
have ratified Council of Europe Convention for the
Protection of Vertebrate Animals used for Experimental
and other Scientific Purposes (an example being Switzer-
land)), will use the same standards for care and accom-
modation. Broader controls on the use of animals in
biomedical research, and specific controls on the use of
nonhuman primates, appear to be developing across Europe
and are more stringent in the member States of the Euro-
pean Union.
welfare outputs. Unlike trends outside Europe, there is
within the revised Directive a move to increased prescrip-
tion and less emphasis on performance standards (
Bayne
et al., 2010
). Authorization at either the national, regional
or local level becomes compulsory for all projects; the
implementation of the Three Rs explicit, as does ethical
review locally and with a role for a national body. Specif-
ically, for the nonhuman primates there is a stated aim to
restrict their use due to the genetic proximity to man, the
challenges of meeting their behavioral, environmental and
social needs, and public concern. Although an ethical
review of proposed animal research is not explicit in the
Directive, animal welfare is emphasized throughout. A ban
on the use of Apes is introduced, with provisions for
exceptions by the European Commission in truly excep-
tional circumstance such as serious human disease
epidemics requiring their use. Provisions are added to
require a feasibility study for the implementation of a ban
on the use of common species, especially macaques, being
sourced from capture from wild populations, by ultimately
allowing only F
2
or later purpose-bred generations to be
used. Nonhuman primate use will only be authorized if no
other species can be used and for: basic research, preser-
vation of the same primate species, and applied research
projects that address “potentially life-threatening or debil-
itating” conditions in man. Identification requirements for
nonhuman primates are extended to require each animal to
have a lifetime personal history record. Enclosure sizes
were increased considerably as a result of the acceptance on
the revised Appendix A of the Convention on care and
accommodation and are now considerably greater than the
majority of requirements outside Europe (
Federation of
European Laboratory Animal Science Associations, 2007
).
The revised Directive sets these out in its Annex IV as
minimum standards, and mandates that any exemptions
must be justified to, and approved by, member States.
European Union Directive
European Union Directives must be implemented by
member States through national law and must be adopted
by any new State which joins the Union. The methods of
implementation of the 1986 Directive have varied among
European States (
Nuffield Council on Bioethics, 2005
), and
they are permitted to adopt stricter measures. Some States
have centralized national authorization, some have regional
authorization, some require authorization for all proce-
dures, and some allow minor procedures to start after
notification. Commonly among the States a two licence
system is operated: one for the establishment, one for the
project. A few States also require individuals to be licensed.
National inspection regimes vary, with inspection visits
ranging from frequent to occasional. Increasingly,
a formalized process of ethical review is used, either
mandated by law or voluntarily (
Smith et al., 2007
). There
are few specific provisions relating to the use of nonhuman
primates in the 1986 Directive, these include individual
identification of each nonhuman primate. Further restric-
tions on nonhuman primates (e.g. special justification for
use of primates, bans of the use of apes), have been
implemented in one or more European States.
The revised Directive (2010/63) on “the protection of
animals used for scientific purposes” significantly extends
the existing 1986 Directive and increases the specific
provisions on the use of nonhuman primates. Its general
provisions move beyond the harmonization approach to
setting out a system of controls for the use of animals in
biomedical research with a strong emphasis on animal
Council of Europe Convention
The Convention also provides a framework upon which
States that ratify the Convention may develop into more
detailed regulations and guidance in the implementation of
their own provisions. The Convention sets out wide range
of controls for all species which were broadly equivalent to
the 1986 European Union Directive (
Bayne et al., 2010
) but
includes relatively few specific provisions for nonhuman
primates. These include:
Requirement to encourage use of purpose bred primates
and make their use mandatory if possible.
l
Specific cage sizes and husbandry requirements for
nonhuman primates (as recently updated and also
adopted by the European Union).
l
Specific reporting on nonhuman primate in statistical
returns.
l
