The ethics of research involving animals - Nuffield Council on ...
The ethics of research involving animals - Nuffield Council on ...
The ethics of research involving animals - Nuffield Council on ...
You also want an ePaper? Increase the reach of your titles
YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.
T h e e t h i c s o f r e s e a r c h i n v o l v i n g a n i m a l s<br />
approximately 30,000 existing chemicals (see Box 9.2). 46 <str<strong>on</strong>g>The</str<strong>on</strong>g> c<strong>on</strong>clusi<strong>on</strong> that the scale <str<strong>on</strong>g>of</str<strong>on</strong>g><br />
testing and use <str<strong>on</strong>g>of</str<strong>on</strong>g> <str<strong>on</strong>g>animals</str<strong>on</strong>g> did not appear to justify the additi<strong>on</strong>al protecti<strong>on</strong> afforded to<br />
society has been widely supported, and discussi<strong>on</strong>s about the actual implementati<strong>on</strong> were<br />
still in progress at the time <str<strong>on</strong>g>of</str<strong>on</strong>g> writing. Whatever its final form, REACH will greatly increase<br />
animal testing across the EU. While we make no detailed recommendati<strong>on</strong> in this area, it is<br />
crucial that new approaches to risk assessment that implement the Three Rs most<br />
effectively should be explored, particularly by making maximum use <str<strong>on</strong>g>of</str<strong>on</strong>g> data sharing<br />
(paragraphs 15.68 and 15.70), and using computati<strong>on</strong>al and in vitro tissue culture methods<br />
where possible.<br />
15.83 <str<strong>on</strong>g>The</str<strong>on</strong>g>re has been particular c<strong>on</strong>cern about toxicity testing <str<strong>on</strong>g>of</str<strong>on</strong>g> what many perceive to be trivial<br />
products, such as cosmetics and toiletry products, or medicines which are very similar to<br />
those already <strong>on</strong> the market. 47 All members <str<strong>on</strong>g>of</str<strong>on</strong>g> the Working Party who, in principle, can<br />
accept some forms <str<strong>on</strong>g>of</str<strong>on</strong>g> <str<strong>on</strong>g>research</str<strong>on</strong>g> <str<strong>on</strong>g>involving</str<strong>on</strong>g> <str<strong>on</strong>g>animals</str<strong>on</strong>g>, agree that unnecessary testing must be<br />
avoided. However, they were not able to agree <strong>on</strong> specific recommendati<strong>on</strong>s because it is<br />
not always straightforward to define a trivial use or a form <str<strong>on</strong>g>of</str<strong>on</strong>g> unnecessary testing. In the<br />
case <str<strong>on</strong>g>of</str<strong>on</strong>g> medicines, improvements are sometimes made in small increments, and although<br />
new medicines may differ <strong>on</strong>ly slightly from products already marketed, they may in fact<br />
be safer or more effective for particular people (see paragraphs 3.13 and 14.40). In the case<br />
<str<strong>on</strong>g>of</str<strong>on</strong>g> cosmetics or toiletry products there is the possibility that some people have sensitivities<br />
or allergies towards ingredients such as colorants which different manufacturers use in<br />
additi<strong>on</strong> to the active ingredient. Some would therefore argue that a range <str<strong>on</strong>g>of</str<strong>on</strong>g> apparently<br />
identical products can be justified, since the different compositi<strong>on</strong>s help to take into<br />
account the variability in sensitivities am<strong>on</strong>g different people.<br />
<str<strong>on</strong>g>The</str<strong>on</strong>g> internati<strong>on</strong>al c<strong>on</strong>text <str<strong>on</strong>g>of</str<strong>on</strong>g> animal <str<strong>on</strong>g>research</str<strong>on</strong>g><br />
Problems in harm<strong>on</strong>ising internati<strong>on</strong>al test guidelines<br />
15.84 Many tests <str<strong>on</strong>g>involving</str<strong>on</strong>g> <str<strong>on</strong>g>animals</str<strong>on</strong>g> are c<strong>on</strong>ducted to provide safety or efficacy data for regulatory<br />
authorities, in compliance with nati<strong>on</strong>al or internati<strong>on</strong>al legislati<strong>on</strong> (see paragraphs 9.4 and<br />
13.49–13.52). Thus, if various authorities require testing to be carried out using different<br />
study designs, a single chemical that is marketed in a number <str<strong>on</strong>g>of</str<strong>on</strong>g> countries might need to<br />
be tested several times. Harm<strong>on</strong>isati<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> test guidelines, so that a single study design is<br />
acceptable to regulatory authorities in many countries, is a very valuable means <str<strong>on</strong>g>of</str<strong>on</strong>g> reducing<br />
the use <str<strong>on</strong>g>of</str<strong>on</strong>g> <str<strong>on</strong>g>animals</str<strong>on</strong>g> in safety and efficacy testing. <str<strong>on</strong>g>The</str<strong>on</strong>g> ICH has managed to improve mutual<br />
acceptance for the pharmaceutical industry, but much still needs to be d<strong>on</strong>e to extend this<br />
approach to other product areas.<br />
CHAPTER 15 DISCUSSION AND RECOMMENDATIONS<br />
15.85 In theory, the adopti<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> guidelines <strong>on</strong> toxicity testing by the OECD should allow nati<strong>on</strong>al<br />
or supranati<strong>on</strong>al regulatory authorities (such as the EPA (Envir<strong>on</strong>mental Protecti<strong>on</strong> Agency)<br />
or FDA (Food and Drug Administrati<strong>on</strong>) in the USA, or the European Commissi<strong>on</strong>) to<br />
incorporate them with minimal change into their own testing requirements. But in practice<br />
this has not always been the case. While, the European Commissi<strong>on</strong> incorporated new in<br />
vitro methods for skin corrosivity more than a year before their final review and approval<br />
by the OECD, the EPA made changes to the protocols for the three new in vivo methods for<br />
acute oral toxicity and also to a new OECD-approved in vivo method for predicting skin<br />
sensitisati<strong>on</strong> (the mouse local lymph node assay). Thus, the EPA delayed acceptance for<br />
some time after their adopti<strong>on</strong> by OECD and, in additi<strong>on</strong>, the EPA’s requirements for acute<br />
46 Institute for Envir<strong>on</strong>ment and Health (2001) Testing requirements for proposals under the EC White Paper – Strategy for future<br />
chemicals policy available at: http://www.le.ac.uk/ieh/webpub/webpub.html. Accessed <strong>on</strong>: 21 Apr 2005.<br />
47 <str<strong>on</strong>g>The</str<strong>on</strong>g>se medicines are sometimes also referred to as me-too medicines.<br />
283