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 ...
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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 />
Regulati<strong>on</strong>s requiring the use <str<strong>on</strong>g>of</str<strong>on</strong>g> <str<strong>on</strong>g>animals</str<strong>on</strong>g><br />
13.48 So far, we have c<strong>on</strong>centrated <strong>on</strong> regulati<strong>on</strong> that authorises and prescribes the ways in which<br />
<str<strong>on</strong>g>animals</str<strong>on</strong>g> can be used in <str<strong>on</strong>g>research</str<strong>on</strong>g>, seeking to minimise possible harm. As we have said (see<br />
paragraphs 8.22 and 9.4), animal <str<strong>on</strong>g>research</str<strong>on</strong>g> is also undertaken because regulati<strong>on</strong>s at both<br />
the nati<strong>on</strong>al and internati<strong>on</strong>al levels stipulate that medicines, vaccines and chemicals for use<br />
in agriculture, industry, food and household products must be tested for efficacy and safety.<br />
Some regulati<strong>on</strong>s require that <str<strong>on</strong>g>animals</str<strong>on</strong>g> must be used, whereas others merely require that<br />
tests must be undertaken according to best practice, which is <str<strong>on</strong>g>of</str<strong>on</strong>g>ten interpreted as requiring<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>. Companies and instituti<strong>on</strong>s within countries such as the UK, which are<br />
members <str<strong>on</strong>g>of</str<strong>on</strong>g> many different internati<strong>on</strong>al organisati<strong>on</strong>s and operate in internati<strong>on</strong>al<br />
markets, are also subject to overlapping legislati<strong>on</strong> and guidelines.<br />
Testing <str<strong>on</strong>g>of</str<strong>on</strong>g> medicines<br />
13.49 In the UK, new medicines must meet the requirements <str<strong>on</strong>g>of</str<strong>on</strong>g> the Medicines Act 1968 in order<br />
to be licensed. <str<strong>on</strong>g>The</str<strong>on</strong>g> Act states that a medicine must dem<strong>on</strong>strate that it is safe, effective and<br />
<str<strong>on</strong>g>of</str<strong>on</strong>g> high quality and this is usually interpreted as requiring testing <strong>on</strong> <str<strong>on</strong>g>animals</str<strong>on</strong>g>. 43 EU<br />
legislati<strong>on</strong>, particularly Directive EC 2001/83 <strong>on</strong> the Community code relating to medicinal<br />
products for human use, now takes precedence over the Medicines Act, which has been<br />
amended several times to align with new requirements. <str<strong>on</strong>g>The</str<strong>on</strong>g> Directive requires that all new<br />
prescripti<strong>on</strong> medicines are studied in <str<strong>on</strong>g>animals</str<strong>on</strong>g> before they are tested in humans. It states that<br />
before a new medicinal product can be marketed in the EU, the producer shall obtain<br />
authorisati<strong>on</strong> by the appropriate competent authority (either the nati<strong>on</strong>al regulatory<br />
agency or the EMEA). Article 8 (3) stipulates that an applicati<strong>on</strong> to <strong>on</strong>e <str<strong>on</strong>g>of</str<strong>on</strong>g> these agencies<br />
shall include: ‘Results <str<strong>on</strong>g>of</str<strong>on</strong>g>: physico-chemical, biological or microbiological tests, toxicological<br />
and pharmacological tests, [and] clinical trials’. <str<strong>on</strong>g>The</str<strong>on</strong>g> exact requirements, standards and<br />
protocols for both animal and n<strong>on</strong>-animal tests are described in detail. For example, singledose<br />
toxicity shall be assessed by the following protocol:<br />
‘<str<strong>on</strong>g>The</str<strong>on</strong>g> acute toxicity test must be carried out in two or more mammalian species <str<strong>on</strong>g>of</str<strong>on</strong>g> known<br />
strain unless a single species can be justified. At least two different routes <str<strong>on</strong>g>of</str<strong>on</strong>g><br />
administrati<strong>on</strong> shall normally be used…’ 44<br />
13.50 In other countries, medicines are licensed through equivalent regulatory authorities such as<br />
the Food and Drug Administrati<strong>on</strong> (FDA) in the US and the Ministry <str<strong>on</strong>g>of</str<strong>on</strong>g> Health, Labour and<br />
Welfare in Japan. <str<strong>on</strong>g>The</str<strong>on</strong>g> Internati<strong>on</strong>al C<strong>on</strong>ference <strong>on</strong> Harm<strong>on</strong>isati<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> Technical Requirements<br />
for Registrati<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> Pharmaceuticals for Human Use (ICH) coordinates the pharmaceutical<br />
regulatory authorities <str<strong>on</strong>g>of</str<strong>on</strong>g> Europe, Japan and the USA (see paragraph 12.8). It aims to<br />
harm<strong>on</strong>ise guidelines <strong>on</strong> quality, safety and efficacy in its member countries. Certain <str<strong>on</strong>g>of</str<strong>on</strong>g> its<br />
safety guidelines specify that animal <str<strong>on</strong>g>research</str<strong>on</strong>g> should be performed. 45<br />
Testing <str<strong>on</strong>g>of</str<strong>on</strong>g> chemicals<br />
13.51 Primary UK legislati<strong>on</strong> requiring the testing <str<strong>on</strong>g>of</str<strong>on</strong>g> chemicals includes the following: the Health<br />
and Safety at Work Act 1974, the C<strong>on</strong>sumer Protecti<strong>on</strong> Act 1987 and the Food Safety Act<br />
1990. <str<strong>on</strong>g>The</str<strong>on</strong>g>se acts mostly implement the provisi<strong>on</strong>s <str<strong>on</strong>g>of</str<strong>on</strong>g> corresp<strong>on</strong>ding EU directives. <str<strong>on</strong>g>The</str<strong>on</strong>g> OECD<br />
43 See Animals in Medicines Research Informati<strong>on</strong> Centre, available at: http://www.abpi.org.uk/amric/basic5.asp. Accessed <strong>on</strong> 5<br />
May 2005.<br />
44 EU Directive EC 2001/83, Annex 1, Part 3 Performance <str<strong>on</strong>g>of</str<strong>on</strong>g> Tests: Toxicity.<br />
45 See <str<strong>on</strong>g>The</str<strong>on</strong>g> Internati<strong>on</strong>al C<strong>on</strong>ference <strong>on</strong> Harm<strong>on</strong>isati<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> Technical Requirements for Registrati<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> Pharmaceuticals for<br />
Human Use (ICH): Safety Guidelines, available at: http://www.ich.org/UrlGrpServer.jser?@_ID=276&@_TEMPLATE=254.<br />
Accessed <strong>on</strong>: 5 May 2005.<br />
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