Main proposals of concern in EU Directive revision

Lab macaques in group housingThe draft Directive revision published in late 2008 includes a number of proposals that are of concern to the research community across Europe. Many of these relate to the use of primates and threaten to increase bureaucracy without offering any improvements in animal welfare.

 

 

  • to limit the use of macaque monkeys to second generation (F2) animals born in captivity from seven years after the directive comes into force. It is simply not clear at present whether it will be possible to breed enough to meet this requirement. In addition, there are a number of adverse welfare implications for the macaques, including a large increase in the size of the breeding colonies.
  • to limit re-use of animals to cases where the second procedure is mild or terminal. This could considerably reduce the amount of re-use, which would make the research projects affected harder to conduct and more costly. It would also increase the numbers of animals used and, in some cases, increase the amount of animal suffering.
  • that the competent authority has to carry out ethical evaluations of all project applications “in a transparent manner, by integrating the opinions of independent parties”. Confidential information needs to be protected (something that is included in the provision for non-technical summaries). While we already have local ethical review in the UK, the meaning of this clause is unclear. It could mean that its interpretation is ultimately decided by court cases, if animal protection groups seek the right to be involved in the assessment of applications.
  • that the Commission would define the severity categories by a regulatory committee procedure after the Directive is in force. Since there are restrictions on certain procedures (eg in re-use) to certain severity categories, the decisions reached by this committee procedure could have significant effects. The UK has been considering for some time how best to report severity of procedures
  • that institutional ethical review bodies should conduct annual reviews of all projects would create an unjustified burden of administration.
  • that the European Commission would have the power to ‘undertake controls of the infrastructure and operations of national inspections’ – ie have the power to tell Member States how to carry out their inspections – appears dangerous. It seems likely that this would be used in response to complaints that the inspection process was not working properly.

 See also the resources on our Primate Research page

 

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