Problems with the Commission proposal
1. The list of areas where the directive will not apply includes 'practices that are not invasive'. The meaning of this is not clear so a recital is required to explain how it should be interpreted.
2. The proposal to limit the use of macaque primates to second generation born in captivity animals from 7 years after the directive comes into force. It is simply not clear at present whether it will be possible to breed enough F2 macaques to meet this requirement.
3. The proposal to limit the use of primates to research that "is undertaken with a view to the avoidance, prevention, diagnosis or treatment of life-threatening or debilitating clinical conditions in human beings" may prevent these animals being used is some areasof fundamental research where the primary aim is to gain new knowledge. It is not always possible to demonstrate the relevance of such knowledge to particular diseaases or conditions at the time the work is proposed.
3. The proposal to limit the use of primates to research that "is undertaken with a view to the avoidance, prevention, diagnosis or treatment of life-threatening or debilitating clinical conditions in human beings" may prevent these animals being used is some areasof fundamental research where the primary aim is to gain new knowledge. It is not always possible to demonstrate the relevance of such knowledge to particular diseaases or conditions at the time the work is proposed.
4. The proposal 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.
5. The proposal that the competent authority had 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). The meaning of this clause is unclear, which could mean that its interpretation is ultimately decided by court cases, when animal protection groups seek the right to be involved in the assessment of applications.
6. The proposal that the Commission would define the severity categories by a regulatory committee procedure after the Directive was 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.
7. The proposal that institutional ethical review bodies should conduct annual reviews of all projects would create an unjustified burden of administration.
7. The proposal that institutional ethical review bodies should conduct annual reviews of all projects would create an unjustified burden of administration.