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Dossier Directive 2010/63/UE

Criteria for feasibility, health and welfare assessment of requirement to use second and subsequent generations of non-human primates or animals from self-sustaining colonies in research

Extract from an expert group report endorsed by EFPIA, FELASA, ESLAV and ECLAM, 2010 [Extrait d’un rapport d’experts entériné par l'EFPIA, FELASA, ESLAV et ECLAM, 2010]
Critères d’évaluation de la faisabilité, de l’incidence sanitaire et des répercussions sur le bien-être animal, relatifs à l'obligation future d'utiliser des primates non humains issus uniquement des animaux de deuxième génération et plus ou des animaux provenant de colonies d'élevage auto-entretenues pour la recherche expérimentale
Thierry Decelle, Lars  Friis Mikkelsen, David Smith et Magda Chlebus


La directive européenne 2010/63/EU sur la protection des animaux utilisés à des fins scientifiques exige qu'une étude de faisabilité soit conduite par la Commission européenne afin de déterminer si l’approvisionnement en primates non-humains à partir de géniteurs élevés en captivité (F2) ou de colonies d'élevage autosuffisantes, peut être possible. Cette étude devra également inclure une évaluation de la santé des animaux et de leur bien-être. Avant le début de cette étude par la Commission européenne, l'EFPIA et FELASA ont estimé que les critères à utiliser pour les évaluations de la faisabilité, de la santé des animaux et du bien-être animal devraient être définis rigoureusement par des experts pour faciliter et accélérer le travail de la Commission européenne. Cet article identifie les critères qui peuvent être utiles dans la prise de décisions politiques sur la confirmation de l’exigence de la directive ou sur le réexamen de l'échéancier de mise en œuvre de l'exigence d'utiliser dans le futur uniquement des primates non-humains de générations F2. Un élément clé avant qu'un certain nombre de critères puissent être évalués est la détermination de données de base relatives à l'offre et la demande de primates non humains, à leur état sanitaire et leur état de bien-être dans les colonies de reproduction destinées à approvisionner le marché européen. Trois grandes catégories ont été identifiées, à savoir la faisabilité de gérer ces colonies d'élevage, leur incidence sur la recherche scientifique et la garantie du bien-être animal. Pour chaque catégorie, un certain nombre de paramètres sont définis et justifiés, avec des éléments d'information suggérés et discutés.

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Soumis juillet 2011. Accepté septembre 2011

Texte intégral

1 Rationale

1The new Directive 2010/63/EU on the protection of animals used for scientific purposes (2010) only allows use of non-human primates in research when they are the offspring of animals born in captivity. Inter-institutional negotiations resulted in a requirement to subject this so-called “F2 provision” to feasibility, health and welfare impact assessment before it is implemented.  At the same time, the European Parliament and the Council recommended that the feasibility of sourcing animals for research from self-sustaining colonies as an ultimate goal to be examined.

2Directive 2010/63/EU deals with this subject in Recital 19, Article 10 and Annexes I, II and III.

3The result of the study referred to in Paragraph 1 of Article 10 is due in 2017, and will determine whether or not the timelines for implementation of the F2 requirement (currently 5-years after the publication of the outcomes of the impact assessment, i.e. 2017) are to be changed or not. Considering the time necessary for legislative procedure to amend Annex III, the study should actually be available at the minimum a year before the implementation deadline.

4The ability to breed sufficient F2 generations of macaques was partially investigated in the past e.g. by Prognos (2007) during impact assessment of policy options for revision of Directive 86/609. Prognos concluded that “due to the number of uncertainties, the likely impacts cannot be reliably estimated”.

5In order to address the feasibility, including health and welfare impacts, as accurately as possible, EFPIA and FELASA hosted two brainstorming workshops, 2 July 2009 and 8 July 2010, with experts from the private and public research sectors, NHP breeders, scientific NGOs and animal welfare organisations. The objective was to develop a set of objective criteria that could be used as a basis for establishing a detailed audit programme (EFPIA, FELASA, ESLAV, ECLAM).

6This document presents the outcome of these two brainstorming workshops and subsequent comments and suggestions provided by the participants.

2 Definitions

7For the purpose of this document the following definitions were agreed:

8F2 colonies mean those in which the first generation (F1) born in captivity from wild-caught animals (F0) is used only for reproduction and cannot be supplied for research purposes.

9Self-sustaining colony means a colony in which animals are bred only within the colony or sourced from other colonies, where they have been bred, but not taken from the wild, and where these animals are kept in a way that ensures that they are accustomed to humans. This means that F1 generation from self-sustaining colonies can still be used in research as no further animals are taken from the wild.

Table 1

Article10 - Animals bred for use in procedures

1-   Member States shall ensure that animals belonging to the species listed in Annex I may only be used in procedures where those animals have been bred for use in procedures.
However, as from the dates set out in Annex III, Member States shall ensure that non-human primates listed therein may be used in procedures only where they are the offspring of non-human primates which have been bred in captivity or where they are sourced from self-sustaining colonies.
For the purpose of this Article a “self-sustaining colony” means a colony in which animals are bred only within the colony or sourced from other colonies but not taken from the wild, and where the animals are kept in a way that ensures that they are accustomed to humans.
The Commission shall, in consultation with the Member States and stakeholders, conduct a feasibility study, which shall include an animal health and welfare assessment, on the requirement laid down in second subparagraph. The study shall be published no later than 10 November 2017. It shall be accompanied, where appropriate, by proposals for amendments of Annex II

2-   The Commission shall keep under review the use of sourcing non-human primates from self-sustaining colonies and, in consultation with the Member States and stakeholders, conduct a study to analyse the feasibility of sourcing animals only from self-sustaining colonies
The study shall be published no later than 10 November 2022.

3-   Competent authorities may grant exemptions from paragraph 1 on the basis of a scientific justification.

Directive 2010/63/EU, Article 10

3 Objective and scope of the paper

10— To establish criteria for a feasibility, health and welfare assessment of the supply of non-human primates arising from colonies operating to an F2 or self-sustaining breeding strategy as indicated in the Directive 2010/63/EU

11— This paper is not an exhaustive list of parameters, but it suggests key parameters that would deliver information which would set useful grounds for policy decisions  

12— The concepts of F2 and self-sustaining colonies are different and therefore not all criteria would apply/apply in the same way to them

4 Statement of Principle

13The use of non-human primates as experimental animals is questioned by many people on ethical, welfare and conservation grounds due to their high level of development and sentiency, their behavioural and social complexity, and the threat status of wild populations due to habitat loss and overexploitation. Non-human primates are still used as a necessary animal model to evaluate certain drugs for efficacy and safety prior to the testing in humans, to model certain human disease states, and in fundamental research when no acceptable alternative methods exist and no other species can be used. In addition, their use must be clearly justified and the number kept to an absolute minimum. Initiatives to replace, reduce or alleviate the need for non-human primates are ongoing and their outcomes implemented where possible.  

14All animals used in biomedical research should be of a defined health, origin and breeding history and, where possible, be purpose bred. Their welfare is paramount since robust experimental data can only be obtained when animals are maintained under good welfare regimes. The use of non-human primates follows the same requirements.

5 Challenges to be addressed

5.1 Establishing the baseline

15Several criteria outlined in this document can only be assessed against a clearly established baseline which is not available today, and includes:

16— Trends in numbers, age, sex and generations of non-human primates to be used in research

17— Trends in geographical location of the users - within or outside Europe

18— Health and welfare status of current breeding colonies: experts suggested developing a set of criteria based on UK Home Office or similar audit criteria

19A calculation model examining variations in size of breeding colonies over time and depending on specific scenarios (unilateral EU requirement or global trend) should also be developed.

20Establishing these benchmarks should be the first step in the feasibility assessment.

5.2 Collaboration of breeding establishments

21The gathering of baseline information as well as the conducting of audits and studies necessary for the feasibility assessment requires the collaboration of all major breeders supplying the European markets. In the absence of such a voluntary collaboration, any study would only deliver partial results.

22As reliability of data is of utmost importance for the study, information from establishments with recognised reliable recording systems should be prioritised.

5.3 Lack of tools to clearly identify various generations

23With the exception of costly and complex DNA fingerprinting approaches of relevant animals and ancestors, there are no practical tools to unambiguously determine whether a given animal is F2 or not. In the absence of such tools existence of reliable documentation at the breeding site is vital. The breeding records should contain data on maternity and information on the number and origin of mature males in the breeding group. Inevitably part of the assessment process would therefore rely on third party generated information and trust.

5.4 Unilateral measures by the EU

24The impact assessment should also take into account that for the time being the F2 provision may be imposed only by the EU and should therefore indicate stakeholders with whom dialogue would have to be engaged for successful implementation. Therefore, different scenarios would have to be envisaged including:

25— Unilateral European requirement (and potential export quotas for breeding establishments or source countries)

26— Move towards F2 or self sustaining colonies in other regions / regulatory jurisdictions, e.g. in collaboration with such groups as ILAR in the United States

6 Proposed criteria for a feasibility,  health and welfare assessment

27For each proposed criterion three important aspects are addressed:

28What should be assessed (which parameters)?

29Why are these parameters an important part of the assessment?

30How should these parameters be evaluated (important aspects, points to consider, stakeholders’ consultation)?

31In the light of a number of policy drivers, the public opinion, animal welfare (including reducing impact on wild populations) and research reality on the other hand, the following three groups of criteria are proposed:

32Feasibility is the first condition

33— Appropriate quality of animals in relation to scientific requirements/outcomes and the 3Rs comes second

34— Finally, animal health and welfare issues should be examined and given high priority in the final outcome of the assessment

35The criterion “Species conservation and wild population size” was not included in the list, given the difficulty of conducting such a study within the timelines of the legislative timetable and in light of the proposed prioritisation. However, data on wild population resilience and trends may be sought from those conducting on-going field research on the relevant species and assessments by multilateral organizations such as CITES.

36Any feasibility assessment should evaluate possible negatives and positives of sourcing primates from either F2 or self-sustaining colonies (e.g., animal health and welfare, continuity of supply, variability, etc.). It should be conducted in collaboration with scientists as well as local authorities and breeding/supplying establishments for all relevant NHP species, also taking into due account the specificities of animals of different origins. The collaboration of scientists from relevant disciplines, such as: primate behaviour, ecology, welfare and reproduction as well as biomedical research fields where non-human primates are mostly used (e.g.: toxicology, pharmacology, neurosciences, infectious diseases, immune system disorders, aging diseases, etc.) is of utmost importance.

37This assessment should focus on the species most commonly used in biomedical research. Further consideration on a case-by-case basis should be given to those species that are used infrequently.

6.1 Feasibility

38The feasibility parameters can only be measured against a clearly established baseline as outlined in section 5.1. It is therefore assumed that trends in numbers, sex, age and generations of NHPs currently used, trends in geographical locations where NHPs are used and status of current colonies would be measured as step one of the feasibility and impact assessment study.  

6.1.1 Continuity of supply of NHPs for European research programmes

39What: The possible impact on the supply of NHPs for the European market and on the competitiveness of European research compared to other regions of the world should be considered and assessed.

40Why: According to the Prognos assessment, the total demand for NHPs (macaques) from the research community exceeds the supply capacity. This is especially true for certain animal models / origins although the demand and supply capacity is variable over time.  Compared to other regions of the world, European customers already have stricter requirements which in turn require an increase in resources and investment which must be sustained by breeding and supplying establishments wishing to sell to these clients.

41How: A large-scale survey involving NHP breeders and suppliers of the different relevant NHP species (e.g. macaques) and from the different origins should be conducted in order to assess the possible impact on the availability and continuity of supply of NHPs for European biomedical research. Such a survey should be constructed in collaboration with the research community in order to ensure that the different research needs and specificities are covered and data generated needs to be evidence-based.

6.1.2 Productivity (fecundity)

42What: A comparison of the rates of weaning (number weaned versus number born) between animals born to captive and wild-born parents should be performed to assess the impact of these factors on the production of animals that may be available for use.

43Why: While captivity may affect basic reproductive parameters there is a strong possibility that captive conditions and/or management practices (e.g. early maternal separation and housing in same sex group post weaning) may negatively influence the likely survivorship of infants through to weaning age. Evidence indicates that maternal separation and early weaning can result in deficient reproductive and parental behaviour that can result in infant abandonment and sometimes death or an increase in the need for cross-fostering or hand-rearing and all the attendant problems of cross-species attachment. Some of these consequences may be countered by retaining offspring in their natal group beyond usual forced weaning age allowing them to learn parenting skills from their parents.

44How: Data should be collected on birth rates and weaning rates in wild caught and captive bred, F1 and further generation animals, animals from a variety of breeding centres for each of the relevant NHP species. Additional data required for the interpretation of these data include general housing and husbandry practices as well as management practices such as weaning strategy, growth and development data including interventions like hand-rearing rates.

6.1.3 Reproduction and breeding performance

45What: A comparison of fertility, breeding performance and maternal behaviour between animals born from captive-bred and wild caught parents should be performed to assess the potential impact of these factors on reproductive parameters. Captive bred animals are generally weaned at younger ages than their wild counterparts and this should be taken into account to establish specific strategies for rearing future breeders e.g. in the context of a family group.

46Why: In animal species such as NHPs that have reproductive strategies involving the production, over a long period, of only a few offspring in which they invest significantly during a long period of dependency appropriate reproductive behaviour is an essential component of fertility. Prolonged dependency of the infant on its mother coupled with patterns of emigration and kin-bonding in NHP social groups provide vital opportunities for social learning and infant care experience that may significantly influence reproductive competence. Preliminary data suggest that fertility parameters of animals born from captive bred breeders may differ from parameters of animals born from wild caught breeders. This may be in part due to removal of infants from their mother and natal group (weaning) earlier than would take place in the wild.

47How: Data on reproductive performance, including maternal behaviour, collected from animals of various breeding centres for the relevant NHP species should be analysed retrospectively and compared with those obtained in wild caught animals.Consideration should be given to whether current weaning and feeding, or other husbandry strategies, might have an impact on those biological features. Breeding systems and maintenance of future breeding stocks may need to be refined.

6.1.4 Breeding costs (facilities, manpower, operating costs)

48What: The breeding and purchasing cost of F2 and further generation animals and those from self-sustaining colonies should be estimated and compared to the current costs.

49Why: Increased number of animals to be kept in captivity, surplus animals, inbreeding and possible impairment of breeding performance, possible increased susceptibility to spontaneous disorders, investments needed for increasing the capacity of housing facilities in breeding centres, increased manpower needs, etc. may lead to a significant increase in breeding costs and purchase price of F2 and further generation animals than those from self-sustaining colonies.

50How: Breeding and supplying establishments for NHPs of the relevant species and from the different origins should be involved in the evaluation of the impact on purchasing costs of NHPs. Depending on animal origin, species and characteristics the anticipated purchasing cost should be compared with current costs (F1).

6.2 Research and science

6.2.1 Animal health

51What: The incidence of spontaneous health disorders (e.g., impaired fertility, metabolic syndrome, obesity, diabetes) and susceptibility to induced diseases (as in some infectious disease models) should be evaluated and quantified as well as husbandry and housing standards.

52Why: Observations from some breeding centres suggest that these biological characteristics might differ in animals born from wild caught breeders and animals with captive parents. Such observations need to be validated and the possible causes further investigated, although genetic, nutritional and behavioural factors have been hypothesized. Further, minimum husbandry and housing standards should be established and implemented.

53How: Collaboration with experienced and accredited breeders (from different regions) of the relevant NHP species is essential to collect appropriate data and produce reliable information. Research groups working on relevant programmes should also be involved in retrospective comparative studies and literature reviews. An increased incidence of pathologies and disorders in animals born from captive breeders should be verified and the possible effects of the husbandry system investigated and addressed so to rectify the problems. Define minimum global acceptable husbandry and housing standards,.

6.2.2 Geographical genetic diversity and origin

54What:  The possible reduction of geographical genetic diversity due to the loss of some important genetic traits, together with procedures to prevent uncontrolled inbreeding in the colonies should be evaluated plus the future need for animals of different origin.

55Why: Evidence supports that animals of the same species may vary in their genetic profile and sometimes shows different biological characteristics depending on their origin. As an example, rhesus macaques of Indian origin — Export of Rhesus monkeys from India has been abolished in the 1970’s, this is just an example of relevant differences between geographically different subpopulations. — differ in their immunological response to HIV from animals of other origins, being more suitable for this kind of research. The need of NHPs of the same species, but from different locations should be evaluated along with the consequences of reducing genetic diversity. In addition the importance of continued supply of NHPs of high genetic homogeneity (e.g. macaques from Mauritius) should also be assessed.

56Compared to those breeding systems where a small proportion of wild caught breeders are regularly used to replace breeders, closed colonies should have an appropriate breeding strategy in place to avoid inbreeding and the loss of fundamental genetic characteristics.

57How:  Data on specific characteristics of NHP populations from different geographical origins should be collected and reviewed in order to identify important genetic profiles to be maintained for research needs. The colony production systems and measures to avoid inbreeding over time should be scientifically established.

6.3 Animal welfare

6.3.1 Animal welfare, behaviour, socialization (excluding breeding performance)

58What: Animal welfare, capability to cope with the environment and adapt to changes, behaviour, socialization within the group and with humans and cognitive capabilities should be compared in animals born from wild caught breeders and animals born from captive bred parents. In addition, the welfare of the wild caught breeders should also be assessed, as well as specific needs for the proper raising of prospective breeders.

59Why: For obvious practical reasons, keeping large numbers of NHPsin captivity — In order to keep inbreeding in the colony under control, breeding centres necessarily need to reach a minimum size and number of breeders — does not allow full replication of the living conditions in the wild and this may impact on animal welfare. Socialization, group structure, transmission of species-typical behaviours (sexual, social, feeding and general activity) and other learned behaviours may not always be acquired properly by animals which have not been in contact with naturally behaving animal in appropriate social contexts... It will be necessary to determine if there is an inherent welfare challenge of moving to an F2 or self-sustaining breeding colony status.

60Some captive environments may not fully meet the animals’ needs and captive stressors may also include fear of humans for newly captured animals and social stress, which might be different for socialized animals born in captivity. Wild caught animals may have clinical or subclinical conditions, which they may transmit to the animals of the captive colony and vice versa. Not least, altered animal socialization and behaviour may significantly impact (negatively or positively) stress levels and, consequently, research outcomes.

61How: Collaboration with experienced and accredited breeders (from different regions) of the various NHP species is essential in order to collect appropriate data and produce reliable information. Research programmes should also consider retrospective comparative studies of wild-caught versus captive-bred as well as F1 versus F2 animals, when historical data, including from health screening, are available. Experimental studies of behavioural and physiological differences of wild-caught, F1 and F2 generations in the breeding context are likely to necessary.

6.3.2 Total number of animals to be maintained in captivity

62What: The impact on the total number of animals to be maintained in captivity to cope with the global demand should be analysed. In the eventuality that breeding stocks need to be increased, it is important to determine the capability and willingness of breeders to meet the necessary increases in investment and adaptations to enrichment and husbandry regimes. Special attention should also be given to the continued use of feral animals that are already included in breeding stocks and provision for the holding of future breeding animals until they reach maturity.

63Why: It is expected that breeding in closed, self-sustaining colonies would initially necessitate a significantly larger number of animals in captivity compared to producing captive bred F1 animals from wild caught breeders. One reason for this is the need to keep future breeders up to the age of maturity in captivity before they can be included in the breeding programs. Furthermore, if the breeding performance of captive bred breeders remains lower than the reproduction rates of wild caught breeders, it should be assessed whether more breeders might need to be included in the production programmes to produce a given number of offspring, resulting in more animals to be maintained in captivity than in the current scenario. Also, early replacement of feral breeders will mean that these should be euthanized, neutralised or kept without being able to use their offspring for research purposes.

64How: Data should be collectedfrom different breeding centres for the relevant NHP species and analysed retrospectively. The impact of measures to improve the fertility of captive bred breeders would need to be taken into account, as well as risk stemming from a larger size colony in case of a disease outbreak.

6.3.3 Management of surplus animals during transitional period

65What: Factors such as the number of surplus animals which could not be used for research or breeding purposes as well as the potential for a shortage of females for reproductive toxicity studies should be considered.

66Why: Most studies, apart from reproductive toxicity studies, require equal number of males and females. In the wild as well as in captivity, NHPs, such as macaques, can breed well in large groups composed of one breeding male and 10 or more mature females, or even bigger groups with two males. When breeders are taken from the wild population, this ratio may easily be maintained: the male surplus accidentally trapped may be released. In closed, self-sustaining colonies, without frequent changes of breeding males, only a very limited proportion of males will be used as breeders, while not all surplus males might be used in research programmes. It may therefore happen that a significant number of males will be in excess.

67How: Based on prospective and retrospective data, the number of expected surplus animals should be calculated in collaboration with breeding centres from the different regions and for the different relevant species. Possible solutions for surplus animals must be assessed and identified before implementation of the requirement, in order to avoid the unnecessary euthanasia of surplus animals every year.

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ECLAM. European College of Laboratory Animal Medicine

EFPIA. European Federation of Pharmaceutical Industries and Associations

ESLAV. European Society of Laboratory Animal Veterinarians

FELASA. Federation of Laboratory Animal Science Associations

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Thierry Decelle, Lars  Friis Mikkelsen, David Smith et Magda Chlebus, « Criteria for feasibility, health and welfare assessment of requirement to use second and subsequent generations of non-human primates or animals from self-sustaining colonies in research », Revue de primatologie [En ligne], 3 | 2011, document 18, mis en ligne le 15 octobre 2011, consulté le 29 juin 2016. URL : ; DOI : 10.4000/primatologie.853

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Thierry Decelle

European Federation of Pharmaceutical Industries and Associations (EFPIA)

Lars  Friis Mikkelsen

European Federation of Pharmaceutical Industries and Associations (EFPIA)

David Smith

European Federation of Pharmaceutical Industries and Associations (EFPIA)

Magda Chlebus

European Federation of Pharmaceutical Industries and Associations (EFPIA).
Author for correspondence :

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