Animal testing

Basic principles

The MEB sets industry requirements to reduce the use of animal testing in the national and international development of medicinal products. The MEB encourages industry to develop tests that serve as an alternative to animal testing and to submit these tests for approval. The MEB is also working on the development of international regulations and agreements to reduce the use of animal testing.

The MEB is aware that it takes a lot of time and effort to produce medicinal products that have not been tested on animals. There are (as yet) no alternatives to cell and animal testing for the development of certain medicinal products in order to produce a safe product.

Strategy

• To stimulate the reduction and replacement of animal testing in the development of medicinal products.
• To contribute to renewal of (international) regulations.
• Participation in projects, stimulation of scientific research and sharing of knowledge with the aim of limiting animal testing.

Reduction and replacement of animal testing

The MEB asks companies to develop alternatives to animal testing and stimulates the 3R approach in medicinal product development, known in Dutch as the 3V approach:

• Replacement / Vervanging: use of other research methods.
• Reduction / Vermindering: use of fewer animals.
• Refinement / Verfijning: increasing the well-being of laboratory animals.

The MEB is critical in its requests for animal experiments in national and European scientific advice and also in advice to the EMA about the development of medicinal products for children. The added value of an animal experiment must be essential and useful.

Renewing of (international) regulations

The MEB is active in international discussions about designing the authorisation system in such a way that the use of laboratory animals is replaced or reduced wherever possible. The MEB promotes obtaining consensus at a European (CHMP/EMA) level in the Safety Working Party, particularly with regard to products. The aim is to create intense discussion between authorities, so that all parties can reach similar agreements about animal testing.

• Amendment of the international regulations at global ICH level has a high priority on the agenda. The MEB focuses on the requirements regarding risks of cancer, use during pregnancy and use by children.
• The MEB contributes to the activities of the Joint Expert Group 3Rs. This group works with the European Medicines Agency (EMA) to reduce the number of animals used in testing by coordinating all the relevant working groups, such as the Safety Working Party and the Biologics Working Party.
• This includes intense efforts to write new quality requirements, or revise existing requirements, for biological medicinal products in European working groups.

Projects, scientific research, sharing of knowledge

• The MEB is collaborating in the creation of a register that will contribute to a reduction in the number of animals used in the early stages of medicinal product development. This register includes animal models that have proven predictive value for the evaluation of efficacy during the early stages of medicinal product development. The register is being created in cooperation with Utrecht University and is supported by the Ministry of Economic Affairs, the Ministry of Health, Welfare and Sports, Nefarma and EFPIA.
• As far as the sharing of knowledge and scientific research are concerned, the MEB works together closely with organisations such as ZonMW (Committee More Knowledge Fewer Animals) and the National Institute for Public Health and the Environment (RIVM) (3R research projects).

• European regulations now state that animal testing is no longer required to substantiate the safety of biosimilars, generic products of existing biotechnological medicinal products. The MEB note “Use of non-human primates (NHPs) for the development of biosimilars” formed the basis of these regulations.
• The MEB shares its knowledge about documentation of requested marketing authorisations, for example through systematic evaluation of pharmacological and toxicological data. Various initiatives in this field have been included:

1. A database has been developed that includes all the carcinogenicity studies for all products that entered the market from 1980 onwards. The assessment of this database is ongoing and will contribute to the discussion at ICH level about carcinogenicity. This is a collaboration with Wageningen University. The database was created with the support of SLIM (Sneller van Innovatie naar Mens) and the European Partnership for Alternative Approaches to Animal Testing (EPAA).
2. A database has been developed that includes all reproductive toxicity studies from authorised products, among others, from 2004 - 2013. This research was submitted to the ICH Expert Working Group, which will work on the revision of the ICH directive in this field. This was a collaboration with the National Institute for Public Health and the Environment (RIVM) and the Hogeschool Utrecht. The project was supported by SLIM and ILSI-HESI (Developmental and Reproductive Toxicity Technical Committee).