Impact of Directive 2010/63/EU on European Pharmacopoeia texts

In the context of the introduction of the new EU Directive 2010/63/EU on the protection of animals used for scientific purposes, the European Pharmacopoeia Commission decided at its 141st Session (November 2011) that its Groups of Experts should review all monographs and chapters prescribing animal tests. On 20 June 2012, a meeting took place at the EDQM premises, during which the Chairs of the relevant European Pharmacopoeia (Ph. Eur.) Groups of Experts had the opportunity to discuss issues of common interest on the subject of the 3Rs (replacing, refining and reducing the use of animals in tests). A representative from the EU Commission was present to answer questions from the participants and to make suggestions. Specialists in the 3Rs from the Ph. Eur., the European Centre for the Validation of Alternative Methods (ECVAM) and the Joint Committee for Medicinal Products for Veterinary Use/Committee for Medicinal Products for Human Use Ad-hoc Expert Group on the Application of the 3Rs in Regulatory Testing of Medicinal Products (JEG 3Rs) were also present, thereby ensuring consistency within the European bodies involved in animal welfare.

The meeting started with a general presentation by the EU Commission’s representative on the new Directive 2010/63/EU.  The impact of the Directive on Ph. Eur. texts was evaluated. A clear need was identified for the wording of Ph. Eur. texts to be explicit when prescribing the use of non-animal tests to replace animal tests or when exemptions are given to revert back to animal testing.  Participants also expressed their wish to see guidelines developed on criteria for validating in vitro methods as replacements for animal tests. It was recognised and acknowledged that, despite the efforts of European experts in the field of the 3Rs, tests using animals may remain in the Ph. Eur. for many years to come. The reasons for this varied from technical difficulties and lack of investment by interested parties to cost in animals to develop the alternatives, etc.

Specific technical subjects raised by the Chairs of the Groups of Experts in the fields of radiopharmaceuticals, human vaccines, veterinary vaccines, blood products and recombinant DNA proteins were also debated. A suggestion to delete the test for abnormal toxicity from the Ph. Eur. was brought to the assistance and would be closely evaluated in the coming months.

The recommendations from the meeting will be further discussed by each of the Ph. Eur. Group of Experts during their forthcoming meetings. Specific recommendations will be made to the Ph. Eur. Commission at its 144th Session (November 2012) so that the status of work is clear and available on 01 January 2013, i.e. the date of implementation of the new Directive.