Vaccines for human use and for veterinary use
Biological and biotechnological products
The protection of animal rights and in particular those used for experimentation has long been a subject of interest for the Council of Europe. The first milestone was achieved in 1986, when the European Convention (ETS 123) for the Protection of Vertebrate Animals used for Experimental and Other Scientific Purposes was open for signature.
It is interesting to note that the European Convention ETS 123 was adopted before the EU’s Directive 86/609/EEC (adopted on 24 November 1986) and that the provisions of the Directive are based on the Convention. In September 2010, the EU adopted a new Directive 2010/63/EU on the same subject that replaces the 1986 Directive 86/609/EEC and it comes into effect on 1 January 2013.
The main areas of activity at the EDQM that are actively involved in the application of 3Rs principles include:
the elaboration of the European Pharmacopoeia itself;
the Biological Standardisation Programme (BSP);
The achievements of the last years could not have taken place without the dedication of all the players in this exercise and the excellence of the relationship between EDQM and all European or non-European partners, who are gratefully acknowledged. Groups of Experts of the European Pharmacopoeia, the EDQM Biological Standardisation Programme, the EDQM Laboratory and our external partners: the WHO, the US-FDA, the ECVAM, the EU Commission and the EMA. Finally, the work could not be done without the contributions from the manufacturers of the substances or preparations concerned. Their generosity, patience and good will have been essential to the progress made.
In 1986, the opening for signature of the European Convention on the Protection of Vertebrate Animals used for Experimental and other Scientific Purposes marked the beginning of an intensification of the activities of the European Pharmacopoeia Commission to review all animal tests in monographs with a view to applying the precepts of the Convention for Replacement, Reduction and Refinement of the use of animals for test purposes.
The Ph. Eur. Commission continuously revises general texts and monographs, re-evaluates the relevance of animal tests mentioned in the Ph. Eur. texts. and if deemed appropriate includes alternative methods. This work is based on consensual discussions within Group of Experts and involve all interested parties (OMCLs, industry, universities and regulators), including representatives from other institutions such as the World Health Organization (WHO), the European Medicines Agency (EMA) and US Food and Drug Administration (FDA).
The Biological Standardisation Program aims at validating new pharmacopoeial methods and establishing Ph. Eur. reference preparations for the quality control of biological medicines. The programme is particularly committed to consider promising alternative 3R methods.
Since the start of the programme 125 BSP projects have been initiated. These cover a large variety of biological products: vaccines for human use, vaccines for veterinary use, blood-derived products (plasma, coagulation factors, immunoglobulins,…) and biotechnology products.
So far, 21 of these projects were devoted to the establishment of alternatives to animal use.
The BSP actively works to improve the implementation of the 3R approaches. Among other activities, as member of the Vaccines Project Team, the BSP contributes to the Technical Platform for 3Rs in Regulation of the European Partnership for Alternative Approaches to animal Testing (EPAA), a partnership between the EU Commission and industry.
Article: E. Charton and P. Castle. Reduction, Replacement and Refinement of animal tests in the European Pharmacopoeia: recent developments for monographs on biological substances and preparations. Pharmeuropa 2001;13.1;94-96.
European Convention for the Protection of Vertebrate Animals used for Experimental and Other Scientific Purposes (Council of Europe - ETS No. 123; Strasbourg, 18.III.1986)
The Directive 2010/63/EU of the European Parliament and of the Council on the Protection of animals used for scientific purposes will take full effect from 1 January 2013