Back Council of Europe leading the way in animal welfare for over 40 years

EDQM Strasbourg, France 18/03/2026
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Council of Europe leading the way in animal welfare for over 40 years

Animal welfare has long been a major concern for the Council of Europe and the European Directorate for the Quality of Medicines & HealthCare (EDQM). The five conventions on the protection of animals developed within the Council of Europe were the first international legal instruments laying down ethical principles governing the transport, farming and slaughter of animals, as well as their use for experimental purposes and as pets. Today, as we celebrate the fortieth anniversary of the European Convention for the Protection of Vertebrate Animals used for Experimental and Other Scientific Purposes (“Convention ETS No. 123”), we look back at what has been achieved in the intervening years and reflect upon what remains to be done.

On 18 March 1986, when the Council of Europe invited its member states to sign Convention ETS No. 123, it set in motion an intensive effort to transpose the “3R principles” – replacing, reducing and refining the use of animals in scientific experimentation – into real-world medical and scientific practice. The EDQM’s European Pharmacopoeia Commission (EPC) began reviewing all animal tests described in the monographs of the European Pharmacopoeia (Ph. Eur.) – the harmonised, legally binding quality standards for manufacturers marketing their products in the 39 Council of Europe member states that have signed the Convention on the Elaboration of the European Pharmacopoeia – the goal being to amend the texts to introduce 3R-compliant methods. This work sent a strong message: seeking animal-free alternatives not only supports a more humane and ethical approach to testing, it also fosters the development of more precise and cost-effective tests.

The scale of this undertaking was considerable, with each monograph revision requiring extensive validation studies and broad consultation to promote the widest possible acceptance and implementation. Over the years, its impact has been profound, directly shaping medicinal product testing regulation and practices throughout Europe, and even worldwide. In parallel, the Biological Standardisation Programme (BSP), established jointly with the European Union (EU) in 1991, accelerated progress for biological medicinal products such as vaccines and blood products, leading to the inclusion of several 3R-compliant methods in Ph. Eur. monographs.

Another major milestone on the road to improving animal welfare was reached with the adoption of Directive 2010/63/EU on the protection of animals used for scientific purposes in 2010. Closely based on Convention ETS No. 123, the Directive reinforced the 3R principles by introducing additional provisions such as a severity classification of procedures that reflects levels of animal suffering during tests. Article 13 states that animal-free, 3R-compliant alternatives are to be used when available within the EU. This also means that EU legislation implicitly recognises the pan-European pioneering and harmonising role played by the Council of Europe and the EDQM in animal welfare within a medical and scientific context. This leadership has also helped make European regulatory science become globally influential in advancing the 3R principles.

In 2013, when the EU Directive came into full effect, the EPC took a further decisive step by deleting the target animal batch safety test for veterinary vaccines from the Ph. Eur., significantly reducing animal use in veterinary vaccine control. In 2019, the abnormal toxicity test (ATT) – a general safety test requiring the injection of batches of the product into guinea pigs and/or mice – was deleted from 49 Ph. Eur. monographs.

More recently, major achievements include the complete removal of the rabbit pyrogen test (RPT) from the Ph. Eur., marking a turning point toward fully in vitro pyrogenicity control. Another milestone for animal welfare was the deletion of the general chapters on Histamine (2.6.10) and Depressor substances (2.6.11), which described tests using guinea pigs and cats. As of 1 January 2027 (Ph. Eur. Issue 13.1), recombinant factor C (rFC) – a validated, synthetic solution – will be one of the seven methods in general chapter 2.6.14. Bacterial endotoxins. This alternative to the limulus amoebocyte lysate (LAL) methods, requiring the use of horseshoe crabs, should reduce pressure on this protected species. Such advances in animal-free testing are paving the way for an end to decades of reliance on animal-based methods and ushering in a new era of innovation and sustainability not only for the Ph. Eur., but for medical and scientific research globally, while preserving the highest standards of patient safety and scientific rigour. In recent years, the concept of “removal”– phasing out obsolete animal tests without replacement – has gained momentum, effectively adding a fourth “R” to the traditional three.

Our commitment remains clear and unwavering: to promote non-animal methods in medical testing and other scientific applications. While remarkable progress has been achieved – improving dozens of Ph. Eur. texts and reducing the number of animals used for scientific purposes worldwide – further international and intersectoral collaboration is essential to meet the challenges of real-world implementation. Progress has been slow but sure. The recent symposium, “Pyrogen testing 2.0: Ethical, Evolving and Eco‑friendly – Implementing safe, rapid, state‑of‑the‑art and sustainable non‑animal approaches worldwide”, provided an excellent opportunity to take stock and renew our collective commitment to advancing the global transition to animal‑free testing and fully realising the humane vision of Convention ETS No. 123. Now entering its fifth decade – and soon to be reviewed by the Council of Europe Steering Committee on the Environment (along with all the other animal welfare conventions) – the European Convention for the Protection of Vertebrate Animals used for Experimental and Other Scientific Purposes continues to deliver on its promise to enhance the well-being of animals used in science.

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