The European Directive 2010/63 that protects animals required for scientific purposes was enforced in Member states in 2012. The Directive introduced the 3R principles of replacement, reduction and refinement of animal procedures into regulation. The scientific community has recognised the Directive as the world’s most progressive and stringent framework seeking to ensure high animal welfare standards while encouraging the development of alternative methods. As a result of this new legislation, there has been a growing interest in the development and implementation of alternative methods. One initiative pursuing this goal is the European Partnership for Alternative Approaches to Animal Testing (EPAA).
On December 1 of last year, EPAA celebrated its tenth anniversary with a conference in the European Parliament. EPAA, a Public-Private Initiative formed by EU Commissioners, industry representatives and Members of the European Parliament, was established in 2005 to push forward the principles of Replacement, Reduction and Refinement (3Rs) in animal research and their regulatory acceptance. EPAA brings together key players in the 3Rs dialogue allowing them to share information to progress alternative methods in regulatory safety testing in terms of acceptance, validation and incorporation into guidelines.
Partially funded by the European Parliament, EPAA brings together upstream and downstream stakeholders to foster knowledge sharing to implement the 3Rs. The downstream stakeholders are the industry representatives, as initial drivers of research and development of new methods. They are represented in EPAA by 36 companies from seven industry sectors: animal welfare, chemicals, cosmetics, fragrances, pharmaceuticals, soap and detergents, and fabrics.
EPAA upstream stakeholders are the regulators, responsible for validating and incorporating into guidelines new methods seeking to replace, reduce and refine the use of animals in scientific research. Five departments (Directorate General, DG) of the European Commission are represented in EPAA: DG Internal Market, Entrepreneurship, Industry and SMEs (GROW), DG Research and Innovation (RTD), DG Health and Food Safety (SANTE), DG Environment (EN) and DG Joint Research Centre (JRC).
In the past year alone, the EPAA initiative has published five peer-reviewed articles on state-of-the-art methodologies and has organised four workshops that allowed the exchange of knowledge. Over these ten years, the EPAA has facilitated cross sharing from different industries and raised awareness of stakeholders around the globe on projects where 3R advances can be made and further developed to implement in regulatory guidelines.
The Vaccine Consistency Approach (VCA) is an example of this type of initiative. The VCA has the potential to reduce 10-15 million animals per year by removing batch testing in the quality control of Rabies, DTaP (Diphtheria, Tetanus and acellular Pertussis) and Clostridia vaccines. The VCA states that the quality of subsequent batches of a previously characterised vaccine is guaranteed by strict application of a quality system and of a consistent production of batches identical to reference lots of known potency and safety. As a result of EPAA coordinated efforts to raise awareness, industry leaders agreed to support further research to develop the VCA so that it can potentially be fully implemented.
Other projects the EPAA has worked on since 2005 are:
Computational Chemistry for research into liver mitochondrial toxicity
Stem Cells-based alternatives for safety testing
Regulatory testing of medicines and chemicals for carcinogenicity assessment
Acute Systemic Toxicity Testing
Alternatives for skin sensitisation
Extended One-Generation Reproductive Toxicity Study: Assessment of a substance’s harmful effects in reproduction by using one breeding generation instead of two whenever possible
Global harmonisation of 3Rs in regulatory safety testing for biologicals products
The EPAA’s 10 year anniversary conference delivered a state-of-the-art summary of the joint initiatives that public and private research stakeholders are carrying out in order to develop alternative methods aiming to replace, reduce and refine animal procedures in research and to promote their regulatory acceptance. The action programme for the next five years will continue to work towards bridging the gap between development and acceptance by identifying existing barriers for acceptance of 3R methods, research gaps and priorities in the 3Rs and improving access to information and existing tools.