The Commission has this week published their response[1] to the European Citizen’s initiative on ‘Save Cruelty Free Cosmetics – Commit to a Europe Without Animal Testing[2]. This initiative goes beyond cosmetics, calling for the ‘Modernisation of science in the EU by calling on the Commission to commit to a legislative proposal plotting a roadmap to phase-out all animal testing in the EU before the end of the current legislative term’. Relevant to use in pharmaceutical development, the Commission’s response proposes to:

• kick off work on a roadmap towards replacing animal testing in chemical safety assessments, with multiple actions and a step-by-step path to replacing animal testing, involving all relevant stakeholders;
• initiate a series of actions to accelerate the reduction of animal testing in research, education and training, including exploratory workshops, and sustaining new training initiatives for early career scientists;
• continue to support research on alternatives to animal testing with EU funding.

EFPIA members, representing the innovative pharmaceutical industry, are committed to the science-based phase-in of methods to replace the use of animals for scientific purposes and the deletion of animal tests which are obsolete or redundant. EFPIA members aim to lead progress on this by engaging in a wide range of practical activities to help drive the development, uptake and promotion of non-animal technologies (NATs) and new approach methodologies (NAMs) so that these can be phased-in as soon as it is scientifically possible to do so.

Since the adoption of the EU legislation governing animal use, EFPIA and its member’s have been publishing reports giving an extensive overview of their actions on putting animal welfare principles and the 3Rs into action. The latest report is available here  6th report .[3]

It is important to note that while applying alternative methods may lead to significant reduction in animals used, however, most of these methods are not yet able to fully replicate the complexity and reactions of a living organism especially for systemic and chronic conditions. This is why the industry is cautious of the implementation of bans or the non-science-based phase-out of animal testing in the EU.

Kirsty Reid, Director of Science Policy states ‘The pharmaceutical industry remains committed to continue to invest in collaborative research initiatives and to work with regulators and other stakeholders to advance the science in this field and through policy development`

Regulatory opportunities

Pharmaceutical legislative review: The recent legislative proposals from the Commission to revise the pharmaceutical legislation[4], both in the Proposal for a Directive on the Union code relating to medicinal products for human use and the Proposal for a Regulation laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing a European Medicines Agency, provides opportunities to decrease animal testing, increase data sharing and demonstrate that the 3Rs concept has been applied with regard to any animal study conducted. The legislation also identifies the tasks of the European Medicines Agency, with increased obligations toward 3Rs, regulatory support and scientific advice for, and facilitate the development, validation and regulatory uptake of NAMs; and facilitating joint studies and data sharing to avoid duplication of tests using animals.

In particular, the proposal aims to strengthen the environmental risk assessment, Industry welcomes the proposal for the prioritisation and risk-based approach of legacy human medicinal products.  The prioritisation of testing of legacy active pharmaceutical ingredients (API) and development of intelligent testing methods (to decrease the use of animals) has been, and continues to be, a significant research priority for the pharmaceutical industry and the European Commission through the Innovative Medicines Initiative (IMI).

Industry estimates that there are a large number of legacy APIs (likely to be in region of 1,000 APIs) with incomplete data to adequately conclude on environmental risk. Therefore, the generation of such data needs to be prioritised to avoid unnecessary pressure on limited environmental testing capacity in laboratories as well as an increase in animal (in particular, vertebrate) testing. 

The IMI PREMIER[5] project (Prioritisation and Risk Evaluation of Medicines In the Environment) (and the previous iPiE project) is working towards delivering an optimized set of tools for testing and assessing the environment exposure without relying on animal testing. 

The European Medicines Agency - The EMA has recently re-established its 3RS working party[6] with the objective to monitor and supervise the different 3Rs activities required to achieve the strategic goals in line with the EMA Regulatory Science strategy 2025 and the 3-year workplan of the non clinical domain. Industry applauds the EMA on their ambitious workplan.

Research opportunities

IHI, the Innovative Health Initiative, provides a platform for organisations involved in health research and healthcare to form consortia and participate in cross-sector partnerships that bring together a range of stakeholders to tackle challenges in health research including animal testing. Today, the IHI has published a call for proposals on Accelerating the implementation of new approach methodologies and other innovative non-animal approaches for the development, testing and production of health technologies[7]

The pharmaceutical industry members of EFPIA

·       Are fully committed to the principles of 3Rs;

·       Continue to support the objectives of the Directive 2010/63/EU on the protection of animals used for scientific purposes which has enhanced animal welfare standards and mandated the application of replacement, reduction and refinement across the EU while ensuring Europe remains a world leader in biomedical research;

·       Will continue to strive to go beyond what is legally required and work to develop and validate systems leading to improved 3Rs, animal welfare and high-quality science and technologies in every day practice and ultimately improve the lives of the people and animals that stand to benefit from the research. Training of staff will remain an essential element of good science and good welfare;

·       Are committed to continue to invest in collaborative research initiatives and projects to improve animal welfare and 3Rs, and support start-ups with expertise in new approaches as we transition from the Innovative Medicines Initiative (IMI – the largest health public private partnership) to the new Innovative Health Partnership;

·       Will continue to work with regulators, the scientific community and civil society to improve implementation of the science and speed up regulatory acceptance of alternative methods in the EU and at a global level;

·       Will strive to lead by example by disseminating beyond own department and own establishment to drive improvements in welfare and general quality of science;

·       Will improve the systems in place working with academia, CROs, animal breeding and testing facilities to share good practices, new methodologies and lead by example by uptake of high 3Rs and animal welfare standards in the daily activities;

·       Will be transparent in telling what we do and how we do it, to explain and justify where live animals are required and used and also inform on the work and commitment of companies to reduce the sectors reliance on animals;

·       Will continue to identify, develop and implement their phase-in strategies and communicate on animal use through either dedicated webpages or CSR reports. Open communication and dialogue with the public are key to highlight our contribution to phasing-in replacement methods.

[1] https://single-market-economy.ec.europa.eu/system/files/2023-07/C_2023_5041_1_EN_ACT_part1_v6.pdf

[2] https://europa.eu/citizens-initiative/initiatives/details/2021/000006_en

[3] https://www.efpia.eu/media/637068/putting-animal-welfare-principles-and-3rs-into-action.pdf

[4] https://health.ec.europa.eu/medicinal-products/pharmaceutical-strategy-europe/reform-eu-pharmaceutical-legislation_en

[5] https://imi-premier.eu/

[6] https://www.ema.europa.eu/en/committees/working-parties-other-groups/chmp/3rs-working-party

[7] https://ec.europa.eu/info/funding-tenders/opportunities/portal/screen/opportunities/topic-details/horizon-ju-ihi-2023-05-01;