(Science|Business) Plan to phase out animal testing leans too heavily on existing funds

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The European Commission is moving ahead with plans to gradually replace animal testing in chemical safety assessments, but lobby groups are concerned that insufficient funding has been set aside to back up the strategy.

“The roadmap lacks dedicated funding streams, which is a significant gap,” said Kirk Leech, executive director of the European Animal Research Association, an advocacy group for the biomedical sector. “Developing, validating and achieving regulatory acceptance for new approach methodologies (NAMs) is expensive and time-consuming,” he told Science|Business.

This concern is shared across the aisle. “We agree that secure, consistent funding is critically important,” said Emma Grange, director of science and regulatory affairs at Cruelty Free International, which campaigns for an abolition of animal testing. “Unfortunately, we don’t expect to see a specifically ringfenced budget for delivery of the roadmap’s objectives. It’s likely that financial support will come through the diversion of other funding streams.”

The Commission’s roadmap, which was released on June 1, sets out 22 actions intended to help phase out animal use in tests to identify hazards, toxic properties and other health and environmental risks before products or substances are placed on the market. It covers 15 legislative domains ranging from pharmaceuticals to food and feed additives. 

The roadmap’s first pillar focuses on the “three Rs” principle of replacement, reduction and refinement of animal use. Replacement, for example, might mean using computational models to simulate how a drug moves through the body rather than animals, while refinement might involve using evident toxicity as an endpoint in animal studies rather than death, which implies greater suffering. 

The second pillar of the roadmap aims to leverage artificial intelligence to reduce animal use. The third pillar concerns collaboration, with a steering team to be set up to oversee the roadmap, along with collaborative structures linked to the European Chemicals Agency, the European Food Safety Authority and the European Medicines Agency. One of these, the Collaborative Platform on Alternatives to Animal Testing under the European Chemicals Agency, also launched on June 1.

The Commission will begin implementing the roadmap immediately, drawing on a range of existing resources. “Its actions, ranging from method development, validation and standardisation to organisational support and workshops, require different funding approaches,” a spokesperson told Science|Business.

Horizon Europe, for instance, will fund two calls focused on advancing NAMs in 2026, worth €49 million and €2.9 million respectively. There is also a European Research Area action on NAMs, and scope for using the pre-commercial procurement action under the European Innovation Ecosystems part of Horizon Europe.

Leech is critical of this approach. “These channels are already stretched and not specifically ready for this transition,” he said.

Julia Pochat, chemicals strategy political adviser at Eurogroup for Animals, is more optimistic, considering the “clear bridges” that the roadmap establishes with EU initiatives such as the European Innovation Act, the Apply AI and AI in Science strategies, the European Health Data Space Regulation and the Biotech Act. She expects these will “propose or update funding mechanisms to align with the objectives of the roadmap.”

Meanwhile, “the involvement of European research partnerships and projects and industry-driven initiatives [. . .] offers a pool of experts and resources that can support the implementation,” she added.

For others, this complexity is a source of worry. “We are concerned that initiatives running in parallel to the roadmap’s implementation will direct funds and attention to further embedding the use of animals for testing chemicals,” Grange said. “No amount of good coordination across the EU’s institutions and stakeholders can fully compensate for a lack of funding. The development of new test methods, and in particular their validation, requires significant investment.”

Change will take time

The roadmap is a response to a 2023 European citizens’ initiative demanding the phase-out of animal testing, which gathered more than 1.2 million signatures. Although three years have passed since then, Brussels has not been dragging its heels. 

“During that time, the Commission took the opportunity to make some early moves to push in the right direction,” Grange said, citing the adoption of a chemical safety data sharing platform under the One Substance, One Assessment initiative last November.

The Commission will take stock of progress in delivering the roadmap in 2029, but already expects some areas to take longer than others. For example, phasing out animals will be most difficult for long-term toxicity endpoints such as chronic toxicity for environmental organisms, reproductive and developmental toxicity, and carcinogenicity.

“Achieving replacement for these endpoints will require more fundamental changes to regulatory risk assessment, recognising that non-animal approaches generate different types of information,” the Commission spokesperson said.

Acceptance and approval of new methods for safety testing are a further bottleneck. “Regulatory harmonisation through OECD is essential but slow,” Leech said. “Moreover, a method can be technically valid yet not globally accepted, leading to duplicate testing rather than replacement.”