Barriers to regulatory acceptance of 3R models, and ways forward

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Barriers to regulatory acceptance of 3R models, and ways forward

A paper published earlier this year in Regulatory Toxicology and Pharmacology examines the barriers that slow regulatory acceptance of 3R models (models that replace, reduce, or refine existing animal tests), and suggests ways to accelerate the process. (Disclosure: AltTox Management Team member Bas J. Blaauboer is one of the co-authors on this paper.)

Through an initiative organized by Netherlands Organisation for Applied Scientific Research (TNO), the Utrecht University School of Governance, the Netherlands Knowledge Centre on Alternatives, and the Dutch Ministry of Health, two expert panels – representing the pharmaceuticals sector and the chemicals sector – were assembled to address two questions:

  • “What are the main factors influencing the regulatory acceptance and use of 3R models for the safety/efficacy testing of pharmaceuticals and the safety testing of chemicals?”
  • “How can the involved stakeholder groups contribute to optimizing this process?”

Experts on each panel represented regulatory, policy, research and manufacturers’ perspectives. The panels identified obstacles such as the need to minimize risk, the lack of international (and cross-sectoral) harmonization of test requirements and regulations, and the need for more information on 3R models (especially re: predictability and in vitro-in vivo extrapolation). To facilitate acceptance of 3R models, the authors propose “the 4Cs”: commitment, communication, cooperation, and coordination among stakeholders. “These 4Cs are considered of key importance to align the developments at the macro-, meso-, and micro-level* and thereby enable this 3R model to become accepted for regulatory purposes” (p. 45). They go on to propose and prioritize specific actions that can be taken by each stakeholder group.

Article citation: Schiffelers, M.J., Blaauboer, B.J., Bakker, W.E., Beken, S., Hendriksen, C.F.M., Koeter, H.B.W.M., and Krul, C. (2014). Regulatory acceptance and use of 3R models for pharmaceuticals and chemicals: Expert opinions on the state of affairs and the way forward. Regulatory Toxicology and Pharmacology 69: 41-48.

*As the authors explain, the micro-level is “where 3R models are developed and validated;” meso-level refers to “the existing regulatory regime;” and macro-level refers to “the societal context” (e.g., the level of risk aversion, or concern for animal welfare) (p. 47).

Posted: November 20, 2014