The European Union (EU) has maintained active intramural research programs for nearly 50 years, predominantly through the intramural activities of the European Commission’s (EC) Joint Research Center. During the 1980s, with the single European market being created, the EU, through its Directorate General for Research (DG-Research) took on an active role in stimulating and coordinating research in its member countries, as well as in developing overarching policies to guide both its internally and externally funded research activities.
Although the use of animals in fundamental and applied research falls outside the current scope of Directive 86/609/EEC, DG-Research requires that all EU-funded scientific investigations adhere to high ethical standards. To this end, the EC carries out ethical reviews of proposals that raise sensitive ethical issues, including use of nonhuman primates and genetically modified animals. Additionally, investigators are required to obey relevant international conventions and declarations. In the case of animal experiments, the Amsterdam protocol on animal protection and welfare provides that “animal experiments must be replaced with alternatives wherever possible. The suffering of animals must be avoided or kept to a minimum. This applies in particular to animal experiments involving species which are closest to human beings.”
Each year, DG-Research awards tens of billions of euros in extramural research funding. The priorities and budget for EU-funded research are defined in multiannual Framework Programmes (FPs) developed by the EC and subject to amendment and ratification by the European Parliament and Council. Since the EU’s first framework program (FP1) was launched in 1984, the FPs have played a lead role in cooperative multidisciplinary research, continually evolving to reflect the ever-changing nature of scientific and technological research, as well as EU and international priorities.
A longstanding precondition for FP funding has been that projects must be transnational, i.e., only consortia of partners from different member and associated countries have been eligible to apply. However, FP6, which ran from 2002 to 2006, allowed for partnership with organizations in non-EU countries for the first time. This move toward increased international cooperation has enabled the commitment of more than €80 million in EU and corporate funding in support of more than a dozen targeted, multiyear 3Rs research projects. Examples include:
- ACuteTox: a 35-partner integrated project budgeted at €15.6 million (EC contribution €9 million) to optimize and prevalidate an in vitrotesting strategy for predicting acute toxicity in humans
- BBMO (Biosensors Based on Membrane Organization to Replace Animal Testing): a 17-partner integrated project budgeted at €744,000 to develop and validate alternative techniques in drug screening and environmental control
- BioSim: an EU Network of Excellence comprising 26 academic, 10 industrial, and 4 regulatory partners and mandated to develop in silicosimulation models of cellular, physiological, and pharmacological processes to provide a deeper understanding of biological processes
- CarcinoGenomics: an integrated project to develop a battery of mechanistic in vitrotests representative for various modes of carcinogenic action, in lungs, liver and kidney, as an alternative to the chronic rodent bioassays
- Liintop (Liver Intestine Optimization): an integrated project aimed at optimizing in vitromodels of the liver and intestines for pharmacokinetic and pharmacodynamic studies
- MemTrans: an integrated project budgeted at €3.2 million (EC contribution €1.9 million) to optimize and prevalidate in vitrocultured cell models to predict oral absorption and pharmacokinetics
- NHR DevTox: an 8-partner, EU-funded prospective analysis of mechanisms of nuclear receptors and their potential as tools for the assessment of developmental toxicity
- OSIRIS (Optimized Strategies for Risk Assessment of Industrial Chemicals through the Integration of Non-test and Test Information): an integrated project with an EC contribution of €10 million to apply “intelligent testing strategies” in order to reduce animal tests as part of implementing the REACH regulation
- PredictOmics: a 14-partner integrated project budgeted at €3.4 million (EC contribution €2.3 million) to develop short-term in vitroassays to evaluate long-term toxicity; a parallel European Partnership on Alternative Approaches to Animal Testing (EPAA) initiative is also slated to begin in 2008
- Rainbow Project: an EC-funded international, multisectoral workshop on integration of in vivo and in vitrodata with computer-based modeling
- ReProTect: a 35-partner integrated project budgeted at €13.9 million (EC contribution €9.1 million) to develop the concepts behind 3Rs testing strategies in the areas of reproductive and developmental toxicity
- Sens-it-iv: a 28-partner integrated project to develop novel testing strategies for in vitroassessment of allergens
- ToxDrop: an 8-partner integrated project budgeted at €2.9 million (EC contribution €1.6 million) to further develop nano-drop “cell on chips” as a novel high throughput approach to toxicity screening
- VitroCellOmics: a 9-partner integrated project budgeted at €3.7 million (EC contribution €2.9 million) to establish stable cell lines that reliably reflect human hepatic properties for use in preclinical safety studies of pharmaceuticals
The current FP7, which runs through 2013 with a budget of €53.2 billion (a 63% increase over FP6), offers many more opportunities for collaborative 3Rs research. For example:
- The Health section specifically highlights the need for tools and medical technologies to predict suitability, safety, and efficacy of therapies (i.e., “to develop and validate biological markers, in vivo and in vitromethods and models, including simulation, pharmacogenomics, targeting and delivery approaches and alternatives to animal testing.”)
- The Nano-sciencessection calls for the development of novel approaches for evaluating nanoparticles’ “impact on human safety, health and the environment; metrology, monitoring and sensing, nomenclature and standards.”
- The Environmental Technologies section encourages the development of “methods and tools for environmental risk and lifecycle assessment … including alternative testing strategies and in particular non-animal methods for industrial chemicals.”
As FP7 moves into its implementation phase, calls for proposals will be made available on the Community Research & Development Information Service (CORDIS) website.