The EU has maintained active programs of intramural research for nearly 50 years, predominantly through the intramural activities of the Commission's 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.
Research Policy
Although the use of animals used 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 Commission carries out ethical reviews of proposals that raise sensitive ethical issues, including use of non-human primates and genetically modified animals. Additionally, investigators are required to abide by 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."
Extramural Funding
Tens of billions of Euros in extramural research funding are awarded each year by DG-Research. The priorities and budget for EU-funded research are defined in multi-annual Framework Programs developed by the Commission and subject to amendment and ratification by the 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, for the first time in FP6, which ran from 2002 to 2006, provision has been made for partnership with organizations in non-EU countries. 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, multi-year 3Rs research projects. Examples include:
- ACuteTox – a 35-partner integrated project budgeted at €15.6 million (EC contribution €9 million) aimed at optimizing and prevalidating an in vitro testing 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 comprised of 26 academic, 10 industrial and 4 regulatory partners mandated to develop in silico simulation 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 vitro tests 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 vitro models 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 vitro cultured 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, which addresses the reduction of animal tests in the implementation of the REACH regulation through the application of "intelligent testing strategies."
- PredictOmics – a 14-partner integrated project budgeted at €3.4 million (EC contribution €2.3 million) aimed at developing short-term in vitro assays to evaluate long-term toxicity. A parallel EPAA initiative is also slated to begin in the coming year
- Rainbow Project – an EC-funded international, multi-sectoral workshop on integration between in vivo and in vitro data with computer-based modeling
- ReProTect – a 35-partner integrated project budgeted at €13.9 million (EC contribution €9.1 million) aimed at developing the concepts required to develop 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 vitro assessment 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 for predicting suitability, safety and efficacy of therapies (i.e., "to develop and validate biological markers, in vivo and in vitro methods and models, including simulation, pharmacogenomics, targeting and delivery approaches and alternatives to animal testing.")
- The Nano-sciences section 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.
|
