The Commission is keen for all key players in this domain to work together strategically and coherently. This does not only speed up the process but ensures pooling of resources to achieve more, better and faster. All players have a specific role and proper exchange and dialogue between them is crucial for success.
Therefore, the Directive established the EU NETVAL and PARERE networks to bring more direct resources to the validation of alternative approaches as well as to ensure smooth transition from method development through validation into the regulatory uptake and use. In addition, EURL ECVAM hosts ESAC and ESTAF to ensure proper, independent, scientific scrutiny of the validation work as well as appropriate interaction with key stakeholders in the process.
Directive 2010/63/EU requires the Commission and Member States to contribute to the development and validation of alternative approaches. It further calls for Member States to identify and nominate suitable specialised and qualified laboratories to carry out such validation studies.
These requirements have led to the establishment of the European Union Network of Laboratories for the Validation of Alternative Methods, EU-NETVAL. The mission of EU-NETVAL, co-ordinated by EURL ECVAM, is to provide support for EURL ECVAM validation studies aimed at assessing the reliability and relevance of alternative methods that have a potential to replace, reduce, or refine the use of animals for scientific purposes.
Validation efforts should be invested in those methods that deliver “Three Rs” benefits and have the highest likelihood of being useful in the regulatory context. Equally, their regulatory acceptance process should be expedited. To facilitate this, Directive 2010/63/EU foresees the nomination of a single point of contact by each Member State to provide advice on the regulatory relevance and suitability of alternative approaches proposed for validation and to follow closely the progress.
Following an invitation from the Commission, Member States have nominated representatives that form the network of Member States. In order to swiftly draw the appropriate experience from all relevant areas of experimental animal use within the Member State, internal networks are being set up at national level.
In addition, relevant EU regulatory agencies have also been involved including nominations from EFSA, ECHA, EMA and the DG SANTE Scientific Committees. These together with the Member State network constitute the Preliminary Assessment of Regulatory Relevance network, known as PARERE, which is systematically consulted by EURL ECVAM on the proposed alternative approaches and strategies.
Not only will PARERE assess the regulatory relevance early on in the process but equally close involvement from the start will facilitate regulatory acceptance through improved information exchange and better understanding of the capabilities, limitations and functioning of these methods.
The primary role of the ESAC is to carry out high quality independent peer reviews on validation studies to assess the scientific validity of test methods i.e. the reliability and relevance, and specifying the capacity and limitations of the proposed methods. The outcome of the ESAC peer reviews are published as "ESAC Opinions".
ESAC Opinions serve as the basis for the development of detailed "ECAVM Recommendations" which summarise the advantages and disadvantages of a validated test method, its applicability, its limitations and its use for a given purpose for example as a component of a testing strategy to assess chemical safety under the REACH legislation.
Alternative approaches constitutes a research and policy arena where a variety of stakeholders are active including (1) academic researchers, (2) scientists in research in development in chemical, pharmaceutical and other companies developing/marketing products that may have adverse effects on human health and the environment, (3) industry associations advocating their sectorial interests and (4) civil society organisations such as animal welfare and patient organisations. To foster a structured dialogue with this rich stakeholder community, EURL ECVAM has in 2011 set up the EURL ECVAM Stakeholder Forum, ESTAF. ESTAF's roles are: