Draft guiding principles on good practices for the availability / distribution of the protected elements in OECD test guidelines

Following the workshop organised at OECD in September 2017 (OECD, 2018), there is agreement that more guidance, transparency and communication are needed around protected elements resulting from innovation in sciences and techniques that are gradually integrated in OECD Test Guidelines (TGs). The aim of the present document is to serve as a guide for organisations (e.g. private companies, universities, etc.) having developed and claimed intellectual property on material and techniques that could be readily used to fulfil a regulatory need, if it was integrated in an OECD Test Guideline. By observing and following the guiding principles, test developers would join the Programme with increased awareness of expectations and requirements.

The document explains the process and documentation needed by the TG Program at various steps of TG development. The document includes the principles and conditions for accepting protected elements in TGs, and lays out the conditions to meet for the distribution and availability of the protected elements, and for the development of performance standards enabling the development of similar methods. These Guiding Principles were elaborated in 2018 by a group of experts in intellectual  property issues and in various sectors ranging from biotechnology applications to standards development, and experts in anti-trust. Experts were nominated by their National Coordinators and are practitioners generally representing national patent offices, lawyers in private companies, or IP experts in regulatory agencies.

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