HCF 2016: Bob Diderich
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Global data sharing aims to increase cooperation between countries on chemical safety information. The current system results in duplicative testing and inconsistent data formats and property protections between jurisdictions. The vision is for common electronic formats for collecting, exchanging, and publishing data, along with global consortia of data owners that agree all data can be used for any regulatory purpose anywhere. This would ensure information is only prepared and submitted once. Existing OECD instruments provide recommendations around proprietary data protection, exchanging confidential data, and lists of non-confidential data that could form the basis for expanded global cooperation.
![• Recommendation on the Protection of
Proprietary Rights to Data Submitted in
Notifications of New Chemicals
[C(83)96/Final]
• Recommendation on the Exchange of
Confidential Data on Chemicals
[C(83)97/Final
• Recommendation on the OECD List of Non-
Confidential Data on Chemicals
[C(83)98/Final
Existing OECD Instruments](https://image.slidesharecdn.com/bobdiderich-160527204811/85/HCF-2016-Bob-Diderich-7-320.jpg)
HCF 2016: Bob Diderich
- 1. GLOBAL DATA SHARING Bob Diderich, OECD Helsinki Chemicals Forum, 26-27 May 2016
- 2. • Increase of regulatory collection of safety information on chemicals – More countries – More regulatory programmes (GHS, chemicals, biocides, pesticides…) • Differences in – Formats – Protection of Intellectual Property – Public access The issue
- 3. • Nothing gets typed more than once. • Nothing gets prepared for submission more than once. • All Robust Study Summaries are made publically available. • Any published Robust Study Summary can be used for regulatory purposes anywhere in the world. The Vision
- 4. • Common electronic formats for data collection, exchange, publication. Technical prerequisites
- 6. • Global consortia of data owners. – Agreement between producers that all data can be used for any regulatory purposes. • Global harmonised protection of data ownership • Global harmonised approach to confidential/non-confidential data Policy prerequisites
- 7. • Recommendation on the Protection of Proprietary Rights to Data Submitted in Notifications of New Chemicals [C(83)96/Final] • Recommendation on the Exchange of Confidential Data on Chemicals [C(83)97/Final • Recommendation on the OECD List of Non- Confidential Data on Chemicals [C(83)98/Final Existing OECD Instruments
- 8. • Post-2020 SAICM? Global venue