GLOBAL DATA SHARINGBob Diderich, OECD

Helsinki Chemicals Forum, 26-27 May 2016

• 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

• 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

• Common electronic formats for data collection, exchange, publication.

Technical prerequisites

• 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

• 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

• Post-2020 SAICM?

Global venue