The Organisation for Economic Co-operation and Development (OECD) has published a best practice guide that details effective approaches by governments and industry for disclosing health, safety, and environmental data while protecting proprietary rights. The guide is not intended to be prescriptive and, instead, seeks to lay out the different ways governments and industry have addressed these issues.
The ‘Best Practice Guide for Access and Protection of Proprietary Rights to Non-clinical Health, Safety and Environmental Data and Information on Chemicals’ was developed to support implementation of the Recommendation of the Council Concerning Access and Protection of Proprietary Rights to Non-Clinical Health, Safety and Environmental Data and Information on Chemicals.
The guide notes that countries have different legal frameworks with respect to public disclosure, transparency, and protection of proprietary information and health, safety, and environmental data. It highlights that the increasing amount of data generated by industry and used by governments to assess the safety of new and existing chemicals has raised the following two concerns:
- How can governments review industry-sponsored data in an open and transparent manner to assure the public that regulatory decisions are based on sound science?
- How can making such data more available be done in a way that also protects confidential information and/or companies’ intellectual property rights (IPRs) and does not create disincentives to innovation?
Balancing the release of and access to information and protecting IPRs can be a difficult balancing act, the guide warns. Governments must consider all available data when conducting a regulatory risk assessment, including data that is not available to some national producers and importers. Sometimes governments find themselves caught between protecting the rights of data owners and protecting the public’s right to know about the decisions governments are taking on their behalf.
The guide highlights elements of best practice, with an overview of each issue, relevant provisions of the Council’s Recommendation, and examples of good practices by both governments and industry. It outlines how governments have addressed the issues in different ways, and provides guidance and support with respect to efforts to implement the Recommendation.
The best practice elements detailed in the guide are:
- Disclosing health, safety, and environmental data to the maximum extent possible, and taking measures to ensure disclosure does not breach proprietary rights or data exclusivity rules;
- Taking measures to ensure requirements concerning health, safety, and environmental data and information on chemicals protect proprietary rights;
- Governments using effective and efficient approaches that require a third-party user to obtain prior consent from the owner of data before the third party can reuse such data;
- Implementing effective mechanisms for the sharing of health, safety, and environmental data between the data owner and a prospective purchaser;
- Ensuring effective mechanisms for the sharing of health and safety test data between a government that possesses an industry study and another government, with prior consent by the data owner; and
- Promoting transparency and access to data by third parties, without infringing on proprietary rights.
The OECD Chemicals and Biotechnology Committee (CBC) declassified the document on 15 April 2022. [Publication: Best Practice Guide for Access and Protection of Proprietary Rights to Non-clinical Health, Safety and Environmental Data and Information on Chemicals]