THE COUNCIL ,
HAVING REGARD to Article 5 b) of the Convention on the Organisation for Economic Co-operation and Development of 14 December 1960;
HAVING REGARD to the Decision-Recommendation of the Council on the Systematic Investigation of Existing Chemicals [ OECD/LEGAL/0232 ] and the Decision-Recommendation of the Council on the Co-operative Investigation and Risk Reduction of Chemicals [ OECD/LEGAL/0441 ];
HAVING REGARD to the Dubai Declaration on International Chemicals Management and the Overarching Policy Strategy, adopted by the International Conference on Chemicals Management of 4 to 6 February 2006, as part of the Strategic Approach to International Chemicals Management (SAICM) and the Resolution of the Council on the Implementation of the Strategic Approach to International Chemicals Management (SAICM) [ C(2008)32 ];
HAVING REGARD to the 17 Sustainable Development Goals (SDGs) of the 2030 Agenda for Sustainable Development of September 2015 [ A/RES/70/1 ], in particular SDG 12 and Target 12.4, which refer to the sound management of chemicals and waste, SDG 3 on good health and well-being, and SDG 6 on clean water and sanitation;
HAVING REGARD to the World Trade Organisation Agreement on Trade-Related Aspects of Intellectual Property Rights, in particular Section 7 on the protection of undisclosed information;
CONSIDERING the importance of production and international trade in chemicals and the mutual economic and trade advantages which accrue from harmonisation of policies for chemicals control;
CONSIDERING the economic value of certain data and information on chemicals, and relevant legal requirements, to protect certain non-clinical health, safety and environmental data and information from unauthorised use or disclosure;
CONSIDERING the goal of reducing animal testing, including by avoiding duplicative testing, facilitating wider access to existing supporting data and by facilitating the development of non-animal based alternative technologies, through encouraging the exchange of proprietary health, safety and environmental test data and information;
CONSIDERING the importance of the availability of health, safety and environmental data and information regarding chemicals, so that the public can have access to such data and information, and can take informed decisions about their use of chemicals as well as have confidence in regulatory decisions regarding chemicals;
CONSIDERING that the Best Practice Guide for Data Access and the Protection of Proprietary Rights to Non-Clinical Health, Safety and Environmental Data and Information provides guidance for, examples of, and possible definitions relevant to, approaches taken by governments, academia and industry to promote access to health and environmental safety information on new and existing chemicals – including sharing data across governments and between companies;
CONSIDERING that the Members and non-Members having adhered to this Recommendation (hereafter the “Adherents”) have different legal frameworks concerning public disclosure, transparency and protection of proprietary information and data, and noting that proprietary rights may be time-limited;
On the proposal of the Chemicals and Biotechnology Committee:
I. AGREES that, for the purpose of this Recommendation, the word “chemicals” covers new and existing chemicals;
II. RECOMMENDS that Adherents facilitate transparency and maximum possible disclosure of health, safety and environmental data. To that effect, Adherents should:
i) respect applicable confidentiality protections and limitations;
ii) make clear to the public that:
a. this disclosure by the Adherent is not intended as an explicit or implicit permission or licence for the relevant data and information and their content to be used, reproduced, or otherwise exploited in breach of any proprietary right or data exclusivity rules or as an explicit or tacit statement as to whether and what proprietary rights do or do not apply to the data disclosed
b. the public authority making the disclosure shall not be responsible for its use by third parties.
III. RECOMMENDS that Adherents take measures to protect proprietary rights concerning required health, safety and environmental data and information on chemicals. To that effect, Adherents should:
i) require each data submitter to provide certification or other evidence of the right to use the data and information, and
ii) not accept non-clinical health, safety, and environmental data and information if:
a. it requires the generation and submission of such data or information to fulfil a particular data requirement, and
b. the submitter cannot provide certification or other evidence of the right of use.
IV. INVITES Adherents and the Secretary-General to disseminate this Recommendation.
V. INVITES non-Adherents to take account of and adhere to this Recommendation.
VI. INSTRUCTS the Chemicals and Biotechnology Committee, to:
a) Serve as a forum to exchange information on experiences and best practices with respect to the implementation of this Recommendation;
b) Update regularly the Best Practice Guide to support the implementation of this Recommendation;
c) Promote international awareness of this Recommendation, with a view to informing, advising and encouraging non-Adherents to participate in the OECD’s work in the field of chemicals; and
d) Monitor the implementation, dissemination, and continued relevance of this Recommendation and report to the Council no later than five years following its adoption and at least every ten years thereafter.