The OECD Guidelines are a unique tool for assessing the potential effects of chemicals on human health and the environment. Accepted internationally as standard methods for safety testing, the Guidelines are used by professionals in industry, academia and government involved in the testing and assessment of chemicals (industrial chemicals, pesticides, personal care products, etc.). These Guidelines are regularly updated with the assistance of thousands of national experts from OECD member countries. OECD Test Guidelines are covered by the Mutual Acceptance of Data, implying that data generated in the testing of chemicals in an OECD member country, or a partner country having adhered to the Decision, in accordance with OECD Test Guidelines and Principles of Good Laboratory Practice (GLP), be accepted in other OECD countries and partner counties having adhered to the Decision, for the purposes of assessment and other uses relating to the protection of human health and the environment.
Test Guidelines that have been deleted or replaced by updated versions
These obsolete Test Guidelines have been deleted in order to allow national/regional regulations that make reference to specific Test Guidelines and versions to be updated accordingly. They should not be used for new testing. They are included here because it may be useful to consult them in the framework of the assessment of substances based on old study reports. The guaranties of Mutual Acceptance of Data (MAD) would not apply if these Test Guidelines were used for new testing.
In November 2012, the Joint Meeting of the Chemicals Committee and Working Party on Chemicals, Pesticides and Biotechnology decided on a transition period of 18 months, between the Council Decision and the effective deletion, for Test Guidelines that have been updated or deleted. For more information, please read the presentation: Update of Test Guidelines and the Mutual Acceptance of Data.
Terminology in OECD Test Guidelines to designate what is tested
In June 2013, the Joint Meeting agreed that where possible, a more consistent use of the term “test chemical” describing what is being tested should now be applied in new and updated Test Guidelines. However, it is important to note that previously adopted OECD Test Guidelines will still use the terms "test item", "test compound", "test substance" or other similar term to describe what is being tested.”
The intention of this proposal is not to provide a new definition of the term “chemical(s)”, but rather to be consistent with the UN definition of it when applicable, i.e. in Test Guidelines that make reference to the UN GHS for Classification and Labelling where “chemical” means “substance and mixture”.
ISSUES RELATED TO INTELLECTUAL PROPERTY ELEMENTS IN OECD TEST GUIDELINES
Intellectual property rights (IPR) aim to stimulate innovation by enabling inventors to appropriate the returns on their investments. IP also plays an important role in the creation, dissemination and use of new knowledge for further innovation, as contained in the inventions disclosed in patent documents (source: http://www.oecd.org/sti/inno/intellectual-property-statistics-and-analysis.htm).
With the development of new technologies, new ways of testing chemicals have emerged and will increasingly develop. These new methods generally include IPR. To date, many Test Guidelines for in vitro methods already include proprietary elements. This has initially led to potential concerns regarding market monopoly for test methods contained in OECD Test Guidelines. In April 2012, the WNT discussed how to deal with the issue of monopoly when a single test method including proprietary elements is available for a hazard/endpoint. It was noted that this issue exists in all standardisation organisations, and that legal procedures exist in case of monopoly abuse. The development of performance standards was agreed as the solution to overcome this problem, and to enable the development of similar test methods (http://www.oecd.org/chemicalsafety/testing/performance-standards.htm).
It is desirable that the field of test method development benefit from continuous technical innovation. It is important that new methods containing protected innovation are easily accessible to users for generating chemical safety data for purposes of human health and environmental protection. Good licensing practices are thus strongly encouraged.
In February 2006, a Recommendation of the OECD Council on the Licensing of Genetic Inventions was adopted. It recommends that member countries promote good licensing practices and take due account of and implement the principles and best practices for the licensing of genetic inventions. The Guidelines for the Licensing of Genetic Inventions were subsequently adopted by member countries. The Guidelines set out principles and best practices for those in business, research and health systems who enter into license agreements for genetic inventions used for the purpose of human health care. These Guidelines are targeted at those involved in innovation and the provision of services in health, and particularly at those involved in the licensing of such inventions.
Although the Recommendation and Guidelines relate to genetic inventions used for the purpose of human health care, their principles can generally be promoted in other areas, particularly in the field of regulatory testing of chemicals for the protection of human health and the environment. Recommendations provided in sections B1 "Licensing generally", B3 "Research freedom" and B4 "Commercial development" of the Guidelines for the Licensing of Genetic Inventions are of particular interest and relevance.
Proposals for projects aiming at the development of new Test Guidelines should provide information on IPR aspects, as transparently as possible. In particular, the following information is expected from the proponent:
"Describe if the test method includes components, equipment or other scientific procedures that are covered (or pending) by Intellectual Property Rights (IPR) (e.g., patents, patent applications, industrial designs and trademarks) and/or intended to remain confidential. Information should be provided on the overall availability of the IPR-protected components including whether they are commercially available or require a Material Transfer Agreement (MTA) or other licensing agreements. In addition, the possibility of providing a generic description of the IPR-covered component/test system as well as any other element intended to remain confidential should be disclosed and whether Performance Standards have been developed for the test method."
OECD Test Guidelines should not contain elements that are confidential to the extent that this impedes adequate scientific validation of mechanistic relevance of the method.
Test method developers have to contact their National Coordinator to develop a project proposal for a new Test Guideline. Project proposals for new Test Guidelines need the active support of regulatory authorities in at least one member country, and have to meet regulatory need in member countries.
MATERIAL TRANSFER AGREEMENT (MTA): TEST GUIDELINES WITH COMPONENTS COVERED BY MTA
For most in vitro test methods in OECD Test Guidelines, a MTA is required with respect to the cell line or other proprietary components of the test method. A MTA is generally signed between a Provider and a Recipient/user. It is used to document the transfer of protected materials and may include a number of terms and conditions.
MTAs may be necessary to obtain components to conduct testing according to some Test Guidelines; however, they should not include terms or conditions that would prevent or limit availability of cell lines or other components of these Test Guidelines for purposes outlined below. It is essential that the MTAs:
Furthermore, MTAs should refer to the Test Guidelines concerned to avoid any doubts whether users of the OECD Test Guidelines can obtain the MTA-covered components.
Disclaimer: Any MTA is an agreement between the cell bank (provider) owning the biological materials concerned and the recipient of such materials. Therefore, the OECD shall have no responsibility.
This is an area of rapid development. The Working Group of the National Coordinators of the Test Guidelines Programme (WNT) is following closely the development of new test methods that contain IP elements, and is identifying solutions to issues as they arise. The OECD will keep communicating those solutions and recommend good practices to ensure OECD Guidelines for the testing of chemicals continue to benefit from innovation while remaining accessible to users in countries.