The OECD Test Guidelines Programme regularly receives proposals for new and innovative test methods for chemical safety testing. These methods may contain elements protected by intellectual property. Forms of protection may include patents for examples, but are sometimes just protected under the claim of Confidential Business Information. As the goal of the Test Guidelines Programme is to develop and standardise relevant and reliable methods, transparency is important from a regulatory perspective. Therefore the Test Guidelines Programme is developing a policy to deal with confidentiality claims so that it remains an attractive programme for innovative methods, while ensuring that developers identify other means to protect their assets.
In order to evaluate the potential impact, advantages and disadvantages of this policy on the test developer community (academic, business) and the views of regulators and the broader community, the OECD wishes to collect feedback on the following questions by 31 August 2020.
Ten years ago, OECD developed tools to maintain transparency in OECD Test Guidelines containing IP elements. As a result, the concept of Performance Based Test Guideline; the development of an OECD Material Transfer Agreement (MTA) template, the requirement to provide information related to the IP elements in a test method from the submission of a new project to the Test Guideline work plan have been implemented.
With the development of new technologies, new ways of testing chemicals have emerged and will increasingly develop given the trend to move away from animal testing. These new methods generally include IPR. To date, many Test Guidelines for in vitro methods already include proprietary elements.
To overcome the issue of monopoly when IP elements are contained in a reference test method, the OECD agreed that the solution was the development of performance standards to enable the development of similar test methods.
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.
In September 2017, the OECD held a workshop to present and discuss issues associated with the availability, distribution means and transparent access to protected elements in OECD Test Guidelines (TGs).This workshop report summarises the presentations and discussions held, and recommendations for further work in this area for the OECD Test Guidelines Programme.
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 such as Trademark and Patent.
There are different ways in which rights may be transferred.
An MTA is an agreement between the cell bank (provider) owning the biological materials concerned and the recipient of such materials. It is used to document the transfer of protected materials and may include a number of terms and conditions. For several 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.
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 testing.
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. Consult the Example test guideline material transfer agreement (MTA) template.
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.
In a license agreement, the licensor, typically the rights holder with respect to a protected invention, will grant to the licensee the right to use the protected invention according to the conditions outlined in the agreement and for a specified period in return for various considerations. Moreover, the license agreement and the scope of the licence may be worldwide or may be limited to certain jurisdictions (country or region).
Proposals for projects aiming at the development of new Test Guidelines should provide information on IPR aspects, as transparently as possible.
OECD Test Guidelines should not contain elements that are confidential to the extent that this impedes adequate scientific validation and independent review of thhod.
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.
OECD’s interest in standardising similar test methods is primarily to 1) assess methods with potentially better performance or practicability, and 2) avoid monopolies from single supplier in case of protected elements.
New proposals are made by member countries based on their regulatory needs and are included in the work plan once they have been approved.
The following criteria are considered for uptake of mechanistically and functionally similar methods in an OECD Test Guidelines:
Other aspects influence decisions on project proposals, such as: resources available and priorities in the Programme, dictated by the needs of OECD member countries, to develop new approaches and address emerging issues.