Testing of chemicals

Intellectual Property elements in OECD Test Guidelines


Presentation - How does OECD currently address protected elements in OECD Test Guidelines

Issues related to Intellectual Property elements in OECD Test Guidelines

  • Intellectual property rights

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).

  • Good licensing practices

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 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. 

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 in the field of regulatory testing of chemicals for the protection of human health and the environment. Recommendations are provided in the Guidelines or the Licensing of Genetic Inventions sections B1 "Licensing generally", B3 "Research freedom" and B4 "Commercial development".

  • New Test Guidelines Proposals

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:

  • Allow the use of the MTA-covered components for testing in member countries for purposes of assessment and other uses relating to the protection of man and the environment.
  • Allow commercial entities to access the MTA-covered components for the purposes given above.

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.

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.

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.

Principles and criteria for integrating similar methods in Test Guidelines

The work plan of the OECD Test Guidelines Programme is annually fed by new proposals made by member countries for projects to revise or develop new Test Guidelines or other related documents. Proposals are made by countries on the basis of their regulatory needs for chemical safety testing.  OECD Test Guidelines should build on best available technique but should also be broadly available and applicable, and therefore when possible, avoid propriety elements within a test method that is available from a single supplier only.

Protected elements in OECD Test Guidelines mainly concern in vitro methods. As data generated from in vitro test methods become more widely accepted for regulatory use, OECD anticipates an increasing number of mechanistically and functionally similar test methods will be proposed for inclusion in the Test Guidelines Programme work plan. 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. There is no a priori limitation in the number of similar methods contained in a Test Guideline. However, validating and reviewing additional similar methods may require substantial resources of the Test Guidelines Programme and OECD expert groups. Therefore, when the regulatory need is already addressed by a number of broadly available in vitro methods, the inclusion of further similar methods in the OECD Test Guidelines Programme work plan may be deprioritised so that the limited resources available in Member Countries are invested in areas of higher priority, especially if no clear added value is identified in the new similar method.

The following criteria are considered for uptake of mechanistically and functionally similar methods in an OECD Test Guideline:

  • No intellectual property restriction/freely available
  • Broader geographical availaibility
  • Broader/complementary domain of applicability
  • Reduced cost or reduced time to perform the test and analyse data
  • Reduction in animal/animal product use (e.g. serum)
  • Inherent metabolic capacity or proven possibility of combination with a metabolic system
  • Improved mechanistic insight
  • Additional toxicity endpoint(s) (to those covered in the TG)
  • Reduction in hazardous reagents
  • Improved performance (reproducibility and/or predictive capacity)

These criteria are contained in the project proposal form and need to be addressed by the proposing country. As mentioned above, other aspects also influence decisions on project proposals, such as: resources available and priorities in the Programme, dictated by needs of OECD member countries, to develop new approaches and address emerging issues.

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