Material Transfer Agreement Lipi

A material transfer contract (MTA) is a contract that governs the transfer of research material between two organizations when the recipient intends to use it for his or her own research purposes. The MTA defines the rights of the supplier and the rights and obligations of the recipient with respect to materials and all offspring, derivatives or modifications. Biological materials such as reagents, cell lines, plasmids and vectors are the most frequently transferred materials, but MTAs can also be used for other types of materials such as chemical compounds, mouse models and even certain types of software. In the event of a public health emergency, it will be important to ensure that samples and associated data can be moved, accessed and used for many important purposes, including identifying and characterizing the officer responsible, diagnostic objectives, clinical decision-making, epidemiology and the development or validation of diagnostic tools. Given the emergency context, simple and transparent measures are desirable to protect the interests of all parties. This may include provisions to protect the supplier who sent the samples in good faith to a home. During the public consultation on this instrument, several informed people found that there was no comprehensive international public health framework that regulates access to samples and related data from non-flu diseases. There were widely differing views on the appropriateness or feasibility of developing such a framework. In its absence and given that a rapid response to a public health emergency may depend on the ability to move relevant samples and associated data from one location to another. The transfer of these samples and associated data should be as simple and transparent as possible, while protecting the interests of the owners of the samples and associated data. The instrument echoes the view of many involved in the development of the importance of continuing to work for the “broader public good”. In the context of public health, these objectives will include both short-term goals to prevent the spread of disease and reduce mortality and morbidity, as well as longer-term goals of preventing future outbreaks and building capacity to mitigate their effects.

Some of the comments made during the public consultation highlighted possible differences in understanding the importance of a broader public good and the challenges of doing so in the presence of commercial and personal interests. In the early days of an emergency, it will probably be government officials signing equipment transfer agreements. Governments are unlikely to be able – and do not want – to negotiate trade terms that apply to potentially unknown future commercial players. In addition, there are not necessarily existing researchers/producers working with the pathogen with which they are supposed to negotiate, nor an established marketplace for counter measures that can be used to provide information on the value of potential benefits. Therefore, even if potential manufacturers are identified and included in the negotiations, they are unlikely to have a good understanding of their chances of success in developing a counter-measure, their ability to manufacture such a product, what could be the value of that product, etc. The tool is intended to be used before a public health emergency to develop relevant human capacities – not to develop an MTA during such an epidemic. MTA negotiations are more likely to take time if the parties recognize the need to protect their own interests and manage risks. If this is not possible, either because a standard MTA is implemented without modification, or because a promotion agency or another party (z.B. a biorepository) uses a standard MTA, the transfer process is often accelerated.