After the conclusion of the intended use, what is to happen to remaining samples and associated data, their derivatives or information generated? An MTA should be clear on the purpose and scope of use of the material shared and what happens to the material once the purpose and scope are realized. There should also be clarity over how unused material should be dealt with. For transfers governed by the Convention on Biological Diversity, any further use beyond the intended purpose and scope stated in the MTA may require prior informed consent of the supplying country.
Some MTAs include an expectation for further use - that the samples and associated data transferred, and the results produced, are used within a specific timeframe towards an intended public good (such as expanding our knowledge of the disease).
In open access models, the recipient is empowered to freely share the remaining materials and derivatives produced.
Other MTAs specifically limit to what other uses the samples or associated data might be put. Not addressing this issue in an MTA (depending on how the purpose of the transfer is captured) may lead to a lack of clarity on this issue. MTAs used in other settings often require the transferred materials and associated data to be destroyed or returned to the supplier after the intended use. This may not be desirable in the context of a public health emergency where the samples and associated data may be irreplaceable. Some MTAs specify that the recipient partner is to store the remaining materials pending a decision on further use, sometimes specifying details of what can or cannot be done during storage.
Past consultations on MTAs for use in public health emergencies heard of a need to find the right balance between conservation of samples and blocking any use of them. It has been suggested that the challenges of agreeing the optimal use of valuable samples and associated data, for example through a common research agenda, could potentially prevent important research from being undertaken.
Issues to be considered when drafting a section on further use include:
Is there an expectation that data or results generated will enable further relevant work? If so, under what conditions might a third party undertake such work?
How should the samples and associated data be preserved, for how long, and at whose cost?
Who gets to decide the future of samples and associated data?
Should a percentage of samples and associated data be specifically set aside for future use?
What should happen to residual samples and associated data (unused material), especially in terms of availability for third parties, permitted uses, or existing research agenda(s)?
In which context(s) and under which condition(s) is it acceptable to keep remains of samples and associated data for potential further use?
In which circumstances is it critical to keep remains of samples and associated data for potential transfer to a biobank or for further research for the public good?
How will any planned further use be vetted against rules and ethical oversight requirements in the supplier’s country?
What should happen with derivatives, such as virus isolates?
What happens if a relevant biobank(s) is created?
When, how and with what notification or agreements should remaining or unused samples and associated data be destroyed?
What role is there for community engagement or input from the individuals or communities from which the samples and associated data were drawn?
Answering these questions may not be necessary in the MTA itself, instead a placeholder may be inserted clarifying how they might be dealt with in the future. For example, simple clauses might be included that require the recipient to reach agreement with the supplier before any further use is pursued, or residual samples and associated data is transferred or destroyed. This could significantly simplify the MTA required for the initial transfer. It might minimise the administrative burden during a public health emergency.
A future use clause might limit use for the intended purposes, perhaps by determining the scope of access, but set out how a recipient might obtain permission for additional uses. This could include determining the details of the request, for example that it must be made in writing, it could determine to whom such requests must be addressed, or how to handle requests for future use by third parties.
Some MTAs also clarify that the supplier has the right to supply remaining materials, or similar samples and associated data to others. This helps clarify that the transfer does not form an exclusive arrangement.
It may also be possible here to differentiate between future uses - including those determined to be for research purposes, and those considered to be for commercial development or exploitation. This may have a notable impact on other sections of the MTA that deal with benefit sharing and intellectual property by allowing broad principles to be agreed in an initial MTA and more detailed discussions over the future value of the materials being determined at a later date, potentially after the public health emergency is concluded or specific future uses determined.
Differentiating between “commercial” and “research” uses of material may not be feasible in complex public-private product development systems such as those that commonly exist in the United States. For example, “research” conducted by a U.S. academic or government laboratory on a diagnostic product could later have “commercial” potential if licensed to a commercial actor to allow for mass production. In general, it should be determined whether “commercial” and “research” uses can be acceptably differentiated, and, if so, how the differences can be enforced in an MTA.