Recent consultations on MTAs for use in public health emergencies heard that different stakeholders held incompatible views as to who owned samples and associated data, or whether ownership, rather than guardianship, was the most appropriate framing of this issue. It has been suggested that the MTA tool should not be too specific on issues of ownership – where necessary, the tool should reflect the divergence of opinion on this issue, bearing in mind different contexts, legal regimes and scenarios.
One approach that can help address these concerns is to address the acquisition of rights or title by the recipient over the samples and associated data transferred. This sidesteps the issue as to who owns the samples.
All rights to the Materials and Information shall exclusively be and remain vested in the supplier. The supplier hereby grants the Recipient the right to use such Materials and Information for the Purpose (it being explicitly understood and agreed that any other use shall be subject to the supplier`s advance agreement in writing). Recipient will not claim any rights in respect of such Materials and Information, other than as explicitly provided herein.
Some MTAs explicitly state that the recipient gains no rights over the samples.
The Recipient acknowledges and agrees that the ownership of Materials and Data Set(s) may be specifically regulated in the Supplier’s country; such regulations may differ from those applicable in the country of the Recipient. Without limitation to the provisions of the preceding sentence, the parties agree that the Recipient does not obtain any right, title, or interest in any of the Materials and Data Set(s) furnished by the Supplier.
In some cases, MTAs place obligations on the recipient to acknowledge the source of the materials they are using, especially when reporting or publishing findings based upon their use.
The RECIPIENT agrees to provide appropriate acknowledgement of the source of the MATERIAL as requested by the PROVIDER.
One potentially important differentiation is between the ownership of any background materials or technology (the things being transferred) and any results produced through their use. Some MTAs specify that background materials remain the property of the supplier.
Each Beneficiary shall remain the exclusive owner of its Background. Participation in the Action shall not affect such ownership rights in its Background, without prejudice to any rights and obligations under this Consortium Agreement and the Grant Agreement.
Failing to address the ownership of any results can cause confusion as to what can be done with them. Would a laboratory receiving samples and associated data primarily for diagnostic purposes be able to aggregate and anonymise the data generated and use it in part of a publication? Such papers have been traditional outputs from recipient laboratories following their involvement in addressing a public health emergency. They are seen by some as a quid pro quo for their involvement. Careful definition of ‘results’ and ‘purpose’ might be necessary to explicitly capture permission and in what way the contribution of those supplying the sample and associated data should be reflected. This may also be connected to a publication section in an MTA.
As a result, some MTAs explicitly state that any results produced are owned by those that generate them (i.e. the recipient).
Results are owned by the beneficiary that generates them.
It is also possible to divide ownership of the results generated - for example where materials being transferred are made available to multiple beneficiaries. This creates a more complicated requirement to specify the allocation of ownership (or to establish terms to decide it) and to consider the provision of access or rights over the results.
Some funders place restrictions on the ownership of results and other research output. For example, those pursuing public health objectives sometimes prohibit ownership of results.
The foundation’s approach has been to not take ownership in technologies created with its funds, although it’s possible that the foundation may take limited residual (march-in) rights if during the due diligence process it determines that such rights are necessary to ensure the achievement of the strategic objectives toward Global Access; provided, however, if such rights are sought, they will be expressly described in either the body of the grant agreement or the project’s underlying collaborative documentation.
There are also important considerations as to the ownership of any derivatives generated through the intended use. For example, some might argue that an isolated culture is sufficiently different from the original sample to have a different ownership.
1.The PROVIDER retains ownership of the MATERIAL, including any MATERIAL contained or incorporated in MODIFICATIONS.
2.The RECIPIENT retains ownership of: (a) MODIFICATIONS (except that, the PROVIDER retains ownership rights to the MATERIAL included therein), and (b) those substances created through the use of the MATERIAL or MODIFICATIONS, but which are not PROGENY, UNMODIFIED DERIVATIVES or MODIFICATIONS (i.e., do not contain the ORIGINAL MATERIAL, PROGENY, UNMODIFIED DERIVATIVES). If either 2 (a) or 2 (b) results from the collaborative efforts of the PROVIDER and the RECIPIENT, joint ownership may be negotiated.
Equally, the resources produced during the intended purpose may be intangible, for example, genetic sequence data. Who would own this data? There may not be simple answers to these questions and they are being explored outside of a public health emergency. For example, the relationship between physical samples and the corresponding genome sequence data is being considered by an Ad Hoc Technical Expert Group under the Convention for Biological Diversity and the Nagoya Protocol.
Past discussions have also highlighted that in order to ensure that the interests of individual providers of samples and associated data, and where relevant, donor communities, are given due weight in efforts to prepare relevant MTAs, it may be useful to consider:
How to avoid causing direct or indirect harm to such individuals or groups?
How to include these community interests in any agreement?
How to engage these communities, in particular on any agreed further use of the material?
How to obtain relevant consents?
What to do when consent cannot be sought? (e.g. death or unavailability of the donor or their representatives)
How to protect privacy & confidentiality?
How to foster participation of researchers from affected countries? (capacity building)
How to deal with incidental findings?
During the development of the tool, it was suggested that whilst there may be confusion over the ownership of materials, this could actually support stronger benefit sharing requirements in favor of affected populations – ensuring that those most affected by the disease directly benefit from the use of any samples and associated data.