A number of relevant benefit sharing principles were identified during past consultations on MTAs, including:
Equity - What is fair and equitable in a public health emergency? What benefits can be expected in the shorter term? Or the longer term? Consideration of securing priority status to access to countermeasures developed from the sharing of samples and associated data may be important.
Reciprocity - Access to samples and associated data on the basis of the MTA and the sharing of benefits arising from its use should occur on an equal footing.
Public health interests - Access to benefits should be negotiated in good faith with the consideration of global public health priorities at the core.
Third party access to benefits - Consideration of whether to pass on benefit sharing obligations to third party recipients and successive transfer recipients should be considered and negotiated as appropriate.
Convention on Biological Diversity, the Nagoya Protocol and access and benefit-sharing measures – Many Member States now have legally binding obligations derived from these instruments. The MTA needs to be constructed so as to facilitate compliance with these obligations. Clarity as to the appropriate focal point for meeting these obligations during a public health emergency and any special provisions that might be in place (such as retroactive notification of transfers and negotiation of attendant benefit sharing) may be desirable.
Different types of benefit might be derived from the sharing of samples and associated data and there are different mechanisms that might facilitate the sharing of these benefits
Knowledge
Reasonable acknowledgement of the supplier of samples and associated data in publications derived from the use of the materials.
Training sessions and transfer of know-how during and post outbreak.
Results
Sharing with the supplier of samples and associated data any data, results and findings from research conducted.
Products or Medical Countermeasures
Preferential access of the supplier of the samples and associated data to any product or medical countermeasure derived from the use of the materials for public health purposes. Some have raised concerns over any state being provided preferential access.
Commercialisation
Management of all intellectual property derived from the use of the samples and associated data on terms which take into consideration global public health objectives.
Reagents and Services
Access on preferential terms for public health purposes for the supplier of samples and associated data to reagents or services derived from the use of the materials.
Development
Direct involvement in setting research agendas, or in the prioritization of research objectives.
Broader support for the supplier of samples and associated data to take advantage of developments in public health and strengthened capacity to build an effective economic sector.
When considering benefit sharing, it will be important to take into account the importance of data sharing during public health emergencies.
There may be practical challenges to addressing benefit sharing issues within the MTA itself, especially during the early stages of a public health emergency. For example, during the public consultation on this tool, it was suggested that “it will likely be government representatives who are signing agreements to transfer materials. Governments will likely be unable – and unwilling – to negotiate commercial terms that apply to future, potentially unknown, commercial actors. As a result, detailed benefit sharing terms may need to be negotiated at a later date when the specific partners, uses and expected benefits can be better defined.”
It was also suggested that “It is also potentially difficult to pre-negotiate benefits with commercial partners. Unlike the Pandemic Influenza Preparedness Framework regarding influenza viruses with pandemic potential, there is no overarching arrangement governing access to samples of other infectious diseases. There may not be researchers or manufacturers working with the relevant pathogen with which to negotiate, or any established marketplace for countermeasures that can be used to inform the value of any potential benefits. As a result, even if potential manufacturers are identified and engaged in the negotiations, they’re unlikely to have a good understanding of their chances of success in developing a countermeasure, their capacity to produce such a product, what the value of that product might be, etc..”
Discussions of issues around ‘access on preferential terms’ have occurred repeatedly in the context of MTAs. Some feel that any form of preferential access comes at a cost to others and possibly to the efficacy of the broader public health response. As a result they have called for a multilateral approach. Others have called into question the utility or feasibility of one overarching agreement.
There is also no universal understanding as to the meaning of key terms. Access, for example, is connected to affordability, research input, research outputs, and product development. Access might mean lower prices for countermeasures developed using a sample and associated data. It can also be connected with fewer intellectual property barriers to generate more innovation, and greater product possibilities. Access issues are therefore intertwined with the intellectual property issues.
Challenges in identifying in advance the most effective forms of benefit sharing have also been raised. For example, during the public consultation on the tool it was suggested that “in the early days of an outbreak, it may be premature to commit to providing a specific country with priority access to countermeasures when, depending on the dynamics of the outbreak, the most appropriate/effective global public health response strategy to an emerging disease may require deploying countermeasures elsewhere.”