This issue identifies agreement provisions that set out the rights and obligations of agreement parties to make project data and results publicly available. Global health agreements often contain requirements to make publications in accordance with open access principles, meaning that the information is made available online, at no cost, and with limited restrictions on reuse. Many major global health funders such as The Wellcome Trust and the Bill and Melinda Gates Foundation are part of cOAlition S, a group of research funders that are committed to making research funded by public or private grants immediately available through open access channels.

A requirement for open access publication can have a longer term impact on access to medicines as it contributes to research knowledge in the relevant field, and makes the information more easily accessible to researchers in low and middle income countries who may not be able to pay journal subscription fees. In addition, requirements to publish ‘negative’ research results (i.e. when the project is not successful) help to ensure efficient use of future funding by providing researchers and funders with information about approaches that have already been tried.

Questions to consider when developing provisions for publication of results

• What information are the parties required or permitted to publish?
• What is the required timeline for making data available?
• What are the acceptable publication channels?
• Is compliance with a specific open access policy required?

Example approaches found in the MAPGuide

• What information is the developer required to publish?
  • Some agreements in the MAPGuide have fairly general provisions permitting the publication of data and results related to the project. However, other agreements, particularly those with global health funders, contain obligations to publish specific types of data. Examples of these requirements are clinical data (including interim and/or negative results), non-clinical data and information related to animal models, correlate of protection, diagnostics data, and disease-specific assays.
  • In addition, some publication provisions set out specific acknowledgement requirements beyond crediting the researchers and authors of the paper. These may include recognizing the funder, or crediting the country in which clinical trials were performed.
  • As well as publication requirements, some development funding agreements require product developers to share project data in accordance with the WHO 2016 Guidance for Managing Ethical Issues in Infectious Disease Outbreaks and WHO 2016 Guidance on Good Participatory Practices in Trials of Interventions Against Emerging Pathogens.

• What is the required timeline for making data available?
  • Not all publication provisions in the MAPGuide include a required timeline. Those that do generally refer to ‘prompt’ or ‘timely’ publication, although a few agreements set out more detailed timelines.
  • A number of agreements in the MAPGuide allow for reasonable delays to prompt publication in order to allow parties sufficient time to seek protection for related intellectual property rights (e.g. making patent applications) before they publish their data.

• What are the acceptable publication channels?
  • Some MAPGuide agreements require all publications related to the project to be deposited into PubMed Central or made freely available after final publication. Alternatively agreement parties may be required to publish in open access journals.
  • Some agreements also include specific requirements related to clinical trials such posting the details on a publicly accessible register and/or making the trial data available to the relevant country’s ministry of health.

• Is compliance with a specific open access policy required?
  • Some publication provisions in the MAPGuide specify compliance with a specific open access policy such as that of the Wellcome Trust, the Bill and Melinda Gates Foundation, or the principles of Plan S.