Solidarity, trust and the governance of data sharing during a public health emergency

By Ciara Staunton and Deborah Mascalzoni.

The timely access to and sharing of personal data during a public health emergency (PHE) is critical. It is essential for disease surveillance, to inform national and more localised responses, but it is also critical for research into new diagnostics, therapies and vaccines, as well as safety monitoring of these new interventions.

Early in the COVID-19 pandemic, there were calls by scientists to reduce barriers to data sharing, the making of patient level data publicly available was urged, and open science was seen as critical to ending COVID-19. A new “normal” has been set by introducing different standards for data sharing during pandemics.

Much of the data that is shared is identifiable data and is protected by the General Data Protection Regulation (GDPR) and data protection regulations in other jurisdictions. Sensitive personal data, such as health and genetic data (both key to research during COVID-19), receives a higher level of protection. However, the sharing of this data is permitted if its use is in the public interest as regulated under EU law or national law. So there is leeway for the sharing of our data for research during recognised public emergencies such as  the COVID-19 pandemic .

But just because it is legally permitted to share our data, should we do so?

In this global sharing of data, solidarity (understood in the biomedical context as a “commitment to carry costs…to assist others”) is often the principle invoked as the basis for explaining and justifying this exceptional data sharing: COVID-19 requires a collective response and we must share our data (the cost) for research on COVID-19 tests, treatments, and vaccines (to assist) for a collective benefit (others).

Heeding this call, we have shared our data as part of this collective, global COVID-19 response. This data sharing has brought many benefits: it has contributed to the rapid development of new COVID-19 related interventions, it has helped identify new variants, and we now have a number of vaccines. But it is here that the collective response has stopped, with national and commercial interests taking over.

It strikes us that this global call to solidarity has been exploited for national and commercial interests. Publicly funded research puts its results available in the open access space and those results inform and push forward private research as well. Pharma industries accessed freely a wealth of personal data and research results made available from academia in response to the call to solidarity in the public interest, but the distribution and access to vaccines in the middle of an official crisis seems to be driven by other interests entirely. Vaccines have been inequitably procured and some countries that were a site for vaccine trials and producing vaccines in its borders experienced considerable difficulty in accessing vaccines. Data on the distribution of vaccines shows that many countries will be left behind.

This collective data sharing does not reflect a collective return.

If we are sharing our data on the basis of solidarity and the public interest, then this framework should underline the entire research process during a PHE. Benefits must be globally felt, and during a PHE, at a minimum, benefits will be new diagnostics, therapies, and equitable access to vaccines. This does not require a re-conceptualisation of solidarity, but rather ensuring that solidarity is embedded in our policies and data cycle, from collection, sharing, freely accessing trial results of the research process, and crucially to the equitable distribution of its benefits. This is an approach mandated by the ACT-Accelerator.

Our experiences during COVID-19 is that solidarity is a meaningless concept if it is not grounded into societies that guarantee a proper solidarity governance framework. Thus data practices must be supported by transparent, accountable, and legally enforceable agreements that specifies what is expected of the recipient of the data. As it stands, the patent regime is challenging equitable access and equitable distribution of research results along with contractual clauses that respond to a commercial, but not a collective interest.

Governance can foster trust and embed solidarity into our response, but trust and solidarity without clear and transparent governance is an imbalanced request that can lead to inequity and exploitation. The current lack of legally binding commitment to the equitable sharing of data and the equitable distribution of any resulting diagnostics, therapies and vaccines  must change. Any access to data during a PHE must be contingent on the equitable access to research results. Otherwise, this makes the call for open science on the basis of solidarity an imbalanced and hypocritical request.

Authors: Ciara Staunton and Deborah Mascalzoni

Affiliations:

CS: Law, Middlesex University London

DM: Centre for Research Ethics & Bioethics, Uppsala University

Competing interests: None declared

Social media accounts of post authors:@ciaralstaunton and @Dmascalzoni

 

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