For the past 10 years, teams of scientists have been working to catalogue the 37.2 trillion or so cells in the human body.
In total, there are more than 3,600 scientists across 100 countries collaborating on the Human Cell Atlas, which is one of the most ambitious projects in biology and has been described as the heir to the Human Genome Project to sequence the human genetic code.
Cells are the basic building blocks of living things. The atlas offers far greater understanding into how the body works—in health and in fighting disease. Knowledge of where specific cells are located, combined with in-depth information about the genes and any markers, is raising understanding with new insights into biology and disease.
Let's unpack the legal implications of this ambitious international project.
Investing in long-haul research
The project is being touted as a 'Wikipedia for the human body.' The Human Cell Atlas (HCA) is being bank-rolled by more than 9,000 international donors and funders. Thanks to the effort of the project teams, there is now data on around 62 million human cells, categorised by 18 biological networks—including maps of the nervous system, lungs, heart, gut and immune system.
Typically, research projects—including those involving large-scale public and private consortia—often have a limited lifespan, with 10-years often deemed generous. The HCA project has already made a strong start, but it is likely to be a long-haul with global funders expected to be patient and willing to double down on their commitment. But at some point, there may be an aspiration from some backers to establish routes to monetise their investments.
Open access versus proprietary ownership
It's clear balancing ownership of emerging findings with open access to all poses significant challenges. So far, the HCA continues to encourage contributors to share findings, data and methodology openly in the common spirit of advancing scientific discovery. But there is also recognition of the proprietary interests of researchers and institutions invested in developing resources and sharing findings.
Success hinges on striking a delicate balance safeguarding the IP rights of scientists and innovators, by ensuring findings can be published with some certainty they will benefit from the findings without the risk of them going viral, or widespread commercial exploitation.
In an effort to pre-emptively tackle potential legal challenges, policies like the Fort Lauderdale principles are in place. They can help safeguard contributors' IP interests while enabling open access to pre-competitive resources. But at the same time, clear guidelines need to be established to set out ownership, data-sharing protocols and precise IP rights, to ensure equitable collaboration, innovation, collaborative and open - without undermining the opportunity's global scope.
Complex challenges demand technical understanding and trusted advisers
It's clear commercial and regulatory demands are growing. While the science is often tricky, there are also relentless pressures to deliver to timelines and budgets. Navigating the Life Sciences sector is tricky—boundaries are being pushed and the future of healthcare is continually being re-shaped.
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