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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