The recent publication of the
European Commission’s proposed Artificial Intelligence
Regulation (AIR) has been met with intense interest across the
globe, being the first ever legal framework intended to govern the
use and development of AI.

The regulation aims to go above and beyond existing frameworks
and position the EU as the leader in global AI development. It does
so with an eye to ‘high impact’ sectors identified as key
areas of future AI development, the economic opportunities
presented by the technology and the potential for AI to impinge on
individual rights enshrined in the EU’s Charter of Fundamental
Rights.

However, this determined attempt to raise the bar on existing AI
standards may seem like déjà vu to the life sciences
sector, as no industry is more familiar with hype around new
technologies, exaggerated claims and the difficulties of future
proofing than the field of life science regulation.

Indeed, AIR’s attempts to create a new tranche of notified
bodies, require permits on software for the first time ever and
prohibit the use of AI for a purpose other than that for which it
is permitted, presents new challenges to developers of software who
have not been subject to product regulation until now. It also adds
extra compliance obligations to developers of technologies which
are already regulated, such as medical devices and diagnostics
(IVDs).

For life sciences, the ethical and social issues that now
surround AI are hardly novel: they are part of the very fabric of
life science policy and of the regulation that emerges from public
and legislative debate. IVF, cloning, human embryonic stem cells,
hybrid and synthetic embryos, GMOs, human genome editing: truly,
the sector has seen it all, watching the fresh ink of new laws
being pelted by the rain of new science, new technologies and new
attitudes.

The interest in AI within the life sciences is considerable and,
whatever the hype, its transformative power is something to be
taken extremely seriously. It is for exactly this reason that those
who develop regulations for legislative approval have to keep their
feet firmly on the ground, just as they have done and must do with
advances from regenerative medicine to CRISPR Cas9.

Raising the bar raises the difficulty

Life sciences lawyers are almost spoiled for choice when it
comes to examples of previous efforts of aspirational regulatory
‘bar raising’ that have not quite gone as planned.

The sector has just seen the EU Medical Devices Regulation (MDR)
reach the end of its transition period on the 26^th May
2021, following four years of market turbulence after the
requirements to gain a CE-mark were raised. Like the AIR, the MDR
did “grandfather” existing lawful products, but required
re-certification of all products. Beyond this, the MDR also
required the re-qualification of all notified bodies, which
predictably created a very painful bottlenecks.

Perhaps more concerning for the sector is the In Vitro
Diagnostics Medical Device Regulation (IVDR), scheduled to come
into force in the EEA in May 2022. Building on the MDR, the IVDR
requires the vast majority of in vitro diagnostics to obtain a
CE-mark with the involvement of a notified body, whereas previously
manufacturers were able to self-certify. Notified bodies, only just
recovering from the MDR, are already faced with a mountain of
applications. Notably the European Federation of Pharmaceutical
Industries and Associations and the European Cancer Patient
Coalition recently called for a delay to the implementation of the
IVDR. The MDR/IVDR experience teaches us that regulations that look
good on paper can fail if there’s simply too much paper and not
enough infrastructure.

Regulation is warranted, necessary and vital for a healthy,
trustworthy life sciences sector, but turn the regulatory throttle
too far and it can quickly become counterproductive, a fact vividly
illustrated by the EU’s GMO Directives. Designed to protect
human health and the environment from the theoretical dangers of
organisms produced using recombinant DNA techniques, the GMO
directives ended up super-bureaucratising the use of
precision-edited organisms, whilst exempting the production of
random mutants by ionising radiation. Far from protecting the
environment or human health, the GMO Directives have spelled
disaster for European research and competitiveness at a time when
genetic editing technologies have a vital role to play in meeting
the global challenges of food security, climate change,
biodiversity, health, energy use and sustainability. The European
Commission is well aware of the problem. Tasked by the EU Council
to reassess the regime, it recently concluded that “there are
strong indications that the applicable legislation is not fit for
purpose for some [new genetic technologies] and their products, and
that it needs to be adapted to scientific and technological
progress”. Critically, many senior Green politicians agree.
Having posed EU failures in GM regulation to argue for legislative
independence, the UK government is now undertaking a similar review
to the Commission.

If the MDR/IVDR story acts as a warning of regulatory overload,
the GM story teaches that regulations really can be too cautious.
AI regulation MUST learn from this experience: protect that which
is at risk, but encourage technologies which offer benefits to the
environment, human health and economy. It is entirely feasible to
get the balance right and to draft legislation that brings a
win-win, while building in a review process to respond to future
developments. That, in essence, is what AIR is seeking to achieve.
But can it succeed?

Frameworks and aspirations

One method through which to get this balance right, raising the
bar to become a global leader in AI standards whilst advancing AI
development, is by relying on existing frameworks and templates to
serve as foundations for more aspirational regulation.

This has not been lost on the Commission, as AIR is almost
pedantically based on the template of “New Legislative
Framework” (NLF) regulations, under which conformity
assessment is undertaken by notified bodies that are accredited for
that purpose. The NLF is a tried-and-tested approach for many
product areas, including medical devices and IVDs. The approach has
provenance but, as we have suggested may be the case for the IVDR,
if the infrastructure is overloaded it can impeded development and
access to important technologies.

In the case of AIR, complexity is introduced not only through
the breadth and depth of the proposed regulatory remit, but from
the interplay between the ‘standards and conformity’
approach to certification that seeks to encourage new AI
development, and the principles-based aim of protecting individual
rights that is folded into it. The test of any AI regulation is
going to be balancing economic advantage against risks to human
rights in a pragmatic way. But can AIR succeed?

Responding to requests from both the European Parliament and
European Council, the Commission drafted the AIR to establish
‘an ecosystem of trust’ in which AI development is promoted
while upholding the rights of citizens under the EU Charter. In
introducing its proposal, the Commission lists 17 Charter
provisions that AIR would uphold. Indeed, the Commission was, in
the words of its AI White Paper of 2020, ‘closely involved’
in developing the OECD’s five AI Principles of the previous
year. In that same White Paper, it had approved the seven ‘key
requirements’ recommended by an independent ‘High Level
Expert Group on AI’ that it had set up for the purpose. In
principle, therefore, the AIR could have followed the example of
the GDPR by incorporating those principles. It didn’t, because
AI systems are products. Quite aside from human rights, a faulty AI
system can kill.

But if AIR is less explicit about its human rights underpinnings
than the GDPR, the Commission nonetheless appears confident that
the AIR will set an ‘international gold standard’ for AI
regulation, just as the GDPR did with data protection. Given that
forty-two countries have agreed to adopt the OECD principles, this
is a bold claim. Squaring the protection of rights with making the
EU ‘a global leader in the development of […] artificial
intelligence’ may be bolder one, and certainly more
questionable. Where rights are respected, the test will be whether
businesses can afford the regulatory burdens of development. The
GMO experience shows that the cost of over-regulation can deter
small innovative businesses leading to a market dominated by
corporate goliaths. By contrast, the AIR aims to help SMEs by
including provisions for ‘regulatory sandboxes’ to foster
the development of AI systems in a controlled environment for a
limited time. But is it enough? Will there even be enough expertise
to fill the job description of an AI notified body? Are we heading
for a regulatory bottleneck?

Time to sand off the rough edges

Just as AI algorithms need human oversight to function safely
and effectively, regulation needs continued input from industry to
be fit for purpose. Fast approaching horizons are par for the life
science course, and must be for AI too. The review process included
in the draft AIR is a welcome sign that the Commission has
recognised this notion, hopefully future-proofing the AIR against
the infamously exponential curve of technological development.

The potential of AI for gene editing, drug discovery, in vitro
diagnostics and beyond is staggering, and it is up to the life
sciences sector to work within the system of consultations and
iterative reviews to ensure that a regulation with such potential
becomes, and stays, fit for purpose. The current draft raised
eyebrows, the next should raise hopes.

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