2. • Innovation is essential, but always
carries risk
• Framing risk rigorously makes
decisions more robust
• Context matters: science is not the
only lens
• Shaping regulation and decision-
making: it can be done!
2 Innovation: managing risk, not avoiding it
Innovation – managing the risks
3. • Increases in life expectancy
(and reductions in infant
mortality)
• Global gdp increases
3 Innovation: managing risk, not avoiding it
Innovation is essential to growth and
wellbeing
4. • Cars and trains
• Contraception
Combined oral contraceptive pill - first used in USA
in 1960. Currently used by over 100 million women
worldwide
Has been called “greatest scientific invention,” of
20th
century by some commentators
Impacts for women include: choice as to whether to
have children, further education and a career
Societies respond by a
mix of changing
behaviours, regulation
and legislation
4 Innovation: managing risk, not avoiding it
Innovation has always been contested
5. • Population growth (and
restructuring)
• Climate risks
• Socio-economic trends
5 Innovation: managing risk, not avoiding it
21st Century context is
different
6. • Big data
• Satellites
• Robotics and autonomous
systems
• Synthetic biology
• Regenerative medicine
• Agri-science
• Advanced materials
• Energy storage
• Quantum
• Internet of things
6 Innovation: managing risk, not avoiding it
Future growth, security and wellbeing
depends on effective exploitation of emerging
technologies
7. • Innovation is essential, but always
carries risk
• Framing risk rigorously makes
decisions more robust
• Context matters: science is not the
only lens
• Shaping regulation and decision-
making: it can be done!
7 Innovation: managing risk, not avoiding it
Framing risk
8. Review the evidence…….
…and acknowledge that all
evidence is
•Contingent
•Uncertain
Remember that the numbers
you choose are not neutral
8 Innovation: managing risk, not avoiding it
Apply the “science” of risk and
risk communication
9. We place trust for specific
purposes.
We expected the trustworthy
institution or individual to
Critical Trust is especially
important if cause and effect
are difficult for the layperson to
determine.
•Invisible, pervasive
•Long term
•Highly technical
• Take account of our interests
• Be competent
• Not be self-serving
9 Innovation: managing risk, not avoiding it
Placing trust
10. The system
• Systematic and cross-
Departmental
• Rapid response
• Independent verification
• Credibility
Recent emergencies
• Ebola
• Flooding
10 Innovation: managing risk, not avoiding it
UK has a systematic approach to
managing top national risks
11. • Innovation is essential, but always
carries risk
• Framing risk rigorously makes
decisions more robust
• Context matters: science is not the
only lens
• Shaping regulation and decision-
making: it can be done!
Context matters
11 Innovation: managing risk, not avoiding it
12. If you can’t stand the heat get out of
the kitchen
•Hazards: bleach
•Exposure: bleach in the stew
•Risk = hazard x exposure: poisoning
•Vulnerability: children have greater
sensitivity and greater likelihood of
exposure.
•Uncertainty = degree of confidence in
hazard, exposure and vulnerability
Terminology:
Risk is not the same as hazard
12 Innovation: managing risk, not avoiding it
13. Individual responses to risk are
shaped by:
•“Availability” draws on the
analytical and emotional
systems in the brain
•Often based on rules of thumb,
reinforced by personal
experience and personal
networks
•With a tendency to:
– Fear a loss more than a
foregone gain
– Overestimate frequency of
events that can easily be
recalled
We know a lot about how individuals
assess cost and benefit
13 Innovation: managing risk, not avoiding it
14. Anticipating types of innovation
14 Innovation: managing risk, not avoiding it
Five Broad Categories Examples Responses
1. Who pays? Some medical drugs NICE
2. My pain, your gain Nuclear waste Public engagement
Decisions at multiple levels
3. Science meets values Early GM, geo-
engineering
Strengthen science base.
Public engagement. Don’t
confuse science with values.
4. Unanticipated
consequences
Internet Monitor, debate, trial and learn
5. New challenges Some
nanotechnologies
Monitor, adapt, regulate
15. Science is not the only lens
Can view “fracking” in terms of:-
•Suite of technical risks e.g.
seismological or well engineering
(“hydraulic fracturing”)
• Impact on local amenity
(“not in my backyard”)
• Impact on global energy and
carbon policy
(“growth” and “greenhouses
gases”)
15 Innovation: managing risk, not avoiding it
Credit: greensefa/CC BY 2.0
Credit: Al Granberg
16. Cultural factors - precautionary by default?
Leading to large variations
in approaches to
innovation and risk and on
different issues in different
countries
National identity and values
•Stem cells
•Nuclear power
•GM
•Handguns
16 Innovation: managing risk, not avoiding it
17. GM crops: practical working guidelines
Be specific
•What gene?
•In what organism?
•For what purpose?
17 Innovation: managing risk, not avoiding it
Have a broad view
•Consider inaction as well as
action
•Look at multiple pathways
•Science is essential, but not
the only lens
18. • Innovation is essential, but always
carries risk
• Framing risk rigorously makes
decisions more robust
• Context matters: science is not the
only lens
• Shaping regulation and decision-
making: it can be done!
Shaping regulation
18 Innovation: managing risk, not avoiding it
19. Challenges
•Systemic pressures
– Economic regulators
(and price)
•Asymmetric incentives
– Neonicotinoids
(unintended
consequences)
•Lack of proportion
– Pig inspection (what
you can’t see for
looking)
Challenges for regulation
19 Innovation: managing risk, not avoiding it
20. More challenges and opportunities in the
future
20 Innovation: managing risk, not avoiding it
Challenges
•Future regulation will need to
become far more agile and
responsive.
•Technological change and the
guardianship and use of information
present key challenges
•The governance placed on
regulators themselves will need to
address asymmetric incentives to
action and encourage more
collaborative, transparent
approaches.
21. HFEA and mitochondria replacement
therapy
HFEA: Extended consultation
Multiple strategies
Outcome: Shift in public and expert
opinion
Advised Secretary of State: clear public
support for clinical use of mitochondria
replacement treatment.
It can be done!
21 Innovation: managing risk, not avoiding it
22. UK has strong institutions to
supply evidence and advise on
risk
•Government “science advisory
ecosystems”
•NICE
•What Works Centres
•National Academies
•Scientific Advisory Group in
Emergencies
•Academic centres of
excellence and leading
practitioners
Well informed debate requires
sustained capability
Strong institutions able to carry out
meta-analysis and look across
disciplines, working over months
and years
BUT the risk community is
small and fragmented.
Ad hoc studies as required
Trusted relationships, very rapid
responses
22 Innovation: managing risk, not avoiding it
23. Call to action
Key areas where we can build on existing
approaches:-
• Investment: Aligning national priorities for investment
on resilience, infrastructure and innovation with an
evidence and risk-based approach;
• UK coordination: Ensuring a more coherent and
structured approach to assessing impact of risk in
policy, regulation and crisis management;
• Regulators: Putting in place the right governance
structures and incentives in relation to our regulators
and regulated industries;
• Science-based EU: Rooting the approach to policy
and decision-making in EU in robust scientific
evidence.
23 Innovation: managing risk, not avoiding it
24. Every effort has been made to trace copyright holders and to obtain their permission for the use of copyright material. We
apologise for any errors or omissions in the included attributions and would be grateful if notified of any corrections that should be
incorporated in future versions of this slide set. We can be contacted through go-science@go-science.gsi.gov.uk .
@uksciencechief
www.gov.uk/go-science
Notes de l'éditeur
•Technological improvements will increase productivity by as much as 25% and will generate predicted $3.7 to $10.8 trillion for world economy by 2025.
•Since inception, Global Alliance for Vaccines and Immunisations and Global Fund have worked to prevent 5.5 million and 6.5 million deaths respectively.
•Chemical and pharmaceutical industries are UK’s biggest manufacturing export earner – they have a turnover of £60 billion and support 500,000 jobs.
•Over past 150 years, life expectancy in UK has steadily increased 2 to 3 years each decade – from about 40 years it has doubled to 80 years.
•20 years ago, fewer than 3 million people with internet access, now there are nearly 2.5 billion.
Innovation has always been contested
Societies respond by a mix of changing behaviours, regulation and legislation
•As digital access increases, estimated that four billion people will be online by 2020, using up to 50 trillion gigabytes of data
•African continent has twice as many mobile phones as United States.
•European Union aims to reduce carbon emissions by 80% by 2050 from 1990 levels.
•In 1950, there were 200 million people over age of 60. Today, that figure is nearly 800 million. By 2050, it is projected to stand at 2 billion.
•When Iceland’s Eyjafjallajökull volcano erupted in 2010 it caused several of the largest global airports to shut down, resulting in an estimated $5 billion in losses.
•In 2012, UK’s Climate Change Risk Assessment identified an increase in risk of flooding as greatest threat to the country from climate change.
•Winter of 2013-14 caused flooding in about 7,000 properties, but some 1.4 million properties were protected by flood defences, and there was no direct loss of life.
•In 2011, global insurance industry suffered the worst year of natural catastrophe losses on record – in excess of US $120 billion
Great Technologies listed are David Willetts’ “Eight Great Technologies” plus two additional technologies identified by Horizon Scanning Work (quantum and internet of things)
Technologies represented are:-
Quantum
Autonomous systems (experience of Docklands Light Railway)
Nanotechnology (part of advanced materials)
Regenerative medicine
Synthetic biology – “design and engineering of biologically-based parts…” [Royal Academy of Engineering: “Synthetic Biology: scope, applications and implications” (2009)]
Agri-science (GM crops)
In 2004, British Standards institution pioneered development of first international standards committee on nanotechnologies.
Between 2002 and 2007, UK invested over £150 million in research into development and impact of nanotechnologies
Doubling the risk” will be heard as more serious than “increasing a risk from one in a million to two in a million”.
Example given is that of fictional medical example used by Tversky and Kahneman, In their story, 600 people have a fatal disease and are offered two treatment options. One option is introduced either as one that “saves 200 lives”, or as one in which “400 people will die”. Option two uses a probabilistic presentation, offering either a one-third probability that 600 people will be saved and a two thirds probability that no-one will be; or a two thirds probability that 600 people will die and a one-third probability that no-one will. If the two options were presented in terms of how many lives they saved, 72% of readers preferred option one over option two. But if the options were introduced by stating the number of resulting fatalities, only 22% preferred option one. Crucially, the quantative element of each option was the same.
Case study refers to MMR, bowel disease, autism and measles – widespread media concerns in late 1990’s.
UK’s Strengths of performance on approach to national risk identification and management:-
Systematic and cross-Departmental
Rapid turnaround of response COBR (Cabinet Office Briefing Room) and SAGE (Scientific Advisory Group for Emergencies)
Independent verification
Credibility
Recent emergency responses –
Flooding – emergencies under both inland flooding and coastal flooding
Ebola – non-pandemic human disease
Images are from case studies on Fukishima 2011 nuclear catastrophe at nuclear powerplant in Japan. Issues around radiation exposure.
Bisphenol A (BPA) – banned from babies bottles under EU legislation and subject to ongoing safety review by European Food Safety Authority.
Bishphenol A – European Food Safety Authority (EFSA) found risks to be low. Some member states have announced new laws and controls on BPA. Acting in advance of or contrary to an EFSA opinion risk undermining the process of risk-based decision making. Adverse unintended consequences e.g. from problems with safety and effectiveness of replacements for BPA.
Images relate to:
Thames Barrier and behavioural responses to flooding.
Community networks and public resilience.
Images represent geo-engineering, internet and nano-technology
We need to be more aware of these differences, so that we can have healthier and clearer debates that make better policy at all levels. For example, there are two fundamental confusions that bedevil debate on several important regulatory topics, particularly within Europe. The first is the way in which the notions of hazard and risk are differently embedded in national modes of policymaking. This is why it is so important that we share a common understanding of the distinctions between hazard, risk, and vulnerability.
The second is a drift of interpretation of the precautionary principle from what was, in effect, a holding position pending further evidence, to what is now effectively a stop sign. To be meaningful, the precautionary principle requires a rational response to uncertainty (as distinct to risk).
Only three GM crops have been approved for commercial cultivation in Europe since 1990; in the United States, there have been 96 commercial GM approvals since 1990; Australia has approved 12 GM crops since 2002
Now takes approximately 10 years and up to £300 million to cover the regulatory costs for a new GM crop variety and up to £1 billion for a new drug.
GM crops – Issues arising from low level of EU approvals for commercial GM crops include role of EU in international debate, loss of crops that have shown better potential soil stabilisation, more efficient water use and reduced pesticide use.
Issues and case studies in annual report on potential downside consequences of banning/not permitting various technologies:-
Economic regulators – There are specific issues around encouraging innovation in the industries regulated by economic regulators where there is a specific emphasis on price.
Neonicotionoids – Unclear what farmers will do in response, and how this might impact pollinators – use fewer pesticides, switch to more harmful pesticides, grow fewer crops that benefit pollinators
Pig inspection regime at EU level – Controls were based on those of 100 years ago, a visual inspection to pick up parasites and defects visible to the naked eye. Did not pick up main causes of foodborne disease (which are microbiological - pathogens such as Salmonella and Campylobacter). Consultation on new regime March-May 2014 based on evidence from FSA and EFSA. New package better targets risks – removing controls that did not help but actually added to the risk (physical inspection) and tightening testing for pathogens.
Future attempts to regulate may be better focused on achieving desired outcomes, rather than how the outcome is achieved. Self-regulation, behavioural insights and social regulation e.g. online review sites (such as TripAdvisor) can achieve similar outcomes to consumer protection laws, without the need for enforcement.
We will need to adapt regulatory approaches to respond to innovation as technological advancements (e.g. self drive cars, robots), new business models (e.g. sharing economies) create new challenges on the use of information e.g. ensuring data is not distorted and does not overwhelm consumers/ regulators. Government/ regulators will need to address how it manages large quantity of data and how it can help to regulate the digital economy. There are also issues around safeguarding the digitally excluded.
KEY MESSAGE:
A sophisticated regulator, empowered to conduct public debate as part of its work, can deliver advice over a prolonged period while both science and technology continue to evolve to enable new interventions and treatments. Even where an area is complex, uncertain and highly contested.
HFEA (Human Fertilisation and Embryology Authority): UK’s independent regulator ran extended consultation 2011-2-14 – HFEA took no position
Multiple strategies (deliberative workshops, public representative survey, open consultation meetings, patient focus groups)
Outcome: Opinion moved from risk-averse anxiety to clearly-expressed view that benefits of mitochondrial replacement treatment outweighed possible risks and ethical misgivings.
HFEA advised Secretary of State: there was clear public support for the clinical use of mitochondria replacement treatment.
HFEA: UK’s independent regulator of treatment using eggs and sperm, and of treatment involving human embryos.
Mitochondria replacement therapy aims to eliminate faulty DNA from reproductive process; and so address mitochondrial disease for which there is no known cure and limited treatment options. Two techniques 1.) maternal spindle transfer; and 2.) Pronuclear transfer. Both procedures involve genetic material from three parties and genetic modification.