Ingeborg Blancquaert, m.d., Ph.D. PHGEN II Final Conference Rome ...

Ingeborg Blancquaert, m.d., Ph.D.
PHGEN II Final Conference
Rome, April 19 th , 2012

Development of the Declaration of Rome
Complexity arising from:
• multiplicity of actors involved
• division of responsibilities into pillars and work packages
• analysis of all public health (PH) tasks subsumed under the
PH wheel
• need to extract the essence from three comprehensive pillar
reports in order to develop the Declaration of Rome
BUT:
‣ All relevant perspectives are taken into account for each
aspect of the genome-based information and technologies
(GBIT) translational process
‣ Opportunities for cross-fertilisation among PHGEN members
are maximized

Public health wheel and tasks
(Beskow, 2001)

Adapting the public health wheel for PHG
a posteriori
HIA and policy
evaluation
competencies
& communication
skills
influence
practice and
organisation
+ disseminate
guidelines,
regulations, …
+ HNA and
horizon scanning
+ guidelines,
regulations,
QA norms…
+ HTA and
a priori HIA
at micro,
meso and
macro levels
involve actors
/ organisations
in NTFs

Three pillar reports
• Provide a comprehensive overview of:
– background literature
– current situation and exemplary practices
– existing guidelines
– current and future challenges
• Constitute a reference document that:
– serves as a basis for a common understanding
• across Europe
• across stakeholder groups
– is essential for harmonisation and promotion of best
practices

Challenges ahead (# 1)
The need for further guidance has been identified
for each PH task, BUT:
Optimising the system management
within each jurisdiction is equally important to
ensure that the various tasks are accomplished
smoothly, efficiently and in a coherent way

Public health wheel: system management
(Beskow, 2001)

Challenges ahead (# 1)
National Task Forces are thus essential to maintain
good communication and collaboration between
actors / institutions involved in different PH tasks,
but:
‣ The mobilisation of additional institutional,
professional and regulatory bodies may be required
in some jurisdictions
‣ The commitment of governmental and health care
authorities is necessary
‣ An overarching international network is needed

Challenges ahead (# 2)
The P4 paradigm shift requires a « reconciliation »
between individual and collective/societal
perspectives,
BUT:
(e.g. need for convergence between PH and clinical
individualised and patient-centered care)
The methodological implications for Public
Health Genomics (PHG) and for each of the PH tasks
have yet to be thoroughly analysed

Challenges ahead (# 2)
• Individual perspective: patients and users’ needs,
values and preferences play a role in personal
decision-making regarding GBIT
o The sum of individual decisions influences GBIT uptake and
downstream health care (HC) services utilisation
• Societal perspective: in publicly-funded HC
systems, availability of GBIT depends on prioritysetting
and resource allocation
o PH assessment tools (HNA, HTA, and HIA) contribute to
these decision-making processes

Challenge #2: Anticipated implications for HTA
• « PHG will require a shift from CU to PU »
o Clinical utility (CU): benefits = improved health outcomes
o Personal utility (PU): benefits = value of risk information
• Currently, data on CU are frequently lacking and
questions remain as to the efficacy of behavioural
interventions following personalised risk assessment and
communication
• In such a context, the following questions need to be
addressed:
‣ To what extent does the shift from CU to PU lower the evidence
threshold for the evaluation of benefits and risks
‣ Will expected gains in terms of a more rapid technology transfer
materialize
‣ How will HC costs and system capacity be affected

Challenge # 2: Implications for other PH tasks
• Health needs assessment (HNA) :
o Does going personalised entail a shift from epidemiological evidence
of health burden and health care needs to evidence of perceived need
or demand for GBIT (amenable to market forces)
• Health impact assessment (HIA) :
o Will the sustainability of the publicly-funded health care systems be
evaluated for the field of GBIT as a whole or will economic analyses
focus on value for money and affordability from an individual
perspective and for specific GBIT applications

PHG Paradox
• Individual perspective perceived as more important in the a
priori evaluation of utility
• Yet, organisational and economic consequences justify a
more rigorous societal assessment (possibly a posteriori)
Therefore, if PHG is to promote an effective and
responsible translation of GBIT, it is important to:
‣pursue methodological developments and examine links
between the various PH tasks
‣invest in appropriate monitoring and data collection
regarding health and health system outcomes
‣develop a global vision in order to achieve a proper
balance between individual and societal perspectives
throughout the PH wheel

Conclusion
The Declaration of Rome and the three pillar reports
are extremely important resources, but further
collaborative efforts are required with respect to :
‣ Processes: need to optimise system management
‣ Methods: need to analyse the implications of the
P4 paradigm shift for all PH tasks and to monitor
the impact on the GBIT translational process and on
HC systems