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Oncopolicy programme
Several regulatory initiatives are of direct
concern
to
paediatric
haematology-
oncology and the implementation of the
SIOPE Strategic Plan. SIOPE has developed
expertise and skills to monitor and influence
the development of relevant European
cancer health and research policy themes,
and to ensure that the needs of the paediatric
haematology-oncology community are taken
into account when regulations are drafted or
revised:
g
Each
National Cancer Plan
should address
the needs of children and adolescents
with cancer, according to the European
Cancer Plan.
g
The
Cross Border Healthcare Directive
(2011/24/EU) was established in 2010. This
is the framework for the development of
the future paediatric oncology European
Reference Network (via the ExPO-r-Net
project).
g
The
Clinical Trials Regulation
(536/2014/
EU) is expected to enter into force in 2016
and to facilitate academic trials, and SIOPE
will help European institutions and ECTGs
to implement their trials within the new
Regulation (through the CTF platform,
see above) and ensure that experiences,
issues and hurdles encountered in
paediatric haematology-oncology are fed
back to the relevant bodies.
g
The
Data Protection Regulation
(2012/0011(COD)) is under discussion at the
time of the publication. In its current form,
it would be detrimental to outcome
research in paediatric oncology – a
major objective of the SIOPE Strategic
Plan – as well as to the interdisciplinary
research collaborations involving different
institutions, in order to ensure the best
quality of care to the patient. SIOPE is
joining oncology stakeholders to ensure
that the needs of academic research and
epidemiology are taken into account.
g
The
Paediatric Medicine Regulation
(1901/2006/EC and 1902/2006/EC)
entered into force in 2007. The European
paediatric oncology community is engaged
in pushing for immediate changes to
its implementation, in order to better
address the unmet needs of children
and adolescents with cancer. Because
cooperation between all stakeholders
(patients, survivors, parents, academia,
industry, regulators) is crucial, the CDDF-
SIOPE-ITCC multi-stakeholder paediatric
platform (see above) was created to
propose the immediate changes and to
prepare for the revision of the Regulation,
which could occur in 2017.
Cross-tumour
programmes
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A EUROPEAN CANCER PLAN FOR CHILDREN AND ADOLESCENTS
Credit Joke Emmerechts Photographer for SIOPE, Belgium