the clinical trial has the potential to produce a direct benefit for the pregnant or breastfeeding woman concerned, or her embryo, foetus or child after birth, outweighing the risks and burdens involved; or

It is generally accepted that the Paediatric Regulation will lead to more clinical trials with children, but that its aims should be achieved without subjecting children to unnecessary clinical trials.

Translating clinical outcome into clinical practice: to create the knowledge bases for clinical decision-making and to address the translation of outcomes of clinical research into clinical practice, especially addressing patient safety and the better use of medicines (including some aspects of pharmacovigilance and scientifically tested complementary and alternative medicines) as well as the specificities of children, women and the elderly population.

In 2012, the project RARECARENET (Information Network on Rare Cancers)[46], which built upon some of previous activities of the Project RARECARE (Surveillance of Rare Cancers in Europe)[47] which provided estimations for incidence, survival, prevalence and mortality for all rare cancers. The project aims (i) to provide updated indicators of rare cancer burden, (ii) to collect and disseminate information on the health care pathways for rare cancers, (iii) to identify the criteria for centres of expertise for rare cancers, (iv) to produce and disseminate information on diagnosis and management of rare cancers, (v) to develop a clinical database on very ra ...[+++]re cancers, (vi) to provide new knowledge on these diseases and their clinical management, and (vii) to develop and disseminate information for patients including a list of patients’ associations dedicated to rare cancers. In 2013, the European Expert Paediatric Oncology Reference Network for Diagnostics and Treatment (ExPO-r-NeT), to support the provision of healthcare to children and young people with cancer in a Member State other than the Member State of affiliation, when the expertise with certain cancer conditions is rare and case volume low, contributing to provide cross-border best care to rare childhood cancer populations.

to make appropriate proposals as soon as possible in the form of incentives, regulatory measures or other supporting measures in respect of clinical research and development, taking account of the ethical aspects of clinical trials on children, to ensure that new medicinal products for children and medicinal products already on the market are fully adapted to the specific needs of that population group, and taking into account also the internationally acknowledged standards for the protection of minors with regard to medical scientific research".

The basic clinical services — preventive services, well baby clinics, basic community mental health services, those types of things, are all funded by the federal government in the communities.